The nation has a huge need for kidneys, livers and other organs for transplant, but federal law has one absolute rule for donors: no HIV infections.
Some Johns Hopkins doctors now argue that HIV should not disqualify the organs from transplant into recipients who also are already infected with the virus.
"If this legal ban were lifted, we could potentially provide organ transplants to every single HIV-infected transplant candidate on the waiting list," says Dr. Dorry L. Segev, an associate professor of surgery at the Johns Hopkins University School of Medicine whose recent study concluded that there are 500 potential donors disqualified every year.
The ban was included in the National Organ Transplant Act of 1984, a time when the AIDS epidemic was new and the disease unknown, Segev said.
But now that HIV has become a chronic treatable disease rather than a death sentence, there appears to be growing consensus in the medical field that infected organs should be considered. Even some practitioners who have expressed concerns that HIV patients could become sicker are still calling for studies, and at least one set of Illinois doctors has pursued a change.
Segev and others say that lifting the ban wouldn't just benefit those with HIV, but everyone waiting for a transplant. More than 100,000 people are in need of organs, and up to 20 people a day die waiting for them, according to the United Network for Organ Sharing, the nonprofit that manages the nation's organ transplant system for the federal government.
Further, HIV-positive patients have for about a decade been successfully receiving healthy organs – about 130 kidneys and 40 livers in 2010. Doctors say that new livers are often needed by HIV-infected patients who also have hepatitis, and kidneys are needed by those who also have hypertension and diabetes or have complications from HIV or the antiretroviral drugs that control the virus.
A large study of HIV patients who receive uninfected organs is ongoing but doctors say early data show success similar to transplants in non-HIV infected patients.
Segev and other researchers found the 500 potential new donors blocked by the ban through data included in two national registries. The Nationwide Inpatient Study found an average of 534 each year between 2005 and 2008 and the HIV Research Network found and average of 494 each year between 2000 and 2008. Segev's findings were published online March 28 in the American Journal of Transplantation.
Many other doctors, bioethicists and lawmakers agree that the ban should be lifted. Illinois passed a law reversing a state ban in 2004, only to discover that it was not enforceable because of the federal ban.
To be sure, some practitioners have questions about using infected organs. They want to know if the organs would be healthy enough, if patients with well-controlled HIV would be infected with new, potentially aggressive strains of the virus and if there are safeguards for those without HIV.
Advising a slow approach is the HIV Medicine Association, which represents doctors and other health care professionals who focus on HIV. The group supports clinical trials to collect data before there is widespread use of infected organs.
Dr. Kathleen Squires, chairwoman of the group, said the ban should be lifted so the organs can be used in such trials.
The only information practitioners have now comes from South Africa, where a few transplants have been performed recently. But data have only been reported on four patients who had surgery in 2008 according to a report in the New England Journal of Medicine just two years later.
She said she believes there is broad support for more research, especially among those who work in the HIV field and see how medicine has turned the disease into a chronic condition. Those with HIV now have normal life spans, she said.
"The whole concept needs to be studied to see if the transplants can be done safely and effectively," said Squires, also director of the Division of Infectious Diseases at Thomas Jefferson University Hospital in Philadelphia. "I'm sure some people would ask why anyone would even think of doing that, but there is a clear reason, there's a shortage."
But others disagree that trials are necessary, including Dr. Gregory W. Rutecki, a bioethicist and kidney disease specialist at the University of South Alabama Medical School. He said patients who are facing death should be given the choice now.
He said those with hepatitis have a choice. Transplants from those with hepatitis to others with that disease have been done successfully for years, and he said similar steps and precautions could be taken with HIV donors and patients.
"Times have changed," he said. "Those with HIV are living long and very productive lives, and those that have received a transplanted organ are doing very well. Changing this rule would be a phenomenal decision ... and would only be controversial among lay persons who don't keep up with treatment of HIV."
In Illinois, the law reversing the ban was not controversial, said Dr. Michael Abecassis, chief of the division of organ transplantation at Illinois Northwestern Memorial Hospital and a driving force behind the change there. He said a politically connected patient took the idea to the legislature, which approved of the measure with large majorities. It was signed by then Gov. Rod Blagojevich.
Abecassis, also the president of the American Society of Transplant Surgeons, said when the governor asked who might oppose the change, "We said nobody. This wasn't a struggle at all."
After consultation with HIV specialists, he said that he believes existing antiretroviral medications would be effective against any strain introduced through an infected organ, and anyone who had developed drug resistance would be disqualified from donating organs. New clinical trials wouldn't be necessary, he said.
"It occurred to me that we waste a number of organs every year in this country," said Abecassis on the origins of the Illinois law. "Why can't we use HIV positive organs on HIV positive recipients? ...Those people could go right to the front of the list."
But a change in the statute is needed. A spokesman for the Health Resources and Services Administration, the government agency that oversees the organ donation system, said he was unaware of any lawmaker taking up the HIV ban. No other diseased donors, including those with cancer, are absolutely barred from donation if the organs are deemed suitable.
Segev said he'd like to take the issue to Capitol Hill. And at least one advocacy group is evaluating the next steps. That's the civil rights group Lamda Legal, which fought a decade ago for the rights of those with HIV to get transplants of healthy organs and still battles with states that continue to deny public funding for such transplants.
Scott A. Schoettes, the group's HIV Project director, said the group recently began learning about the federal ban and hasn't decided on measures — or even how hard such an effort would be.
"It wasn't a slam dunk at the beginning," he said about the original transplants in HIV patients. "And it lingers a decade from when the first transplant occurred."
But one thing is certain, said Schoettes, who is HIV positive. He would like to again register as an organ donor. "I don't have that option anymore and I welcome the possibility. I imagine others do, too."
April has been designated Donate Life Month in an effort to encourage people to sign up to be organ donors.
+More than 110,000 Americans are on the waiting list for a transplant, including more than 2,000 in Maryland
+Almost half of Marylanders have indicated their donor designation on the Maryland Donor Registryhttp://www.donatelifemaryland.org/about.aspx
+Nine lives can be saved by one donor
+There were 2,406 transplants in January from 1,195 donors
Source: Donate Life Maryland, United Network for Organ Sharing