Doctors Get Shiley Letter Warning of Valve Risks : Heart patients: Physicians and emergency room personnel told what symptoms to look for.

Shiley Inc. has sent more than 270,000 letters to physicians and emergency room practitioners nationwide to update them about the risk associated with one of its heart valves and to describe symptoms to look for in patients whose implanted valves might have fractured.

The letters were mailed shortly after March 24, when the Public Citizen Health Research Group, a Washington-based watchdog group founded by Ralph Nader, filed a suit in Los Angeles Superior Court asking the court to order Shiley and its corporate parent, Pfizer Inc. of New York, to notify people who received valve implants of potential malfunctions.

Shiley officials, however, said that the mailing was not connected to the lawsuit. “The letter was drafted and ready and an appointment had been made with the (Food and Drug Administration) to discuss it some weeks before that lawsuit was filed,” said Dr. Roger Sachs, vice president-medical director at Shiley.

Although Shiley had no new information to convey about the valves, which the company no longer manufactures, he said the letters were mailed to counter “a lot of confusion” caused by recent reports in the media.

Sachs added that in the next few seeks Shiley intends to send similar letters to physicians overseas, where about half of the Bjork-Shiley valves were sold.

The Irvine-based company said it has sent out warning letters periodically since 1980 after the first valve fractures were reported and the valves began to be pulled off the market. But the company said this is the first time that family physicians and internists as well as emergency room personnel and their professional organizations are being notified.

Previously, Shiley said, warning letters were sent only to a much smaller group of heart surgeons and cardiologists, under the assumption that most patients with heart valves would be under the continuing care of these specialists.

Since the first of two Shiley valves that are the center of controversy went on the market in 1979, the company has reported a total of 389 failures resulting in 272 deaths. About 85,700 of the two valve models were produced before the company stopped manufacturing and selling them in 1986.

A copy of Shiley’s most recent “Dear Doctor” letter, dated March 30, said, “Emergency room and primary care physicians who usually do not attend or monitor patients with heart valves should be especially alert to signs and symptoms of heart valve malfunction.”

It said that malfunctioning of the Bjork-Shiley 60-degree Convexo-Concave heart valve “may occur without warning and is life-threatening. If medical personnel do not quickly identify prosthetic heart valve failure as the source of a patient’s difficulties, valuable time can be lost in instituting treatment.”

The letter further advises physicians to let their patients and the patients’ family members know the symptoms and what to do in the event of a valve malfunction. It suggests that patients carry a card with information about their implant in their wallet or purse and possibly also a bracelet or other device containing the information.

The mailing also follows hearings by a subcommittee of the House Energy and Commerce Committee on the FDA’s oversight of Shiley. The hearings included testimony that heart valve failures have been misdiagnosed.

For instance, Frank Barbee, a Wisconsin resident, testified that his wife died from a valve malfunction because the problem was misdiagnosed by emergency room personnel.

“I believe she would still be alive today if some effort had been made to inform the appropriate people of the potential malfunction of something as critical to life as a mechanical heart valve,” Barbee said.

Barbee also noted that if he had been aware of the symptoms, he would not have incorrectly concluded she was suffering a heart attack, which led him to “take her to a closer but limited facility that could treat a heart attack but not a broken valve.”

FDA spokesman Mark Barnett said the content of Shiley’s letter was approved by agency officials, who, he said, added the recommendation that valve recipients wear identification.

The FDA is conducting a series of public hearings to decide whether to revise its policy that calls for the manufacturer or medical facility at which a heart valve is implanted to notify physicians about defective devices.

“The physician then uses discretion in deciding whether and how to explain the situation to each patient,” the FDA said in a background paper attached to a notification of the first meeting on the issue that was held March 26.

Attorneys for the Public Citizen Health Research Group said that organization believes that Shiley’s latest letter is more “complete and accurate” and less “promotional” than previous ones. They also said they were pleased that family physicians are being informed, although they would still prefer patients themselves to be notified.

“We think it is an undue burden to place on the physicians to expect them to notify the implantees. It is one step short, but it is a step in the right direction,” said Jim Capretz, one of the patient advocacy group’s attorneys.

Sachs at Shiley said that at this point, the company is making no effort to contact implant patients. “The basic reason is we still believe the proper avenue for patient information is through the physicians,” he said.

Sachs also said that notification of all people who had Bjork-Shiley valve implants would be impossible because the company doesn’t know who they are. He said hospitals that implanted the valves mailed back information cards to the company in only about half of the cases.

In response to the research group’s contention that the current notification letter is more candid and less “promotional” in tone than previous Shiley letters, Sachs said the criticism wasn’t fair.

“Obviously when you are no longer marketing a valve, nothing can be intended or interpreted as promotional,” he observed. But, he added, “we still feel the benefit of the valves outweigh the risk. The ultimate reason for withdrawing the valves completely (from the market) was that the climate was so bad. We weren’t selling any.”