Double blind study with placebos is best

Oliver Wendell Holmes, poet, writer, physician, and the probable inspiration for Arthur Conan Doyle’s “Sherlock Holmes,” speaking to the Massachusetts Medical Society in 1860, said, “I firmly believe that if the whole “Materia Medica” (all the medicines in the world), except for digitalis and opium, could be sunk to the bottom of the sea, it would be all the better for mankind … and all the worse for the fishes.”

Dr. Holmes said these words at a time when patent medicines, bloodletting, leeches and medical quackery of all sorts were in vogue. Medical science and the drug industry have come a long way since 1860 and today, while still not perfect, the health and safety of the public is very well protected by the exacting requirements of the Food and Drug Administration.

Every new drug, before it can receive the approval of the FDA, must pass a series of very rigorous tests demonstrating not only its effectiveness in treating the condition or illness for which its use is indicated but also its relative safety. Every medicine or treatment is a two-edged sword, able to help but also to cause harm. It is up to the physician to use good judgment and experience to balance the potential benefit of a particular drug or treatment against its possible adverse side effects and possible interactions with other drugs the patient may be taking for other diseases or conditions.

The FDA lists the effectiveness of each drug against a particular illness, indication or condition and also lists all the side effects and drug interactions that were observed and reported during the years the drug was being tested, as well as any adverse side effects that only became apparent after the drug was approved for use by the public.

The various side effects are reported as having occurred in a certain percentage of the patients using the drug as compared to the same side effects occurring in patients who received a placebo instead of the actual drug.

These drug trials are called double blind studies because neither the doctor doing the evaluation of the side effects nor the patient participating in the trial knows whether the real drug or the placebo was administered. In other words, the patient and the doctor are both blind as to who received the drug and who received the placebo. This is the best and most scientific method of evaluating the results of the trial.

The frequency of occurrence of a particular side effect is compared to the frequency with which the same side effect occurred in those patients taking the placebo. All this information is available to the prescribing physician from a variety of sources and you should always ask your doctor about the possible chances of having a side effect from the medication that was prescribed for you.

Have a Question? Call Dr. Okun at 718-241-6767

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