13450Kansas City Star 11-09-2003 Large-scale patient search founders while FDA del
- Nov 9, 2003(I love the one place in here that a guy says something like why bother with people who have hep c and won't get sick from it... I'm like huh? when 80% or more people who contract hep c go chronic?)
Posted on Sun, Nov. 09, 2003
Large-scale patient search founders while FDA delays
By KAREN DILLON
The Kansas City Star
In 1999, federal health officials pledged to pursue a nationwide hunt for at least 188,000 people who had received transfusions of blood infected with hepatitis C.
It was urgent to notify those people that they might be carrying the potentially deadly virus, officials explained as they prepared for the search.
A delay, according to the U.S. Food and Drug Administration, "would increase each recipient's risk of serious disease complications and speed the spread of infection."
But the search for patients stalled. In fact, it turns out, federal health officials never ordered it.
Although some hospitals say they have made attempts to find patients, many continue to wait in confusion for the government to act.
Patient groups and even some federal advisers were stunned when told the effort had quietly faltered.
"It's a damn shame," said Alan Brownstein, president and chief executive officer of the American Liver Foundation. "We've lost four years."
But officials say there has been no foot-dragging. The search for patients, known as a lookback, simply takes time to organize, said Jay Epstein, director of the FDA's Office of Blood Research and Review.
In 1992, advanced screening tests were implemented, making it extremely rare to be infected with hepatitis C from a transfusion. But before that, millions of people received infected blood, and many of them contracted the virus.
Infected patients can adjust their lifestyles, receive treatment and keep from spreading the virus if they know they have it.
But some Americans don't even know whether they received blood during surgery.
For those infected by transfusion, delays in the lookback are dangerous because the virus can silently corrode the liver for decades before it is discovered, critics say.
"Our hospitals have patients coming in today not realizing they are dying of hepatitis C, and they don't know where they got it," said John Penner, a hematologist at the Michigan State University clinical center and a member of the federal blood committee.
"There is still a large group out there, and it's now coming to fruition."
In 1981, Teresa Cox received two units of blood after she developed complications during childbirth at a St. Joseph hospital.
But it took 20 years before fatigue and nausea sent the Lee's Summit woman to a doctor, who diagnosed her with hepatitis C. Cox, who works for a radio station, helped form a support group and quickly discovered a connection with some of the patients.
"A lot of women in the group got it during childbirth," she said.
Indeed, there are hundreds of thousands of transfused patients.
While many who were infected by transfusion have died of other causes, the Centers for Disease Control and Prevention has said for years that about 300,000 remain alive. But in an adjusted estimate, the CDC calculated the number may be closer to 450,000 still living.
Publicly, CDC officials use the smaller number.
"We're comfortable with 300,000," said Miriam Alter, the CDC's leading hepatitis C epidemiologist. Transfusions make up only a small proportion of hepatitis C cases anyway, she said.
"I don't think it is going to make much of a difference if there are 150,000 more."
A surprising decision
The story of the lost lookback begins in October 1989, when hundreds of blood industry representatives met in New Orleans.
Many feared they would hear bad news. They were at the end of a tense AIDS lookback and thought the government might order another, much bigger one for hepatitis C.
Millions of transfusion patients had been infected with hepatitis C during the 1970s and 1980s, research had indicated. A new screening test for blood would soon make it possible to trace many of those already infected.
Indeed, AIDS had made the blood industry familiar with how lookbacks work. Hundreds of lawsuits and a public scandal over that virus had forced blood banks and hospitals to look for patients who had received transfusions tainted with HIV.
Generally, a lookback works like this: A blood bank finds records of donors who have tested positive for a disease, then finds the number of times that donor gave blood. The blood bank contacts the hospital, which traces the patients who received the blood.
And now, in 1989, it appeared to blood officials like a hepatitis C lookback was quite possible, costing money to trace patients, replace donors and fight lawsuits.
As they braced themselves that autumn day in New Orleans, an FDA official took the microphone and delivered a surprising verdict: There would be no lookback.
The audience cheered.
"It made the hair stand up on the back of my neck," said Enid Eckert, a California nurse whose husband was a patient activist.
But the decision brought great relief to blood bank leaders. In fact, many in the industry continue to be agitated by the thought of looking for HCV-infected patients.
A lookback is difficult and costly without many rewards, blood bank officials say.
Many of the patients who are found wouldn't actually be infected, they say. Most of those infected wouldn't be sick, and many of those who are sick would be hard to find after a number of years. Besides, most already would be dead from other causes.
"It doesn't matter if you are going to get a disease that is not going to alter or change your lifestyle," said F. Blaine Hollinger, former chairman of the Blood Products Advisory Committee, which recommends blood policy to the FDA.
"I mean, who cares?"
Ross Eckert did.
Eckert, an economics professor, had contracted AIDS and hepatitis C from blood products he needed as a hemophiliac. In 1993, a year before he died, he told a federal blood committee:
"For blood bankers and FDA officials not to provide information that is relevant to the health of many people when they know that they would want to be informed themselves if the roles were reversed seems to me to be indefensible."
After New Orleans, support for the lookback languished for much of the decade. One blood bank group instead recommended the government conduct a public education campaign, but that didn't happen either.
Occasional pressure came from Congress, especially Rep. Christopher Shays, a Connecticut Republican. And in 1996, the Committee on Government Reform and Oversight recommended a lookback.
A 1997 General Accounting Office report also recommended notifying patients, pointing out that the government was treating hepatitis C differently from HIV.
That was the year that Donna Shalala, then head of Health and Human Services, appointed the Advisory Committee on Blood Safety and Availability to counsel her office. Its first priority would be the lookback, she said.
The committee recommended a lookback, and one finally occurred. The FDA announced it in 1998, and it was nearly complete by November 1999.
But the lookback ignored the great majority of those at risk. Its target was only 115,000 patients:
� Blood bankers would look only for donors who tested positive from 1992 to 1998 -- after most infected donors had already been detected and barred from giving blood.
� Blood banks that found an infected donor would pull the records for each time the donor had given blood back to 1988, and recipients of that blood would be notified. But most tainted transfusions occurred before 1988.
Even before the lookback was done, Shays blasted Health and Human Services in an October 1998 report, saying the lookback plans had not gone far enough.
"HCV `look back' is too limited," the report said.
Legacy of failure
Under continued pressure, the FDA admitted it needed to try again.
In 1999, it proposed a second, much bigger lookback. The search would focus on infected donors identified between 1990 and 1992.
The government estimated the lookback would seek another 188,000 patients.
This lookback would extend the search for patients indefinitely before 1988 if their records were computerized or readily retrievable.
As it planned for the expanded lookback, the FDA said the effort would repair the breach in public confidence that was opened by the AIDS crisis, causing a costly drop in blood donations.
"FDA believes that the public trust demands the timely communication of relevant risk information," it said.
But four years after being proposed, that lookback still hasn't gone into effect.
And until they were contacted by The Kansas City Star, at least two members of the blood safety committee didn't know that.
"I think they just pushed this under the table and just left it," said Penner, the Michigan State hematologist who is one of those committee members. "It looks like the foot-draggers won out."
Epstein of the FDA said nothing has been hidden about the way the FDA has proceeded with the lookback.
"All of this is in the public record," he said. "Whether members sort of got it or didn't get it, I can't comment on."
After The Star raised questions, a Health and Human Services official said in January that the rule ordering a lookback would become official in the spring. That still hasn't happened.
Epstein said the expanded lookback has taken so long for several reasons, including a need to address comments the FDA got from the blood industry and others. The FDA received 42 comments over the past four years.
The former chairman of the blood safety committee said the FDA has been heavily lobbied by the hospital industry, which thought the lookback would be expensive with few results.
"Tremendous pressure was exerted by the hospitals and the blood bankers to stall the lookback," said Arthur Caplan, a prominent bioethicist. "Many behind the scenes were not only arm-twisting, but I would say they got to the point of broken bones."
A spokeswoman for the American Hospital Association disagreed, saying hospitals have not fought the lookback and are simply waiting for the FDA to act.
"The nation's hospitals have strongly supported the goals of HCV lookback," Alicia Mitchell said.
Health and Human Services officials said the lookback remains a priority.
"This administration has not forgotten hepatitis C," said William Pierce, spokesman for Tommy Thompson, Health and Human Services secretary. "It's just that it has to go through a decision-making process."
Surgeon General Richard Carmona would not comment.
But Shalala, the former health secretary, said she could not defend the delay. "There is no excuse for it," she said.
Even if the lookback went into effect today, hospitals would probably have until 2005 to complete the search.
It already is too late to find some patients because their transfusion records have been destroyed. The blood industry requires hospital transfusion services to keep them for only 10 years.
On the shelf
In some cases, the lookback has moved ahead even though the FDA hasn't acted.
Many blood banks -- including the Community Blood Center in Kansas City -- say they have completed their role, which is to give records of infected blood to hospitals.
But many hospitals haven't notified patients, blood industry officials say.
Kay Gregory, director of regulatory affairs for the American Association of Blood Banks, said many hospitals haven't searched because the FDA's lookback rules aren't final.
"If the FDA should change their mind about what they want done, we will have to go back and do it all over again," she said.
In a spot check by The Star, Truman Medical Center on Hospital Hill said it had completed the expanded lookback. But St. Luke's Hospital of Kansas City and the 10 HCA Midwest Division (formerly Health Midwest) hospitals said they couldn't do the search because records were not easily available -- or even still in existence at some HCA hospitals.
And University of Kansas Hospital might have done the search but isn't sure.
The names of 58 living patients who received tainted blood were sent to the KU hospital departments that were responsible for their care. Those doctors were asked to notify the patients but were not required to report their findings.
"Unfortunately, we did not collect that information," said Bob Hallinan, hospital spokesman.
If any area patients have been contacted, at least one Kansas City gastroenterologist has seen no evidence of it.
"I have never had a patient who got a lookback letter," said Bradley Freilich, who has treated hundreds of hepatitis C patients. "Obviously, the lookback was poorly or haphazardly done."
Critics of the FDA concede that a lookback isn't easy -- it would always be hard to find great numbers of infected people. In fact, the FDA has estimated that both lookbacks would find only about 5,000 patients who are still alive and don't know they have the disease.
Critics point out, however, that the lookbacks could have been more effective. Each year of inaction only increased the likelihood that blood bankers would be right -- that a number of patients would have died or moved away.
"By delaying 10 years they will be able to prove their point," said Norwood Hill, a former blood bank director in Dallas, where few of the hospitals have done the lookback.
"They might have been able to save a few lives along the way if they hadn't been so slow about it."
Even now a lookback could benefit a lot of people, said Ron Gilcher, head of the Oklahoma Blood Institute and a member of the blood safety committee.
"Unfortunately, there still are a lot of people out there who were transfused in the distant past, who were infected and they don't know it," Gilcher said.
Database editor Gregory S. Reeves and projects reporter Mike McGraw contributed to this report.
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