Boston Scientific, J&J Stents Leave Doctors Divided |
Avram Goldstein Bloomberg |
October 25, 2006—A dispute over the safety of heart stents from Johnson & Johnson and Boston Scientific Corp. is causing a public rift among cardiologists. Doctors at a scientific conference in Washington this week are at odds over new data showing the companies' best-selling stents may cause more life-threatening blood clots than initially anticipated. The stents, which generated more than $5 billion in 2005 sales, are metal tubes that keep coronary arteries open to prevent heart attacks. Studies presented at the meeting and at one in Europe last month suggest that the $2,200 stents coated in drugs to help keep arteries clear are linked to a higher rate of clots than the $800, bare-metal versions. Some doctors at this week's meeting say the studies are erroneous, while others argue that the reports affirm a trend they long suspected. The clot studies have led to a 5.4 percent drop in stent sales in eight months. "We should not have adopted these stents the way we did in 90 percent of patients here in the U.S.," said cardiac pathologist Renu Virmani, 64, in an interview at her lab in Gaithersburg, Maryland, speaking of the drug-covered devices. Virmani began warning of the risks in 2003. "Even today they haven't quite learned the lesson," she said of doctors who continue using the drug-coated stents in all situations. "The physicians think, 'The majority of my patients don't have this problem, so why do This week's Transcatheter Cardiovascular Therapeutics meeting attracts doctors who use catheters and wires to detect and treat cardiovascular disease without surgery. Company Studies Boston Scientific, based in Natick, Massachusetts, says that there is a higher risk of blood clots in its Taxus drug-coated stent. Yet the death rate among those given the Taxus stent is no higher, even accounting for the increased clots, Boston Scientific said. Boston Scientific shares rose 1 cent to $15.73 at 4:16 p.m. in New York Stock Exchange composite trading yesterday. The stock is down 36 percent in 2006. J&J's shares increased 8 cents to $68.83 and have gained 15 percent this year. Last year, coated stents accounted for 43 percent of sales for Boston Scientific and 5.2 percent for the more diversified Johnson & Johnson. When Boston Scientific reported a decline in third-quarter stent sales, the stock had its biggest loss in five years. Studying the Dead Virmani's views evolved after studying more than 600 stented blood vessels recovered from dead people using study techniques that few others perform because they involve special equipment, she said. Gregg W. Stone, co-chairman of the Transcatheter Cardiovascular Therapeutics conference and a professor at Columbia University, says the stents have been maligned. Stone, who works on Boston Scientific-sponsored studies, says drug-coated stents have not gotten the credit they deserve for saving lives by preventing excessive scar tissue from growing inside the stent, triggering heart attacks. The lives saved that way exceed the number of lives lost to clots, he said. Sanity and Hysteria Stone told attendees that blood clots developed in two to four patients out of every 1,000 who received a drug-coated stent. He also announced expansions of patient tracking and clinical studies to 48,000 stent patients, "mega-trials" that would prove their safety. "We have tremendous respect for Dr. Virmani," Stone said in a pre-conference telephone interview. "We disagree with her saying that the rate of stent thrombosis is extraordinarily high and that overall these are unsafe devices. With all due respect, she is mistaken." Mitchell Krucoff, a Duke University cardiologist and member of the U.S. Food and Drug Administration stent advisory committee, said Virmani can't overcome the inherent bias of someone whose patients are all dead. Criticizing Companies "It is simply not part of her perspective for Dr. Virmani to see whether for that one dead person whose pathology specimens she can see there are 10 or 1,000 or 100,000 or 1 million people who are not dead." Virmani criticizes the companies for maintaining tight control of proprietary scientific data and says they have kept independent investigators like her from checking the companies' claims. Drug-coated stents were approved in 2001 in Europe and in 2003 in the U.S. They gained acceptance from doctors who read reports saying they outperformed bare-metal models in preventing restenosis, the development of excessive scar tissue that impedes blood flow. Virmani said she would never let anyone implant a drug-coated stent in her heart. "Once you put them in, you can't take them out," she said. "You should be 100 percent sure." |
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