PHARMA BITES THE HAND IT FEEDS
"People" wonder why so many of us do not trust the safety of vaccines or the integrity of the agencies that approve, oversee and administer them. Check out this circuitous debacle. The NYT reported yesterday (HERE) that J&J is claiming it can not be sued for problems with one of its birth control products because the FDA, a federal agency, approved the drug. And it appears that they might win.
Next, Reader's Digest has a scathing report (HERE) about the state of the FDA, saying that the agency is a shambles and that it receives upward of 50% of its funding from "industry."
From the J&J story: For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.
But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.
From the Reader's Digest Online Story: There's pressure to speed decisions, and there's pressure to soft-pedal problems. That means drugs may go on the market without adequate vetting -- or follow-up. Critics of the FDA like to say it's the best agency the pharmaceutical industry can buy. That's a political jab, and agency advocates say it's unfair. "The extraordinary efforts of these committed staff members are the very reason further catastrophic food-and-drug events have been averted," an otherwise scathing review by the FDA's Science Board concluded last November.
But most agree that there's at least a problem of perception, and perhaps more than that, caused by the growing chunk of the agency's budget that comes directly from drug companies. Industry dollars now pay for more than half of the FDA's drug-review budget; in five years, that proportion is expected to jump to 70 percent.