How safe are America’s medicines? Ask the pharmaceutical industry or the FDA, and you will be told that we have the safest drugs in the world.
But the Vioxx fiasco has Americans starting to wonder if this is true, especially since an FDA insider has blown the whistle on the agency. According to Dr. David Graham, the public is “virtually defenseless” against serious side effects discovered after a drug is approved by the FDA.
Dr. Graham is Associate Director for Science in the FDA’s Office of Drug Safety. He testified before Congress that as many as 160,000 Americans may have suffered a heart attack or a stroke as a side effect of Vioxx. If this is true, it could be one of the biggest scandals in FDA history.
Vioxx was a popular arthritis medicine that was withdrawn by its maker, Merck, several weeks ago. A study showed that Vioxx may cause heart attacks and strokes, even in people at low risk of such events.
There were signals for years that Vioxx posed a risk, but FDA officials did little to alert either physicians or the public to the problem. That may be in part because once the agency gives a drug the green light for approval, it has a stake in the outcome. If the drug causes harm, it could reflect badly on the FDA. Consequently, there is a tendency to resist bad news.
To describe this conflict of interest, Dr. Graham has used the analogy of a parent with an unruly child. When a neighbor complains about bad behavior, parents may deny that their kid could be causing trouble. They don’t want to admit that their parenting skills might leave something to be desired. In a similar vein, FDA staffers hate to admit that a drug they approved is harming people.
A big part of the problem at the FDA is the failure of so-called “post-marketing surveillance.” The FDA looks carefully at the research done by the manufacturer before a drug is approved. But serious side effects may not become apparent until hundreds of thousands of patients are exposed.
The FDA has limited resources to devote to following drugs once they hit the market. The main system for collecting adverse drug reactions is called MedWatch. It allows health professionals and patients to report problems.
But a lot of bodies may have to stack up to get the attention of over-extended med-watchers at FDA. Even after Vioxx was taken by tens of millions, the agency did not detect a problem. If it missed a signal of such magnitude, one wonders what else the FDA may be overlooking.
The problems with Vioxx and questions about antidepressants have led some in Congress to suggest that a separate office of drug safety be established within FDA. This might seem like a logical solution, but it still permits a conflict of interest between those who approve a drug and those who track it.
Congress realized long ago that in the arena of transportation, there needed to be two separate institutions to avoid such a conflict. That’s why the FAA (Federal Aviation Administration) approves airplanes for flight and the NTSB (National Transportation Safety Board) investigates accidents.
Likewise, we urge the establishment of a separate agency for drug safety. Perhaps then Americans could regain confidence in the safety of their medicines.