Organ transplant experts are worried that proposed new federal health guidelines will limit the number of available donors and recipients willing to accept organs newly classified as risky.
If you've had sex with two or more partners in the past year, you may be considered a risky organ donor, at least according to proposed new federal health guidelines that have drawn sharp protests from transplant experts who say they're far too broad.
“With the new guidelines, every college student in America will be high risk,” said Dr. Harry Dorn-Arias, a transplant surgeon at the University of Virginia. “Right now, it's probably a prostitute or a guy with a needle in his arm. Next time, it will be just a young guy."
Under the new policy proposed this fall by the Centers for Disease Control and Prevention, deceased and living donors who were not monogamous in the previous 12 months would be considered at increased risk of transmitting HIV, hepatitis B and hepatitis C -- even if they had no other risk factors
CDC officials say the proposed guidelines are aimed at making the organ supply safer and preventing accidental transmission of life-threatening infections. The policies wouldn’t absolutely ban anyone from donating, especially in an exceptional or life-saving situation, but they would call for more scrutiny and testing.
“It’s geared for the patient so the patient knows as much as they can about the organ being transplanted in them,” said Dr. Matthew J. Kuehnert, director of the CDC’s office of Blood, Organ and Other Tissue Safety.
But transplant experts are outraged because they say the proposal arbitrarily focuses on monogamy and could limit both the number of available donors and the number of recipients willing to accept organs newly classified as risky.
They worry that potential living donors may balk at donating if they know their sexual history alone could raise questions about their suitability, particularly if the situation involved a family member.
“If you were going to give your organ to your mom or dad or sister, you’re going to be ashamed of that,” said Dorn-Arias. “You’re either going to say no, or you’re going to lie.”
The proposed policy could also require families of deceased donors to answer uncomfortable questions -- ones they may not even know the answers to -- about the specific sexual behaviors of their loved ones.
“It’s probably going to triple what we consider high risk at this point,” said Tracy Giacoma, transplant administrator at the University of Kansas Hospital. “It may scare patients off from taking these organs. More patients may die because they don’t take these organs.”
More than 28,000 organs are transplanted each year, but more than 112,000 people are on organ waiting lists, according to figures from the Organ Procurement and Transplantation Network.
The guidelines could affect a wide swath of potential donors, particularly younger people. About a quarter of women and nearly 30 percent of men ages 20 to 24 said they had two or more sexual partners in the past 12 months, according to a 2006-2008 report by the National Center for Health Statistics.
When tragic deaths occur, those are precisely the people who should donate their organs, if possible, Giacoma said.
"If you have a [donor] that's 19 years old and he had multiple partners, we'll have to tell the recipient, this is a high-risk organ," she said.
The sexual partner tally is only one of several new factors that could tag a potential donor as being at increased risk of infection. It’s part of a larger set of guidelines that would update 1994 Public Health Service policies for preventing transmission of HIV through human tissue and organs.
"Our priority here is patient safety," said Kuehnert, who noted that the guidelines describe "increased risk," not "high risk," of infection. "[Patients] should know if they're getting an organ at elevated risk."
The 1994 guidlines exclude certain groups as donors, including men who have had sex with other men within the past five years, people who've used IV drugs or exchanged sex for money or drugs in the past five years, hemophiliacs, those exposed to HIV, and people who've had sex with anyone in those categories. They also limit people who've been incarcerated.
The new plan calls for the first-ever guidelines for testing living donors and it adds hepatitis B and hepatitis C to the list of must-test viruses, along with HIV, Kuehnert said. As it stands now, only HIV is included in the guidelines, though most organ transplant centers do test for a range of other potential diseases.
The proposal also calls for use of the most sensitive tests available to detect infection and for shorter testing windows to avoid transmitting infections, which occurs in an estimated 1 percent of transplant cases and has been fatal, Kuehnert said.
Between 2007 and 2010, the CDC participated in more than 200 investigations of suspect unexpected transmission of infections including HIV and hepatitis B and C, with dozens of cases confirmed, Kuehnert added.
The risk of infection from organs may be rare, but it's real. Helen Boucher's husband, George, 54, of Pawtucket, R.I., died in 2005 after receiving a kidney tainted with a rare infection traced back to a virus from the donor's pet hamster. The new guidelines wouldn't have helped detect the Lymphocytic Choriomeningitis virus -- known as LCMV -- but Helen Boucher, now 61, said preventing the trauma her family endured is worth any extra scrutiny.
"My gut feeling is if you want to be a donor, you’re doing a wonderful thing, but you also have to think about what could happen to the recipient," she said. "If I’m willing to be a donor, I’m willing to answer any of those questions that someone is going to ask of me."
The proposed guidelines shorten the time frame for many of the higher-risk behaviors from five years to one year. But they also classify as risky people who have used kidney dialysis during that time; people who have snorted cocaine or heroin nasally; those who've been in prison, jail or juvenile detention centers for more than three consecutive days in the past year; those who currently have or who have been treated for syphilis, gonorrhea or genital ulcers in the past year and people who have immigrated to the United States within the last year from a country with a high prevalence of hepatitis B.
Other aspects of the plan have drawn fire from transplant experts who object to tests that might be too expensive and too slow for all centers to administer.
But it's the new emphasis on two or more sexual partners that has ignited most ire, judging from public comments about the proposal being accepted through Dec. 21 at www.regulations.gov.
“I am opposed to the guidelines as written,” wrote Dr. John Radomski, chief of surgery at Our Lady of Lourdes Medical Center in Camden, N.J. “The list of high risk behavior seems way too broad.”
CDC officials downplayed the controversy, saying that the proposal is a draft and can be changed, particularly if there's strong evidence to support any alteration. They said the primary goal is to obtain as much information about transplanted organs as possible, whether that comes from personal histories or advanced screening tests.
Using a set of behaviors to gauge risk makes sense, Kuehnert said, and studies suggest that having more than one sexual partner raises the risk of infection.
“We can quibble about whether it should be two sexual partners or three or five or 10, but we’ll have to have a cut-off point,” he said.
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