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FDA: Big Pharma Ties Threaten Objectivity

How does Big Pharma exert so much pressure, as it seemingly does, on the FDA to push for approvals of new and toxic drugs before all the groundwork needed to ensure their safety is done? The New York Times, one of my favorite newspapers, published a great story today about some of the history behind the "shotgun marriage" between the FDA and Big Pharma -- an idea supported in 1992 by Congress and the White House -- that left both entities horribly comprised today.

After that ill-fated union more than a decade ago, the FDA changed gears, slashing its laboratories and network of independent drug-safety experts in favor of hiring more people to approve experimental drugs. That forced the FDA to become far too needy of drug-company money, which, according to the Times, is why it took so long for the Feds to uncover the toxicity of Vioxx.

More than a decade ago, Big Pharma agreed to give the FDA many millions that these days amount to "chump change" based on new drug sales -- $200 million -- only if the agency spent a specified level of money on new drug approvals.

In my opinion, here's the key factoid to remember: Since 1992, the FDA's drug center has cut everything else, but those new drug reviews. In 1992, the FDA spent 53 PERCENT of its budget on new drug reviews. The remainder went to ensure existing drugs on the market were safe. Last year, an astounding 79 PERCENT of that funding was devoted to new drug reviews.

In the early 90s, the FDA had more independence to investigate on-market drugs for potential problems. Now, it relies almost entirely on the willingness of drug makers to report problems that crop up after bringing new drugs to market. This dependency has put the clamps on the FDA confronting Big Pharma, leaving patients vulnerable, which is why I remain so committed to my vision to replace the existing drug-based/quick fix mindset for one that promotes lasting optimal health.

New York Times December 6, 2004

Seattle Post-Intelligencer December 6, 2004

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