Comments on: Merck’s Dick Clark Has An Epiphany

By: Jim

Jim — Mon, 12 May 2008 14:18:37 +0000

HorusCat I take your point — I wouldn’t want to unleash a bureaucracy like the UK’s NICE on our market. The challenge is that the market does not really provide any incentive for corporations to conduct comparative studies, more often than not they backfire, PROVE-IT being a classic example. But there clearly is a need for data like this.

And while there may be no constitutional mandate for the government to conduct trials, an example of the type of NIH-supported trials I am talking about would be ALLHAT. The study itself was far from perfect, but that’s the model I was referring to.

Again, I would agree with you that the expectation that we could get unbiased data from government supported trials (when the governments economic incentive to restrict the utilization of innovative therapies is so powerful) is optimistic to say the least.

By: HorusCat

HorusCat — Sat, 10 May 2008 00:31:29 +0000

“NIH-funded academically-managed comparative trials” is where you lost me, Jim. It is not the federal government’s constitutional mandate to fund medical research. Not only would it be yet more thievery of private property, it would mean the government would be deciding which disease states merit resources and which don’t. We would, perhaps, end up much like England, where “life-style” altering medications such as the interferons for MS are severely limited in their use–not being cost-effective, you know.

By: Jim

Jim — Fri, 09 May 2008 21:36:50 +0000

This is a very important thread and my compliments to the many thoughtful contributors. Nathan’s point about the perverse incentives created by the current patent structure is critical - and not discussed often enough by industry. Accompanied by an adequately funded FDA, NIH-funded academically-managed comparative trials, a revision of the patent system would go a long way towards getting the industry where everyone wants it — providing innovative medicines, data to support their appropriate use, and the ROI the capital markets require.

But then Mssrs Waxman, Stupak, and Dingell wouldn’t get any good Capitol Hill theater out of such a system, so I won’t hold my breath waiting for it.

By: Justice in Michigan

Justice in Michigan — Sun, 04 May 2008 15:43:59 +0000

Good point, Jaynesday. Whatever may be the real problems with the civil justice system, “tort reform” and lurid portrayals of “greedy trial lawyers” became pure political fodder some years ago.

“Big bad pharma” serves the same purpose for some number - a completely one-dimensional condemnation, used to make political hay, which blinds everyone to the realities.

So we end up with the politicized counter-demonizing you describe. Thinking through good policy is already hard enough.

Turning it all into a circus, or political theatre, doesn’t help.

By: Jaynesday

Jaynesday — Sun, 04 May 2008 13:31:26 +0000

Politically speaking – the weakness of politics anymore is that if one side takes a stand on an issue the other side seems to have to take the polar opposite view and justify it somehow. More than that they use the issues as a weapon to beat the other side into oblivion. The result is that practically nothing gets done. The more we politicize issues the less will actually change things because some people would rather defend their political party than support the real solution. Putting any problem into a political blame game causes the “contestant’s” rational thinking to go into an “I must win this battle for my team” mentality. Not good.

By: laura

laura — Sun, 04 May 2008 12:28:13 +0000

Nathan,
OK, maybe you’re not a closet anti-preemptionist. Maybe, instead, you’re a pro-preemptionist with a conscience (and, as you may be demonstrating, they usually eventually become anti-preemptionists;))
Justices comment, “FDA preemption is so grotesquely unfair, “perverse” as the New York Times described it, that it is hard for people to believe it is what it is.”, is absolutely correct. I can’t believe it is what it is, and I’m living it.
When I tell people about my families situation, (and I don’t tell many because of the “stigma” attached to filing a lawsuit), they truly cannot believe that our basic right of seeking relief through the justice system, our sole means of holding the medical device company accountable for what they sell, has been taken away from us. This entire process has shaken my confidence in the way our government works. I used to be a Republican, although I am certainly not a “George Bush Republican”. I guess I’m a Republican with a conscience, and I think they eventually become Democrats;)

By: Justice in Michigan

Justice in Michigan — Sun, 04 May 2008 01:14:26 +0000

For Nathan - The fence is a reasonable place to be. I know that companies have, and no doubt will, send out their own info on preemption. I would be happy to try to respond to any aspect. Yes, I am obviously not neutral. But I will try to present the facts as I understand them.

In the meantime, with regard to Jaynesday’s comment, I always emphasize that there are very self-interested reasons for industry people to be against preemption. While it may provide “cover” in the short-term, in the long terms I believe (as I’ve reiterated) it will inevitably lead to a disaster for the industry as much as the rest of us (which disasters obviously are part of the same thing)).

Likewise, I do not deny that the trial lawyers (on all sides) have their share of sleaze. But that can be reformed short of the nuclear option. (E.g., clear and reasonable limits on class actions, punitive damages, share of any awards that gos to lawyers, etc.)

Agree with Nathan re: patent life and long-term studies.

By: Jaynesday

Jaynesday — Sun, 04 May 2008 00:54:06 +0000

Whenever a person or a company comes up against the crisis of decision about their ethical behavior they are in the midst of a battle between what is best for themselves or what will benefit someone else. Part of the equation for those that are generally dishonest or unethical(maybe a good number of we sinners at times), is what do I feel like I can get away with? Another avenue of what’s best for me.

Preemption puts the opportunity to get away with it on a whole new level. What do you think, maybe 20%, maybe 50% more articles about disturbing breaches of ethics in the future?
Of course we can only go on the past experiences that we are aware of to estimate the probability of future behavior.
I would think that maybe the probability of future unethical behavior would directly correlate with suffering, death and profit.

By: Nathan

Nathan — Sun, 04 May 2008 00:46:51 +0000

jaynesday says:
“Side effects that develop over the long term use of the drug that weren’t evident in the trials - seems to be part of the problem, in that it is apparently too easy to make sure that the long term effects don’t show up in the trials.”

As I’ve pointed out, there is no financial incentive to do long term studies. I really think this is part of a fundamental problem in our industry. We need longer patent life that will allow companies to do the long term studies they need and still have enough patent life remaining in order for a profit motive to be in place.

(this is exactly one of those situations where free-market works AGAINST ethics! Free market demands short trials while ethics demands longer trials)

By: Nathan

Nathan — Sun, 04 May 2008 00:34:43 +0000

Sorry — not much time to respond tonight — but my thought over the last couple of days about this topic are definately making me reconsider my opinions about preemption. I haven’t switched sides yet, but I’m definately on the fence….