If the government protects itself and drug companies, who protects us?

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.