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More Shady Dealings in the FDA
By Dr. Joseph Mercola
The FDA has decided to back down from a recent planthat would have required long-term studies of new psychiatric drugs before allowing them on the market.
The reversal came after a panel of experts unanimously recommended against requiring such studies. The panel's vote came in the wake of complaints from industry executives, academic researchers, and patient advocates.
Studies of Eight Weeks or Less
The new plan would have called for companies to conduct studies for as long as six months before seeking approval. Currently, psychiatric drugs are generally approved after only two short-term studies, which may last only eight weeks. This is the case for many forms of medication.
Physicians, however, usually prescribe psychiatric drugs for much longer periods. Regulators in the European Union and other countries require longer-term data.
Life-Saving Information Suppressed
Meanwhile, The Independent, a British newspaper, reports that vital information about prescription medications has been suppressed by the FDA. Even if the information can save lives, the FDA, under pressure from the pharmaceutical industry, routinely conceals information that could affect the commercial value of the drugs, rendering physicians unable to assess the real risks.
Where to Go for News?
Mike Adams, NewsTarget's Health Ranger, in his editorial on this information, discusses the many problems with the FDA, and also the disturbing implications of the fact that this report did not appear in a domestic media outlet. It is, he points out, difficult to find an outlet, other than sites such as Mercola.com or NewsTarget itself, that accept no advertising from drug companies. The inevitable result is that news that is not acceptable to the advertisers is soft-pedaled or ignored, lest they pull funding.
Washington Post October 26, 2005NewsTarget.com October 14, 2005
Dr. Mercola's Comment:
Once again, the FDA reveals that it is only beholden to its true constituents -- drug company executives.
However, you might have been surprised to note that the safety testing wasn't just protested by industry executives, but also by academic researchers and patient advocates. Why would this be? Why would patient advocates argue in favor of only eight-week trials on drugs that patients may take for months or years?
It might be interesting to find out who those 'patient advocates' actually were. The FDA has a long history of using 'experts' who are little more than industry shills.
Federal law prevents the FDA from hiring experts with any potential conflicts of interest. However, between 1998 and 2000, the FDA waived this restriction more than 800 times. It has been estimated that over half of all the members of their advisory panels have financial ties to the pharmaceutical companies that stand to gain or lose from their decision.
The New York Times investigated possible conflicts of interest in the controversial 2005 panel that allowed the deadly COX-2 painkillers to remain on the market (Vioxx, Celebrex, Bextra). They found that one-third of the panel had ties to the very drug company they were seeking to regulate. If the votes of these individuals were removed, then the COX-2 inhibitors would not have been allowed to return to the market. The FDA has yet to overturn their decision.
FDA senior associate commissioner Linda Suydam, who is responsible for waiving conflict of interest restrictions, states that often the best experts to hire are the same experts that consult the industry. Unfortunately, this does not explain how "consumer representatives" on advisory panels often also have financial ties to the industry.
When it comes to consumer protection, the FDA is no great savior. When it comes to protecting the interests of businesses, however, the FDA will cheat, lie, ignore its own guidelines, and do whatever it takes to get the job done.
News like this merely reinforces just how broken this conventional health care model truly is, and why more people are taking better responsibility for their health by seeking alternative methods that treat their conditions more safely.
If for some reason this statement surprises you, I encourage you to review the interview with one of my heroes, Dr. David Graham, an FDA insider who helped expose the Vioxx scandal to Congress. He reveals many of the secrets going on in the FDA in this amazing interview.
About the Author
This article is reprinted from Mercola.com, the world's #1 most visited and trusted natural/alternative health website. For a limited time only, you can take the FREE "Metabolic Type Test" to help you learn the right foods for your particular body type so you can achieve optimal fitness & health. Just go to http://www.mercola.com/forms/mt_test.htm right now to take this quick test!
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