A Food and Drug Administration advisory panel yesterday recommended that the controversial program implanting permanent artificial hearts be continued at Humana Heart Institute in Louisville, despite concern about serious complications during experimental use of the device in the first patients.
Dr. Charles McIntosh, a cardiovascular surgeon who heads the influential advisory group, said last night that the panel voted unanimously to approve continuation of the Jarvik-7 program subject to three new conditions.
These are a "case-by-case" review by the FDA, in a strengthened "oversight role," of each additional artificial-heart implant and quarterly rather than annual updates; a requirement that the heart manufacturer and researchers give the agency a "revised protocol" outlining additional steps in patient care to reduce potential problems with the heart; and that the for-profit Louisville institute bring in additional experts to review the program.
McIntosh, who works at the National Heart, Lung and Blood Institute, added that the FDA would be asked to consult with the advisory panel in carrying out the provisions. After more than six hours of closed deliberations, McIntosh emphasized that although changes were being requested, "the spirit is not that of a moratorium." He also said the panel had been "impressed by the information presented to us today."
Dr. Robert Jarvik, inventor of the Jarvik-7 artificial heart, said at a news conference that he would work closely with the FDA, expressing satisfaction that the agency had not asked for a "formal prohibition."
The recommendation now goes to the FDA chief, Dr. Frank Young, for a decision. In the past, FDA officials have generally followed the advice of such advisory panels.
The Jarvik-7 plastic pump is manufactured by Jarvik's Salt Lake City-based company, Symbion Inc. While Jarvik urged the panel yesterday to allow continued experimentation, critics said the research should be stopped until changes are made.
Since December 1982, the device has been implanted as a permanent heart replacement in four Americans and one Swedish patient. Three of them suffered strokes and all had bleeding complications. Two are still alive, but remain hospitalized with long-term problems at the Humana Hospital Audubon in Louisville. William J. Schroeder, who is the longest-living recipient after more than a year on the device, has suffered debilitating strokes that left him permanently disabled.
Jarvik said the "Jarvik-7 heart has performed extraordinarily well," that complications are to be expected in pioneering work and that the device had been used only in patients with a "uniformly fatal" prognosis.
"We have obtained a wealth of information and there is still much to be learned," said Jarvik, who predicted that a successful heart-replacement device could potentially save as many as 50,000 lives in this country each year.
But Boston University lawyer George Annas and Dr. Sidney Wolfe of the Health Research Group urged the FDA panel to place a moratorium on further experimental permanent implants.
Annas said the results had been "devastating" and that it was up to the FDA to protect "dying, terminally ill patients who will grasp at anything." Wolfe argued that "it is time to go back to the drawing board" with animal research and that most artificial-heart candidates could now be considered for human heart transplants, which offer more success and a return to normal life for many patients.
Dr. William DeVries, now at the Humana Heart Institute, is the only surgeon in the United States with government permission to do permanent artificial-heart implants. He was granted permission to do seven implants, and the debate yesterday was whether he should be allowed to perform the remaining three.
The Jarvik-7 also has been implanted on a temporary basis in three patients in Tucson, Pittsburgh and Minneapolis as a "bridge" to keep them alive until a human heart becomes available for transplant. This use was not at issue in yesterday's FDA hearing.
At the open hearing, several representatives of medical organizations expressed concern that DeVries had failed to publish his scientific results, making it difficult for independent scientists to scrutinize his work. Symbion and DeVries submitted a review last summer to the FDA, but this has not been made public. DeVries published a scientific report on his first patient, dentist Barney Clark, but has not published detailed information about his subsequent patients.
Clark's widow, Una Loy Clark, endorsed the research yesterday, saying it is "not only fully justified but is essential to medical progress."