Friday, July 31, 2009


Science Dies Again

The U.S. House has put so many stipulations around the potential uses of comparative efficacy data, that it is--in the words of another blog--entirely "neutered."

So insurance will continue to be the ones who _do_ deny and ration care based on their own versions of comparative efficacy. So will formularies based on the usual "arrangements," some legal, some not. And science will be flushed down the toilet.


  1. Previously on this site we were exploring the lobbyist issue. I wonder if this is an example of the Pharmaceutical Industry's investment in our legislative process to further future profit?

  2. I don't think so, David. I think it is purely about protecting innovation and the continuing availablility of life-saving medications to all people, everywhere.

  3. To know the ROI (Return on Investment) we would need to know how many millions were spent on lobbyists and how many billions will be reaped in profit.
    Maybe these numbers would put us in the ball park -
    50,000,000 in lobby expense (probably high)/

    50,000,000,000 in future profit (probably low)

    That would be a 1000% ROI - Pretty good work if you can get it. Fortunately for Pharma our Congress is eagerly taking applications.

  4. Sorry Dan, I posted before seeing your post.
    So I would ask - how will not allowing comparison of similar drugs and devices protect innovation and preserve the health of Americans?

    To an extent I can see your point but I quickly see the downside of such a situation.

  5. David,

    The question is, what is a "similar drug." It may be true, in a test of large numbers, that Drug A is better at lowering cholesterol than Drug B. But there will always be individual patients who do better on Drug B. The concern is that, if comparative efficacy is used to make the decisions on what is available, those patients are out of luck.

    An example are the current statin options. Most insurance plans cover generic simvastatin but not Lipitor, which has not yet become generic. But there are many patients who do better on Lipitor even though, if you only crunched large numbers, the two drugs would look roughly equivalent. Thus the formulary approves simvastatin but not Lipitor.

    That is the present situation of most insurance plans. There is no reason to think a government plan would be more "liberal," and many reasons to think the opposite would be true.

  6. Good points Dan - It seems there are good and bad arguments for almost all pharmaceutical issues today. But there also seems to be too much lack of hard data to back up either point of view.

    Is it more of a problem to compare drugs and control availability or allow some differentiation of drugs?

    One argument you made up stream that I've seen used by any number of people for a variety of pharmaceutical supporting arguments is that we must have this or that so that we can continue -

    "protecting innovation and (have) the continuing availability of life-saving medications to all people.."

    This is a stunning statement that no one in their right mind can argue against. Of course we want to protect innovation and we don't want pharma companies to stop making their products. But honestly is this an argument or a scare tactic?

    Dan, I hope you don’t think the fine people in our pharmaceutical companies don’t have the wherewithal to invent new products that are not only beneficial but also safe and cost affective.

    Unparalleled technical skills are there, good management and marketing practices are deeply lacking.

  7. David--Of course, I agree with you. But if comparative efficacy meant that only the "winner" drugs would end up being covered that would hurt both patients and innovation.

    It would hurt patients because those who happen to benefit most from the "not winner" drugs--but still effective ones--would not have those options available to them.

    It would hurt innovation because, while companies would compete to win, it would not make any sense to pour millions of dollars into the creation of a drug that might not be the most effective viewed for a population, but still the best drug for large numbers of people.

    Again, we see insurance companies do that all the time. They will cover the cheapest option and appeal to the large studies which show it may be just as effective as a name brand (e.g., again, like Lipitor). Those who are fortunate enough to be able to afford Lipitor would still get it, without coverage. But if you had a large government bureaucracy making these calls, it is not clear that a drug in this category would survive. And, eventually, they might stop being being made.

    I understand that sounds like a scare tactic. Sometimes it is used that way. But it is also a possibility that needs to be considered, I believe.

  8. This is all interesting, but it's not how the government actually works. Look at the Baycol story.

    When Baycol came out, it was adopted by the Tricor (armed forces) formulary, not because it was more effective than other statins (it wasn't), but because Bayer low-balled and sold it cheaper.

    Lots of vets were switched from drugs like Lipitor, which was working for them, to Baycol. And a good number of them ended up developing rhabdo, becoming seriously ill or dying.

    Genuine comparative efficacy (which includes safety) could have prevented that. Instead, there was comparative bargain hunting, and people died who would not have.

  9. I believe in innovation, but at the same time, I think a lot of new drugs are old drugs with tiny changes. We need comparative studies and good science to find the best answers.

  10. Agreed Dianne and Dan, we need an effective compromise for this problem.

    Dianne, also agreed that some new drugs are old drugs with tiny changes but with huge marketing budgets. You know, enough budget that it can convince people that they must have the drug.

    This is certainly a tactic used in other industries to bolster sales and profit but given the overwhelming cost of prescription drugs and medical devices in our country and the extreme affect they have on our bodies, isn't it time that we say enough is enough and put some 3rd party controls on the situation?

    Not 3rd party as in the FDA though. 3rd party as in - a can't be manipulated by big money party.

    Here I am a conservative Republican calling for more controls on an industry gone wild. What’s the world coming to?

  11. The of course there is the problem of skewing the data in order to fit the description of what it would take to "create" a winner.

    Don't say it doesn't happen, or how dare I suggest it. Just think about Vioxx. In the post Vioxx era, we have found several others who are supressing cardiotoxicity data for other drugs.

    There needs to be an independe board of experts who review all the raw data in it's entirety. I would also suggest that the drug and all identifying information as to the company is completely bolinded to the independent reviewers....

    This is the only way to get everybody off the hook!

  12. As he acknowledges, the potential issues that Dan raises are true of _all_ "managed care," PBMs, formularies, etc.

    In reality, most pts are able to get a particular drug or treatment that is appropriate for their particular situation, although it may take a bit more effort and paperwork than their using the "standard" treatment. That is true in Medicare as well. So the suggestion that a government designed plan would be any more restrictive and rationing than what we have now reveals a kind of knee-jerk, anti-fed bias, but does not reflect reality.

    David--Lots of conservative Republicans have recognized the need for more rational government regulation precisely to save a fair and competitive system. T.R. is probably the best example. Milton Friedman recognized the centrality of civil liability (lawsuits) in his self-regulating vision, and he would despise the arguments of the preemptors who invoke him.

    There would be no sucessful pharm. industry at all were it not for the FDA's setting rational standards and protocols, long as it has taken, and uncertain and open to corrpution as it remains. Most of industry recognized this themselves when Gingrich & Co. tried to dissolve FDA in the 90s. And, yes, they relied on precisely the same scare language we hear today--end of innovation, end of healthcare, losing one's doctor, losing one's treatment, etc. etc.

    It is time to move on.


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