Thus Spake Zuska

Race and Biomedical Research: Two New Books

I found out about both of these courtesy of the Chronicle Review Note Bene/New Books in Print feature. Both look extremely interesting.

First, Revisiting Race in a Genomic World, from Rutgers University Press.

With the completion of the sequencing of the human genome in 2001, the debate over the existence of a biological basis for race has been revived. In Revisiting Race in a Genomic Age, interdisciplinary scholars join forces to examine the new social, political, and ethical concerns that are attached to how we think about emerging technologies and their impact on current conceptions of race and identity.

Essays explore a range of topics that include drug development and the production of race-based therapeutics, the ways in which genetics could contribute to future health disparities, the social implications of ancestry mapping, and the impact of emerging race and genetics research on public policy and the media.

As genetic research expands its reach, this volume takes an important step toward creating a useful interdisciplinary dialogue about its implications.

The second is Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials, also from Rutgers University Press. The Chronicle review opens with this scary statement:

For tens of millions of Americans without health insurance, finding care can be a struggle. Today a growing number of the uninsured and underinsured have turned to a potentially risky source: clinical research trials.

Later in the review:

Physicians can earn substantial money turning their private practices into research settings. Still, there are qualms. Some think patients may feel coerced. Others grouse about restrictions on care. For example, a doctor conducting a trial of an obesity drug cannot recommend diet and exercise when a drug developer expects a product to be tested against a placebo without any life-style changes. Some physicians also feel uncomfortable that much of what they are testing are “me-too drugs designed to capture market share rather than revolutionize medicine,” Fisher writes. Site coordinators, usually nurses, have the most contact with patients and have to learn that “research is not care.” Some end up rejecting applicants who are too sick, fearing that they will get placebos in a clinical trial when existing drugs are available for them.

This calls to mind a comment I left on a post of mine last December:

…Calling someone a patient is describing exactly what they are…But calling someone who goes to see their doctor a “consumer” changes that relationship in significant ways in my opinion. Names are important. When I worked in the pharmaceutical industry I often argued with some of my colleagues about whether or not participants in clinical trials ought to be referred to in our documents and conversations as “patients”. My feeling was, no: we are not providing them with health care, they are offering their bodies for medical investigation. They are subjects in a study, not patients in a doctor’s office, and they ought to be called just that – subjects…

The last paragraph of the Chronicle review is just depressing.

There are two dominant demographics for trials, Fisher says. Uninsured middle-class white women are the most common subjects for efficacy trials that require people with a given condition to test a new drug or do comparison studies. Low-income minority men, who in the Southwest are often Latino and undocumented, are the main source for healthy-subject trials that test the toxicity of new drugs and involve higher stipends but higher risks. Yes, there are informed-consent procedures, but Fisher’s findings are disturbing. In both kinds of trials, minds appear to be made up before the consent forms surface. The documents lack clarity and are sometimes ignored. After all, the author points out, the form never answers the one question patients most want to know: Will they get the placebo or the drug?

As the review points out, since a lot of these trials are being conducted with private practice physicians, not in academic settings, IRBs are generally not involved. Truly scary.

Comments

  1. #1 Oliver
    February 17, 2009

    For all the true problems described, this one boggles the mind:

    “The documents lack clarity and are sometimes ignored. After all, the author points out, the form never answers the one question patients most want to know: Will they get the placebo or the drug?”

    What, precisely, does the author think is the point of a double-blind trial? Rather than answering that question, the forms should state in an unmistakable and unoverlookable way “If you participate in a clinical trial, you may be part of the placebo group and thus not receive any drug at all. Do not expect to be cured in a clinical trial”. Now, that would probably reduce the number of willing participants, but it needs to be explainedn nonetheless.

  2. #2 Lilian Nattel
    February 17, 2009

    Sad. Just really sad.

  3. #3 Luna_the_cat
    February 19, 2009

    Oliver, you’re missing the point. OF COURSE the form doesn’t answer that question. the point is that the study groups are, in the case of the uninsured, almost certainly people who are only there because that is their only chance to get *a* drug — the only chance to get a potentially decent treatment at all. They are there because a 50/50 chance of getting something that still may not work is nevertheless better than getting nothing. And in the case of the healthy test subjects, they are only there in the hope that they get the placebo, because no-one wants to really subject himself to possible toxicity — but they need the money, and they’re willing to risk themselves based on the chance that they will get something non-toxic. And the point is that the question of “will I get the drug or the placebo” is the only thing that these people really to want to know; the discussion of risks of one or the other is ignored, because to a large degree the risks are irrelevant to their decision. And since the “what will I get” question is indeed never answered, they may ignore the paperwork entirely.

    And it’s just sad that people’s lives drive them to this. It isn’t motivated by a genuine desire to contribute to science and medicine and human good, and it’s not “informed” in that it’s not about weighing risks of possible side effects. It’s just pure damn desperation.

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