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Gallery of Chiropractic Ads and Other Promotional Materials

This gallery illustrates how chiropractors promoted themselves before the development of the Internet. I collected most of the newspaper ads from local papers, but some were mailed to me from other areas. Where many ads were placed by an individual chiropractor, I have grouped them into individual files. Before 1980, nearly all of the marketers …

This gallery illustrates how chiropractors promoted themselves before the development of the Internet. I collected most of the newspaper ads from local papers, but some were mailed to me from other areas. Where many ads were placed by an individual chiropractor, I have grouped them into individual files. Before 1980, nearly all of the marketers promoted subluxation-based philosophy and suggested that chiropractic’s scope was unlimited. After that time, these ideas persisted but gradually became less prominent.

A 13-city study published in a chiropractic journal found that of 5,456 chiropractors listed in the yellow pages during 1985 and 1986, 14.7% bought additional space in the regular listing section, 11.6% purchased large display advertisements, and 73.7% listed only their name and phone number. Of those who bought additional space, 10.8% advertised techniques, 11.6% mentioned symptoms, 14.7% mentioned injuries, 3% mentioned professional affiliations, and 4% offered free services. Since the late 1970s, I have collected more than 1,100 yellow-page display ads but have not done a statistical analysis.

In 1987, the American Chiropractic Association noted that advertising claims had been “getting worse and worse” and urged chiropractors to “stop the garbage yellow page ads” that contained coupons, offered free spinal x-rays, promised that there would no out-of pocket expense, or made exaggerated and unprofessional claims.

Inclusion in this gallery should not be interpreted as an assertion that all of the items were misleading. Most were, but some were not. My intention in posting them is simply to illustrate what I happened to collect. To place the items in perspective, please see the commentary articles listed below and other Chirobase pages that discuss the types of promotional claims that were used.

Early Promotional Materials
Pennsylvania Ads and Fliers from the Late 1960s and Early 1970s
Pamphlets
Booklets
Newspaper Ads and Mailers from the Mid-1970s through the Mid-1990s
Turn on health” bumper sticker from the 1980s
Yellow Page Ads
Other Promotional Materials
American Chiropractic Association Public Relations Materials
Internet Claims
Other Noteworthy Ads
Advertising Regulation


Dr. Joseph Mercola Ordered to Stop Illegal Claims

Joseph Mercola, D.O., who practiced for many years in Schaumburg, Illinois, now operates one of the Internet’s largest and most trafficked health information sites. Since 2012, Mercola has stated that his site has over 300,000 pages and is visited by “millions of people each day” and that his electronic newsletter has over one million subscribers …

Joseph Mercola, D.O., who practiced for many years in Schaumburg, Illinois, now operates one of the Internet’s largest and most trafficked health information sites. Since 2012, Mercola has stated that his site has over 300,000 pages and is visited by “millions of people each day” and that his electronic newsletter has over one million subscribers [1]. The site vigorously promotes and sells dietary supplements, many of which bear his name. It also publishes a steady stream of propaganda intended to persuade its visitors nit to trust mainstream healthcare viewpoints and consumer-protection agencies.

For many years, Dr. Mercola and other staff members saw patients at his clinic, which was called the Optimal Wellness Center. In 1999, Mercola announced that about one third of his new patients were autistic and that he had treated about 60 such children with secretin, a hormone he said “appeared to be a major breakthrough.” [2] After it was well settled that secretin is ineffective against autism [3], Mercola’s Web site still said it would work if a child complied with his recommended diet strategies [4].

In 2004, Medical Economics reported that Mercola’s practice employed 50 people and that he employed 15 people to run his newsletter, including three editors [5]. Much of his support has come from chiropractors who promote his newsletter from their Web sites. Two of his books hit the #2 sales rank on Amazon Books shortly after his newsletter plugged them for the first time. In 2017, a former employee told The Ringer that most of the articles on his website were ghost written and reviewed by him [6].

In 2006, an article in Business Week concluded that he was “one of a fast-growing number of alternative-health practitioners who seek to capitalize on concerns about the conventional health care system—in his case relying on slick promotion, clever use of information, and scare tactics.” The article described how his promotions included (a) promises of “free’ to sell stuff; (a) lots of “bonuses,” (c) reports of real news that link to marginally related products, and (d) exaggerated claims. [7]

In 2012, an article in Chicago Magazine reported that Mercola had stopped practicing medicine six years previously to focus on his Web site [8]. However, his decision may have been influenced by a 3-year battle with the Illinois Department of Financial and Professional Regulation [9]. I did not see any mention of this on his Web site, and the site invited patients to come to his clinic—which was renamed Dr. Mercola’s Natural Health Center—for offbeat practices that included detoxification, chiropractic, Dispensary, Emotional Freedom Technique (EFT), Functional Medicine Program, homeopathy, Neuro-Structural Integration Technique (NST), Nutritional Typing Test, thermography, Total Body Modification (TBM), and Active Isolated Stretching.

In September 2014, Mercola announced that he had closed the clinic “in order to devote his full time and attention to research, education and increasing public awareness.” [10]

Many of Mercola’s articles make unsubstantiated claims and clash with those of leading medical and public health organizations. For example, he opposes immunization [11] fluoridation. [12], mammography [13], and the routine administration of vitamin K shots to the newborn [14,15]; claims that amalgam fillings are toxic [16]; and makes many unsubstantiated recommendations for dietary supplements. He has advised against eating many foods that the scientific community regards as healthful, such as bananas, oranges, red potatoes, white potatoes, all milk products, and almost all grains [17]. He has also given silly advice, such as minimizing exposure to electromagnetic fields by avoiding electric razors, microwaving of foods, watches with batteries [18]. Mercola’s reach has been greatly boosted by repeated promotion on the “Dr. Oz Show.”

Mercola’s Profits

Mercola is very critical of drug company profits and proudly states:

Mercola.com does NOT accept any third-party advertising or sponsorship, and I am in no way tied into any pharmaceutical company or any other corporate “interest” whatsoever. So you get the real inside scoop on health issues, with practical advice that matters to you untainted by outside influence! [1]

He has also stated:

Mercola.com is not . . . a tool to get me a bigger house and car, or to run for Senate. I fund this site, and therefore, am not handcuffed to any advertisers, silent partners or corporate parents. . . .

Profit generated from the sale of the products I recommend goes right back into maintaining and building a better site. A site that, startling as it may be with all the greed-motivated hype out there in health care land, is truly for you [19].

I don’t doubt Mercola’s sincerity—and I know nothing about how he allocates his income. But the BlockShopper Chicago Web site stated that in 2006 he purchased a house in South Barrington, Illinois, for $2 million and that it had 5,563 square feet. It was sold in 2016 after he had relocated to  Florida. The Bing Maps aerial view indicates that the property is quite luxurious. His current Florida home, which he also uses as a business address, is much larger.

In 2011, Mercola announced the formation of Health Liberty, a nonprofit coalition whose goals include promoting organic foods and targeting fluoridation, vaccination, genetically modified foods, and the use of amalgam fillings [20]. In a video accompanying the announcement, Mercola stated that he planned to donate $1 million to catalyze the project. In addition to Mercola.com, the coalition members are:

  • National Vaccine Information Center (NVIC), which understates the benefits and exaggerates the risks of vaccination.
  • Fluoride Action Network (FAN), the leading promoter of misinformation about fluoridation. Its donations are funneled through the nonprofit American Environmental Health Studies Project.
  • Institute for Responsible Technology, which understates the benefits and exaggerates the risks of genetically modification of foods
  • Consumers for Dental Choice, which vigorously attacks amalgam use with misinformation, propaganda, lobbying, and lawsuits.
  • Organic Consumers Association, which irresponsibly promotes unpasteurized milk and spreads false alarms about food irradiation, agricultural biotechnology, and vaccines.

The money for the donations was funneled from Mercola.com Health Research LLC through Mercola’s nonprofit Natural Health Resources Foundation, which showed the following grants for the above groups on its tax returns:

 

2011

2012

2013

2014

2015 2016 2017

Total

Consumers for Dental Choice

103,152

75,000

100,000

175,000

175,000 220,000 240,000

1,088,152

National Vaccine Information Center

300,000

400,000

400,000

400,000

400,000 500,000 401,000

2,801,000

Organic Consumers Association

505,000

200,000

460,000

580,000

580,000 861,000 720,000

3,906,000

American Environmental Health Studies Project

10,000

10,000

25,000

20,000

20,000 30,000 15,000

130,000

 

The “health freedom” argument involves deception by misdirection. It focuses on individual freedom but does not consider how people who fail to protect their health put the rest of society at physical and/or financial risk. Failing to vaccinate, for example, decreases herd immunity so that contagious diseases spread more widely. In 2012, Mercola began calling his newsletter “Health Liberty Newsletter.”

In 2013, Williamette Week reported that Mercola had donated a total of $26,975 in cash and in-kind contributions that included polling and a YouTube video to support the efforts of the antifluoridation group that is opposing a fluoridation referendum in Portland, Oregon. The report also stated that “Mercola has questioned whether HIV causes AIDS, suggests that many cancers can be cured by baking soda, and warns parents not to vaccinate their children. He also says that animals are psychic.” [21]

The Washington Post has reported that by 2010, Mercola’s businesses were generating $3 million a month and that in 2017, he indicated that his net worth was over $100 million [22].

Mercola lives with Erin Elizabeth, whose health-related views and activities are similar to his and describes herself as “a long-term health nut, author, and public speaker.”

Better Business Bureau Reports

Mercola markets his supplements through Mercola Health Resources, LLC. In 2011, after a customer complained that she thought a product she purchased was overpriced, I began checking whether the Better Business Bureau had received any complaints. I found that the company was rated C- on a scale of A+ through F. On February 1, 2012, the BBB reported that during the previous 36 months, there were 26 complaints—which is not an unusually high number for a high-volume business—but the report contained the following comments:

A recent review of consumer complaints filed with the BBB of Chicago & Northern Illinois against your Mercola Health Resources, LLC delineates a pattern of consumer allegations. Consumers are alleging that Mercola Health Resources does not honor the 100% money-back guarantee listed on your website. Customers have reported that refunds have not been provided for returns that were specifically covered under this guarantee. Consumers have also reported that they have experienced delivery issues. While www.mercola.com states that orders ship within 10 business days, consumers say they have waited much longer for their products. Customers allege that the company’s service staff has been unable to provide explanations regarding this delay. Some consumers have also reported that Mercola provided them with shipment tracking numbers that were not valid with their respective carriers [23].

On November 26, 2013, I checked again and found that during the previous 36 months there had been 34 complaints, but Mercola Health Resources was rated A+. In September 2015, I checked and found that there had been 10 complaints but the rating remained A+. In January 2017, I checked again and found there had been 5 complaints and the rating was A-. In July 2020, I checked again and found that there had been no complaints and the rating was A+.

FDA Warnings

In 2005, the FDA ordered Mercola and his Optimal Wellness Center to stop making illegal claims for products sold through his Web site [24]. The claims to which the FDA objected involved three products:

  • Living Fuel Rx, claimed to offer an “exceptional countermeasure” against cancer, cardiovascular disease, diabetes, autoimmune diseases, etc.
  • Tropical Traditions Virgin Coconut Oil, claimed to reduce the risk of heart disease and has beneficial effects against Crohn’s disease, irritable bowel syndrome, and many infectious agents
  • Chlorella, claimed to fight cancer and normalize blood pressure.

In 2006, the FDA sent Mercola and his center a second warning that was based on product labels collected during an inspection at his facility and on claims made on the Optimum Wellness Center Web site [25]. This time the claims to which the FDA objected involve four products:

  • Vibrant Health Research Chlorella XP, claimed to “help to virtually eliminate your risk of developing cancer in the future.”
  • Fresh Shores Extra Virgin Coconut Oil, claimed to reduce the risk of heart disease, cancer, and degenerative diseases.
  • Momentum Health Products Vitamin K2, possibly useful in treating certain kinds of cancer and Alzheimer’s disease.
  • Momentum Health Products Cardio Essentials Nattokinase NSK-SD, claimed to be “a much safer and effective option than aspirin and other pharmaceutical agents to treating heart disease.”

The warning letters explained that the use of such claims in the marketing of these products violates the Federal Food Drug and Cosmetic Act, which bans unapproved claims for products that are intended for curing, mitigating, treating, or preventing of diseases. (Intended use can be established through product labels, catalogs, brochures, tapes, Web sites, or other circumstances surrounding the distribution of the product.)

In 2011, the FDA ordered Mercola to stop making claims for thermography that go beyond what the equipment he uses (Medtherm2000 infrared camera) was cleared for. The warning letter said that statements on Mercola’s site improperly imply that the Meditherm camera can be used alone to diagnose or screen for various diseases or conditions associated with the breast, they also represent that the sensitivity of the Meditherm Med2000 Telethermographic camera is greater than that of machines used in mammography. The statements to which the FDA objected included:

  • “Revolutionary and Safe Diagnostic Tool Detects Hidden Inflammation: Thermography”
  • “The Newest Safe Cancer Screening Tool”
  • “[b]ecause measuring inflammation through thermal imaging is a proactive, preventative method you can use for detecting disease, which significantly improves your chances for longevity and good health.”
  • Additionally, thermograms provide: “Reliable and accurate information for diagnosis, treatment, and prognosis. . .”
  • “Yes, it’s true. Thermograms provide you with early diagnosis and treatment assistance in such problems as cancer, inflammatory processes, neurological and vascular dysfunction, and musculoskeletal injury.”
  • Thermography can benefit patients by detecting conditions including: Arthritis: “[d]ifferentiate between osteoarthritis and more severe forms like rheumatoid.” Immune Dysfunction, Fibromyalgia and Chronic Fatigue, “Digestive Disorders: Irritable bowel syndrome, diverticulitis, and Crohn’s disease . . .” and “Other Conditions: including bursitis, herniated discs, ligament or muscle tear, lupus, nerve problems, whiplash, stroke screening, cancer and many, many others.” [26]

In 2011, the Chicago Tribune reported that Mercola had not complied with the FDA’s order and intended to “fight the FDA . . . if they decide to take it further.” [27] However, in 2012, the Illinois Department of Financial and Professional Regulation asked Mercola to attend an informal conference to discuss a complaint that he was “making deceptive claims promoting thermography as a standalone diagnostic tool for detecting cancer and other diseases and is attacking the use of mammograms.” Mercola’s Web site still promotes thermography and trashes mammography, but the site stopped offering thermography appointments later that year—and Mercola’s special report, “The Safe Breast Cancer Screening Test Your Doctor Isn’t Telling You About,” is no longer apparent.

FTC Action

In 2016, Mercola, Mercola.com, LLC and Mercola.com Health Resources, settled a Federal Trade Commission complaint by agreeing to stop selling tanning beds and to pay to $5,334,067 to cover the cost of refunds and administration of the refund program. The defendants were charged with falsely claiming that their indoor tanning devices would enable consumers to slash their risk of cancer and improve the clarity, tone and texture of their skin, giving them a more youthful appearance. Commenting on the case, Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, noted that indoor tanning is not safe because it increases the risk of skin cancer, including melanoma [28].

COVID-19 Response

Mercola has reacted to the COVID-19 pandemic by claiming that many of his products can boost immunity and by attacking the preventive advice given by public health agencies throughout the world. He has claimed, for example, that masks cause “oxygen deprivation” and that the mainstream recommendation for mask-wearing “has nothing to do with decreasing the spread of the virus, but more to indoctrinate you into submission.” [29] He is also encouraging “civil disobedience” in areas where mask-wearing is mandated [30].

In August 2020, the Center for Science in the Public Interest and other nonprofit legal groups urged the FDA and FTC to stop Mercola from marketing at least 23 products with false claims that they can prevent or treat the disease. The letters state:

Mercola Group has been capitalizing on the coronavirus pandemic by advising consumers to purchase vitamins, supplements, and other products sold on its website to prevent or treat the virus. Mercola Group’s website contains many misleading articles, such as “Nutrition and Natural Strategies Offer Hope Against COVID-19,” and a “Coronavirus Resource Guide” compiling various unsubstantiated claims about the COVID-fighting properties of various supplements. It also offers “medical” advice, including the extraordinarily dangerous and unsubstantiated recommendation that individuals actually try to contract COVID-19 after using the supplements it sells to ameliorate the symptoms.

Mercola Group and Dr. Mercola make multiple deceptive and unsubstantiated claims in marketing supplements and other products. The products that Mercola Group sells through its online store, and that Dr. Mercola has endorsed in public statements (described below) for the prevention and/or treatment of COVID-19, include: vitamin C (specifically, liposomal vitamin C); vitamin D; zinc and selenium (which Mercola Group sells together); melatonin; licorice; molecular hydrogen; astaxanthin; n-acetyl cysteine; prebiotics, probiotics, and sporebiotics; saunas; ozone therapy; elderberry extract; spirulina; beta-glucan; lipoic acid; and sulforaphane [31,32].

The letters were accompanied by a chart that detailed the challenged claims [33].

For Additional Information
References
  1. Mercola JM. Health website rankings: Mercola.com is now world’s most visited natural health site. Mercola.com, accessed Feb 1, 2012.
  2. Mercola JM. Milk linked to autism, schizophrenia. Optimal Wellness Center Web site, March 21, 1999.
  3. Williams K and others. Intravenous secretin for autism spectrum disorders (ASD). The Cochrane Collaboration, 2012
  4. Mercola JM. Single injection of secretin does not treat autism. Originally published in 1999 or 2000..
  5. Joseph Mercola: The physician as entrepreneur. Medical Economics, August 20, 2004, p 37.
  6. Gumpert DE. Old-time sales tricks on the Net. Bloomberg Business, May 22, 2006.
  7. Knibbs K. The most honest man in medicine?The Ringer, Jan 5, 2017.
  8. Smith B. Dr. Mercola: Visionary or quack? Chicago Magazine, Feb 12, 2012.
  9. Barrett S. Dr. Joseph Mercola’s battle with his state licensing board. Casewatch, Sept 1, 2015.
  10. Dr. Mercola’s Natural Health Center home page, accessed Sept 2, 2014.
  11. Buttram H. Vaccine safety and benefits not scientifically proven. Optimal Wellness Center Web site, Jan 15, 2003.
  12. Mercola JM. Is fluoride as safe as you are told. Optimal Wellness Center Web site, Feb 2, 6, and 9, 2002.
  13. Mercola JM. Mammograms don’t save lives. Mercola.com Web site, Oct 1, 2000.
  14. Mercola JM. The dark side of the routine newborn vitamin K shot. Mercola.com, March 27, 2010.
  15. Jones C. Separating fact from fiction in the not-so-normal newborn nursery: Vitamin K shots….. Science-Based Medicine, Dec 6, 2013.
  16. Mercola JM. The experts get it wrong about mercury again! Optimal Wellness Center Web site, Dec 9, 2004.
  17. Mercola JM. Reaching for optimal wellness. Mercola.com, accessed, Aug 31, 2000.
  18. Mercola JM. Reaching for optimal wellness outline. Mercola.com, accessed  Aug 17, 2000.
  19. Mercola JM. Why trust me? Mercola.com Web site, March 19, 2011.
  20. Mercola JM. New plan to help you take back your health freedoms. Mercola.com, Oct 3, 2011.
  21. Mesh A. Dr. Joseph Mercola gives $15,000 to anti-flouride campaign. Williamette Week, May 6, 2013.
  22. Satija N, Sun LH. A major funder of the anti-vaccine movement has made millions selling natural health products. Washington Post, Dec 20, 2019.
  23. BBB reliability report for Mercola Health Resources LLC. Better Business Bureau, Feb 1, 2012.
  24. Walker SJ. Warning letter to Joseph Mercola, D.O., Feb 16, 2005.
  25. MacIntire SJ. Warning letter to Joseph Mercola, D.O., September 21, 2006.
  26. Silverman S. Warning letter to Dr. Joseph Mercola, March 22, 2011.
  27. Tsouderos T. FDA warns doctor: Stop touting camera as disease screening tool. Chicago Tribune, April 26, 2011.
  28. Marketers of indoor tanning systems to pay refunds to consumers: Defendants ran ads claiming that Indoor tanning is safe, Doesn’t increase the risk of skin cancer. FTC news release, April 14, 2016]
  29. Masks—the most controversial COVID-19 debate (video). Mercola.com, July 29, 2020.
  30. Masks do not likely inhibit viral spread (video). Mercola.com, July 19, 2020.
  31. Briskin C and others. Request for FDA enforcement regarding unlawful COVID-19 disease claims by Mercola Group, July 21, 2020.
  32. Briskin C and others. Request for FTC enforcement regarding false COVID-19 disease claims by Mercola Group, July 21, 2020.
  33. CSPI and others. Illegal claims pertaining to Mercola Group products. July 2, 2020.


Pamphlets from Chiropractic Communications of America (1986)

Chiropractic Communications of, America Inc., located in Baldwin, Michigan, was incorporated as a for-profit corporation in 1986. Its president was Robert Natzel. Its products included pamphlets and a tabloid newspaper called The Chiropractic Way that could be used to attract patients. The overall message was subluxation-based. The pamphlets included: The Philosophy of Chiropractic Drugs and …

Chiropractic Communications of, America Inc., located in Baldwin, Michigan, was incorporated as a for-profit corporation in 1986. Its president was Robert Natzel. Its products included pamphlets and a tabloid newspaper called The Chiropractic Way that could be used to attract patients. The overall message was subluxation-based. The pamphlets included:

  • The Philosophy of Chiropractic
  • Drugs and Surgery Should Be Your Last Resort
  • Scoliosis: Some Straight Talk
  • The “Slipped Disc” Syndrome
  • Chiropractic Treatment of Sports Related Injuries

Click here to access the full text of these pamphlets.



Pamphlets from the American Chiropractic Association (1970s)

The American Chiropractic Association, which was formed in 1963, is the largest professional organization for chiropractors in the United States. The pamphlets listed here are undated but were published between 1963 and 1980. Chiropractic Contributions Enrich Modern Science Your Kidneys and Your Health Chiropractic Corrects Poliomyelitis How to Conquer Nerve Tension Digestive Defects Are Correctable …

The American Chiropractic Association, which was formed in 1963, is the largest professional organization for chiropractors in the United States. The pamphlets listed here are undated but were published between 1963 and 1980.

  • Chiropractic Contributions Enrich Modern Science
  • Your Kidneys and Your Health
  • Chiropractic Corrects Poliomyelitis
  • How to Conquer Nerve Tension
  • Digestive Defects Are Correctable
  • Save Those Tonsils for Better Health!
  • So You Have An Allergy?
  • Chiropractic for Gastric Ulcers
  • Chiropractic Corrects” Tractor Back” and Other Farm Injuries
  • How to Attain Normal Blood Pressure
  • You Can Control Obesity . . . An Abnormal Condition—with Proper Diet and Essential Normal Nerve Function
  • Constipation Can Cripple You
  • Lumbago

Chiropractic Contributions Enrich Modern Science alleges that chiropractic has made five outstanding contributions to modern science, one of which is that “subluxations occur frequently.”

Your Kidneys and Your Healtasserts that, “Whatever the particular form of kidney disorder which may affect one, your chiropractor has been especially educated and trained to detect its nature and its cause, and to correct that cause, permitting nature to restore normal function.”

Chiropractic Corrects Poliomyelitis states: ” To prevent polio . . . . Periodic chiropractic spinal examination is important for all ages, but especially for children” and “Adjustment of spinal distortion to reduce nerve pressure and irritation and promote nerve reactivation is pre-eminent in the distinctive chiropractic corrective procedure for polio.” The fact that polio vaccination was avail]able was not mentioned.

All but one of the pamphlets includes the message, “If you do not enjoy good health, consult your chiropractor first.”

Click here to read the full text of the eight pamphlets.



A Skeptical Look at Kelly Victory, M.D.

In a recent YouTube video, Kelly Victory, M.D. asserted that (a) COVID-19 is less serious than generally believed, (b) social distancing is not necessary, (c) wearing a mask does more harm than good, and (d) Americans should feel “secure and confident to fully return to your lives, your businesses, schools, and places of worship without …

In a recent YouTube video, Kelly Victory, M.D. asserted that (a) COVID-19 is less serious than generally believed, (b) social distancing is not necessary, (c) wearing a mask does more harm than good, and (d) Americans should feel “secure and confident to fully return to your lives, your businesses, schools, and places of worship without fear and without limitations.” [1] The video had more than 700,000 views before YouTube removed it for violating its community guidelines. This article tells why I believe her advice is dangerous and should be ignored.

Background History

In the video, Dr. Victory introduces herself this way:

I’m a trauma and emergency physician with a specialty in disaster preparedness and response and the management of mass casualty. For the past two decades, I’ve been in public health working with and advising Fortune 500 companies, hospitals, schools, and municipalities; developing plans and training them to respond effectively to the worst ever cases whether that be a hurricane, a flood, an active shooter, or a pandemic.

Victory—whose formal first name is Colleen—was born in 1961 in Ohio. She obtained a bachelor’s degree from Duke University, studied literature at Oxford University in England, and received a master’s degree in clinical psychology from the University of Illinois [2]. After  obtaining her medical degree in 1990 from the University of North Carolina Chapel Hill School of Medicine in 1990, she completed a residency program in trauma and emergency medicine at the Carolinas Medical Center. She became licensed in Colorado in 1993 and Ohio in 1995 and practiced emergency medicine until 1997 when she developed a degenerative spine disease that made it impossible to continue [3]. During the next few years, she co-founded and became managing partner of R.S. Gordon & Associates Inc., a consulting firm that specialized in medicolegal case review and care-quality reviews for hospitals. She was also involved with fundraising and marketing strategies for a number of health care and biotech companies [2]. From 2002 through 2008, she was the chief medical officer for Whole Health Management, which set up in-house health-care clinics for large companies [4]. She now resides in Steamboat Springs, Colorado. She is not listed as a staff member of the hospital chain that serves that community.

Many websites, including her main blog site, describe Victory as board certified in emergency medicine. However, she is not listed in the database of the American Board of Medical Specialties or my 2007 Directory of Medical Specialists. I assume that she achieved certification during the 1990s but her certification is no longer current. If so, it would be misleading to describe herself as board-certified.

Since 2006, Victory has been president of Victory Health, of Steamboat Springs, Colorado, which provides organizational training for mass-casualty incidents. The company was registered as a for-profit corporation in Ohio from 2004 to 2005 and has been registered as a domestic limited liability company in Colorado since 2007.

In an online biography, Victory says she was “a member of” Harvard’s National Preparedness Leadership Initiative (NPLI) and “served for many years” on a leadership council at Harvard’s public health school. However, The Denver Post has reported that a Harvard spokesperson said that Victory went through a 10-day NPLI program about a dozen years ago and only briefly was a member of the leadership council [5]. She has also been a member of Gov. Mitt Romney’s healthcare policy team.

In 2008, Walgreens announced that it had purchased Whole Health Management, which it described this way:

Whole Health Management is a leading operator of on-site and near-site employer sponsored clinics, health and wellness centers, and pharmacies in the United States. Since 1981, Whole Health has provided comprehensive and integrated occupational health, preventive care, urgent and primary care, physical therapy, fitness programs, health risk and disease management, health coaching and behavioral health counseling to corporate employees and their families. Whole Health clinics deliver significant savings to corporations through lower health care costs, increased productivity, reduced employee sick time, and decreased pharmacy costs. Whole Health currently serves more than 300,000 employees, and in many cases, spouses and dependents, at 69 sites, including many large corporations and Fortune 500 companies [6].

I gather from all this that Dr. Victory was trained in emergency medicine and disaster preparedness, practiced emergency medicine for a few years, and then transitioned into administrative and consulting work. Her main experience—as part of a large team at Whole Health Management for six years— involved administrative supervision of a thriving chain of company clinics. Despite extensive online searching, I have found nothing about her professional activities since 2008. The people I trust most for advice about COVID-19 have extensive training, clinical experience, and research expertise in the fields of infectious disease, epidemiology, immunology, and statistics and are networked with other experts in these fields. She does not fit this description.

False Assertions in the Video

Victory’s 17½-minute video contains at least twelve statements that are false. My comments in bold red type explain why I believe they are false.

  1. “We know that COVID-19 is a mild disease in the vast majority of people; 85% of people who contract COVID-19 have few if any symptoms at all. Another 10% or so actually become ill the way you might with the flu and need to seek medical care, but only a very small number actually require hospitalization. And although any deaths are tragic, only a tiny fraction have died from this infection.” — I don’t believe enough is known to determine what percentages get sick enough to seek medical care and/or die. But—using Victory’s numbers—if taking no precautions means that 15% of the American public will become “ill the way you might with the flu,” that would be 50 million people, and a “tiny percentage” of deaths that would be hundreds of thousands. Moreover, many who do not die would develop serious and perhaps permanent complications. Victory’s numbers seem low because the U.S. Centers for Disease Control and Prevention (CDC) estimates that about 40% of Americans have at least one underlying health condition that would put them at risk for severe complications of COVID-19 [7],
  2. “This particular virus doesn’t do well when exposed to warm temperatures or to sunshine. It simply can’t survive for more than a few minutes when the temperatures are above about 70 degrees and certainly not when temperatures are in the mid-80s or higher.” — The recent surge of cases in Southern states make it clear that COVID-19 virus can spread easily in warm climates.
  3. “Outside of New York City this virus has essentially been a nursing home problem. The general public has simply not been impacted the way the media and public health officials have led us to believe. — The share of COVID-19 deaths occurring in nursing homes and assisted living facilities is estimated to be 40-45% [8]. That does not make the “general public” deaths any less serious. 
  4. “Social distancing isn’t even an established health care concept … The whole idea of social distancing was based on a theoretical model explored by a high school student in a science fair some years ago.” — In 2006, a very bright teenager developed a computer simulation with help from her father, who was a senior scientist at Sandia Laboratories’ National Infrastructure Simulation and Analysis Center [9]. Since then, however, the concept has been extensively studied and proven valid [10]. One study of 58 cities, for example, has that each day’s delay in social distancing, added 2.4 days to the length of an outbreak [11].
  5. “Multiple medical organizations have now acknowledged that there is no scientific justification for normal healthy people to be wearing masks.” — When the pandemic became apparent, some organizations caused confusion by advising the general public against mask use so that frontline healthcare workers could obtain respirator (N95) masks that were in short supply. We now know it is possible for infected people to spread the disease before they develop symptoms and that cloth masks also reduce the distance that infectious particles can travel. So there is near-universal agreement among experts that cloth mask use plus social distancing will greatly reduce the spread of COVID-19 [12].
  6. Many masks “are not porous enough to allow carbon dioxide that we exhale to fully dissipate. So in every inhalation we breathe back in more carbon dioxide. — This claim is nonsensical. Masks reduce the spread of infectious droplets that can carry the virus [13], but the materials used are still porous enough to allow passage of gas molecules like carbon dioxide and oxygen, which are about 10,000 times smaller than the virus [14]. If carbon dioxide built up as Victory claims, medical professionals who wear tight-fitting respirator masks would quickly become short of breath. But that simply does not happen.
  7. “Habitual wearing of masks decreases the body’s natural immune response.” — It has been hypothesized that exposure to germs throughout life can bolster immunity. Even if this were proven true, there is no logical reason to believe that mask-wearing would interfere with this because masks are not airtight and are usually worn for short periods of time.
  8. “Children are at virtually no risk.” — The incidence of COVID-19 in children under age 10 is low but not zero. The incidence among children ages 10 to 19 is fairly low, but some have had severe complications. 
  9. “There is a very low risk from exposure to children . . . . We don’t need to be concerned about being in close contact with them. . . . One of the best things we can do is allow children to be out and about, knowing that if they do get exposed, they have virtually no risk of actually becoming ill but they will develop antibodies that will protect them and others from future outbreaks by contributing to the overall immunity of the herd.” — A large study from South Korea has found that “children younger than 10 transmit the coronavirus to others much less often than adults do, but the risk is not zero.” Furthermore, those between the ages of 10 and 19 can spread the virus at least as well as adults do [15].
  10. Referring to hydroxychloroquine: “More and more doctors around the world have been using this drug for patients with COVID-19 and treating those patients early on in their illnesses. So we are gathering a tremendous amount of data that will allow us to say with certainty that it is effective. — Drugs should only be used if the expected benefits outweigh the probable risks. Three recent studies have found no benefit [16], and the the FDA has warned about significant risks, including death [17].
  11. “We know the things that are most useful in assuring that our immune systems are able to operate at peak efficiency. Healthy diet; adequate sleep; regular exercise; exposure to the sun; taking extra vitamin D, and vitamin C, and zinc particularly during cold and flu season.” — Although adequate amounts of these factors help maintain immune function, normal immune function is not sufficient to protect against COVID-19 infection. Taking extra nutrients has not been proven beneficial against respiratory diseases.
  12. It is safe “to fully return to your lives, your businesses, schools, and places of worship without fear and without limitations.” — Victory reasons that if things went back to normal, the pandemic would eventually subside because herd immunity would be achieved. There are several problems with this: (a) it is not yet known whether infection with the COVID-19 virus makes a person immune to future infection [18], (b) assuming that survivors will be immune, the percentage of the population needed to set up herd immunity is unknown but probably in the neighborhood of 70-90%, and (c) if 70-90% of 330 million people get infected with COVID-19, tens of millions would get very ill, millions would develop serious complications, and millions would die unnecessarily. These numbers are vastly greater than numbers experts now predict with social distancing and mask-wearing. The scientific community believes that herd immunity cannot be safely achieved until a vaccine is available.

Two other commentators have dissected other false assertions in the video [19,20].

Criminal Conviction

In 2012, a local newspaper reported that Victory was sentenced after pleading no contest to disorderly conduct (a misdemeanor). The charge stemmed from an early morning episode during which police said Victory displayed a .38-caliber handgun while arguing with another woman. Victory was arrested on suspicion of driving under the influence of alcohol and using a weapon in a prohibited manner. (These charges were withdrawn.) Her sentence called for 24 hours of community service plus six months of unsupervised probation. She already had surrendered her concealed weapons permit and underwent an alcohol evaluation. Victory maintained that she had done nothing wrong. Her attorney said she pleaded no contest to bring an end to the painful legal process [21].

YouTube Removal

YouTube’s “COVID-19 Medical Misinformation Policy” states that videos can be removed if they spread medical misinformation that contradicts the World Health Organization or local health authorities’ medical information about treatment, prevention, diagnosis, or transmission of COVID-19 [22]. In August 2020, YouTube removed 24 copies of the video discussed in this article.

The Bottom Line

Colleen Victory, M.D. (a/k/a Kelly Victory) asserts that (a) concerns about the  COVID-19 pandemic are overblown, (b) wearing a mask does more harm than good, and (c) it is safe to “fully return to your lives, without fear and without limitations.” Her ideas were being spread primarily through a YouTube video that was filled with false information and poor medical reasoning. Following her advice might kill you. 

References
  1. Victory K. Breaking down – COVID-19. Posted to YouTube, July 6, 2020.
  2. Management team. Whole Health Management website, archived Feb 3, 2004. (Click link to Victory’s name).
  3. Kelly Victory. Crain’s Cleveland Business, July 5, 2004.
  4. Kelly Victory. Linkedin page, accessed July 19, 2020.
  5. Wingerter J. Colorado candidate campaigns with doctor who shared coronavirus conspiracy theories. The Denver Post, April 7, 2020.
  6. Walgreens completes acquisitions of worksite health care providers I-trax/CHD Meridian Healthcare and Whole Health Management. Businesswire, May 1, 2008.
  7. Razzaghi H and others. Estimated county-level prevalence of selected underlying medical conditions associated with increased risk for severe COVID-19 illness — United States, 2018. Morbidity snd Mortality Weekly Report 69:945-950, 2020.
  8. Roy H. Nursing home deaths from COVID-19: U.S. historical data. Foundation for Research on Equal Opportunity web site, July 15, 2020.
  9. Reed O. Social distancing born in ABQ teen’s science project. Albuquerque Journal, May 2, 2020.
  10. Brooks JT and others. Universal masking to prevent SARS-CoV-2 transmission—The time is now. JAMA, July 14, 2020.
  11. Du Z. Effects of proactive social distancing on COVID-19 outbreaks in 58 cities, China. Emerging Infectious Diseases 26:9, 2020
  12. Chu DK and others. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet 395:1973-1986, 2020.
  13. Tereszcuk T. Fact check: Hypercapnia does NOT occur from constant use of a mask as advised during The COVID-19 outbreak. Lead Stories, May 25, 2020.
  14. Howard J. Face masks against COVID-19: An evidence review. Proceedings of the National Academy of Sciences, April 10, 2020.
  15. Park YJ. Contact tracing during coronavirus disease outbreak, South Korea, 2020. Emerging Infectious Diseases 26:10, 2020.
  16. Kuperschmidt K. Three big studies dim hopes that hydroxychloroquine can treat or prevent COVID-19. Science & Medicine, June 9, 2020.
  17. FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems: Does not affect FDA-approved uses for malaria, lupus, and rheumatoid arthritis. FDA news, updated July 1, 2020.
  18. Herd immunity and COVID-19 (coronavirus): What you need to know. Mayo Clinic website, June 6, 2020.
  19. Miller D. Fact check: Dr. Kelly Victory’s ‘COVID Facts’ video includes many claims that are NOT facts. Lead Stories, July 13, 2020.
  20. Dr. Kelly Victory: Another despicable physician spreading disinformation about COVID-19. Respectful Insolence, July 15, 2020.
  21. Stensland M. Victory charges dropped as part of plea deal. Steamboat Pilot & Today, June 15, 2012.
  22. COVID-19 Medical Misinformation Policy. YouTube, accessed July 25, 2020.


Significant Journal Reports

The links below lead to summaries or full-text versions of important articles from peer-reviewed scientific journals. Please contact us to suggest articles that should be added to this page. Chiropractic Identity and Practices Gliedt JA. Chiropractic identity, role and future: A survey of North American chiropractic students. Chiropractic & Manual Therapies 23:4, 2015. Murphy DR …

The links below lead to summaries or full-text versions of important articles from peer-reviewed scientific journals. Please contact us to suggest articles that should be added to this page.

Chiropractic Identity and Practices
Advertising and Marketing
Chiropractic care, cost and effectiveness
Reliability of chiropractic procedures
Education
Immunization and immune function
Spinal manipulation, appropriateness
Spinal manipulation, complications
Spinal manipulation, effectiveness


Misuse of X-Rays in Chiropractic Posture Queen Contests

From the 1920s to the late 1960s, chiropractic organizations used posture pageants to draw media attention to their profession. Except for the emphasis on posture, the earlier ones were similar to other beauty contests of their day. But in 1954, a chiropractor named Clair O’Dell suggested that the contest focus on the straightest spine as …

From the 1920s to the late 1960s, chiropractic organizations used posture pageants to draw media attention to their profession. Except for the emphasis on posture, the earlier ones were similar to other beauty contests of their day. But in 1954, a chiropractor named Clair O’Dell suggested that the contest focus on the straightest spine as demonstrated by x-ray. The main score was for spine and body alignment with other points given for poise, beauty, and personality [1].

During the next few years, the National Chiropractic Association, International Chiropractors Association, and Canadian Chiropractic Association jointly administered a “posture week” project with a  “Posture Queen” contest throughout North America. To nominate a contestant, an individual chiropractor submitted a full-spine x-ray plus the contestant’s photograph. At state finals, judging was based half on spinal structure and half on spinal structure. At the height of their popularity, winners visited presidents, interviewed  on television shows, and were featured in newspapers, Time and Life magazines, and other publications [2].

Full-spine x-rays provide very little useful diagnostic information and expose patients to large amounts of radiation. Only a small percentage of chiropractors still use them. It was improper to expose young women to medically unnecessary radiation so they could compete in beauty contests.

References
  1. Hynes RJR. The most beautiful spines in America: The history of the Posture Queens. Chiropractic History 22(2):65-71, 2002.
  2. Eveland AC. Posture queen visited Walla Walla in 1962. Union Bulletin, Jan 22, 2017.


Victim Case Reports

The number of people harmed by quackery-related activities is unknown. Most such harm is not publicly reported because the victims are either too confused or too embarrassed to step forward. As historian James Harvey Young, Ph.D., noted in The Health Robbers: A Close Look at Quackery in America: Failure seldom diminishes patient loyalty. When regulatory …

The number of people harmed by quackery-related activities is unknown. Most such harm is not publicly reported because the victims are either too confused or too embarrassed to step forward. As historian James Harvey Young, Ph.D., noted in The Health Robbers: A Close Look at Quackery in America:

Failure seldom diminishes patient loyalty. When regulatory agencies seek to prosecute quacks, the agencies have a difficult task getting hapless patients to testify in court. Partly this results from the desire to avoid public exposure as a dupe; but often this objection to testifying rests on an inability to realize that deception has taken place. Many quacks do such a good job of exuding sincerity that their explanations seem all too plausible. Even patients faced with death believe in the “kindly” person who says the special remedy would have worked if treatment had only begun a little sooner.

To illustrate quackery’s dangers, this web site will post reports of victims whose stories have become public—either through their direct efforts or through civil suits or criminal prosecutions that have come to our attention. It takes great courage for victims (or their survivors) to admit that they or their loved one made a serious error.

Even when a suit is filed, there may be little or no publicity. The news media often decide that it would be unfair to the defendant to publicize the case until a jury verdict has been rendered. The attorneys instruct their clients not to discuss their case with anyone. Plaintiffs’ attorneys fear that a judge might conclude that publicity interfered with the defendant’s right to a fair trial. Defendants’ attorneys want to minimize publicity that could damage the reputations of their clients. Both sides may also fear that loose talk might hurt their case in other ways. The majority of meritorious cases are settled out of court years later with an agreement not to disclose the terms of the settlement and, in some cases, the details of the case. Such secrecy agreements may prevent the media from learning about the settlement and may make it impossible for the media to get sufficient detail to consider it newsworthy.

Individual Case Reports
  • Lorie Atikian (died of malnutrition and pneumonia under naturopathic care)—link to another site
  • Kristie Bedenbauer (killed by chiropractic neck manipulation)—revised 12/17/99
  • Debbie Benson (died of breast cancer while relying on “natural” methods)—posted 10/23/97
  • MB (testimony of a woman whose father died in 1986 after relying on an unlicensed herbalist for cancer treatment—posted 12/27/11
  • Feingold diet victim (could not concentrate and suffered humiliation during childhood)—posted 3/15/04
  • Hanne (cancer patient vitimized by Hulda Clark follower)–link to another site
  • HB (autistic child mistreated by chelation doctor)—posted 11/28/01
  • Lisa Campbell (frightened and upset by an iridologist)—posted 4/19/12
  • Ruth Conrad (face burned off by quack treatment with salve for nonexistent cancer)—posted 2/16/02
  • Paulette Cooper (trouble after writing a book critical of Scientology)—link to another site
  • Children seriously harmed by vitamin A poisoning—posted 12/22/18
  • Lucille Craven (chose bogus “alternative” treatments for her cancer)—posted 2/27/02
  • Tawnya Cummiskey (induced by doctor to buy unnecessary herbal products)—posted 10/18/99
  • Frances Denoon (stroke from chiropractic neck adjustment)—link to another site
  • Penelope Dingle (died of cancer under homeopathic care)—link to Homeowatch
  • Marian Fowden: (Her mother was a lifelong victim of quacks)—posted 2/21/02
  • Dale and Susan Fox (ripped off by Herbalife)—posted 2/14/04
  • Amy C. Hays (how a chiropractor used scare tactics to keep her coming back)—posted 1/4/00
  • Amy Hermanson (died of undiagnosed diabetes under Christian Science care)—link to another site
  • Lori Hoeksema (father with cancer defrauded by James Gary Davidson)—revised 9/15/02
  • Pam Hysong’s husband (sickened by phony cancer cure)—posted 4/18/02
  • Robert D. Johnson (nearly paralyzed by chiropractic negligence)—posted 9/9/20
  • Robert E. Jones (wife exploited at Tijuana cancer clinic)—posted 10/20/06
  • J. Kesterson (mistreatment by an unethical chiropractor)—posted 9/15/02
  • Lorrie Kruse (a/k/a Lorrie Hellier) (harmed by Sargenti dental paste)—revised 11/3/13
  • Sam Loschavio’s son (defrauded by Greek Cancer Cure clinic)—posted 8/29/20
  • Virginia MacConnell—swindled by immuno-augmentatuive therapy clinic (posted 9/10/18
  • Lisa McPherson (alleged Scientology victim—link to another site
  • Aubakar Tariq Nadama (autistic child killed by chelation therapy)—posted 7/11/07
  • Pancreatic cancer patient exploited by Nicholas Gonzalez, M.D.—posted 9/5/20
  • Chuckie Peters (nearly killed by toxic dosage of vitamin A)—posted 12/19/18
  • Ryan Pitzer (killed by unfounded advice in a book)—posted 3/27/99
  • Mercedes Ponzanelli (defrauded by Hulda Clark)—posted 8/11/07
  • Robyn (suffered needlessly during the terminal phase of breast cancer)—posted 3/7/02
  • Kelley Smith (how a chiropractor ruined her life)—posted 6/11/01
  • Sheri Spencer (father victimized by a cancer quack)—posted 2/11/05
  • Ezekiel Stephan (died of meningitis after patients failed to seek appropriate medical care)—link to another site
  • Kimberly Strohecker (died of epileptic seizures after chiropractor advised stopping medication)—posted 7/7/03
  • Matthew Swan (died of untreated meningitis under the care of Christian Science practitioners)—posted 9/23/97
  • Scott Tatro (chiropractic neck manipulation made him quadriplegic)—posted 11/17/09
  • Cherry Teresa (scammed by Kevin Trudeau)—link to another site
  • Kim Tinkham (Died of breast cancer after following Robert O. Young’s advice instead of using standard treatment)—posted 12/26/12
  • James Turner (11-year-old child paralyzed by chiropractic neck manipulation)—posted 10/18/01
  • Andrew Twitchell (died of untreated peritonitis under Christian Science care)—link to another site
  • Sean Walsh (died after thermography misled him into believing that his Hodgkin’s disease was controlled by “alternative” methods—link to BBC report
  • Andrew Wantland (died of undiagnosed diabetes under Christian Science care)—link to another site
Multiple Case Reports

Many people ask why Quackwatch doesn’t post case reports about people who die from “medical quackery,” which they define as any form of improperly delivered mainstream care (malpractice). Our focus is on fraud and quackery. Malpractice is the failure to meet mainstream standards of care. Fraud is deliberate misrepresentation. Quackery, as we define it, involves the promotion of methods that are unsubstantiated and lack a scientifically plausible rationale. Although some overlap exists, most cases of malpractice involve negligence rather than fraud or the promotion of bogus methods.

What You Can Do

Individual cases indicate that great harm is being done, but don’t indicate how many people are being harmed. Former National Council Against Health Fraud president William T. Jarvis, Ph.D., has suggested developing a quackery reporting system patterned after the Centers for Disease Control and Prevention’s system in which doctors report cases of communicable disease. This would enable us to keep track of what is being promoted, where the “hot spots” are, and what legal and educational efforts are needed for an effective response.

In the mid-1980s, the American Dietetic Association asked its members to report cases of people harmed by inappropriate nutrition advice from bogus “nutritionists,” health-food store operators, and others. Between 1986 and 1990, the association received more than 500 such reports. Unfortunately, the system contained no mechanism to make the data useful for research or public education. Although the dietitians submitting the reports knew the identity of the victims, the reports contained no identifying information, and no attempt was made to seek the victim’s permission to permit publication or further inquiry.

If you have been victimized and would like Quackwatch to report your experience, please contact us. We are also interested in reports from people who have been smart enough to spot a scam and avoid it.



“Mask Exemption” Cards Are Not Government-Supported

Quacks never sleep. Within days of the first moon landing, they were offering “moon dust” for arthritis. Today their wares include cards for people who live where masks are mandatory but don’t want to wear one. If you are tempted to buy one, you should know two things. The first is that infected individuals can …

Quacks never sleep. Within days of the first moon landing, they were offering “moon dust” for arthritis. Today their wares include cards for people who live where masks are mandatory but don’t want to wear one. If you are tempted to buy one, you should know two things.

The first is that infected individuals can spread the virus before they develop symptoms. Thus, to protect others, a mask should be worn whenever you might come in close contact with other people. The picture to the right shows how masks work. If everyone who can do so would wear a mask, the spread of COVID-19 would be greatly reduced.

The second thing you should know is that  “exemption cards” said to be issued or supported by a U.S. government agency are fake. And so are the reasons for not wearing masks that many of their sellers are spreading.

Cards are circulating online and on social media that say the holder has a disability that prevents wearing a mask and that it’s illegal for any business to ask them to disclose their condition. Variations of the card include the seal of the U.S. Department of Justice (DOJ), one of the federal agencies responsible for enforcing the Americans with Disabilities Act (ADA). Such cards are neither issued nor endorsed by DOJ or any other U.S. government agency. The most widely offered cards have been offered by the “Freedom to Breathe Agency,” whose Web site also provides misinformation about masks. The first card below included the DOJ logo and a real number of the ADA Information Hotline.

The New York Times has noted that the “Freedom to Breathe Agency” is not a government agency. Neither is the entity that operates the phone number on the second card.



COVID-19 Schemes, Scams, and Misinformation

Thirty years ago, as AIDS and chronic fatigue syndrome came to national attention, John Renner, M.D. observed that most of the quack cancer clinics began offering the same “treatments” for AIDS and chronic fatigue syndrome—a tendency he coined “rascal rollover.” Today, dubious pitchmen have “rolled” into COVID-19. Here’s a handy compilation of advice, enforcement actions, …

Thirty years ago, as AIDS and chronic fatigue syndrome came to national attention, John Renner, M.D. observed that most of the quack cancer clinics began offering the same “treatments” for AIDS and chronic fatigue syndrome—a tendency he coined “rascal rollover.” Today, dubious pitchmen have “rolled” into COVID-19.

Here’s a handy compilation of advice, enforcement actions, and trustworthy information sources related to the coronavirus pandemic. For up-to-date news and scientific developments, visit the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Fraudulent products can be reported to FDA-COVID-19-fraudulent-products@fda.hhs.gov. Other COVID-19 frauds can be reported to FTC Complaint site or the Disaster Fraud Hotline at (866) 720-5721. The FTC publishes a running total of COVID-19-related complaints it receives. To see the latest total, click the most recent date.

Terminology
  • COVID-19, which is short for Coronavirus Disease 2019, is the name of the disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
  • “Asymptomatic” is a medical term that means “no symptoms.”
  • Asymptomatic spread” refers to the fact that people who are infected can transmit the virus before they feel sick.

An article in the International Journal of Biosciences describes how the COVID-19 outbreak developed.

Schemes and Scams
  • Prevention scams: Many individuals and companies are claiming that their dietary supplements, herbal, and/or homeopathic products can prevent disease by “supporting,” “boosting” or “strengthening” the immune system.” Many chiropractors and acupuncturists are making similar claims about their procedures. All such claims should be ignored.
  • Testing Scams: Scammers are selling fake at-home test kits or going door-to-door performing fake tests for money.
  • “Mask exemption” cards. Scammers are selling mask mask exemption cards that claim that the card-holder has a disability that prevents wearing a mask. Such cards may include the seal of a government agency. No such card is government-supported or has any legal significance..

  • Treatment scams: Scammers are selling fake vaccines, medicines, tests, and cures for COVID-19. Ignore electronic offers for a COVID-19 vaccine, cure, or treatment. Remember, if there is a medical breakthrough, you will not hear about it for the first time through an email, online ad, or other unsolicited sales pitch.
  • Supply scams: Scammers are claiming they have in-demand products, like cleaning, household, health, and medical supplies.  When an order is placed, the scammer takes the money and never delivers the order. To avoid being victimized, check online reviews of any company offering COVID-19 products or supplies. Avoid companies whose customers have complained about not receiving items
  • Telemedicine frauds: Scammers are cold-calling people, claiming to offer free telemedicine visits, braces, or medicine in an attempt to get insurance information they can use to submit false insurance claims.
  • Charity scams: Scammers are fraudulently soliciting donations for non-existent charities to help people affected by the COVID-19 crisis.  Scammers often use names that are similar to the names of real charities. Research any charities or crowdfunding sites soliciting donations in connection with COVID-19 before giving. Remember, an organization may not be legitimate even if it uses words like “CDC” or “government” in its name or has reputable looking seals or logos on its materials. Be wary of any business, charity, or individual requesting payments or donations in cash, by wire transfer, gift card, or through the mail. Do not send money through any of these channels. The (FTC) Web site has additional tips on avoiding charity frauds.
  • Phishing schemes: Scammers, posing as local contact tracers or national and global health authorities such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), are sending fake emails or texts to trick the recipient into sharing personal information, including account numbers, Social Security numbers, or login IDs and passwords. Never give your personal or financial information to someone unless you are absolutely sure they are legitimate. Make sure that the anti-malware and anti-virus software on your computer is operating and up to date. Do not click on links or open email attachments from unknown or unverified sources.  Doing so could download a virus onto your computer or device. If you are eligible for a payment, you will receive a payment directly from the IRS. Do not pay anyone who promises that they can expedite or obtain a payment or a loan for you. If you are eligible for relief, you will not need to make any up-front payment or pay any fee to receive a stimulus payment. You will not be charged any “processing fees.”
  • App scams: Scammers are creating mobile apps designed to track the spread of COVID-19 to insert malware that will compromise users’ devices and steal personal information.
  • Provider scams: Scammers pretending to be doctors and hospitals that have treated a friend or relative for COVID-19 and demand payment for that treatment.
  • Insurance scams: These include (a) low-cost “corona insurance,” (b) additional Medicare coverage, (c) worthless travel insurance, and (d) fake policy-cancellation notices intended to gather personal information or lead to links that install malware.
  • Investment scams: Scammers are promoting the stock of small companies, which have limited publicly-available information, using false or misleading claims that the companies’ stock will increase dramatically due to the COVID-19 outbreak, such as claims that a company can prevent, detect, or cure COVID-19. The U.S. Securities and Exchange Commission (SEC) is warning about online promotions, including on social media, claiming that the products or services of publicly-traded companies can prevent, detect, or cure coronavirus and that the stock of these companies will dramatically increase in value as a result.
  • Grandparent scams: Scammers pose as panicked grandchildren in trouble, urging you to wire money immediately. They’ll say they need cash to help with an emergency – like paying a hospital bill or needing to leave a foreign country. Resist the urge to act immediately no matter how dramatic the story is. Verify the caller’s identity by asking questions that a stranger couldn’t possibly answer. Call verifiable contacts to check the story. Don’t send money you can’t get back from scammers: cash, gift cards, or money transfers.
  • Taxpayer relief scams: The Internal Revenue Service urges taxpayers to be on the lookout for emails, text messages, websites, and social media attempts that appear to come from the IRS and ask you to verify or provide your financial information so you can get a coronavirus economic impact payment or your tax refund faster. Scammers may use words like “Stimulus Check” or “Stimulus Payment.” They may mail a bogus check, perhaps in an odd amount, then tell the taxpayer to call a number or verify information online in order to cash it. Suspicious messages that appear to be from the IRS or an organization closely linked to the IRS, such as the Electronic Federal Tax Payment System (EFTPS), should be forwarded to phishing@irs.gov. For more information go to the Report Phishing and Online Scams page and the Coronavirus Tax Relief page on IRS.gov.
  • Price gouging: Individuals and businesses selling essential goods, like hand sanitizer, for significantly higher prices than in a non-emergency setting.
Misinformation about Masks

Infected individuals can spread the virus before they develop symptoms. Thus, to protect others, a mask should be worn whenever you might come in close contact with other people. This picture illustrates how masks work:

Unfortunately, many incorrect ideas about supposed “dangers” of mask-wearing have been circulating. I have posted one article about this and have another in progress.

Customs Enforcements

As of May 4, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) special agents have opened over 315 investigations nationwide; seized over $3.2 million dollars in illicit proceeds; made 11 arrests; executed 21 search warrants; analyzed over 19,000 COVID-19 domain names; and worked alongside U.S. Customs and Border Protection to seize 494 shipments of mislabeled, fraudulent, unauthorized or prohibited COVID-19 test kits, treatment kits, homeopathic remedies, purported anti-viral products (such as diluted cleaning solutions), and personal protective equipment (PPE).

Other U.S. Federal Civil Actions
Criminal Prosecutions
State and Local Actions
Foreign Actions
Untrustworthy Information Sources (Investigative Reports)
Trustworthy Information Sources


Dr.London is a professor of public health at California State University, Los Angeles, editor of Consumer Health Digest, and a scientific and technical consultant to the Committee on Skeptical Inquiry.



“Functional Neurologist” Reprimanded for Unprofessional Conduct

The College of Chiropractors of British Columbia (CCBC) has disciplined Daniel Sullins, D.C., for conduct associated with his practice of “functional neurology.” [1] Sullins, who had operated North Shore Brain Balancing in North Vancouver, for several years, had described himself as a “board-certified functional neurologist” and had claimed that his “brain balancing” could help people with …

The College of Chiropractors of British Columbia (CCBC) has disciplined Daniel Sullins, D.C., for conduct associated with his practice of “functional neurology.” [1] Sullins, who had operated North Shore Brain Balancing in North Vancouver, for several years, had described himself as a “board-certified functional neurologist” and had claimed that his “brain balancing” could help people with a long list of common symptoms.

A 2011 graduate of Texas-Based Parker College of Chiropractic, he had done business as the Applied Neurology Health Canter in Dallas, Texas, before moving to Canada in 2017. In 2016, that clinic’s Web site stated:

A doctor practicing functional neurology is highly trained in brain based care and the nervous system on a postdoctorate level. This is important to you, the patient, because the brain controls and regulates every action in the body in some way. This type of doctor is especially trained to detect subtle hints at things that are affecting the body in such a way that these subtle, often unnoticed events, may be caught before symptoms appear even.  At Applied Neurology Health Center, we practice only board certified functional neurology dealing with the brain and how it controls the body. . . .

Proper board certified brain care can help with:

ADHD; dyslexia; traumatic brain injury; post stroke rehab; optimized brain function to decrease risk of Alzheimer’s disease; short term memory rehab; speech problems; academic grade level acceleration in school; allergies; arthritis; asthma; back pain; bed-wetting; carpal tunnel; chemical or hormonal imbalance; cold and flu; depression; diabetes; digestive problems; ear and upper respiratory infections; fatigue; fibromyalgia; headaches; heart trouble; heartburn; high blood pressure; hyperactivity; infertility; insomnia; irritable bowel syndrome; irritability; menstrual problems; migraines and cervicogenic headaches; muscle tension; neck pain; osteoporosis; rehabilitations of the neuraxis after comas and strokes; rheumatism; SAD (seasonal affective disorder); severe whiplash; sciatica; sleeping problems; sports injuries and performance; stiffness; thyroid related conditions; vertigo; visual disturbance unhelped elsewhere; and many more! [2].

Sullins’s Linkedin account states that his training in “functional neurology” was obtained at the Carrick Institute for Graduate Studies in Neurology from 2009 through 2012 [3].

In June 2019, the CCBC announced that it had suspended Sullins’s registration while it investigated several concerns [4]. The suspension was lifted in March 2020. In June 2020, the CCBC announced that Dr. Sullins had entered into a consent agreement in which he acknowledged that he had:

  • advertised treatment of conditions for which there was not acceptable evidence of efficacy contrary to the College’s Efficacy Claims Policy
  • advertised treatment of conditions that are not within the scope of practice for chiropractors in BC
  • failed to practice within the scope of practice for chiropractors in BC
  • failed to maintain records in accordance with College standards
  • failed to cooperate with a College inspection
  • advertised using a Groupon coupon
  • practiced while suspended.

Under the agreement, Sullins was reprimanded, fined CN$200, ordered to pay costs of CN$4,000, and have his practiced monitored for four months [1]. He was also required to work within the legal scope of practice, bring his marketing into line with CCBC standards, and maintain required records [5].

Questionable Theories and Practices

Functional neurology, as mainly practiced by chiropractors, is difficult to summarize because its theories are nebulous and its components vary significantly from practitioner to practitioner. RationalWiki describes it as a “rebranding of chiropractic neurology”  spearheaded by Frederick “Ted” Carrick, D.C. [6] Its primary promoter is the Carrick Institute, in Cape Canaveral, Florida, which offers extensive coursework. Certification is provided primarily through two organizations, the American Chiropractic Neurology Board, and the American College of Functional Neurology.

Proponents claim to be able to treat many conditions by diagnosing dysfunctional areas of the brain and improving their function with spinal manipulations, dietary modification, and various exercises characterized as “brain training.” One such procedure—called blind-spot mapping, brain function testing, brain mapping, or “cortical mapping—is claimed to enable chiropractors to determine whether spinal manipulation can correct brain functions [7].

A recent review concluded that “no acceptable evidence on the effect or benefit of functional neurology in relation to various conditions and purported indications for intervention.” [8] Another recent review advised that (a) changes in “brain function” can occur in response to spinal manipulation but are inconsistent, (b) their relevance is unknown, and (c) it is therefore “premature to promote the use of spinal manipulation as a treatment to improve ‘brain function.’” [9]

References
  1. Action taken against Daniel Sullins. College of Chiropractors of British Columbia, June 29, 2020.
  2. Applied Neurology Health Center home page, archived Oct 24, 2016.
  3. Dr. Daniel Sullins, DC, DACBN. LinkedIn, accessed July 16, 2020.
  4. Action taken against Daniel Sullins. College of Chiropractors of British Columbia, June 18, 2019.
  5. Lindsay B. B.C. Chiropractor who advertised unproven “brain balancing” treatment fined $200. MSN News, July 14, 2020.
  6. Functional neurology. RationalWiki, Dec 12, 2018.
  7. Hall HA. Blind-spot mapping is a worthless procedure. Quackwatch, March 2, 2003.
  8. Meyer A-L, Leboeuf C. Unravelling functional neurology: A review of clinical research articles on the effect or benefit of the functional neurology approach. Chiropractic & Manual Therapies 26:30, 2018.
  9. Meyer A-L and others.Unravelling functional neurology: does spinal manipulation have an effect on the brain?—a systematic literature review. Chiropractic & Manual Therapies 27:60, 2019.


Licensing Board Actions against Chiropractors

Most of the actions listed below were carried out by chiropractic licensing boards. However, a few involved medical board actions against chiropractor whose marketing suggested that they might be medical doctors and/or whose practice went beyond the chiropractic’s lawful scope. United States J. Mitchell Adolph, DC (2000) Frank J. Amato, DC (2001, 2005) Christine Anderson, …

Most of the actions listed below were carried out by chiropractic licensing boards. However, a few involved medical board actions against chiropractor whose marketing suggested that they might be medical doctors and/or whose practice went beyond the chiropractic’s lawful scope.

United States
Australia
Canada


Chiropractic Antitrust Suit: Index

In 1976, a series of lawsuits was begun against the AMA, other professional organizations, and several individual critics, charging that they had conspired to destroy chiropractic and to illegally deprive chiropractors of access to laboratory, x-ray, and hospital facilities. Most of the defendant groups agreed in out-of-court settlements that their physician members were free to …

In 1976, a series of lawsuits was begun against the AMA, other professional organizations, and several individual critics, charging that they had conspired to destroy chiropractic and to illegally deprive chiropractors of access to laboratory, x-ray, and hospital facilities. Most of the defendant groups agreed in out-of-court settlements that their physician members were free to decide for themselves how to deal with chiropractors.

The American Medical Association (AMA), the American College of Radiology (ACOR), the American Academy of Orthopedic Surgery (AAOS), seven other groups, and and four individual defendants chose to defend in court. In January 1981, after an 8-week trial, the jury ruled unanimously in their favor. However, the case was reversed on appeal and the parties agreed to retry it in front of a judge rather than a jury.

In 1987, federal court judge Susan Getzendanner concluded that during the 1960s “there was a lot of material available to the AMA Committee on Quackery that supported its belief that all chiropractic was unscientific and deleterious.” The judge also noted that chiropractors still took too many x-rays. However, she ruled that the AMA had engaged in an illegal boycott. She concluded that the dominant reason for the AMA’s antichiropractic campaign was the belief that chiropractic was not in the best interest of patients. But she ruled that this did not justify attempting to contain and eliminate an entire licensed profession without first demonstrating that a less restrictive campaign could not succeed in protecting the public. Although chiropractors trumpet the antitrust ruling as an endorsement of their effectiveness, the case was decided on narrow legal grounds (restraint of trade) and was not an evaluation of chiropractic methods.

First Trial
Second Trial


Pamphlets from Allen Unruh, D.C., 1984-1992

Allen D. Unruh, D.C. (1948– ) has been a prolific communicator and political activist throughout his chiropractic career. After graduating from National College of Chiropractic in 1970, he began practicing in Elkton, South Dakota and relocated to Sioux Falls, SD in 1976 [1]. His father was a naturopath [2]. In the 1980s, he began marketing educational pamphlets …

Allen D. Unruh, D.C. (1948– ) has been a prolific communicator and political activist throughout his chiropractic career. After graduating from National College of Chiropractic in 1970, he began practicing in Elkton, South Dakota and relocated to Sioux Falls, SD in 1976 [1]. His father was a naturopath [2]. In the 1980s, he began marketing educational pamphlets that chiropractors could use in their offices. Over a 20-year period, at least 60 such pamphlets were published by him; Complete Health Communications (CHC), Inc.; and/or Unruh Publications. In the mid-1980s, CHC also offered educational tapes for chiropractors and a set of 53 editable newspaper columns.

Unlike most pamphleteers of his day, Unruh promoted conservative musculoskeletal care, targeted exercises, and dietary improvement and rarely made subluxation-based claims that chiropractic care improves general health and is effective against from a wide range of diseases. However, his pamphlet on The effects of spinal misalignment asserted:

Few realize that pinched nerves in the spine can  be a contributing or primary cause of almost any ailment. . . .

For instance, misalignment in the neck region can disturb nerve function, resulting in headache, nervousness, insomnia, high blood pressure, chronic tiredness, dizziness, sinus trouble, eye trouble, ear trouble, neuritis, chronic cough, sore throat, stiff neck, pain in the upper arms, or bursitis. Many patients take all kinds of medication for these symptoms, not realizing the cause of the problems is in the neck.

Misalignments in the mid-back can disturb nerve function, resulting in asthma and difficult breathing, functional heart conditions, gallbladder condition s, liver conditions, poor circulation, arthritis, stomach trouble, indigestion, heartburn and dyspepsia and gastritis, kidney trouble, chronic tiredness, skin conditions, and gas pain .

Misalignments in the lower back can cause constipation, colitis, diarrhea, cramps, bladder trouble, menstrual trouble such as painful or irregular periods, change of life symptoms, bed wetting, many knee pains, sciatica, backaches, difficult, painful or too frequent urination, poor circulation in the legs, swollen ankles, weakness in the legs, and leg cramps, or sacro-iliac conditions and pain at the end of the spine on sitting.

A few other pamphlets promoted chiropractic as generally equivalent or superior to medical care. For example:

  • Geriatrics and Chiropractic asserts that “millions have found chiropractic as safe and effective alternative to taking strong medication that their body is sensitive to, especially in later years. Chiropractic adds more years to your life and more life and more life to your years.”
  • IS MEDICINE SCIENTIFIC falsely implies that most drugs are ineffective and asserted that medical practice in America is “full of priests and rituals and beliefs, but the evidence is clear that there is no scientific base.”
  • Chiropractic for medical failure cases asks, “How much would the public health be improved, and the percentage of drug-induced illness be prevented  if only our nation’s sick would consult chiropractors first instead of last?”
  • Maybe you need a second opinion by a Chiropractor advises that “when your doctor’s advice and treatment does not give you the results you want, it may be wise to get a second opinion by a chiropractor.”
  • Chiropractic: the safest healing profession known to man claims that, “The gentle manipulative therapy chiropractors provide has resulted in severe side effects only in the rarest circumstances.”

Four other pamphlets were not flamboyant but implied that chiropractors were especially qualified to deal with the causes of various pains:

  • Pain—An angel in disguise
  • What to do for muscle spasms
  • Pain between the shoulder blades
  • Illness as a Teacher

To access the full text of these pamphlets, descriptions of Unruh’s other materials, and how they were marketed to chiropractors, click here.

References
  1. Meet Dr. Allan Unruh. A. Unruh Chiropractic Clinic website, accessed July 10, 2020.
  2. Who’s Who in Chiropractic International, 1980, pp 244-245.


Chiropractic Pamphlets from Barge Chiropractic Clinic (1991)

Fred H. Barge, D.C. (1933-2003) was a prominent chiropractor who had 18 other chiropractors in his extended family. Following graduation from chiropractic school he interned with chiropractic’s developer, B.J. Palmer. He practiced at the Barge Chiropractic Clinic in LaCross, Wisconsin, taught at five chiropractic colleges, served as president of the International Chiropractors Association, and held many …

Fred H. Barge, D.C. (1933-2003) was a prominent chiropractor who had 18 other chiropractors in his extended family. Following graduation from chiropractic school he interned with chiropractic’s developer, B.J. Palmer. He practiced at the Barge Chiropractic Clinic in LaCross, Wisconsin, taught at five chiropractic colleges, served as president of the International Chiropractors Association, and held many other positions in other chiropractic organizations. His colleagues considered him one of the leading spokespeople for chiropractic philosophy and subluxation-based chiropractic. He advocated regular (typically monthly) spinal checkups and adjustments from birth onward. His literary output included nine books, many articles, and a dozen pamphlets. A flyer for his book, One Cause, One Cure stated:

For as long as man has existed on the face of the earth, he has searched for The Cause. The cause of disease, the cause of health, the cause of success of failure … the cause of his problems and as long as chiropractic has existed as a profession it has been accused of being a cult, of embracing a One Cause, One Cure concept of disease. . . .

This book promises to be an enlightenment to all seeking knowledge in health, healing and life. It explains the teachings of Drs. D.D. and B.J. Palmer as revolutionary and revelationary concepts that were bound to engender the wrath of the allopathic medical physician who was still steeped in the heroic medical concepts of the tum of the century. The Palmers spoke of cause not of symptoms, and of the uniting in man of mind, body and spirit.

Here are some excerpts from the pamphlets that Barge’s clinic was marketing in 1991:

  • Chiropractic Care falsely claimed that “chiropractic care works in all disease” and that “regular chiropractic care is your insurance that your body maintains a good state of health.”
  • Pregnancy and Chiropractic Care recommended that pregnant women receive regular chiropractic care “right up to delivery” and that “infants should be checked by a chiropractor as soon as practical after the delivery.”
  • The Senior Years Need Not Be Like This falsely claimed that “chiropractic care benefits most all health problems.”
  • Deterioration, Degeneration and Back Pain claimed that “regular chiropractic spinal care is your best insurance against spinal deterioration.”
  • Immunization: Your Choice or Your Command?  asserted that “a spine chiropractically maintained in youth is the best assurance to a healthy life that you can give a child.”
  • Scoliosis & Curvature claimed that “chiropractic care has often proven to be the most effective means of [spinal] curvature control and correction.”
  • Bed Wetting Explained and Chiropractic’s Approach to That Problem falsely claimed that bedwetting can be caused by “subluxations” of three neck bones.
  • Children Need Chiropractic Care asserted that “simple spinal adjustments can solve a host of childhood problems” and that “once children experience chiropractic benefits they will ask to come again.”
  • The Cause of Disease: The Soil? or the Seed? claimed (nonsensicall)y) that “if the germ theory of disease were correct, there would be no one living things to believe it.”
  • The “Common Cold” Explained asserted that colds are the result of lowered resistance (not the presence of germs) and can be prevented by strengthening the immune system with monthly spinal adjustments.
  • Torticollis: The “Disc Block Subluxation” of the Neck claimed that “little beginnings like a ‘stiff neck’ can lead to life long spinal distortions>”
  • Tortipelvis: The “Slipped Disc” Syndrome stated that “chiropractic methods should be a primary consideration in all cases of backache.”

To read the full text of these pamphlets and book fliers, click here.



Chiropractic Pamphlets from Baxter Healthcare Corporation (1990-1991)

Baxter International Corporation is a large company that markets medical devices and drug products. In the early 1990s, it had a subsidiary that marketed pamphlets that chiropractors could use in their offices. Low Back Pain Back Exercises Stress and Your Back Understanding Common Back Problems Chiropractic Approach to Low Back Pain Chiropractic Approach to your …

Baxter International Corporation is a large company that markets medical devices and drug products. In the early 1990s, it had a subsidiary that marketed pamphlets that chiropractors could use in their offices.

  • Low Back Pain
  • Back Exercises
  • Stress and Your Back
  • Understanding Common Back Problems
  • Chiropractic Approach to Low Back Pain
  • Chiropractic Approach to your Headache

The chiropractic pamphlets stated that the primary method of treatment is spinal adjustment that can relieve pressure on nerves and correct faulty structural relationships that cause pain and that they may also use heat, cold, light, massage, movement, exercise, electrical stimulation, acupuncture, ultrasound, postural realignment, traction, ice compression, trigger point therapy, physical therapy, and relaxation techniques like yoga, meditation, or visualization. The other four pamphlets provide general medical information about causes and treatment of back pain but say nothing about chiropractic. Despite extensive searching, I can find no information online about Baxter’s involvement with chiropractors. To see the chiropractic pamphlets, click here.



Chiropractic Pamphlets from G.T. Press (1965-1987)

Golden Touch, Inc., of Blue Springs, Missouri, published pamphlets that could be displayed in chiropractic offices or distributed monthly to selected patients through G.T.’s “Direct Patient Motivation Mailing Plan.” Between 1965 and 1987, at  least 75 were published: Allergy • Amazing Stomach • Arm and Shoulder Pain (2 brochures) • Arthritis • Arthritis: The Number …

Golden Touch, Inc., of Blue Springs, Missouri, published pamphlets that could be displayed in chiropractic offices or distributed monthly to selected patients through G.T.’s “Direct Patient Motivation Mailing Plan.” Between 1965 and 1987, at  least 75 were published:

Allergy • Amazing Stomach • Arm and Shoulder Pain (2 brochures) • Arthritis • Arthritis: The Number One Crippler ( 2 versions) • B-A-C-K-A-C-H-E • Back Pain • Backache • Children and Chiropractic (2 versions) • Chiropractic Family Plan • Chiropractic Insurance Coverage • Chiropractic Medicare and You • Chiropractic Nerve Chart • Common Headache • Disc Problems: How Not to Have Them • Education of a Chiropractor • Emphysema – America’s No. 2 Killer • Feminine Facts • Head and Neck • Health Is Within You Now • High Blood Pressure • How Chiropractic Heals (2 versions) • How Old is Old? • How to Lift • How to Prevent Back Pain • Is Asthma Serious? • Just Plain Tired – Are You? • Low Back Pain • Mama . . . My Bed’s Wet • Medical Research Proves Chiropractic • Migraine Headache (3 versions) • Nerves – Just Nerves • Nutrition & Exercise • Osteoporosis & Your Health • Pain • Pathways to Health • Patient Testimonial Blanks • Peace of Mind • Peace of Mind • Periodic Health Care • Pinched Nerves • Pinched Nerves: The Great Imposter • Prostate Facts for Men • Sciatic Nerve • Sciatic Pain • Sciatica • Scoliosis: What Is It? • Sinus Trouble • Sports Injuries • The Amazing Story behind Chiropractic • The Education of a Chiropractor • The Last Hope • The Master Builder • The Road Back to Health • The Story of Your Amazing Liver • The Story. of Your Amazing Stomach • The Wonderful Kidney • To the New Chiropractic Patient (2 versions) • What Shall Man Live By? • What to Do in Case of an Auto Accident • What Urinalysis Tells Your Chiropractor • What You Should Know about Whiplash Neck Injury • What’s Your Health Problem? • Whiplash Neck Injuries (2 versions) • Why Are Medical Doctors Are Trying to Steal Chiropractic? • Why You May Need X-ray • Your 100 Year Heart • Your Case Analysis • Your Progress Report

Most of these pamphlets can be read by clicking here.

Examples of Far-Fetched Claims
  • Many of the pamphlets said that misaligned vertebrae (“subluxations”) are the “ROOT CAUSE of disease” and that chiropractic adjustments can restore health by correcting them.
  • “How Chiropractic Heals” characterized subluxations as “Health’s Worst Enemy.
  • “The Education of a Chiropractor” (1966) falsely claimed that “Today’s chiropractor is the best trained doctor the world has ever known.”
  • “To the New Chiropractic Patient” (1973) falsely described chiropractic as “the most modern, effective, and fastest-growing  health profession in the world.”
  • “Nerves – Just Nerves” contains this chart which falsely suggests that spinal misalignments cause more than 75 ailments that chiropractors can help.

G.T. also published newsletters that focused on a few of the above topics and could be customized with the chiropractor’s clinic information.



FDA Attacks Claims for Reflexology Device (1976)

In the mid-1970s, I received a brochure for the Rowe Reflex-O-Sage Hand & Foot Roller, which was developed and marketed by Lowell V. Rowe (1920-1997), a chiropractor who practiced in  Hot Springs, Arkansas. The brochure claimed that rolling the device on the hand or foot would relieve many ailments: Reflexology, upon which the device was …

In the mid-1970s, I received a brochure for the Rowe Reflex-O-Sage Hand & Foot Roller, which was developed and marketed by Lowell V. Rowe (1920-1997), a chiropractor who practiced in  Hot Springs, Arkansas. The brochure claimed that rolling the device on the hand or foot would relieve many ailments:

Reflexology, upon which the device was based, is a pseudoscience whose proponents claim that each body part is “represented” on the hands and feet and that pressing on specific areas on the hands or feet can have therapeutic effects in other parts of the body.

The brochure was accompanied by an article in which Rowe outlined a plan to donate money to chiropractic colleges. The device retailed for $11.95. If 5,000 or 6,000 chiropractors averaged 5 sales per month, he would donate $3 per sale which total about  a million dollars annually. The article also contained this disclaimer:

I am not suggesting that doctors or the colleges endorse this product. As the brochure points out, Rowe Reflex-O-Sage was designed for massage therapy or sub-clinical conditions. We make no clinical claims that would take away from your professional image. Nor is it contrary to F. D. A. regulations. Rowe Reflex-O- Sage is responsible for all contents of the Brochure.

It turned out, however, that the FDA saw things differently. On May 20, 1976, Rowe’s company issued this notice:

URGENT: DEVICE LABELING RECALL

The U. S. Food & Drug Administration has alleged that the labeling and literature accompanying the Rowe Reflex-O-Sage Device is false and misleading as to health claims, and fails to bear adequate directions for the use of the device. Consequently, pursuant to the request of the FDA, we are recalling all Reflex-O-Sage literature and labeling.

Please fill out the enclosed card if you are a purchaser or distributor of the Reflex-O-Sage device, and return it by· means of the enclosed return envelope. If you have in your possession any Reflex-O-Sage labeling or literature, please return it immediately by means of the enclosed envelope so that it might be destroyed.

This recall is being made with the knowledge of the U. S. Food & Drug Administration and the Arkansas Department of Health. We appreciate your assistance.

Melinda Bacon
Director of Sales

 

I received no further mail about this device and can find no information about it by searching with Google. So it looks like its marketing was short-lived.



Quackery-Related Depositions

This page provides convenient access to depositions in quackery-related lawsuits and regulatory actions. Some include admissions that severely dimish the credibility of the deponents. Alvin Arzt, DDS (dental malpractice suit, 10/19/95) Robert C. Atkins, MD (false advertising case, 6/25/80) Kenneth Bock, MD (chelation case, 2/27/04) Tim Bolen (Cavitat case, 4/12/06) Jerry E. Bouquot, DDS Disciplinary …

This page provides convenient access to depositions in quackery-related lawsuits and regulatory actions. Some include admissions that severely dimish the credibility of the deponents.



A Skeptical Look at Deborah E. Banker, M.D.

Deborah Ellen Banker, M.D. (1952-2007), was an ophthalmologist who died of breast cancer [1] during a period when the Medical Board of California was questioning her fitness to practice. The DrBanker.com Web site, which has been maintained by one of her long-time associates, describes her this way: In The Field of Ophthalmology and Regenerative Nutrition …

Deborah Ellen Banker, M.D. (1952-2007), was an ophthalmologist who died of breast cancer [1] during a period when the Medical Board of California was questioning her fitness to practice. The DrBanker.com Web site, which has been maintained by one of her long-time associates, describes her this way:

In The Field of Ophthalmology and Regenerative Nutrition For The Eyes, Dr. Banker recognized that the health of the entire body, as well as nutrition and attitude, has a great deal to do with vision, energy of the body and the aging process. Dr. Banker’s non-invasive approach to vision improvement combines techniques of Western, Oriental and Holistic medicine. Dr. Banker’s approach to Non Surgical, Alternative Eye Care integrates modern medicinal understanding of optics, refraction and anatomy along with ancient techniques such as Yoga, Chinese Acupressure, Tai Chi, Ayurveda, Tibetan eye exercises, Japanese Shiatsu, Chinese Medicinal Herbal Eye Care Supplements, and more—along with classic Western Orthoptics and Holistic Ophthalmology. Dr. Banker’s associates work with people both on an individual basis and in group sessions and classes offered several times per year. Dr. Banker’s personally trained associates will guide you through Self Help Vision Improvement exercises for your body and eyes originating from all over the world, such as Bates, Ballet, Kinesiology, Polarity Therapy, Reflexology, Auricular Therapy, Energy Healing, Anti-Aging Techniques, Manual Energy Transfer, Massage and more. Called a “Modern Galileo” by the National Health Federation, Dr. Banker lectured throughout the country crusading for Electromagnetic Medicine and Natural Vision Improvement [2].

The Web site describes Banker’s “electromedicine” this way:

For more than 100 years, electromagnetic medicine has been used to treat various diseases of the body with great success, especially those for which there have been no cures. But little is known to the general public. Electromagnetic medicine dates back as far as 1882 to the work done with batteries by Dr. S.E. Morrill M.D.

Dr. Banker has incorporated twenty years of scientific research on the human electromagnetic field into her specialty of regenerative medicine for the eyes. This knowledge led to the creation of her patented SEEDS machine. Dr. Banker employs electromagnetic medicine or microcurrent stimulation as an integral part of her unique treatment program along with other traditional healing methods and alternative modalities. She uses a microcurrent stimulating device she invented, SEEDS (subtle electromagnetic energy device system), to stimulate energy and life force into damaged or traumatized nerve cells and tissue. In many cases, the nonfunctioning nerve is swollen, not dead, and can be reactivated.

We see tremendous results using the SEEDS system on degenerative eye diseases such as Macular Degeneration, Diabetic Retinopathy, Vascular Retinal Disease, Retinitis Pigmentosa, Glaucoma and Blindness. Besides improving many forms of progressive blindness, the SEEDS machine helps to reset the autonomic nervous system, boosts the immune system, has brought people out of comas and helps reverse many types of degenerative eye diseases. Dr. Banker has thousands of case studies showing miraculous improvements with diseases formerly considered incurable. Some of the “Transcutaneous Electrical Nerve Stimulation” (TENS) devices currently used in the medical treatment of neurological eye diseases are the SEEDS System, the Electro-Acuscope 80, the Micro Stim 100 and other microcurrent systems [3].

Although she claimed to have done research, I was unable to locate any research reports published under her name in a scientific journal or elsewhere. Nor could I locate any details about the SEEDS device.

Her 286-page book Self-Help Vision Care [4] contains hundreds of recommendations for exercises, dietary systems, dietary supplements, Bach flower remedies, and herbal products, not just for eye problems but for dozens of other ailments. Most of the recommendations were useless but physically harmless, but her recommended dosage of vitamin A (25,000 to 50,000 IU per day) was high enough to cause liver toxicity and some of her dietary suggestions could led to dietary inadequacy.

Her acupressure recommendations illustrate her extreme departure from rational medical care. The chart below from page 6-5 of the book is followed by a 3-page table that says which points should be pressed or “shaken” to treat astigmatism, blurry vision, cataract, colds, color blindness, conjunctivitis, diabetes, dizziness, dry eyes, excessive tearing, facial paralysis, facial paralysis, farsightedness, glaucoma, headache, infantile convulsions, insomnia, jaw spasm – grinding teeth, macular degeneration, nearsightedness, night blindness, optic atrophy, pain/swelling, retinitis pigmentosa, sinusitis, tooth problems, twitching eyelids, and several other conditions.

To use the book, she recommends that you try what seems to suit your needs and personality and “check your vision before and after your exercises or methods, to see which ones improve your eyes the fastest and stick with these the most, but do all of them periodically.” A more appropriate title for the book would be Delusional Medicine: A Handbook for People Who Are Clueless.

People who wanted more guidance could order Banker’s Self Help Vision Care Kit—which included a workbook, five tapes, a vision game, and laminated charts—or could purchase phone consultations, self-improvement classes, or a week of treatment (approximately 30 hours) at the Malibu Life Center, which cost $4,000 in 2002 [5].

Medical Board Actions

Dr. Banker received her premedical training at the University of Colorado and obtained her medical degree in 1978 from the University of North Dakota. She completed a residency program in ophthalmology at the University of California, Irvine, but did not become board-certified. She had additional training in acupuncture and Oriental medicine. She became licensed in Colorado in 1988 and practiced there, but failed to renew her license in 1997. In 1998, the Colorado State Board of Medical Examiners charged her with unprofessional conduct and summarily suspended her license. The board was concerned that she was (a) practicing after her medical license had lapsed, (b) treating macular degeneration patients with electrotherapy, massage, and other nonstandard modalities, and (c) prescribing controlled substances after her narcotics license had expired. A few months later, the matter was settled with an agreement under which she was not found to have engaged in unprofessional conduct but would never apply for reinstatement of her Colorado license.

After leaving Colorado, she began practicing in California, which had licensed her since 1989. However, based on what had happened in Colorado, the California Medical Board wanted her competence evaluated. In 2000, she signed a stipulation under which she was reprimanded, was assessed $2,000, and agreed to complete the Physician Assessment and Clinical Education (PACE) Program at the University of California, San Diego, School of Medicine. However, she did not complete the program and told the board:

  • She could not afford the cost of the program because her income was low and the Internal Revenue Services, to which she owed $100,000, had seized money that she was saving to pay for the program.
  • She could not study adequately for the assessment because her vision was impaired.
  • She was concerned that she would not pass the tests given to PACE participants because they were based on Western medicine while most of her medical practice is grounded in alternative medicine.
  • She did not want to undergo a physical and mental examination at PACE because her physical and mental states were never at issue in either the Colorado or California disciplinary action.

In 2006, after additional proceedings, the board placed her on probation for a minimum of two years and indicated that failure to complete the PACE program within a year would be considered a violation of her probation. She was also ordered to pay $$6,706.75 for prosecution costs and was banned from practicing medicine from home [6]. It would be interesting to know whether or not PACE’s examiners would have judged her mentally competent to return to practice, but she appears to have died before they could do so.

Current Promotion

Banker’s methods and products are now promoted by John Monroe, of Boulder, Colorado, who describes himself as a “Natural Vision Educator.” In a recent podcast, he said:

I met Dr. Banker back in the early ’90s like ’91, and I started working with her full time in 1993, so I’ve been doing this over 20 years now. She developed the Self-Help Vision Care Kit. It’s basically used for improving nearsightedness, farsightedness, presbyopia, which is trouble reading small print. We also use it for amblyopia, lazy eye. It’s also used to help get more energy and blood circulation to the eye which can help with eye diseases like macular degeneration, diabetic retinopathy, retinitis pigmentosa. We also work with glaucoma and cataracts.

We’ve had people who are children, adults, seniors. People in their 80s and 90s work with this. We also use attitude changes, lifestyle changes, environmental changes. We also go into diet, nutrition, supplements, herbs, vitamins, Chinese herbal medicines that we’ve been using for years. We’ve helped reverse eye problems and halt the progression of them. If we catch these problems in early stages, the eye diseases and things, it’s a lot easier to reverse them. And then, depending on how strong your prescription is on your glasses and contacts and bifocals and readers, that determines how long it will take to eliminate your need for the glasses.

Among other things, Monroe claimed that exercise can strengthen and improve circulation in the muscles that control the eye, which can help improve such problems as macular degeneration, retinitis pigmentosa, and diabetic retinopathy [7]. DrBanker.com still markets Banker’s book, herbal products, supplements, and “Natural Vision Improvement Workshops.”

Potential Danger

The idea that exercise can improve vision was popularized in the early 1900s by William Horatio Bates and thoroughly debunked by the scientific community [8]. Banker wrote that Bates was correct but said that other techniques she had added improved on what he advised [4]. I believe that for most people, following her advice would be a waste of time, money, or both. But for those with age-related macular degeneration (AMD), it could prove dangerous. In the most serious form (called wet AMD), blood vessels behind the retina grow and leak fluid, which distorts the retina, causes scarring, and interferes with central vision. If detected early, the growth and leakage can usually be controlled by periodic injections into the eye of a drug that stops the abnormal blood growth [9]. If not treated, most of the person’s vision will be lost. The earlier that treatment is started, the better the outcome will be, which means that delaying treatment by pursuing ineffective methods—in some cases, even for a few days—can have serious consequences.

Dr. Banker was only 55 when she died of breast cancer. It would be interesting to know whether her negative feelings about standard medical care influenced her survival time.

References
  1. Obituary: Deborah Banker. The Malibu Times, May 30, 2007.
  2. Deborah E. Banker, M.D.: ophthalmologist / general practitioner, internationally known lecturer in health and vision improvement. DrBanker.com Home page, accessed November 30, 2019.
  3. Research. DrBanker.com, accessed June 26, 2020.
  4. Banker DE. Self Help Vision Care: The Best Preventive Eye Care of Western, Oriental and Wholistic Medicine. Printed by Malibu Life Center Foundation, Malibu, California, March 1994.
  5. Products. DrBanker.com, archived Dec 9, 2002.
  6. Decision after nonadoption. In the matter of the accusation against Deborah Ellen Banker, M.D. before the Medical Board of California, Case No. 16-1999-95260, Dec 14, 2005. (Includes all the previous regulatory documents to which the article refers.)
  7. Monroe J. Healthy eyes and ears. Aging Info Radio podcast, Jan 17, 2016.
  8. Pollack P. The Bates system. In Pollack P. The Truth about Eye Exercises, Chiulton Co., Philadelphia, 1956.
  9. Barak Y and others. The past, present, and future of exudative age-related macular degeneration treatment. Middle East African Journal of Ophthalmology 19:43-51, 2012.


Sparks Fly at Denenberg Hearing on Chiropractic (1972)

During the 1970s, chiropractors campaigned relentlessly for a law that would force Pennsylvania Blue Shield to pay for chiropractic x-rays. In  1972, while one such bill (H.B. 816) was being considered, Insurance Commissioner Herbert S. Denenberg scheduled a hearing to consider a Blue Shield request to increase its premiums. When I asked him to include …

During the 1970s, chiropractors campaigned relentlessly for a law that would force Pennsylvania Blue Shield to pay for chiropractic x-rays. In  1972, while one such bill (H.B. 816) was being considered, Insurance Commissioner Herbert S. Denenberg scheduled a hearing to consider a Blue Shield request to increase its premiums. When I asked him to include discussion of chiropractic’s role in health care, he agreed to do so and invited me to testify.

Denenberg, who was sometimes referred to as “the Ralph Nader of Insurance,” had spoken out repeatedly about excessive medical costs and the overuse of x-rays by medical doctors and dentists. About a year before the hearings were held, I suggested that he also look at chiropractic use of x-rays. He invited me to meet with a member of his staff and to send relevant documents, which I did. He also received reports from the Pennsylvania Medical Society.

My concern about chiropractors was largely provoked by chiropractic ads that greatly exaggerated what they could do. About six months before the hearing, syndicated columnist Jack Anderson became interested in this topic and asked me to keep him informed. At that time, a practice-building organization called Share International marketed collection of newspaper ads that it said had been used effectively in many parts of the country. The instructions for the ads said: ““Re-type each ad on your own stationery for presentation to your editor. This would indicate that they are your own creations, and that the cases mentioned, conditions discussed, etc., are from your own files.” [1]

One of the chiropractors lobbying for passage of the insurance bill was Monroe Schneier, D.C., president of the Pennsylvania Chiropractic Association. Schneier was newsworthy because he had treated Pennsylvania Governor Milton J. Shapp and had contracted with the state to evaluate chiropractic invoices to the Medical Assistance program. Nine days before the hearing, after learning from me that Schneier was using the Parker advertising system, Anderson reported this [2] and Philadelphia’s press outlets amplified the story. During the evening before the Denenberg hearing, I notified the network TV newsrooms that I would be testifying at the hearing and would display the ads.

The hearing was fascinating. Denenberg had done his homework. During the morning  he displayed studies which concluded that chiropractic had no scientific validity and was dangerous. He also asked chiropractors whether they had “anything to really refute these studies” and they said no. During this time and in the early afternoon, no TV crews were present and I began to worry that they would not show up. But five minutes before I was scheduled to testify, two camera crews rolled in. As I approached the podium their floodlights went on, which made it clear to everyone that they had come to film me!

I spoke about the shortcomings of chiropractic education, deceptive advertising, and the probable costs of H.B. 816. In addition to displaying ads in which Schneier had advertised case histories of patients whom he had never seen, I showed ads from other Pennsylvania chiropractors who claimed they could treat gall-bladder disease, heart disease; flu, ulcers, high blood pressure, and hundreds of other conditions. Then I played part of a speech by a prominent chiropractor who says that everyone should see a chiropractor at least once a week for what he called “preventative maintenance.”  I also suggested  that “if chiropractors and their patients want insurance, they should start their own company.” [3]

After I finished, Denenberg invited Schneier and two other chiropractors to join me for a “roundtable discussion.” However, instead of responding to the content of what I had said, Schneier asserted that my testimony was invalid, that I knew nothing about chiropractic, had not studied it, had not practiced it, had not researched it, and had merely presented my own “biases.” After droning on for several minutes about supposed chiropractic benefits and medical shortcomings, he said again that “no one but chiropractors are capable of talking about chiropractic coherently.” At that point, Denenberg referred to the critical studies he had reviewed, which Schneier (incorrectly) claimed were outdated, and they argued back and forth for about half an hour more. The TV crews stopped filming about a minute after Schneier began to speak.

On the day of the hearing, Denenberg issued a news release that cited the H.E.W. Report in Chiropractic and two other reports that were very critical of chiropractic [4]. Newspapers also notred that he handed out a statement that called chiropractic a “cult” and said that Pennsylvania should reconsider its policy of licensing them [5,6]. After the hearing, I told my local legislators that voting for H.B. 816 at the same time the Insurance Commissioner might make headlines opposing it would not be politically smart—and I asked them to point this out when they caucused with other legislators to discuss the bill.

The chiropractors apparently panicked. Instead of waiting until the heat died down, their lobbyists pressured the bill’s sponsors for an immediate vote. This backfired, however, and the bill was defeated by a vote of 107 to 70.

One week later, Schneier ran an ad which characterized the critical studies presented the hearing as the “historical equivalent” of a “scientific study” that the Nazis used in 1952 to “prove” that “Jews were an “inferior and dangerous people who should be exterminated.” [7]

A law was eventually passed to force Pennsylvania Blue Shield to pay for chiropractic x-rays. But the publicity generated by Jack Anderson’s column and the Denenberg hearing helped to delay its passage for several years.

Postscript

In 1976, while the Pennsylvania House passed a similar bill, a lobbyist for the chiropractors had sat next to the sergeant-at-arms during the127-54 roll call vote. On the following day, The Philadelphia Evening Bulletin reported that immediately after the vote, the lobbyist had passed out campaign contribution checks at the rear of the House chamber to at least three of the legislators who voted for the bill. The paper also reported that  chiropractors who lobbied for the bill had given free professional services to staffers and legislators in the nurse’s office in the Main Capitol building [8].

References
  1. Barrett S. Share International’s fraudulent ad system. Chirobase, Nov 14, 2014
  2. Anderson J. Shapp’s chiropractor.  Sept 18, 1972.
  3. Transcript. Public Hearing on Premium Request of Blue Shield of Pennsylvania and the Health Care Delivery System in Pennsylvania. Philadelphia, Sept 27, 1972.
  4. Denenberg questions value of chiropractic treatment. News release, Pennsylvania Insurance Department, Sept 27, 1972.
  5. Sprague B. Denenberg urges ending Pa. chiropractor licensing. Bethlehem Globe -Times, Sept 28, 1972.
  6. Coverage denied: Chiropractic bill defeated in House. Allentown Morning Call, Sept 28, 1972.
  7. Schneier M. Denenberg’s dilemma. Middletown Press-Journal, October 4, 1972.
  8. Runkel D. Lobbyist paid 3 in House. The Evening Bulletin, April 6, 1976, pp 1,12.


James Gary Davidson and the Monterey Wellness Center

The Monterrey Wellness Center—previously called the Davidson Cancer Clinic—was an outpatient facility operated by James Gary Davidson in Monterrey, Mexico, that was falsely claimed to have a very high cure rate for cancers. According to its Web site: The therapy has proven effective in a wide variety of cancers, including breast cancer, brain cancer, lung …

The Monterrey Wellness Center—previously called the Davidson Cancer Clinic—was an outpatient facility operated by James Gary Davidson in Monterrey, Mexico, that was falsely claimed to have a very high cure rate for cancers. According to its Web site:

The therapy has proven effective in a wide variety of cancers, including breast cancer, brain cancer, lung cancer, bone cancer, skin cancer, prostate cancer, cancers of the stomach, liver cancer, colon cancer, pancreatic cancer, leukemia, all of P-53 gene category cancer. The patient is asked to undergo two treatments a day for an amount of time to be determined after doctor’s diagnosis. The treatments consist of lying on a table similar to getting an MRI or X-ray. . . .

A world renowned scientist has developed a scanning method of locating the cancers in a person’s body by focusing on a specific protein found in cancer. Then, by directing a specific electromagnetic frequency [similar to a radio wave] at the cancer cells, the cancer cells implode in the body. Once the cancer cells are killed, the dead cells and matter are absorbed and excreted through normal body processes. These proteins can be detected and measured in the patient’s urine, although the clinic does not conduct measurements. There are no chemicals introduced to the body, and this cancer treatment is absolutely non-invasive with no side effects [1].

To receive the treatment, the patient lay on a table inside a “treatment ring” that created a magnetic field for up to a hour, twice a day. The cost was US$17,500 plus Mexican taxes of US$2,625. These figures did not include travel costs, hotel, food, and other incidental expenses.

The site also claimed that “people have come to this Clinic with inoperable cancer and have left with the cancer completely cured.” Although the Web site did not directly advise whether to give up standard treatment, it encouraged women diagnosed with breast cancer to “consider coming before having any surgery, because CT scans done before and after the Clinic’s treatment have shown clearance of the cancer.” [2]

There is no reason to believe that any of the above claims of effectiveness were true. There is no scientific evidence exposure to magnetic fields is effective against cancer, that cancer cells respond differently than normal cells to a magnetic field, or that the magnetic field produced by the clinic’s device can cause any cell to implode.

The magnetic resonance imaging (MRI) devices used for medical diagnosis use radiofrequency waves, a very strong magnetic field, and a computer to produce cross-sectional images of the body. The patient is placed inside a large magnetic coil. When the magnetic field is turned on, it causes hydrogen nuclei (protons) within the body to line up in one direction. Then selected radiofrequency waves flip these particles in another direction. When the waves are turned off, the particles realign, releasing an electromagnetic signal that the computer translates into an image. The procedure produces no known permanent effect on cell structure or function. It may show the presence of a cancer by producing shadows that represent tumor masses. But it cannot detect any difference between normal and cancer cells at the cellular level.

If magnetic fields were capable of killing cells, MRI devices might seriously damage the patient’s body. Furthermore, even if powerful magnetic fields could kill cancer cells, there is no reason to believe that the clinic’s device—which had a much weaker magnetic field—could have had the same ability.

Because cancers frequently recur, cancer survival statistics are usually expressed in terms of 5-year follow-up. Thus, even if a procedure can cure, it would not be possible to know the outcome without following the patient’s status for many years. Thus the clinic’s claim that people were completely cured before they left was not credible. In addition, there was good reason to conclude that clinic owner, James Gary Davidson, was not trustworthy.

Background History

In 1980, when Davidson lived in Michigan, he made local headlines with claims that he had invested a way to change water into “hydroziene,” a fuel that allegedly delivered nine times the mileage of propane used in trucks. The Grand Rapids Press reported that Davidson had claimed to have a doctorate in nuclear physics from Ohio State University, a master’s degree in microbiology from Ohio University, and a bachelor’s degree in mechanical engineering from Southern Illinois University. However, officials at Ohio State and Ohio University told the reporter that they were unable to find any record that he had attended these schools, and a Southern Illinois official reported that a James Davidson had attended for two semesters at age 17. Although Davidson’s patent attorney said that Davidson had said he had worked for the Atomic Energy Commission, a personnel official at the Department of Energy said that Davidson had never worked for the Commission. The newspaper report indicated that investors had sunk $625,000 into a Davidson-run company that supposedly was studying the fuel, but they had received no test results [3].

In 1992, Davidson was named as a defendant in a civil suit that charged  that he and others conspired to defraud investors in a company called Adtech [4]. Davidson settled with the plaintiffs in 2005, but the court records do not contain the settlement details.

In 1994, Davidson was charged with four counts of securities fraud by selling shares in a plan to develop a synthetic fuel called Chasoline. The criminal information accused him of falsely claiming that (a) he had a Ph.D. degree, (b) “Chasoline”—supposedly made from corn, coal, and water—was better than gasoline, (c) he would build a plant in Illinois to manufacture the product, (d) the licensing for “Chasoline” had been  sold to the Tennessee Valley Authority [5]. Press reports indicate that he  had allegedly bilked about 25 investors out of $45,000 and promised to employ 1,200 people at the manufacturing facility [6]. After pleading guilty to one count of fraud, he received an 18-month conditional discharge and ordered to pay restitution of $19,425 plus fines and court costs [7].

In 1994, Davidson and the company that was supposedly developing Chasoline were accused in a civil suit of borrowing a new tractor, claiming ownership, and trading it in to purchase a different one [8}. The bill of sale was attached to the complaint. I do not know the outcome of the suit.

In 1996, the state accused him of violating the terms of his plea agreement by practicing medicine without a license in Tennessee—using a device claimed to alleviate pain in cancer patients. He then negotiated an agreement in which his conditional discharge was extended by six months and he was fined $6,000 plus $784 for costs [9].

Second Fraud Conviction Leads to Prison Sentence

In June 2000, Davidson, five others, and Macrotech (a corporation he founded) were charged with criminally defrauding clinic patients and investors in the corporation [10]. The 63-count indictment stated:

  • Macrotech was incorporated in Illinois in 1989 and conducts business from its principal office in Paris, Tennessee.
  • As Macrotech’s president and director, Davidson directed its promotion and sale of “investments” in various medical and other ventures, based on false claims that its methods were effective against cancer and various other serious diseases.
  • The others charged in the scheme were:
    • Davidson’s wife Marilyn, was secretary and a director of Macrotech.
    • Thomas S. Sawyer, a vice president or director who promoted the sale of “investments.”
    • Edward Griswold, Jr., a consultant who promoted the sale of “investments.”
    • Graydon Hoover, company accountant who later became a director.
    • William Hardy, assistant manager of the company.
  • The conspirators falsely represented that Macrotech was a scientifically advanced company capable of investigating and offering effective treatments for cancer, multiple sclerosis, arthritis, coronary heart disease, AIDS, emphysema, Alzheimer’s disease, and muscular dystrophy.
  • Through Macrotech, Davison offered treatment for cancer and multiple sclerosis which consisted of passing the victim through a ring-type device that allegedly produced a magnetic field that would allegedly cure the specific disease.
  • Davidson falsely claimed that:
    • He had obtained a doctorate in physics from Karl Marx University in Germany.
    • He was a “Nuclear Physics Doctor.”
    • He was involved in the teaching of “pre-med” students.
    • He was a retired or former agent of the Central Intelligence Agency (CIA)
    • He was born in Germany as a result of human breeding experiments.
  • Davidson discouraged victims from receiving legitimate medical treatment by falsely representing that to severely ill cancer victims that conventional chemotherapy treatments interfered with his treatment.
  • Davidson falsely represented that the cancer treatment offered by Macrotech was capable of exploding or imploding cancer cells which were then purported to have been discharged through the urine of the patient in the form of protein.
  • The defendants used false and fraudulent statements to obtain money as investments or payments to purchase the rights to the falsely represented medical technology and medical treatments. Two investors signed agreements to pay a total of $2.9 million (not all of which was subsequently paid).
  • The defendants omitted and/or fraudulently misrepresented material facts concerning the true nature of Macrotech and the defendants’ qualifications, criminal history, and medical results, namely that:
    • The defendants had no education, training, viable experience or medical credentials related to diagnosing, treating, researching, or administering of medical disease treatments.
    • The defendants falsely claimed to have cured large numbers of cancer patients with Macrotech’s treatments.
    • Potential investors in Macrotech were not told that Davidson had been convicted of a felony securities fraud violation in Illinois.
  • In 1995 and 1996, Davidson falsely represented to several patients and/or their family that the patients were cured or cancer-free after receiving treatment at his clinic. [Assistant U.S. Attorney R. Leigh Grinalds, who prosecuted the case, told the Commercial Appeal reporter that all of the patients were dead.]
  • The various schemes resulted in payments totaling $675,000 to Macrotech [11].

In March 2002, Davidson pleaded guilty to one count of money laundering and one count of mail fraud. The other five defendants had their charges dismissed as part of Davidson’s plea agreement. Davidson faced a minimum sentence of nearly six years in prison, a $500,000 fine, and an order to pay $675,000 in restitution [12]. On September 13, he paid the restitution and was sentenced to 88 months in federal prison plus 2 years of supervised release. He was released on March 17, 2009.

Additional Information
References
  1. Non-invasive, non-chemical based cancer treatment. Monterrey Alternative Wellness Center Web site, accessed June 23, 2000.
  2. FAQs. Monterrey Alternative Wellness Center Web site, accessed June 23, 2000.
  3. Gryzan M. Local inventor, hydroziene remain mystery. The Grand Rapids Free Press, Oct 26, 1980.
  4. Complaint. Philip E. Boynton and others v. Headwaters, Inc., f/k/a Covol Technologies, James G. Davidson, and others. U.S. District Court for the Western District of Tennessee, Case No.1:02-cv-01111, filed May 6, 2002.
  5. Information. People of the State of Illinois v. James Gary Davidson. In the Circuit Court of the Second Judicial Circuit, filed July 18, 1994.
  6. Rash J. J.G. Davidson charged with fraud in Chasoline plan. Hardin County Independent, July 14, 1994.
  7. James G. Davidson convicted of fraud in Chasoline scam. Hardin County Independent, Dec 13, 1994.
  8. Complaint. Bill Nolen v. James Gary Davidson and Panopic Energy Research Corp., Circuit Court of the Second Judicial Circuit Case No 94-LM-19, filed Sept 28, 1994.
  9. Order revoking and modifying conditional discharge. People of the State of Illinois v. James Gary Davidson. Circuit Court of the Second Judicial Circuit, Case No. 94-CF-20, filed April 8, 1997.
  10. Sullivan B. Macrotech Corp. accused of cancer-fighting quackery. Commercial Appeal, June 20, 2000..
  11. Indictment. United States of America, plaintiff, v. James Gary Davidson, Marilyn Davidson, Thomas A. Sawyer, Edgar Griswold, Jr., Albert Graydon Hoover, a/k/a/Graydon Hoover, William Hardy, and Macrotech Corporation, defendants. In the United States District Court for the Western District of Tennessee, Eastern Division. Filed June 19, 2000.
  12. Paris man pleads guilty. USDOJ press release, March 4, 2002


Laetrile in Historical Perspective

Laetrile’s history has been complex, tortuous, kaleidoscopic. Beginning inauspiciously like hundreds of other small-time anti-cancer schemes, Laetrile soared to a notorious pinnacle as the unorthodox brand-name health promotion generating the largest amount of public furor in the nation’s history. Numerous actors played roles in this perfervid drama. Laetrile’s history, first, may be placed within three …

Laetrile’s history has been complex, tortuous, kaleidoscopic. Beginning inauspiciously like hundreds of other small-time anti-cancer schemes, Laetrile soared to a notorious pinnacle as the unorthodox brand-name health promotion generating the largest amount of public furor in the nation’s history. Numerous actors played roles in this perfervid drama. Laetrile’s history, first, may be placed within three successive periods which may be designated: the creation by the Krebs, the McNaughton ascendancy, the appeal to freedom. Then the Laetrile pattern may be compared with the pattern of earlier cancer unorthodoxies.

The Creation by the Krebs

Two men, each named Ernst T. Krebs, father and son, bring Laetrile to market and dominate its early years. Their backgrounds may prove instructive.

Ernst Krebs, Sr., born in 1876, son of a California pharmacist, himself worked as a pharmacist before attending the San Francisco College of Physicians and Surgeons [1,2]. He received his medical degree in 1903. Practicing in Nevada during the influenza pandemic of 1918, Dr. Krebs became persuaded that an old Indian remedy possessed great efficacy in combatting the flu. A rare species of parsley, Leptotoemia dissecta, Krebs wrote in a Nevada State Board of Health bulletin, had permitted the Washoe Indians to survive the epidemic without loss of life, whereas members of other tribes died in great numbers [3,4].

Krebs promptly commercialized his discovery. In San Francisco he set up the Balsamea Company to market a proprietary named Syrup Leptinol, recommended for use in epidemic influenza, bronchial asthma, whooping cough, pneumonia, and pulmonary tuberculosis [5]. A later version called Syrup Bal-Sa-Me-A, with rhubarb added, bore labeling which recounted how Leptotoemia had protected the Washoes and which promised users “miraculous results” [6]. “It strikes at the cause,” the circular read, “quickly checking germ action.” Such claims so disturbed Krebs’ fellow physicians that he resigned from medical societies and never rejoined [1]. Such claims also disturbed the Bureau of Chemistry of the Department of Agriculture, in charge of enforcing the Pure Food and Drugs Act of 1906. The Bureau had shipments of Krebs’ proprietary seized in Missouri, Illinois, and Oregon, terming its labeling false and fraudulent [5,6]. When no claimants appeared, courts condemned the medicines and ordered them destroyed. Dr. Krebs did not give up on his product. At the end of the 1950s a Syrup of Balsamea was still being sold, and Krebs’ promotion contained the suggestion that he had discovered the first antibiotic [7,8]. No longer an over-the-counter proprietary, Krebs now distributed Balsamea under the guise of an investigational prescription drug.

In the intervening years Dr. Krebs had continued to seek new therapeutic entities. Before 1951, when Laetrile surfaced surely in the public record, he had been involved with both cancer treatments and apricot kernels. Krebs had promoted an enzyme, chymotrypsin, as a cancer remedy, explaining its action by the same trophoblastic theory, borrowed from John Beard, a turn-of-the-century Edinburgh embryologist, that was to undergird later Laetrile promotion [9]. And in 1945 Krebs submitted a New Drug Application (NDA) for a drug called Allergenase, manufactured from the kernels of shelled apricot seeds, and claimed to be ”a systemic detoxicant” for treating all allergies, including arthritis, asthma, and “shingles.” [10,11] He had begun work on this drug, he said, in 1924. In due course Allergenase evolved into pangamic acid, otherwise known as Vitamin B-15.

Dr. Krebs told two tales about Laetrile’s origin. The earlier account ascribed a recent discovery date. The later account, furnished in a court affidavit signed by Dr. Krebs in 1965, provided a more remote origin. As of 1965, having a long history for Laetrile had become legally important, because of so-called “grandfather” clauses relating to drugs in both the 1938 Food, Drug, and Cosmetic Act and the 1962 Kefauver-Harris Amendments to that law. Drugs in use before critical dates escaped some aspects of regulation.

Some versions of the Laetrile legend traced the drug’s origin to Dr. Krebs’ researches in the 1920s aimed at making bootleg liquor palatable [12]. In his 1965 affidavit Krebs stated that he had first made an extract from apricot kernels in 1926, calling it Sarcarcinase, containing amygdalin, a chemical known for a century [13]. A later critic has denied that Sarcarcinase could have been Laetrile’s amygdalin-containing ancestor, because Sarcarcinase was a chloroform extract of apricot kernels, and the amygdalin would have gone down the drain with the discarded aqueous portion [14]. In any case, Dr. Krebs stated in his affidavit that sarcarcinase proved too toxic a drug when injected into rats. Steadily improving his extraction process, Krebs asserted, he achieved an ever higher level of amygdalin purity. In 1949 Krebs’ son slightly modified his father’s process and named the result Laetrile. This version of Laetrile’s origin became the standard canon among its promoters.

The earlier tale that Dr. Krebs had told about Laetrile’s beginning dated its birth to 1951. In an interview with Food and Drug Administration officials during December 1952, Dr. Krebs said that ten months before he had begun experimenting with a cyanogenetic glucoside which he had extracted from a mixture containing apricot pits [15]. He had tested it successfully on patients, he asserted, but had kept no records. Injected near the site of a cancerous lesion, Laetrile worked by liquefying the malignant growth through the release of cyanide.

Soon Dr. Krebs and his son presented a more elaborate explanation for Laetrile’s mode of action. The theory proved to be the same one which they had recently used to justify the presumed anti-cancer activity of an enzyme with which they had been experimenting.

Ernst Krebs, Jr., who coined the name Laetrile, had come home to California after peripatetic schooling. He did not have a Ph.D. from the University of Illinois, as he sometimes asserted, nor had he yet received his only claim to the doctorate, an honorary Doctor of Science degree from the American Christian College in Tulsa, Oklahoma [16]. According to California state investigators, Krebs had attended colleges in Mississippi, Tennessee, and California before receiving a bachelor of arts degree in 1942 from the University of Illinois. Also before going to Illinois, Krebs had spent three years as a medical student at Hahnemann Medical College in Philadelphia, the second of which was a repetition of the first year’s work. Krebs devoted two years, from 1943 to 1945, to graduate study of anatomy at the University of California, but was dismissed because of his pursuit of what was deemed unorthodoxy [17].

Krebs, Jr., continued his researches in collaboration with Dr. Charles Gurchot, a pharmacologist who also had left the university (18). The two had published a letter in Science, “Growth of Trophoblast in the Anterior Chamber of the Eye of the Rabbit” ([19] and now set up a foundation bearing Beard’s name to seek a cancer cure fitting his principles [18].

In 1950 Krebs-père and -fils published their own version of Beard’s trophoblastic or unitarian thesis [9]. All cancer, they asserted, is one, brought on when the normal trophoblast cell goes wrong. This cell, which in both sexes emerges from a very primitive cell, is best known for its role in securing the embryo to the uterine wall. This function, the Krebs stated, demands erosion, infiltration, and metastasizing. In becoming cancerous, trophoblasts do the same things, dangerously. Beard had said that some pancreatic enzymes attack trophoblasts. The Krebs and Gurchot had found an enzyme they believed to be specifically antithetical to malignant cells.

The 1950 article, seeing great promise in the enzyme chymotrypsin, did not mention Laetrile. At about the very same time, however—at least, according to Dr. Krebs’ 1952 account—Laetrile was born. And soon the Krebs presented a Beardian explanation for Laetrile’s mode of action. The Laetrile molecule, the theory held, when it reached the site of the cancer, was hydrolyzed by an enzyme, beta-glucosidase, releasing cancer-killing hydrogen cyanide [20,21]. This enzyme accumulated in cancerous areas in much greater quantity than it did in healthy cells, so the cyanide was released where it was needed. Moreover, normal cells were protected by another enzyme, rhodanese, which detoxified any cyanide that might be liberated in or stray to them. Cancerous cells lacked rhodanese. Thus Laetrile, according to its promoters’ theory, fulfilled a prime objective of the nascent field of cancer chemotherapy, specificity of action: it targeted damage to cancerous cells without injuring normal cells unduly.

Right from the start Laetrile became related to a number of separate but intertwining organizations, legally distinct but linked, at least so FDA officials came to believe, through Ernst Krebs, Jr., their “guiding light.” [8,22] The John Beard Memorial Foundation, the research unit, became Krebs, Sr.’s province. Krebs, Jr., personally supervised production in the Krebs’ Research Laboratories. The finished product then went to the Spicer-Gerhart Company in Pasadena which distributed Laetrile as an investigational drug. Some California general practitioners began to use it in treating patients with cancer, and requests for it came in from other states and from overseas. A New Jersey group of doctors, for example, used Laetrile. Their business manager, Glenn Kittler, upon hearing a tape recording of Krebs’ explanation of the trophoblastic theory, responded by opining that Krebs was “well on his way toward the Nobel Prize.” [22]

California cancer specialists were not so quickly persuaded. The Cancer Commission of the California Medical Association sought to secure some Laetrile from Krebs to permit a clinical trial under the direction of the Research Committee and the Tumor Board of the Los Angeles Hospital. While “anxious” to have clinical work commenced, Krebs, Jr., replied, he foresaw difficulties [23]. Especially he objected to tests made by physicians ignorant of trophoblastic theory. “Conducting work under these conditions,” he wrote, “is almost tantamount to attempting to conduct an orderly practical industrial implementation of nuclear fission with the cooperation of physicists who failed to accept the E=mc2 formula and were gravely in doubt about the atomic constitution of matter.” Unless a doctor of his own choosing could direct the experiment, Krebs would send no Laetrile. Such a stance recurred not infrequently in Laetrile’s future: an expressed desire, sometimes a demand, for trials, but heel-dragging about complying with the established parameters of scientific research, a denial that mainstream scientists could test Laetrile fairly. In Krebs’ metaphor from physics, be it noted, he baldly transposed orthodoxy and unorthodoxy.

With a supply of Laetrile secured from the Food and Drug Administration [24], the Cancer Commission of the California Medical Association sponsored at three cancer research centers controlled trials of Laetrile as a treatment for various cancers in mice [25]. None of the tests revealed that Laetrile had any effect on the course of the disease. The Commission also assembled as much information as it could about patients who had been treated with Laetrile—forty-four cases in all—and found no objective evidence that Laetrile alone exercised any control over cancer. The conclusion was based on examination of seventeen cancer sufferers still alive and on autopsies of nine of the nineteen patients who had died. Furthermore, the Commission disputed the explanation by the Krebs as to how Laetrile purportedly functioned. The molecule-cleaving enzyme which supposedly released hydrogen cyanide at the site of the cancer, held by the Krebs to be more abundant in cancerous than in normal cells, in fact, said the Commission, was not; normal cells contained more of the enzyme than did neoplastic tissue. In time scientists were to presume that, because of the extremely small concentrations of beta-glucosidase in human tissues, Laetrile administered parenterally would undergo scarcely any metabolic breakdown and would leave the body in the urine virtually intact [26].

Krebs, Jr., and the small coterie of Laetrile physicians dismissed the California Cancer Commission’s report. A newer improved version of Laetrile and new dosage levels, they said, invalidated the Commission’s distorted findings [22,27]. In any case, asserted one Laetrile doctor, no curative claims had ever been held out, only the promise of stopping the cancer’s growth and prolonging the patient’s life with diminished pain and greater comfort. Despite the denial, Dr. Krebs, Sr., had in fact been quoted in the press as saying that Laetrile wrought cures in forty percent of cancer patients and brought improvement to the remaining sixty percent [28].

Laetrile’s proponents no doubt welcomed controversy as a way of making their product better known. They had courted publicity. The Cancer Commission first heard about Laetrile through a barrage of inquiries from national magazines, news services, and the California press [25]. A Laetrile physician had given a list of his patients to a newspaper, inviting reporters to interview and photograph them. Krebs, Jr., worked hard at expanding the market for his investigational drug. Some insight into his zeal may be derived from what he wrote, some years later, to an entrepreneur hoping to market Laetrile under his own trade name in foreign areas:

… [T)he field of cancer chemotherapy is a law to itself. This jungle offers the greatest opportunity anywhere in commerce at this moment, but there are snakes in every bush. I believe . . .  it’s best to push hard, sell, don’t be backward about disaffecting a few, and establish . . . [Laetrile] right from the start as something precious that not even hospitals get for nothing.” [29]

In the same letter Krebs noted: “. . .  [O]ne can usually buy even the top medical investigators as one does sirloin steak—and at about the same price.”

In fact, reports suggesting Laetrile’s utility in cancer came not from the top but from a few clinicians overseas and several American general practitioners (26] American cancer experts dismissed the pro-Laetrile studies as purely anecdotal or so poorly designed as to lack validity. If the market grew for Laetrile during the 1950s, it was at a modest rate. Krebs, Jr., secured a British patent for the product, but it did not mention cancer [30].  He joined with Fred J. Hart, a promoter of therapeutic devices, in testifying against a California bill aimed at curbing cancer quackery, but the law passed anyway [31]. Another signal ominous for the Krebs appeared at the start of the new decade. In 1960 the Food and Drug Administration made its first seizure of an interstate shipment of Laetrile. That same year a decade of litigation had finally driven Harry Hoxsey from the field of cancer quackery [32]. His successor at the Dallas clinic, barred from using Hoxsey’s mix of botanicals, had ordered the lot of Laetrile which the FDA had seized [33].

The Food and Drug Administration had watched the Laetrile venture from its early days. The California Cancer Commission critique of 1953 raised the question of taking regulatory steps. After weighing the matter at the highest level, FDA opted for continuing close scrutiny of operations, not immediate action. Other projects held higher priority, and manpower was short. Laetrile was both small in size and difficult to combat. “. . . [T)his type of promotion, namely an article distributed as a new drug for investigational purposes but indirectly promoted for use in cancer, is hard to handle” (34] So concluded a headquarters memorandum. If Laetrile were directly offered as a cancer treatment in printed labeling, chances for controlling it through regulation would be “brighter.” Thus the Krebs’ cautious approach, depending mainly on word-of-mouth promotion instead of bold labeling claims, postponed trouble, probably at the expense of growth. The 1960 seizure signaled a change.

The first period of Laetrile’s history, during which the Krebs’ brand of amygdalin, shrewdly but cautiously promoted, made modest gains without encountering serious regulatory troubles, ended about 1963. By then both state and federal governments, the latter with powerful new weapons given it by the Kefauver-Harris law, had attacked in force. Public worry about drugs, cued by Senator Estes Kefauver’s hearings and the frightening thalidomide episode, which lay behind the Tennessee Senator’s law, had soared to new heights. Besieged by regulatory actions, the Krebs yielded real control over their enterprise to a Canadian citizen possessing capital, audacity, and a broader vision of Laetrile’s destiny.

The McNaughton Ascendancy

Andrew Robert Leslie McNaughton first met Ernst Krebs, Jr., so McNaughton testified, in a Miami drugstore in 1956 or 1957 [12]. Shortly before this, McNaughton had informally set up a foundation in Montreal, incorporated in 1958, to support researchers possessing unorthodox but possibly useful ideas who found it difficult to secure funds elsewhere. In 1960, after spending several weeks in the Krebs’ San Francisco laboratory, McNaughton Look some Laetrile back with him to Canada, persuaded several tobacco companies to contribute research funds, and, through his McNaughton Foundation, distributed Laetrile to a number of Quebec physicians as an investigational drug. In 1961 McNaughton founded Biozymes International Ltd., a manufacturing concern, which the next year began to produce Laetrile [36].

McNaughton came from a notable family and had enjoyed a glamorous if at times checkered career [36-38]. His father had headed Canada’s armed forces during World War II. The son had served as chief test pilot for the Royal Canadian Air Force. He had sold arms to Israel and had let Fidel Castro capture weapons which McNaughton had been commissioned to sell to Batista, the Cuban president, for use in suppressing Castro’s insurgency. In time McNaughton and his foundation became targets of a suit brought by the U.S. Securities and Exchange Commission, charging promotion and sale of unregulated securities, stock in Biozymes International-al. In 1973 a district court in California, not having received an answer to the complaint, rendered a default judgment of permanent injunction (39]

Besides launching his Laetrile enterprises in Canada, McNaughton undertook an initiative in the United States. Taking Krebs, Jr., and a pro-Laetrile. physician along, McNaughton went to Washington. Through the good offices of a New Jersey Congressman, he secured conferences with Health, Education and Welfare and Food and Drug Administration officials [40,41]. What would it take, the Laetrile party asked, to have a New Drug Application favorably considered? Krebs explained the rationale behind Laetrile’s purported action, indicating that dosage levels now were higher than those first used. No claims for cure of cancer would be made, only for palliation. While safety data seemed complete, evidence of effectiveness admittedly rested on clinical research outside the nation’s borders, although three United States clinical investigations were under way. In the granting of an NDA was only safety considered? Not, FDA officials replied, with drugs prescribed for life-threatening diseases. In such cases safety and efficacy could not be separated. An innocuous product which failed to help the patient would constitute a hazard when used in lieu of treatment that offered some promise of success. Without sound clinical evidence from recognized experts, the government men told Krebs and McNaughton, a New Drug Application could not be deemed complete.

In November 1961 the FDA charged Krebs and the John Beard Memorial Foundation with violating the law [42]. The case involved not Laetrile, but Krebs’ other major product, pangamic acid or Vitamin B-15. Krebs had shipped capsules of this new drug into Oregon and Florida without having an effective NDA, in the same way in which he was distributing Laetrile. Both the Foundation and its sole officer pleaded guilty to the charge, Krebs being fined $3,750 and sentenced to prison. Imprisonment was suspended when Krebs agreed to the terms of a three-year probation. One of those terms barred Krebs and his Foundation from manufacturing and distributing Laetrile until there should be an approved NDA.

The court shortly agreed to a modification of the probation order permitting Krebs to exhaust the supply of Laetrile on hand by shipping it without payment to the McNaughton Foundation in Montreal and to a few physicians in the United States so that experiments might continue [43,44]. Laetrile patients and their families had written pleading letters to the judge.

When the small reserve supply of Laetrile came to an end, interstate distribution supposedly would cease. NDAs submitted by both Krebs, Jr., and Krebs, Sr., fell short of meeting FDA’s standards for acceptance [45]. Krebs, Jr., and the John Beard Memorial Foundation obeyed the court’s ruling and stopped making Laetrile. But production and distribution did not stop. Krebs, Sr., and Krebs Laboratories, according to FDA records, picked up the task. And McNaughton’s Canadian venture quickened. He got some of his raw material for making Laetrile from England, Krebs, Jr., thought, and for one stage in the production process sent the drug into New Jersey [46].

Indeed, McNaughton increasingly made his powerful presence felt on the entire Laetrile scene. He strove, without success, to get the Damon Runyon Cancer Fund to evaluate Laetrile, reaping some headlines from the effort [47]. However, a vastly more successful publicity coup soon followed. The American Weekly, a Hearst publication, during March 1963 ran two articles presenting Laetrile in a most favorable light [48]. They were followed shortly by a paperback book from which they had been taken, Laetrile, Control for Cancer[2]. “The most important medical news of our time, “the cover promised, “First major breakthrough in the cancer mystery. The day is near when no one need die from cancer. LAETRILE, the revolutionary new anti-cancer drug . . . WILL BE TO CANCER WHAT INSULIN IS TO DIABETES.” Written by Glenn D. Kittler, who earlier had acclaimed Krebs, Jr., as Nobel Prize material, the book presented a highly dramatic version of Laetrile’s discovery and a most optimistic rendering of Krebs-sponsored clinical experience with the drug. To use the term “cures” for cancer Kittler considered “inaccurate. but he added: “The idea of a cancer control, on the other hand, is perfectly plausible. In the minds of an increasing number of leading scientists, the best control now available is Laetrile.” The book concluded by quoting Andrew McNaughton to the same effect. McNaughton contributed also the book’s foreword, to which he appended his Foundation’s Montreal address. Letters of inquiry sent to the Foundation received replies saying Laetrile might soon be available

from Canada and asking cancer sufferers to have their doctors write the Foundation [49]. Some United States citizens crossed the border to Montreal to get Laetrile injections [50].

While thus deeply involved in a publicity venture tremendously expanding Laetrile’s national visibility, McNaughton also worked away on other fronts. He sent Laetrile made in Canada to a foreign trade zone in San Francisco for trans-shipment to markets in the Far and Middle East [51]. And he continued to deal with the Krebs. Relations were sometimes tense, but McNaughton — at least in the judgment of observing food and drug officials — came to assume the upper hand [52]. In speaking of Laetrile, he often used the proprietary “we,” and he acted as if he were making the important decisions. When the probation stock of Laetrile ran out, it was McNaughton who went to Washington, this time alone, to see if he could pressure the FDA into letting him have more, arguing that he should not be penalized for the misdeeds of Ernst Krebs, Jr. [53]. FDA officials pointed out that Laetrile still did not have a completed NDA and that the new Kefauver law had stiffened standards for admitting new drugs to the market.

Legal difficulties, indeed, soon cast shadows across the publicity coup resulting from Kittler’s book. California, after holding hearings under its new law aimed at specious cancer treatments, banned Laetrile as a quack remedy [54,55]. The Canadian Food and Drug Directorate barred further distribution of Laetrile by the McNaughton Foundation on the grounds that its safety and efficacy had not been proved [56]. McNaughton, calling unconstitutional the law under which the Directorate had moved, sought in 1964 to enjoin the Directorate from enforcing it. But McNaughton lost in court. The next year the Food and Drug Administration strove to curb Dr. Krebs, Sr.’s small-scale but persistent shipment of Laetrile in interstate commerce. After protracted court action, he was enjoined, later cited for criminal contempt, and finally fined for violating his probation [57]. Dr. Krebs probably prescribed Laetrile for his patients through the remainder of his life, although he gave up manufacturing and distributing it, while maintaining the production of pangamic acid [58]. He died in 1970 from a fall on the stairs at the age of 94 [59,60].

In the meantime, Andrew McNaughton had moved to California. Both the Krebs, father and son, had been enjoined from dealing in Laetrile, and in Canada so had McNaughton himself. Using several corporate names, McNaughton continued the manufacture of Laetrile in San Francisco, then in Sausalito [38,61], and from his transplanted McNaughton Foundation he tried once more in 1970 to get FDA approval for experimental use of Laetrile on human subjects [62-64]. McNaughton’s submission of an IND, an Investigational New Drug application, a document required by the Kefauver-Harris Act before human trials could proceed, became a cause celebre. Upon receipt of the IND, the FDA routinely approved it, in accordance with then prevailing practice. A quick appraisal did not reveal in the application the kind of promising evidence from animal experimentation that would provide a reasonable basis for expecting anti-tumor activity in man. Eight days later the FDA wrote McNaughton that the IND could not be continued without more satisfactory data, and when no new information arrived before the deadline set in regulations, the FDA cancelled the application. Further information later submitted by McNaughton did not persuade Food and Drug officials to change their minds. Manufacturing controls and preclinical and clinical data all remained unsatisfactory.

Laetrile supporters reinterpreted these events into a tale of FDA’s perfidy. According to this version, FDA’s initial automatic acceptance of an IND until the evidence could be examined became instead a bona fide acceptance which the agency then reversed under pressure from the political moguls of the cancer research establishment [65,66]. A pro-Laetrile reporter predicted “a showdown” between the hidden forces of repressive orthodoxy and champions of alternate modalities [65].

A showdown did indeed occur. A varied constellation of circumstances had moved the Laetrile cause upward on the path of political power. Not only had Hoxsey’s star set through governmental action and exposure, so too had Krebiozen’s virtual demise arrived by 1966, thus creating a vacuum at the apex of cancer unorthodoxy ready for filling by a new contender. The publicity generated by Kittler’s book gave Laetrile a good boost toward the top. Moreover, McNaughton gained a recruit to his cause from the inner citadel of the cancer research establishment who was destined to play for Laetrile something like the role Andrew Ivy had played for Krebiozen. Dean Burk, who had received his Ph.D. in biochemistry from the University of California, had devoted a more than forty-year career to cancer investigation, with many honors along the way, and now was chief of the Cytochemistry Section of the National Cancer Institute [65,67]. In 1968 McNaughton had persuaded Burk to undertake research on Laetrile, and by the time two years later of FDA’s rejection of the McNaughton Foundation’s IND, Burk had become a fervent Laetrile champion, calling many of his contrary-minded governmental associates “scientifically immoral.” [65] Stepped-up Laetrile publicity focused the spotlight on Burk.

The scope of Laetrile publicity had also broadened because a new organization had sprung up to wave its banner and because an established league of unorthodox health promoters had taken up Laetrile’s cause. The new group, the International Association of Cancer Victims and Friends, was founded in 1963 by a San Diego schoolteacher, Cecile Pollack Hoffman [50,68]. She herself had turned to Laetrile with despair and hope. In 1959 she had sustained a radical mastectomy because of breast cancer, and three years later the spread of cancer led to further surgery. She learned of Laetrile when her husband saw a copy of Kittler’s book in an airport lobby. Cued by McNaughton’s foreword, Mrs. Hoffman journeyed to Montreal for Laetrile injections. She continued receiving them closer to home, by crossing the border to Tijuana, becoming the first Laetrile patient of a Mexican physician, Ernesto Contreras Rodriguez. Persuaded that Laetrile had saved her life, angry that this treatment was not legally available in the United States, Mrs. Hoffman established her International Association. Through print, meetings, and personal evangelism, the association castigated “out-of-date, outmoded, so-called ‘orthodox’ treatment” and vigorously espoused what Mrs. Hoffman termed “non-toxic, beneficial therapies,” especially Laetrile. Krebs, Jr., Contreras, and in time Dean Burk addressed IACVF assemblies [69-71]. The organization provided cancer sufferers with information on how to get to Tijuana. When Canada joined the United States in making Laetrile illegal, Dr. Contreras’ business boomed. Mrs. Hoffman died in 1969 of metastatic cancer, but her organization continued on [72].

Mrs. Hoffman’s emphasis upon “Freedom of Choice” in cancer treatment echoed the constantly reiterated dominant theme of another organization which had been established eight years before she founded the IACVF. The National Health Federation was founded in 1955 [73,74]. The moving spirit in its creation was Fred J. Hart, a California promoter of health devices who had just been enjoined by Food and Drug Administration initiative from distributing them in interstate commerce. Other NHF founding fathers also had encountered legal restraints, some spending time in jail, for false claims about devices, dietary wares, and so-called cancer treatments. One of Harry Hoxsey’s lawyers became the Federation’s first legal representative in Washington. The Federation developed into a powerful league linking the various segments of health unorthodoxy. They held up each other’s spirits and sought new converts at frequent meetings, developed skillful propaganda playing on public anxieties and frustrations, grew adept at pressure politics, mobilizing the faithful for letter-writing campaigns and confrontation lobbying. Hart and Krebs both testified against the California cancer law, and the Federation welcomed Laetrile supporters to its ranks and gave their cause strong support. Condemning overweening and bumbling bureaucracy for administering health laws to favor the medical establishment, the NHF pleaded for patient freedom of choice so that each ailing person might treat himself from amongst unorthodoxy’s abundant catalog of wares. The Federation journal pictured Washington and Lincoln on its cover over the caption, “They Too Fought for Liberty Against Great Odds.” These criticisms of governmental actions in the health field mounted amidst the growing broader disillusion with governmental policy resulting from the war in Vietnam.

The distorted Laetrile version of the FDA’s rejection of McNaughton’s IND received widespread coverage in the publications of unorthodoxy and in the sensationalist press [75]. A barrage of angry mail bombarded Washington. FDA’s police state tactics, charged one protester, “reduce[d] Hitler and Stalin to the status of small time hoodlums.” [76]

Mail deluged the Congress as well as the FDA [77]. The National Health Federation Bulletinhad explicitly urged this action [78]. Representative Lawrence H. Fountain, after committee hearings, brought pressure on Elliot Richardson, Secretary of Health, Education, and Welfare, to sponsor further evaluation of Laetrile’s efficacy [79]. The FDA checked its own internal judgment by soliciting external expert opinion. A panel of independent cancer specialists was assembled, which reviewed the data submitted in McNaughton’s application, heard face-to-face what McNaughton and Burk had to say, sought whatever new information Laetrile physicians like Contreras might have to offer, then concluded that the sum total of evidence did not warrant testing Laetrile on humans. Further rodent tests in recognized independent laboratories, the committee held, might be desirable. The Secretary considered the conclusions of FDA’s ad hoc committee valid [63,80]. National Cancer Institute tests on mice had offered no promise of Laetrile’s effectiveness, and no new NCI tests seemed worth undertaking. That Institute, however, the Secretary said, would recognize grant applications for further testing from qualified independent investigators. Secretary Richardson reported his judgments to Congressman Fountain who did not continue to press the issue. A bill introduced into the House by another member, to authorize research on and testing of non-toxic substances for the diagnosis, treatment, and prevention of cancer, made no headway [81].

Regulatory pressure on Laetrile promoters did not subside. In 1971 the state of California began a criminal case against Ernst Krebs, Jr., charging him with practicing medicine without a license and, aided by his brother Byron, an osteopathic physician, with distributing a prohibited drug [82-84] Two years later the brothers pleaded nolo contendereto violating the state cancer act’s taboo on Laetrile. The judge fined them and placed them on probation. The terms required them to obey all city, state, and federal laws, especially the cancer treatment provisions of the California code, and forbade Krebs, Jr., to practice medicine without a license. California took further legal steps as well. A case against Mary Whelchel sought to impede the turning wheels of an accelerating “underground railroad” which assembled cancer victims from all over the nation in a boarding house on the United States side of the border, then ran them across to Tijuana for Laetrile treatment in Dr. Contreras’ flourishing operation [84,85]. In 1971, Mrs. Whelchel was convicted of delivering an illegal compound for treating cancer, fined, and, as a term of her probation, was forbidden to transport anyone to Mexico. (It should be noted, however, that this conviction was set aside two years later.)

The Appeal to Freedom

Such relentless regulation coupled with scant success from the epistolary campaign in Washington sped changes already launched that remade Laetrile’s self-image, the explanation for its therapeutic action, indications for its use, the strategy and tactics of its promotion, even its very name. Andrew McNaughton remained commanding general but became an officer in exile. In 1974 his reputation in his Canadian homeland suffered a blow when a judge convicted him of conspiring fraudulently to affect the market price of a mining stock [86]. The United States, with Laetrile under attack on both state and federal levels, must have seemed increasingly hostile. McNaughton took up residence in Tijuana. The press credited his foundation with sponsoring both manufacturing and clinical facilities for Laetrile in the Mexican city [36], stations at the underground railroad’s terminus. The railroad began to run the other way, carrying smuggled Mexican Laetrile into the U.S.A. [87].

McNaughton thus continued, as a reporter put it, “more than any other man … the driving force behind the Laetrile movement.” [88] In this third period, however, McNaughton in exile gained powerful allies of great leader-ship potential in the United States. This chain of events began in 1972 when a California general practitioner, Dr. John A. Richardson, was arrested at his Albany clinic, charged with prescribing Laetrile in violation of the state’s anti-quackery law [89]. The dramatic arrest, filmed on television cameras, involved policemen with drawn guns and a thorough search of the premises. The physician spent a brief time in jail. A trial before a judge, finding Richardson guilty, was quashed on appeal. Two jury trials followed, both ending with jurors split [36,90] Eventually the California Board of Medical Quality Assurance revoked Dr. Richardson’s license to practice medicine on grounds of “Gross negligence and incompetence.” [91,92]

Richardson’s initial arrest upset some of his fellow members of the John Birch Society. Such dedicated disciples of freedom-from-government doctrine saw in Richardson’s plight a prime example of bureaucratic oppression. Led by Robert W. Bradford of Los Altos, a small group of ultraconservatives founded yet another organization to help Laetrile’s besieged prescribers [93]. Bradford was a nuclear technician on the Stanford University staff, working on the building of a linear accelerator for research in subatomic physics. Poised, articulate, skilled at organization, Bradford, aided by equally dedicated associates, quickly made a success of the new Committee for Freedom of Choice in Cancer Therapy [36,94,95]. In 1975 he gave up his Stanford job to devote full time to the Committee and to Laetrile. Ties with the nation’s already existing conservative network surely helped immensely in the speed with which the Committee established local branches. By 1977 Bradford claimed five hundred chapters with some 35,000 members.

The Committee and its allies focused upon freedom, making any governmental interference with a cancer sufferer’s right to take any remedy available seem a violation of the Constitution and the fundamental rights of man. Thus an atmosphere of high principle infused the zealous campaigning in Laetrile’s behalf. Laetrile’s opponents, in the Committee’s propaganda, constituted a selfish conspiracy of those involved in orthodox cancer research and therapy, futilely cutting, burning, and poisoning their victims, and rejecting hopeful treatments like Laetrile for fear of doing themselves out of their jobs. The Committee showed great ingenuity at making their message widely known. They employed meetings, films, pamphlets, paperback books, quickly triggered letter-writing campaigns, and the assembling of the faithful for legislative hearings. Full-time crusaders sought out cancer victims and urged Laetrile upon them and upon members of their families [96]. Counsel could be given as to how to get to Contreras’ clinic in Mexico or how to acquire Laetrile in the United States. Indeed, some Committee leaders, including President Bradford himself, allegedly at great personal profit, engaged in a conspiracy to smuggle Laetrile in from Mexico and, with much surreptitious ingenuity, distribute it within the United States. After a three-month trial in 1977, Bradford, Dr. Richardson, and others were convicted of this conspiracy; the Court of Appeals for the Ninth Circuit confirmed the convictions [97]. McNaughton, also indicted, pleaded guilty [87].

Laetrile in the 1970s assumed a different character from the chemotherapeutic Laetrile with which the Krebs began. In 1963, in a letter to the Food and Drug Administration, Dr. Krebs had asserted: “The cyanogenetic glucosides belong to the nutritional vitamins and should not be classified as drugs.” [98] Here appears the earliest reference encountered in the file to Laetrile’s future destiny. Already, Krebs, Jr., had committed himself, as part of his probation, not to distribute Laetrile as a drug. Perhaps both father and son had begun to wonder if legal restrictions might not be less stringent under the food sections of the law. Such a shift in Laetrile’s status would require a modification of the prevailing chemotherapeutic explanations of Laetrile’s mode of action. Shortly Krebs, Jr., published a pamphlet, not really retreating, but adding the suggestion that Laetrile could be characterized as a pro-vitamin for B-12. The pamphlet bore the title, “Cancer Is a Deficiency Disease.” [21]

As regulatory actions mounted, Krebs, Jr., in 1970 brought his pamphlet title to full flower. In an article in the Journal of Applied Nutrition he asserted that Laetrile and other “nitrolosides” made up a true vitamin which he denominated B-17 [99]. Vitamin B-17, he wrote, amounted to a cancer-protective factor. Moreover, Krebs asserted, in this “new vitamin . . . all of us are severely deficient.” Cancer could be cured by massive injections of the vitamin. Cancer could also be prevented by smaller quantities, made from de-fatted apricot kernels, regularly taken by mouth. Four years before the appearance of this article Dr. Krebs had begun to distribute an oral dosage form of Laetrile (100]. Now that form became popular, widely publicized by McNaughton, as co-therapy with injections of Laetrile in cancer treatment and, among perfectly healthy people, as a presumed preventive. Chewing unprocessed apricot kernels bought at health food stores also came into vogue.

If one were interested in Laetrile as a commercial venture, one might anticipate several advantages from this combination of new directions. Vitamin status for a product, one could argue and hope, might bring some immunity from actions under the drug provisions of both state and federal law. Moreover, the concept of cancer prevention would certainly elicit broad public interest, for of all threats, including war, Americans feared cancer most. Potential sales of a preventive could be enormous. And, if to the popular mind the word “cancer” bore ominous overtones, the word “vitamin” evoked glamorous reverberations of buoyant health (101]. Americans had mounted to a new plateau of concern about their health, accompanied by a wide variety of approaches toward do-it-yourself safeguarding, by no means all of them sound. Health food marketers, including National Health Federation members, both agitated the public’s concern about health and oversold the need for vitamin supplementation [102].

Nutritional scientists repeatedly denied that Laetrile fulfilled any of the criteria for a true vitamin [103-105]. “In short,” summed up a veteran vitamin researcher, Dr. Thomas H. Jukes, “nothing could be less like a vitamin than laetrile.” (106] Despite such criticism, Laetrile’s vendors continued to assert this claim. In testifying in 1977 before Senator Edward Kennedy’s Subcommittee on Health, Ernst Krebs, Jr., termed Laetrile “a scientific revolution as profound as the germ theory of disease . . . and the Copernican theory.” [107] What Vitamin C is to scurvy, niacin to pellagra, and Vitamin D to rickets, he suggested, Vitamin B-17 is to cancer. If every American took Laetrile regularly, Dr. Richardson told the subcommittee, “in 20 years cancer would be relegated to the dusty pages of history.”

To make amygdalin accessible for regular self-dosage by the American public, Laetrile’s sponsors displayed much marketing skill. In 1972 there appeared in California a consumer product bearing the trade name Seventeen. Just in front of the name on the carton came a picture of a bee. A McNaughton Foundation representative offered a reporter from a San Jose newspaper a chance to interview the noted cancer specialist, Dean Burk, who happened to be visiting the Bay area [108,109]. By this route Burk’s praise for the new food supplement found its way into the press. Bee-Seventeen, Burk said, contained three percent Laetrile, thirty percent protein, fifty percent unsaturated fats, with the remainder minerals. The powder was to be taken daily with juices or milk. Laetrile, Burk told the reporter, could both prevent and cure cancer, but no medical claims were being made on behalf of Bee-Seventeen. It was offered for sale solely as a food.

Such a ruse did not protect the product from action by the Food and Drug Administration. The manufacturers of Bee-Seventeen were enjoined from distributing what the court termed both an unapproved food additive and a misbranded drug [110]. Other amygdalin-containing products, like Aprikern, though devoid of therapeutic claims in their labeling, were also barred from the marketplace [111].

Laetrile’s champions not only propagated their vitamin gospel with aggressive vigor; they also took the offensive against their critics in other ways. Oppressed by federal food and drug law and by the California anti-quackery statute, the Laetrile coalition turned its attention to legislative chambers. Several efforts to repeal the efficacy provision in the California law failed [112]. In the national Congress, Laetrile supporters favored a bill introduced by Representative Steven D. Symms of Idaho which would have repealed the provision of the Kefauver-Harris Act requiring that new drugs be proved effective before being permitted on the market [113,114]. This bill gained some 140 co-sponsors in the House but made no progress toward enactment.

Laetrile’s major legislative push aimed at persuading state legislatures to pass laws legalizing the extract made from apricot kernels. Bills differed in substance from state to state, although most would at least permit physicians to prescribe Laetrile for patients certified as terminally ill of cancer [115]. Cancer specialists pointed to the great difficulty in achieving any satisfactory definition of the word “terminal.” [116] Alaska enacted the first such law in September 1976, and within two years sixteen other states had followed suit. Other legislatures pondered Laetrile bills and defeated them. The deliberative bodies in Indiana, Illinois, and Rhode Island enacted their measures over vetoes by the governors [117,118]. In New York, two years in succession the governor’s veto held.

The scenarios in the several states had much in common [119]. A cooperative assemblyman introduced a bill at the request of a constituent. In due course the health committee held hearings. The hearings, replete with drama, became newsworthy happenings, recorded by television cameras, widely reported in the press. In some states, orthodoxy and unorthodoxy got equal time in number of testifying witnesses. In other states, pro-Laetrile sentiment was dominant. In news coverage, unorthodoxy—the underdog, the challenger—received the greater play. Members of The Committee for Freedom of Choice in Cancer Therapy turned out in force. Wearing campaign buttons, they packed the galleries, intense, completely absorbed. Depending on the strictness of the rules imposed, Laetrile’s friends either shouted or murmured praise for pro-Laetrile testimony, and heaped imprecations, either loudly or sotto voce, upon spokesmen from the state medical society, nearby universities, the American Cancer Society, the Food and Drug Administration, who explicated Laetrile’s unproven status. The Laetrile lobby produced living testimonials claiming to demonstrate the contrary. After my operation—so the pattern went—my doctors gave me only a year to live, but I took Laetrile and here I am three years later, speaking before you legislators. The main thrust, however, of Laetrile spokesmen, often the national leaders of the movement, fell upon freedom of choice. State legislators had their own problems with the powerful federal presence, and might listen with sympathy to constituents blasting segments of the Washington bureaucracy. In any case, pleaded Laetrile witnesses in many states, only a little freedom was being sought, freedom for the dying, under a doctor’s direction, to try Laetrile as a last resort.

After the hearings came continued pressure upon legislators, through conversations and a massive deluge of mail. Occasionally, if the terms of initial bills seemed too broad for acceptance, successive versions would follow with ever weaker provisions, until skeptical assemblymen would consider the measure too innocuous to matter and could thus satisfy both their consciences and the demands of those who had sent in the preponderance of mail.

No matter how weak the laws enacted, each one, announced to the nation through growing media coverage, contributed to bandwagon psychology, giving the imprimatur of another state’s approval to Laetrile. To the ordinary citizen, sanction might equate with efficacy. Thus each new law enhancing Laetrile’s prestige made it seem like legitimate therapy to victims of cancer and their families, including those victims whose cancer had just been diagnosed. And each law, making a specific exemption of Laetrile, dealt a new blow to the theory behind the federal law, which many states had imitated, that promoters of new drugs must prove them efficacious and safe before they could be marketed. The Kefauver law, moreover, demanded a high standard for proving efficacy, the results of adequate and well-controlled studies, not random cases proclaiming benefit, whether presented in paperback book or in testimony at committee hearing.

The state laws, however, did not negate the national law, and Laetrile remained illegal in interstate commerce. It was reported that McNaughton, allied with Bradford in a new John Beard Research Institute in Palo Alto, hoped to set up plants to manufacture Laetrile and clinics to dispense it within states enacting favorable laws [120], although these projects did not move rapidly forward. And in Illinois at least, where legal use of Laetrile was hedged in with many restrictions, the pattern set by the law has not been much employed [121]. Rather, black market Laetrile has continued to be vended in the most dangerously careless way. A Chicago reporter told of buying Laetrile surreptitiously from a foot doctor downstate who asked no medical questions [122].

A second legal route for Laetrile prescribing, this one breaching the ban on interstate commerce, developed from action in the federal courts. As the Laetrile forces undertook a counter-offensive against regulation on the legislative front, so also did they on the judicial front. The key case in the campaign centered on Glen L. Rutherford, a manufacturer’s representative who lived in Conway Springs, Kansas [123]. Upon receiving a medical diagnosis that he suffered from a cancerous polyp, Rutherford refused radical surgery of the larger bowel. Instead he went to Dr. Contreras’ clinic in Tijuana. The physician in charge of Rutherford’s case later wrote a federal judge that Rutherford was treated with Laetrile and proteolytic enzymes, and then the remaining polyp was “cauterized.” [123] Cancer specialists indicate that the excision of a polyp of this type solves the problem in a high proportion of cancer cases [124].

Upon returning home, Rutherford sought to ensure himself of a continuing supply of Laetrile. He joined a law suit already begun, became the sole surviving plaintiff, and in 1975 won from the United States District Court in Oklahoma an injunction against federal regulators which permitted him and other terminally ill cancer patients to import from Mexico a limited amount of the drug for their personal use [123]. Judge Luther Bohanon insisted that each patient present a physician’s affidavit certifying to the stage of illness and specifying the quantity of Laetrile needed to be imported.

Upon appeal of the Rutherford case, the United States Court of Appeals for the Tenth Circuit upheld the injunction [125]. The court also instructed Judge Bohanon to require the Food and Drug Administration to develop an administrative record on two points contested in the case: whether or not Laetrile was a “new drug” as defined by law, and whether or not it was exempt from premarketing approval requirements by reason of being “grandfathered.” FDA complied. In its proceeding, the agency received four hundred written statements from friends and foes of Laetrile and held in May 1977 two days of public hearings in Kansas City [126]. Jammed with Laetrile supporters, these hearings had the emotional flavor of hearings in the states [105]. Cheers greeted pro-Laetrile speakers, boos and hisses their opponents. To one distinguished scientist present, “the affair appeared to be a confrontation between two cultures. One side was characterized by the voice of science—skeptical, analytical, orderly, but sometimes bluntly critical and uncompromising. The other side faced the situation with fervor, passion, conviction, revolt against logic, all emotionally expressed. They seemed to willfully reject distasteful facts.” [105]

Food and Drug Commissioner Donald Kennedy and his staff turned their court-appointed responsibility into a comprehensive review of Laetrile, as thorough, broad-gauged, and insightful an analysis of a highly promoted but unorthodox drug as could be found in the American literature [21]. Besides answering the court-posed issues—Laetrile had not been “grandfathered” under either the 1938 or 1962 law; experts did not consider it either safe or effective for its prescribed uses—the report discussed other significant matters relating to Laetrile. Laetrile’s composition and identity would be difficult to define, the report stated, because so many different chemical entities had appeared under that name in both the literature printed about and the products distributed as Laetrile. The Commissioner countered the various claims made for Laetrile’s effectiveness in cancer, disputing the shifting theories, remarking the inadequate anecdotal character of pro-Laetrile case reporting, and citing the lack of promise in  numerous well controlled animal studies that had been made by the National Cancer Institute and private cancer research centers. The few animal tests interpreted as favorable to Laetrile by Dean Burk and others, the report criticized directly, concluding that Laetrile had failed “to show any effect in the animal system.” The document found the nature of Laetrile’s appeal in the psychology of patients and their loved ones caught in the crushing cancer crisis. The “disparagement of conventional therapy,” the Commissioner stated, “a bulwark of the campaigns of Laetrile proponents, is perhaps the most morally reprehensible aspect of the pattern of the drug’s promotion.” This disparagement led sufferers away from proven remedies, that might offer some chance, to almost certain disaster. Even short delays could mean the difference between life and death.

Commissioner Kennedy met the “freedom of choice” argument head on. Congress had decided, he noted, “that the absolute freedom to choose an ineffective drug was properly surrendered in exchange for the freedom from the danger to each person’s health and well-being from the sale and use of worthless drugs.” In any case, the choice to use Laetrile, made in an atmosphere of double stress, compounded from fear of disease and from the zeal of Laetrile advocates, with seldom any “rational laying out of competing arguments,” can seldom be properly described as free.

The Commissioner’s conclusions and all their buttressing evidence did not persuade the Oklahoma judge. He ruled that Laetrile was exempt from the need for pre-market approval and forbade the Food and Drug Administration from interfering with its importation and transport in interstate commerce or with its use by licensed medical practitioners in treating cancer patients [127]. Again the FDA appealed.

When the Tenth Circuit considered FDA’s appeal of this new Rutherford decision, the judges cut back markedly on the District Court’s liberality toward Laetrile, but still authorized its use for a restricted segment of the population [128]. Ruling in July 1978, the appellate judges concluded that the law’s taboo against unsafe and ineffective drugs did not apply to people who were dying. Therefore, patients whose physicians would certify that they were terminally ill with cancer could legally import Laetrile—but only for intravenous injections, not in its oral form.

This last proviso revealed that the Court of Appeals was taking into account, as the District Court had not, evidence of amygdalin’s toxicity when taken by mouth. Evidence submitted to the Commissioner’s review, testimony given before Senator Kennedy’s subcommittee, and stories in the press cited severe poisonings and even deaths from the ingestion of Laetrile tablets and apricot kernels [21,129-132]. Enzymes in the gastrointestinal tract split the amygdalin molecule and released its cyanide.

The Tenth Circuit did not heed other evidence submitted to it with the FDA’s appeal, that the long-vaunted claims made in behalf of injectable Laetrile’s non-toxicity might not be completely true. Little research had been undertaken on Laetrile’s action when injected into the body. Some physicians began to report unfortunate consequences, surmising that many such adverse effects had earlier occurred but had been blamed not upon the treatment but upon the disease [133].

That the dying should be barred from the law’s protective mantle, Commissioner Kennedy deemed a “remarkable finding” indeed, and he urged an appeal of the Tenth Circuit’s opinion to the Supreme Court [134]. In August 1978 the Commissioner thought his hand strengthened when the Court of Appeals for the Seventh Circuit rendered an anti-Laetrile decision. In 1977 FDA had seized apricot kernels, partially processed kernels, and empty capsules intended for filling with Laetrile at perhaps the largest processing plant in the United States, a former dairy in Manitowoc, Wisconsin. Later the company, which had sold two million dollars worth of its illegal product, was enjoined from continuing its business [135]. On appeal, the Seventh Circuit ruled that Laetrile could properly be excluded from interstate commerce until it should be proven safe and effective [136]. In due course the Supreme Court could be expected to decide between the contrary opinions of the Tenth and Seventh Circuits [137].

Other con and pro decisions marked Laetrile’s increasingly litigious history. In California, the state’s effort to restrain Laetrile practitioners ran into a snag. A state appeals court called the California cancer law unconstitutional, ruling that the state had no power to deny doctors the right to use non-toxic unorthodox cancer treatments [138]. The state Supreme Court in 1978 granted a petition for review of this decision [139]. In Georgia, a jury exonerated one of the most notable personages in the ranks of Laetrile proponents. Larry P. McDonald, physician and member of the John Birch Society and of the United States Congress, had prescribed only Laetrile for a patient’s cancer [140]. When the man died, his family sued for malpractice. The jury decided not so, yet feeling sympathy for the widow decided that she should be reimbursed for the expense of her dead husband’s treatment.

The Food and Drug Administration continued seizing imports of Laetrile from Mexico and from Germany not protected by court-ordered physician affidavits swearing that the drug was intended for a particular patient who was terminally ill. Moreover, some samples offered for import turned out to be not amygdalin at all, but a dangerous fever reducer; other samples were contaminated with fungus [141,142]. Indeed, even the affidavit system itself, the FDA soon charged, had become a cloak for fraud (143]. Reporters visiting Tijuana observed stacks of presigned affidavits available for the asking to Laetrile purchasers [122]. Hitherto Laetrile smuggling, as revealed in the trial at which Dr. Richardson and Bradford had been convicted, had been an underground operation. Now, the government alleged in a seizure action, the druggist at a Baltimore pharmacy had manipulated the affidavit system for his own profit [144,145]. He had obtained affidavits from a physician and had filled them in for the maximum importable amount of Laetrile, using the names of cancer patients who had in fact ordered smaller quantities or none at all. The druggist had then sold the surplus to other patients, sometimes getting the authorized release and sometimes not. A judge upheld the validity of the seizure, but, pending a Supreme Court decision, would not order the seized Laetrile destroyed.

The extensive litigation and the legislative battles in the states made Laetrile an issue of national interest and debate. News magazines carried cover stories [37]. Television—including the program “60 Minutes” [146]—looked at Laetrile. The press kept tabulated track of contests in the states. Conservative columnists, most notably James J. Kilpatrick, attracted to the freedom-of-choice theme, repeatedly gave Laetrile users a prestigious boost [147]. The promoters intensified their own publicity. Paperback successors followed Kittler’s original success: G. Edward Griffin’s World Without Cancerin 1974 [148]; Mike Culbert’s Freedom from Cancer in 1976 [149]; John Richardson’s Laetrile Case Histories [90] and Robert Bradford’s Now That You Have Cancer in 1977 [150]. A majority of American citizens, according to a Louis Harris poll, thought decriminalization of Laetrile would be a good idea [151]. Some Laetrile leaders sounded smug at their success.

“Rest assured, gentlemen,” Bradford told Senator Kennedy’s subcommittee, “that the people demand Laetrile. And they are going to get it whether Big Brother wants it or not . . . . [W]e cannot expect that thousands of American cancer sufferers are going to wait for more long years, while the Federal Government fiddle-faddles through animal tests and more red tape.  Do we really want another American civil war?” [152]

So disturbed became the state of the mass mind that a segment of sober opinion, unbelievers in Laetrile’s efficacy, concluded that the speediest way to quiet public clamor would be to let Laetrile’s worthlessness be proved either by widespread use or in a series of well controlled clinical trials in humans conducted by investigators of unimpeachable integrity and skill. Some scientists, indeed, believe that any drug should be tested for which suggestive evidence exists, even hearsay, that the drug might be of benefit. To test Laetrile in humans would breach the prevailing system, which puts the burden of proof upon a new drug’s sponsor. Such a step, further, would fly in the face of the weight of animal evidence. The major pro-Laetrile animal experiments, announced in 1977 at a National Health Federation meeting by Harold W. Manner, a zoologist at Loyola University in Chicago [153,154], have received severe criticism on the grounds of inadequate methodology [155]. Human trials with Laetrile, therefore, posed grave ethical questions respecting patient rights and the value of expending limited resources available for testing in such a way [156]. But so dangerous seemed the consequences of the spirit behind the new Laetrile state laws that some commentators, both laymen and physicians, resorted to the forbidden fruit argument. The way to dampen “Laetrilomania,” suggested F. J. Ingelfinger, distinguished editor of the New England Journal of Medicine, might be to reduce the glamor derived from its illicit status by making it freely available, and then keeping accurate records of patient experience [157]. The editors of the New York Timestook a similar tolerant approach toward Laetrile distribution [158]. Charles G. Moertel of the Mayo Clinic favored a less extreme course: if Laetrile’s sponsors would not assume their legal obligations, then reputable scientists must undertake the task. “The only established means of proving a drug effective or ineffective, safe or unsafe, is by a properly designed, tightly controlled clinical trial.” [159]

Officials at the National Cancer Institute reluctantly reached the same conclusion. If such action had to come, FDA Commissioner Kennedy argued at Senator Kennedy’s hearing, at least all parties must agree on the specific chemical formula, among the many that had been posited and marketed, of the “Laetrile” to be tested [160]. Senator Kennedy labored diligently throughout the hearing and believed he had achieved a consensus on this point which included Laetrile’s promoters. Tests would weigh the merit of amygdalin [161].

After careful review of the situation, National Cancer Institute officials decided not to launch human trials immediately, but to undertake a retrospective study of patients who, according to their .physicians, might have benefited objectively from the use of Laetrile [162]. From the purportedly 70,000 patients in the United States who had been treated with Laetrile, the NCI hoped to get full enough records to permit analysis of two or three hundred cases. In quest of such records a much publicized appeal went forth to the more than 400,000 physicians and other health professionals in the nation. The director of the project sought to persuade the Laetrile inner ring of leadership to urge physicians active in Laetrile prescribing to submit case records [163].

In the end, however, only ninety-three cancer cases were submitted for evaluation, only twenty-two of them concerning patients who had been treated with Laetrile alone for whom the records were adequate for appraisal [164]. A panel of twelve cancer experts stated that under Laetrile treatment apparently seven of the patients had worsened, nine had remained the same, and six had responded favorably, two with complete and four with partial remissions. These conclusions, the reviewers granted, had to be taken with a grain of salt because of the possible “submission of incorrect clinical interpretations, falsified data and intentional or unintentional omission of data.” Nor had the review been designed to discover patients who had not responded to Laetrile. Nonetheless, more than two hundred physicians had volunteered evidence about more than a thousand patients who had shown no beneficial response.

After further review, the National Cancer Institute revived its earlier decision to undertake a clinical trial of amygdalin in some 150 to 300 terminal cancer patients. Dr. Arthur Upton, NCI director, announced the plan in September 1978, expressing hope that the outcome would resolve the debate over Laetrile “once and for all.” [165]

Such optimism seemed scarcely warranted. Laetrile proponents, while publicly appealing for testing, had been customarily reluctant or unable to provide complete data on patients for evaluation. The FDA’s request for clinical records to Dr. Contreras and to a German experimenter, Dr. Hans Nieper, had not brought in usable material. Nieper submitted no data at all, and Contreras’ case records, when evaluated by NCI scientists, showed no patient benefits ascribable to Laetrile [166]. Contreras, in fact, insisted to a reporter that employing his clinic for purposes of research would be unethical [167]. Nor had a whole succession of animal experiments, which to established cancer researchers offered no hint of Laetrile’s efficacy, satisfied Laetrile’s proponents, who sought to reinterpret a few such trials in a way favorable to their product [168].

From the beginning, indeed, as a basic premise, Laetrile’s supporters questioned the validity of experiments conducted by experimenters who did not share faith in the theories supporting Laetrile’s value. Pro-Laetrile physicians must direct the clinical trials, Krebs, Jr., had told the California Cancer Commission in 1952, or he would not provide Laetrile for experimentation [23]. In 1977 Krebs made essentially the same point: those inside and outside the Laetrile movement “do not necessarily speak the same language.” [107] Each dwells “in a different universe.” [60] Unless, a pro-Laetrile physician told the Kennedy subcommittee, the NCI study should be conducted “in the way that the proponents of Laetrile . . . are urging that it be done,” then “it will be an absolute sham.” [107] Robert Bradford echoed these sentiments: “the protocols that exist for orthodox therapy are not applicable, for the most part, to metabolic therapy and Laetrile.” [95] Traditional oncologists, for example, held that the removal or reduction in the size of a neoplasm measured the success of therapy, whereas espousers of Vitamin B-17, believing cancer to be a deficiency disease, considered the size of the lump irrelevant. “You do not and cannot expect to get results from laetrile treatment,” Bradford said at the Kansas City hearing, “unless you are a trained metabolic physician.” [169]

Commissioner Donald Kennedy wondered if some maneuvers by Laetrile’s promoters might not be intended for the purpose of disparaging test results adverse to the drug [160]. “[I)n sifting the strange mixture of nomenclature, alleged chemical identity, and proposed mechanism of action that comprises Laetrile’s record of the past twenty-five years,” Dr. Kennedy said, “one becomes gradually convinced that these uncertainties are not accidental. They provide an effective cover for the promoters, since failure to achieve a result can always be attributed to having used the wrong material and arguments against one hypothesis of action can always be met by embracing another.”

During the Vitamin B-17 period, the increasing stress upon “total metabolic therapy” marked another change in approach to the promotion of Laetrile. In treating cancer, according to the new doctrine, Laetrile alone could not be relied upon. While Vitamin B-17 held the indispensable place, it needed to be administered as part of a complex program involving a multitude of variables [150]. The other parts consisted of diet, exercise, rest, detoxification, minerals, enzymes, vitamins A, C, and E, and that other major Krebs’ promotion, Vitamin B-15 or pangamic acid. A patient might require “several dozen tablets every day.”

In Bradford’s book, Now That You Have Cancer, he likened the metabolic program to a crown containing nine jewels, with Laetrile “the crown jewel within that diadem.” [150] Such a “total approach,” combining an attack on the cancer, a bolstering of the body, and a positive mental attitude, metabolic physicians held, provided “the best chance to control cancer.” If the metabolic doctrine bolstered Laetrile with a host of attendant therapies, the system also expanded Laetrile’s prowess beyond cancer. In a book titled How You Can Beat the Killer Diseases, Harold W. Harper accorded Laetrile a role in preventing and treating a broad range of other ailments, including diabetes, emphysema, arthritis, and cardiovascular disease [170].

The diversified regimen of metabolic therapy certainly complicated the problem of evaluating in human trials Laetrile’s role as a possible therapeutic agent for cancer, and made second-guessing of results inevitable. Nonetheless, the National Cancer Institute’s Dr. Upton stated that, in devising the Institute’s experiments, he would “not rule out the possibility of looking at combinations” of Laetrile and high-potency vitamins [165]. Laetrile’s advocates greeted the NCI’ s retrospective review as ”Laetrile’ s biggest breakthrough,” because “from now on the myth as to the ‘officially’ observed lack of validity in Laetrile has been destroyed.” [171] Yet Bradford had told the Kansas City hearing that no “effective agreed upon protocol” for a study of cancer under metabolic therapy could be set up [169]. Whatever a NCI trial might show, disputations between advocates of orthodoxy and champions of unorthodoxy seemed certain to continue.

The Pattern of Cancer Unorthodoxies

Health quackery has flourished since that ancient day when, as Voltaire put it, the first knave met the first fool. Through most of American history, nourished by the Enlightenment concepts of the Revolutionary generation, the presence of quackery has been acknowledged but its status has been considered transitory. When medical science had expanded its horizons a little further, when the populace had received a little more schooling, when the Congress had enacted another protective law, then would quackery vanish, consigned to the museum of outmoded delusions. Certainly through the Progressive period at the beginning of our own century, such optimism sustained itself [172]. When the Pure Food and Drugs Act became law in 1906, the New York Times editorialized: “the purity and honesty of the . . . medicines of the people are guaranteed.” [173]

As the twentieth century has proceeded, despite enhanced medical science, more universal schooling, and a great increase in social legislation, observers have grown less confident about predicting quackery’s imminent demise. The course of events and the pathways of philosophy both have chilled such naive optimism. The doctrine of inevitable progress fell under the impact of a series of terrible wars. Faith in the inherent goodness of human nature, battered by new philosophical perspectives, crumbled under the revelations from the Nazi concentration camps. Belief in education as a panacea withered. Science-technology inventiveness did continue to produce wondrous products for mankind’s benefit but also devised nuclear weapons and polluted the environment. Modern industrial civilization struck many people as part of the cause for burgeoning unhappiness, Ernst Krebs, Jr., among them. At the Kansas City hearing, Krebs expressed abhorrence for “the horrible onslaught of technology blindly impinging upon the fragile flesh that contains our flame of life.” [60] Some disturbed souls sought to return to nature. Pressing upon this long developing crisis of confidence came Vietnam, an unpopular and unsuccessful war that put generations at each other’s throats, and Watergate, seeming proof of what some voices had long been crying, that blame for the discontents of civilization could be laid upon leadership.

Such an atmosphere induces irrational approaches to fundamental problems. The disillusioned, questing for new faith, are terribly vulnerable to false prophets. Distrust of established authorities encompasses all those who have traditionally sought to protect the public from charlatanry. The medical profession suffers suspicion, including the specialists within it concerned with cancer. In a behavioral survey sponsored by the Food and Drug Administration and other federal agencies, it was revealed that forty-two per-cent of American adults would not be persuaded by almost unanimous expert opinion that an unorthodox “cancer cure” held out false hope [101].

Cancer quackery in America goes back to the earliest days. In colonial times one purported cure consisted of alleged “Chinese Stones” vended by a self-styled Frenchman who hawked his wares from town to town [174]. At the beginning of this century, the first major case lost by the government under the 1906 law had aimed at suppressing Dr. Johnson’s Mild Combination Treatment for Cancer [175]. By mid-century unorthodox cancer promotions loomed largest among the illegal operations which regulatory agencies sought to control.

Basic to this circumstance were both the impact and the image of cancer in our society. With the decline of infectious diseases as a cause of death, due to sanitation, vaccines, and chemotherapy, cancer had risen to second place in the mortality lists. The 1900 death rate for malignant neoplasms was 64 per 100,000 deaths, the 1977 estimated rate 177 [176]. On the disease and death front, cancer had moved to the center of public attention. A sense of urgency led to an all-out attack, with billions of dollars appropriated by the Congress in imitation of the nation’s venture into outer space, in an effort to conquer cancer once and for all. But the enemy proved to be too complex for such a battle plan. Despite many advances, failure to fulfill the central promise brought new disillusionment [177].

Yet the image of cancer may be an even more important force for quackery than its factual circumstances. Heart deaths exceed cancer deaths, but no wave of cardiovascular cures has surfaced similar to those in the cancer field. That centuries ago cancer began to acquire a hostile and terrifying image may be deduced from the word “cancer” itself, derived from the Greek work for crab. The crawling spread of cancer, gradual but mainly relentless, whether external and observable or internal and secretive, through the centuries appeared to be, and indeed generally did amount to, a sentence of death. This image hangs on, a powerful force in men’s minds, a force not adequately revised by the victories orthodoxy increasingly has won. In our mythology, Susan Sontag has written, cancer has become a “cosmic disease: the emblem of all the destructive, alien powers to which the organism is host . . . [C]ancer is thought of as a disease of the contamination of the whole world.” [178] “As long as a particular disease is treated as an evil, invincible predator, not just a disease,” she states, “most people with cancer will indeed be demoralized by learning what disease they have.” And Sontag cites Karl Menninger to the effect that “the very word ‘cancer’ is said to kill some patients.” This deeply imbedded fear is constantly revivified in the lurid tracts and the camp meeting oratory of orthodoxy’s opponents.

Four major unorthodoxies have emerged in the United States during the last half century. First, a Detroit physician, William F. Koch, proclaimed his newly discovered Glyoxilide an anti-toxin for cancer. Each ampule, costing $25, Koch said, contained one part Glyoxilide to one trillion parts of water. Three thousand American health practitioners bought and administered the purported chemical, charging up to $300 per injection [179].

Second, a former coal miner, Harry Hoxsey, after treating external cancers with caustics here and there in Illinois, made his way to Dallas, Texas, where he set up a clinic for treating internal cancer. At its peak, the clinic had ten thousand patients on its books, charging each one a fixed four hundred dollar fee, prescribing a “pink medicine” and a “black medicine.” The former contained lactated pepsin and potassium iodide, the latter a botanical laxative in an extract of prickly ash bark, buckthorn bark, barberry root, licorice root, pokeweed, alfalfa, and red clover blossoms [32,179].

Third, two Yugoslavian brothers named Durovic brought from Argentina to the United States a whitish powder called Krebiozen, said to have come from the blood of horses which had been injected with a micro-organism responsible for “lumpy jaw” in cattle [179,180]. Their assertion that Krebiozen could cure cancer won the dogged allegiance of one of the nation’s leading cancer experts, Dr. Andrew Ivy of the University of Illinois. Thousands of physicians secured vials of this so-called investigational drug for eager patients, making a nine dollar “donation” for each ampule. In 1963 a team of FDA chemists, analyzing the only sample of Krebiozen ever secured from its sponsor, discovered it to be the common amino acid, creatin monohydrate. Simultaneous analyses of the Krebiozen distributed to physicians revealed it to be nothing but mineral oil.

The fourth major promotion has been that of Laetrile.

Laetrile possesses a more complex chronicle and a more varied cast of characters than those of Glyoxilide, Hoxsey’s botanicals, and Krebiozen, and has created greater public impact and gained more political power than did its three predecessors. Nonetheless, Laetrile impresses the historian as conforming to a ten-point profile of health quackery de-rived from a study of past quackish ventures [181].

Exploitation of Fear

Quacks have traditionally scared their victims with disturbing language, frightening pictures, and grim statistics, stressing pain and threat of death. A turn-of-the-century pamphlet described gruesomely how cancer ate away the sufferer’s nose, face, palate, and throat [182].

The modern promotional mode employs greater subtlety in playing on the morbid fear of cancer in our society. Laetrile agents try to reach patients when cancer has just been diagnosed and panic is high, and, like others before them, interpret orthodox therapies as essentially useless and more painful than the disease itself. One physician testifying in Kansas City told of a patient who, within a day of having lung cancer diagnosed, received Laetrile advertising in the mail [183]. “Cutting, burning, and poisoning” to characterize surgery, radiation, and chemotherapy have become a litany in Laetrile literature [184]. “Voodoo witchcraft” would do more good.

Promise of Painless Treatment and Good Results

“No knife or pain,” advertised a Chicago cancer quack in 1912, promising to cure breast cancer [185]. The history of cancer quackery reveals constant assurances of easy treatment and good results. In earlier days, sure cures were promised. More recently, prudence has dictated greater caution. By treating cancer with nothing more painful than injections of a non-toxic drug, according to a Laetrile tract, fifteen percent of patients with advanced metastasized cancer and eighty percent of those with early diagnosed cancer “will be saved.” [186] And Dr. Richardson evoked the vision of a cancerless nation in a mere two-score years, achieved by nothing more arduous than regular oral doses of Laetrile [107].

Claims of a Miraculous Scientific Breakthrough

Marvelous new discoveries are a dime a dozen in the literature of quack promotions. In earlier times the secret might be an herb brought back by a missionary from some primitive overseas tribe or pried loose by an explorer from an Indian medicine man [187]. Hoxsey attributed his botanical formula to the perception of his great-grandfather who noted the healing of the cancer on the leg of his horse which grazed in a pasture where the plants grew [32]. Recent “discoveries” have generally been said to derive from inspired research. The Durovics’ horse experiments in the Argentine furnish an example.

Laetrile’s heroic tale centers on the humble physician, Ernst Krebs, Sr., busy with his practice yet always seeking out drugs and vitamins to benefit mankind, and on his son, Krebs, Jr., inveterate researcher, who modified the cyanide-containing chemical his father had found in apricot kernels so that it could kill cancer cells but leave healthy cells unharmed [2]. To the audiences at the legion of Laetrile meetings before which Krebs, Jr., appears, he has become a figure of awe and veneration, acclaimed as a Pasteur and linked with the signers of the Declaration of Independence [188], a myth in his own time.

One Cause / One Therapeutic System

Quacks often win allegiance to their doctrines by promising to end confusion and doubt and to make complexity simple and comprehensible to the untutored mind. Disease, the quack says, has but one cause. Therefore, one treatment is all that is needed to fight it. In the nineteenth century Benjamin Brandreth blamed all illness on vitiation of the blood caused by constipation [189]. For a perfect panacea, therefore, try Brandreth’s cathartic pills. Later Samuel Hartman’s high-alcoholic Peruna promised only to cure catarrh, but Hartman defined catarrh to cover almost every symptom in the book [190].

A similar sweeping boldness has operated in the cancer realm. Reputable authorities now assert that there are as many different cancers as there are different common colds, over a hundred, with a broad range of causes. But for Koch all cancer came from a single toxin. For Hoxsey all cancer resulted from a disturbance in body chemistry. At the start, Laetrile’s sponsors rooted their explanation in the unitarian or trophoblastic theory, and more lately have denominated all cancer dietary deficiency disease. Initially Laetrile alone played the role of virtual specific. “Laetrile does not palliate,” Dr. Krebs wrote in an early pamphlet, “it acts chemically to kill the cancer cell selectively without injury to the normal tissues of the body.” [191] Recently Laetrile in its new guise of Vitamin B-17 has assumed central place in a therapeutic system, complex, but according to its proponents, integrated. Robert Bradford envisioned metabolic health centers as “the wave of the medical future,” replacing orthodoxy’s rugged and allegedly futile methods, and heralding the day “when the killer degenerative [disease) . . . of the civilized world would come to an end.” [150] In the same year Dr. John Richardson could posit use of Laetrile alone as a universal cancer preventive [107].

The implication of these futuristic claims is bold enough, in contrast with the restraint about Laetrile’s current effectiveness in public utterances. At the hearings held by the FDA in Kansas City and by Senator Kennedy’s subcommittee in Washington, Laetrile’s sponsors made the most modest of claims. The public record, however, and private conversations sometimes take on a different tone. Ernst Krebs, Jr. , could say in Kansas City, “We disclaim saving anyone’s life.” [60] But during a trial at which the state of California had charged Krebs with violating his probation, evidence indicated that his promises were not so circumscribed [192]. A widow testified that her husband, learning that he had lung cancer, had rejected the operation which his doctor had told him had a ninety percent chance of success. Instead, having heard Krebs on television, the man looked his name up in the telephone directory and asked his advice. Krebs told the inquirer that, if he relied on Laetrile, his chance of recovery would be one hundred percent. Krebs sent the man to Dr. Richardson. Nine months later the man was dead.

The Galileo Ploy

In response to criticism from the community of scientists, quackery has often brought into play the Galileo ploy. The unorthodox say the orthodox are wrong, just as earlier critics condemned pioneering explorers, inventors, and scientists. We are, the unorthodox assert, like Columbus, Jenner, and Pasteur—the list is long. We are today misunderstood by blind men but are destined to be heroes to future generations.

In 1951 at the trial of a woman who sold a so-called Radio Therapeutic Instrument, claiming it could cure cancer of the breast with rays beamed over great distances, her attorney trotted out Columbus, Harvey, and Semmelweiss in her defense [193]. Laetrile promoters have offered the same gambit. The text of a film strip, World Without Cancer, likened Krebs, Jr., to these three worthies, as well as to Galileo and the Wright brothers (184]. In praising Krebs before Senator Kennedy’s subcommittee, Robert Bradford admitted that Krebs had “only an honorary doctorate,” then added: “Are you aware, gentlemen, that Christopher Columbus never went to nautical school? Can we recall the shoddy credentials of Thomas Edison? Was Albert Einstein all that bright a student in school?” [95]

The Conspiracy Theory

Another time-tested response to criticism is the shouting of conspiracy. The scientific establishment doesn’t dare recognize the validity of my great discovery, the quack claims, for it will undermine their power and prestige and eliminate their jobs. So the establishment scientists conspire to suppress the wonderful new remedy.

Koch, Hoxsey, and the Krebiozen forces all resorted to the conspiracy theory, and so do the Laetrile supporters. Dr. Richardson sees the Rockefeller family at the center of the web, controlling pharmaceutical manufacturers and preventing them from developing drugs not made from oil [194]. The Rockefellers also control the American Cancer Society, a staunch foe of Laetrile. In this nightmare, the National Cancer Institute, the Food and Drug Administration, and organized medicine are likewise deemed members of the selfish conspiracy to suppress Laetrile.

Shifts to Adjust to Circumstances

Quackery has never felt obliged to retain a given posture if some change might offer greater prosperity or safety. In the nineteenth century a cold cure that wasn’t selling became a stomach remedy and reaped huge profits.

Laetrile’s history has been marked by many changes. When the Krebs’ version of amygdalin emerged, chemotherapy as a mode of treating cancer was new, public excitement about it high. The first pro-Laetrile paperback, Kittler’s Control for Cancer, grafted the apricot pit drug onto that interest, stressed Laetrile’s chemical nature, did not mention the word “vitamin.” [2] By the 1970s nature’s way toward health enjoyed great public favor, chemicals in cancer therapy had slipped some in popular prestige, and chemicals in the environment had come under grave suspicion. John Richardson’s Laetrile Case Histories blasted chemotherapy in cancer, denied explicitly that Laetrile was a “drug,” and concluded that control of cancer had been found “in nature.” [195] From drug to vitamin, from cure to palliative and preventive, from low dosage to high dosage level, the pattern of Laetrile’s postures has been kaleidoscopic. “The mere fact that there is a constantly changing set of theories as to why laetrile should be used or how it does work,” asserted the American Medical Association to the Kennedy subcommittee, “is sufficient to lead objective persons to question the validity of any of the theories put forth.” [196]

Reliance on Testimonials

Through history the testimonial has been a major weapon in the arsenal of quackery. When someone just like you and me says, with urgent sincerity, “I was cured,” the persuasive power ranks high. “Our experience of more than thirty years in the enforcement of the Food and Drug Act,” a former Commissioner once wrote, “has demonstrated that testimonials may be obtained for practically any article labeled as a treatment for practically any disease.” [197] But testimonials given in the first flush of hope prove sadly premature. Old newspapers contain instances of testimonials appearing in the same issues with the obituaries of the testators [198]. Modern science holds that drug efficacy can not be determined by individual instances, nor even by a series of such cases. Much more sophisticated scientific methods are required. As a matter of law, the Supreme Court has so ruled [199].

All major cancer unorthodoxies have relied heavily on testimonials. The despairing cancer victim hears or reads such success stories as part of an enthusiastic promotional presentation, one that resounds with a sense of conviction and with every evidence of sincere concern for the victim’s welfare. He is offered hope, told things he himself may do to take his own treatment into his own hands. His new painless therapy, his new diet, his sense of support from new acquaintances, his more cheerful expectations, do indeed enhance the way he feels. The placebo effect is powerful, if temporary, medicine. An injection of confidence may indeed give the patient a better appetite, let him gain weight, enhance the way he looks, improve the way he feels. If he has been suffering from the side effects of effective treatment, perhaps nausea and the loss of hair, a switch to unorthodoxy may end these unpleasant consequences. Under these circumstances both the patient and the doctor who is administering the unorthodox treatment may pen testimonials. If, as a result of previous or concomitant orthodox therapy, the patient’s health may indeed be improved, the testimonial may nonetheless give all the credit to unorthodoxy.

In preparing for legal action against Hoxsey’s enterprise, the Food and Drug Administration investigated the writers of all the testimonials which Hoxsey had printed in behalf of his internal cancer treatment [32]. Hoxsey’s claimed cures, the FDA was able to demonstrate in court, fell into three classes. Either the patients had never had cancer — and some cancers are extremely difficult to diagnose—although treated for it at Hoxsey’s Dallas clinic. Or they had been cured of cancer by proper orthodox treatment before or while consulting Hoxsey. Or they had had cancer and either still were afflicted despite Hoxsey’s treatment or else had died. This evidence substantiated the scientific inadequacy of anecdotal evidence, no matter how sincere the testimony. The same findings resulted from the National Cancer Institute’s evaluation of Dr. Contreras’ cases [166].

Further, one of the odd paradoxes relating to quackery is that failure seldom diminishes patient loyalty. The duped seem unable to realize deception has occurred. The quack has done such a good job of exuding sincerity and concern that the victim believes the false explanation that the specious remedy or routine would have healed had treatment only begun a little sooner. And the misery of the decline toward death had seemed, under the unorthodox regimen, less arduous than would otherwise have been the case [200].

Laetrile promotion has relied heavily on testimonial evidence, given by patients before legislative committees, compiled by Laetrile advocates between the covers of books. The scientific weakness of such an approach, as exemplified by Dr. John Richardson’s Laetrile Case Histories, receives stark underlining in the analysis of this volume presented in Commissioner Kennedy’s report to the Oklahoma court [21].

Distortion of the Idea of “Freedom”

Before food and drug laws were enacted, quacks waved the banner of “freedom” to smear criticism aimed at them by physicians and pharmacists. When drug laws came, quacks formed protest groups with high-sounding names, like the National League for Medical Freedom and the American Medical Liberty League [201]. “Freedom” is certainly one of the most treasured words in the American lexicon. As has been seen above, the manipulation of this word by unorthodox health promoters has constituted their major symbolic campaign during the last quarter century. Thus Laetrile’s loud appeal for “freedom of choice” in cancer therapy is nothing new. Pushed with vigor, however, by those with ultraconservative convictions about the governmental role in society, in a climate of opinion worried about over-regulation, Laetrile’s “freedom” pitch has persuaded more numerous converts to its cause than any previous unorthodoxy has succeeded in winning. The prevailing mythology of cancer, Susan Sontag has written, conjoins with “a simplistic view of the world that can turn paranoid.” “Perhaps,” she adds, “right-wing groups are the main organized support for quack cures like Laetrile because they also share a paranoid view of the world.” [178]

Such a direction for “freedom” leads toward the license of those ancient days, when “the toadstool millionaires,” operating without restraint, fleeced and often killed their victims. That is a fate from which seven decades of constructive legislation, beginning with the Pure Food and Drugs Act of 1906, has somewhat rescued the nation. Complex, modern, industrial, urbanized society, with standards of medical judgment far more precise than in the nineteenth century, can not afford to let the nation’s health concerns be governed by a distorted definition of that great symbol “freedom” which would return piratical anarchy to the realm of health.

Large Sums of Money Are Involved

It was Oliver Wendell Holmes who termed nineteenth century nostrum vendors “toadstool millionaires.” [202] They might not make a million, but money was their goal.

Laetrile is big business. Investigations by California authorities revealed what huge sums some of the Laetrile leaders had been putting in the bank [36,92]. Robert Bradford, according to an agent of the Food and Drug Bureau cited in the New York Times, had been taking in an estimated $150,000 to $200,000 a month in Laetrile sales. In slightly over two years, Dr. John Richardson had deposited some $2,800,000 in a single checking account [203].  The quantity of Laetrile that Judge Bohanon determined to be a six-month supply would have cost the user about $2,250 [204]. Estimating Laetrile users at 75,000, the mathematics mounts to millions.

Laetrile Within the Perspective of the Past

Fear of cancer, suspicion of government, a primitivistic retreat from complex civilization to “natural” ways, skillful organization, adept lobbying, and a shrewdness at borrowing time-tested techniques from quackery’s well-stocked past, such factors undergird the Laetrile movement. In the face of scientific evidence and informed advice, frightened people place vain hope in it.

What guide might the past provide as to Laetrile’s future? The other major cancer unorthodoxies of the twentieth century, Glyoxilide, Hoxsey’s botanicals, Krebiozen, have virtually disappeared within the United States, although they linger outside the nation’s borders, available to the desperate traveler. What brought Koch, Hoxsey, the Durovics and Ivy down from their peaks of prominence was a combination of vigorous regulatory action, sustained critique, and faddist fascination with still newer unorthodoxies.

Dr. William Koch underwent two very long trials in 1943 and 1946, charged with promoting misbranded and ineffective drugs [179]. The first ended with a hung jury, the second when a juror became ill. Koch gave up business and retired to Brazil. Against Harry Hoxsey, the Food and Drug Administration initiated numerous actions. Injunction proceedings begun in 1950 before a judge disposed in Hoxsey’s favor were finally won only after the case had twice reached the Supreme Court [32]. In 1957 an injunction closed Hoxsey’s satellite operation in Pennsylvania. Krebiozen came to a halt in interstate commerce when its sponsors withdrew a plan for the investigational use of the drug which they had submitted to the FDA [179,180]. This ban held, even though the government failed to convict the Durovics and Dr. Ivy in a nine-month criminal case decided in 1966 by a Chicago jury. Later, an investigation of jury tampering led to the conviction and jailing of one of the jurors. Thus regulatory action almost completely removed the unorthodox cancer treatments from interstate commerce, permitting their sponsors almost no elbow room for continuing promotion.

Not that unorthodoxy did not fight back. Hoxsey, for example, strove strenuously for political support, gaining favorable recognition from several United States Senators [32]. And he sought to establish and ally with organized support for his cancer clinic. In 1959 Hoxsey spoke at a naturopathic convention in Chicago, which also hearkened to the National Health Federation’s president, Fred J. Hart. At NHF membership rallies, Hart solicited funds to help Hoxsey carry on his contest with the FDA, and Hoxsey in turn gave royalties from his autobiography to help finance the NHF. Despite his efforts, Hoxsey did not develop an institutional base broad and strong enough to permit his unorthodox clinics to survive. Nor did the promoters of Glyoxilide or Krebiozen succeed with similar attempts.

Prior to Laetrile’s series of victories in the legislatures of seventeen states, the major political triumph achieved by the forces of unorthodoxy came in the national Congress with the enactment of the Vitamin Amendments of 1976 [102]. Led by the National Health Federation, promoters of nutritional products skillfully mobilized their followers into a powerful lobbying force. By securing the new law, the health food industry not only succeeded in thwarting the Food and Drug Administration’s attempt to tighten the stringency of regulation in this field, they won from Congress a curtailment of FDA’s authority below that which had been given the agency by Congress in the 1938 law.

This episode reveals that health unorthodoxy has the capability of mounting sufficient political power to win important victories. The obviously growing strength of nutritional unorthodoxy may well have played a role in Laetrile’s transmogrification into a “vitamin.” The National Health Federation has accepted and promoted Laetrile’s vitamin status. In 1977 the NHF made legalizing Laetrile its “No. 1 priority.” [205] It remains to be seen whether the millions of Americans who flirt with nutritional unorthodoxy will welcome an anti-cancer Vitamin B-17. Not all citizens who believe in extra vitamins as a sure road to extra pep may so readily accept vitamins in the treatment of cancer.

No previous cancer unorthodoxy ever approximated the institutional base which Laetrile achieved, resting on the International Association of Cancer Victims and Friends; the Cancer Control Society, formed by dissident members of the IACVF [206)] and particularly the Committee for Freedom of Choice in Cancer Therapy, whose motivation is as much political as therapeutic. The big question is whether this political base is firm enough to establish Laetrile in an institutionalized sense in our society, whatever else may happen. Indeed, it may be surmised that Laetrile’s boom has peaked and now is in decline. Reports about toxicity doubtless dampened public ardor. Laetrile bills before state legislatures did not fare so well during 1978 as in 1977 [115]. Future consideration and reconsideration may find state assemblymen looking more probingly past the freedom of choice argument at the scientific facts, following the example of Massachusetts [207]. Inquiries about Laetrile to the Food and Drug Administration have fallen off [208]. Media coverage has declined, despite such newsworthy events as the announcement of the National Cancer Institute’s proposed trials and the Tenth Circuit’s decision in the Rutherford case. Even should that decision stand, the legal use of Laetrile would be drastically curtailed from the level defined in Judge Bohanon’s decision, with oral dosage forms eliminated. The Supreme Court, in adjudicating between the Tenth and Seventh Circuits, may confirm the FDA’s authority to ban Laetrile completely from interstate commerce [209].

Even if Laetrile should follow Krebiozen and the others off center stage, this does not mean unorthodoxy’s demise. As long as cancers remain a grave problem and wear a fearful image, quackery threatens. Much disenchantment exists with scientific medicine. Cancer patients have felt rejected by some orthodox physicians who have seemed to lose interest in their cases when nothing more medically could be done. The unorthodox offer considerable psychological support. The quixotic state of public feelings about health conduces to strange enthusiasms and open sesame for charlatans. Despite such a hopeful development as the hospice movement [210], offering skilled and considerate support to the dying and their families, a gloomy prognosis is hard to avoid. The broader and more diffuse approach of metabolic therapy, in which Laetrile is now enveloped, may prove a more difficult regulatory problem to confront than combatting a single unproven entity.

A shrewd and seasoned observer, looking ahead, recently took a somber tone:

During the past decade, a change has taken place in public attitudes toward medical science. There has been an increasing acceptance of misinformation, as shown for example by the success of the laetrile and ‘health food’ movements. This acceptance has been aided by the media, especially television, which publicize sensational and erroneous statements. These are seldom rebutted. There is distrust of the ‘establishment,’ and a feeling that doctors are exploiting patients. I believe this trend is so well established, and so little challenged, that its impact will produce a decline of scientific medicine, and its replacement by quackery [211].


This article was originally presented at the symposium on politics, science, and cancer held at the 1979 annual meeting of the American Association for the Advancement of Science in Houston, Texas. Dr. Young was professor of history at Emory University.


References and Notes
  1. Report by Jack Forbragd and Kenneth B. Ewing of interview with Ernst T. Krebs, Sr., Dec. 11, 1962, San Francisco District File CF: 10 183, Krebs Laboratories, vol. 1, Food and Drug Administration Records (San Francisco).
  2. G.D. Kittler, Control for Cancer (Paperback Library, New York, 1963).
  3. Bull. Nev. State Bd. of Health, Jan. 1920, clipping, FDA report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Recorqs (San Francisco).
  4. Nevada Appeal, Carson City, Nov. 14, 1957, clipping, ibid.
  5. Bureau of Chemistry, Department of Agriculture, Notices of Judgment 11193 (1923) and 12047 (1924).
  6. FDA D.N.J. 17066 (1930).
  7. S.B. Gilmore and J.B. Corson to San Francisco District, Apr. 1, 1958, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  8. San Francisco District Summary and Recommendation for Prosecution, Oct. 20, 1960, ibid.
  9. E. Krebs, Jr., E. Krebs, Sr., and H. H. Beard, The Unitarian or Trophoblastic Thesis of Cancer (McNaughton Foundation, Montreal, 1950).
  10. Walter Van Winkle, Jr., to Ernst T. Krebs, May 7, 1945, [re NDA 5703), AF 26-731, vol. 1, FDA Records (Rockville).
  11. Edward V. O’Gara to San Francisco District, July 14, 1945, ibid.
  12. D. Rorvik, New West, Apr. 25, 1977, p. 51.
  13. Affidavit of Ernst T. Krebs, Sr., Apr. 28, 1965, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  14. Statement of Eric E. Conn on Patent Specifications 13228, vol. M, item 424, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  15. Russell C. White and Donald L. Taylor to San Francisco District, Dec. 15, 1952, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  16. Statement of Carol M. Hehmeyer, Banning of the Drug Laetrile from Interstate Commerce by FDA (95th Cong., 1st sess, Hearing before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, U.S. Senate, July 12, 1977 [hereafter, Hearing before Kennedy subcommittee]), pp. 239-40.
  17. Ralph Weilerstein to San Francisco District, series of 1945 memoranda, AF 26-731, vol. 1, FDA Records (Rockville).
  18. Eugene Eno to San Francisco District, Sep. 13, 1950, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco.
  19. Science, 103, 25, (1946).
  20. E.T. Krebs, M.D., Laetrile (San Francisco, n.d.), in Laetrile file of exhibits, AF 26-731, Accession 88-73-6, box 50, FDA Records, Record Group 88, Washington National Records Center (Suitland, MD) (hereafter, WNRC).
  21. FDA, Laetrile, Commissioner’s Decision on Status, Fed.Reg. 42, 39773 (1977).
  22. Richard M. Stalvey to San Francisco District, Sep. 10, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  23. Krebs, Jr., to Ian McDonald, Dec. 8, 1952, ibid.
  24. Memorandum of interview between Ralph Weilerstein and L. Henry Garland, Dec. 9, 1952, ibid.
  25. Cancer Commission of the California Medical Association, Calif. Med. 78, 320 (1953).
  26. R. T. Dorr and J. Paxinos, Ann. Internal Med. 89, 389 (1978).
  27. Memorandum of interview between Ralph Weilerstein and E.W. DeLong, Aug. 24, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  28. San Francisco News, Mar. 24, 1953.
  29. Krebs, Jr., to Richard E. Sponholz, Mar. 28, 1961, in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  30. Patent Specification 788,855 (1958).
  31. San Francisco District Report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco).
  32. J. H. Young, The Medical Messiahs (Princeton University Press, Princeton, 1967), pp. 360-89.
  33. FDA D.D.N.J. 6543 (1960).
  34. M. L. Yakowitz to J. R. Cain, July 6, 1953, AF 26-731, vol. 1. FDA Records (Rockville).
  35. Deposition of Andrew R. L. McNaughton, June 2, 1964, The Canadian Laetrile (Anti-Cancer Drug) Case (Montreal, 1964), in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  36. New York Times, June 26, 1977.
  37. Newsweek June 27, 1977, pp. 48-56.
  38. The Financial Post, Toronto, Mar. 10, 1973.
  39. SEC v. Biozymes International Ltd., et al. U.S. District Court, Northern District of California, Civil Action No. C72-2217-SW, Apr. 27, 1973.
  40. Memorandum of interview at HEW by W. B. Rankin, Oct. 18, 1961, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco) .
  41. Memorandum of interview at FDA by Ralph G. Smith, Oct. 18, 1961, ibid.
  42. FDA D.D.N.J. 7062 (1962).
  43. Many documents dealing with the circumstances of Krebs’ probation are filed in San Francisco District File l- 412P, vols. 3 and 4, FDA Records (San Francisco).
  44. Krebs argued that his violation of the law had been technical, cued by his haste to beat the Russians in pangamic acid research, which, because oxygen utilization was involved, might help the United States triumph over the Soviet Union in the space race. Krebs to Robert M. Ensign, Sep. 18, 1963, ibid., vol. 4.
  45. Maurice P. Kerr to Chief Inspector, Dec. 9, 1963, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  46. Krebs to John A. Sprague, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records (San Francisco).
  47. Gregory S. Stout to California State Board of Health, June 27, 1963, ibid., vol. 4.
  48. G. D. Kittler, “The Struggle,” American Weekly, Mar. 3 and 10, 1963.
  49. James Nakada to District Directors, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records, (San Francisco).
  50. Interview with Cecile Pollack Hoffman by William P. Leckwold, Feb. 12, 1965, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  51. McKay McKinnon to Wallace Janssen, June 12, 1964, San Francisco District File l-412P, vol. 4, FDA Records, (San Francisco).
  52. Arthur Dickerman to William Goodrich, Jan. 25, 1963, ibid., vol. 3.
  53. Memorandum of interview with McNaughton by G. S. Goldhammer, Feb. 1, 1963, ibid.
  54. California Cancer Advisory Council, Report on the Treatment of Cancer with Beta-Cyanogenetic Gluosides (“Laetriles”) (1963), exhibit to affidavit of w. Sherwood Lawrence, Vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  55. San Francisco Examiner, June 6, 1963.
  56. FDA Report on Enforcement and Compliance, Aug. 1964, pp. 8-9.
  57. William C. Hill to K. F. Ernst, May 25, 1967, Krebs Injunction 508 File, vol. 2, FDA Records (San Francisco).
  58. San Francisco District Report, Sep. 22, 1969, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1969-71, FDA Records (San Francisco).
  59. San Francisco Chronicle, Jan. 27, 1970.
  60. Testimony of Ernst Krebs, Jr., vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  61. Numerous documents during 19~9 and 1970 in San Francisco District File, CF: 10 183, Krebs Laboratories, FDA Records (San Francisco).
  62. FDA news release about NDA 6734, Sep. 1, 1971.
  63. HEW Secretary Elliot Richardson to Congressman Lawrence H. Fountain, Aug. 26, 1971, AF 26-731, vol. 12, FDA Records (Rockville).
  64. FDA letters to McNaughton Foundation, Apr. 20 and 28, 1970, ibid.
  65. Don C. Matchan in Alameda (CA) Times-Star, July 14, 1970.
  66. Dean Burk to Secretary Richardson, Mar. 23, 1971, AF 26- 731, vol. 12, FDA Records (Rockville).
  67. Dean Burk, in Who’s Who in America, 40th Edition, 1978-1979 (Marquis Who’s Who, Chicago, 1978), vol. 1, p. 470.
  68. C. P. Hoffman and E. N. Blaauw, If It Is True Cancer Can Be Controlled Why Isn’t It?, 1964 pamphlet, in San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  69. James A. Crandall to Los Angeles District, July 12, 1965, ibid., vol. for 1965-68.
  70. John w. Holten to Los Angeles District, Aug. 23, 1965, ibid.
  71. Memorandum of telephone conversation between Gordon R.Wood and T. M. Rice, June 23, 1969, ibid., vol. for 1969-71.
  72. S. Barrett and G. Knight, eds., The Health Robbers (George F. Stickley, Philadelphia, 1976), p. 9.
  73. Ibid., pp. 189-201.
  74. Young, The Medical Messiahs, pp. 383-84, 400-401.
  75. Clippings from the National Health Federation Bulletin, Prevention, and National Enquirer, AF 26-731, vol. 11, FDA Records (Rockville).
  76. Walter Ermer to M. J. Ryan, Oct. 16, 1970, ibid.
  77. Numerous letters, ibid., vols. 11 and 12.
  78. NHF Bulletin, Sep. 1970, clipping, ibid., vol. 11.
  79. Fountain to Richardson, Mar. 16, 1971, ibid., vol. 12.
  80. FDA news release, Sep. 1, 1971, with attached Report of the Ad Hoc Committee of Oncology Consultants.
  81. H. R. 12092, introduced by John G. Schmitz, Dec. 7, 1971, Cong. Rec., 92nd Cong., 1st ses., p. 45120.
  82. People v. Ernst T. Krebs, Jr., Malvina Cassese, and Byron Krebs, San Francisco Municipal Court, Dept. 6, Docket No. G-14656 et al.
  83. Testimony of Carol M. Hehmeyer, Hearing before Kennedy subcommittee, pp. 226, 237.
  84. Resume of Laetrile cases, State of California, Health and Welfare Agency, Department of Health Services, various dates.
  85. People v. Mary Whelchel, San Diego Superior Court, Dept. 18, Docket CR 23718, Jan. 14 and 17, 1972; Feb. 13, 1974.
  86. Her Majesty the Queen v. Andrew R. L. McNaughton, Province of Quebec, District of Montreal, Court of Sessions of the Peace, No. 499-72, Judgment, Apr. 22, 1974.
  87. McNaughton pleaded guilty to a charge of conspiracy to facilitate the transportation of smuggled Laetrile. United States v. Andrew R. L. McNaughton, U.S. District Court, Southern District of California, No. 76-0448- Criminal, Judgment, Dec. 12, 1977.
  88. Newsday, Apr. 23, 1977.
  89. Unsigned memorandum for file, Mar. 10, 1972, AF 26-731, vol. 19, FDA Records (Rockville).
  90. J. A. Richardson and P. Griffin, Laetrile Case Histories (Bantam Books, New York, 1977), pp. 13-17, 71-73.
  91. California Board of Medical Quality Action Report, 10/1/ 76-12/30/76, John A. Richardson, M.D., Albany, Nov. 29, 1976.
  92. Testimony of Herbert B. Hoffman, Joseph Consentino, and Louis Castro, Hearing before Kennedy subcommittee, pp. 189-98.
  93. Robert W. Bradford to Dear Friend, The Committee for Freedom of Choice in Cancer Therapy brochure, [early 1973), in AF 26-731, vol. 22, FDA Records (Rockville).
  94. San Francisco Chronicle, Aug. 11, 1976.
  95. Statement of Robert W. Bradford, Hearing before Kennedy subcommittee, pp. 280-311.
  96. Affidavit of O.E. Kelly, vol. K, item 389, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  97. U.S. v. Bradford and U.S. v. Richardson, U.S. District Court, Southern District, California, 76-0448 Criminal, Judgment and Probation filed Dec. 12, 1977; U.S. v. Richardson, Bowman, Salaman, and Bradford, U.S. Court of Appeals, 9th Circuit, Nos. 77-2203, 77-204, 22-2262, and 77-2288, opinion filed Oct. 20, 1978.
  98. Ernst Krehs, Sr., to FDA, Apr. 18, 1963, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  99. E.T. Krebs, Jr., Jnl. Applied Nutrition 22, 75 (1970).
  100. Frank D. Corum memorandum, Mar. 24, 1966, San Francisco District File 131-699B, FDA Records (San Francisco).
  101. National Analysts, Inc., A Study of Health Practices and Opinions (National Technical Information Service, Springfield, VA, 1972).
  102. H. Young, “The Agile Role of Food,” in Nutrition and Drug Interrelations, J.N. Hathcock and J. Coon, eds. (Academic Press, New York, 1978), pp. 1-18.
  103. M. Greenberg, West. J. Med., 122, 345 (1975).
  104. National Nutrition Consortium, Inc., Statement on Laetrile-Vitamin B 7, Dec. 21, 1976.
  105. H. Jukes, Nutrition Today 12, 12 (Sep.-Oct. 1977).
  106. Testimony of Thomas H. Jukes, vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  107. Testimony of John A. Richardson, Robert Bradford, Ernst T. Krebs, Jr., and Bruce Halstead, Hearing before Kennedy subcommittee, pp. 272-74.
  108. Mercury, San Jose, Sep. 7, 1972.
  109. Merlyn Wurscher to San Francisco District, Oct. 19, 1972, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1972, FDA Records (San Francisco)
  110. FDA N.J.s 29 (Oct. 1975) and 31 (Nov. 1975).
  111. FDA N.J.s 32 and Inj. 660 (Apr. 1978).
  112. Sacramento Bee, June 24, 1978. On the California cancer quackery law, first enacted in 1959 and made permanent in 1969, see L. F. Saylor, Calif. Med. 112, 94 (1970).
  113. R. 12573, introduced by Steven D. Symms, Mar. 16, 1976, 94th Cong. 2nd ses., p. H2002.
  114. Symms interview, U.S.News and World Report, June 13, 1977, pp. 51-52.
  115. L. Nightingale and F. D. Arnold, Legal Aspects of Medicine 6, 31 (1978).
  116. Affidavit of Peter H. Wiernik, vol. H. item 200, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  117. New York Times, May 2, Aug. 16 and 25, 1977; June 7, 1978.
  118. Atlanta Journal and Constitution, Nov. 20, 1977.
  119. Based on author’s observations in one state and conversations with several observers in other states.
  120. Arizona Republic, Phoenix, June 20, 1977.
  121. Chicago Tribune, Aug. 27, 1978.
  122. Chicago Sun-Times, Mar. 5, 1978.
  123. Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla., 1975).
  124. Medical World News, June 28, 1976, pp. 17-20. Medical World News quotes Rutherford as saying that in Mexico surgeons “cauterized” the growth, and also quotes a Chicago pathologist as stating: “It is exceptionally rare for this type of tumor to metastasize. Local excision of the polyp virtually always cures the patient.”
  125. Rutherford v. United States, 542 F. 2d 1137 (10th Cir. 1976).
  126. FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  127. Rutherford v. United States, 438 F. Supp. 1287 (W. D., Okla. 1977).
  128. Rutherford v. United States, 10th Circuit opinion, text cited in United States v. Rutherford, Petition for a Writ of Certiorari, filed with the Supreme Court, Oct. 10, 1978.
  129. Statement of Joseph F. Ross, with exhibits, Hearing before Kennedy subcommittee, pp. 62-188.
  130. Medical World News, Jan. 9, 1978, pp. 16, 21.
  131. Charlotte (NC) Observer, Sep. 12, 1976.
  132. P. Lehmann, FDA Consumer 11, 10 (Oct. 1977).
  133. F. P. Smith et al., JAMA 238, 1361 (1977).
  134. FDA Talk Paper, July 12, 1978.
  135. United States v. Mosinee Corp., Inj. 789, FDA news release, May 16, 1977.
  136. FDA news release, Aug. 18, 1978.
  137. On June 18, 1979, a unanimous Supreme Court reversed the Tenth Circuit, holding that the safety and effectiveness standards in the law do apply to terminal patients. The high court did not address some issues which the district court had raised but the circuit court had not. United States v. Rutherford, No. 78-605.
  138. People v. Privitera, Court of Appeals, Fourth Appellate District, Division One, 4 Cr. No. 8323 (1977).
  139. The Supreme Court reversed the appellate course in this case. People v. Privitera, Supreme Court of the State of California, No. Crim. 20340 (1979), Sup., 153 Cal. Rptr. 431.
  140. Atlanta Constitution, Feb. 1-23, 1978, passim.
  141. FDA news release, Mar. 26, 1978.
  142. FDA Drug Bulletin, Nov.-Dec. 1977.
  143. United States v. Articles of Drug . . . Amigdalina Cyto Pharma De Mexico, S.A., Docket No. K77-1283, U.S. District Court for Maryland, filed Aug. 4, 1977, cited in Brief Amicus Curiae of the American Cancer Society, by Grace Powers Monaco, Mar. 8, 1979, in United States v. Rutherford, No. 78-605, in the Supreme Court of the United States, October Term, 1978.
  144. Medical World News, Sep. 5, 1977, p. 22.
  145. Interview with Eu9ene Pfeifer, Oct. 25, 1978.
  146. On Mar. 31, 1974.
  147. Atlanta Constitution, Aug. 21, 1975; Feb. 10, Apr. 1, May 13, 1976; Apr. 19, Dec. 8, 1977; Feb. 9, 1978.
  148. American Media, Westlake Village, CA,1974.
  149. ’76 Press, Seal Beach, CA, 1976.
  150. Choice Publications, Los Altos, CA, 1977.
  151. Cited in statement of Robert W. Bradford, Hearing before Kennedy subcommittee, p. 285.
  152. Ibid., pp. 272, 310.
  153. Los Angeles Times, Sep. 8, 1977.
  154. H.W. Manner, The Remission of Tumors with Laetrile Therapy (text of presentation to annual meeting, NHF, 1977) .
  155. Robert S.K. Young, Review of “The Remission of Tumors with Laetrile Therapy” (text of critique, 1977).
  156. M.B. Lipsett and J.C. Fletcher, N. Engl. J.  Med. 297, 1183 ( 1977) .
  157. J. Ingelfinger, N. Engl. J.  Med.. 296, 1167 (1977). After toxicity evidence concerning Laetrile had begun to mount, Ingelfinger told a reporter that he might not write the kind of editorial again that he had earlier written. Chicago Sun-Times, Mar. 8, 1978.
  158. New York Times, Feb. 11, 1977.
  159. G. Moertel, N. Engl. J.  Med.. 298, 218 (1978).
  160. Statement of Donald Kennedy, Hearing before Kennedy subcommittee, pp. 26-38.
  161. Hearing before Kennedy subcommittee, pp. 248-50, 295.
  162. Statement by Guy R. Newell, M.D., Deputy Director, National Cancer Institute, on Retrospective Evaluation of Laetrile Anticancer Activity in Man, Jan. 26, 1978.
  163. Neil M. Ellison, Report on a Doctors’ Workshop on Metabolic Therapy, Amygdalin, and Cancer–Newark, New Jersey, Feb. 4-5, 1978.
  164. M. Ellison, D. P. Byar and G. R. Newell, N. Engl. J. Med. 299, 549 (1978).
  165. Atlanta Constitution, Sep. 28, 1978. In December 1978 the NCI ‘ormally applied to the FDA for an IND to permit the clinical trials.
  166. Robert C. Wetherell, Jr., Status of Laetrile, Feb. 6, 1975, AF 26-731, vol. 31, FDA Records (Rockville).
  167. Newsday, Apr. 25, 1977.
  168. Dean Burk to Edward Kennedy, Nov. 16, 1977, and exhibits, Hearing before Kennedy subcommittee, pp. 384- 419.
  169. Testimony of Robert W. Bradford, vol. 0-2, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  170. D. Leff, Medical World News, May 1, 1978, pp. 43-51.
  171. Editorial, The Choice (Oct. 1978).
  172. J H. Young Cimarron Rev., No. 8, 31 (1969).
  173. New York Times, July 1, 1906.
  174. Pennsylvania Gaazette, Philadelphia, Oct. 17 and 31, 1745.
  175. Young, The Medical Messiahs, pp. 48-49.
  176. American Cancer Society, 1977 Cancer Fact & Figures (New York, 1976).
  177. Donald Kennedy, text of speech on “Cancer Politics,” Nov. 3, 1977.
  178. Susan Sontag, New York Review, Jan. 26, pp. 10-16; Feb. 9, pp. 27-29; and Feb. 23, 1978, pp. 29-33. These articles have been combined into a book, Illness as Metaphor (Farrar, Straus and Giroux, New York, 1978).
  179. W.F. Janssen, Analytical Chem., 50, 197A (1978).
  180. Young, The Medical Messiahs, pp. 401-402, 420.
  181. This pattern the author first explored in Newsday, May 1, 1978.
  182. American Medical Association, Nostrums and Quackery, 2nd ed. (AMA Press, Chicago, 1912), p. 56.
  183. Testimony of David T. Carr, vol. 0-1, FDA Administa¬tive Record, Laetrile, Docket No. 77N-0048.
  184. Edmund Griffin, World Without Cancer, transcript of sound track of documentary film, supplied by Food and Drug Administration.
  185. American Medical Association, Nostrums and Quackery, p. 39.
  186. Edmund Griffin, in Richardson, Laetrile Case Histories, p. 64.
  187. H. Young, The Toadstool Millionaires (Princeton University Press, Princeton, 1961), pp. 165-89.
  188. San Francisco Chronicle, Aug. 11, 1976.
  189. Young, Toadstool Millionaires, pp. 75-89.
  190. Ibid., pp. 220-21.
  191. Affidavit of W. Sherwood Lawrence, vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  192. California v. Krebs and Cassese, San Francisco Municipal Court, No. G 14673 and G 14670, 1977.
  193. Young, The Medical Messiahs, pp. 239-57.
  194. Richardson, Laetrile Case Histories, pp. 97-102.
  195. Ibid., pp. xv, 4, 55-65.
  196. Statement of the American Medical Association, Hearing before Kennedy subcommittee, pp. 327-32.
  197. G. Campbell to Leland M. Ford, Mar. 4, 1941, Inter-state Office Seizure No. 16224-E File, FDA Records, RG 88, National Archives Bz an ch , WNRC.
  198. Arthur J. Cramp, Nostrums and Quackery and Pseudo-Medicine (AMA, Chicago, 1936), pp. 198-208.
  199. Weinburger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609.
  200. An apparent example of this circumstance is revealed in a letter headed “Cancer and Oncologists versus Laetrile,” July 25, 1975, AF 26-731, vol. 30, FDA Records (Rockville).
  201. Cramp, Nostrums and Quackery and Pseudo-Medicine, pp. 218-21.
  202. W. Holmes, Medical Essays (Houghton Mifflin, Boston, 1891), p. 186.
  203. Richardson comments on these circumstances in Laetrile Case Histories, pp. 76-77.
  204. Order and Affidavit and Extension, filed May 10, 1977, by Judge Luther Bohanon, Rutherford v. United States. I have multiplied the quantity of tablets and injectable liquid authorized by the then current cost, one dollar a tablet and ten dollars for a 3g. ampule.
  205. Form letter from National Health Federation, [Dec. 1977), promoting “Fund to Stop Government Ban on Laetrile,” Decimal File 539,ILX, vol. 33, FDA Records (Rockville).
  206. A most useful sociological study of persons who attended a “Cancer Control Symposium” sponsored by a Michigan chapter of the Cancer Control Society appears in G. E. Markle, J.C. Petersen, and M.O. Wagenfeld, Soc. Sci. & Med., 12, 31 (1978).
  207. Boston Herald-American, May 19, 1978.
  208. Interview with Stuart L. Nightingale, Oct. 24, 1978.
  209. It has been suggested, however, that the right of privacy doctrine established by the Supreme Court in Griswold v. Connecticut, 381 u. S. 479 (1965), might provide grounds for a challenge of federal law restrictions on the consumer’s free choice of drugs. D. G. Rushing, UCLA Law Rev., 25, 577 (1978).
  210. Death Education devoted its double Spring/Summer 1978 issue to the Hospice movement.
  211. Thomas H. Jukes to author, Aug. 11, 1978.


Karima Hirani, M.D., Accused of Unprofessional Conduct

In March 2020, the Medical Board of California accused Karima Hirani., M.D. of gross negligence; repeated negligent acts; and excessive prescribing or treatment in her management of a nine-year-old girl with a chief complaint of intermittent stomach pain. The Accusation, shown below, states that Hirani: Recommended and/or prescribed a gluten-free, dairy-free, sugar-free diet, several six …

In March 2020, the Medical Board of California accused Karima Hirani., M.D. of gross negligence; repeated negligent acts; and excessive prescribing or treatment in her management of a nine-year-old girl with a chief complaint of intermittent stomach pain. The Accusation, shown below, states that Hirani:

  • Recommended and/or prescribed a gluten-free, dairy-free, sugar-free diet, several six nutritional supplements.
  • Ordered approximately 30 laboratory test panels, many of which were redundant or lacked medical justification.
  • Diagnosed the child with active Lyme disease, active varicella (chickenpox), and mycoplasma (walking pneumonia) infections, diagnoses that were not properly supported by the laboratory results.
  • Ordered a homeopathic product for the alleged Lyme disease without disclosing that no peer-reviewed studies supported its use.

Hirani operates the Hirani Medical Wellness Center in Culver City, California where she practices what she calls “holistic and preventative medicine.”


XAVIER BECERRA
Attorney General of California
JUDITH T. ALVARADO
Supervising Deputy Attorney General
PEGGIE BRADFORD TARWATER
Deputy Attorney General
State Bar No. 169127
California Department of Justice
300 South Spring Street, Suite I 702
Los Angeles, California 90013
Telephone: (213) 269-6448
Facsimile: (213) 897-9395
E-mail: Peggie.Tarwater@doj.ca.gov

Attorneys for Complainant

BEFORE THE
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA

In the Matter of the Accusation Against:

KARIMA HIRANI, M.D.
9736 Venice Boulevard
Culver City, California 90232

Physician’s and Surgeon’s Certificate
No. G 79715

Respondent.


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Case No. 800-2017-038476

FIRST AMENDED ACCUSATION

 

FILED March 7, 2018

Complainant alleges:

PARTIES

  1. Christine J. Lally (Complainant) brings this First Amended Accusation solely in her official capacity as the Interim Executive Director of the Medical Board of California, Department of Consumer Affairs (Board).
  2. On August 24, 1994, the Medical Board issued Physician’s and Surgeon’s Certificate Number G 79715 to Karima Hirani, M.D. (Respondent). The Physician’s and Surgeon’s Certificate was in full force and effect at all times relevant to the charges brought herein and will expire on April 30, 2020, unless renewed.

JURISDICTION

  1. This First Amended Accusation is brought before the Board under the authority of the following laws. All statutory references are to the Business and Professions Code (Code) unless otherwise indicated.
  2. Section 2227 of the Code provides that a licensee who is found guilty under the Medical Practice Act may have his or her license revoked, suspended for a period not to exceed one year, placed on probation and required to pay the costs of probation monitoring, or such other action taken in relation to discipline as the Board deems proper.

STATUTORY PROVISIONS

  1. Code section 2234 states, in pertinent part:

The board shall take action against any licensee who is charged with unprofessional conduct. In addition to other provisions of this article, unprofessional conduct includes, but is not limited to, the following:

(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the violation of, or conspiring to violate any provision of this chapter.

(b) Gross .negligence.

(c) Repeated negligent acts. To be repeated, there must be two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.

(1) An initial negligent diagnosis followed by an act or omission medically appropriate for that negligent diagnosis of the patient shall constitute a single negligent act.

(2) When the standard of care requires a change in the diagnosis, act, or omission that constitutes the negligent act described in paragraph (1), including, but not limited to, a reevaluation of the diagnosis or a change in treatment, and the licensee’s conduct departs from the applicable standard of care, each departure constitutes a separate and distinct breach of the standard of care.

¶….¶

  1. Code section 725 states:

(a) Repeated acts of clearly excessive prescribing, furnishing, dispensing, or administering of drugs or treatment, repeated acts of clearly excessive use of diagnostic procedures, or repeated acts of clearly excessive use of diagnostic or treatment facilities as determined by the standard of the community of licensees is unprofessional conduct for a physician and surgeon, dentist, podiatrist, psychologist, physical therapist, chiropractor, optometrist, speech-language pathologist, or audiologist.

(b) Any person who engages in repeated acts of clearly excessive prescribing or administering of drugs or treatment is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($ I 00) nor more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days nor more than 180 days, or by both that fine and imprisonment.

(c) A practitioner who has a medical basis for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances shall not be subject to disciplinary action or prosecution under this section.

(d) No physician and surgeon shall .be subject to disciplinary action pursuant to this section for treating intractable pain in compliance with Section 2241.5.

FIRST CAUSE FOR DISCIPLINE

(Gross Negligence)

  1. Respondent is subject to disciplinary action for gross negligence under Code section 2234, subdivision (b). The circumstances are as follows:
  2. Respondent practices functional medicine and complementary alternative medicine in an integrative practice.
  3. On September 17, 2017, Patient I, a nine-year-old female, presented to Respondent with a chief complaint of intermittent stomach pain. Her health history also included recurrent ear infections, fear of kidnapping, and a history of an autoimmune illness called Henoch Schonlein Purpura, a disease causing swelling of small blood vessels commonly found in children. Overall, Patient I had seen her pediatrician in May 2015 for an insect bite that had resulted in a fever. Patient 1 ‘smother explained that she wished to be proactive in minimizing stomach sensitivities that may disrupt schooling.
  4. On the first visit, Respondent recommended a gluten-free, dairy-free, sugar-free diet. She recommended six nutritional supplements. She ordered approximately 30 laboratory panels, which included redundancies, such as two celiac panels from two different laboratories and herpes simplex virus antibody and human herpes virus 6 antibody tests from two different laboratories. Many of the labs were not relevant to Patient l’s chief complaint of intermittent stomachache.
  5. Respondent proceeded with extensive testing while also acknowledging that blood tests are often not useful in looking for food sensitivities and that positive outcomes for Patient 1 ‘s complaints could occur with a simple anti-inflammatory dietary intervention.
  6. Patient I returned for a follow-up visit on October 18, 2017. Patient 1’s mother reported that the stomachaches had subsided with the dietary changes, a probiotic, a digestive enzyme, and L-glutamine amino acid.
  7. The standard of care requires a physician practicing complementary medicine to ordr tests appropriate for the nature and severity of the chief complaint.
  8. Respondent was grossly negligent in the care and treatment of Patient 1 in that she engaged in excessive and unnecessary testing without medical justification.

SECOND CAUSE FOR DISCIPLINE

(Repeated Negligent Acts)

  1. Respondent is subject to disciplinary action under section 2234, subdivision (c), in that she committed repeated negligent acts in her care and treatment of Patient I. The circumstances are as follows.
  2. The allegations in the First Cause for Discipline are incorporated by reference.
  3. Respondent diagnosed Patient 1 with active Lyme disease, active varicella (chicken pox), and mycoplasma (walking pneumonia) infections, diagnoses which are not properly supported by Patient l’s laboratory results. During an interview related to Patient l’s care conducted on behalf of the Board, Respondent admitted that Patient 1 did not have active infections to these agents, but rather an autoimmune process or reaction to the agents that could have been better explained.
  4. Respondent told the mother of Patient I that Lyme disease could be transmitted through spider bites and mosquito bites without explaining that this view contradicted the opinionof the Centers for Disease Control that the disease is transmitted through tick bites or the rare process of in utero transmission.
  5. Respondent recommended a homeopathic treatment for the Lyme disease, consisting of low dose immunotherapy (LDI).1 LDI, while safe, is not the conventional treatment for Lyme disease. Respondent did not explain to the mother of Patient 1 that LOI is an alternative and complementary medicine treatment for Lyme disease nor did she explain that there are no peer­reviewed studies supporting its use. She did not explain or offer the conventional Lyme disease treatment for Patient 1.

1 LDI involves obtaining liquid antigens from a compounding pharmacy and diluting the liquid hundreds of times such that it contains little of the original substances. Homeopathic doctors believe that if properly diluted, a substance that causes disease symptoms in a healthy person can improve the symptoms in a sick person.

  1. Respondent told Patient l’s mother that Patient 1 was not very symptomatic despite the three infections, allergies, and “the mold thing going on.” Respondent said nobody else would find “it” and that, “You’re dodging a big bullet if you follow my recommendations.”
  2. The standard of care is to interpret laboratory tests accurately, explain the results to patients in an understandable way, and to explain the risks and benefits of treatments offered.
  3. Respondent departed from the standard of care in diagnosing active Lyme, Varicella, and Mycoplasma infections instead of taking adequate time to fully explain the autoimmune phenomena.
  4. Respondent departed from the standard of care by stating that Lyme disease can be transmitted by spiders and mosquitoes without explaining that this opinion contradicts that of the Centers for Disease control.
  5. Respondent departed from the standard of care in offering LOI treatment without explaining the homeopathic nature of the treatment and that there are no peer-reviewed studies supporting its use.

THIRD CAUSE FOR DISCIPLINE

(Excessive Prescribing or Treatment)

  1. By reason of the facts alleged in the First Cause for Discipline, Respondent is subject to disciplinary action under section 725, in that she engaged in excessive testing and treatment in her care and treatment of Patient 1.

WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Medical Board of California issue a decision:

  1. Revoking or suspending Physician’s and Surgeon’s Certificate Number G 79715, issued to Respondent Karima Hirani, M.D.;
  2. Revoking, suspending or denying approval of Respondent’s authority to supervise physician assistants and advanced practice nurses;
  3. If placed on probation, ordering Respondent to pay the Board the costs of probation monitoring; and
  4. Taking such other and further action as deemed necessary and proper.

DATED: Mar 23, 2020

_______________________
CHRISTINE J. LALLY
Interim Executive Director
Medical Board of California
Department of Coinsumer Affairs
State of California
Complainant



FCC Proposes Record $225 Million Fine for Massive Spoofed Robocall Campaign

On June 9, 2020, the Federal Communications Commission (FCC) proposed a $225 million fine against Texas-based health insurance telemarketers for apparently making more than one billion illegally spoofed robocalls. The FCC news release said the action was the largest proposed fine in the FCC’s 86-year history and reflected the seriousness of the apparent violations by …

On June 9, 2020, the Federal Communications Commission (FCC) proposed a $225 million fine against Texas-based health insurance telemarketers for apparently making more than one billion illegally spoofed robocalls. The FCC news release said the action was the largest proposed fine in the FCC’s 86-year history and reflected the seriousness of the apparent violations by John C. Spiller and Jakob A. Mears, who used business names including Rising Eagle and JSquared Telecom.

Rising Eagle made approximately one billion spoofed robocalls across the country during the first 4½ months of 2019 on behalf of clients that sell short-term, limited-duration health insurance plans. Mr. Spiller admitted to the USTelecom Industry Traceback Group that he knowingly called consumers on the Do Not Call list as he believed that it was more profitable to target these consumers. The FCC’s Enforcement Bureau determined that at one point Rising Eagle used at east 60 spoofed caller IDs and made at least 86,864,456 robocalls to wireless phones as well as 56,635,935 robocalls to numbers listed on the National Do Not Call Registry. 

The robocalls falsely claimed to offer health insurance plans from well-known health insurance companies such as Aetna, Blue Cross Blue Shield, Cigna, and UnitedHealth Group. For example, one call stated:

Are you looking for affordable health insurance with benefits from a company you know? Policies have all been reduced nationwide such as Cigna, Blue Cross, Aetna, and United just a quick phone call away. Press 3 to get connected to a licensed agent or press 7 to be added to the Do Not Call list.

If they did press 3, consumers were transferred to a call center with no affiliation to the named companies, where call center representatives then would attempt to convince the consumer to purchase an insurance product sold by one of Rising Eagle’s clients. Rising Eagle’s largest client, Health Advisors of America, was sued by the Missouri Attorney General for telemarketing violations in February 2019.

Beginning in 2018, there was an increase in consumer complaints and robocall traffic related to health insurance and other health care products. The Traceback Group determined that approximately 23.6 million health insurance robocalls were crossing the networks of the four largest wireless carriers each day. The FCC Enforcement Bureau’s investigation found that a large portion of this unwelcome robocall traffic was driven by Rising Eagle.

The Truth in Caller ID Act prohibits manipulating caller ID information with the intent to defraud, cause harm, or wrongfully obtain anything of value. The FCC’s investigation found that the robocalls made by Rising Eagle were spoofed in order to deceive consumers, targeted millions of Do Not Call list participants, and were received on many wireless phones without prior consumer consent. The scam also caused the companies whose caller IDs were spoofed to become overwhelmed with angry call-backs from aggrieved consumers. At least one company was hit with several lawsuits because its number was spoofed, and another was so overwhelmed with calls that its telephone network became unusable.

Illegal robocalls are the FCC’s top complaint. In recent years, the agency has issued a number of very large fines and proposed fines for spoofing violations. In addition, it has permitted phone companies to block suspected malicious robocalls before they get to consumers; led the push for caller ID authentication using STIR/SHAKEN standards; worked to reduce unwanted calls to reassigned numbers; took steps to prevent scam robotexts; and provided many alerts, tips, and other education tools to help consumers protect themselves from scammers. Unfortunately, as two of the five FCC Commissioners pointed out in the Notice, the Department of Justice has lessened the agency’s effectiveness by failing to help collect fines imposed in previous cases.

The proposed action, formally called a Notice of Apparent Liability for Forfeiture, or NAL, contains only allegations that advise a party on how it has apparently violated the law and may set forth a proposed monetary penalty. The Commission may not impose a greater monetary penalty in this case than the amount proposed in the NAL. Neither the allegations nor the proposed sanctions in the NAL are final Commission actions. The party will be given an opportunity to respond and the Commission will consider the party’s submission of evidence and legal arguments before acting further to resolve the matter. More information about robocall regulation is available at: https://www.fcc.gov/spoofed-robocalls.

The FCC’s action against this scheme provides some hope that robocalls can be controlled. But it also spotlights why laws are needed to make illegal robocalling a crime that can be punished by imprisonment.