Saturday, March 7, 2009


With the lonely exception of the great state of Michigan, America, for now, has been saved from FDA preemption. However, I find it hard to believe the idea will simply dry up and blow away. Levine won, but the bad guys are still out there, waiting for their chance to pounce.

We need laws that protect citizens from un-American notions like FDA preemption. Michigan’s 1996 Drug Immunity Law--that gave drug makers total immunity from product liability--has been in existence for 14 years. Then governor John Engler asserted the Michigan model was intended to be the law of the land. America missed that bullet, but what about the next time? What loop hole made it possible that an industry had the right to strip citizens of legal redress?

I don’t feel that assured about the future. And, Michigan still has a stinky law.

Please tell us your thoughts. Thanks.

See: ThePopTort: Drug Company Immunity Remains Status Quo in Michigan Unless Legislature Acts


  1. Hi Dianne--DDL's analysis of Levine is interesting in this regard. They put it in the context of a general rejection of "deregulation," which is most pronounced in discussions of the economy. My sense would be there has been an ideological shift. As others have written, the days of Reagonomics, of which preemption was one reflection, may be over.

    That said, Michigan's statute is only one of many bad laws. I would not call any of them "un-American." We have always been a complex country. Slavery was American at the same time that expanding democracy was. There was a Progressive movement before women were allowed to vote.

    So I don't think this is about "loopholes." It is about the ebb and flow of politics. Preemption reflects _one_ strand (not Clarence Thomas's) of the conservative movement that flowered in the 80s and 90s and reached its peak, in terms of power, in the Bush 2 administration. Preemption was one facet of neocon ideology. It is still with us, but may spend more time back in the "think tanks" for a while than in the nations's (and FDA's) highest offices.

  2. My thoughts? Look at what you write: "Levine won, but the bad guys are still out there, waiting for their chance to pounce."

    My thoughts?? My thought is that you are a biggot. We (the pharma industry) are not "the bad guys getting ready to pounce". We are not "unamerican". That kind of sentiment does no good for anyone. People's ideas may be misguided, they may even be dead wrong. But people on both sides (Levine and the pharma industry) are trying to improve the healthcare in America. We just have fundamentally different views about how to do it.

    Please watch your language in the future. I do not like being called "the bad guy" or "unamerican". I work for the pharma industry and I'm proud of what I do for a living. Unfortunately, lawsuits like Levine are killing us and I'll likely be out of a job by the end of the year thanks (in part) to cases like this one.

  3. Nathan you are the bad guys! Hiding data, ghost written studies from marketing to JAMA, NEJM etc. Selling off label to children, falsifying and embellishing outcomes, minimizing dangers, steeling tax payer monies, just GREED plain and simple! People in your industry are a bunch of criminals, murdering thieves that claim to be pure as the driven snow. Go pay off another KOL, and order lunch for your office tomorrow! Nice try but the gig is up!

  4. Anonymous - My way of thinking is that there are some bad players in any large industry or even in any large company. To paint the whole with one brush does not help. However we do need protections in place to deal with the renegades. Elimination of preemption does that.

    How can we say that the pharmaceutical industry as a whole are the bad guys? If that were true we would all be fools to take any drug or device. I doubt that any of us would be willing to do that.
    Also labeling like this closes down any hope of finding common ground. Change is needed on both sides.

  5. Nathan:

    My attack was not directed at you personally. However, I do not apologize for what I said or how I said it. Those who would strive to rob us of our civil rights are, indeed, un-American. They are the worse kind of “bad guys.”

    As far as you losing your job, are you saying that if the industry is forced to do things right, they are not going to do it at all? I would think they would need honest, ethical people even more.

  6. I unqualifiedly reject any attempt to brand "the industry" in a way that includes everyone who works in it, or 99+% of the people who do.

    The stuff we were about are the responsibility of a small number of decision-makers. Yes, I would like it if some of the others expressed their outrage a little more publicly. But I understand why they don't. And broadside attaqcks are one of the reasons.

  7. Dianne, the Depression dried up and blew away, as will Michigan's Drug Immunity Law. In the meantime, look here:

    Clara Cannucciari, a cook from upstate New York, offers measures to soothe the souls of us all.

  8. Correction: In the preceding post, "Drug Immunity Law" should be "drug industry immunity law. :-)

  9. Diane writes: "As far as you losing your job, are you saying that if the industry is forced to do things right, they are not going to do it at all?"

    I'm saying that the combination of a number of factors has created a "perfect storm" that is in the process of completely wiping out the industry as we know it. Here's the factors: Excessive liability lawsuits, increased regulatory delays and scrutiny, blatent attacks our intelectual property from the generic companies, and shrinking budgets of key payers such as governments and insurance agencies.

    It's foolish for people outside the industry to somehow believe that industry can overcome these factors and continue to develop new, exciting medicines at the pace we have done so in the past. We CANNOT do it. While all these factors I mention may have merits, they also have a price: they WILL (and have already) reduced the output of lifesaving and life-altering drugs available to treat mankind. People (like yourself) see the merits of lawsuits like Levine -- but you don't see the price. As an employee in big-pharma R&D, I see the price. It's likely I'll also PAY the price with my job.

  10. Hi again, Nathan--genuine question. Do you think the industry (meaning, top decision-makers) bears any responsbility at all for the situation in which it finds itself?

    When the auto industry went belly up (more than once) here in Motown, there was all kinds of discussion of their short-term thinking, denial, going for quick bucks, igoring the big picture, etc.. They did not put all the blame on externals; in fact, maybe the put _too_ much on themselves.

    I won't pretend to weigh the importance of this or that factor. But studies have shown that a few percentage points increase in public confidence translates into more percentage points increase in market share.

    The combination of blockbuster model, loss of patent (legitimately), starved pipeline (actually), and the understandable--but still contemptible--willingness of some companies to push the envelope via dangerous off-label promotion, burying studies, and promoting the hell out of whatever "while the sun shines" (before the wider AE picture emerges) must certainly play a role.

    I am not "blaming industry" for everything that has happened. But I am blaming its top decision-makers for _some_ of it. And they are the ones who have happily parachuted away, leaving people of integrity, who are the vast majority, to deal with some of the mess they made (and for which so many others pay the price, those within the industry among the first).

  11. I really don't know how much blame to put on pharma execs. I know we are far from a perfect industry and that we've made some mistakes. In most industries, mistakes just cost money. In this industry, mistakes cost lives. We know that. But the flipside of that is that success SAVES lives. In most industries, success just makes for a better quality car or a cheaper MP3-player. The pharma industry plays for much higher stakes than other industries.

    My point is that I'm just asking people (in this case Diane) to remember that lawsuits (and the other factors I mentioned) have a nasty consequences that few people like to consider. It's easy for people like Diane to paint the big corporate giants as a the "bad guys" and "unamerican". The reality is far more complex.

  12. Nathan,

    I think we are all agreeing on the same thing. Just like the people who were behind the mortgage/banking scandals of current issue, there are some higher ups in Pharma who should be taking responsibility for what they have done, and continue to do. Thankfully they are not the majority, but they have the power to wreak havoc. We need to create laws and rules that ensures that this will not happen again.

    At the risk of sounding like a broken record, after all my years of experience in Pharma, my opinion is that informed consent, transparency is what will save the industry.

    We have all got to take responsibility for our own health.

  13. Nathan:

    My frustration is based on what has happened under the name of science and tort reform. I want you to know I have the highest regard for science and do not wish that you or anyone lose their job. Our country needs good scientists and inventors more than ever. When I think of science and invention, names like Salk, Watson and Crick, Thomas Edison, come to mind. Furthermore, I am against exploitive lawsuits; they are as unjust as preemption. My desire is that justice be preserved in America and returned to the people of Michigan.

    Truce, I hope?

  14. Do you ever stop and think, Nathan, that your blanket defense of the industry is just as detrimental as another's attacks on it? I don't think I've ever seen your voice raised on the side of the victims (yes, victims) when industry has egregiously harmed people - you say nothing. The willful misbehavior of some pharmaceutical and device companies is appalling and must needs be punished. The fact that they do some good can't overshadow their bad deeds. What is your opinion of this little history of Lilly and Zyprexa? Do you really think Lilly shouldn't have been punished for it? Or that the punishment was just?

    There are shades of gray. Not everything is done with intent to harm, but there are laws against negligence too. Is knowing someone might be hurt and not warning them less of a crime than hurting them yourself?

    btw - better quality cars save lives too.

  15. Nancy, Thanks for Clara’s website, she’s adorable! My mom was Italian and would have been 91 this October. There’s seven of us and she was always cooking. If you stopped by, you stayed for dinner. :-)

  16. Dianne, My mom, who just turned 80, always had something in the oven when we were at home (she had five).

    On another note, Michigan citizens may want to check out Roy Poses' March 10 post on the Health Care Renewal blog:

  17. Thanks for the BCBS link, Nancy. My husband sells insurance and I am well acquainted with the Blues. Because they are Michigan’s “last-resort” insurer, they are granted a “tax free” status. Although considered a non-profit, they have $2.25 billion in reserve funds and, as you can see, pay their exes royally.

    If they win increased rates, many more folks in Michigan will have to forego health insurance. Very infuriating is the fact that our legislature voted themselves “life-time” health benefits, even though they serve under term limits.

    Between preemption, Michigan’s drug law and BCBS I feel like I’m constantly fighting for justice. My husband calls me “Mighty Mom.” But I promised him, I’m turning in my cape as soon as these issues are resolved. :-)

  18. Dianne, about your "...constantly fighting for justice..." in Michigan.

    1) You are hangin' out with the right crowd here on PharmaLittle, and
    2) I don't think you will be turning in your cape anytime soon.

  19. I know it... Thanks Nancy.


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