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The FDA’s Independent Advisory Panels: Ignoring Clear Dangers

In February of 2005, 32 pharmaceutical experts convened to discuss the recent problems that had been surfacing amongst patients who had been using Celebrex, Vioxx, and Bextra. These three drugs were the new “super-aspirins” that had been developed by Pfizer and Merck, with the purpose of providing pain relief to arthritis sufferers without the side effect of an upset stomach. While these new drugs certainly did their jobs by not causing upset stomachs, the trade off was an unequal increase in strokes and heart attacks among its users.

The advisory board came to the conclusion that taking these drugs off the market was an unnecessary overreaction. This panel determined that the best possible solution would be to simply put more warnings on the label. Considering that they had been linked to approximately 27,000 strokes and heart attacks by the FDA itself, this decision seemed utterly ridiculous. But if you look at who was actually on this independent panel, the motives behind this decision seem crystal clear.

Of the 32 experts on the advisory panel, ten of them had direct financial ties to Merck, Pfizer, or Novartis, which had its own version of a NSAID in development. Ten of these panelists were either receiving development grants or were receiving consulting fees from the very companies that were having their product called into question. Seventeen other panelists, while not receiving money from Merck, Pfizer or Novartis, were in fact receiving money from other pharmaceutical companies. It’s anyone’s guess as to how a fair and impartial decision can be made this way.

The past few years have seen a dramatic rise in incidents with dangerous prescription pills. Vioxx and other similar NSAID’s were on the market for years, even though the links between these drugs and heart failure were obvious. The Ortho-Evra birth control patch was heavily marketed and made easily available, despite clear evidence that its use caused dangerous defensive blood clotting in healthy women. Recently, an antibiotic called Tequin has been linked to fatal episodes of dysglycemia in patients. Even with these well-documented occurrences, the FDA only takes action after years of deliberation, even if lives are quite literally on the line. How does this happen? Why is it that drugs have such an easy time getting on the market when any other potentially harmful products are regulated with such vigilance? How are advisory committees that are entrusted with the health and safety of millions of Americans staffed with pharmaceutical company employees?

Put simply, the pharmaceutical industry has an enormous wallet. It’s big enough to be able to afford over $800 million in lobbying costs and campaign donations over the past seven years, and these efforts have resulted in everything from the striking down of price controls to the ability of independent companies to lobby the FDA itself. With the constant easing of restrictions and regulations for the pharmaceutical companies, its no surprise that advisory committees can be stacked with impartial observers, even if doing so is against federal regulations. According to the Federal Advisory Committee Act, any independent committee that advises Federal regulatory agencies must be completely made up of people with no conflicting interests. This is an obvious standard for any government to have. Judges and lawyers have to remove themselves from cases where they have interests. Senators and Congressman have to place their assets in a blind trust to avoid impartial decisions. Jurors have been removed and even prosecuted for not disclosing an interest in cases on which they are appointed to serve. And even consumer goods that are much simpler than consumer drugs have to go through stringent testing and guidelines in order to be made available for use. Yet getting the Food and Drug Administration to act on dangerous prescription drugs is left up to advisory panels that are not only improperly staffed, but are directly contrary to federal law. If you are interested in reminding your Senators of this fact, you may contact them by following this link.

The Law Firm of Breit Drescher and Imprevento have proudly represented the rights of injured Virginians for years. Part of that fight is being proactive in helping to fix flaws in a system that directly causes injury. We believe that the current system in place at the Food and Drug Administration is unethical, dangerous to the public, and directly contrary to both the letter and spirit of their stated goals. We urge you to contact your elected officials about this state of affairs as soon as possible. And if you or a loved one has suffered a debilitating injury due to the use of a dangerous pharmaceutical drug, contact our offices for a free legal consultation today.

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