Sunday, September 19, 2010

Clinical Trials

NY Times article on the ethics of clinical trials here

The article raises the issue of randomized assignment to treatment and control to prove a drug's efficacy when the drug seems to be working and people's lives are at stake. Doctors, however, need to know which treatments are truly effective and this is only possible through a rigorous randomized trial. Also, drug companies need to prove to the FDA their drug works. This sadly pits millions of dollars in patent rights against the cost of the lives of those in the control group.

Another issue in this trial is its 'no-blind' design. It was obvious to the doctors and patients who was receiving the treatment and who was not due to the different delivery methods, confronting the doctors and patients with the ethical reality of the trial. As a patient I don't think I could handle knowing I was receiving what appeared to be an inferior treatment.

To argue the other side, randomized trials are necessary because they have the power to confirm what you suspect (the drug is working), dispel what you hope for (you think the drug is working when it's actually not) or save you from worse consequences (you think the treatment is helpful but it actually harms the patients).

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