Coated-stent makers rush to reassure after inquiry

Last Thursday, the day the Food and Drug Administration launched a two-day advisory panel on the risks of drug-coated stents, doctors across the country found an e-mail on their computers from stent maker Johnson & Johnson, inviting them to join a conference call about stent safety.

By yesterday evening, Johnson & Johnson had already hosted three such calls and planned more for today. Rival stent maker Boston Scientific Corp. of Natick had placed a full-page advertisement in several major newspapers and decorated its website with a prominent banner promising "the facts about drug-eluting stents."

The campaign to win doctors and patients back to drug-coated stents is in full swing.

The tiny mesh tubes are among the world's top-selling medical devices, generating more than $2 billion a year for each of the two main manufacturers.

Their high profit margins have been especially crucial to the success of Boston Scientific. But for more than a year, they have been shadowed by a growing body of data showing that compared to older bare-metal stents, they also carry slightly higher long-term danger of blood clots.

Now, with the FDA panel's inquiry into blood clots completed and no dramatic restrictions apparently in the works, stent makers are scrambling to reassure doctors and patients that drug-coated stents, priced at $2,200 each, don't carry any more risk than cheaper bare-metal stents and are more effective.

The drug coating is intended to prevent scarring, which can narrow arteries cleared of blockages.

"I've been bombarded by e-mails," said Dr. Frederic Resnic, director of the cardiac catheterization laboratory at Brigham & Women's Hospital. "It's a big outreach effort, for sure."

Stent sales began to shrink this year as doctors switched back to using the older bare-metal stents in some patients. Boston Scientific's stock price slid as investors worried about the long-term future of the product, and about what the FDA might say after its expert panel met.

In the end, FDA advisers recommended steering a moderate course, focusing heavily on manufacturers' data that shows relatively low risk for drug-coated stents.

Although the FDA hasn't yet issued any formal conclusions, the panel's apparent consensus was that drug-coated stents are safe and beneficial when used as approved.

Compared to the bare-metal stents, they reduce the likelihood patients will need to return to have their arteries re-cleared. And although they may trigger a handful of additional clots, patients are not more likely to have heart attacks or die.

Armed with that neutral-to-positive message, Boston Scientific and Johnson & Johnson have both launched public relations campaigns in the medical world.

Cordis, the stent-making division of Johnson & Johnson, released a three-page letter to heart doctors on Sunday that highlighted the benefits of drug-coated stents and promised future studies to expand their use in more patients. It invited cardiologists to watch a computer slideshow and dial into one of six conference calls to discuss the FDA panel's findings.

Boston Scientific took out full-page advertisements in The New York Times, The Wall Street Journal, USA Today, The Boston Globe, and two newspapers in Minnesota, where many of its stents are manufactured. The ads get right to the point: "Q: Are drug-eluting stents safe? A: Yes."

A Boston Scientific spokesman declined to say how much money the company was spending, but said its campaign included "a broad range of activities" to reassure doctors and patients that drug-eluting stents had more benefit than risk.

"We felt, as the leading stent maker, we should speak out after the FDA meeting," said spokesman Paul Donovan.

As companies push their safety messages, doctors and regulators are mulling data showing that in real-world use, stents have higher complication rates than reported in clinical trials.

The risks have led to some loud critics in the past several months, with some doctors urging colleagues to scale back drastically on their use of drug-coated stents.

"There's still some naysayers out there, and that's what they're combating," said Jan Wald, a medical-device analyst for A.G. Edwards & Sons.

Wald pointed out one other shift in the companies' approach: The plain-English Web pages and advertisements are pitched not to specialists, but to patients who have the devices in their bodies.

"This has been a learning process for these companies," he said. "I think they realize now they should talk to the patients."

Stephen Heuser can be reached at sheuser@globe.com.