 Many of us seniors were stunned by the recent announcement by the U.S. Food and Drug Administration that naproxen (Bayer's brand name Aleve) was to be added to the list of questionable medicines. This popular over-the-counter drug is used to treat headaches, arthritis and gout, among other ailments. This announcement followed other surprising warnings made during 2004 which included Merck's Vioxx and Pfizer's Celebrex and Bextra. These drugs are in a subset of nonsteroidal anti-inflammatory drugs, called Cox-2 inhibitors, that were designed to avoid the stomach bleeding and ulcers caused by older drugs like aspirin.
Vioxx was recalled in September 2004 after a study showed significant increase in risk for heart attack and strokes. Within weeks, it was announced that the arthritis drug Celebrex showed an increase for heart risks, and in December 2004 the warning was made regarding heart risks for naproxen.
Naproxen has a 30-year track record, so the troubling results that came from an National Institutes of Healthfunded trial that compared Celebrex, naproxen and placebo in patients at risk for Alzheimer's disease confused both doctors and patients alike. The trial, begun in 2001, was planned for seven years and included 2,625 patients. The use of Celebrex was suspended after the FDA warnings were issued based on another trial; then the early results from this trial showed a 50-percent greater chance of heart attacks or strokes in patients on naproxen when compared with those on placebo, and the use of naproxen was suspended. Subsequently, FDA officials did not urge patients to seek alternative treatment to naproxen, but did urge them when taking naproxen to follow the instructions carefully and avoid using the drug for more than 10 days.
Prescription drugs are not the only safety concern; many will recall the risks caused by phenylpropanolamine found in cough medicines, nasal decongestants and weight loss products. Banned in 2000 due to increased risk of stroke, the drug is still available in other over-the-counter medications. Ephedra is a stimulant used in diet pills and sports drinks that has caused myocardial infarction, stroke, seizures, and even death. Both of these drugs are difficult for the FDA to control because they are in preparations sold over-the-counter. We seniors especially need to read labels carefully before we self-medicate. And the local friendly licensed pharamacist can offer excellent advice.
A 1999 Journal of the American Medical Association reported that 100,000 Americans die every year due to adverse reactions to prescription drugs. Adverse reactions are the fourth-leading cause of death in the U.S. Further, one in five new drugs will have serious side effects after FDA approval.
An interesting study that included new drugs was reported in the journal in 2002. The largest trial of the treatment of high blood pressure ever done—42,000 people at 600 different clinics—was called the ALLHAT study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) performed by the National Heart, Lung and Blood Institute, a department of the National Institutes of Health. The drugs studied were:
1) a calcium channel blocker (Norvasc sold by Pfizer);
2) an alpha-adrenergic blocker (Cardura sold by Pfizer; also sold generically as doxazosin);
3) an angiotensin-converting-enzyme or ACE inhibitor (Zestril sold by AstraZeneca; also sold as Prinivil by Merck; and sold generically as lisinopril); and
4) a generic diuretic or "water pill" of a type that has been on the market for more than 50 years.
The result? The old-time diuretic turned out to be just as good for lowering blood pressure and better for preventing some of the complications of high blood pressure—mainly heart disease and strokes.
"It's like playing Russian roulette. Why risk the health of patients by using new drugs when there are older drugs we know more about?" asks Dr. Sidney Wolfe, director of Public Citizen.
Why, indeed? Dr. Macia Angell, in her new book, The Truth About Drug Companies, reveals some of the reasons that she saw in her capacity as the editor in chief at The New England Journal of Medicine. Part of the problem is the rush to market a new drug before the patent runs out on the previous moneymaker. Another is the high cost of the intense competition to recruit human subjects for the clinical trials. An estimated 80,000 trials were ongoing in 2001 in the U.S. alone; 2.3 million Americans were human subjects. Participants are paid to take part, but this is dwarfed by the payments made to doctors who earn an average of $7000 per patient enrolled. Complicating this is the wishful diagnosis that may happen when just one more patient with asthma (or whatever) is needed, and "if the wrong patients are enrolled, the results of a trial are unreliable, and that is probably often the case," Angell says.
When the health provider prescribes a new drug, seniors can ask, "Is this drug better only because it's a higher dose? Are the benefits worth the risks? Is there a generic or equivalent drug that is cheaper?"
Andrea Dorey is a licensed vocational nurse, medical writer and former AARP president. Contact her at andid@cagreens.org.
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