http://www.nytimes.com/2008/04/06/washington/06patch.html?_r=1&oref=slogin I'm decidedly torn. On the one hand, given the bullshit that drug companies have to go through from the FDA, they should have some immunity. But since the FDA isn't itself liable for poor certifications (they don't even have a reputation to worry about, since they're a government monopoly), this legal shield is only going to mean that there's no responsibility anywhere in the chain, so victims of fraud on the part of the drug companies are going to be up shit creek without a paddle. The silver lining in all of this is that it might help people realize just how utterly worthless the FDA is.
So, hey, drug companies are pretty unscrupulous folk, as this case definitely demonstrates. You advocate getting rid of the FDA then, I take it? Sounds like a great way to allow companies that produce vital, exclusive products that people have to have, frequently right now, not five years off when another company's R&D catches up, to be even more unscrupulous! The FDA came about not so that the government could weasel its way deeper into the private sector. It was because the private sector was busy subjecting the public to snake oil and hilariously dangerous "medication" and lying about its efficacy in ways that would last long enough until the "new and improved!" formula came out. Or, hell, sometimes they'd keep peope just healthy enough so that they'd keep using their products. Other times, they'd take advantage of chemical dependancies to show that the product "really must be working!" Now, I'd argue that if the drug companies had banded together and started self-regulating, much of what the FDA is today would have never come to pass. But like the cigarette industry (and unlike the alcohol industry), they just didn't bother, because it would have negatively effected the bottom line.
Yeah, I would be against any protections for the drug companies. If anything, both the FDA and the companies should be sued for fuck-ups.
This case is a case of trivialities. 40 (or even 50) deaths in over 900,000 users? Seriously there are a lot worse drugs out there. Anytime you use a drug there are risk. Try reading the information sheet thatcomes with your prescription, or asking the pharmacist. Seriously, where is the personal responsibility people? Any time you screw with your endocrine system and artificial hormones, expect trouble.
I agree with you for the most part. On the other hand.... If you've read some of the contraindication sheets that come with your prescriptions, you have to know that they're not really user friendly, and the print is.....tiny, in most cases. I read those things all the time, not so much because I'm conscious of my personal responsibility, but because I'm wanting to make sure that if I start observing those contraindications, that I'm prepared to save my own life, or the lives of family members taking the stuff. I'm not intimidated, and I've got a PDR, and I will use the 'net to figure out just what all of the medical jargon means. I don't know that I'm common. Not that I'm any smarter than anyone else, but I'm cynical about my doctor, and about what he might be giving me to ingest. Lots of people put faith in their physicians, and don't feel that they need to wade through all that dry, sometimes tough-to-understand verbiage that's packed into those sheets. I agree that there needs to be personal responsibility, but somewhere along the line, specialists, and those who are supposed to have expertise in these fields should be held accountable as well. If their judgment can't be trusted, we're paying an awful lot of money and not getting a whole lot of value. On the other hand, I'm not advocating lawsuits and so on, unless there's obvious and gross negligence that results death or permanent disability.
You've gotta be fucking kidding me. The company lied about the estrogen levels in the drug, and that little information sheet that came with it was wrong because of it. What else where they supposed to do, chemically analyze the drug themselves? Simply not take it? That's fine for this drug, as hormonal birth control is generally optional (though some need it to alleviate some serious period-related problems), but what if it were, oh, I don't know, something that you had to take to treat a disease and that was the only option on the market? Or the only option that, chemically speaking, worked OK with your body? 'Cause those are real issues, and your sputtering platitudes about "personal responsibility" ain't gonna solve 'em.
I can't decide who needs the biggest kick in the ass: the FDA or the pharmaceutical companies. Compromise: kick the shit out of both of them.
I wish they'd get all those damned commercials off my TV. That would save them a shitload of money right there.
Exactly. And it'd helped turn doctors into legal drug dealers, and helped clog up the nation's ERs and clinics. It needs to stop.
Marketers are finally, slowly, beginning to realize that TV advertising is a dead end. Eventually drug marketing will shift entirely to the Internet, and smarter consumers will research their meds online before they take them. Unfortunately, the people who take the most meds are generally the elderly who don't have computer access and wouldn't want it anyway. So they're at the highest risk of bad drug interactions, and of dependency on drugs they may not need. They're also the most easily swayed by those "ask your doctor if X is right for you" ads. It's still a better situation than when people had to schlep to the library and haul out the PDR to get drug info, but it also encourages some docs to be script-happy. But there's an interesting tug-of-war going on between pharma and the insurers that will have surprising outcomes over the next decade or so. In the transition, though, the situation sucks.
