Drug companies claim they are above the law
Every time I pick up a paper or log on to my computer these days, I hear about yet another drug company getting creative with its research and offering up massaged data when it's time to get drug approval from the FDA. And it gets me madder and madder every time. The latest culprit is Johnson & Johnson, currently under scrutiny due to its Ortho Evra patch, heavily marketed as lower in estrogen than more commonly used birth control pills.
This might affect you more directly than you think. You may have a loved one, whether a friend, child or grandchild, who used or is using "the patch," as it has been commonly known. But, just as importantly, J&J lawyers are trying to stem a flood of litigation by advancing a legal argument that would protect the drug companies from any lawsuits filed by the people who were victims of their rearrangement of the facts.
Lawsuits have been rolling in (3,000 so far) against J&J to recompense women (and their families) who suffered from heart attacks, strokes—and , in some cases, death, from using this estrogen-loaded product. You see, according to J&J's own research documents, the patch actually delivered higher levels of estrogen than the pill versions. But they quickly did some fancy finger-work on their calculations and cut their original estrogen-level findings by 40 percent, calling it a "correction factor." Creative math is what that is.
When the FDA caught up to them—thanks to those real-world examples that don't have the privilege of correction factors, they had J&J change their labeling, and the number of prescriptions dropped 80 percent almost overnight.
My first concern is whether the other 20 percent know the truth about the drug their still taking. After that, I worry that if drug company attorneys have their way, we could all lose our right to be compensated for their criminal behavior.
Let me back up for a second. I know lately I probably sound like an ambulance chaser. Nothing could be further from the truth. I'm not in favor of litigation as a rule. But when companies blatantly lie and knowingly risk the very lives of the people their ad campaigns promise to cure, the only way to make them pay is to make them pay.
But drug-company attorneys are relying on an argument called "pre-emption," which claims the FDA is the only agency capable of monitoring and evaluating the drug companies, and that courts have no business questioning their ability. That's right – these same companies that publish false data are now looking for a permanent "get out of jail free" card that would deny their victims their day in court.
And their whole argument relies on the monitoring ability of the FDA, which admits that it's under-funded and stretched thin. Not to mention, they're essentially on the payrolls of the same companies they're supposed to police. Don't forget—the majority of their budget depends on collecting fees from drug companies.
Just as I urged you in March, I ask you again: write or call your congressman and apply the heat. Our window of opportunity to have legal recourse against corrupt companies is fast closing. Go to www.congress.gov to find out how to contact your representatives directly.
