Article ID # 20060305
The FDA's Biased Double Standard on Supplements
by Marc Ullman
Energy Times, March 5, 2006

In this pointed commentary, a supplement industry insider documents the wildly contradictory ways in which the government regards the safety of supplements vs. pharmaceutical drugs, which could eventually lead to the end of Americans' access to vitamins, minerals and herbs. Editor's Note: Millions of overweight people were likely dancing in the streets (and losing unwanted calories) when they read recent news stories about the Food and Drug Administration's potential approval of a new weight-loss drug called orlistat. What they wouldn't be dancing about are the drug's uncomfortable and potentially embarrassing side effects, which apparently aren't on the FDA's radar. Yet in 2004, the FDA was very willing to ban the weight-loss supplement ephedra from the market, although that product's so-called "adverse events," or side effects, were not nearly as serious as with many pharmaceutical drugs currently available to Americans, nor were these associated adverse events ever proven to be caused by ephedra. Many people now feel that the FDA is biased against the supplement industry and that their cohorts in Congress and the drug lobby are involved in a highly organized conspiracy to take healthy vitamins, minerals and herbs away from the American people. How might they do it? By watering down the 1994 Dietary Supplement Health and Education Act (DSHEA) through a non-causal Adverse Event Reporting (AER) law that would effectively have supplements be treated like synthetic drugs. In this commentary, reprinted with permission from his blog for the Natural and Nutritional Products Industry Center (www.npicenter.com), Attorney Marc Ullman, who has represented supplement industry interests during his career, explains some of the ramifications of non-causal AER implementation and points out the serious double standard in which the FDA treats drugs and supplements-in this case orlistat and ephedra. As I was reading the news coverage in January about the FDA's apparent progress towards approval of the weight-loss drug orlistat (Xenical(r)) for over-the-counter (OTC) sale, I noted the apparent lack of concern over some of the alarming side effects (passing gas with discharge and fecal incontinence to name two) that accompany the use of this product and its apparent lack of efficacy (six pounds weight loss in six months). This was particularly striking in contrast to the FDA's refusal to acknowledge the efficacy of ephedra as a weight-loss aid (12 pounds weight loss in six months) and its willingness to consider almost anything bad that happened to anyone who used ephedra an adverse event. In the context of the current push to require "serious" Adverse Event Reporting (AER) for dietary supplements this obvious double standard must make us ask if we can we really trust the FDA to administer any kind of AER for dietary supplements in a fair manner.

The Approval of Orlistat
On January 23, 2006 a joint meeting of the FDA Nonprescription Drug Advisory Committee and Endocronologic and Metobolic Drugs Advisory Committee resulted in an 11 to 3 vote recommending that the FDA permit the OTC sale of orlistat. The Advisory Committees' action came despite several significant questions concerning both the side effects and the efficacy of orlistat. A list of the potential side effects caused by this drug is in the Physicians' Desk Reference, and their prevalence is somewhat alarming. They include anal leakage (26.6% of patients), flatus (passing gas) with discharge (23.9%), fecal urgency (22.1%), fatty or oily stool (20.0%) and fecal incontinence (7.7%). Significant issues also exist as to whether individuals could understand a label warning directing patients using diabetes medication not to use the product and potential concerns over problems the drug may cause in organ transplant patients and those using the blood thinner warfarin (Coumadin). In addition to concerns relating to these fairly alarming (and apparently prevalent) side effects, the Advisory Committees' vote came despite concerns over orlistat's efficacy. In six-month clinical trials involving orlistat, obese patients lost an average of 5.2 to 6.3 pounds (over six months) more than those patients who were given placebos (lookalike pills). In other words, orlistat was responsible for weight loss of one pound a month! One earlier study showed a progressive weight gain in patients that had discontinued use of the drug. FDA panel members also questioned whether consumers would be able to distinguish orlistat from "nonapproved dietary supplements" sold as weight-loss aids.

A Contrasting Attitude Towards Ephedra
The Advisory Committee recommendation is particularly interesting when compared to the FDA's approach to ephedra, and that supplement's eventual removal from the marketplace in February 2004. In that instance, the FDA seems to have applied an entirely different approach to the handling of adverse events/side effects and its evaluation of effectiveness. From the time it first attempted to restrict the marketing of ephedra in a Federal Register Announcement in June 1997, the FDA sounded the alarm to consumers over the potentially life-threatening side effects and the prevalence of adverse events in ephedra users. For example, the FDA warned consumers that ephedra could cause an increased heart rate and might even raise blood pressure-side effects that the agency argued rendered the supplement potentially dangerous in vulnerable populations. In the 1997 Federal Register Announcement, and in its campaign over the next four years, the FDA also argued that the number of adverse events that the agency believed were associated with the use of ephedra justified severe restrictions on the manner in which the supplement should be marketed or even a total ban on its sale. Notably, among the so-called severe adverse events cited by the FDA some occurred under remarkable circumstances, including:
- A patient who died from a shotgun blast to the chest while using ephedra.
- A patient who died in a car accident while driving the wrong way down a one-way street while using ephedra-and having an incredibly high blood alcohol level.
- A patient who was hallucinating while using ephedra-and lithium and a host of other prescription drugs.
- A 76-year-old woman who reported that her menstrual cycle resumed after using an ephedra supplement (even though some people might consider this to be a miracle, not an adverse event). Perhaps even more remarkable is the FDA's view of ephedra's efficacy in comparison to its approach to that of orlistat. While the agency appears on the verge of allowing orlistat onto the OTC market with evidence that it will cause six pounds of weight loss in six months, in February 2004 the FDA removed ephedra from the market after finding that weight loss of two pounds per month over a similar six-month period (12 pounds total) did not constitute "the long-term weight loss necessary to provide health benefits." Furthermore, the FDA noted, "While the improvements in obesity/overweight and the accompanying risk factors [caused by those conditions] may be achieved in as few as one or two months, the improvements must be maintained for years to achieve a reduction in risk."

What's Next?
The double standard that the FDA so brazenly applies to its treatment of products marketed as OTC drugs by major pharmaceutical companies-compared with products marketed by the dietary supplement industry-should give us all pause and cause us to carefully consider the "relationship" between the supplement industry and the FDA. In particular, I submit that the supplement industry needs to carefully evaluate whether, and under what circumstances, it will be beneficial to pursue a legislative agenda that might provide the FDA with reports of all so-called "serious" adverse events "associated" with dietary supplements. While the passage of some sort of AER legislation may be inevitable, and in some ways necessary to at least slow the onslaught of negative media accusing the supplement industry of being unregulated and irresponsible, the implementation of a non-causal AER reporting system must be approached with caution. Remember, this is the same agency that is willing to accept side effects in an OTC drug as alarming as anal leakage and incontinence in large numbers of patients when the drug can contribute only six pounds of weight loss in six months, while removing ephedra from the marketplace because of shotgun blasts to the chest and "insignificant" weight loss of 12 pounds in six months. In 2001, Harris Interactive reported that 177 million Americans use dietary supplements. If only 0.0005 (1/2 of 1/10 of 1%) of those people submitted an AER to the FDA, there would be 88,500 such reports filed. Yet these non-causal adverse events would have normally occurred with or without supplement usage. Can we really trust the FDA to do the right thing or do we need to ensure that any reporting system put into place did not allow this agency free reign to utilize a number like that to justify yet another assault on the supplement industry?

Additional Articles