Healthy Skepticism Library item: 11743

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Publication type: news

Top M.D. Urges Restraint in Adopting New Technology
Reuters 2007 Oct 6
http://en.epochtimes.com/news/7-10-6/60473.html

Full text:

CLEVELAND (Reuters)-The top heart doctor at the Cleveland Clinic, known for its innovation in cardiac medicine, has urged restraint in adopting new technology before the risks are uncovered by longer-term studies.

Dr. Steven Nissen, head of cardiovascular medicine at the clinic, was among the first to warn about the heart risks posed by painkiller Vioxx, later pulled from the shelves, and more recently diabetes drug Avandia.

He has also expressed caution about the widespread use of drug-eluting coronary stents-tiny wire scaffolds that prop open diseased arteries and deliver drugs to keep them from re-clogging.

“The marketing gets ahead of the science. I’d like my colleagues to be a bit more skeptical,” Nissen said in an interview from his office.

“I can’t tell you how often I’ve been through this. With every new technology comes the initial blush of enthusiasm. Everything goes nuts and everyone is jumping on the bandwagon to do it for a while, and this is true for drugs as much as it is for devices. It reaches some point of maximum utilization and then the problems arise and then it comes back and it finds its natural level again,” he said.

That was true of the so-called COX-2 inhibitors, a class of drugs that includes Vioxx, that have been linked to serious cardiovascular risks. Another example is the broad use of CT angiograms, he said.

“Everybody is buying a CT scanner and doing angiograms,” Nissen said, noting the risks of high radiation.

Drug-eluting stents continue to be a hotly debated subject in cardiovascular circles. When the devices were introduced in the United States in 2003, they were met with great enthusiasm and were soon used in about 88 percent of all stenting procedures. Some 6 million people have the devices implanted in their bodies.

But about a year ago, doctors began to highlight the small, but deadly risk of blood clots, or late-stent thrombosis, a year or more after the device was implanted. It is still unclear whether the drug or the plastic polymer that secretes the drug is to blame.

Perils of Early Adoption

“If you adopt a technology too quickly, there may not be an incentive for manufactures to do the necessary trials. It’s a very important part of the equation,” Nissen said. “Why don’t we have huge randomized prospective trials for the off-label indications for [drug-eluting stents]? Because they have nearly 90 percent market share.”

Doctors have since backed away from drug-eluting stents, using them in only about 65 percent of stenting procedures today, a level Nissen thinks is more appropriate.

The market is eagerly awaiting the next generation of drug-eluting stents from Medtronic Inc and Abbott Laboratories, billed by their manufacturers as being safer.

“There’s a very famous quote about this that rings in my head every time I hear these debates come up: Absence of evidence is not evidence of absence. What we have in the stent world is an absence of evidence. We just don’t have the answers here,” he said.

Nissen said he has met Medtronic’s senior leadership about the company’s efforts to develop a safer drug-eluting stent.

“They say: ‘We’ve got this figure out. It’s the polymer, stupid. We have a different polymer. It’s better.’ And I say: ‘Well okay, the road to hell is paved with biological plausibility. It’s plausible, but I say you’ve got to prove it now’.”

Medtronic’s application to sell its drug-eluting stent in the United States will be reviewed by an advisory panel to the U.S. Food and Drug Administration next week.

Nissen has called for a 20,000-patient prospective, randomized, well-controlled clinical trial to get answers.

“Without that, we get inferences about it,” said Nissen.

The sometimes combative cardiologist, named by Time Magazine as one of 100 most influential people, dismissed speculation he is seeking the top job at the FDA.

“It’s not an aspiration. I love my job here and I’m not sure that I’m not better as an outsider looking in than an insider looking out,” he said, adding that the speculation has been fueled by the media.