The growing demand for human body parts has prompted a maverick Virginia doctor to establish a company, believed to be the first of its kind, that would broker human kidneys for sale by arranging for donors throughout the world to sell one of their kidneys.
The U.S. Surgeon General, who was told about the International Kidney Exchange Ltd. by the Food and Drug Administration, counseled the doctor against the commercial venture in July, but said there are no federal regulations that prohibit it. The doctor, H. Barry Jacobs, had written to the FDA last February inquiring whether he needed a license to import organs.
Jacobs, of Reston, whose license to practice in Virginia was revoked after a 1977 mail-fraud conviction involving Medicare and Medicaid, said several of the nation's 7,500 hospitals he contacted by letter last week have expressed interest in removing kidneys of the healthy donors Jacobs plans to solicit.
Under Jacobs' plan, the federal government would pay for the removal operations for organs to be transplanted to Medicare patients. Currently, the Medicare program covers virtually all patients with kidney disease serious enough to require a transplant. The donors would set a price for their kidney, and Jacobs said he will charge $2,000 to $5,000 for his services. The total price for acquiring the organ would be paid by a person needing a healthy kidney.
Jacobs said his preliminary research showed that potential donors set a price of up to $10,000 for one of their kidneys. The motivation to sell part of their body "would be whatever motivates someone to sell: greed, bills," Jacobs said.
"It will be pure, free choice on their part," he said of the donors. "There will be proper, written informed consent. Since many potential donors can't read, it the informed consent conference will be tape-recorded." Many of the overseas donors would then be flown to the U.S. by Jacobs to have the kidneys removed at U.S. government expense.
Jacobs, who served 10 months in jail for his 1977 conviction, said he now works as a consultant in medical malpractice lawsuits. He said he has seven associates contacting individuals and hospitals in Europe and Asia to participate in kidney removals. Eventually, the network would arrange for "organs from U.S. citizens and Third World indigents," he said.
Giving up a kidney, unlike other organs, does not seriously affect the health of a donor. The remaining kidney enlarges to provide the donor with about 70 percent of original kidney function.
Federal health officials believe that the fledgling network violates no laws, although several said the existence of the network would undoubtedly spark some form of regulation. Jacobs said his lawyers have determined the network is legal, and added he would follow whatever regulations or laws are written.
Other health professionals active in transplant activities say they had feared the creation of such a venture and supported a bill introduced in August by U.S. Rep. Albert Gore (D-Tenn.) to prohibit the sale of human organs. Selling human organs raises a host of ethical questions, they argue, including making transplant operations accessible only to the rich and relying for organs on poor donors, many of whom may be in poor health.
"This is an immensely damaging development," said Dr. Harold Meryman, director of a Red Cross lab in Bethesda and past president of the American Association of Tissue Banks. "We are attempting to stimulate legislation to prevent this. This adds a great deal of fuel and urgency to that effort."
"Putting organs on a market basis is abhorrent to our system of values," said Gore. "It seems to be something inconsistent with our view of humanity . . . Prostitution is illegal for reasons that are similar. So is slavery."
Gore said he added the prohibition to his bill after being sent a brochure from a New England company that offered to register donors, offering them the potential of a $10,000 payment if one of their organs was used in a transplant.
Gore said he plans hearings on the issue in October. Two other Congressional committees also are studying problems involved with the nation's system of organ transplantation.
The National Kidney Foundation, which was approached by Jacobs for its approval, did not "endorse or support" the program, according to Tony Englert, president of its Washington branch. The plan also was given a cool reception by the Washington Area Transplant Society, a group of doctors specializing in transplants.
"Although we agree organs are in short supply, most people in the medical community don't feel good about that," Dr. Joel Stephens, a Howard University transplant surgeon and president of the Washington Area Transplant Society, said of the network. "We get letters from people who ask to sell their organs, but this is the first reasonably serious proposal."
Jacobs said his network will change the unhappy lives many dialysis patients have. "I think they (doctors who oppose his network) can't face reality." Jacobs said he got the idea for his network while watching news reports of mass deaths in Bangladesh and "saw the waste of all those organs lying there." He noted, "It's a very lucrative, potential business. If the 'haves' want it, they'll have to pay. If the 'have nots' want it, they'll have to pay, too."
Officials of the Health Care Financing Administration, which administers the Medicare program, said that federal law requires it to reimburse hospitals for all expenses in removing a donor's kidney. "The cost of harvesting" is covered, said spokesman Jack Kittrell. "Medicare has a longstanding policy of paying for certified organ procurement."
The federal government pays for these removal operations because it is anxious to stop paying the high costs of continued dialysis--mechanical cleansing of the blood--for patients awaiting a kidney transplant, he said.
The problem of the great demand and low supply of human organs is one that the federal government itself is trying to solve, also through private enterprise. Some 20,000 Americans need an organ transplant to survive, yet government figures show there were only 2,200 cases last year where Americans agreed to donate major organs of dying relatives.
Surgeon General Everett Koop is convening a second meeting of nationwide medical officials this Wednesday in Millwood, Va. to announce a steering committee to set up a privately-funded foundation to encourage Americans to donate organs.
"We do not feel that the government should be heading this effort," said Jim Buchen, a spokesman for Dr. Koop. "We're hoping that a leader will emerge at the meeting."
The foundation will not allow organs to be sold, Buchen said. Of Jacobs' proposed network, he said, "Dr. Koop has a fear of where this would lead."
His fear is shared by others because of the dramatic medical advances that have led to a greater frequency and success with organ transplants. With the government's recent approval of cyclosporine, a new drug that reduces the likelihood of a body rejecting a transplanted organ, worldwide demand for such operations is expected to further overwhelm the meager supply.
This inequity could lead to some organ-selling companies who might not take the proper medical and legal precautions in obtaining organs, some worry.
"By the end of the decade there will be such a demand for organs that even legislation won't stop (abuses)," said Meryman, of the American Association of Tissue Banks. "There needs to be a national allocation system based on need. Whether this can be controlled by hospitals and doctors remains to be seen."
What is clear is that the immense demand and cost for organ transplants is going to continue to dominate the future debate over health-care dollars. Today medical experts grapple with the ethics of channeling resources into costly heart transplants for a fortunate few while at the same time preventative public health measures are inadequately financed. In the vacuum of any uniform health policy, American hospitals have begun imposing their own restrictions on who and how many people can receive life-saving transplants.
"We limit the number of transplants we do within a given time so that we don't go broke," said C. Edward Schwartz, administrator of the University of Minnesota Hospital, which also imposed a deposit requirement on out-of-state residents seeking heart and liver transplants. As of Jan. 1, 1983, out-of-state residents must pay 80 percent of the cost of the operation before they are admitted.
Because of such hospital restrictions, as well as insurance companies' refusing to pay for costly procedures such as liver transplants, nonwealthy patients have been forced to turn to public begging, Schwartz said.
"It's almost a throwback to the last century," he said. "The parents (of children needing liver transplants) have turned to the media, the newspapers and the TV, as a way of raising funds. It's a nice stop-gap measure, but something else is needed."
In the absence of firm decisions about who gets transplants and who pays for them, commercial companies can be expected to spring up and fill patient demands, Meryman said. "We hope at the least we could stop payments to donors. If not, the whole transplant system will be slanted towards those who can pay. Any millionaire with cirrhosis of the liver will gladly pay a half million dollars. That's not considered to be the American way."