Can you be sure your drugs are safe and effective?
Commercials on television and ads in magazines make medications seem like magic. They are supposed to solve problems like overactive bladder, elevated cholesterol and erectile dysfunction.
Smiling faces and cheerful music emphasize the benefits of pricey prescriptions. Most people tune out the long list of serious side effects that seems nearly endless and irrelevant.
Promotional campaigns work. Perhaps that's because many consumers don't understand what FDA drug approval really means, according to a new study about public perception of prescription drug pros and cons (Archives of Internal Medicine, Sept. 12, 2011).
In this study of nearly 3,000 volunteers, the investigators found: "Thirty-nine percent mistakenly believed that the 'FDA only approves prescription drugs that are extremely effective,' and 25 percent mistakenly believed that “‘only extremely effective drugs can be advertised to consumers.'"
In actuality, the FDA approves many drugs that are marginally effective. All the law requires the manufacturer to do is show that a medication outperforms an inactive sugar pill (placebo). Many antidepressants have barely achieved that minimal standard. A meta-analysis of clinical trials showed that "True drug effects (an advantage of antidepressant medication over placebo) were nonexistent to negligible among depressed patients with mild, moderate and even severe baseline symptoms" (Journal of the American Medical Association, Jan. 6, 2010). That said, more than 100 million prescriptions were written last year for such medications.
Consumers would be surprised to learn how many other medications achieve limited goals. For example, the drug ezetimibe lowers cholesterol, but we don't have good studies demonstrating that this medicine actually prevents heart attacks and prolongs life. Despite this, millions take the drug as Zetia or Vytorin, and sales topped $4 billion last year.
Before accepting a prescription, patients should find out if the medicine has a proven track record and clinical benefit. In other words, has the drug been shown to prevent disease and extend life, or does it just move a number? To learn what questions to ask prescribers about drugs for conditions like asthma, arthritis, diabetes, depression, hypothyroidism and osteoporosis, you may want to consult our brand-new book, “Top Screwups Doctors Make and How to Avoid Them” (Crown).
People often underestimate the likelihood or the severity of side effects from FDA-approved drugs. According to the recent study of patient attitudes, "One quarter mistakenly believed that the 'FDA only approves drugs that do not have serious side effects,'” and 17 percent mistakenly believe that “drugs that have serious side effects cannot be advertised to consumers."
If you close your eyes during a TV commercial for a prescription drug, you will discover that advertised medications can indeed have some very serious, even life-threatening, side effects. The study found that providing patients with clear explanations about the pros and cons of prescription medications helped them make better decisions. The authors call for the FDA to improve communication about what it knows and what it does NOT know about how well drugs work.