HERSHEY – It seems rarely a week goes by where there isn’t a news story about the dangers posed by different drugs or medications. These stories often lead to near panic and, not infrequently, patients deciding to discontinue their treatment without first speaking with their physician. Today we talk about encouraging and empowering patients to be more involved in their personal health care. However, patients are not empowered when they rely on information that is inaccurate or incomplete.
Pharmaceutical and medical device companies are required by the U.S. Food and Drug Administration (FDA) to carry out comprehensive evaluation of all products submitted for commercial use. The sequence commonly involves animal testing followed by small-scale human studies assessing questions of safety, toxicity and dosage. If these early studies reveal that the drug or device performs as anticipated and appears safe, larger FDA-approved and monitored trials on human subjects are performed. No product reaches the public without extensive FDA review and approval. Based on the results of these trials, the FDA determines what indication(s) the product is approved for and what the sponsor is allowed to claim, advertise or promote.
During these trials, side effects and safety are monitored by a safety data monitoring board independent of the company or trial sponsor, as well as the health-care professionals involved in carrying out the study. If there is any signal or question as to significant adverse patient events, trials are suspended or stopped for further analysis. When a trial is completed, there is a careful examination of the data collected, and if warranted, these results are commonly presented at large medical symposia and/or in medical journals.
Depending on the product and initial results, the news media is often clamoring for information and may obtain it in one form or another prior to its dissemination to health-care professionals. This practice only adds to the confusion of consumers and can be a disservice to patients and the public, not to mention many dedicated health-care professionals.
Unfortunately, clinical trial results are often misinterpreted. Their results may be exaggerated or denigrated inaccurately and prematurely. Contradictory or confusing information is sometimes promulgated. The public needs to understand that results obtained from well-controlled clinical trials may not completely indicate the potential side effects, toxicity or perhaps unexpected benefits of a drug or device once it is used in large numbers of patients who may not be equivalent to the trial’s subjects originally tested.
Most physicians and their professional societies recommend that patients discuss all medication questions and changes with their physicians before making arbitrary and perhaps unwarranted changes. So the next time you read or hear anything concerning your health in the news, first check with your doctor to see what he or she recommends.