The New York Times published an interesting article yesterday about the continuing story of the Bush Administration trying to protect drug companies from lawsuits being brought against them for drugs that were approved by the FDA.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
But, what happens when the company isn’t being honest? If the FDA doesn’t have the information, or doesn’t do its job investigating the information, where does that leave people?
In the case of Ortho Evra (the birth control patch), that question is very much up in the air. When making the results public, Johnson and Johnson applied a “correction factor� to the results of a test showing the higher levels of estrogen in the patch. An attorney for the company explains:
“The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction,� Bob Tucker, a lawyer representing Johnson & Johnson, said in an interview Thursday. “Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.�
Uh, thanks for clearing that up. The patch was then released and advertised with the incorrect information. And since technically the FDA had access to this information (rather hidden in the report), Johnson and Johnson claims they did what they’re supposed to. Only after women started getting sick and dying, did the FDA start to pay attention. And a subsequent study revealed that Ortho Evra can give twice the risk of blood clots as birth control pills.
But, if the Bush administration and the drug companies get their way, consumers won’t be able to sue in cases like this. That’s just ridiculous. Cases against Johnson and Johnson are pending, waiting to see if they can move forward at all. In the meantime, we're all stuck hoping the greedy drug manufacturers and the overworked FDA don't kill us.
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Welcome to Michigan- this sorry state of affairs has been the status quo here for some time now. The status of personal injury and medical malpractice law is so anti-plaintiff that even insurance defense attorneys have essentially litigated themselves into the unemployment line! I love my home, but MI has become the "F-U State, legally speaking....
I think there should be more transparency of reports and data leading up to and after drugs going on the market. The more eyes on it (especially eyes that aren't funded by pharma or government) the better. There should be penalties for delaying publication of research which suggests probable adverse drug reactions. See Paxil controversy
The research side of hte pharma industry should be nationalized. All research should be conducted by trials designed by the NIH by 3rd parties with no financial connection to big pharma.
Here's how it works:
1) Pharma company wishes to pursue drug approval for X.
2) NIH comes up with clinical trial testing protocol. Law states that the candidate drug must be tested against both placebo AND OTHER MARKET-LEADING DRUGS OF THE SAME CLASS.
3) NIH comes up with a cost estimate for the new drug trial and the pharma company hands over that money to the NIH
4) NIH starts the research studies using multicenter locations spread around the country. Mandatory parameters include testing across both genders and the 4 major racial lines in this country: latino, asian, white, black.
5) The results of these trials are posted online in a public database for everyone to peruse over, and later published in one of the leading medical journals.
6) If the results are favorable above a certain threshold from placebo, then the NIH notifies the FDA, which allows big pharma to seek patent protection and begin widescale production and distribution of their drug.
This preemption doctrine is sickeningly clever for drug companies and anti-regulation zealots. If the victim of a defective drug wants any sort of financial justice, they have no choice but to sue the FDA. Then, the FDA is even more overburdened with costly lawsuits and has even less time to police the drug industry, leading to more defective drugs. As an added bonus, the anti-regulation crazies can use the lawsuits as proof that government programs don't work and then cut funding.
Again, sickeningly clever.