William J. Schroeder recently passed the one-year mark with an artificial heart in his chest, but debate continues about the desirability of experimental use of the device on a permanent basis.
The Food and Drug Administration has scheduled a Dec. 20 advisory panel meeting to consider whether changes should be made in implant procedures before additional operations are permitted, in light of complications suffered by artificial heart recipients to date.
The FDA originally gave Dr. William DeVries, now at the Humana Heart Institute in Louisville, permission to do a total of seven permanent implants with the Jarvik-7. He is the only surgeon in the country with such approval.
DeVries' first four patients suffered major blood complications, primarily strokes, and only two of them remain alive today. Schroeder has had three strokes and remains hospitalized, severely debilitated and able to speak only a few words at a time, according to recent reports. Murray P. Haydon, who received the heart last February, had a minor stroke and remains in the hospital with breathing problems.
The first patient, dentist Barney B. Clark, died in March 1983, after three months with the device. Jack Burcham died in April of bleeding problems, 10 days after his implant. In Sweden, a fifth Jarvik-7 patient died last month after a stroke.
DeVries has vowed to finish the final three transplants, although it has been more than six months since his last attempt. Until now, the FDA has largely maintained an arms-length relationship with him, allowing the research to continue but asking DeVries and Symbion, the Salt Lake City manufacturer of the heart, to submit a mid-course progress report rather than waiting until all seven have been completed.
The head of the FDA's circulatory system devices panel, Dr. Charles McIntosh of the National Heart, Lung and Blood Institute, asked to have a meeting to review the issues, FDA spokesman David Duarte said. He emphasized that the agency had made no decisions about the permanent artificial heart.
The FDA has also granted permission to four centers to do temporary artificial heart implants for patients waiting for human heart transplants.
ONE THING LEADS TO ANOTHER . . . In basic scientific research, one discovery often has a ripple effect, leading to unforeseen advances in other areas. The announcement this week by the National Cancer Institute of promising results in initial human studies of a new immune therapy for cancer began a decade ago in the laboratory of NCI's Dr. Robert Gallo.
At that time, Gallo's team identified and purified a natural substance made in small amounts in the body by specialized white blood cells, known as T-cells. He called it "T-cell growth factor" and went on to use it in basic laboratory studies that led to the discoveries of the first human cancer viruses. More recently, notes Howard Streicher, a senior staff fellow there, the protein was essential in growing laboratory T-cells that made possible the discovery of a related virus that causes AIDS -- Human T-Cell Lymphotropic Virus-3, or HTLV-3.
While Gallo was using it in his studies, Dr. Steven A. Rosenberg saw the substance -- later renamed interleukin-2 -- as a potential practical aid in cancer therapy.