An experiment inspired by rebellious organ transplant patients who discarded their vital anti-rejection medicine suggests some can be weaned off the drugs, which are prescribed for life but often cause debilitating side effects.
The drugs, lauded when introduced a decade ago because they made previously risky transplants commonplace, nevertheless leave patients open to infection and cancer. Yet all recipients of donated organs have been required to take drugs the rest of their lives to keep their own immune systems from fighting the foreign tissue.
Over time, a few patients balked at the side effects and threw away their pills. Some fell ill and had to resume medication. But some thrived without it.
Now, researchers have weaned 25 children with transplanted livers off anti-rejection drugs for as long as 7-1/2 years. Six other children in the carefully selected group went back on their pills.
“None of them have died, and none of them have required a retransplant,” said Dr. Jorge Reyes, director of liver transplantation at Children’s Hospital in Pittsburgh, who heads the study. Most transplant patients take either cyclosporin or FK506, also called tacrolimus, to suppress their immune systems. With their natural infection fighters hobbled, patients develop cancer so commonly that their form of it has a name: post-transplant lymphoproliferative disorder.
“Every year, I get a child who comes in with it,” Reyes said.
Cyclosporin can also cause high blood pressure, thickened gums, arrested growth, extra facial and body hair and a reddened, puffy face.
Some patients battling organ rejection also take steroids, which can weaken bones and cause severe acne, blindness and mood swings.
More than 24,000 liver transplants have been performed since 1988, but Reyes estimated fewer than 10 percent of the recipients would be good candidates to give up drugs.
He said additional studies focusing on other transplanted organs would be needed before researchers could speculate on a drug-free existence for non-liver recipients. “We believe in principle that everybody could eventually come off,” he said.
Reyes firmly cautioned that no transplant patient should cease anti-rejection medicine without a doctor’s consent.
Dr. Alan Langnas, a liver-transplant surgeon at the University of Nebraska, said he, too, learned that some of his patients do well after halting their drugs while others do very badly.
“There’s a high price to be paid if you choose the wrong patient,” Langnas warned.
Reyes said liver patients were the only group appropriate for the study because doctors can monitor the liver’s function and restore the medicine at the first sign of rejection.
A researcher would not suggest heart recipients, for example, give up drugs because the first sign of rejection could be a fatal heart attack.
At the study’s onset, all 31 children had had their new livers for at least five years and had gone at least two years without a rejection episode.
Eighteen were taken off drugs abruptly because they had developed cancer or an infection. The 13 others were taken off gradually as researchers tested their liver function, at first every week then tapering off to 10-week intervals.
The patients who tapered off had fewer rejection episodes than the patients who were withdrawn abruptly, and the cancers and infections that afflicted the latter group disappeared when their immune systems were restored.
One boy in the study, Kevin Wilkens, 16, of Oak Harbor, Ohio, was 5 when he got a new liver at Children’s. He took cyclosporin and prednisone, a steroid, but was taken off prednisone because of stomach cramps. Over the last few years, his dose of cyclosporin has been reduced to nothing.
He’s taken no transplant medicine the last two months and says he feels fine.
“It sort of surprises me, too,” said Kevin. “I’m just like any other 16-year-old around, other than I got some scars on me.”
Dr. Thomas Starzl, who pioneered liver transplants in 1967, has a theory why some patients can discontinue anti-rejection drugs.
In all organ recipients who survive a long time, doctors find cells from the grafted organ settled into the host body’s skin, lymph nodes, heart and bone marrow, and cells from the host body in the new organ. Starzl and Reyes believe the exchange of cells promotes harmony.
Other researchers believe the determining factor in host-graft harmony is how well tissues match. Body tissue has a type, just as blood does.
Reyes said researchers might never have tried the experiment if not for those willful patients who threw their drugs away - and lived.
One of the rebellious patients was Betty Baird, a Uniontown woman who received a new liver in 1980, flushed her pills down the toilet three years later and has been fine without them. The drugs had warped her emotional stability; one morning she “came to” just as she was placing a pillow over her wailing baby’s face.
“I didn’t even keep a few just in case,” Baird said.
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