Socrates once declared that medicine "acts as both remedy and poison" and that "this charm, this spellbinding virtue, this power of fascination, can be—alternately or simultaneously—beneficent or maleficent." Modern America clearly appreciates the benefits. Today, a full 61 percent of adults use at least one drug to treat a chronic health problem, a nearly 15 percent rise since 2001. More than 1 in 4 seniors gulp down at least five medications daily. The trend has multiple causes: a spike in diabetes, heart disease, and arthritis related to obesity; revised medical guidelines that treat high blood sugar, hypertension, and high cholesterol sooner; and a multibillion-dollar push by pharmaceutical companies to speak directly to consumers about the payoff in trusting our hearts to Lipitor, say, or taking Boniva to help stop bone loss.
Therapeutic advances have, no question, proved lifesaving for many. Heart disease deaths have dropped steadily over the past 15 years, for example, thanks in large part to cholesterol-lowering statins and clot-busting drugs administered during heart attacks and strokes. But a growing chorus of experts worries that one unintended effect of all the pharmacological success is that many people may be blithely taking drugs they don't need, potentially setting themselves up for severe consequences. Clinical trials that prove a medicine safe and effective may demonstrate nothing about long-term risks or whether it benefits elderly folks or people with multiple health issues; usually new drugs are tested for just three or so years in a few thousand middle-age adults with a single particular problem. Given that a drug's serious side effects might show up only after months or years on the market, someone whose dangerous heart disease can't be controlled by existing meds has a much clearer incentive to try a new drug than people with a mild condition. Consider Vioxx, the blockbuster arthritis drug withdrawn from the market in 2004 after researchers estimated that it caused between 88,000 and 139,000 heart attacks during the five years it was prescribed.
"As we treat lower-risk populations, a drug has to be safer" to justify its use, says Steven Nissen, head of cardiology at the Cleveland Clinic. His 2007 study showing a link between the diabetes drug Avandia and heart attacks, along with a similarly damning study published in June by Food and Drug Administration researchers, has led many experts to call for the drug to be pulled off the market; the FDA decided last month to severely restrict access to the drug, allowing prescriptions only for those whose diabetes can't be controlled with other medications. Doctors shouldn't be prescribing any drug without considering whether a patient's personal risks exceed his or her clear benefits, Nissen says. And patients should be asking: How will this drug help someone with my medical history? What are the possible side effects? Has it been shown to prevent clinical events like a heart attack or bone fracture?
Nissen and other experts have loudly criticized the FDA for the way it monitors the safety of drugs after they've arrived on pharmacy shelves. While the agency often requires ongoing studies, drug companies decide how the research will be conducted—and they have a history of reaching positive results. An August study in the Annals of Internal Medicine found that 85 percent of industry-sponsored trials showed a drug worked well, compared to 50 percent of government-funded trials. "Companies often lack an interest in addressing safety questions after a drug is approved," says Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.
In the case of Avandia, the FDA wanted a post-approval safety trial of how it works when used along with the drug metformin, as it would normally be prescribed. But manufacturer GlaxoSmithKline decided instead to compare Avandia's effectiveness in lowering blood sugar against metformin and another drug; Avandia was found to work best. Other GSK research has shown that users are no more likely to have strokes or heart attacks compared with those who took other diabetes medications, though FDA medical team leader Thomas Marciniak recently re-analyzed that data and called the study "inadequately designed." GSK spokesperson Mary Anne Rhyne told U.S. News that the study "was conducted according to good clinical practices and the data are reliable."
[What Now for the Diabetes Drug Avandia?]