Symposium

0 Comments | Insight on the News, August 12, 2002 | by Kathleen B. Deoul, | Bruce Silverglade

Q: is the Food and Drug Administration overregulating the dietary-supplement industry?

YES: The agency's bureaucracy protects `Big Pharma,' while tightening its grip on vitamin vendors.

The Food and Drug Administration (FDA) exemplifies how Washington bureaucrats can corrupt an otherwise reasonable idea in the blind pursuit of power and influence. Established to protect public health, the FDA sometimes threatens it--largely because the agency has entered into an unholy alliance with the pharmaceutical industry it is supposed to regulate.

As a result, the FDA has allowed lethal medicines to reach the American public, costing thousands of lives. At the same time, the agency has acted to block safer alternatives because they threatened "Big Pharma's" stranglehold on health care.

A May article in the Journal of the American Medical Association (JAMA) illustrated the problem. It described a study reviewing the history of all drugs approved by the FDA between 1978 and 1999. It found that 10.2 percent of the drugs approved subsequently were found to have lethal side effects or were withdrawn from the market for being unsafe. When the researchers restricted their analysis to the most recent drug approvals reviewed in their study, the figure increased to 20 percent. This means that there now is a one-in-five chance that a drug approved by the FDA will be found to be lethal!

Nine of the drugs withdrawn from the market after FDA approval were linked to at least 755 deaths and thousands of severe injuries. And that's just the tip of the iceberg. Take the case of the diet drug Redux, for example. While 123 deaths have been reported, its manufacturer, American Home Products, has set aside $9.5 billion in a contingency fund to pay future claims. Clearly, the company believes that a lot more than 123 people were hurt.

An article in the July 26 issue of JAMA tells the tale. It estimated that properly administered prescription drugs cause at least 100,000 fatalities each year. Another 2.2 million patients suffer adverse reactions to these products and require hospitalization.

How can this happen under the FDA's allegedly strict review process? One answer may be material conflicts of interest within the agency and among its reviewers.

For a drug to be approved it first must pass muster before an FDA advisory committee. These committees are supposed to bring together unbiased experts who review the clinical-trial data on a drug's safety and efficacy. The committee then votes on whether to recommend approval. In practical terms, approval by an advisory committee is tantamount to approval by the agency. Therefore, the committee's role as an "honest broker" is essential to maintaining the integrity of the drug-approval system.

The integrity of the advisory-committee system itself, however, is in question. A review of the official records of the 159 FDA advisory-committee meetings held between Jan. 1, 1998, and June 30, 2000, was conducted by USA Today. The results, published Sept. 25, 2000, revealed a startling fact: In 55 percent of the meetings that took place during this period, at least one-half of the participants had financial conflicts of interest. The types of conflicts included serving as a paid consultant for the company whose drug was under review, owning stock in the company or receiving research subsidies from the company. An astounding 92 percent of the meetings had at least one participant with a financial conflict.

How could this occur? Simple. FDA bureaucrats issued 803 conflict-of-interest waivers during the period reviewed. When asked by congressional investigators why the agency issued so many waivers, the FDA bureaucrats demurred, saying it was the nature of medical research that such conflicts would exist. If they wanted the best people on the committee, they had to issue the waivers.

Yet, there are more than 770,000 licensed physicians in the United States. It defies belief that the FDA could not find 20 (roughly the size of an advisory committee) who did not have financial conflicts of interest related to each drug under review. It also defies belief that such conflicts would not influence reviewers' decisions--both in terms of unwarranted approvals and denied applications from potential competitors.

But there are other financial conflicts of interest plaguing the agency. Since 1992 the FDA has charged a fee to the pharmaceutical companies for new drag-approval applications in order to hire additional FDA staff. On the surface, it seems like a good idea: Drug approvals are faster and the industry foots the bill. Increasingly, however, the user-fee program is becoming the tail that wags the dog.

In its most recent budget request the FDA calls for user fees to increase to $295 million. This equals roughly 17.1 percent of the agency's total budget. The fees would add 500 industry-funded positions, bringing the total number of FDA employees funded by the pharmaceutical industry to 1,530--roughly one in seven. More important, with the new positions, 55 percent of all drag reviewers would be paid by the pharmaceutical industry. This amounts to putting the fox in charge of the chicken coop!