Take No Prisoners

When Ethics Committees Kill

Excellent piece on Bad Science about how ethics committees lead to real deaths of real patients due to delays and status quo effects.

One Comment

  • Matt
    Posted October 11, 2011 at 3:36 am | Permalink

    This might be a UK thing- this is what is happening RE: Ethics on the third phase of a clinical trial for progesterone (Or progoesterone if you’re across the pond) in traumatic brain injury happening at Emory right now. It will probably change the standard of care for TBI once finished, the way hypothermia protocols are helping in anoxic brain injury post cardiac arrest. Progesterone will only be a big pharma issue if it gets repackaged somehow (see: Serafim) as it’s currently generic in oral form.


    “Exception from Informed Consent (EFIC)

    As part of the trial, patients who are enrolled in the study may be provided the progesterone hormone without consent of family members or next-of-kin, in large part because success of the drug is highly dependent on being administered to the patient as quickly as possible after sustaining a brain injury.

    According to Dr. Wright, researchers normally get permission (consent) before a person participates in a clinical study. If that person is unconscious, such as in a traumatic brain injury (TBI), they will be unable to consent for themselves. In these cases researchers will ask for permission from a person’s legal guardian (usually next of kin). However, since TBI must be treated quickly, there might not be enough time to locate and talk to someone about the study before the medication is started.

    “In ProTECT III, a person might very well be enrolled in the study without a legal guardian’s or family member’s consent, explains Wright. “The U.S. Food and Drug Administration (FDA) has, in fact, created a set of special rules, called “Exception from Informed Consent” (EFIC). These rules allow research studies in certain emergency situations to be conducted without consent.”

    EFIC applies only when all of the following apply:
    A. The person is in a life-threatening situation
    B. Current treatments are unproven or unsatisfactory
    C. The study might provide direct benefit to the person
    D. It is not possible to obtain informed consent from: 1) the person because of his or her medical condition or 2) the person’s guardian because there is a very short amount of time required to treat the medical condition.

    “No new treatment for severe TBI has been approved in over 30 years,” says Wright. “With such promising success in laboratory testing and in our previous clinical trial, we certainly hope to conclude that this national trial – along with standard medical trauma care – works better than standard medical care alone in reducing brain damage caused from a TBI. If progesterone helps brain injury patients get better, it will be a nothing short of incredible for patients who suffer such debilitating injuries in the future.””

    I also don’t think that treatment options other than ethics committees are truly “choos[ing] one randomly at will, on a whim, in clinic,” in general practice (non-clinical trial stuff) they usually come in when no clear goal of treatment can be reached other than standard-of-care life support in a patient that can’t consent themselves and also no one of a clear legitimate ability to consent (spouse, power of attorney, guardian, etc) can be found after a reasonable search.

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