More Adventures In Oversight

Another batch of Sergeant Schutzes uncovered, this time at the FDA.

In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Charming. I suppose the next administration will have the pleasant job of figuring out how many recently-approved drugs don’t work or have ridiculously dangerous side effects. But look on the bright side! The brouhaha that follows could put more trial lawyers’ kids through college than asbestos.






18 replies
  1. 1
    rachel says:

    It sure makes me angry that medicines in the USA are so expensive because of all those predatory lawsuits against poor, picked-on drug companies. The administration had better hurry up with “tort reform.” /sarcasm

  2. 2
    Andrew says:

    The problem with using homeless and orphans for low cost drug testing is that you can’t use their corpses for animal feed if they take too many drugs.

  3. 3
    Zifnab says:

    I’m really disappointed in the drug companies for failing to police themselves. I’m equally bummed out that this Administration continues to knowingly or carelessly cause so many problems.

    Fortunately, I’ve got a few Zanex left in the bottle, so this won’t be bothering me in short time.

  4. 4

    […] Here is an interesting post today onHere’s a quick excerptIn a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer … […]

  5. 5
    Jake says:

    See, told ya! Government oversight is useless. We should just let the Pharm Cos self-regulate. And no, you can’t purchase drugs from Canada, they’re too dangerous.

  6. 6
    TenguPhule says:

    “In many ways, rats and mice get greater protection as research subjects in the United States than do humans,”

    I welcome our new invincible mice overlords pumped up on red wine.

    After the last six years, they’ll be an improvement.

  7. 7
    Dreggas says:

    No one could have predicted that Vioxx would cause so many heart attacks…

  8. 8
    TenguPhule says:

    No one could have predicted that Vioxx would be discovered by the public to cause so many heart attacks

    Fixed.

  9. 9
    Dreggas says:

    TenguPhule Says:

    No one could have predicted that Vioxx would be discovered by the public to cause so many heart attacks

    Fixed.

    excellent!

  10. 10
    superdestroyer says:

    It would help if you guys actually understood how clinical trials occured. The drug companies do not do their own clinical trials. They are performed at hospitals (generally university based teaching hospitals). For many people it is either get on a protocol to take an investigational new drug or die quickly because the standard drug did not work.

    The U.S. has a very high standard for proving that a new drug will work. That stanard ensures that some drugs that would benefit people never reach the market.

    The number is not that high considering that the same investigaitonal drug could be in use at 20 or more hospitals and each hospital would count it as a different trial.

    If you do not want research, then what is the alterantive?
    If you do not want drug companies developing drugs, what is the alternative? The U.S Department of medical development and marketing?

  11. 11
    rachel says:

    I volunteer superdestroyer as a human test subject. That’s OK, right?

  12. 12
    superdestroyer says:

    Rachel,

    How do you think medical progress is made without research protocols? Most onoclogy protocols let the person know that they are going to die because the standard of care treatment did not work but that there is an experimental drug or treatment that may or may not work.

    The real question is why are supplements and vitamin makers allowed to make medical claims that the drug companies would never be allowed to make?

  13. 13
    TenguPhule says:

    The U.S. has a very high standard for proving that a new drug will work. That stanard ensures that some drugs that would benefit people never reach the market.

    Some people are so stupid that it makes you wonder how they can write.

    What part of ‘they’re not monitoring the trials’ was missed the first time SD?

  14. 14
    superdestroyer says:

    TP,

    I see that you have the activist nitpicking routinte down well. Remmeber, when you make nitpicking the most important thing that government does, you are saying that people and companies should stop doing wht they are doing. Do you really want less medical research in the U.S.?

    The standard that I was referring to was the burden of proof that the drug actually works and performs better than the existing drugs. Most drugs are never approved by the FDA because the standards the the FDA demands for efficacy is very high. The data to show or not show efficacy is created in clinical trials.

    What the study is proposing is a pro-government worker, pro-union position to hire more GS-12 drug inspections to go around to healthcare facilities and review the paperwork that institutional review boards maintain.

    The unanswered question is how will that will paperwork review make patients safer? If is discourages new drug development, does it make patients less safe? If is prevents larger number of patients with uncurable diseases from getting onto research protocols, would you consider it a failure?

  15. 15
    Officious Pedant says:

    I’m sorry, SD, but I need to make sure I have this straight.

    If less than 1% of trials are being observed, and negative results are being downgraded by third parties, what burden of proof are you referring to? And how does closer inspection equal wanting research ended?

    Oh, and how does assuring the quality, efficaacy, and safety of a drug that could be administered to thousands,if not hundreds of thousands, qualify as nitpicking? Pretty important nit, no?

    I ask only because contradictory positions such as these are not the basis for a logical argument. Just sayin’.

  16. 16
    superdestroyer says:

    OP,

    The review is while the trial is going on. The FDA reviews all of the data after the trial is over. That is why the article is so poor. It mixed up during trial external audits with after trial data review to determine safety and efficacy. The FDA has a very high standard for efficacy. That is one of the reasons that drugs are so expensive to develop.

    Adding more during trial audits which would be performed by non-physicians would probably add little to patient safety. They would be paperwork reviews to ensure that all of the patients signed the consent forms, that Institituional Review Board reviews would have occured, and that they organizations were aware of any adverse reactions.

    If the FDA started regulating the same way as the Nuclear Regulatory Commision regulates (unannounced inspections that review the practice of medicine) most physicians would probably drop out of clinical trials. Most physicians do not make enough from doing clinical trials to warrant the current level of administrative oversight. Adding a couple more layers would probably drive most physicians to stop altogether. Is that what most people in the U.S. want?

  17. 17
    Officious Pedant says:

    So your argument still doesn’t address this bit:

    Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

    But the totally unsubstantiated suggestion that doctors would drop clinical trials in the event of random,then begs the question–what is it about random inspections that would be so burdensome? Particularly when it was you that voiced:

    The U.S. has a very high standard for proving that a new drug will work. That stanard ensures that some drugs that would benefit people never reach the market.

    Because without inspections, a thorough analysis of after the fact, and (forgive me) potentially doctored data, there is no question that review afterward meets this standard?

    You argument asserts that inspection, any inspection, during a medical trial would be considered so odious as to destroy medical testing in the US. On the one hand, that’s pretty hysterical, on the other, it’s totally unsupportable. All kinds of things get inspected in the US, and I defy you to name a single one that ceased doing business, or participating in research, as a result.

  18. 18

    […] Same old story, one small difference. Instead of screwing the country the Republicans fucked themselves this time. If the GOP was a roofing contractor nobody in their right mind would go anywhere near them. […]

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  2. […] Here is an interesting post today onHere’s a quick excerptIn a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer … […]

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