Laraness (![[info]](http://l-stat.livejournal.com/img/userinfo.gif){kind=small} laraness) wrote,@ 2008-04-08 18:30:00 |
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The FDA's Miraculous Cure-All Elixir
Thanks to Dr. Paul Uster, who delivered an excellent speech on ethics in the pharmaceutical industry, I know that the nation has come a long way from cocaine and alcohol-containing syrups and guarantees on magical snake-skin concoctions. Nonetheless, the current-day FDA has quite a stretch before it can consider itself ethically sound.
Specifically, I'm writing in response to the recent Bush Administration push to consider all drug-related legal cases "pre-emptive," and shove the FDA to acrophobia-inducing heights, beyond the reach of the Justice system.
Read about it:
NY Times "Drug Makers Near Old Goal: A Legal Shield" April 6, 2008
This situation raises two questions:
1) Has the FDA demonstrated that it is capable of restraint from industrial influences and is devoted to scientific integrity?
Though my impulse is to say, "I would not trust them with my life," the truth is I already have. However, I would not give them any more leeway than granted under the threat of legal responsibility - a process already too blind and inefficient for my taste. My thoughts on the subject are informed by the even brief acceptance of DES; industry-driven conclusions about Bisphenol-A's risks; unfounded approval delays for Plan B birth control; and a slew of concealed side-effects of drugs such as the birth control patch, Zyprexa, Depakote, Vioxx, and Ambien (just to name a few).
2) Is the Justice Department scientifically and ethically informed enough to judge the FDA?
Though this is a question the administration and pharmaceutical companies put forth, I do not really believe it matters. There is not an individual, company, or department considered too specialized to fall within the legal system - what on earth makes the FDA an exception? The whole point of suits presented on a case-by-case basis is that prosecution and defense can equally inform the judges on the relevant scientific facts at hand. And certainly ethics is the constant rumination of every judge. Sure, it's costly and laborious, but it is often the only route by which corruption in profit-hungry pharmaceutical companies and the power-hungry FDA is exposed.
Do we really want to pull another blanket over our heads? I'm certainly not comfortable with the prospects of paying to die when the classic "cure is worse than the disease" scenarios are common enough. Oh, but would it not be ironic for the Supreme Court to rule on its own ineptitude? Then I really won't know which department is more dysfunctional...
Thanks to Dr. Paul Uster, who delivered an excellent speech on ethics in the pharmaceutical industry, I know that the nation has come a long way from cocaine and alcohol-containing syrups and guarantees on magical snake-skin concoctions. Nonetheless, the current-day FDA has quite a stretch before it can consider itself ethically sound.
Specifically, I'm writing in response to the recent Bush Administration push to consider all drug-related legal cases "pre-emptive," and shove the FDA to acrophobia-inducing heights, beyond the reach of the Justice system.
Read about it:
NY Times "Drug Makers Near Old Goal: A Legal Shield" April 6, 2008
This situation raises two questions:
1) Has the FDA demonstrated that it is capable of restraint from industrial influences and is devoted to scientific integrity?
Though my impulse is to say, "I would not trust them with my life," the truth is I already have. However, I would not give them any more leeway than granted under the threat of legal responsibility - a process already too blind and inefficient for my taste. My thoughts on the subject are informed by the even brief acceptance of DES; industry-driven conclusions about Bisphenol-A's risks; unfounded approval delays for Plan B birth control; and a slew of concealed side-effects of drugs such as the birth control patch, Zyprexa, Depakote, Vioxx, and Ambien (just to name a few).
2) Is the Justice Department scientifically and ethically informed enough to judge the FDA?
Though this is a question the administration and pharmaceutical companies put forth, I do not really believe it matters. There is not an individual, company, or department considered too specialized to fall within the legal system - what on earth makes the FDA an exception? The whole point of suits presented on a case-by-case basis is that prosecution and defense can equally inform the judges on the relevant scientific facts at hand. And certainly ethics is the constant rumination of every judge. Sure, it's costly and laborious, but it is often the only route by which corruption in profit-hungry pharmaceutical companies and the power-hungry FDA is exposed.
Do we really want to pull another blanket over our heads? I'm certainly not comfortable with the prospects of paying to die when the classic "cure is worse than the disease" scenarios are common enough. Oh, but would it not be ironic for the Supreme Court to rule on its own ineptitude? Then I really won't know which department is more dysfunctional...
