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Mar 1, 2005 *This email alert is being re-sent to include new information.*

When the FDA announced it would hold hearings regarding the safety of COX-2 inhibitors, the hope was that the agency would finally shed its image as guardian of the pharmaceutical industry. If ever there was a perfect opportunity for the FDA to reverse years of accusations and innuendoes concerning its questionable record in protecting the public; this was it. In the past few years, the FDA had been besieged with a number of charges by medical experts, scientists, public watchdog organizations, members of Congress, and even well-respected members of its own research staff that strongly suggested a problematic relationship between the FDA and the very industry it was supposed to be monitoring. These included:

• Allegedly premature FDA approval of several drugs which had to be withdrawn from the market due to extremely dangerous side effects that injured or killed thousands of people. (Is the “fast track” process a failure?)1

• Inadequate policing of highly misleading, inaccurate, and incomplete Direct to Consumer Advertising (DTCA – See Parker & Waichman Newsletter for February 2005).

• Improper “pressure” being brought to bear on key FDA employees to withhold or “soften” unfavorable opinions with respect to drugs under consideration for approval.

• Pharmaceutical companies withholding negative research data and privately funded studies from the FDA both before and after approval.

• FDA “pressure” on drug regulators in other countries to issue warnings rather than recalls for certain blockbuster drugs.

• Repeated FDA failures2 or reluctance3 to issue “black box” warnings even after adverse reaction reports or previous research studies demonstrate the existence of a drug’s potentially dangerous side effects.

Now, with Merck’s unprecedented massive voluntary withdrawal of Vioxx, the revelation of previously unreported adverse study results, a highly respected (FDA employee) “whistleblower” and other well respected scientists poised to offer damaging testimony, the entire class of COX-2 inhibitors appeared to have “one foot in the grave and the other one on a banana peel.” When the testimony was in and the votes counted, however, Celebrex, Bextra, and yes, even Vioxx, rose from the ashes, like the Phoenix of myth and legend, to fly again with the renewed approval of the FDA.

How and why did this happen? We offer the following for our readers’ consideration.

First: What better way to make it appear as if you’re doing something than to appear to be doing it? Sound confusing? Well, think about this. As a result of a series of events (unfortunate or otherwise), the FDA was put on the defensive. Unless something was done (like hold hearings with respect to the safety of COX-2 inhibitors), the FDA’s critics would have even more reason to believe that the agency’s loyalty was really to the pharmaceutical industry and not the public.

If the FDA held hearings, allowed a “whistleblower” like Dr. David Graham to testify, and reviewed all of the allegedly negative data before voting it could claim it did everything possible (albeit belatedly) to make sure the public was protected. However, since the medical evidence now pointed to the conclusion that all COX-2 inhibitors posed a significantly elevated risk of cardiovascular problems, an adverse finding would mean that all of the drugs would be pulled off the market in the United States. This would certainly cause a financial disaster for Merck (Vioxx), Pfizer (Celebrex and Bextra), and Novartis (Prexige).4

An unfavorable finding would also give the injured plaintiffs in the pending and prospective litigation against Merck and Pfizer a significant advantage since they would now be able to point to Merck’s withdrawal of Vioxx and an FDA ban on all COX-2 inhibitors as proof positive that the drugs were, and had always been, too dangerous to be on the market.

The only way the FDA could make it appear as if it was looking out for the public’s wellbeing while still protecting the drug companies from a major financial catastrophe would be to make certain that the vote would not go against any of the drugs no matter what the evidence showed. Of the thirty-two government drug advisers who would vote on the issue, ten had consulted for Merck or Pfizer in recent years.

When the votes were tallied, the results were shocking to many but quite predictable if the FDA’s questionable track record in protecting the public was taken into consideration. The committee voted unanimously that all of the drugs significantly increased the risk of heart attack and stroke.

Despite this finding, which could not have been otherwise, Vioxx, a drug pulled from the market by its own manufacturer (Merck) only last September, rose from the ashes on the wings of a 17-15 vote. (Without 9 of the 10 “questionable” votes going in favor of the drug, however, the committee would have voted 14-8 to ban Vioxx). Bextra, a drug which, like Vioxx, has serious legal problems, survived by a margin of 17-13-2 (abstentions). (That vote would have been 12-8 against Bextra without 9 favorable votes from the 10 advisers in question). Celebrex survived by a 31-1 margin (even though the evidence against it was equally compelling). (The vote still would have been an amazing 21-1 in favor of Celebrex without the 10 “interested” voters). The panel did recommend all COX-2 inhibitors carry “black box” warnings. Serious? Yes. Fatal? No.

Needless to say, the vote was met with shock and outrage by activists, medical experts, and researchers alike. Several highly reputable news agencies like CBS News, The New York Times, and Forbes, for example, also questioned whether the panel had been “stacked” in favor of the pharmaceutical companies with advisers who had significant “conflicts of interest.”

Despite the fact that every news outlet had been forecasting the end of the COX-2 era in its reports up to February 19, everything changed on February 20. Now, the very same journalists were actually writing articles about the possible “comeback” of Vioxx, Merck’s salvation with respect to the litigation against it, how Celebrex could recover its “luster,” and how the FDA vote immediately translated into stock increases of 6% for Pfizer and 12% for Merck.

The FDA and its safety procedures have been criticized variously by investigative reporters, activists, FDA employees, and medical experts as follows:

• “FDA Drug Oversight Fails Patients” (AP 5/23/01)

• “FDA Failing in Drug Safety, Official Asserts” (The New York Times, 11/19/04)

• “Are Too Many Unproven Drugs Receiving FDA Early Approval?” (The Wall Street Journal, 3/1/05)

• “A Rudderless, Leaderless FDA” (Los Angeles Times, 1/18/05)

• A broken agency that needs to be “fixed” (Forbes, 1/13/05)

• “Study Faults Drug Approval Mechanism” (Yahoo! News, 5/7/02)

Notwithstanding the fact that the FDA has been portrayed as a “failure” when it comes to protecting the public, we believe that such an analysis is far too simplistic. In its 68 years of existence, the FDA has always been embroiled in the ongoing conflict between consumer safety and corporate profits.5 Being able to influence the drug approval process is the industry’s goal and it has limitless funds with which to accomplish that objective. The reason for this is that the FDA has the potential to: (1) affect billions of dollars in pharmaceutical industry profits; (2) cause significant stock market fluctuations; (3) have an impact on pending and prospective litigation; and (4) make determinations which could actually cause a drug company to go out of business.

Unfortunately, on the other side of this “tug of war” is the noble ideal of protecting the public. Activists, “whistleblowers,” professors, and other crusaders, however, cannot even begin to match the financial and political clout possessed by the pharmaceutical industry as a whole or individual corporate giants like Merck, Pfizer, and GlaxoSmithKline. In fact, the pharmaceutical lobby is the largest in the country. Thus, when it comes to buying “access” and influencing politicians, there is no contest.

So, instead of a group of bumbling incompetents that one might picture when the word “failure” is used, the FDA is quite the opposite. It may have failed to protect the public but, the high level politics and behind-the-scenes influence involved in orchestrating that “failure,” has been nothing short of brilliant. It’s just too bad that the thousands of innocent victims of the COX-2 debacle will never be able to appreciate the astonishing way in which this modern-day Phoenix was able to rise from the ashes.
1 Apparently, disasters with other hastily approved drugs like Rezulin, Baycol, Vioxx, Raplon, Duract, Posicor, and Fen-Phen failed to make an impression on the FDA. Even when prominent experts repeatedly question a drug’s safety before it is approved, the FDA takes a “damn the torpedoes, full speed ahead” approach. Just this past week, the MS drug Tysabri was pulled from the market when two patients contracted a fatal brain disease (one of the patients died). Tysabri, another “fast-track” approval, managed to stay on the market only four months. The shame of this newest (fatal) failure is that a renowned expert in MS and neurobiology repeatedly had warned for years of the potential for serious immune-system side effects with this type of drug. The New England Journal of Medicine also published an editorial to the same effect almost two years before the drug was approved. Even though testing was incomplete and limited to small groups of subjects, an FDA spokesperson still claimed that Tysabri “was a product that absolutely fit the criteria for accelerated approval.” Really?

In addition, the entire “fast-track” process has been questioned by a number of experts who maintain that the safety of “new agents” cannot be known unless and until a drug has been on the market for several years. Public Citizen now strongly recommends that you do not take a drug until it has been successfully marketed for a full seven years.

2 The FDA now claims in Senate hearings, that in the case of Vioxx, the agency was guilty of “lapses” with respect to the more than one year delay in getting the heart risk warning onto the prescribing label provided to doctors and in failing to make certain that this critical information was “in the forefront of the consciousness of the prescribing physician.” Nonetheless, Vioxx survived the FDA vote which would have written its obituary.

3 .Although the safety of the cholesterol drug Crestor has been seriously questioned with respect to potential kidney failure and muscle damage risks, the FDA has repeatedly defended the drug and limited its “warning” to merely telling physicians to be more judicious in prescribing the drug. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group called this decision “another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs.”

4 To be sure, when a major drug is found to be dangerous and is pulled from the market, the financial impact on the company involved is quite serious. “Disaster” is not too strong a word. When Vioxx was withdrawn, Merck suffered an immediate stock value loss of some $27 billion. When Biogen Idec and Elan Corp. withdrew the new multiple sclerosis drug Tysabri from the market on February 28, the combined market value loss to both companies was about $17 billion. Interestingly, in the days and even hours before the bottom fell out of Biogen Idec’s stock value, company insiders sold $15 million in stock at near record prices. The stock options that produced millions of dollars in profits for there “insiders” would have been worthless once the Tysabri recall was announced. The company is defending the sales as proper. The SEC has not disclosed if it intends to investigate the matter.

5 In 1927, Congress created the Food, Drug and Insecticide Administration. It was renamed the Food & Drug Administration (FDA) in 1937. In 1933, President Roosevelt drafted legislation to strengthen the FDA and protect the public from unsafe, ineffective drugs. However, drug industry lobbyists kept the legislation trapped in committee for 5 years. Eventually, the bill was “gutted” it of its efficacy requirements. A major disaster and a public outcry to bring about reform came in 1937, when "Elixir of Sulfanilamide," containing a sulfa "wonder drug" mixed with a solvent closely akin to radiator antifreeze, caused 108 deaths; most of them children. This prompted new legal requirements that safety be proven before new drugs could be marketed. The comprehensive Food, Drug and Cosmetic Act of 1938 remains the basic law governing the FDA. Drugs marketed before 1938, however, were permitted to remain on the market without proof of safety.
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