Thursday, May 30, 2013


In Chasing Medical Miracles, journalist Alex O’Meara’s looks at our medical system today and examines complex world of clinical trials, a $24 billion industry.

In recent years, clinical trials have shifted from academic settings into the commercial realm. The FDA continues to add new layers of rules and requirements for clinical trial in a reactive manner. Mr. O’Meara describes how this contributes to the difficulty academic institutions face, or even some big pharmaceutical companies, to recruit and monitor the highly specific patients that the FDA typically requires.

Pharmaceutical companies engage Clinical Research Organizations (CROs) that specialize in administering clinical trials are highly profitable. Companies recruit and pay tens of thousands of people to participate in tests. Mr. O’Meara raises ethical concerns about clinical trials including the possibility of CROs skewing results and the financial incentive for clinical-trial applicants to lie about their medical history.

While the “subject” participating in a clinical trial can also profit, participants that consent to a long term study are said to be in “lockdown” until it’s over. The allure of the money, as well as contributing to new medicine is exciting, but few realize the risk they enter while consenting to be a subject in a clinical trial.

Mr. O’Meara, a clinical-trial patient himself, found the experimental cell-transplant diabetes treatment worked briefly, but eventually the transplanted cells failed. While the trial did not cure diabetes, the message remains that his participation might have helped advance medicine.

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