Saturday, October 3, 2009


Editorial on Device case

Today's NYT carries an editorial on the device case discussed last week on Pharmalittle--the intervention by four Dem congressmen on behalf of a device, its getting fast-track appoval without appopriate review of either safety or efficacy (both of which had gotten thumbs-down by earlier FDA reviewers), and the pols receiving large campaign contributions from the manufacturer soon after. FDA will now do the review it should have done in the first place.

The editorial is here

The NYT calls it "shoddy." A little understated in my view. A knee device, like this one, seems unlikely to cause avoidable death. But serious injury, which could lead, in turn, to death, does not seem out of the picture. So this is potentially negligent homicide on the part of the pols and FDA Commish Von Esch who was there at the time, and involved in the bogus approval.

If there are any FDA'ers out there, current or former, I wonder if they could estimate how often such approvals occur?

Should the facts so indicate, all in this case should be prosecuted. And not for "shoddiness."


  1. Related to the above, Frank Pallone, one of the Dems involved in pushing "shoddy" approval, has also been a point guy on reversing Riegel on device preemption.

    Here is the NYT on that:

    My current view is that the first fraud suit should be brought against Pallone himself.

  2. The FDA is still investigating itself. What assurance does the public have that drugs and devices are safe?

    There needs to be an oversight group that is not allowed to received money from industry or any special interest group.

    No politician should be allowed to take donations from industry.

  3. This would mean an entirely publicly funded election system. I'd favor that, but I don't think it has much chance of happening. No contributions from anyone, industry or otherwise.

    Re: FDA, I don't think it has ever happened that the agency has named specific pols leaning on it and identified a former Commish as being on the take. I think we're seeing Sharfstein and Hamburg at work, and I think they're working well.

  4. You’re right, Justice. There is not much chance of that happening. It would require a politician who has not taken any campaign (or other) money from industry to introduce a bill outlawing the giving or receiving of large contributions. Treat a company like an individual in that regard; limit their contribution to what an individual can give. Unfortunately, there is probably no politician who has not filled his/her own coffer, who could get in the public’s face with a bill and expose the givers and the takers.
    Perhaps Michael Moore would consider running.

  5. This an addendum to Dianne's post--I hadn't realized there is a wider study the FDA commissioned the IOM to do concerning its device approval process. So the pol-Commish scam is part of that. Why FDA chose to release it at this particular moment is interesting to speculate about.

    Since Pallone has been a point person in the effort to revise the MDA to allow liability, it certainly messes with his credibility--a response I certainly share. The O administration itself has spoken in more than one way about "tort reform." On one side, they've been explicit about agency preambles and preemption. On the other, they have responded positively to some of the (mostly) Republican pressure to include some version of "tort reform" in the healh care reform bill.

    Since the MDA is not a preamble, but a law passed by Congress, the O administration could well argue that its earlier, anti-preemption statements would not apply here.

    On the other hand, Cass Sunstein, chief legal advsior to the White House, has been one of the favorite targets lately of Fox News,Inc. Since Sunstein has actually bee a moderate conservative on these issues, the Foxies might actually be stepping on their own tails....and, thereby, entered an Only Spin Zone.

  6. I agree, Justice, Drs. Sharfstein and Hamburg are doing good things. But “shoddy” has been around for a long time. Looking forward, meds and devices will most likely be safer. But for victims the damage is done. Special interest and their lobbyists have taken a huge toll on our safety, health and democracy.

    “Until special interest lobbying is removed from every level of the health care decision-making process, all schemes at controlling costs are chimerical.” -, What ReGen Tells Us about Health Care Reform | Gooznews

    America is in desperate need of investigative reporters who will tell the story of how large corporations use lobbyists to influence lawmakers and how that is affecting all of us.

    Foxies need not apply.

  7. All the time. Just take a look at these reviews.

    On page 897 - 898 it's suggested that FDA officials and a Pfizer VS Larry Alphs have likely committed crimes including witness tampering.

    In fact if you go through the reviews you find clear statements by certain FDA officials that are clearly false including one that is contradicted by an e-mails to that individual. I believe this may be evidence of falsifying government documents which is a felony.


Note - Due to a time out issue with Blogger, you may receive a message that requires you to resend your comment. This will not affect its contents.