BY ADAM S. CHAMBERLAIN
Politicians and reformers, in the name of "protecting public health," have been active lately. Due to the scare created by the COX-2 class of drugs, which includes the nefarious culprits known as Vioxx, Celebrex and Bextra, cries for more caution and slower drug approval have resounded through Washington D.C.
Slow down and save lives, or so they claim. But being overly cautious with a drug or medical device can have unintended consequences.
A prime example is the FDA's slow approval of the drug-eluting stent, which occurred two years ago this April. A stent is a tiny tube inserted in an artery to prevent restenosis, or the reblockage of a vessel, after it has been cleared through angioplasty. At first, stents were bare metal, but soon it was discovered that drug-coated stents which slowly released (eluted) their medication greatly decreased the chances of restenosis.
FDA's approval of the drug-eluting stent was wonderful news, except for one problem: the same stent was available in Europe a full year earlier. Considering that more than 800,000 patients a year receive angioplasties, and the vast majority receive stents, the year delay was significant. An estimated 50,000 patients could have avoided further heart problems had a drug-eluting stent been used instead of the conventional kind.
Studies have confirmed the benefits of this variety of stent. An assessment of published trials revealed that restenosis was as much as 64 times lower in patients who received the drug-eluting variety over the bare metal type. Another study discovered that the new eluting stents make stenting an option for up to 30 percent of patients who would otherwise need to go through bypass surgery. As one doctor noted, "We're making a quantum leap of improvement."
Due to these positive reports and glowing recommendations, the popularity of drug-eluting stents is growing. Approximately 90 percent of implanted stents are now drug-eluting as cardiologists become convinced of their added benefits. This translates into 80,000-90,000 major cardiac events (heart attacks, deaths and emergency stenting procedures) that can be avoided each year, as compared to the complication rates for bare metal stents.
Such statistics are hard to ignore. Delayed approval of the stent denied US heart patients a first-rate treatment option when it was available to people in Europe. In addition, the FDA's foot-dragging changed the time frame in which the device's use could spread among cardiologists. While hard to calculate, its rapid acceptance in the medical world shows that the drug-eluting stent would have been widely utilized here had it been marketed in 2002.
Despite these positive results, news of supposed medical complications from drug-eluting stents persisted. Reports of alleged adverse effects began to appear soon after the stent's approval. In response, the FDA issued two warnings in October and November 2003 to notify doctors and patients about possible risks. And recently, concerns rose after a 58-year-old man died from a hypersensitivity reaction that took place a year and a half after his drug-eluting stent was implanted.
But last October the FDA reaffirmed the new stent's benefits. It found that one of the risks, known as sub-acute thrombosis, is "a relatively rare event that occurs within the first 30 days following the stenting procedure." Similarly, it found that severe hypersensitivity reactions were quite rare, occurring only after medications were no longer taken. Other studies support these statements, pointing out that "the concerns about safety and stent thrombosis have substantially diminished."
All said, the drug-eluting stent is far from dangerous, and its slow approval harmed a significant number of heart patients. Is this what congressmen and activists mean by "protecting public health"?
Adam S. Chamberlain is a research associate at the Competitive Enterprise Institute, a non-profit public policy organization dedicated to advancing the principles of free enterprise and limited government.