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Medical and Osteopathic Board Actions

All of the physicians listed below have been the target of at least one regulatory action by their licensing authority. Most cases involve the use or alleged use of methods that are criticized on our sites. The links lead to copies of complaints, orders, and, in many cases, to summaries of the relevant regulatory history. …

All of the physicians listed below have been the target of at least one regulatory action by their licensing authority. Most cases involve the use or alleged use of methods that are criticized on our sites. The links lead to copies of complaints, orders, and, in many cases, to summaries of the relevant regulatory history. Where possible, the documents reflect final actions, including decisions and any court appeals. However, a few cases are ongoing. If you encounter any complaints, final orders, or court documents that you believe should be added, please notify Dr. Barrett.

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Additional Information


Disciplinary Actions against Lloyd A. Wright, D.C.

In 1997, the Florida Department of Health charged that Lloyd A. Wright, D.C., had treated a patient many times without documenting a need the amount of service. The administrative complaint (shown below) stated: Between November 1988 and April 1995, the patient received chiropractic care approximately 205 times. Between March 1993 and December 1994 the patient …

In 1997, the Florida Department of Health charged that Lloyd A. Wright, D.C., had treated a patient many times without documenting a need the amount of service. The administrative complaint (shown below) stated:

  • Between November 1988 and April 1995, the patient received chiropractic care approximately 205 times.
  • Between March 1993 and December 1994 the patient had undergone 29 separate Metrecom tests. [The Metrecom skeletal analysis system is a  computerized goniometer designed for postural evaluation, spinal analysis, and measurements of joint range of motion. Aetna considers it “experimental” because its use has not been proven to improve treatment outcome.]
  • Wright failed to reduce the frequency of tests or spinal adjustments after maximum medical improvement was reached in December 1990.
  • Wright’s records did not justify the extent, frequency, total amount, or type of treatment he administered.

In 2008, the case was settled with a stipulation in which Wright agreed to (a) pay an administrative fine of $2,000 plus up to $750 for the cost of processing the case, (b)serve six months on probation, during which his practice would be monitored, and (c) complete 25 hours of continuing education that included at least one unit on record-keeping. 

In 2002, the board charged Wright with exerting influence over a patient for financial gain by ordering excessive tests without documenting a need for the tests. The case was settled in 2007 by a stipulation in which Wright agreed to (a) receive a letter of concern, (b) pay a $2,500 fine plus $5,000 for administrative costs, (c) take 5 additional hours of continuing education, and (d) serve probation with monitoring for two years. In 2008, the Department of Health suspended Wright’s license for failing to pay the $7,500.

Wright began practicing in Florida in 1977. In 1980, a former patient sent me court documents indicating that Wright had sued him for refusing to pay for treatment of acne. The cost included a charge of $65 for a worthless hair analysis test. The judge dismissed the case after concluding (based on expert testimony) that it was inappropriate for a chiropractor to treat acne. However, a motion for a new trial was granted, and I don’t know what happened after that.


STATE OF FLORIDA
DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH,

PETITIONER,

vs.

LLOYD A. WRIGHT, D.C.

RESPONDENT.


CASE NUMBER: 95-14457

ADMINISTRATIVE COMPLAINT

COMES NOW, the Petitioner, the Department of Health, hereinafter referred to as “Petitioner”, and files this Administrative Complaint before the Board of Chiropractic against LLOYD A. WRIGHT, D.C., hereinafter referred to as “Respondent”, and alleges:

  1. Effective July 1, 1997, Petitioner is the state agency charged with the regulating the practice of chiropractic pursuant to Section 20.43, Florida Statutes (Supp. 1996); Chapter 455, Florida Statutes: and Chapter 460t Florida Statutes. Pursuant to the authority of Section 20.43 (3) (f), Florida Statutes, the Petitioner has contracted with the Agency of Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils; or boards, as appropriate.
  2. Respondent is, and has been at all times material hereto, a licensed chiropractic physician in the State of Florida, having been issued license number CH 000275. Respondent’s fast known address is 801 W. Granada Blvd., #301, Ormond Beach, FL 32174.
  3. From on or about November 14, 1988, through April 20, 1995, Respondent provided chiropractic care for Patient H.O. approximately two hundred and five (205) times.
  4. From on or about March 11. 1993, through December l. 1994, Respondent’s medical records for Patient H.O. revealed documentation of twenty-nine (29) separate Metrecom tests.
  5. Respondent failed to reduce the frequency of tests or adjustments once Maximum Medical Improvement (MMI) was reached on or about December 1990.
  6. The written chiropractic records as maintained by the Respondent do not justify the course of treatment for Patient H.0. because:

a) Respondent’s written records do not justify the extent. frequency, total amount or type of treatment rendered by Respondent;

b) Respondent failed to provide medical documentation justifying the Metrecom testing for Patient H.O from on or about March 11, 1993, through December 1, 1994;

c) Respondent failed to document in the daily notes any information that changed the treatment plan for Patient H.O.;

d) Respondent’s objective findings and assessments for Patient H.O. were substandard.

COUNT I

  1. Petitioner realleges and incorporates by reference the allegations contained in paragraphs one (1) through six (6) as if fully stated herein.
  2. Based on the foregoing, the Respondent’s license to practice chiropractic in the State of Florida is subject to discipline for violating Section 460.413 (l)(m), Florida Statutes. for failing to keep written chiropractic records justifying the course of treatment of the patient ‘including, but not limited to, patient histories, examination results, test results, X-rays. diagnosis of a disease, condition, or injury.

COUNT II

  1. Petitioner realleges and incorporates by reference the allegations contained in paragraphs one (1) through six. (6) as if fully stated herein.
  2. Based on the foregoing, the Respondent’s license to practice chiropractic in the State of Florida is subject to discipline for violating Section 460.413 (1) {n), Florida Statutes, for exercising influence on the patient or client in such a manner as to exploit the patient or client for financial gain of the licensee.

WHEREFORE, Petitioner respectfully requests the Board of Chiropractic enter an order imposing one or more of the following penalties: revocation or suspension of the Respondent’s license, restriction of the Respondent’s practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, and/or any other relief that the Board deems appropriate.

SIGNED this 27th day of October, 1997.

_________________________
James T. Howell. M.D., M.P.H.,
Secretary

BY: Nancy M. Snurkowski
Chief Attorney
Agency for Health Care Administration

COUNSEL FOR PETITIONER:

Gregory W. Files
Legal Trainee
Agency for Health Care Administration
Post Office Box 14229
Tallahassee, Florida 32317-4229
(904) 487-2225

Filed: 10-31-97



Index to Information on Laetrile

Laetrile is the trade name for a synthetic relative of amygdalin, a chemical in the kernels of apricot pits, apple seeds, bitter almonds, and some other stone fruits and nuts. Proponents claim that Laetrile kills tumor cells selectively while leaving normal cells alone. Many have called it “vitamin B17” and falsely claimed that cancer is …

Laetrile is the trade name for a synthetic relative of amygdalin, a chemical in the kernels of apricot pits, apple seeds, bitter almonds, and some other stone fruits and nuts. Proponents claim that Laetrile kills tumor cells selectively while leaving normal cells alone. Many have called it “vitamin B17” and falsely claimed that cancer is a vitamin deficiency disease that Laetrile can cure. Although Laetrile has been promoted as safe and effective, clinical evidence indicates that it is neither. When subjected to enzymatic breakdown in the body, it forms glucose, benzaldehyde, and hydrogen cyanide. Some patients treated with Laetrile have suffered nausea, vomiting, headache, and dizziness, and a few have died from cyanide poisoning. Tests of Laetrile in at least 20 animal tumor models have found no benefit either alone or together with other substances. Studies of human case reports have also been uniformly negative. 

In 1975 a patient named Glen Rutherford filed a class-action suit to stop the FDA from blocking the distribution of Laetrile. Early in the case, a renegade federal district court judge ruled that cancer patients could import a 6-month supply of Laetrile for personal use if they could obtain a physician’s affidavit that they were “terminal.” In 1979 the U.S. Supreme Court ruled that it is not possible to be certain who is terminal and that even if it were, both terminally ill patients and the general public deserve protection from fraudulent cures. In 1987, after further appeals were denied, the affidavit system was terminated. Today few sources of Laetrile are available within the United States, but it still is utilized at Mexican clinics. In 2011, a Cochrane review concluded that there is no reliable evidence for the alleged effects of Laetrile or amygdalin for curative effects in cancer patients. 

Critical Articles
FDA Laetrile Rulemaking Proceeding
The Rutherford Case
Other Civil Cases
Criminal Prosecution
Licensing Board Actions
Proponent Organization
Proponent Publications


Nearly Paralyzed under Chiropractic Care

In 1972, I read the book At Your Own Risk by Ralph Lee Smith and was startled into an awareness that exactly the same procedures and techniques as quoted by Mr. Smith were used on me about a few years before that when I was “cared for” by a local chiropractor in Allentown. The beginning …

In 1972, I read the book At Your Own Risk by Ralph Lee Smith and was startled into an awareness that exactly the same procedures and techniques as quoted by Mr. Smith were used on me about a few years before that when I was “cared for” by a local chiropractor in Allentown.

The beginning of the story started one day when I suddenly experienced a sharp pain in my lower back and nerve pain down my left leg. This was soon after some work during the construction of my new home.

A few well-meaning friends suggested a local chiropractor. I proceeded to make an appointment and made my way to his office. The first step was an immediate x-ray. This method (the entire back) was identical to that described by Ralph Lee Smith. Indeed, I never saw the actual x-ray, as the chiropractor simply returned from an adjoining room and informed me that I had a “subluxation” of the lower back.

The cure was the now recognized method of lying on the special motorized couch and the manipulation of my lower back, legs, and entire vertebrae, accompanied by comments such as “My, you really are tight,”

The charge for this first visit was $28.00, twenty dollars of which the chiropractor explicitly told me was covered by Blue Cross – Blue Shield.

When I suggested that he submit the bill for payment (the normal procedure), he suggested that this was not the method he used and gave me a receipt after I had given him my check. I submitted the bill and found out that such coverage does not come under the Blue Cross-Blue Shield Plan. Nor did it ever come under the plan. I have concluded that the chiropractor either was totally ignorant of such coverages or deliberately deceptive. I questioned him later about the coverage, and he simply replied with a quizzical attitude.

The cost didn’t bother me, for, if cure was possible, it would have been worth it. But after many repeated visits (all of them suggested in identically the same wording and manner as that indicated by Mr. Smith’s book and the quotations of a guidebook for chiropractors) After one year my painful condition was not being cured. In fact, I was getting worse and I was losing the feeling in the left side of my foot.

At this point I had a close personal friend who was a resident surgeon at the Allentown Hospital and one of the most respected doctors on the staff. Up to this point, I had failed to heed his warnings and advice. But now, with numbness in my foot and literally unable to get into or out of bed without severe pain, I decided the time to consult my doctor friend was at hand.

He advised going directly to bed and to making an appointment as soon as possible with a local orthopedic surgeon. This I did, and after a few days wait for the appointment, he examined me.

The rest of the story is much brighter—as with pointed alarm, he indicated to me what was happening. Following x-rays (this time by a trained technician on only the affected area of my back), he ordered me to bed for at least a month. Otherwise, hospitalization and possible back operation would be necessary.

Needless to say, I followed his instruction to the letter. and within a two-month period, I was walking comfortably and began to exercise slightly. A few months later (and incidentally, with only about four check-up visits to the orthopedist) I was cured. My back has never bothered me again. I have watched with caution what I lift and do take caution on how I exercise.

Since this experience, I have watched with great interest the practice of chiropractic. I have never considered myself to be a leader in a specific cause, but I feel strongly that citizens should be aware of the methods used by chiropractors. If, after exposure, they still choose to visit them, then that is their fate, I thank God I was able to walk away with my health.

I also have become increasingly alarmed at how chiropractors are attempting to infiltrate our governments with lobbyist tactics for the coverage of Medicare payments and other compensation. This amounts to nothing more than precious tax dollars going toward the support of ‘quack’ medicine.

I almost lost the use of my legs. Others, no doubt will lose their lives by innocently entrusting their care to these so-called “doctors”. I hope you will do everything in your power to oppose chiropractic inclusion in Federal health programs.


Mr. Johnson edited and published MEMO magazine. This report is a slightly edited version of a letter he sent to his local Congressional representative in 1972 to oppose chiropractic inclusion under Medicare.



Judge Awards $2.1 Million in Chelation Case (1995)

In December 1995, the Houston Chronicle reported that State District Judge Mark Davidson had found Mohammed Kakvan, M.D. negligent in the 1992 death of 61-year-old Frank Vecchio. Testimony in the case indicated: Vecchio underwent quadruple bypass at age 46 but experienced no other major health problems until 1992 when he began experiencing chronic chest pains. …

In December 1995, the Houston Chronicle reported that State District Judge Mark Davidson had found Mohammed Kakvan, M.D. negligent in the 1992 death of 61-year-old Frank Vecchio. Testimony in the case indicated:

  • Vecchio underwent quadruple bypass at age 46 but experienced no other major health problems until 1992 when he began experiencing chronic chest pains.
  • Veccho began chelation with Kakvan on October 20, 1992 but died of a heart attack on November 20th.
  • Chelation had been condemned by major health organizations.
  • Kakvan should have recognized the severity of Vecchio’s symptoms and referred him for hospitalization under the care of a heart specialist.

The judge awarded $600,000 in actual damages and $1.5 million in punitive damages to Vecchio’s widow and his estate.



Disciplinary Actions against Michael D. Margolis, D.D.S.

Michael D. Margolis, D.D.S. who practices what he called “biological dentistry,” has been disciplined by the Arizona Board of Dental Examiners ten times. In 1984, he was placed on one year’s probation and ordered to take 21 hours of continuing education. In 1987, the board concluded that he had failed to adequately document the reasons …

Michael D. Margolis, D.D.S. who practices what he called “biological dentistry,” has been disciplined by the Arizona Board of Dental Examiners ten times.

  • In 1984, he was placed on one year’s probation and ordered to take 21 hours of continuing education.
  • In 1987, the board concluded that he had failed to adequately document the reasons for several procedures that the board suspected were questionable. After concluding that he had acted unprofessionally, it fined him $200 and placed him on probation for one year.
  • In 1989, the board censured him for installing a crown improperly and ordered him to pay restitution of $330 to the patient.
  • In 1995, the Board censured him for failing to supervise a dental assistant whom he had authorized to polish teeth.
  • In 2004, 2012, and 2013 (shown below), he was disciplined for inappropriately diagnosing and treating a patient for “neuralgia inducing cavitational osteonecrosis” (“NICO”) and unnecessarily extracting teeth based on diagnoses made with a Cavitat device. He had also performed invasive jawbone surgery that was unnecessary and had left the patients with persistent jaw discomfort. In the 2004 case, he was ordered to take 12 hours of board-approved continuing education. In the 2012 case he was ordered to take 24 hours of continuing education. In the 2013 case, he was ordered to pay restitution of $11,986 to the patient.
  • In 2015, he was fined $2,000, required to take 12 more hours of continuing education, and ordered to pay restitution of $7,000 to the patient for doing unnecessary surgery on a patient who had  been treated for NICO by another dentist.
  • In 2016, the board fined him $5,000 for doing an unnecessary procedure and failing to properly investigate the cause of a patient’s jaw pain.
  • In 2019, the board concluded that Margolis had failed to meet the standard of care in his management of two patients, one of whom had been repeatedly overcharged and had had implants improperly placed. He was placed on probation for two years and required to take continuing education in implantology.

The NICO diagnosis is used by a tiny minority of dentists who claim that most facial pains and even pains and diseases located far from the mouth are caused by cavities (cavitations) within the jaw bones that can be diagnosed with a Cavitat device and should be treated with invasive and irreversible surgeries and extractions. The Cavitat is an ultrasound device that does not have FDA approval for diagnosing disease. In 2012, the American Association of Endodontists issued a position statement that concluded:

The American Association of Endodontists cannot condone surgical interventions intended to treat suspected NICO lesions. Even when a NICO lesion is suspected to be associated with an endodontically treated tooth, no surgical procedures should be performed until orofacial pain specialists confirm the diagnosis. . . . In addition, the practice of recommending the extraction of endodontically treated teeth for the prevention of NICO, or any other disease, is unethical and should be reported immediately to the appropriate state board of dentistry.

Despite the many board actions, Margolis’s website still promotes and offers treatment for “cavitations.


BEFORE THE ARIZONA STATE BOARD OF DENTAL EXAMINERS
IN THE MATTER OF:

Michael D. Margolis, D.D.S.

Holder of License Number D 2957
For the Practice of Dentistry
In the State of Arizona

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Case No. 201300171

DISCIPLINARY
CONSENT AGREEMENT
AND ORDER

 


In order to resolve this case quickly and judiciously, the Arizona State Board of Dental Examiners (Board”) and Michael D. Margolis. D.D,S, enter into this Disciplinary Agreement and Order (“Consent Agreement) in lieu of further administrative and judicial proceedings. It is consistent with the public interest and the requirements and statutory authority of the Board, specifically, A.R.S. §§ 32-1263.01, 1263.02 and  41-1092.07(F)(5). This Consent Agreement shall resolve all issues the Board has reviewed and investigated regarding the allegations in this matter.

Therefore, in lieu of further proceedings, Michael D. Margolis, D.D.S. admits and understands that:

  1. Any record prepared in this matter, all investigative materials prepared and received by the Board concerning the allegations, and all related materials and exhibits may be retained in the Board;s file pertaining to this matter.
  2. Dr. Margolis waives any right to a hearing or re-hearing of this matter and any right to judicial review of  the attached Findings of  Fact,  Conclusions of of Law, and Order.
  3. Dr. Margolis has the right to consult with an attorney prior to entering into this Consent Agreement.
  4. The findings contained in the Finding of Fact portion of’ the Consent Agreement are conclusive evidence of the stated facts. The Board may consider this Consent Agreement when and if future disciplinary proceedings arise.
  5. This Consent Agreement is subject to the Board’s approval and will be effective only when the Board accepts it and it is signed on behalf of the Board. In the event that the Board, in its discretion, does not approve this Consent Agreement, it will be deemed withdrawn, will be or no evidentiary value and shall not be relied upon or introduced in any disciplinary proceeding by any party. Dr. Margolis agrees that should the Board reject this Consent Agreement and this case continues through the administrative process, he shall assert no claim that the Board was prejudiced by this review and discussion of this document or any related records.
  6. Dr. Margolis further understands that this Consent Agreement, if approved and signed by the Board,  constitutes a public document that may be disseminated as a formal action by the  Board, including being reported to the National Practitioner Data Bank.
  7. Dr. Margolis agrees to the Board approving the following Findings of Fact,
    Conclusions of Law and Order.

DATED this 12 day of November 2012.

_________________________
Michael D. Margolis, D.D.S.

FINDINGS OF FACT

1, Dr. Margolis holds license no. D 2957 initially issued by the Board on June
22. 1983.

2. Patient DT initially presented to Dr. Margolis on January 25, 2010. Dr. Margolis noted that DT had 3 endodontically treated teeth in the maxillary left quadrant which he identified as teeth nos, 13 14, 15 or 16. Dr. Margolis also noted that DT has, multiple health problems that correlate to her teeth. including headaches, sinus problems, low blood pressure, allergies, a history of breast reduction surgery, fatigue, and sleeping difficulties. Dr. Margolis obtained a complete set of radiographs and 3-D cone beam radiographs.

3. Dr. Margolis advised DT of NlCO (Neuralgia Inducing Cavitational
Osteonecrosis). On January 20, 2010, Dr. Margolis performed Cavitat on DT;s upper 1eft quadrant.

4. Based on the results of the Cavitat, Dr. Margolis treatment planned DT for the removal of teeth numbers 13, 14 and 15. with a biopsy of tooth no. 16 area. He completed the procedures on March 1, 2010., The treatment included removal of bone with the biopsy. DT’s treatment records do not indicate that any of the teeth Dr. Margolis removed were symptomatic.

5. On May 27,  2010. Dr. Margolis delivered a partial denture for DT’s maxillary left quadrant.  DT experienced persistent discomfort. Dr. Margolis adjusted the partial denture several times. DT alleged that the partial denture never seemed to fit. Given the removal of bone in the maxillary left quadrant, it is likely that the partial denture would not have a secure fit.

6. The consent form and documentation Dr. Margolis provided DT for the upper partial denture and surgery did not describe the removal of bone and likely difficulty with removable appliance retention. IDT was given and signed a standard consent form. This form did not describe the end result of bone removal and how this would impact further restorative procedures in this area.

7. Dr. Margolis performed a second Cavitat on DT that, according to Dr. Margolis, indicated abnormality in the mandibular right quadrant. On November 16, 2010, Dr. Margolis performed invasive surgery in the maxillary right and mandibular right quadrants involving the regions of teeth nos. 1 and 32. Following (that surgery, DT had persistent numbness of her lower lip on the right side.

8. Dr. Margolis, on six occasions, saw [DT subsequent to the November 16, 2010 surgery and provided multiple homeostasis and autodyne light therapies in an attempt to improve DT’s condition of numbness. On April 28, 2011, at DT’s six-month recall appointment. Dr. Margolis noted in DT’s treatment records that DT had persistent numbness at that time. DT’s treatment records do not contain any documentation regarding a referral to a micro-neural specialist.

9. Dr. Margolis should have referred D’T to a specialist for her numbness within the first 4 months following its onset. DT has permanent numbness or the right side of her lower lip.

10. Dr. Margolis made no notes discussing the physical status or radiographic findings associated with the maxillary left, maxillary right and mandibular right quadrants.

11.  Dr. Margolis’ treatment of DT was predicated on the results of a Cavitat. The Cavitat has not been found conclusive for pathology requiring invasive and destructive procedures. The surgery and removal of asymptomatic endodontically treated teeth Dr. Margolis performed was not indicated by routine, accepted methodologies of diagnosis, It is Dr. Margolis professional opinion that the Cavitat, in combination with a 3D cone beam x-ray, clinical examination and patient complaints, is sufficient to provide a diagnostic basis to support removal of bone tissue.

CONCLUSION OF LAW

The conduct and circumstances described in the above Findings of Fact constitute unprofessional conduct as defined by A.R.S. § 32-1201.21(n).  Such conduct is grounds for discipline under A.R.S. § 32·1263(A)(1).

ORDER

IT IS HEREBY ORDERED that, within thirty days from the effective date of this Consent Agreement and Order. RESTITUTION in the amount of $11.,986,00, payable to  Complainant. Dr. Margolis shall submit the restitution in certified funds to the Board for delivery.  In the event Dr. Margolis fails to timely comply with this paragraph, the Board may take further disciplinary action, after notice to Dr. Margolis and an opportunity to be beard,

2. IT IS FURTHER ORDERED that Dr. Margolis is hereby CENSURED.

DATED this 10th day of December,  2013.

ARIZONA STATE BOARD OF
DENTAL EXAMINERS

_________________________
Elaine Hugunin
Executive Director

A copy of  the following mailed by CERTIFIED MAIL this 11th day of December to:

Michael D. Margolis, D.D.S.
2045 S. Vineyard Road
Mesa, AZ 82510

D.T.

A copy by US MAIL to:

David W. Williams, Partner
Davis Miles McGuire Gardner, PLLC
80 E. Rio Salado Parkway, Suite 401
Tempe, AZ 85281



Socially Harmful But Unapparent Effects of the NCCAM Columbia University Gonzalez Protocol

The National Center for Complementary and Alternative Medicine (NCCAM) has a mandate from the US Congress to investigate methods that are generally not accepted by the scientific medical community. In so doing, it has broad options as to which of hundreds of methods to study, and under which conditions. The NCCAM has chosen as one …

The National Center for Complementary and Alternative Medicine (NCCAM) has a mandate from the US Congress to investigate methods that are generally not accepted by the scientific medical community. In so doing, it has broad options as to which of hundreds of methods to study, and under which conditions. The NCCAM has chosen as one of its studies the protocol of Nicholas Gonzalez, a physician in New York City who claims that his method of special diet, supplements, and coffee enemas has resulted in pancreatic cancer patients living longer than normally expected. The NCCAM and the implementing institution, Columbia University, in sponsoring the study, lend an air of legitimacy to the protocol, which is recognized as ineffective by most oncologists. The physician investigators, in not giving patients informed opinion on the protocol background and the plausibility of its effectiveness, divert patients from more plausible studies and contribute to patient uncertainty and emotional distress.

While the untimely death of a loved one is not a unique circumstance, I hope that the following account of my recent experience with cancer, which involved both a highly regarded medical institution and an “alternative” medical protocol, will inform others and be of some benefit to readers.

In 2002, I was pursuing a PhD in mathematics at the City University of New York. On March 26, a close friend, the 46-year-old father of two boys, one of whom was my son’s best friend, discovered that he had stage IV pancreatic cancer. I, along with other friends and relatives, tried to help him and his wife get good medical advice, and I decided to devote my time to researching treatment of the illness.

His first scan had been at New York Hospital, where a small cyst was found on the tail of his pancreas. Exploratory surgery was recommended. The surgeon chosen by my friend was John Chabot MD, of Columbia Presbyterian Hospital, who has an outstanding reputation.

Every year, approximately 30 000 people are diagnosed with pancreatic cancer, and every year approximately 30 000 die. Many of them die within the same year. When my friend received the bad news that his cyst was, in fact, a cancer, that it had metastasized, and that no standard cure for his disease was yet available, we began to look for clinical trials that would give him the best possible chance of prolonging his life.

Initially, my friend consulted with various doctors in New York, including another highly regarded surgeon, Murray F. Brennan, FACS, at Memorial Sloan Kettering, who agreed that further surgery was not indicated. Dr O’Reilly, an oncologist at the same hospital, offered grim statistics: while a small percentage of patients (10%40%, depending on whom you ask) on chemotherapy achieve remissions that last 6 months to a year, ultimately metastasized pancreatic cancer returns and progresses.

My friend’s wife was a believer in homeopathic medicine. She and others in her community suggested that he look into a protocol run by Nicholas Gonzalez, MD, who advocates vitamins, enzymes, and coffee enemas as a possible cure for cancer. Dr Gonzalez claims that some patients of his lived up to 2 years after this same diagnosis. His protocol was being funded by the National Institutes of Health (NIH) and the National Center for Complementary and Alternative Medicine (NCCAM) and implemented at Columbia Presbyterian. My friend’s surgeon was one of the investigators.

While I broadened my inquiries about possible clinical trials, my friend decided that the Gonzalez protocol seemed to offer the most hope for survival. I had heard nothing about the doctor, so I had no opinion. My friend arranged to meet with Dr Gonzalez during the 2 weeks that followed his recovery from surgery to determine whether or not he was eligible for the trial. He was encouraged when he was found to be acceptable. Dr Gonzalez told him that in order to meet the criteria one had to be still strong enough to follow an arduous regimen: 150 vitamin and enzyme tablets and capsules, along with 1 to 2 coffee enemas daily for 16 days, followed by 5 days of rest. Diet was strictly controlled. Meats and most fats were eliminated for the 16 “on” days. During the “resting” days certain foods (strawberries and cream or specific oils, for example) were permitted, depending on Dr Gonzalez’s classification system. The trial investigator, Dr Chabot, advised him of this and other options. He also assured him that he could start the “alternative” protocol and drop out if he wanted to try chemotherapy.

By this time we had ascertained that standard combination chemotherapy involved gerncitabine and other drugs, and that there were no reports of any one protocol showing decided advantages over any other. My friend decided to try the Gonzalez protocol first, as one was no longer eligible for it if one had already had chemotherapy. He was anxious to begin some form of treatment and not lose other options.

I had contacted other well-known institutions: Dana Farber, the M. D. Anderson Clinic, the Mayo Clinic, and the University of California, San Francisco, among others. By April 8 I had found that at Johns Hopkins in Baltimore, patients were being accrued to start a Phase II trial for a vaccine targeting metastatic pancreatic cancer. The results from the Phase I trial of the vaccine looked promising, but Phase II was not to start until May. I accepted an invitation to visit the research facility, which I was to do on April 18, bringing a specimen of my friend’s tumor to the laboratory.

During this time I also investigated the Gonzalez protocol. I had obtained a copy of an article by Michael Specter in the February 5, 2001, issue of the New Yorker magazine. The article seemed to indicate that although this protocol had been funded by the NIH, was some debate as to its value by physicians at Columbia Presbyterian. I was disturbed to read that Dr Gonzalez had been successfully sued and that New York State had made attempts to remove his license. On Monday, April 14, I placed a call to Dr Chabot’s office. It was not returned. I proceeded to place a call to every physician mentioned in the article, and also spoke to Michael Specter.

On April 15 I placed two calls to Pierre Guesry, PhD, an advocate for Dr Gonzalez, at his office at the Centre des Researches Scientifiques for the Nestle Company near Lausanne, Switzerland. He said he thought that Dr Gonzalez’s results were extraordinary and that experiments were being conducted on ferrets at the University of Nebraska in order to study them further. When I asked him under whose direction, he said that the information was confidential, and hurried off the telephone.

Dr Gonzalez advised my friend to have fillings from his teeth removed by a dentist in Connecticut, which he did on April 16. He had just begun the vitamin and enzyme protocol, which was very time-consuming. He had also contacted doctors at Johns Hopkins, but decided not to accompany me on my visit. He planned to go there nearer the time when the vaccine trial started. His wife was by that time already extremely busy obtaining all the pills and foods that were required for the Gonzalez regimen.

That same day, I called Karen Antman, MD, head of oncology at Columbia Presbyterian, whom I had met when I was diagnosed with breast cancer. She had given me excellent advice at the time. This time she said that my friend had been offered many different treatment options, and had chosen the Gonzalez one. She encouraged me to do further research.

On April 17 I once again called Dr Chabot’s office and spoke with his secretary, saying that I had some questions about the Gonzalez trial. I was informed that I should speak to Michelle Gabay, the nurse who was running the protocol, but that she would not be able to return my call until the following day. As I was to be in Baltimore, it would be a few more days until we spoke. When we did, she had no answers to my questions about Gonzalez protocol results.

By April 17 I succeeded in contacting Tony Hollingsworth, PhD, the recipient of the grant for cancer research at the University of Nebraska. at their facility. He informed me that to his knowledge there were no animal models for pancreatic cancer under study at the University of Nebraska or anywhere else. I also spoke with other physicians—one at Columbia Presbyterian, William Sherman, MD, who expressed great skepticism about the Gonzalez protocol.

My friend was determined to try as hard as he could to maintain the regimen, which is extremely difficult. He had been told that pain might be an indication that the tumors were being dissolved, and that he could expect weight loss as he was detoxifying his body. I saw him on April 26, when he told me that he was in more pain. It was obvious that he had lost a significant amount of weight. In the next few weeks he was to describe himself to his mother as looking like “a concentration camp victim from Auschwitz.”

He was having difficulty sleeping. Whether this was because of coffee enema stimulation or because he was experiencing ever-increasing pain and stress, I do not know. I told him that I had been impressed by what I had learned about Hopkins. He was interested, but said that he was going to stick with this regimen until the next appointment, when he would get the results. He was determined to give it his utmost effort.

I told him that I was going to attend the annual conference of the American Society of Clinical Oncology (ASCO) and would report on other options to him. Once at ASCO, I learned quickly and definitively that the Gonzalez protocol was a fraud; no mainstream doctors believed it was anything else and they were surprised that anyone with education would be on it.

Despite this, I had spoken with Dr Chabot and asked him to speak with my friend about his appointment being moved ahead, as he was not doing well. Dr Chabot said that I was free to speak to my friend, if I wished, and said his secretary took care of appointments.

During the following month, my friend lost 3040 pounds and became so weak that he could no longer walk his dog around the block. The pain was becoming unbearable, and he was eager to be evaluated and have another scan.

I went to the hospital on May 30 to ascertain when he would be scanned. We were eager for the scan as he needed explanation for his symptoms, and to make the next treatment decision. The sooner he got chemotherapy, the better were his chances at achieving a remission, and he had already lost 45 days.

My friend was not scanned until Sunday, June 2, when he received bad news. The tumors had progressed. The Gonzalez regimen had not worked.

On Monday he made an urgent appointment with Dr Sherman, the oncologist at Columbia Presbyterian, whom I had spoken with and recommended.

By this time my friend was extremely thin and weak. He was given prescriptions for pain medication and chemotherapy, and scheduled for additional intravenous therapy the following week.

At one point I said to him, “You are not ever going to feel as bad as you felt last month (while on the Gonzalez protocol), from here on,” and he said, “I think you’re right.” He felt better in June. I continued to look for hope, attending a conference in Houston given by the M. D. Anderson Tumor Institute. Although my friend  started eating regular food and sipping concentrated food supplements, he was unable to regain weight and did not show an obvious early response to his 3 chemotherapy treatments during the month of June.

Over the Fourth of July weekend, between chemotherapies, his lungs filled with fluid. He was rushed to a hospital near his home and then transferred to Columbia Presbyterian hospital on the following Monday. Over the course of that month he stabilized somewhat, but he continued to weaken. He went home on Friday, July 26, intending to talk to his doctor, who had been away that week. He did not live to have the conversation. During that week, he also asked me if he could try the vaccine on a compassionate basis, but I had been told by the doctors at Hopkins that he was no longer eligible, and that the trial there had been delayed.

By Sunday, hospice care was called in and he died a few days later, in the early morning of August 1, 2002. That he died was not surprising, as pancreatic cancer is a terminal disease. That he died as quickly and as brutally as he did, however, is tragic.

The care he received did not reflect the reputation of the institution he turned to. Specifically, neither the surgeon nor the medical oncologist involved in the Gonzalez study told the full truth about Dr Gonzalez or his therapy. The information given was “neutral”; the protocol being described as neither good nor bad, reasonable nor unreasonable, or whether positive results were plausible or not. If the surgeon had such information, he did not share it, referring us to the protocol nurse, who could not answer penetrating questions. Only Dr Sherman, the oncologist we consulted, gave us usable information and confirmed what I had found on my own.

This situation irretrievably affected my friend’s access to treatment options, the quality of his life in his last days, and his ability to enjoy his remaining time with family and friends. My friend was not in denial, and did not go in search of false hope. He did not seek out Dr Gonzalez because he was unwilling to confront the possibility that treatment might not work and might have side effects. A graduate of Harvard, he was an intelligent and courageous individual who believed what that he would get honest answers when he went to the mainstream medical community.

He was an artist—a painter and a sculptor—and he had little scientific knowledge. When Dr Chabot was neutral about the Gonzalez protocol, and when Dr Antman said nothing adverse about it, my friend assumed that they must genuinely believe that the treatment could work.

We had many conversations about treatment options, and he intended to meet with the doctors at Johns Hopkins, but the Gonzalez protocol quickly overwhelmed him; first by being impossibly time-consuming and then by being so physically debilitating. Had he realized this in early April, he would have had a real chance to examine his options. But once the decision was made to begin the Gonzalez protocol, with the apparent support of those involved in his care at Columbia Presbyterian, he became committed to it.

By remaining neutral about the Gonzalez regimen, physicians at Columbia Presbyterian who place patients in this trial effectively preclude them from starting other options, because of the demands it places on patients and their families. If physicians believe they are truly being neutral by not fully explaining the Gonzalez protocol’s nature to cancer patients, it is they who are in denial.


This article was published in the Fall-Winter 2003-2004 issue of The Scientific Review of Alternative Medicine. At the time it was written, Susan Gurney was a Ph.D. candidate in the mathematics department of the City University of New York. The NCCAM-funded study to which this article refers demonstrated that Gonzalez’s treatment did not prolong survival and lowered quality of life. Gonzalez died in 2015.



Stephen Barrett, M.D. Biographical Sketch

Stephen Barrett, M.D., a retired psychiatrist who lives near Chapel Hill, North Carolina, has achieved national renown as an author, editor, and consumer advocate. In addition to operating Quackwatch, he is a Fellow of the Committee for Skeptical Inquiry. In 1984, he received an FDA Commissioner’s Special Citation Award for Public Service in fighting nutrition …

Stephen Barrett, M.D., a retired psychiatrist who lives near Chapel Hill, North Carolina, has achieved national renown as an author, editor, and consumer advocate. In addition to operating Quackwatch, he is a Fellow of the Committee for Skeptical Inquiry. In 1984, he received an FDA Commissioner’s Special Citation Award for Public Service in fighting nutrition quackery. In 1986, he was awarded honorary membership in the American Dietetic Association. From 1987 through 1989, he taught health education at The Pennsylvania State University. He is listed in Marquis Who‘s Who in America and received the 2001 Distinguished Service to Health Education Award from the American Association for Health Education. He is also a board member of Prescription Justice, a nonprofit group that is working toward lower drug prices. His research library, pictured below, houses more than 5,000 books and 100,000 documents and recordings collected over a 50-year period.

An expert in medical communications, Dr. Barrett operates 23 Web sites; co-edits Consumer Health Digest (a free weekly electronic newsletter); and has been a peer-review panelist for several top medical journals. He has written thousands of articles and delivered more than 300 talks at colleges, universities, medical schools, and professional meetings. His 53 books include The Health Robbers: A Close Look at Quackery in America and eight editions of the college textbook Consumer Health: A Guide to Intelligent Decisions. One book he edited, Vitamins and Minerals: Help or Harm?, by Charles Marshall, Ph.D., won the American Medical Writers Association award for best book of 1983 for the general public and became a special publication of Consumer Reports Books. His other classics include Dubious Cancer Treatment, published by the Florida Division of the American Cancer Society; Health Schemes, Scams, and Frauds, published by Consumer Reports Books; The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods, published by Prometheus Books; and Reader’s Guide to “Alternative” Health Methods, published by the American Medical Association. His most recent book, Homeopathy in America: The Ups and Downs of a Medical Heresy, was published in 2019 by Kindle Books. From 2012 through 2016, he served as North American co-editor of the journal Focus on Alternative and Complementary Therapy (FACT). His media appearances have included Dateline, the Today Show, Good Morning America, ABC Prime Time, Donahue, CNN, National Public Radio, and more than 200 radio and television talk show interviews.

Since moving to North Carolina in 2007, Dr. Barrett has been swimming competitively and has won 140 state championship events, 46 awards in national events, and 16 medals in international events and has set 19 state records. At the 2012 U.S. Masters Spring Nationals, he and three teammates earned Relay All-American Awards for the fastest times swum in the U.S. in 2012 in the age 75-79 men’s 200 freestyle and 200 medley relay events. During the 2013 season, he won 3 three gold medals at the North Carolina Senior Games, 3 silver medals at the National Senior Games, and became a world champion by winning the age 80-84 men’s 50-meter butterfly event at the Huntsman World Senior Games. In 2014, he won 2 gold, 1 silver, and 2 bronze medals at the U.S. Masters Summer National Championships and 5 gold and 1 silver medal at the North Carolina Senior Games. In 2016, he became certified as an instructor in the U.S. Masters Adult Learn-to-Swim program.

The Center for Inquiry began maintaining the Quackwatch network of Web sites in February 2020 and will receive Dr. Barrett’s research library later this year.

Additional Information
How to Contact Dr. Barrett (Please mention how you found this Web site)
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Any Questions?

When time permits, your questions related to consumer health will be answered by e-mail. The most interesting ones will be posted (without the sender’s name) to this Web site. Before sending a question, please search Quackwatch to see whether the topic has been covered! If you prefer to phone, please send an email message first so I can retain your contact information.



FDA Commissioner Blasted for Political Cowardice

Eric Topol, M.D. editor-in-chief of Medscape, has severely criticized FDA Commissioner Stephen Hahn, M.D., for making COVID-19-related policy statements based on pressure from the Trump Administration rather than on science-based information. In an open letter, Topol urged Hahn to either stand up for science or to resign. The letter stated: Dear Dr. Hahn, I’m writing …

Eric Topol, M.D. editor-in-chief of Medscape, has severely criticized FDA Commissioner Stephen Hahn, M.D., for making COVID-19-related policy statements based on pressure from the Trump Administration rather than on science-based information. In an open letter, Topol urged Hahn to either stand up for science or to resign. The letter stated:

Dear Dr. Hahn,

I’m writing because I’m gravely concerned about your leadership of the Food and Drug Administration (FDA). The circumstances of your statements in recent days has led to a crisis in confidence. Not only has your credibility been diminished but so has that of the FDA, its 15,000-plus staff members, and, most importantly, your ability to oversee the health interests of the American people.

Let me remind you of the FDA’s mission statement:

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

The emphasis here is on accurate, science-based information. Since you were sworn in on December 17, 2019, you have serially demonstrated your willingness to deviate from this bedrock premise. Immediately after President Trump widely and aggressively promoted hydroxychloroquine as a “miracle drug,” on March 30, 2020, you granted an Emergency Use Authorization (EUA) for this drug without any sufficient or meaningful supportive evidence. Proof of that was borne out on June 15, 2020 when you revoked that EUA, acknowledging lack of efficacy and “ongoing serious cardiac adverse events and other potential serious side effects.”

The second major breach of accurate, science-based information came on August 23, 2020 when you participated in a press conference with President Trump and Health and Human Services Secretary Alex Azar billed as a “very historic breakthrough.” You said, “I just want to emphasize this point, because I don’t want you to gloss over this number. We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients. This is a major advance…[A]nd a 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — [of] 100 people who are sick with COVID-19, 35 would have been saved because of the admission of plasma.”

Every part of that statement is incorrect and a blatant misrepresentation of the data. Your statement was based on a preprint, which by definition has not been peer-reviewed, published by Mayo Clinic’s Michael Joyner and coauthors. It is a retrospective, observational study of over 35,000 patients who received convalescent plasma, without any controls or untreated patients for comparison. The claim of reduction of mortality is totally unsubstantiated. That was based on improved survival in a subgroup of a subgroup of a subgroup from about 1000 patients, who were partitioned by timing of plasma administration (early vs late), whether they had endotracheal intubation, their age, and level of antibody in the plasma they received. The antibody level was determined post facto. You know full well as an oncologist and researcher that this is an illegitimate analysis that, at best, is hypothesis-generating, requiring a prospective, placebo-controlled trial to confirm.

Nonetheless, you posted this data-dredging subgroup analysis on the FDA website with the headline statement “Another Achievement in Administration’s Fight Against Pandemic.” Your EUA announcement came the day after President Trump tweeted “The deep state, or whoever, over at the FDA is making it very difficult…@SteveFDA”, addressing you directly with your Twitter handle.

It took 24 hours before you started to make a correction on Twitter. You wrote “What I should have said better is that the data show a relative risk reduction, not an absolute reduction.”

That is a grossly insufficient correction and does not represent the truth. Here’s what you didn’t say:

  1. There are no data or evidence from prospective, randomized trials for convalescent plasma to support any survival benefit.
  2. The data I am citing are from a subgroup analysis from a preprint, which is intended to formulate a hypothesis without any definitive findings or conclusions.
  3. The 35% survival benefit, and 35 people’s lives saved per 100 sick with COVID-19, was completely off-base. If the preprint data held up in a proper randomized controlled trial, it would be avoiding deaths of 3 or 4 people per 100 who would have died. We know that fewer than 1 out of 100 people who have a COVID-19 infection die, so it is impossible to save 35 people’s lives of 100 people sick with COVID-19. I made a terrible, monstrous error and I deeply apologize for that.
  4. It is frankly unlikely for there to be a major survival benefit of convalescent plasma, as it contains a broad admixture of patient antibodies, most of which are not neutralizing — that is having no effect against the virus. We need randomized trials to determine if there is any benefit and, if so, what is the magnitude of benefit. Such trials are ongoing and need robust support and participation.
  5. There are still potential safety issues of convalescent plasma that are unresolved, such as transmission of a virus or immune reaction.

The third breach of evidence-based data was your EUA issued August 28, 2020 broadening the remdesivir approval to include any patient hospitalized with moderate COVID-19. There are insufficient data to support this approval, as it is based on small, open-label studies with subjective endpoints. Remdesivir is an expensive drug, costing approximately $3000 per treatment, in short supply, and even its approval for severe COVID-19 was based on time to recovery in a relatively small trial of just over 1000 patients. That is unlike the proof of dexamethasone benefit for survival in a randomized trial of over 6400 patients.

These repeated breaches demonstrate your willingness to ignore the lack of scientific evidence, and to be complicit with the Trump Administration’s politicization of America’s healthcare institutions.

In a recent interview with the Financial Times, you said you were prepared to authorize a vaccine before Phase 3 trials were complete. May I remind you that Phase 3 trials are in progress for a few vaccine programs and have only now fulfilled half of their enrollment? It will take many months to establish both safety and efficacy. While most vaccines are safe, trials are needed to demonstrate that participants in these trials do not develop severe immune-mediated reactions to exposure of the virus via antibody-dependent enhancement or immune complex disease. Efficacy data are needed to prove there is a substantial suppression of infections in the vaccine group, compared with placebo. Both safety and efficacy endpoints require adequate statistical power. All of this takes time.

Any shortcuts will not only jeopardize the vaccine programs but betray the public trust, which is already fragile about vaccines, and has been made more so by your lack of autonomy from the Trump administration and its overt politicization of the FDA.

You have one last chance, Dr Hahn, for saving any credibility and preserving trust in the FDA at this critical juncture amidst the pandemic. You need to organize a press conference and tell the truth. Tell Americans exactly how you were pressured to make a breakthrough announcement. Tell all of us how you completely misrepresented the facts about convalescent plasma, and not hide this with the obscurity of technical terms such as relative and absolute differences. Tell us that you are capable and worthy of this pivotal leadership position and that you will not, under any condition, authorize a SARS-CoV-2 vaccine approval before the full Phase 3 completion and read-out of a program.

Otherwise, you need to resign. We cannot entrust the health of 330 million Americans to a person who is subservient to President Trump’s whims, unprecedented promotion of unproven therapies, outrageous lies, and political motivations. You have two choices to do the right thing. We cannot and will not rest until you make that choice.

If you agree with Dr. Topol, please express your concern to Dr Hahn.



Herbalife Agrees to Pay $123 Million to Resolve Foreign Corrupt Practices Act Case

U.S. Department of Justice Press Release, August 28, 2020 Audrey Strauss, the Acting United States Attorney for the Southern District of New York (“SDNY”), and Acting Assistant Attorney General Brian C. Rabbitt of the Criminal Division of the United States Department of Justice (“DOJ”) announced today the filing of criminal charges against HERBALIFE NUTRITION, LTD., a …

U.S. Department of Justice
Press Release, August 28, 2020

Audrey Strauss, the Acting United States Attorney for the Southern District of New York (“SDNY”), and Acting Assistant Attorney General Brian C. Rabbitt of the Criminal Division of the United States Department of Justice (“DOJ”) announced today the filing of criminal charges against HERBALIFE NUTRITION, LTD., a multinational corporation headquartered in Los Angeles, for conspiring to violate the books and records provisions of the Foreign Corrupt Practices Act (“FCPA”). The charges arise out of a decade-long scheme by HERBALIFE to falsify books and records and provide corrupt payments and benefits to Chinese government officials for the purpose of obtaining, retaining, and increasing HERBALIFE’s business in China. In connection with the filed charges, SDNY and DOJ entered into a deferred prosecution agreement (DPA) with HERBALIFE. Pursuant to the DPA, HERBALIFE admitted to participating in the charged conspiracy and will pay a criminal fine of $55,743,093.

Acting U.S. Attorney Audrey Strauss said: “As admitted in the deferred prosecution agreement entered into today, Herbalife approved the extensive and systematic corrupt payments to Chinese government officials over a 10-year period to promote and expand Herbalife’s business in China. Moreover, in an effort to conceal this widespread corruption scheme, Herbalife maintained false accounting records to mischaracterize these improper payments as permissible business expenses. In addition to admitting its criminal conduct, Herbalife has agreed to pay combined penalties of more than $123 million. This case signifies this Office’s commitment to ensuring that companies operating in the U.S. do not gain an unfair advantage through corruption and illegal bribes of foreign officials.”

Acting Assistant Attorney General Brian C. Rabbitt said: “By engaging in a decade-long scheme to falsify its books and records to conceal corrupt and other improper expenditures, Herbalife misrepresented the information available to investors. Today’s resolution reflects the department’s ongoing commitment to combating corruption and ensuring that investors can trust the accuracy of the financial statements of publicly traded companies.”

According to the allegations contained in the criminal Information, which was filed today in Manhattan federal court, the statement of facts set forth in the DPA, and other publicly available information:

HERBALIFE conducts business operations in China through a group of wholly owned subsidiaries based in China (collectively, “Herbalife China”). By 2016, Herbalife China was responsible for approximately $860 million, or approximately 20 percent, of HERBALIFE’s worldwide annual net sales, which exceeded $4 billion. In China, to engage in direct selling – selling a company’s products through independent sales representatives – Chinese law required a company to obtain a direct selling license from national authorities as well as local authorities for each province in which a company intended to engage in direct selling. From March 2007 through 2016, Herbalife China obtained licenses to engage in direct sales in 28 provinces.

Yanliang Li, a/k/a “Jerry Li,” was the director of sales and/or sales vice president at Herbalife China from in or about 2004 through in or about December 2007, and then the managing director of Herbalife China from in or about December 2007 through in or about April 2017. From in or about December 2012 through in or about February 2017, Li also held the title of senior vice president at HERBALIFE. Hongwei Yang, a/k/a “Mary Yang,” was a high-level executive at Herbalife China and the head of external affairs from in or about 2006 through in or about April 2017.

Beginning in or about at least 2007 through in or about 2016, HERBALIFE, through Li, Yang, and others, engaged in a scheme to falsify books and records and provide corrupt payments and benefits to Chinese government officials, including officials of Chinese government agencies and a state-owned media outlet, for the purpose of obtaining, retaining, and increasing HERBALIFE’s business in China by, among other things, (1) obtaining and retaining certain of Herbalife China’s direct selling licenses; (2) improperly influencing certain Chinese governmental investigations into Herbalife China’s compliance with Chinese laws applicable to its business; and (3) improperly influencing certain Chinese state-owned and state-controlled media for the purpose of removing negative media reports about Herbalife China.

During the course of the scheme, in order to conceal these improper payments and benefits, HERBALIFE, through Li, Yang, and others, knowingly and willfully conspired and agreed with others to maintain false accounting records that did not accurately and fairly reflect the transactions and dispositions of HERBALIFE’s assets, by, among other things, falsely recording certain improper payments and benefits as “travel and entertainment expenses” and maintaining false Sarbanes Oxley sub-certification letters in HERBALIFE’s books, records, and accounts.

In a related matter with the Securities and Exchange Commission (“SEC”), HERBALIFE agreed to pay to the SEC disgorgement and prejudgment interest totaling approximately $67,313,497.

In November 2019, the Government unsealed related criminal charges against Li and Yang, both of whom remain at large. See United States v. Li and Yang, 19 Cr. 760 (VSB).

Ms. Strauss praised the outstanding work of the Federal Bureau of Investigation and the U.S. Department Justice’s Office of International Affairs of the Department’s Criminal Division, and also thanked the SEC for its assistance and cooperation in this investigation.

This case is being handled by the Office’s Securities and Commodities Fraud Task Force and the FCPA Unit of the Fraud Section of DOJ’s Criminal Division. Assistant United States Attorneys Joshua A. Naftalis and Scott A. Hartman, and Trial Attorney Jason Manning of the FCPA Unit, are in charge of the prosecution.



Liefcort for Arthritis: Worthless and Dangerous

Liefcort was a drug mixture developed and marketed by Robert Liefmann, M.D., of Quebec, Canada, for treating the symptoms of arthritis. Its principal components were prednisone (a form of cortisone), and testosterone (a male sex hormone), and estradiol (a female sex hormone). The American Medical Association, the Arthritis Foundation, and the U.S. Food and Drug …

Liefcort was a drug mixture developed and marketed by Robert Liefmann, M.D., of Quebec, Canada, for treating the symptoms of arthritis. Its principal components were prednisone (a form of cortisone), and testosterone (a male sex hormone), and estradiol (a female sex hormone).

The American Medical Association, the Arthritis Foundation, and the U.S. Food and Drug Administration (FDA) all warned that Liefcort was dangerous. Prednisone has legitimate use for some types of arthritis, but it could have serious side effects, including internal hemorrhaging, peptic ulcer, cataracts, spontaneous fracture of bones, and mental derangement. Dosage must therefore be carefully regulated and individual patient reaction closely observed. Supplies of Liefcort were sold by Dr. Liefmann to patients who had traveled long distances to obtain the drug and took them for months without further medical supervision.

Testosterone and estradiol, which had no proven value therapeutic value in treating arthritis, can also produce serious side effects. An FDA analysis found that the amount of estradiol was ten times the usual medically prescribed dose [1]. Time Magazine reported that Canadian arthritis specialists that men taking Liefcort developed enlarged breasts and women had grown beards [2].

Liefmann studied medicine at the McGill University Faculty of Medicine in Canada. In 1954 he took the examination for licensing as a private practitioner but failed the oral examination in surgery. In 1962 he passed this examination and was certified by the Quebec College of Physicians and Surgeons to practice medicine in Canada. Prior to his licensure he worked as a researcher at Montreal’s Royal Victoria Hospital.

He was suspended by the hospital for implanting the pituitary glands of newly slaughtered calves into the thighs of six arthritis patients. He was later reinstated but then left his position and set up a commercial operation called Endocrine Research Laboratories, in Beaurepaire, Quebec, which created and distributed hair tonics, hair-growing preparations, and vitamin preparations [3].

In 1957, a warrant for his arrest was issued in the United States on charges of introducing a misbranded drug into interstate commerce in violation of the U.S. Federal Food, Drug, and Cosmetic Act. The case involved distributing an alleged baldness cure called “R-20” that contained estradiol and isopropyl alcohol. The FDA charged that the preparation was both worthless and dangerous. Although Liefmann lived in Canada, investigators determined that he was trying to market the product through a distributor located in Minnesota. The arrest warrant was issued after Liefmann failed on several occasions to appear in Federal District Court in Syracuse, New York, for arraignment. He avoided prosecution by remaining in Canada.

The FDA learned that Liefcort was compounded in Liefmann’s home in Montreal and labeled as being distributed by Endocrine Research Laboratories [4]. The agency prohibited the importation of Liefcort into the United States and on two occasions initiated seizure and destruction of shipments that came to the U.S. from Canada. The Canadian Food and Drug Directorate prohibited the distribution of Liefcort to Canadian doctors for investigational purposes. In 1959 it also seized bottles of Scalp Antizyme RX-200 and RX-20 because the estradiol content exceeded the labeled potency by 35 times. Two lots of a vitamin and mineral preparation called Vita VO-25 were also seized during that year [5]. The Directorate, however, was not empowered to prohibit a licensed Canadian physician from prescribing drugs and therefore could not stop Dr. Liefmann from selling Liefcort to his own patients.

A 1962 article on Dr. Liefmann and Liefcort in Look Magazine [6] attracted widespread interest in Liefcort and caused many U.S. and Canadian arthritis sufferers to journeyed to Dr. Liefmann’ s office in Quebec to obtain a supply.

The FDA reported that a 71-year-old California woman developed uterine bleeding after taking Liefcort, was hospitalized, contracted pneumonia after an operation to stop the bleeding, and died. In 1963, the medical director of the Arthritis Foundation told the Senate Committee on Aging that at least two other people had been killed by the drug. He also accused Look Magazine of “irresponsible journalism” for describing Liefcort as a “secret cure” when the article’s author knew what it contained and that the article would cause thousands of people to rush to Liefmann’s clinic [7].

In 1968, the Canadian Food and Drug Directorate raided Liefmann’s clinic and charged him with marketing an unapproved drug and other violations. In 1969, he was convicted on 16 counts of violating Canada’s Food and Drugs Act and fined $2,400. However, he was able to continue treating his own patients while appealing his case [8]. He died in 1972 while the case was still on appeal.

In 1979, Consumer Reports noted that Liefcort or similar preparations could still be obtained from a few sources in the United States, Canada, and Mexico [9].

References
  1. Arthritics warned on using Liefcort. AMA News, Oct 29, 1962.
  2. Medicine: Border crackdown. Time Magazine, Oct 19, 1962.
  3. Data sheet on Liefcort. American Medical Association. Undated, distributed in 1960s.
  4. Hunter M. Arthritis pills barred from U.S. The New York Times, Oct 10, 1962.
  5. FDA press release, May 20, 1962.
  6. Zimmerman G, Breslin C. New arthritis controversy. Look Magazine, May 22, 1962.
  7. Hecht A. Hocus-pocus as applied to arthritis. FDA Consumer, Sept 1980.
  8. Lamont-Havers RW. Testimony at hearing on frauds and quackery affecting the older citizen. January 15, 1963.
  9. A two-part report on arthritis. Consumer Reports, June/July 1979.


Government Action against the Fremont Christian Clinic (1961)

The Freemont Cancer Clinic, which operated in California, was shut down in 1961. The following account, obtained from the files of the California Cancer Advisory Council, describes how they defrauded patients. The Freemont Cancer Clinic was operated by four individuals—the ringleader of the group, Roy W. DeWelles, a chiropractor; two elderly physicians, W.W. Sherwood, M.D. and …

The Freemont Cancer Clinic, which operated in California, was shut down in 1961. The following account, obtained from the files of the California Cancer Advisory Council, describes how they defrauded patients.


The Freemont Cancer Clinic was operated by four individuals—the ringleader of the group, Roy W. DeWelles, a chiropractor; two elderly physicians, W.W. Sherwood, M.D. and Charles L. Hawk, M.D; and a business manager named Schickadanz. On February 29, 1960, Mr. and Mrs. B.P. went to this clinic because of an intestinal condition in the wife. She was given a short physical examination, and X-rays of the chest and colon before and after a barium enema were taken.

In consultation with Dr. Hawk, she was told that the right lung was full of cancer and that the left showed a beginning of cancer. Hoxsey medication was prescribed. The total cost for the physical examination, laboratory work and Hoxsey medication was to be $580, but, since there was only $190 in the checking account, DeWelles, who had now taken over from Dr. Hawk, suggested that the husband write two checks: one for $190 and the other for $390, and he would hold the latter until a transfer from savings to checking account had been made. The wife was also told that her intestinal condition would require additional colonic therapy which would cost approximately $400.

After return to their home, the wife was examined by a local physician and no cancer was found.

In June 1959, Mr. T.P.M. received a diagnosis of tumor in the bowel and an exploratory operation was recommended. The patient was ready to submit to surgery but was diverted to the Fremont Christian Clinic by a friend. The usual diagnostic studies were performed there and he was told that he definitely had cancer. The Hoxsey treatment was prescribed for him, as well as intestinal treatments consisting of the instillation of oxygen into the large bowel. The price was between $800 and $1,000. He took the oral medication and the oxygen treatments but became progressively weaker. This continued until December 10, 1959, when he had a massive intestinal hemorrhage and was taken to a local hospital. A week later, surgery was performed and a large malignant tumor was noted.

At his ninety-day checkup after surgery, the wife was told that his cancer had metastasized widely. The patient died in May, 1960. His conventional treatment had been delayed six months while he was treated with the worthless Hoxsey medication.

S.J.M., a 2½-year-old child, had a diagnosis of sarcoma of the lower leg made at the University of California and an amputation was recommended. This was declined and, on April 9, 1960, the child was taken to the Fremont Christian Clinic where a diagnosis of cancer was confirmed without biopsy. Krebiozen was prescribed, and three injections were given in Los Angeles. This treatment was continued by the family physician when they returned to their home. After a dozen injections, there was no improvement in the child’s condition and the Clinic was so informed. Following this, the parents received a package of various pills and liquids which were identified as the Hoxsey treatment. The pills were too large for the child to swallow, and the liquid was refused because of its taste. The child expired on August 3, 1960. A refund, which had been promised the parents by the Clinic should the child die, was not made.

On June 22, 1960, an undercover operative visited the Clinic for the Department. She was given a superficial examination, X-rays of the chest were taken and, although she had no signs of cancer recurrence, the Hoxsey remedy was prescribed “to prevent a recurrence.” The total bill was $545.

On July 22, 1960, another undercover operative visited the Clinic. Everything about the Clinic—the instruments, the enema tube, the surgical gowns, the dressing room floors and a blanket were described as dirty. She was given a superficial examination, including an anoscopic, but a diagnosis of cancer was not made until she stated that, since she did not have cancer, she was not going to pay almost $600 for the Hoxsey medication and the examinations. At this point, Dr. Hawk reversed his diagnosis and stated that cancer did show up on the chest X-rays.

It later was learned that a supply of X-ray films was kept in the view box and were represented as belonging to the patient whose diagnosis was then being considered. One of the persons working in the Clinic in a clerical position finally became suspicious and reported her suspicions to the bunko squad in Los Angeles. The incident which finally convinced her that there was a fraudulent operation going on in the Clinic occurred one day when a male patient was told that he had cancer in both lungs. He was shown an X-ray of the chest which they said was his but actually was from a female patient and the breast shadows of the latter patient were pointed out to the male patient as representing cancer in both lungs. After he had purchased his medication and departed, the operators of the Clinic laughed uproarously over the whole incident.

The bunko squad, on receipt of the above-mentioned information, reported it to the Bureau of Food and Drug Inspections of the State Department of Public Health and this Bureau desired to take criminal action. Consequently, the administrative action of the cancer quackery program was deferred pending results of the criminal action. The principals of the Clinic were arrested on March 29, 1961 and, after a Grand Jury indictment, the trial began on January 15, 1962 and lasted ten weeks. It ended with a hung jury. The second trial began in June, this time without a jury and, after two or three weeks, the judge found all defendants innocent of all charges. Prior to the arrest, the cancer quackery program had held investigatory hearings on September 28 and October 19, 1960 and the accusatory hearing, initially scheduled for the spring of 1961, was deferred as indicated above, awaiting the criminal trial. In July of 1963, both Dr. Sherwood and Dr. Hawk consented to the issuance of Cease and Desist Orders which were then issued on August 29, 1963. After the trial, Dr. DeWelles, the guiding light of the Clinic, disappeared from the State, but word about him was received a year or two later. It seems he had been carrying on a diagnostic racket in Indiana and a federal agency had determined this and had him convicted of fraud, receiving a 10-year jail sentence. Subsequent to that, it was learned that the Bureau of Internal Revenue had assessed him for approximately $160,000 for unpaid income taxes

Dr. Sherwood has retired from practice, but Dr. Hawk is in practice by himself and specializes in weight reduction—much of it probably directed to the pocketbook.



Government Actions against Everett W. DeLong, M. D.

Everett W. DeLong, D.O. was disciplined in 1965 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council. In February 1958, Mr. B.S. went to DeLong because of a growth on the right ear. A salve was applied. later, several lesions …

Everett W. DeLong, D.O. was disciplined in 1965 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council.


In February 1958, Mr. B.S. went to DeLong because of a growth on the right ear. A salve was applied. later, several lesions on the face were removed with a liquid, and similar treatment was attempted to remove a small lesion on the base of the nose. None of these lesions was biopsied. The nose lesion became worse and laetrile shots and Mexican animal cell treatments were prescribed.

In March, 1962, the patient was seen by a surgeon in Redlands, where biopsy revealed squamous cell carcinoma. A surgical procedure followed, in which part of the upper lip, the lateral portions of the nose and the nasal septum were removed.

In January 1962, recurring cancer was removed from the lip, the upper jaw and the nose.

In March 1963, a further recurrence was noted and radiation therapy was applied.

In May 1963, a massive recurrence was noted. Further surgery was believed contraindicated, but further irradiation therapy was applied. The patient died in June, 1964, after having paid $2,168 to DeLong during a two-year period prior to seeking conventional help.

Mr. L.K., in April, 1961, had a kidney removed for cancer, following which chemotherapy was recommended but refused. Farly in August, he went to DeLong, where he received laetrile three times a week and was promised a cure. later

in August, Mucorhicin was prescribed. $380 was paid to Dr. DeLong. Still later in August, Mr. L.K. went to Dr. Hendricks, where he received the Koch treatment for $75, cellular treatment for $150, bbod and urinalysis performed in Switzerland—$150. The patient died of his disease in January of 1962.

Mr. W.I., an undercover operative who had carcinoma of the prostate, visited Dr. DeLong in February of 1962. No physical examination was performed but De Long took the patient’s word for the presence and type of disease. The patient was given an injection of laetrile and chorionic gonadotropin, a supply of the latter for home use and a bottle of Mucorhicin. At the time of this visit, De Long admitted to the use of several other agents.

On September 5, 1962, an investigatory hearing was held at which Dr. De Long was directed to bring samples of laetrile, pancreatic enzyme, chymotrypsin, Mexican cell treatment, Mucorhicin, ointment for external cancer, liquid for external cancer and instructions for performing the Bolen Diagnostic Test. Dr. DeLong brought none of these to the hearing.

An accusatory hearing was scheduled for March 6, 1963, but, because of repeated continuances in deference to a criminal trial which was pending against him, the accusatory hearing was not held until August 9, 1965. The hearing officer found in favor of the Department of Public Health and recommended that Cease and Desist Orders against the agents named in the subpoena be issued. This was accomplished on October 14, 1965.

Subsequently, Dr. DeLong was convicted in criminal court of wiretapping and insurance fraud. The sentence was five years probation and a charge to cooperate with the probation officer for medical treatment and to obey all laws, orders, rules and regulations of the Probation Department and the Court.



Regulatory Action against Wendell G. Hendricks, D.O.

Wendell G. Hendricks, D.O., was disciplined in 1963 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council. Complaints about Dr. Hendricks’s practice began in approximately 1952 and, although there were numerous investigations by the Board of Osteopathic Examiners, nothing came …

Wendell G. Hendricks, D.O., was disciplined in 1963 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council.


Complaints about Dr. Hendricks’s practice began in approximately 1952 and, although there were numerous investigations by the Board of Osteopathic Examiners, nothing came of them until the 1960s.

One complaint was made by Miss V.P. , who went to Dr. Hendricks because of a breast lump. She continued with him for 18 months and received in succession the Koch treatment, the animal cells, a poultice applied locally which was supposed to bring the tumor out through the skin and, finally, injections of two other agents which produced chills and fever. She paid a total of $1200 and, at the end of 18 months, went to a surgeon where malignancy of the breast was diagnosed and a radical mastectomy performed. She later died of her disease.

In June 1961, the Osteopathic Board received a telephone call from Mrs. M.D., who had a cancer background and who expressed her intent to seek cancer treatment from Dr. Hendricks. The patient’s suspicions were aroused because of the very strong “sell” by the receptionist when an appointment with Dr. Hendricks was requested. Since she did have this suspicion and since something was known of Hendricks’ operations, the patient agreed to serve as an undercover operative and to visit Hendricks for treatment.

She was told by Dr. Hendricks that he would treat her with a cancer antitoxin which originated in Russia but which he now obtained in Canada, and if she had cancer she would get a reaction with chills and fever. Later, after continued treatment, when she no longer got such a reaction it would mean that she no longer had cancer. When that happened, he would then start on the cell treatment, an injection method—the agent being made from lyophilized cells of unborn animals, usually lambs. The agents are made both in Switzerland, where they originated, and in Mexico. He also stated that he had the Lincoln method of treatment and the Koch oxidation catalyst. This patient was charged $250.

In October, 1961, Mrs. T.T., another undercover operative, a laryngectomee with a ten-year cure, visited Dr. Hendricks. During the two visits this patient made, she was given an injection into the hip, supposedly the Koch treatment, and also an injection into the vein, presumably the detoxification agent or the antitoxin from Canada. She was also told about the cellular treatment which would be obtained from Switzerland and which could be administered to her for $1,300. This patient paid Hendricks a total of $160.

Dr. Hendricks was subpoenaed to appear at an investigatory hearing and directed to bring samples of the agent he used in the treatment of cancer. The names of these agents and their synonyms were listed on the Subpoena Duces Tecum. Hendricks appeared, was represented by counsel, but brought none of the agents with him. He was then summoned to an accusatory hearing held before a hearing officer where the State’s evidence was presented. The hearing officer proposed that a Cease and Desist Order be issued based on the feature of the law which permits a conclusive presumption that the agents in question are of no value if the proponent fails to produce requested samples or other information.

A Cease and Desist Order dated July 23, 1963 was issued against Dr. Hendricks.

In 1964, subsequent to the issuance of the Cease and Desist Order, additional complaints reached the Department of Public Health. One of these was from a patient with multiple myeloma who was treated with the cell treatment. A total of $3,000 was paid.

Another was a case of malignant melanoma which was treated by Hendricks with the Koch Oxidation Catalyst, and was promised treatment with the cellular injections. Both of these patients have died of their disease.

Since by this time, the Professional and Vocational Standards were interested in Dr. Hendricks’ activities, no further attempt was made by the State Department of Health to gather additional evidence. The action of the Professional and Vocational Standards resulted in the revoking of Dr. Hendricks’ license to practice medicine.



Regulatory Action against Howard F. Parsons, M.D.

Howard F. Parsons, M.D., was disciplined in 1965 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council. On February 24, 1961, Mrs. O.J.R., the daughter of a patient having widespread cancer of the cervix, wrote a letter of complaint to …

Howard F. Parsons, M.D., was disciplined in 1965 by the Medical Board of California for violating California’s Cancer Law. The following summary came from the files of the California Cancer Advisory Council.


On February 24, 1961, Mrs. O.J.R., the daughter of a patient having widespread cancer of the cervix, wrote a letter of complaint to the San Francisco County Medical Association. With this letter, the daughter enclosed a letter from Dr. Parsons in which he complained about stoppage of payment of the daughter’s check for the mother’s treatments.

She felt that she and her mother were being victimized by a cancer racket sponsored by Dr. Parsons whose integrity therefore she felt to be questionable. One reason for her suspicions was the fact that Dr. Parsons had influenced her mother not to accept treatment from the University of California Hospital in San Francisco. She had tried to interest a district attorney in her home town and also the University of california in investigating Parsons but neither was receptive to her pleas for help.

In Dr. Parsons’ office, the mother was given a Bolen Test for cancer and injections of Koch antitoxin, both of which have been discredited by the Cancer Advisory Council and banned in California.

On January 16, 1963, Mrs. N.B.N. visited Dr. Parsons because of an intestinal difficulty. After physical examination and a blood test for cancer which was claimed to be negative, Dr. Parsons diagnosed her illness as a chronic virus infection and recommended that a vaccine be prepared from her urine by a laboratory in Oregon. It was the patient’s understanding that the treatment would last only about six weeks, but later on it developed that it was planned to keep her coming for treatment for from nine months to two years. The patient felt that he had misrepresented the facts and was engaged in misleading business practices. During the patient’s visits at Dr. Parsons’ offices, she heard about two cancer patients who had been treated successfully with similar vaccine. The patient complained of her treatment to the San Francisco County Medical Society and the complaint eventually reached the State Health Department. Since treatment of cancer was not involved in this patient, her testimony was not used.

Late in 1962, a complaint was received from Mr. R.S., an East Bay businessman regarding the treatment of his mother by Dr. Parsons. By use of the Bolen Test, he had diagnosed this patient as having a low-grade malignancy, and proceeded to treat her with vaccine prepared from urine. She received injections of this vaccine for approximately three months. He advised against biopsy or any type of surgery, stating that such a procedure would allow the cancer to invade the bloodstream and result in widespread metastases. Parsons stated the injections would case the cancer to be exuded through the skin. It did break down and discharged purulent materiel but certainly not as a result of the injections.

In 1963, a complaint was received from Mr. C.C., the son of a patient who had advanced carcinoma of the bowel. She had seen Dr. Parsons and bad the Bolen Test and the vaccine had been prescribed for her. However, the patient died before the vaccine could be administered.

As a result of these complaints, two undercover operatives were sent to Dr. Parsons’ office where they stated that they had or had had cancer and that they were concerned about a recurrence. The first of these, Mrs. B.C.T., was given the Bolen Test, was told that it was about 98 or 99 percent accurate, and that it showed cancer was present. The Koch Oxidation Catalyst was prescribed. She was given several injections of this agent at weekly intervals and, after the fifth visit, a Bolen Test was repeated and Dr. Parsons stated that the patient was showing wonderful improvement. This patient has had periodic health examinations since her original surgery for cancer of the cervix, 10 or 12 years ago, and has shown no evidence of recurrence.

The second operative, Mrs. D.C., made five visits to Dr. Parsons. On the first visit, the patient was given a Bolen Test and was told that she had cancer throughout her system. This visit was in July of 1961 and, to date, the patient has shown no evidence of recurrent cancer. An elaborate diet and numerous health foods were prescribed for the patient, as well as treatment by Samuels’ Short-wave Instrument. Dr. Parsons also stated that Krebiozen, Chymotrypsin, and Mucorhicin are of value in the treatment of cancer, but he administered unidentified injections on three occasions.

Dr. Parsons was summoned to an investigatory hearing where he denied using any of the methods described above in either the diagnosis or treatment of cancer. However, the State had evidence to the contrary, so an accusatory hearing was scheduled. Before this hearing came about, however, Dr. Parsons stipulated to a Cease and Desist Order. He has now closed his San Francisco office and has reopened in Menlo Park, after having stated that he was retiring from practice. He does not appear to be treating cancer, but advertises pain relief thru hypnotism.



Silly Claims for “Spine-Align” (A Dietary Supplement)

In the early 1990s, Vita-Herbs, of St. Louis, Missouri, marketed “Spine Align,” which the label described as a “biologically active concentrate of freeze-dried raw whole spinal column.” Literature for the product claimed that  contained “organ-specific cellular components ” that could “help repair, regenerate, correct, and normalize the specific cellular complexes they were derived from.” The …

In the early 1990s, Vita-Herbs, of St. Louis, Missouri, marketed “Spine Align,” which the label described as a “biologically active concentrate of freeze-dried raw whole spinal column.” Literature for the product claimed that  contained “organ-specific cellular components ” that could “help repair, regenerate, correct, and normalize the specific cellular complexes they were derived from.”

The product was also claimed to “activate the body’s own Innate.” (This referred to “Innate Intelligence,” the metaphysical term used by fundamentalist chiropractors to describe the body’s self-healing capacity.)

Vita-Herbs, Inc., was registered in Missouri as a for-profit corporation in 1966, by Ralph W. Rector and Harold Black. An article I found in a spiritualist magazine described Rector this way:

By trade, Rev. Rector is a pharmacist, specializing in homeopathy. He’s been a student of naprapathy, chiropractic and naturopathy. Rev. Rector is president of Physical Institute, Inc., a St.Louis based firm which dispenses homeopathy prescriptions and provides psychic healing treatments to those who seek attention. Mr. Rector’s shopis located at 7600 Broadway and is open three days a week. At 70, he’s not in the business to get rich, at least, not at $8 a visit. His prescriptions are merely suggested and offered along the same lines which you buy vitamins or patent medicines across the counter. . . .

Rev. Rector’s specialty is strengthening muscles. His bone adjustments are made by strengthening the respective muscles which then pull displaced bones into place. He believes in convincing his patients, a bit unusual for a practioner. Before he recharges your energy level, he often insists on testing the muscle strength. This is one of the things your chiropractor would do at the first visit. After a treatment, the process ¡s repeated. When you can feel vertebra out of place, Rector will ask you to note the sensitivity and the bulge if any, before and after. In that way, he believes, you receive a psychological lift too.

Occasionally, patients speak of feeling something shift in the back or other area treated. That’s all though, until the pain starts. And start it does within a few hours. The best comparison his patients give sounds like the aftermath of a severe series of adjustments by a chiropractor. The aches and sorenesses are there, but within a day or two all fades.

It’s uncanny the way Rector works. He’s not abrupt, and tries to answer every question. His magic isn’t restricted to touch, magnetic passes or space, so it seems. On occasion, he treats while out of the patient’s room. Put to the test he has purposefully thrown aligned bones out of place, then walked out of the room and willed them back. He doesn’t say, “try me.” He just likes to prove that his theories on magnetic energy can be duplicated again and again, whether he’s present or not! [1]

Records filed with the Missouri Secretary of State indicate that Black took over Vita-Herbs in the 1970s and that the corporation was dissolved in 2014.

Spine-Align was distributed by Spinal Support Systems, which was registered as a fictitious name in 1990. The product was said to be made from Whole New Zealand Bovine tissue specifically processed to preserve biologically active substances, naturally occurring nucleoprotein, enzymes, organ-specific nucleic acids & cellular components that occur naturally.” Literature I collected during the early 1990s suggested that Spine Align would “support” and “strengthen” chiropractic spinal adjustments by normalizing the parts of the body that corresponded to the parts of the cows from which the product was derived. These claims were nonsensical because:

  • There is no logical reason to believe that extracts of tissues from animals would target corresponding tissues in humans.
  • Even if “biological activity” was preserved by freeze-drying—which is unlikely—any proteins, enzymes, or nucleic acids capable of biological activity would be broken down by the user’s digestive process.
  • Rather stimulating any repair processes, they would merely add trivial amounts of nutrients to the body’s total supply.
References
  1. Painless chiropractics. The National Spiritualist Summit, Aug 1979, p. 18.
  2. Spine Align Brochures, Vita-Herbs, Inc., 1990


Miscellaneous Chiropractic Pamphlets (1950s to 1980s)

The pamphlets listed below come from many sources, some of which are not identified in the pamphlets. Most were issued during the 1970s. Nearly all exaggerated what chiropractors can do. Click here to read them. “Why Won’t You Go to the Chiropractir? For Your Family’s Health MS: CORRECT the CAUSE . . . and REGAIN …

The pamphlets listed below come from many sources, some of which are not identified in the pamphlets. Most were issued during the 1970s. Nearly all exaggerated what chiropractors can do. Click here to read them.

  • “Why Won’t You Go to the Chiropractir?
  • For Your Family’s Health
  • MS: CORRECT the CAUSE . . . and REGAIN HEALTH
  • Drugs Offer Only Temporary Relief
  • Children Are Subjected to Tremendous Shocks
  • Hay Fever
  • The Farmer’s Best Friend
  • Chiropractic Information Series: #10 Digestion, #40 Thyroid, #41 Uterus
  • How Long Will It Take to Get Well
  • Spinal Health & Wellness
  • How to Overcome Discouragement on the Way Back to Health
  • Chiropractic: The Good Health Habit
  • What’s Your Health Problem?
  • Chiropractic Do’s and Don’ts
  • Good Health Is a Family Affair
  • The Search for a Healthier Life Is No Mystery . . .
  • The Whip-Lash Injury
  • Your First Chiropractic Adjustment
  • What Kinds of Conditions Do Chiropractors Treat?
  • Chiropractic Practice in Oregon
  • What Is Chiropractic?
  • Chiropractic and the Working Man
  • Eye Trouble
  • Hay Fever
  • Liver Trouble
  • How Long to Health
  • Innate Intelligence: The Power Within
  • Why Is He Down in the Doldrums ?????
  • The Power of Your Immune System
  • Your Doctor Wants You to Know . . . Backache
  • Your Doctor Wants You to Know . . . Scoliosis

 



Pamphlets from the International Chiropractors Association (1968-1972)

The International Chiropractors Association (ICA), which is the second largest chiropractic organization in the United States, represents chiropractors who advocate subluxation-based chiropractic. During the early 1970s, I collected six pamphlets that the ICA issued to explain its views to patients: Health Is Natural claimed that (a) every organ and cell receives its supply of “nerve energy” …

The International Chiropractors Association (ICA), which is the second largest chiropractic organization in the United States, represents chiropractors who advocate subluxation-based chiropractic. During the early 1970s, I collected six pamphlets that the ICA issued to explain its views to patients:

  • Health Is Natural claimed that (a) every organ and cell receives its supply of “nerve energy” from the brain, (b) this energy activates and regulates body function (c) misaligned (“subluxated”) vertebrae interrupt the proper flow of nerve energy between the brain and affected body parts, (d) chiropractors detect subluxations and adjust the spine to correct them, and (e) this restores the normal flow of nerve energy, which restores the person’s health. 
  • Your Child’s Health claimed that active children are likely to experience “falls, jolts, jars, and sprains” that frequently produce spinal subluxations.
  • Stay Healthy Naturally claimed that “often only the spine stands between a person and good health.”
  • Chiropractic: Natural Means to Good Health claimed that “chiropractors are specially trained to keep your spine in alignment.”
  • Why the Spine Is Important to Patient Health asserted that “a thorough analysis and checkup should be made on every individual at regular intervals.”
  • Diabetes / Chiropractic claimed that diabetes could be caused by a spinal misalignment (subluxation) and corrected by spinal adjustment.

None of the above notions are accepted by the scientific medical community. The diabetes claim is particularly egregious. Click here to read the full text of these pamphlets.



Index to State and Local Enforcement Actions

(Listed in Reverse Chronological Order) Robert O. Young Sentenced to Prison (2017) Lawsuits against Trump University Settled (2016) Harris County Attorney Sues to Stop MMS Sale (2016) Texas Attorney General Sues Robert Linsey Duncan (2014) Texas Attacks Acai Product Marketing Scheme (2009) California Orders Be-Thin Inc. to Stop Selling Franchises Unless Registered (2008) Avian Environmental …

(Listed in Reverse Chronological Order)



Chiropractic Pamphlets from Hardt Publishing Company (1983)

Robert J. Reinhardt, D.C., who practiced chiropractic in Pequannock, New Jersey, dealt mainly with musculoskeletal disorders and accident-related injuries. In 1983, he notified me that a lack of high-quality, non-flamboyant chiropractic educational material had prompted him to develop pamphlets to fill this lack. Doing business as Hardt Publishing Company, he marketed 18 of them: Arthritis • …

Robert J. Reinhardt, D.C., who practiced chiropractic in Pequannock, New Jersey, dealt mainly with musculoskeletal disorders and accident-related injuries. In 1983, he notified me that a lack of high-quality, non-flamboyant chiropractic educational material had prompted him to develop pamphlets to fill this lack. Doing business as Hardt Publishing Company, he marketed 18 of them:

Arthritis •  Disc Problems • Children & Chiropractic • Headache • Low Back Pain • Manipulative Therapy • Mid-Back Pain • Neck, Shoulder & Arm Pain • Pinched Nerve • Sacroiliac Pain • Sciatica • Scoliosis • Sports & Chiropractic • The Elderly & Chiropractic • The New Chiropractic Patient • Torticollis •  Whiplash Neck Injuries • Work-Related Injuries

 I have collected 14 of them, which you can access by clicking here. Unlike pamphlets from other publishers, these contained no subluxation-based claims and did not exaggerate what chiropractors can do.



The American Chiropractic Association’s Improper Attack on Prescription Drug Use

In 1985, the American Chiropractic Association released a Speaking and Personal Betterment Guide that was written by its public relations consultant, Irvin Davis. An ad in the October 1985 issue of the ACA’s Journal of Chiropractic promised that the book would enable chiropractors to speak authoritatively and “use the speaker’s platform and radio and television as a practice-builder.” One …

In 1985, the American Chiropractic Association released a Speaking and Personal Betterment Guide that was written by its public relations consultant, Irvin Davis. An ad in the October 1985 issue of the ACA’s Journal of Chiropractic promised that the book would enable chiropractors to speak authoritatively and “use the speaker’s platform and radio and television as a practice-builder.” One section, which contained proposed speech ideas, included a 10-minute talk titled “Beware of All Drugs and Medications.”

The logical way to evaluate any treatment is to compare the likely benefits against the likely risks. But the ACA’s suggested speech ignored the benefits and exaggerated the risks of appropriately prescribed medications. At the end it even warned: “The best thing you can do for your health is to beware of all of them.” Here is the full text of this speech followed by my reactions:

Beware of All Drugs and Medications

 Where does one draw the line in determining what is a “good drug” and what is a “bad drug”? ls it based on legal implications? Moral determinations? Or, is the most important factor its effect on health? The American public shows great concern over the use of the extreme drugs. Heroin, LSD, Acid, Speed—these are the worry of every parent, and are labeled “bad” because these escape drugs have captured a small percentage of our young generation.

While no reasonable person would condone the use of these deadly and illegal drugs, it is interesting to note that society—and parents in particular—do not seem to be concerned with the thousands of other drugs and medications that are widely prescribed and used.

We forbid our children to use LSD to escape mental reality; yet, on the other hand, we constantly push pills down the throats of these youngsters to escape physical reality. Aspirin, painkillers, and antibiotics are some of the most commonly used drugs, but there are more than 7,000 on the market under various brand names. How can we label one set of harmful drugs as “bad,” and at the same time accept another, much larger set of harmful drugs as “good”?

Iatrogenic, or drug-caused diseases are becoming a national health problem of critical proportions because of the overuse of medicines in our modem society.

There is a trend toward what might appear to be the easy way of treatment—seeking an escape or cover-up for the symptoms of the problem, rather than curing the condition itself.

Medical doctors prescribe drugs recklessly; patients take them recklessly; and too little is known about the final effects of drugs by medical doctors, patients or manufacturers.

If you think that our major concern is the extreme, illegal drugs, the following enlightening facts should be noted about medications found on shelves in most every home:

  1. An estimated one million patients are admitted to hospitals in the United States each year because of drug-induced illnesses.
  2. An estimated 100,000 Americans die each year from drug-contributing illnesses.
  3. 90 percent of drugs and medications are used unnecessarily.
  4. Many drugs have not been adequately tested on human beings prior to release.
  5. Painkilling drugs eliminate or dull the symptoms, but do nothing to eliminate the cause of the pain.
  6. Many drugs are habit-forming, thereby requiring greater and greater dosages for effectiveness.
  7. Many drugs give harmful side effects and can be fatal, especially when used in combination with others.

Although the intent of drug use is for the welfare of the patient, reckless or uninformed prescribing by the medical doctor … or negligence by the patient himself … all too often results in drug-induced illnesses. In many cases, drug reactions have been far more serious than the original health problem. And in too many cases they have been fatal.

It is absolutely essential to health that we neither overuse nor misuse nor become dependent on medicines. The risk is far too great—and the positive results are far too few.

Drug abuse was never more prevalent than it is today. It is interesting to note that since its inception, the chiropractic profession has recognized the danger of drugs and the benefits of natural health care. Chiropractic is a profession that does not use drugs for treatment. In fact, it has loudly voiced its opposition to the use of drugs and medications.

Perhaps you will ask, “Why?”

For numerous reasons—one of the most important of which is the fact that the body has perfect recuperative abilities within itself. The introduction of strong foreign chemical substances has a tendency to upset the natural processes of the body. Drugs often hinder the restoration of normal body functions.

The chiropractic profession recognizes that pain and discomfort serve an important role: They are warning signals of impending danger. They are the symptoms which signal the existence of a health problem. To dull these symptoms, or to eliminate them, does not cure the problem; it merely obscures the problem from the victim and from his physician.

Chiropractic is a realistic and practical health method. It recognizes that the human being cannot exist on pills and medications. He must establish a healthy mental and physical attitude and maintain his health through natural means—which includes a well-balanced diet, regular exercise and spinal care on a periodic basis.

Next time you get ready to pop a pill in your mouth—whatever the reason—be it to relax, to relieve tension, to put you to sleep or to do away with the sniffles, ask yourself: “ls it really worth it?” ls it worthwhile taking the risk of harmful side effects? Consider the accumulative effect. Consider the possibility that you may be covering up the symptoms of a health problem that should be treated . . . perhaps allowing it to get worse.

Ask yourself whether you care so little about your life that you are willing to become dependent on drugs. I hope you will decide, as I have, that it is not worth the risk. Drugs are drugs … whether they be legal or illegal. And the best thing you can do for your health and well-being is beware of all of them.

The above script was originally offered to ACA members in 1971 as part of an elaborately planned public relations campaign with the theme “Don’t Be a Pill Popper,” which included two billboard posters:

Associated “Pill Popper” radio and TV spots asked whether America was becoming “a land of strong pills . . . and weak people.”

The PR materials also included a patient-education pamphlet titled Beware of Overuse of Drugs that had a similar message. It listed more than 100 side effects of commonly prescribed drugs, presented the seven alleged “facts” listed above, and concluded with this statement:

Your doctor of chiropractic employs no dangerous painkillers to lull pain to sleep while body damage continues. He does not use sedatives to give you a false sense of security. He uses no drugs whatsoever in, his treatment, thus avoiding drug-induced illnesses and dangerous side effects often more serious than the condition being treated. His methods are scientifically aimed directly at the cause of the illness; his treatment aids in restoring your body to its normal function.

My Reactions

The speech was aimed to undermine trust of medical treatment and to persuade people to try chiropractic instead. Almost all statements it contained were either false or misleading.

The assertion that “prescribed drugs merely cover up symptoms rather than curing the condition” is potentially quite dangerous as well as false. Countless millions of people with chronic conditions are helped by drugs that can control their symptoms or even keep them from dying. Hormones can replace hormones that the body can not longer supply—as is done in treating Type I diabetes, hypothyroidism, and several other hormonal deficiency diseases. Other drugs can increase or decrease various body functions by blocking or enhancing metabolic pathways as is done in treating abnormal blood pressure. Many infections are cured by an antibiotic that kills the causative organism. Many cancer drugs work by killing cells that are functioning abnormally. Vaccines prevent disease by generating antibodies that kill invading germs, And so on.

The statement that many drugs are habit-forming is misleading. Only a few classes of drugs that affect the central nervous system are habit-forming. As with all drugs, their prescription should be based on whether the expected benefits exceeds the possible risks. The ability to determine this requires many years of medical training and experience. Chiropractic schools do not provide this.

The statement that medical doctors prescribe drugs recklessly is a vast overgeneralization.

The pamphlet’s discussion of adverse effects fails to mention that the drugs it discusses are usually beneficial and in many cases are life-saving. Suggesting that people worry every time they are about to take a pill is unconscionable.

The claims that chiropractic treatment addresses the cause of disease are simply false. The legitimate scope of chiropractic is very narrow.

People who seek “alternative” treatment to avoid taking drugs have a high probability of being misdiagnosed, financially exploited, and suffering needlessly from problems that could have been managed with proper medical care. Over the years, I have talked with hundreds of them.

The drug marketplace does have problems. But the best way to avoid them is not to avoid all drugs but to use the services of doctors who can sort out the facts and determine which treatments would be best for their patients. Chiropractic bad-mouthing can safely be ignored.



Chiropractic Pamphlets from Krames Communications (1993-1996)

In the mid-1990s, Krames Communications of San Bruno, California issued beautifully designed pamphlets that it described as “high-quality tools for informing new and prospective patients about the conditions you treat regularly and the benefits of chiropractic care” and for showing that ” you’re far more than a ‘back doctor.’” The consultant for the series was …

In the mid-1990s, Krames Communications of San Bruno, California issued beautifully designed pamphlets that it described as “high-quality tools for informing new and prospective patients about the conditions you treat regularly and the benefits of chiropractic care” and for showing that ” you’re far more than a ‘back doctor.'” The consultant for the series was Michael Pedigo, D.C., the only chiropractor who had served as president of both the American Chiropractic Association and the International Chiropractors Association. The pamphlets I collected were dated 1993, 1994, or 1996.

  • The 1993 titles were: “What is Chiropractic?,” “Low Back Pain,” “Neck Pain,” “Headaches,” Scoliosis,” and “Whiplash.”
  • The 1994 titles were “Disc Problems,” “Shoulder Pain”, “Sciatica Leg Pain,” “Spinal Degeneration,” “Arthritis,” and “Children and Chiropractic.”
  • The 1996 titles were “Spinal Subluxation,” “Avoiding Back Pain,” “AHCPR Guidelines” “Pregnancy and Chiropractic, “Research Supports Chiropractic, and “Chiropractic Education”

Nearly all of the pamphlets contained these basic messages, with minor variations in some of them:

Chiropractic is a natural method of health care that treats the causes of physical problems rather than just the symptoms. Chiropractic is based on a simple but powerful premise: With a normally functioning spine and nerves and a healthy lifestyle, your body is better able to heal itself. That’s because the spinal cord, which is protected by the spine, is the main pathway of the nervous system. The nervous system controls movement, feeling, and function throughout your body.

Your chiropractor has at least six years of professional training in the sciences and health care, leading to a doctor of chiropractic (DC) degree. He or she works to maintain or restore your health and guides you in a personalized approach to overall wellness. . . .

Just as you need regular dental exams, you also need regular chiropractic exams. Even if you don ‘t have symptoms, chiropractic care is one of the best ways to manage or prevent  . . . problems and maintain a healthier life.

All also implied that chiropractic care could prevent the problems described in the pamphlets and would maintain or restore general health.

No scientific studies have demonstrated that chiropractic treatment generally treats “causes rather than just symptoms” or that chiropractic maintenance care will lead to a healthier life.

Krames’s 1994 catalog for chiropractors offered about 50 more educational items.

Click here to read the full text of the pamphlets.



Pocket Guides from Positive Promotions (1990s)

Positive Promotions of Brooklyn, New York, marketed pocket guides that could be imprinted the chiropractor’s name. Each consisted a jacket that displayed information as a card inside was pulled in and out. During the 1990s, I collected four such guides: The Prevent-A-Backache Guide contained useful tips for sitting, standing, walking, sleeping, diving, shopping & traveling, and exercise …

Positive Promotions of Brooklyn, New York, marketed pocket guides that could be imprinted the chiropractor’s name. Each consisted a jacket that displayed information as a card inside was pulled in and out. During the 1990s, I collected four such guides:

  • The Prevent-A-Backache Guide contained useful tips for sitting, standing, walking, sleeping, diving, shopping & traveling, and exercise & diet.
  • The Exercise Away Your Calories guide could display the number of calories in about 100 food items and the number of calories used per minute with running, swimming bycycling, walking, and aerobics. Sliding the inside card could then indicate the number of minutes of exercise that would burn off the number of calories of the selected food.
  • The Auto Collision Counselor guide, which contained a checklist of things to do in the event of an accident, provided a handy reminder to the collect the necessary  information.
  • The Vitamin/Mineral Guide enabled the user to see what nutrient deficiencies were supposedly associated with acne, depression, excessive thirst, heart trouble, high cholesterol, irritability, and twenty other symptoms or conditions and which foods were the best sources of these nutrients. This approach was irrational because the symptoms would be far more likely to have other causes.

Click here to see the guides.



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.