“We’re not disputing the findings,” says Food and Drug Administration spokeswoman Sandy Walsh. “The numbers are consistent with FDA’s report tracking, but they don’t tell us why.” That data includes more than 15,000 prescription drug-related deaths in 2005—up from around 5,000 in 1998.
According to Thomas Moore, a researcher at the Institute for Safe Medication Practices, a nonprofit group in Huntingdon Valley, Pa., and the study’s lead author, the findings represent widespread failures. “There’s enough blame to go around,” Moore says. “Nobody wants to think about drug safety. Drug companies want to focus on the benefits, doctors don’t want to even consider the possibility that they may be hurting someone, because it makes them uncomfortable, and patients just want to get better.”
The number of reported adverse drug events grew four times faster than the number of prescriptions, according to the study, which analyzed data from ARES, the FDA’s voluntary reporting system for adverse drug events, launched in 1998. ARES takes reports from consumers, doctors and drug companies alike, but the vast majority of reports come from the drug companies themselves.
While nearly 1,500 drugs were implicated, fewer than 300 of them accounted for the vast majority of deaths, disabilities and negative drug reactions. This narrow subset, Moore says, may be the key to improving drug safety. “All drugs are not equal,” he says. “Pharmacists need to focus on these high-alert drugs and educate patients, so that if you’re taking one of these drugs you know more about it.”
Among the 15 worst offenders seven were pain medications, including morphine, oxycodone, fentanyl and acetaminophen-hydrocodone. Four were immune-system drugs, such as Infliximab and Interferon beta. And four were antipsychotics or antidepressants, including Risperidone and Clozapine.
A handful of new biotech drugs—including the popular anti-tumor drug “anti-TNF”—contributed heavily to the upward trend. But two-thirds of the drugs most commonly associated with adverse events have been around longer than the FDA’s reporting system itself. Insulin, for example, was linked to 438 serious adverse drug events in 1998, 1,800 in 2005, and a total of 9,579 adverse events in the seven-year period. Estrogen fared even worse, accounting for 11,514 adverse events in the same time.
Victims of adverse drug events were evenly divided among men and women but were disproportionately older, even after adjusting for the fact that elderly people are more likely to take prescription drugs in the first place. People over the age of 65 account for 12.6 percent of the population but 33.6 percent of adverse drug events.
The FDA’s Walsh cautions that adverse event reports, on which the study is based, do not provide a full picture. “When we get an adverse event report, there’s always a story behind that report that needs to be evaluated,” she says. “Sometimes there’s no way to determine how much the drug itself was actually responsible for the adverse event.” The FDA has launched a new pilot program to continue evaluating the safety of new drugs for up to 18 months after they’re approved.
“The tragedy is that we as a society are really quite good at the business of managing risk,” says Moore. “Look how much we use gasoline, for example, and how safe we are with that. But when it comes to medicine we still take for granted that it’s going to help us, not hurt us.”
