Great Smokies Medical Center of Asheville

Blinded by Double-Blind Scientific Studies?

Evidence-Based Medicine (EBM) is the latest buzzword used to describe an emerging model of healthcare that advocates applying data from scientific double-blind studies to "real" patients in clinical practice.

The double-blind study, the gold standard of scientific research, is a process by which two similar groups of people are studied. One group is given an actual treatment, while the other is given a placebo or "sugar pill." Neither participants nor researchers know which group is which until after the study is completed, hence the term "double-blind."

Proponents of EBM believe that applying research in practice will result in better treatment outcomes.

However, some physicians have concerns about applying scientific research data in their practices. They recognize the limitations of scientific research and thus don’t want to risk over-reliance on it, because doing so could expose their patients to both known and unknown risks.

What are some of the limitations of scientific research?

For starters, study participants may not be representative of people who will be likely to take the drug in real life. Study participants may be younger or healthier, and elderly or sick people do not respond to drugs in the same way their younger, healthier counterparts do.

Also, considering the potential for huge profits in drug sales, the pharmaceutical industry’s funding of research has been shown to buy biased results that, in the opinion of some, resemble paid advertising more than scientific research.

Additionally, even in the most scientifically-sound studies, group statistics do not apply to individuals, because people aren’t test subjects, but are complex and dynamic individuals. Furthermore, contractual agreements between clinical researchers and drug companies can take away the scientific independence of researchers and tie their hands from freely reporting unfavorable data.

Also, the very treatment a patient needs may never be researched. For instance, natural substances cannot be patented and thus don’t have the potential to produce the huge profits necessary to recover research costs, which are routinely in excess of $300 million.

The reliability of scientific research is regularly questioned. Many drugs have passed rigorous scientific studies and clinical trials and gained FDA approval only to be taken off the market because of side effects that became apparent only when the drug was given to "real" patients. Indeed, there is less risk when taking "tried-and-true" drugs that have withstood the test of time than there is from taking newer drugs that have been in the marketplace for only a short time. According to a report released by the General Accounting Office of the U.S. government in 1990, of the 198 drugs that the FDA approved between 1976 and 1985, a staggering 52 percent proved to have “serious post-approval risks.”

Practicing doctors can end up being spoon-fed whitewashed research data, unwittingly becoming the third "blinded" group.

Historically, most major advances in medicine have not resulted from scientific research, but instead from reasoning of individual physicians and their basic observations of the patient and his disease.

Throughout history, the real movers and shakers in medicine have been free-thinking individuals who were unbound by the influence of research money and restrictive political-based regulations.

What’s a patient to do? Cautiously walk, don’t run, toward the latest research. Get second, and third, opinions when needed. Go to physicians who practice integrative medicine, who utilize treatments other than drugs, who get to know their patients as individuals, and who value both the science and the art of medicine.

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