The Office for Human Research Protections Wants to Kill 30,000 People Annually…

…and scuttle one of the best efforts going to reduce the problem of antibiotic resistance. I discussed before how the antibiotic resistance problem is, in the context of hospital infections, an infection control problem:

One of the hidden stories in the rise in the frequency of antibiotic resistant bacterial strains is that this has also been accompanied by an absolute increase in the number of infections. In other words, it’s not the case that you used to have 90 sensitive infections and 10 resistant infections per year in your hospital, and now, you have 50 sensitive and 50 resistant infections (which would be bad enough). Instead, you have the same 90 sensitive infections and 90 resistant infections (for a frequency of 50% resistance). That’s an 80% increase in infections (180 versus 100). This is a bad thing.
Essentially, rising resistance rates in a given hospital mean that infection control has gone to shit–which given the 33% increase over a three year period in the hospital-acquired MRSA infection rate is a pretty accurate statement.

Michigan, in concert with researchers at John Hopkins, instituted a program to use a simple five-step checklist that over an 18 month period this program saved 1,500 lives in Michigan. Nationally, that means…
[the Mad Biologist takes off shoes to do the countings]
…roughly 30,000 lives per year if implemented nationally. So what does the Office for Human Research Protections do?
It shuts the program down. According to the OHRP, since the hospitals did not notify the patients–in the entire hospital–of the checklist, this effectively was an altered treatment without the patients’ consent:
A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.
Yes, Intelligent Designer forbid, doctors who are practicing bad medicine and killing their patients should be exposed. Not only is this an awful decision as it relates to this particular program, and the potential to prevent 30,000 people from dying annually, but as construed, almost any public health intervention to reduce contamination that is not disclosed to patients will be shut down. What happens if a patient decides to object to this hospital-wide study? There are a lot of patients out there, and some of them are fucking morons. Is a data collection pilot program subject to this (beyond the usual HIPAA and IRB concerns)?
I swear, during the Bush Administration, we are either governed by crazed ideologues or complete fucking morons.
Related post: ScienceBlogling Revere discusses this far more calmly (but where’s the fun in that?)

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6 Responses to The Office for Human Research Protections Wants to Kill 30,000 People Annually…

  1. Orac says:

    I swear, during the Bush Administration, we are either governed by crazed ideologues or complete fucking morons.

    Oh, please. As dumb as this sounds, it has virtually nothing to do with the Bush Administration. It would almost certainly have happened no matter who is President. It’s more of an example of the excess caution of the government bureaucracy run amuck.
    I meant to blog this one but somehow didn’t get around to it. Maybe tomorrow, as I’ve discussed before ion the past how HIPAA and inflexible human subjects protections may have passed the point of protecting us over to the point of ridiculousness.

  2. Orac,
    If the Bush Administration puts pressure on OHRP and forces them to change this decision, I promise I’ll post that. Considering that the Bush Administration has micromanaged many different scientific agencies, I would expect them to step up here, since Republicans for years have been crying about excessive government regulation.
    Instead…nothing (so far anyway). If they walked the walk instead of talking the talk about government regulation, they would be all over this. So far, they’re not.
    You will always find idiot bureaucrats in every administration. But competent administrations work around them, particularly when lives will be lost–in this case, a “9/11” every month. Working around administrative incompetence hasn’t exactly been a hallmark of the Bush Administration.

  3. pxcampbell says:

    I’d say governed by fucking moronic ideologues — except, yanno, they’d never admit to actually fucking (they just do it secretly and tell everyone else not to).

  4. Hilary says:

    As a clinical audit co-ordinator, I don’t agree that “A checklist is an alteration in medical care no less than an experimental drug is”. It’s an alteration in medical care, certainly, but fundamentally different to an experimental drug.
    An experimental drug is an intervention for which evidence of effectiveness (and perhaps safety) is lacking, and being sought through the experiment. A checklist is a managerial device intended to ensure that interventions of DEMONSTRATED effectiveness are actually performed. If there is insufficient evidence that (say) hand-washing reduces infection risks, then it shouldn’t be on the checklist.

  5. Hilary,
    good point. Now if only OHRP would understand that…

  6. Dangerous Dan says:

    The New York Times article “A Lifesaving Checklist” (see It shuts the program down above) says in part,

    A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

    In what modern, well-equipped, insurance-supported, malpractice-insured hospital is washing hands and donning new sterile gloves before poking holes in a patient’s vein not a standard practice? Is there anything on the checklist that wasn’t accepted or expected practice before the checklist? If so, then perhaps it is a change in medical care, but if not, then the checklist is not a change in medical care, but a mechanism for preventing a random and undesired change in medical care. If that is the case, forced abandonment of it is about as sensible as removing “All employees must wash hands before leaving restroom” signs.

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