Look forward!

I’d like to get in touch with you directly, but I don’t feel comfortable putting my email address up here. Would you be comfortable putting yours up here, or if not, perhaps we could rope Ed into passing a note for us in class?

Truth is, I don’t keep emotions at arm’s length. I genuinely believe we are heading over a cliff - the industry and, in concert, all of us - if/when preemption is upheld. But there is a point at which screaming, “CLIFF AHEAD!”, just doesn’t help. The sad reality is that we will probably find ourselves in the ravine, look back and up, before we realize how large a mistake we’ve made. There’s some emotion for you!

Beyond that, I do truly believe that this board provides an amazing opportunity - this is not sentimental BS - for learning. Mutual flaming between industry “critics” and “defenders” is something you can get anywhere. The chance to really engage, and try to understand contexts and realities that one doesn’t know, is unique.

There is no way I can teach about this (which is part of what I do) if I don’t try my best to understand how it looks “from the inside” and how many different and complex perspectives “on the inside” there are.

So sue me.

The “peril exists” line actually comes from Andy Von E. himself (soi-meme). So I find it particularly quoteable.

The grace of this site is the fact that people who almost never talk with each other, and genuinely engage with each other, have the change to here. It’s like breaking through a mirror and allowing us to see things from a perspective that is not one’s own. We may not agree, but at least we have the chance to consider. That’s the ballgame, as far as I’m concerned.

Salut!

I don’t think I was advocating abandoning governance solely to the FDA. Rather, I was suggesting that there is a better method than civil jury trials, which I think are a blunt instrument that is too easily manipulated by dodgy defense attorneys. (But my aversion to attorneys has deep roots in my childhood as a doctor’s daughter, so perhaps I am not objective.) I was suggesting a criminal process that would actually get the perpetrators, rather than a civil process that slays the whole dragon, so to speak. And in conjunction with that, a screening committee that weeds out the malingerers and the money-grubbers. And I agree with you that the whole punitive damages thing is not a tool meant for the hands of the populace. Besides, being a libertarian is not synonymous with being a populist, unless one is allowed to insist on personal responsibility first and foremost, with government intervention only a last and infrequent resort.

Time to go to bed. I have had my glass of red wine to raise my HDLs and do all the good things for longevity that red wine is supposed to do (and it tasted good). Now I must do a crossword puzzle to exercise my brain and ward off Alzheimer’s. Good night all.

P.S. Jaynesday and JiM, I can’t tell you how much I value the reasoned discourse coming from you, Nathan, Sal and others. I can’t resist mixing it up every once in awhile with a few of our more emotional comrades, but I do sometimes emerge a little dizzy from the pummeling. My husband doesn’t understand why I do it…it’s one of those things “that make you go ‘hmmm.’”

Re: HC’s comments, I think we are better off with both civil liability and the FDA than either one alone. That would be a fair statement of my views. They are both imperfect systems. They have worked reasonably well together for the last hundred years, as FDA itself has reiterated many times. So I believe there is room to improve both - a lot of room. I also agree with what Senator Leahy said on Friday - to nuke civil liability entirely, which is what FDA preemption means, is a pure power grab. If you favor preemption, you favor that nuclear option. As someone who writes with seemingly libertarian leanings, I have been surprised you would even consider ceding such sole and exclusive power to a government agency. But I guess we are all entitled to inconsistency.

Re: Jaynesday’s list, I have to be super brief. So please don’t take this as a substitute for the references above.

*Without preemption new and important drugs have not come to market because it’s too risky to put them on the market.

Ans: There is simply no evidence for this. Drugs that fail at stage III or earlier do not do so because of liability but because manufactuers realize they just won’t fly. To suggest they are only or even primarily worried about liability is to rate the integrity, and smarts, of pharma companies much lower than I would.

*Without preemption drug companies will go out of business because liability costs are too high.

Ans: A while back, I referenced a Business Week piece on the alleged “tort tax.” But just think of recent cases - Lilly/Zyprexa, Merck/Vioxx, GSK/Paxil. In the contexts of these comapanies’ budgets, the settlements they have made were about as far from threatening their future survival as a bad thunderstorm.

*With preemption we will have safer drugs.

Why would that be? According to Kesselheim/Avorn in JAMA, civil liability has played a critical role in drug safety. I

*Frivolous law suits are rampant and too many unscrupulous people are taking advantage

Ans: I actually agree with HC that the asbestos litigation got out of hand and was resolved appropriately. But most of the “frivolous lawsuit” lingo is pure political rhetoric. The reality is that both the number and cost of lawsuits have been decreasing. Most suits involving pharma are not from plaintiffs but companies suing each other over patent infringement, etc..

Is there a Pfizer person out there who believes their action against Rambaxy was “frivolous”?

*Creative drug design is stifled by the need for safer drugs/devices

Ans: I think this covered above. It is more likely that the support of safety managers that liability provides _increases_ the development of safer drugs/devices

*An emotional jury can not correctly judge damage liability

Ans: Juries work hard but, yes, do not always see the whole picture, and some are more “swayable” than others. It works both ways. To trash “juries” as a whole is really to trash ourselves - that’s who we are. There is some excellent work on the social psychology of jury decisions that deserves consideration.

If you read Cass Sunstein, Law Professor at U-Chicago, the big problem has to do with punitive damages. Juries just don’t have good ways to equate harm with with damages. This is an area where I believe real reform is needed. Jury-trashing more generally is a kind of knee-jerk anti-populism. Mostly thoughtless with without supporting data.

*The FDA has enough capability to adequately protect the public from poorly designed/manufactured drugs and devices and doesn’t need the help of tort.

Ans: Holy Cow! Here, I can only quote Andy Von E. himself - “Peril exists.” As you well know, every other week it seems another major study comes out that tells us how deperately limited are the resources and regulatory culture/means at FDA - IOM, OIG, FDA’s internal studies, you name it. As I wrote in the New York Times (blush), there is a kind of Alice-in-Wonderland quality in talking about FDa preemption in this context.

Once again, see the Kesselheim/Avorn article in JAMA. They document very well how the two systems work together.

*Without preemption drug companies will have to adhere to conflicting requirements of state and federal law.

Ans: There are _some_ instances where it gets tricky. I think the Wyeth case may be once of those, which is why our current Solicitor General - in my view - pushed it to be the poster child case on preemption. Given the amount of scuzzery in cases like, for example, fenphen, Baycol, or Rezulin, it would have been much harder to make a reasonable case for preemption in those instances.

Bottom-line: No civil case requires _any_ requirements of a company. That remains solely within FDA’s jurisdiction. What history suggests is that civil cases have most often _led_ to changed FDA labelling requirements, and even withdrawal in some instances, because of what emerged in the discovery process (suppressed studies, etc.) That is why the two systems have been viewed as complementary rather than contesting.

*others?

Ans: Yeah, I have ten more pages of the pro/con arguments, with answers, answers to answers, and on and on. But I don’t think anyone really wants to see all that here.

I’ll just put in one - the bogeyman that lawsuits remove safe and “life-saving” drugs from the market that would otherwise be available.

As far as I know, there is only one case in which some version of that happened. This was the drug, Benedectin, which was used for morning sickness. That is why preemptors always repeat, “Benedectin! Bendectin! Benedectin!”

But guess what - This “life-saving drug” was actually a combination of doxylamine succinate (the active ingredient in Unisom) and vitamin B6. Both ingredients were available OTC at the time of the Benedectin withdrawal. There have even been articles by Ob-Gyns about how to make “home-made Benedectin” if anyone was so inclined.

So the next time you hear about Benedectin - and undoubtedly you will, since it is the only example preemptors have - take a Unisom and have a good snooze.

We need a process that accurately determines actual fraud or negligence. Then we need a process, probably a criminal one, that punishes the individuals involved–while not irrevocably harming those whose lives depend on their continued employment. Merck didn’t perpetrate the Vioxx damage, if you think of Merck as the tens of thousands of employees and stock holders that make up the corporation–from the janitors to the cafeteria workers to the reps who didn’t even sell Vioxx. A punitive process that significantly damages or even bankrupts a company doesn’t just affect the employees of that company, either–it affects all those people whose lives intersect with those employees: their hairdressers, dog walkers, babysitters, realtors, etc, as well as the stockholders (old people, pensioners, blue collar workers, teachers) whose retirement in part depends on that company.