Note from Dr. Barrett: After the hearing, Rep. Burton (organized quackery’s best friend in Congress) submitted this statement for the record. Burton’s submission is misleading and unfairly attacks Timothy N. Gorski, MD, a National Council Against Health Fraud board member who testified at the hearing. Dr. Gorski was permitted to submit a rebuttal, which we have posted.
As Chairman of the House Committee on Government Reform, I initiated oversight investigations looking at the role of complementary and alternative medicine in our health care system and the Food and Drug Administration’s (FDA’s) implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). We have conducted numerous hearings over the last three years examining these issues. We anticipate completing this investigation over the next 14 months and issuing reports of our findings next fall.
The title of the September 10 Senate hearing, “Swindlers, Hucksters and Snake Oil Salesmen: The Hype and Hope of Marketing Anti-Aging Products to Seniors,” left many believing that the Senate Special Committee on Aging has discounted the benefit of any nutritional supplement for the aging population and condemned all manufacturers as crooks. I find this disturbing, especially at a time when it is increasingly recognized that Americans can improve their health status, prevent disease and chronic health conditions by paying attention to their lifestyle. By improving nutritional support and physical activity individuals can in fact have better health including healthier aging.
On August 8, HHS Secretary Tommy G. Thompson made the following announcement:
At least 10 million Americans at high risk for type 2 diabetes can sharply lower their chances of getting the disease with diet and exercise, according to the findings of a major clinical trial. In view of the rapidly rising rates of obesity and diabetes in America, this good news couldn’t come at a better time. So many of our health problems can be avoided through diet, exercise and making sure we take care of ourselves. By promoting healthy lifestyles, we can improve the quality of life for all Americans, and reduce health care costs dramatically.
The role of dietary supplements is even more important for the aging population given that many seniors are not able to obtain all of their daily vitamin and mineral requirements through food consumption alone.
There is no one in Congress that will tolerate the abuse of vulnerable populations including senior citizens. Whether it is products sold without substantiation for aging-related conditions, telephone scams for bogus charities, scams involving long-term care insurance, credit cards, home improvements, travel, or magazine subscriptions intentionally misleading someone for financial gain is unacceptable and illegal. This is why we have empowered Federal regulatory agencies such as the Federal Trade Commission and the FDA with appropriate authorities to go after those individuals and companies who market illegal products or services or make illegitimate claims.
In 1994, Congress passed DSHEA by unanimous consent and with significant grass roots support. With the passage of the DSHEA Congress recognized the important role that vitamins, minerals, botanicals, and other dietary/nutritional substances can play in improving and maintaining health. Congress found that:
the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;
consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;
although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers; and
dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.
It is often misreported in the media that with the passage of DSHEA the FDA lost the ability to regulate supplements. The fact is that the FDA has seven points of authority to regulate dietary supplements. The FDA has the power to:
- Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary [Section 402(a)]
- Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims [Section 403(a),(r6)]
- Seize dietary supplements that pose an” unreasonable or significant risk of illness or injury” [Section 402(f)]
- Sue any company making a claim that a product cures or treats a disease [Section 201(g)]
- Stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance [Section 413]
- Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [Section 402(f)]
- Require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices), including potency, cleanliness and stability [Section 402(g)]
When asked about the FDA’s power to regulate supplements, Dr. Jane Henney, then FDA Commissioner testified to the Committee on Government Reform in 1999 that the FDA had adequate authority to regulate dietary supplements. One issue of major importance is the full implementation of DSHEA, including most specifically the formation of Good Manufacturing Practices (GMPs) for dietary supplement manufacturers. Until GMPs are in place and the FDA becomes active in looking at enforcing GMPs, we will not have a full implementation of DSHEA. In the mean time, the FDA has the authority to enforce each of its authority including the current GMPs. Many of the concerns the public expresses about quality assurance are directly connected to the FDA’s need to enforce GMPs. The FDA’s written testimony provides information on a series of actions taken over the last decade but provides not a single example of scams against the elderly.
Additionally the Federal Trade Commission has jurisdiction on advertising claims for dietary supplements. The FTC published guidelines for manufacturers and has been very active in regulating these products.
Many of our nation’s seniors are subjected to treatments in “conventional medicine” that are not necessary, cost more and are more dangerous than equally effective alternatives. This is of grave concern to me as well. Senior citizens are also oftentimes the victims of medical errors that result in tragedy and death. The over use of prescription drugs in nursing homes that cause impaired memory and confusion is an ongoing concern. Additionally, many physicians routinely prescribe high cost prescriptions drugs, oftentimes with significant side effects when there are lower cost options with fewer side effects available. Veterans Administration funded research found that Saw Palmetto was equally effective as a prescription drug for treating the symptoms of mild to moderate Benign Prostatic Hyperplasia (BPH). This condition, which affects an estimated 14,000,000 over the age of 50 in the United States. Treatment costs in the United States for BPH exceed two billion dollars a year and account for 1.7 million office visits each year. Saw Palmetto cost and side effects are significantly less than prescription drug alternatives.
Had the FDA not taken action to keep all red yeast products off the market, American seniors would have been able to choose a red yeast rice supplement instead of a prescription statin such as Bayocal. Earlier this year, the National Cholesterol Education Program – which is coordinated by the National Heart Lung and Blood Institute – recommended aggressive treatment of high cholesterol in diabetes and high blood pressure patients through the use of statins. On August 8, 2001, Bayer removed the statin drug Bayocal (cerivastatin) from the U.S. market because of reports of a severe muscle adverse reaction, rhabdomyolysis, which was sometimes fatal. On August 20, 2001, Public Citizen’s Health Research Group urged the FDA to issue strong “black box” warnings on all HMG-CoA Reductase Inhibitors (statins) after researchers found that over the last 13 years the agency had received reports of 81 additional deaths from rhabdomyolysis among people taking statins. Besides the 31 fatalities involving cerivastatin, there were 81 other deaths from rhabdomyolysis involving statins from 1987, when the first one was introduced, through 2000. The statins on the market include lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor). Cerivastatin had, by far, the largest number of reports of fatal and nonfatal rhabdomyolysis, although it held less than 10 percent of the market at the time it was withdrawn. Side effects for these drugs include: an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives; muscle aches, pain, or weakness; “flu-like” symptoms; decreased urine or rust-colored urine; blurred vision; or yellowing of your skin or eyes. Less severe side effects listed are: gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea; cough; headache; or insomnia.
In a multi-center clinical trial of red yeast rice in subjects with elevated cholesterol – 18% were judged to have adverse reactions possibly or probably related to Red Yeast Rice treatment. The reported adverse events were headache, abdominal bloating, and gas. The trial, which took place at 12 U.S. sites confirmed that treatment with a traditional Chinese food, red yeast rice, was well tolerated and was effective in reducing TC, LD-c, TG and ratio of TC:HDL-c, and in increasing HDL-c in patients with hyperlipidemia. The cost of a red yeast rice supplement is only 20 percent of the prescription drug. This translates to approximately $33.5 billion versus $ 5.5 billion annually for the affected Medicare population. As we consider a prescription drug benefit for Medicare, we must think about these options and look for ways to reduce our dependence on expensive prescription drugs.
There is also significant government funded research showing the benefit in the senior population for such nutritional supplements as vitamins C and E, folic acid, coenzyme Q10, and Omega-3 fatty acids. The Office of Dietary Supplements has done a terrific job of providing accurate information and links to public and private resources on their Internet site.
At a meeting of the American Society of Clinical Oncologists in the spring of this year, Dr. Ezekiel Emmanuel presented a study showing that doctors are prescribing chemotherapy to patients for cancers known not be unresponsive. Using billing records of nearly 8,000 patients in the state of Massachusetts they found that 41 % of patients received chemotherapy in the final year of life, 33 % in the final six months, and 25% in the final three months. The researchers found that at six months, three months, and one month before death that chemotherapy was given with the same amount of frequency between the two groups. The research showed that for patients with cancers generally recognized as being unresponsive to chemotherapy (gallbladder, kidney, liver, pancreatic, and melanoma) in the last year of life, doctors prescribe treatments that cost $38,000 when they know it is not going to help. Prescribing expensive drugs with serious side effects when there are lower cost, less dangerous options available and prescribing chemotherapy, which has significant risks associated with it and can cause terrible loss of quality of life, when there is no evidence that it will benefit are serious scams within the medical community that need to be addressed.
I don’t think we in government give Americans enough credit for being able to make their own medical and nutritional choices. Research shows that individuals who have made a determination to use CAM therapies are typically individuals who have at least some college education. I think we as a Government need to do a better job of enforcing existing laws and providing information about CAM and nutritional options.
One of the primary subjects of the September 10 hearing was Gero Vita International and the magazine owned and operated by businesses controlled by Glen Braswell. The provisions of DSHEA specifically state that manufacturers may not make claims to cure, treat, or mitigate disease. If Gero Vita International or any manufacturer is making any disease claim, the FDA has the authority to take action. Additionally if any manufacturer is making claims that they can not substantiate, the FTC has the authority to take regulatory action.
One bad apple does not, however, spoil the whole bushel basket. The entire supplement and alternative medicine industry should not be measured by Glen Braswell and Gero Vita International. The majority of supplement manufacturers are credible, honest businesses that seek to provide quality products and legal information to the consumer. Glen Braswell, convicted of mail fraud, perjury and fraud, who is under investigation for tax evasion and money laundering hired Hugh Rodham and succeeded in bypassing the normal procedures at the Justice Department to receive a pardon from former President William Clinton just hours before he left office.
Additionally, I would like to point out that we have learned that Dr. Timothy N. Gorski is not currently affiliated with the University of North Texas Health Science Center (UNTHSC). Dr. Gorski lists on the first page of his testimony that he is an “Assistant Clinical Professor at UNTHSC. In his testimony he makes strong attacks regarding alternative medicine, including attacks on the credibility of research published after peer-review in the prestigious New England Journal of Medicine. Coming from someone with an academic appointment from UNTSC, these attacks carry significantly more merit than someone who has made a career of attacking CAM practices. Calls from my staff on September 21 to the University of North Texas Health Sciences Center, including to the University President, uncovered that Dr. Gorski is not an employee or on faculty of that center. He is not now, nor has he been on faculty at least as far back as 1998. His intentional misuse of an academic affiliation should completely discount his testimony. A follow up investigation by UNTHSC uncovered that in 1991 Dr. Gorski had been granted a clinical appointment because he was on staff at a community hospital where UNTHSC sent several residents. In 1995 UNTHSC conducted an audit of these clinical appointments, sending letters requesting verification of credentials and licensing was sent to all community physicians. Dr. Gorski never responded and was dropped from the clinical appointment.
Note by Dr. Stephen Barrett: Burton’s accusation is dead wrong and reflects sloppy investigation by him and his staff. To read the facts, click here.
Dr. Gorski attacks the credibility of the Office of Alternative Medicine/National Center for Complementary and Alternative Medicine (NCCAM) , which was created by Congress in order to address the unmet research needs in this field. He goes on to attack individuals, including Dr. Wayne Jonas the former Director of the Office of Alternative Medicine who was appointed to the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). It should be noted for the record that Dr. Jonas, was recently honorably retired from the United States Army as a Lt. Colonel, after twenty years of service to our country. Dr. Jonas continues to serve our country on the White House Commission and offers a level of scientific expertise that few in the world can equal. Expertise that is based on thorough and honest review of existing theories, peer-reviewed scientific evidence, training in CAM therapies, exploration of research methodologies, and rigorous scientific research.
Dr. Gorski further states that the NCCAM “continues to be staffed and controlled by idealogical advocates”. Dr. Stephen Strauss, the NCCAM Director is an expert in clinical research, he has stated in Congressional testimony and in media interviews that he is not an expert in or advocate of complementary medicine. He and his entire staff are committed to gathering information of existing research evidence in CAM, and funding and conducting rigorous research to expand the evidence base of CAM. The same is to be said of the staff of the WHCCAMP. They are highly qualified, dedicated, long-time Federal employees who have given their careers to public service. They do not deserve to be disparaged in that public service. The WHCCAMP was created by Congress to provide much needed advice on CAM. The Commission, which is comprised of individuals knowledgeable in both conventional and complementary and alternative medicine, has been charged with addressing:
- Research on CAM practices and products.
- Delivery of and public access to CAM services.
- Dissemination of reliable information on CAM to health care providers and the general public, and
- Appropriate licensing, education, and training of CAM health care practitioners.
The Commission’s recommendations on public policy and legislation are due to the President through the Secretary of Health and Human Services in March 2002.
I am also concerned that the GAO’s report did not include references to experts they consulted who provided “the rest of the story”, i.e. products and treatments that could provide benefits to senior citizens. It has been reported to the Committee on Government Reform that individuals who the GAO contacted did provide such information. Their names and the positive information provided to GAO was left out of the report.
Given the concerns raised during this hearing, the long-standing Congressional request for the National Institutes of Health’s various entities including NCCAM to conduct research and gather existing scientific data and make it known to the public is more important than ever.
In 1998, the Department of Health and Human Services announced a five year project, “The Healthy Aging Initiative” to identify the best ways to promote health and prevent physical decline among older Americans. To date, this project has focused entirely on clinical services provided under Medicare such as cancer screenings. This may be an appropriate avenue to coordinate a review of the existing science and traditions regarding aging-related nutrition, including supplementation in order to better understand the role of dietary supplements in healthy aging.
We have made tremendous advances in health care over the last century. Americans are more savvy than every before and not easily duped by flashy advertising. Our seniors no more believe television advertising that suggests that arthritis patients will be able to ride skateboards with their grandchildren than they believe Chicken Little if he bought air time and said the sky was falling. Quality dietary supplements can and do offer benefits to the structure and function of the aging body when used wisely. We have laws that should be fully implemented and enforced. Americans deserve nothing less.
This article was posted on November 10, 2001.