“The Body Hunters” by Sonia Shah

shah.jpgThere’s nothing I love more than a good book, unless it’s a free good book. Last week I was sent “The Body Hunters” by Sonia Shah. I’ve been sent free books based on my job before (either as a research professor or as security officer), but I’ve never been sent a book on the ethics of the pharmacutical industry before. It took me a bit to figure out, then I realized that I’m presenting at a Human Subjects conference. I’m sure they sent the book to all of the presenters.

Anyway, I read the book over the weekend and it’s very interesting. Shah takes a close look at the history of drug development and the factors which have let to US companies outsourcing the majority of clinical trials overseas to poor countries. The basic ethical problem comes about from two factors. First, the majority of new drugs are copy-cats trying to cash in on the drug market. They do not attack problems in new ways, they simply attack a problem in a way that’s similar to other drugs currently on the market. For example, all of the proton pump inhibitors for preventing heartburn. Once you know to shut down the acid pumps in the stomach, one way is as good as another. This is also true for anti-AIDS drugs, various anti-parasitics, etc.

The second factor is that statistically demonstrating a new drug is effective is easier in a placebo trial – a trial where the control is no treatment at all. You can still demonstrate effectiveness when the control is active, however, it requires a larger trial that takes more time, money and volunteers.

The ethical problem is that once a safe and effective treatment is known, a doctor has a moral obligation under the 1975 Declaration of Helsinki to ensure that a patient in a clinical trial is receiving that treatment. Moreover, in the U.S., which is by far the biggest drug consumer, patients won’t sign up for a placebo trial once there is a known, effective treatment.

To address the practical problem of not having enough test subjects, clinical trials are increasingly conducted in poor countries where patients often have no choice and grasp at any straw to possibly receive treatment. Shah also provides evidence that the lack of a regulatory structure in many of these countries leads to researchers ignoring the idea of informed consent and lying to get test subjects.

Shah argues that the best way to resolve the ethical problem is to require researchers to prove that their new drug out performs the best available treatments. This would involve testing not against a placebo, but against other, known effective, drugs. It may require larger trials, but it is definitely more ethical.

In addition to addressing the ethical issues, Shah presents a very disturbing look at the financial side of the drug industry. I need to talk to a few friends in the medical industry (one runs medical trials, the other is a phd/md focusing on oncology) to get their impressions, but at the very least I can recommend that folks read the book – it’s a well documented and clearly presented examination of an industry that many of us depend on.

1 Comment

  1. Judy Stone said,

    November 13, 2006 @ 9:55 am

    Interesting web site/blog, and beautiful photography you have.

    Have read some of Shah’s articles, though not yet gotten to her book. I agree with much of what she says but, at least from the articles, her arguments about overseas trials like the Nigerian meningitis fiasco seem too simplistic.

    Hoped you might find my new book of interest–it is a primer about doing clinical trials (and my adventures successfully doing clinical trials though in solo practice).

    I also have a chapter on Ethics as well as on the Politics of Research. Table of Contents are on the website. I would be happy to send you more information/that section, if you are interested.

    Best,

    Judy Stone, MD

    jstone@conductingclinicalresearch.com
    Author of Conducting Clinical Research:
    A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators
    http://www.conductingclinicalresearch.com

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