The answer is the placebo. Hallmarks of good biomedical research, placebos are used throughout the world in double-blind, randomized controlled trials. And recently, they've come under intense scrutiny.
Beatrice Golomb, an associate professor of family and preventive medicine at UC San Diego, has spent years thinking about the use of placebos in modern medicine. In a paper published in the Annals of Internal Medicine last October, she raises concerns that placebos are not regulated by the US Food and Drug Administration, yet can have a direct impact on whether a drug is considered effective or not.
In one classic case Golomb considers, researchers in the 1970s used olive oil as the placebo for a cardiovascular drug. Looking back, modern medical researchers realize that olive oil is anything but neutral in the cardiovascular system, and its use as a placebo likely jeopardized the results of the entire study.
Unfortunately, this is one of the few examples where this type of issue can be spotted, since, as Golomb points out, most placebo formulations are not reported. She analyzed more than 175 placebo-controlled trials published between January 2008 and December 2009 in the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine,and the Journal of the American Medical Association to see if they listed placebo ingredients. In over 90% of the trials that used placebos in pill form, no formulation was mentioned. This "breaches basic scientific standards of rigor" and "compromises the foundation on which medical decisions are based, and on which the fate of lives may rest," Golomb writes.
For its part, the FDA still views placebos as having no effect on either the body or the outcome of the trial, and correspondingly doesn't seem to place too much emphasis on knowing the formulation of placebos used in different drug trials.
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