Friday, August 21, 2009


JAMA, FDA, CDC Speak in Many Voices

The Gardasil vaccine has been mired in controversy pretty since its introduction three years ago. Merck lobbied very hard to make the vaccine mandatory in many states, and very nearly succeeded in a number of them. Were it not for the arm-twisting/pocket-lining suggested by Merck's tactics, and the Vioxx legacy, the company would almost certainly have succeeded.

This week, we have heard a range of messages about the vaccine. JAMA reported on overall safety to date. The summary conclusion was that even the most serious events following administration of the vaccine--including about 30 cases of ALS--could not be causally linked to the vaccine. That said, a JAMA editorial raised the question of whether even this degree of risk was outweighed by the benefits of the vaccine. See

In the meantime, the same JAMA article chastised Merck for promotional tactics (same old, same old) particularly through various medical societies. See Fierce Pharma's summary at:

In the wake of all of this, both the FDA and CDC have pronounced the vaccine safe for use based on current data available. But essentially no one is pushing anymore for mandatory vaccination, as was the case two years ago.


  1. What about immigrant females? Are they still being pushed into mandatory vaccinations?

    “For women who are American citizens, Gardasil is a choice; for women who are immigrants, the vaccine is a federal mandate upon which their presence in this country depends.”

    Or are they the final guinea pigs?

  2. As far as I know, you are right, Dianne. From what I read, the requirement went into effect in October, 2008, an initiative of Homeland Security at the end of the Bush administration. But nothing has changed--thanks for reminding us.

  3. For those interested in this topic, see: Pharmalot:

    Merck’s Gardasil Is Required For US Immigrants // Pharmalot

    The last comment is dated June 24, 2009.

  4. Anyone noticed FDA revamped its entire website beginning of the summer? Health reform more frightening when mandated gov agency to protect information and safety can't get this basic communication/management item right. Reliable sources say FDA staff wasn't informed/warned. Chaos ..told to report missing pages when they find them. Couldn't find where public was warned either. Some replacement pages without dates of origin. No transparency on who consulted, edited. Was in rsch project and lost access via original site links to various documents collected as references. Too many replaced by two words: Not Found

  5. Apologies...didn't mean to look off subject. Gardasil or any other issue? Should be talking about their competency. Without competency the rest is, well......impossible.

  6. Anon,

    When you say "competency" in this context, do you mean CBER's capacity to monitor Gardasil's AEs? And Q is you know--is the reporting rate from docs any different for biologics than for drugs?

    In any event, I recall there was a rather complicated series of Phase IV studies required for Gardasil, most of which would not be completed for a very long time.

    And, yes, I have noticed the new FDA website. Haven't done much with it, but I will try out some of my "favorite" searches. Are you suggesting (as it sounds) an intended purge?

  7. Vera Shavner has an unusually thorough review of the current state of the Gardasil issues at:

  8. Competency in the sense that they appear unable to adequately manage information.

  9. Reading through some of Vera Shavner's information about the Gardasil Chronicles and having just come from a Sci-fi thriller about the future (District 9, thumbs up) followed by a large cup of coffee - my imagination is hyperatctive.

    Anyway, I imagine 25 years in the future. Pharma has taken over the world. They have successfully accumulated the wealth of the world and all citizens have become subjected to them.

    They accomplish this by convincing the world that they are sick. Then produce drugs that cause damage worse than the invented diseases that they were meant to cure. They then purchase the political system and the eventually degrade human health to the point that all of mankind can not live without massive drug consumption.

    Hey, wait a minute... Make that 10 years in the future.

  10. David is off his meds again....

  11. LOL Halfababy,
    But seriously it seems to me that the answer is becoming obvious - we need to put as much effort as a nation into discovering how to avoid medication as we do in discovering how to medicate. Ten or twenty billion dollars spent on that could permanently turn the physical and financial health of this nation around.

    Reading the endless articles about the ill-intentions of some in this mega industry; shouldn't we distance ourselves as quickly as possible?

    I know we can’t completely disconnect from drugs but certainly the current trend is a future filled with pills for all kinds of avoidable ills. And then probably more pills to fix the damage the other pills have done.

  12. Yes, I agree. Most analysts predict that the current pharma business model will inevitably crash--loss of patent protection, picked the "low-handing fruit," etc.. And, of course, many disagree. But it will be interesting if we looked back at the current period the way we now look back at the days of the "medicine shows"--as much circus as healthcare.

    Individualized medicine, based on genetic variations, is the area of promise to which most people point. But how far we are getting, and can get, in that regard--and how much the current profit structure will allow progress in this direction--remains to be seen.

    An example: There is reasonably good evidence that PPIs and Plavix may interfere with each other, at least for some number of pts. It is because they are metabolized by the same liver enzyme, and one, in effect, "blocks out" the other. The issue has been around for several years, but only now are there serious warnings coming from Health Canada, Gastro societies, etc. (Interestingly, fewer cardiologists).

    How many patients are both on Plavix and something like Nexium. Indeed, a PPI is often given with Plavix on the theory (not strongly supported by data) that it may help prevent gastric bleeds. But here we have the second and sixth largest selling drugs which might, in essence, cancel each other out. How long will it take--and against what obstacles, distractions, and denials--before we know the fuller truth?

    BTW, there was a similar issue about the potential incompatibility of Plavix and most statins, especially Lipitor. We are talking about gazillions of pts who are prescribed both. It now _appears_ that the issue has less clinical impact, at least for most, but not all, pts. For the rest, they have luck and or prayer on their side. Forthe most part, they don't have access (genetic testing, and related) to the kind of data that would help resolve the issue for them personally.

    I know a doc in NY who is the world leader in his particular area, a subspecialty in opthamology. The Wizard of Eyes, as I call him. He is distrustful enough about Plavix and these issues that he uses gingko as a "blood thinner" instead.

    Most of us don't have the courage, or the potential foolishness, to fly that blind.

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