"And a big part of the problem, per the article -- the agency doesn't seem to have the organization, science, or money to adequately regulate the drug companies."

This is the same agency - the FDA - accused by some of not bringing some medicines to the public in the USA in a timely manner, some of which are approved by agencies overseas. In such cases, we are apparently supposed to trust the examination procedures of some other agency outside US law. This statement infers that FDA powers are to be increased. Is that really what you want?

The FDA was not established, is not organized, and its behavior is not regulated by "the Bush administration". What does that mean, anyway?

In an era when prescription medicine comes with pages-long monographs outlining risks, what indication is there that these are actually hidden from the user? Hasn't a repeated point of this blog been the need for personal involvement and study of health measures, and doesn't that inherently deny the idea that "FDA approved" equals "automatically correct measure of treatment"?

-----

That said, this should surprise no one who saw the tobacco fiasco, a far more heinous situation where states were allowed to escape liability for tobacco-related death and injury, even as they ignored their own departments of health in order to approve, regulate and subsidize the industry.

Dear Goddess
Outrageous! this is not only civily actionable, this is criminal.

I used to edit some of the drug inserts of one of the major drug companies here. Every time new data regarding the efficacy of a drug that was in clinical trials was introduced, it started a whole litany of editing and sign-offs that were required before the drug could be put into the pipeline for manufacturing and distribution. I had to be so anal retentive when it came to actually making the changes, because to be off by even 1/100th of a percent would cause all the labeling to have to be redone, and then another round of sign-offs. And some of these inserts were pages and pages and pages worth of information. (I was lucky that I was able to edit them in Quark, because as small as the print is on those things, I could blow them up into a readable font and then make the appropriate changes.) But the process is exceedingly long and involved, and there is no room for mistakes. Unfortunately, because I don't have a degree in biosciences of any kind, I never knew what was being hidden or misrepresented. It was my job to make the changes, print the thing out, and bring it around to the various departments for signatures before handing it to my superiors for the final sign-off before it was sent to the FDA for approval. And then the FDA itself might want changes made, which would start yet another round of editing and sign-offs. Regulatory Affairs is even more involved than most people think it is; every drug company has a Regulatory Affairs department that is responsible for submissions to the FDA and the labeling of all drug products that are marketed to the public. It can take years, even after a drug is approved, to get the labeling and packaging right in order for the FDA to approve its sale. The accountability should be held by the drug companies first, THEN the FDA.

Look, if the FDA says it's "safe and effective" based upon real data, then there should be some grant of immunity.

If the FDA was intentionally given false data, then there shouldn't.

I don't see why this is so difficult to comprehend, or why it is so scary. If the company (viz. Merck) intentionally withheld information from the FDA during trials, then there ought to be some retribution for that.

I can't see a blanket pre-emption surviving judicial scrutiny, and if it does, then Congress should (but won't because they are more interested in destroying the economy) direct the FDA to enact such rules.

Nice attempt at an early-Monday BushBash though.

Why is it "BushBash"ing to criticize poor policy?

I criticize Hillary on her health care plan every time I post about the election. Is that HillBashing?

Well, Amy, Bush bashing is different, because you're preying upon a victim of low IQ. ;p

I chose to use the Ortho Evra because it had less estrogen and I would have to worry about it weekly instead of daily. That was the worst week of my entire life. My breasts grew, I was nauseated all the time, I had the worst diarrhea, and I could barely keep my eyes open past 7pm. Also, the patch constantly itched. I switched to a different kind of pill and have been normal ever since. I'm happy to know that there was an actual reason for that, and that I was not just "sensitive" as my doctor claimed.

"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."

and then

"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."

So, we're saying that the courts' judges are so stupid that they can't determine if a company LIED about side affects such as DEATH?

The courts can't be experts on all things but this situation causes me to question the ability of the F.D.A to truly protect consumers (I support tax dollars going towards an agency of highly educated people who can ensure all the risks are studied and revealed to us laypeople).

At the same time I think it's ok to ask of the courts: Was there falsification of documents that went to the F.D.A? Did the F.D.A allow a big, fat, dangerous lie to slip by consumers? This isn't about medical jargon as much as it is about holding people responsible for being unscrupulous.

The "BushBash" is you placing this at the feet of the Bush administration when it's not just this administration. Any government-managed healthcare system (which is what the Dems are after) is going to have this as a necessary method of cost-containment.

Personally, I take this as evidence that the FDA has outlived its usefulness. Either the FDA needs to be given the teeth it needs to force the companies to not withhold information, or the FDA needs to be put in an advisory role only, and not a regulatory one.

If the FDA is to continue as it is, then there has to be some kind of criminal punishment for intentionally withholding information from the FDA prior to approval. But there also needs to be something in place to protect companies who turned everything over in good faith and later find a problem.

I don't see anyone proposing both of those things, they either want total liability, or total immunity.

I think that the scientist who altered the data should be held personally liable for HIS actions. The people at the top can only assume that the data they are making their decisions on is real, the head of regulatory affairs can not check each scientist directly. Now if the scientist was held personally responsible he/she can then point to whom ever ordered him to do it or have to explain why he/she did it in the first place. One or two of these and I think falsification of records will drop very fast and everything that seems questionable will be done in writing.

I'm all for limiting liability based on current data. There is no way to tell with any drug or device what will actually happen when given to the general population. If the company knew this could happen and did nothing then there should be sever penalties.

"Was there falsification of documents that went to the F.D.A?" Also I think it should be asked as to who actually made the falsification?

Hmm. Too busy to think too much about this, but if you are all itchy and either asleep or exploading with diarrhea, that's probably pretty good birth control right there. At least I hope it is...

Sorry, it's one of those Mondays;-)

When I was on the pill, I only took Ovral and Minovral, specifically asking my doctor to give me the lowest dose available that would work (indicator of working is no breakthrough bleeding).

I was going to try the Nuva Ring, which is a piece of plastic you keep inside you for 21 days at a time, but I didn't understand how this piece of plastic was going to release the exact same amount of hormone every day, so I decided not to, as I'm not interested in being a lab rat. It sounds like it would have had the same problems as the patch, because they were using the same sales pitch.

Yes, this is a great idea. Grant immunity from suit to an industry that has a history of burying contrary data when it might thwart their chances of hitting it big with the next Prozac or Viagra. It's not just the patch, anybody remember Celebrex and heart complications? We're supposed to take away people's rights to recover damages entirely on the word of the drug companies and the (understaffed, underfunded, and generally plodding) FDA? If we assume the drug companies to be rational economic actors, then we have to assume that if preemption is permitted, they will test less rigorously and be more inclined to falsify results. After all, once they get past the FDA goal line, it's not their problem anymore. This is really dumb.

"This is really dumb." As opposed to having the plantiff's lawyer who has no conflict of interest set the standard of proof which the company should have met for safety and efficacy?

I've heard some of the spiels for drugs on TV where they go through the list of potential side-effects. To say that some of these drugs are frightening is an understatement.

Which confuses me, because it appears that these companies are holding back information to make the drugs appear "perfectly safe", when the FDA has approved, and people are willingly taking, drugs that come right out and tell you that they might cause profuse rectal bleeding.

So I'm hard pressed to understand why Merck felt the need to hold back info on Vioxx and heart attack risk.

Until the revelation of that little e-mail exchange, I was on Merck's side. Once it was revealed that they knew of a minimal risk, and chose not to disclose, I was willing to see them burn.

A lie of omission is still a lie. And to the best of my knowledge, lying to the FDA only gets your drug pulled and you potentially sued. There's no REAL penalty for it.

Uh, so I started this drug on Saturday. I already have the itching and bathroom problems. I'm not sure what I should do actually, I require hormones or else I grow tumors every one or two years. My other option is the Nuva ring mentioned. I actually am trying out the patch because other hormones increased my blood pressure. Basically this will maybe do even worse for my heart?

I'm torn about whether to at least try it for a month or just back out now and get back to my doctor right away.

My doctor is an internist, and I trust him a lot. My gynecologist I met for the first time and this was what I got. I was happy it was a free sample, though what I should have thought was, “Oh, so this is from a drug company rep?” I read all the warnings and drug facts that went with it, and they did mention estrogen, but most do so I didn’t think anything of it.

I think I will print off the studies to bring with me (I’m going to the doctor soon anyways) and ask whether the medication puts me more at risk than what I doing before. Even if not, maybe the Nuva ring is the way to go. This time I’ll actually look up information about it.

As opposed to having the plantiff's lawyer who has no conflict of interest set the standard of proof which the company should have met for safety and efficacy?

Well, the standard of proof in all civil actions is a preponderance of the evidence; it's not set by any attorney. But that's not really what you are asking.

Basically my answer is yes. I'm OK with the system we have presently, which seems to bring lots of good drugs to the market, frequently compensates companies that produce good drugs quite well, often punishes companies that do lax research or engage in deception, and mostly catches the bad drugs before they are released. We haven't had a thalidomide or similar for a long time, and Merck and Pfizer and etc. seem to keep their shareholders happy for the most part. I think the occasional lawsuit helps keep things honest (well, as honest as anything involving lawyers can be). Some people are overly litigious, but this does not change the fact that tort law does a lot to put pressure on companies to do the right thing.

Although I agree that it would be frightening to remove the state tort cause of action, you're forgetting that courts don't adjudicate solely on the basis of public policy ... there's also the law and precedent.

A recent Supreme Court case, Geier v. American Honda (2000), also dealt with preemption. There was a federal law that preempted the suit, and the court decided in American Honda's favor. It, in effect, said that the federal law eliminated the state law claim--does anyone remember that thing called the Supremacy Clause? Or how about Federalism?

So if the court does rule the same way here: blame the legislature, not the court system.

"Some people are overly litigious, but this does not change the fact that tort law does a lot to put pressure on companies to do the right thing." Wasn't advocating for removal of the tort system. I was advocating for a set of standards revised by FDA, Doctors, Lawyers etc. periodically that all drug companies are required to meet. Once that standard is met unless there is evidence of intentional concealment the companies should be protected from litigation. Prove that the standard is met and the law suite is dropped with penalties for the litigants for frivolous suite, if the same group keeps filling the same suite.

Following a carefully written standard for evidence based drug discovery would result in less law suites and less injured people. That's how the FDA started but they got their teeth pulled during the 80's and 90's.

Stacy, I suggest doing a lot of research about your condition and the options available to treat it. There are a lot of good books in the library, and resources online from hospitals, etc.

It's your body and you should be the expert on taking care of it. Doctors are there to help, but they are very busy and haven't got the vested interest that you have in your body, because it has to last you as long as possible, in the best condition you can maintain it.

With respect to my comments about the NuvaRing, I am just suspicious of anything new on the market. I trusted a previous new product for birth control, which failed. I like the pill because it's been on the market now for about 30 years, so the bugs were ironed out.

I have the same philosophy when it comes to electronic gizmos (DVD players, plasma TVs, etc.). I wait until the price has come down and the defects have been engineered out, then I buy.