Pfizer Criticized on Heart Valve Warning Package : Health: FDA officials say that the advisory to doctors could be mistaken for junk mail and discarded. The firm denies it.
U.S. Food and Drug Administration officials have criticized Pfizer Inc.'s program to warn doctors about the company’s potentially defective heart valve, claiming that the national alert looks more like junk mail than an urgent message about a life-and-death issue.
“The whole package has the appearance of slick promotional material for a new product rather than a notice about an important public health issue,” wrote Joseph S. Arcarese, an FDA training director, in a Dec. 4 letter to Pfizer officials. “I’m very concerned that many office managers may discard the package as simply junk mail.”
Pfizer sent packages about its Bjork-Shiley Convexo-Concave heart valve to some 19,000 U.S. physicians, informing them of an unprecedented effort to contact about 55,000 people who are still living with the valves implanted inside them.
At least 400 of the valves, manufactured by Pfizer’s Shiley Inc. unit in Irvine, have fractured and are blamed in 265 deaths. Thousands of valve recipients are unaware of the potential flaws, officials said.
The FDA, however, said the message isn’t getting through because the warning isn’t packaged properly. The Pfizer materials come in an envelope that shows a picture of a man and a woman talking to a doctor. The FDA wanted something more eye-catching, such as large red letters denoting the message’s urgency.
James Morrison, the FDA’s deputy training director, said Monday that an agency sampling of 24 doctors found that 12 never received the notice and five “didn’t know what it was about and threw it out.
“They thought it was an advertisement,” he said.
Robert Fauteux, a Shiley spokesman, said the company believes the materials are adequate--at least for now.
“We believe it is attractive but modest,” he said. “We do not believe it is slick or promotional, and we believe the packaging reflects the high quality of the information that is enclosed.”
Because the FDA sampling of doctors was so small, Fauteux contended, it is too early to tell whether another mailing is required. Nevertheless, Pfizer sent more than 19,000 telegrams to doctors last weekend to tell them the packages were on the way.
“If the FDA survey is borne out, Shiley will do what is necessary to make sure the information is received and understood by a greater number of doctors,” Fauteux said. “Our goal is to do this right.”
FDA officials also have criticized materials that Shiley prepared for release at a Thursday news conference in Washington to kick off its patient-notification program. The agency says the materials fail to adequately describe the potential danger posed by the valves.
“The way the information is currently presented waters down the problem with the strut fracture,” the FDA said in a memorandum to Pfizer executives.
But Fauteux said that those were draft materials that were a couple of weeks old. “The materials we are going to be presenting on Thursday are in the process of being finalized now,” he said. “I’m not sure it serves any purpose to make comments on old drafts.”
The FDA has previously criticized Pfizer for misleading doctors about the valve’s problems.
Public Citizen, the largest consumer group focusing on the Shiley heart valve issue, alleged that Pfizer was still trying to minimize the fallout from the valve problem.
“The company has for years sent letters to heart surgeons when they knew there were a large number of deaths caused by these defectively manufactured valves, saying everything was pretty much fine,” said Dr. Sidney Wolfe, director of the Public Citizens Health Research Group. “They seem to be continuing this effort now. . . . It is really reckless and irresponsible.”
Pfizer stopped making the Convexo-Concave valve in 1986 after the devices had been implanted in 86,000 people worldwide. Some 55,000 of those recipients are still alive, but many are difficult to find because only names--and not addresses or phone numbers--are in the company’s files.
The company is negotiating with health officials outside the United States to begin similar patient-notification programs.
Pfizer has sent the packets to every cardiologist and cardiovascular surgeon registered with the American Medical Assn., believing it to be the best way to notify valve recipients, company officials said. What’s more, it has hired Medic Alert, a Turlock company, to track down recipients and compile a registry to keep them informed about the valve’s problems, the officials added.
Those wishing a copy of the notice can call Medic Alert at (800) 245-1492.