Sunday, July 23, 2006

POLITICS BEFORE HEALTH AT THE FDA

A survey recently published by the Union of Concerned Scientists should disturb every American:

“FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns”

http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html

The survey, which intended “to examine inappropriate interference with science at federal agencies” was sent to 5,918 FDA scientists, and received 997 responses:

“18.4% of the respondents said that they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."”

“61% of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."”

“Only 47% think the "FDA routinely provides complete and accurate information to the public."”

“81% agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."”

I am aware many conservatives have issues with the Union of Concerned Scientists. Nevertheless, I think it unwise to shoot at the messenger this time – the message is too important. If you study the many cases in which the welfare of the public has been compromised in environmental, public health, or public safety issues, you will find a common thread:

Government action necessary to protect the people’s interests was corrupted by political pressure from special interest groups whose agendas were allowed to trump science.

The pressure can come from anywhere - environmental groups, industry lobbyists, religious groups, or competing government bureaucracies. The resulting action - or inaction - typically rolls over patiently garnered evidence to side with profits, prejudices, or unprovable beliefs.

The direct results can include monies unnecessarily spent, activities unnecessarily curtailed, or prejudices unreasonably reinforced. The practical result is usually a lot of unnecessary human suffering.

In the case of the FDA, the effects are especially poignant: The FDA has approved drugs like Vioxx, later found to be dangerous - just as the suppressed evidence indicated. The FDA has refused to accept overwhelming evidence of the efficacy of drugs like marijuana as an adjunct in the treatment of cancer and AIDS, siding instead with fools who are still confusing “Reefer Madness” with science.

Perhaps the worst example is the political back & forth we have seen over the approval of RU 486. Stalled for years by political pressure from pro-life groups who want to stop all abortions, it was then promoted by the Clinton Administration, which was equally partisan in ignoring safety issues. The ink was barely dry on the relatively liberal September 2000 approval when the GWB administration took over and pressure began to reverse it. The pro-life lobby applied this pressure using the language of the protectionist: Anti RU-486 partisans proposed, in cleverly ambiguous terms, that to be “safe enough” this drug had to have a 100% record of success - something no drug or procedure has ever had - and argued that since it lacked that 100% complication free record it should therefore only be administered by practitioners prepared to cope with the rarest and most extreme of complications, an insistence which would effectively prevent many clinics and physicians from prescribing it at all.

So the argument seesawed between ignoring the complications and obsessing on them - two positions that were equally invalid. Meanwhile uncertainty about the final resolution has retarded the development of a properly expert medical community equipped to use this tool, which is at least as safe as and cheaper than surgical alternatives commonly used…

It shouldn’t matter which side you take on the “rightness” of such a drug. What should matter is the private right of the informed individual who seeks the treatment, and the ability of physicians to manage the treatment and its potential downsides within the context of the alternatives.

Like most bureaucracies, the FDA has a mission statement:

“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”


When the FDA lets political bickering and social agendas interfere with those goals, it fails in its mission, and fails the public.

That should concern all of us – not just the scientists.

Comments:
You have the mission statement incorrect. It really is "What can we approve next?" Safety has NOTHING to do with it.
 
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