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Human Subjects as Political Pawns

When it comes to “alternative medicine” trials, it seems that the NIH is willing to experiment on people in ways that would be unthinkable for real biomedical research. The federal Office for Human Research Protections (OHRP) has posted a preliminary determination letter, dated May 27, 2009, addressing some of the charges we had made against the politics-driven NIH Trial to Assess Chelation Therapy (TACT).

It is a remarkably damning statement, particularly regarding an NIH study. That is, it found—or the recipients admitted—that each of several charges was valid. Among these are misleading statements and unstated risks in the consent form, and the embarrassing backgrounds of TACT investigators. According to the determination letter,

…investigations revealed multiple instances of substandard practices, insurance fraud, and felony activity on the part of investigators.”

On the other hand, the OHRP appears willing to let the TACT continue if it will ‘take corrective actions’. Regarding investigators who are felons, for example:

While concerning, these things do not automatically preclude an investigator from participating in research…

We recommend that the IRBs that reviewed this research re-examine the processes for evaluating study investigators to determine they are obtaining sufficient site and investigator information that is adequate to comply with HHS regulations…”

As disturbing as that recommendation sounds, the OHRP can only regulate what it has statutory authority to regulate. It regulates institutions, not investigators and not IRBs.

We remain concerned, however, that the TACT protocols and investigators did not provide accurate statements to the relevant IRBs in the first place. Wouldn’t such information have been important, not only for IRB deliberations, but for informed discussions with potential experimental subjects? From the determination letter, it sounds as though the OHRP cannot insist that the TACT address such inconvenient questions.

Some of our most important charges are either not mentioned (e.g., a tainted NIH scientific review committee, investigators promoting ‘chelation therapy’ during the study in violation of federal code, a tainted Data Safety and Monitoring Board, and evidence that incompetent investigators have contributed to at least two deaths in the trial) or were deferred to the FDA. Presumably, there is more to come.

We contended that if the TACT had been accurately represented in 2001-2003, no competent IRB or scientific review committee would have approved it. The OHRP determination letter implicitly raises this question: how could any IRB, after discovering the multitude of misrepresentations that were the basis for the study’s original approval, now allow it to continue?

Posted in: Politics and Regulation, Science and Medicine

Leave a Comment (4) ↓

4 thoughts on “Human Subjects as Political Pawns

  1. Sastra says:

    Perhaps they had become too complacent about the virtue of being perpetually “open-minded.”

  2. David Gorski says:

    As disturbing as that recommendation sounds, the OHRP can only regulate what it has statutory authority to regulate. It regulates institutions, not investigators and not IRBs.

    Actually, that’s not entirely true. OHRP administers the Common Rule, which contains the set of regulations that govern the setup and operation of IRBs.

  3. OHRP administers the Common Rule, which contains the set of regulations that govern the setup and operation of IRBs.

    You are correct. I probably overstated that point. It’s my impression, after reading many determination letters and corresponding with the OHRP extensively regarding another case, that it will require general remedies for an IRB (eg, ‘you must keep better records’), but that it is reticent to make pronouncements about IRB judgments in specific cases (eg, ‘you should have insisted upon consultation from a toxicologist’). I interpret that as a fear of venturing beyond strict, statutory language, but maybe I’m wrong.

    In any case, I agree with you that the OHRP could be far more flexible and broad in its determinations without defying the law, if for no other reason than its professed allegiance to the Belmont Report–which opens up a huge realm of interpretation.

  4. overshoot says:

    We contended that if the TACT had been accurately represented in 2001-2003, no competent IRB or scientific review committee would have approved it.

    The state of the art has moved beyond the point where this is an obstacle. The current “best known practice” is to avoid competent IRBs entirely by forming “pocket IRBs” for the purpose of rubber-stamping proposals.

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