Sanofi Aventis rimonabant a diet pill approved but subsequently banned in Europe in 2007 was wrongfully pulled from the market because clinical trials assessing its cardiovascular benefits were prematurely terminated, according to an article published Friday in the Lancet. A clinical trial was supposed to follow 18,000 patients in 42 countries for three years to determine whether rimonabant could also be used to prevent heart problems, but European officials shut the study down due to concerns regarding the drug s increased risk of suicide. After a year of the trial, four people on rimonabant committed suicide compared to only one person in the placebo group.
Matthijs Boekholdt and Ron Peters of the department of cardiology in the Academic Medical Center in Amsterdam agree with the decision to discontinue the clinical trial. Any mortality associated with cardiovascular preventive therapy is generally viewed as unacceptable, they wrote in a commentary for the Lancet.
To which an incredulous ACSH's Dr. Gilbert Ross responds, There s so much wrong with this statement, I don t even know where to begin. To assert that any risk is unacceptable in a drug trial to reduce the risk of cardiovascular disease would make any such trials impossible to conduct. Such a precondition is especially heinous, since heart disease is the most common cause of death in the civilized world.
Eric Topol, director of Scripps Translational Science Institute and the study s lead author, brings logic and reason to the table. We accept trade-offs in medicine, he told The Associated Press, and the psychiatric side-effects might have been acceptable if we had found greater cardiovascular benefits later.
ACSH's Jeff Stier couldn t agree more. How can you say that any mortality is unacceptable? Then you will never have a marketable drug since there could never be a benefit-to-risk comparison. Dr. Boekholdt and Dr. Peters must therefore be opposed to aspirin as well, since even aspirin has some risks.
