Particularly in Texas, there were many benefactors willing to help. Tom DeLay’s strategy of gerrymandering Texas and thereby creating a permanent Republican majority was also tied centrally to “tort reform” as an issue. DeLay was personally obsessed by it, as were some of the major (talking super-”rangers”) contributors to the movement.

Once Dan Troy moved from defending Big Tobacco and Pharma into the FDA Chief Counselor role, the effort took on an ideological super-structure that was, if nothing else, creative. No one said that trial lawyers were hiding weapons of mass destruction, but the suggestion, at least, was that - as a profession - they _were_ weapons of mass destruction. It has obviously caught on, the mirror image of the satanizing of pharma.

HC writes: ” have to stop and ask myself what is the objective? It is to create an environment where there is as little incentive as possible for a company to obscure and obfuscate so that problems can be solved as they arise, with warning to everyone and appropriate risk-benefit analysis, and to provide recourse and recompense to those who are hurt when this doesn’t happen. And to provide for criminal punishment of those who knowingly allow harm to be done.”

I fully agree. But how can that happen with a blockbuster model (make hay while sun shines); the relative ease of getting around regulators; the the ticking patent clock; etc. As I’ve sometime said, being in the pharm. industry is like being a priest in Amsterdam (apologies to Catholics and Dutch people). The temptations are enormous.

When other companies yield, there is a virtually inevitable race to the ethical bottom. All that you mention re: transparency, reasonable ROI, makes sense to me. But I cannot get beyond the notion that pharma needs some kind of inner renewal that may, in part, depend on a different business model, but I don’t think we (all of us) can afford to wait for that.

Re: my particular bugaboo, preemption, it will be a disaster for industry as I’ve said many times. Not only do you get Amersterdam; you get it for free. Human frailty is such that there is no mystery what the final chapter will be. And the short-run party will become a genuine disaster - for companies and for all of us who depend on them.

If anything will kill the “golden goose,” it will be the tsunami of outrage that follows from there.

So companies should fight for lawsuit reform, yes. Scuzzy lawyers should be treated the same way as scuzzy everyone else. But a total shield is a DTC ad from pharma to the rest of us that says: “We can’t be trusted to do the right thing. That’s why we need to work in the dark.”

It’s the worst possible message for an industry that needs to regain public trust. And, scuzzy lawyers notwithstanding, it is an unnecessary message given the integrity that has been, and can be, key in this industry. Work for that. Work against scuzziness everywhere.

Nuclear options like preemption get what nuclear options always get. Scorched earth.

It is clear that the current incentive structure and relevant institutions (FDA, etc.) encourage the following:

- Pushing the law until the law pushes back. Essentially playing _with_ regulation rather than playing by it.

- Only enough compliance to cover-butt if/when one is caught.

- A series of ways resonsibility for consequences is diffused, camouflaged, and denied.

I could go on. As an industry (as opposed to the individuals who work in it) pharma ceos are our contemporary robber barons. Things will change. It’s a quesiton of how long and how many people are hurt along the way.

Or this:

a person who studies a subject or issue in an excessively assiduous and thorough manner: a policy wonk

Jaynesday and Justice,
I have to stop and ask myself what is the objective? It is to create an environment where there is as little incentive as possible for a company to obscure and obfuscate so that problems can be solved as they arise, with warning to everyone and appropriate risk-benefit analysis, and to provide recourse and recompense to those who are hurt when this doesn’t happen. And to provide for criminal punishment of those who knowingly allow harm to be done.

So, how do we do this? On one side, we must create a business environment where companies can make a profit in return for taking risks. They aren’t going to make a profit on everything, there will be a lot of failure, and they have to do sales and marketing, so the public may have to let up on the price, price, price blathering. In return, we can demand complete transparency except where “trade secrets” are concerned. (No one is asking for the secret formula for Coke.) We set up some sort of system where data are published, side effects can be collected, collated and assessed for meaning; and dialogue and conversation occurs. We talk about how we do trials and their inherent limitations. If we can do this, then if a disaster occurs where no fraud has occurred, we have a neutral body that provides recompense. If fraud occurs, it’s Katie-Bar-The-Door, Mr. CEO, your ass is on the line.

The issues are terribly complex–from how to sort the wheat from the chaff with adverse events, to how to design meaningful, ethical trials, to how to talk about off-label uses of drugs. (You can get the schizoid effect from this site–people angry about off-label use of psychotropics, and angry because an insurance company wouldn’t pay for an off-label use of a cancer drug. Can’t have it both ways, people!) We need to talk about profit and private enterprise and admit that we want our pharma stock to do well in our 401ks, but not at the expense of the patient. We need to talk about patient responsibility and how risk-averse Americans have become. We need to talk about giving physicians more time with their patients in order to really talk to them–and paying them for that time. We need to talk about how we are going to pay for all this. And we probably need to keep it out of the sound-bite happy politicians who don’t really want to solve anything, they just want to get re-elected.

And if the Gray Lady follows precedent, there will be a same-day editorial supporting the general view of the article — that FDA preemption should be struck down as a general principle because of, among other things, the evil pharmaceutical industry and an agency that is “in the pocket” of same. Who does this help? Consumers? No. Trial lawyers? Yes. (And we all know that Alex Berenson has many of these folks on speed dial – and visa-versa.) So on Sunday, brew your coffee, toast your bagel – and count how many times trials lawyers are quoted in the article.

In reality, thre was no such editorial. And plantiff’s lawyers were quoted twice, the same number of times that industry lawyers were quoted. Also quoted were a range of company spokespeople, FDA officials, etc.

Why do these guys call themselves “wonks”?

Clearly, the issue is not emotion but justice. Moral outrage or sympathy are not negative emotions and need not cloud fairness and clarity. The wide range of outcomes in the Vioxx cases tell us how unpredictable all of this is, and how it is not reducible to any easy generalizations about juries and jurors.

Likewise, the checks and balances provided by the appeal process.

The question becomes - why is a jury of twelve citizens less an independent arbitrator than some other scheme?