Bloomberg News article about FDA warning published in the Minneapolis paper and brought to my attention by housewifeinvestor on the Yahoo thread. Much more calm and reasoned perspective than the DJ headline I mentioned in last post. L.
FDA report hits SurmModics, J&J, but Cypher still seen safe
Kerry Dooley, Bloomberg News
Published October 30, 2003 STEN30
Johnson & Johnson has reported more deaths and complications among patients with its Cypher heart stent, leading regulators to post an advisory to doctors Wednesday.
Food and Drug Administration officials said they still view the Cypher as a safe product, when used as directed, and are not planning to seek its withdrawal or limit its use.
"We have these [Cypher] reports, and they obviously are of concern to the company and to the agency and to the clinical community, so we're providing whatever information we currently have," said Dan Schultz, the FDA's director of the office of device evaluation.
Still, the news sent shares of Eden Prairie-based SurModics Inc., which makes the surface coating that adheres the drug to the Cypher stent, falling $1.82, or 6.9 percent, to $24.70. Johnson & Johnson shares fell $1.06, or 2.1 percent, to $49.48.
The FDA advisory also has potential implications for Boston Scientific Corp., which employs about 2,600 people in Maple Grove and Plymouth, and is expected to be the second company to bring a drug-coated stent to market. Fridley-based Medtronic and Indianapolis-based Guidant Corp., which has major operations in Arden Hills, are also developing drug-coated stents.
Analysts expect the devices to double industrywide stent sales of $2.4 billion a year.
The FDA has received more than 290 reports of blood clotting in Cypher patients, the agency said on its Web site. In more than 60 cases, use of the company's device was linked to the death of a patient, the agency said.
Stents are mesh tubes implanted to help keep blood flowing in previously clogged arteries. The Cypher is one of a new group of stents with a drug coating to stop excess tissue growth that sometimes builds up on bare-metal versions.
"This may stifle the acceptance of J&J's stent to some extent," said Jordan Schreiber, senior manager of the Merrill Lynch Heathcare Fund. "Anything that impacts the stent is significant for Johnson & Johnson."
Boston Scientific is waiting for FDA approval of its stent, which some doctors say they would prefer to the Cypher. The underlying metal stent was developed and is manufactured in Minnesota. The company could have its stent to market in the first quarter of next year.
Johnson & Johnson's third-quarter profit jumped 20 percent to $2.07 billion, helped by the U.S. approval of the Cypher in April. U.S. sales of the device were $429 million in the quarter.
The FDA posted its report Wednesday partly because of the unusual amount of interest in the Cypher, regulators said. Johnson & Johnson couldn't keep up with demand for the Cypher in the months after its approval, though the company has shipped more than 260,000 of the devices in the United States.
"There has been a lot of attention placed on the Cypher in the clinical community and the public at large," said Neal Muni, an FDA medical officer, in an interview. "It's leading a lot of clinicians to ask about the adverse-event rates."
Doctors have been waiting since the 1990s for a stent that would not cause new clogging in an artery after the device is implanted -- a complication seen in many patients.
"We still think that the data in the clinical trials showed that there is a considerable benefit of using the drug-coated stent over and above what can be achieved with the bare-metal stent," Schultz said.
The FDA has been moving in recent years toward releasing more information about complications reported in connection with medical devices, even as it investigates whether these products have harmed patients or if the connection is coincidental.
The FDA has received more than 50 reports of hypersensitivity reactions such as pain, rash, altered breathing, hives and fever in Cypher patients. Some of the patients that experienced the reactions also died, the agency said.
As part of the device approval, Johnson & Johnson planned to conduct a 2,000-patient study to look for complications in Cypher patients, said company spokesman Marty Schildhouse.
Staff Writer Terry Fiedler contributed to this report. |
