Monday, February 16, 2009


Godzilla versus King Kong: FDA Preemption Meets Comparative Efficacy

Lots of chatter today on the NYT article, linked below, that reports on funds set aside to do comparative efficacy studies in the U.S.. You will note that there is no indication whatsoever about how the resulting information will be used. But we are already hearing dire warnings about the end of the doctor/patient relationship, "rationing" (you're on the iceflow, buddy), and the end of civilization as we know it. Rush hasn't had this intense a day in some time.

Of course, we already have comparative "efficacy": it's called managed care and what your insurance will and will not pay for. It is not based on science. It is based on the lowest bidder and, on occasion, kickbacks. That's how Baycol won the Department of Defense formulary contract, by underbidding the other statins. And that's how we lost a number of good men, and good women.

The real policy questions here are subtle. They will not be solved either by population studies or by disingenuous rants about rationing and socialism. They are issues of policy, ethics, and science. They will require hard thinking, indeed.

In the meantime, it is at least interesting that the same folks who are today hypertensive over the comparative efficacy studies--like Glaxo's leadership--are the first to champion FDA's "expert" and "optimal" weighing of risks and benefits. _Those_ Washington bureaucrats are rightfully uber alles. The ones imagined by the counter comparative efficacy gang are leftist muggers and thieves. (i.e., Canadians). Choose your demons.

Time for everyone to take a deep breath. Medicaid in states like Washington and Oregon did their own comparative efficacy work some years ago. It was not based on cost (despite what its critics say), but on evidence.. That is why a lot fewer people ended up getting Vioxx in those states than in others. And survived.

And, btw, nobody in Idaho or northern California went berserk over this "chaos of conflicting standards."


  1. I didn't see where they had a comment section on the NYT. I have been reading the bmj online over the last few years and their goings on with Natl Inst for Clin Excellence (NICE) in England which sets guidelines for treatment recommendations.

  2. NICE is in England and they seem to be pharma influence free (unlike American treatment guidelines committees) seeing as they frequently draw howls of protest from pharma when they perform evidence based reviews.

  3. Thanks for stopping in, Doug. No doubt the NYT will get letters from the usual suspects on all sides.

  4. NICE has also drawn howls of protest from cancer patient and orphan disease patient who are unable to obtain lifesaving drugs that are readily available in other countries. I'm not sure what the best solution is - but NICE isn't a panacea.

  5. Agree Nathan. Whether it's the feds or private insurance, there is no one size fits all.

    My niece, who developed very serious breast cancer before she was thirty, was denied support for critical treatment by several insurance companies because it was not in the "standard protocol." It was many thousands of dollars more than she could afford, even with the help of family and friends. Apparently, young women are in a signficantly different situation than what is considered "standard."

    She and others fought and eventually won. But they are the lucky ones. So I agree - shouting either "rationing" or "panacea" won't help!

  6. A couple of lines I liked from the article in the NYT:

    "In addition, Republican lawmakers and conservative commentators complained that the legislation would allow the federal government to intrude in a person’s health care by enforcing clinical guidelines and treatment protocols."

    Is it just me or - is it just me? Every time we see something that might help us take a step to universal healthcare, something this country desperately needs, the republicans bring up these lame excuses! What about Preemption? Doesn't that intrude in a person's healthcare, by taking away their right as consumers to ensure that the drug/device being prescribed has been fairly and appropriately tested?

    Another line:
    "Bureaucrats “will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost-effective,” Betsy McCaughey, a former lieutenant governor of New York, wrote on Rush Limbaugh broadcast the charges to millions who listen to his radio talk show."

    Or maybe, just maybe, this information will allow doctors to use their gift of practical wisdom and further enhance their art and skill as physicians.

    We need independent critical analysis as this is the only way we can continue to challenge ourselves to be more innovative when it comes to finding the right drug for the right disease in the right patient.

    We really do have to look at the complete physiology/biology/demographics of the intended patient populations.

    NICE is on the right track, but still has to work a few things out. However, it is a necessary component to a universal health care program. When the government must pick up the tab and is picking up the tab by using tax payers money, we all need to be sure that there is a fair cost being charged that allows for innovation and research to continue, but at a price tag we can all afford to "live" with. When patients have to go to work just to cover the cost of expensive drugs in order to stay alive, then we are not improving anything, we've just created a "drug slave".

    Obama's on the right track....

  7. "When patients have to go to work just to cover the cost of expensive drugs in order to stay alive, then we are not improving anything, we've just created a "drug slave"."

    I'll rephrase: When consumers have to go to work just to cover the cost of expensive food and housing in order to stay alive, then we are not improving anything, we've just created a food/housing slave.

    Mmmm... There is nothing wrong with having to work to stay alive. It's served our species well for millions of years.

  8. Actually, I also agree with your comment. Here I was just talking about drugs in the context of how NICE is trying to find ways of determining efficacy versus cost.

    This is truly one of the most important issues of our time. How do we feed, house, educate and provide health care that is affordable for EVERYONE?

    Nothing wrong with having to work to stay alive, but we need to find ways of reducing, if not eliminating entirely the "working poor". We need a balance. Everyone should have the option of being able to save money and build their own reserves.



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