CV#827TEST. Herbert V. Testimony of V. Herbert on 2/10/00 before NY City Council in support of proposed NYC local consumer protection law requiring supplement sellers to post FDA warnings of possible harms, and notices of need for each person to consult a health professional knowledgeable about their personal health status before taking any supplement.
Testimony of Dr. Victor Herbert on 2/10/00 before NY City Council
New York City Council Hearing of February 10, 2000 on proposed LOCAL LAW Int. No. 583 (July 21, 1999) to amend the administrative code of the city to require marketers of dietary supplements to post warnings of harms reported to FDA from substances (such as ephedra and chaparral) in each of the products they sell.
I am testifying at this hearing at the requests of both the New York County Medical Society and the New York State Dietetic Association.
Appendix A, my abbreviated CV, summarizes my credentials relevant to this hearing. In addition to being a New Yorker essentially all my life, born, raised, and educated in this City's public and high schools, City College, getting my Bachelor's (in Chemistry), medical, and law degrees all at Columbia University here in New York City, my entire career has been, and still is, teaching, patient care, and research in nutrition. I have published over 800 relevant papers in the peer-reviewed scientific literature, relating particularly to scientific determinations of efficacy, safety, and the efficacy-safety ratio. A New York-licensed physician, since 1964 I have been a member of the Nutritional Anemias Consultative Group in the World Health Organization. Since 1979, I have been the US Department of Veterans Affairs representative to the Interdepartmental Committee on Human Nutrition Research (ICHNR), a subcommittee in the Executive Office of the President of the United States. As an attorney, admitted to practice since 1974 before the Bar here in New York City, I was for 5 years Chairman, Committee on Life Sciences, American Bar Association. I am often interviewed and quoted by the media, right up to last week in stories in the New York Times, Washington Post, and WebMD.
The buzz-word "natural" is used by the supplement industry to deceptively convey safety, concealing from the public that herbs and other plants naturally contain a multitude of natural pharmaceutical substances, from digitalis, quinine, and steroids, thru arsenic and cyanide. Believe it or not, arsenic in tiny trace amounts is a nutrient. To quote Hippocrates, "the dose makes the poison." The high dose of poison naturally present in the amount of hemlock given to Socrates naturally killed him. The injunction, "Drink up, Socrates, it's all natural," did not save him.
The branch of pharmacology which deals with natural pharmaceuticals is called pharmacognosy. Herbology is to pharmacognosy what astrology is to astronomy. DSHEA ignores pharmacognosy and promotes herbology. Under DSHEA, you can legally sell hemlock as a supplement, claim it naturally tones the nervous system, and conceal it kills. Regarding ephedra (ma huang) the supplement industry has long known this natural pharmaceutical product can be harmful to lethal, particularly when the product also contains the natural pharmaceutical caffeine. Appendix B is pages 488-489 of our 1994 book "The Vitamin Pushers" noting that, back in 1994, ma huang was well established as "An herb that contains ephedrine, a decongestant and nervous system stimulant. Ephedrine can raise blood pressure and therefore is hazardous to individuals with high blood pressure. Products containing ma huang are marketed as weight-loss aids even though they have not been proven safe and effective for this purpose. Some entrepreneurs are selling ephedrine/caffeine combinations as stimulants. Serious illnesses and deaths have been reported among users of these products."
I asked Harvey Levine to make himself available to you today. Harvey is a gentle and delightful overweight Queens resident who regularly worked out, and, believing their advertising that their product was effective and safe for weight loss, became a victim of a weight loss supplement containing ma huang and a natural caffeine-containing substance. The product produced a fast heart beat called rapid atrial flutter, which led to cardiomyopathy, with subsequent congestive heart failure and acute pulmonary edema, causing his brother, Robert A. Levine, M.D., a Connecticut internist, to send him by ambulance to Yale New Haven Hospital. There, his ejection fraction was found to be only 20%, and the possibility of heart transplant was discussed if his cardiomyopathy did not decrease. He fortunately recovered, after cardioversion, sufficiently that, after 6 months of rest, he was able to return to work. However, for the past 2 months, he has been disabled by fatigue and sleepiness due to the beta blockers he must continue taking to avoid the return of potentially lethal atrial flutter in his permanently ma huang-damaged heart.
As Stephen Barrett, M.D. (Columbia '53) and I (M.D., Columbia'52) detail in chapter 20 (pages 437-452) of our book, "The Vitamin Pushers: How the Health Food Industry is Selling America a Bill of Goods", to maximize profits, the health-food industry must minimize consumer protection by the FDA and all other federal, state, and city agencies. Such consumer protection would forbid the industry from profiteering by making deceptive, misleading, and/or false claims of efficacy and/or safety.
Helped, among others, by John Cordaro's trade association of supplement sellers formed in response to an FDA attempt to regulate the labeling and dosage of supplements, and deceptively named "The Council for Responsible Nutrition" to conceal its bias, the supplement industry's main politician spokesperson, Sen. Orrin Hatch (R, Utah), got through Congress in 1994 the Dietary Supplement Health and Education Act (DSHEA), 21 U.S.C 321, after failure to get it through in 1993 because of a 1993 New York Times editorial on it entitled "The Snake Oil Supplement Act".
The DSHEA set up a committee to promote supplements at NIH, advised by Senator Hatch's side-kick and former summer intern, Loren Israelson, president of the lucrative (multibillion-dollar) Utah branch of the supplement industry, the Utah Natural Health Alliance. The DSHEA also castrated the FDA, forbidding it to prevent the marketing of any product labeled a supplement by the seller, and forbidding FDA from requiring proof of efficacy, proof of safety, or even proof that the product contains what the label says it contains. FDA was denied funds to do laboratory investigations into content or safety. Vocally opposing the DSHEA castration of FDA, FDA Commissioner Kessler, a New Yorker who had taught at our Albert Einstein College of Medicine, resigned.
A typical result of this castration of the FDA is delineated in Appendix C, a 2-page article in the March 2000 Good Housekeeping on the "Hot natural remedies" SAMe, St. John's wort, and kava. As you can see in the table, "SAMe: Why you can't trust the label", Good Housekeeping tested 8 brands of the dietary supplement SAMe, "What we found was shocking. In three brands we detected less active ingredient than listed on the bottle. In one brand we detected no active ingredient at all." Three brands were not enteric coated, making it unlikely their SAMe would be effectively absorbed. Three of the 8 had about 50% more SAMe in them than the label stated. Note: 50% more than the label states in a ma huang product could be lethal.
Appendix D is our Editorial, solicited by the editor-in-chief of Mayo Clinic Proceedings for its May 1999 issue, on the value of "good" supplements like vitamin B12, folic acid, calcium, and vitamin D, and some of the possible harms from dangerous supplements like St. John's Wort, Echinacea, Gingko Biloba, and the "antioxidants" (also discussed in Appendix E, "The antioxidant supplement myth", and Appendix F "Harms from "Immunoenhancing" supplements").
To stay up to date on harms from various supplements, check the web site of my New York City-born-and-educated quackbuster colleague Stephen Barrett, M.D. He keeps it up to date and daily adds the latest responsible literature. His web site is: http://www.quackwatch.com
VICTOR HERBERT, M.D., J.D.,
M.A.C.P., F.R.S.M. (London).
Appendix A: Abbreviated Curriculum Vitae