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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”





Disease spread as blood test was delayed
By KAREN DILLON
2003 The Kansas City Star

Posted on Sun, Nov. 09, 2003

WARNING SIGNS: In the 1970s, about 1,500 hospital patients participated in the Transfusion-Transmitted Viruses Study. Researchers concluded that ALT testing could slow the spread of hepatitis C. However, the blood testing was delayed for years. The infected blood from the study is stored at BBI Biotech in Gaithersburg, Md., for future research. Photo by DAVID EULITT, The Star


WASHINGTON, D.C. - Guardians of the nation's blood supply gathered in 1981 at American Red Cross headquarters to consider a way to prevent hepatitis C from spreading through transfusions.

For more than four hours they talked about using a test that was available and could help screen out blood carrying the virus.

The so-called ALT test was far from perfect. But evidence that it would slow a disease infecting hundreds of thousands of patients each year seemed so persuasive that the blood industry needed to act.

The group concluded:

"Blood collection agencies in the U.S. should prepare to test ALT levels of all blood units."

But that didn't happen. In fact, the blood industry would delay testing for another six years.

It's impossible to know how many hepatitis C infections could have been prevented by the ALT test during those years. But that figure might be more than 300,000 people, based on data from some studies.

Arguments made in January 1981 to use the ALT test, revealed in reports and documents obtained by The Kansas City Star, surprise some of those who were trying to contain the virus.

"I did not know this (report) existed," said Ron Gilcher, head of the Oklahoma Blood Institute. "I was really shocked."

In 1983, Gilcher's blood center broke from the industry to become one of the first to use the ALT test, but he now wishes he had known two years before that the report existed.

"Certainly if I had seen this information I would have had the test in place in 1981," Gilcher said. "What amazed me was the results of this were not communicated to the transfusion community."

Instead, the blood industry reversed course.

Five months after the 1981 meeting, industry groups began recommending a delay in testing, and the government never forced the issue.

 


Blood leaders who opposed the test said it did a poor job of detecting hepatitis C. More study was needed to show it would actually reduce the number of cases. It would cost blood banks too much, especially to replace donors who would be barred from giving blood. And it would be difficult to implement.

Besides, the disease didn't seem that deadly.

Today, many blood bank officials say they shouldn't be blamed for the decision to delay ALT testing.

"Nobody did anything wrong as far as I'm concerned," said Paul Holland, who in 1981 was chairman of a blood industry committee on hepatitis testing.

"In hindsight, maybe we could have done differently, but that's hindsight."

A researcher who backed the ALT test said he nonetheless understood how hard it was for blood bankers to make decisions at the time.

Armchair quarterbacking is easy 20 years later, said F. Blaine Hollinger, director of an Hepatitis C Virus and HIV research center at Baylor College of Medicine.

"When you are going through it, it doesn't quite hit you," he said.

But after the January 1981 meeting, some blood officials clearly felt heavy responsibility.

In fact, one of the participants wrote a week later that some at the meeting "were talking about preventing a disease that we in fact help create through blood transfusion."

Another participant, Johanna Pindyck, began using the test at her blood bank.

"This was a serious disease, and it was a preventable disease," says Pindyck, who was director of the Greater New York Blood program.

The Canadian Red Cross also was concerned about hepatitis C and sent a representative to monitor American discussions in 1981. But Canada waited even longer than the United States to test, and that decision resulted in criminal charges last November against the Canadian Red Cross.

Back in the United States, up to 450,000 people who got hepatitis C through transfusions before 1992 are believed to be alive today. Many of them still don't know they have the disease, which has been called the Silent Epidemic.

There is no way to tell how many of those cases occurred in the early 1980s and could have been prevented by ALT testing.

Need for a test

By the mid-1970s, early studies indicated hepatitis C was infecting 10 percent of all transfusion patients, or about 300,000 a year.

A test for hepatitis B, licensed in 1972, had screened most of that virus out of the blood supply, but there was no test for hepatitis C, or non-A, non-B hepatitis, as it was known then.

One test, ALT -- which stands for alanine aminotransferase, a liver enzyme -- had been used by physicians since at least the 1950s to find damage to the liver. Blood banks in Germany and Austria, but not the United States, had used it since at least 1970 to screen blood for hepatitis.

A study began in 1974, in part to determine the link between transfusions and hepatitis, said Richard D. Aach, principal author of the study and now an associate dean at Case Western Reserve University's medical school.

The Transfusion-Transmitted Viruses Study enrolled 1,500 elective surgery patients who received blood that was measured for ALT levels. They were followed to see whether they developed non-A, non-B hepatitis.

By 1978 the study had reached a preliminary conclusion: The ALT test could reduce cases of hepatitis if used to screen blood donated for transfusions, removing the blood that had high levels of the liver enzyme.

"It became clear after several years, a few years into this study, 1976 or 1978, that ALT was an excellent marker," said Hollinger, an investigator for the virus study and a former chairman of a Food and Drug Administration advisory committee.

James W. Mosley, the study's principal investigator, said he encouraged blood banks to use the ALT test but they remained skeptical.

"We probably should have called more attention to it," he said.

 


By January 1981, though, government and blood bank officials were ready to talk about ALT testing. The American Red Cross invited a group of blood experts to its Washington headquarters.

The group included a top FDA blood expert, a pioneering Hepatitis C Virus researcher at the National Institutes of Health, and representatives of the American Association of Blood Banks, the Red Cross and the Council of Community Blood Centers.

Documents from the meeting show the 1981 group reached several conclusions:

• ALT testing would decrease the number of patients who got infected, based on at least two studies. The participants "agreed that there was evidence that the introduction of ALT testing would reduce the incidence of post-transfusion non-A, non-B hepatitis."

• Evidence for the test was so strong, in fact, that it would no longer be possible to conduct studies in which patients received blood known to have high ALT levels. Participants at the meeting agreed that such studies would no longer be ethical.

• Much needed to be done before testing could begin. The group appointed a working committee to sort through such issues as how to make testing consistent and what to tell donors who have high-ALT blood.

The blood industry would also have to address the loss of up to 3 percent of donors, including many who weren't actually infected but tested positive nonetheless. But that shouldn't stand in the way of testing, said Alfred J. Katz, a blood center director who soon would become executive director of the Red Cross Blood Services.

A week after the January 1981 meeting Katz wrote to a colleague:

"This concern did not outweigh the medical, scientific, ethical, legal, and public relations judgment that it was incumbent upon us to prepare to implement ALT as a donor screening procedure, in order to decrease NANB (non-A, non-B) hepatitis in recipients."

But within five months the industry changed direction based on recommendations of at least two advisory committees.

"The Committee concluded that the available data are insufficient for a decision on introduction of routine ALT testing of blood donors at this time," one blood group wrote in June 1981.

Some of those who met in January 1981 won't talk about the dramatic change, including Katz and Roger Dodd, who wrote the report of the meeting and today is still with the Red Cross.

But a spokesman for the blood banks association describes the rapid turnabout as an evolution, not a reversal.

"Although some of the initial documents could be read to indicate the way is clear and this is what we are going to do, I think the environment in which that conclusion was reached was one of change," said James P. AuBuchon, medical director of the blood bank at Dartmouth-Hitchcock Medical Center and former member of a federal blood advisory committee.

"Additional concerns were raised."

Joseph P. O'Malley, who attended the January 1981 meeting, said a few persuasive people seized control of it and influenced the recommendation to implement ALT testing. The decisions the group reached didn't reflect the thinking of the blood industry, said O'Malley, who retired after 32 years with the Red Cross and FDA.

Indeed, Thomas Zuck was surprised to discover the true thinking of blood bankers in the months following the meeting.

"I think we left that '81 meeting with the expectation that this was going to happen within a year," said Zuck, who at the time worked for the blood banks association. "I don't think we realized the resentment there was in some quarters. They really didn't want to do it."

In fact, Zuck thinks, the Red Cross put the meeting together actually expecting that the group would reject ALT testing.

"The Red Cross was leading the band mainly because they wanted a blockade," said Zuck, who remains a consultant to foreign countries investigating blood contamination.

The Red Cross has refused to talk about the meeting, but it has characterized the conclusions as only preliminary in documents it filed in response to a lawsuit.

 

Obstacles

For the next five years, the industry debated using the ALT test but left it on hold. Among the reasons it offered:

• Lack of evidence.

Despite the January 1981 conclusion, it wasn't clear, after all, that ALT screening would reduce hepatitis C cases, blood leaders said.

The major studies only predicted that ALT testing would decrease hepatitis but did not confirm it, some researchers said. In fact, ALT testing might even have minimal impact.

As a result, instead of being unethical, another study on humans was needed, some top blood officials said in meetings and articles. It could take up to six years and involve thousands of patients and donors.

But Hollinger and some other experts said another study was senseless.

"That was just a bunch of crap," he said.

Indeed, the study was never performed in the United States.

Some say the proposed study wasn't the real point -- the point was to delay the ALT test.

"Was that a ruse for the blood bankers?" said Mosley, a professor emeritus at the University of California-Los Angeles medical school. "Did they say, `Oh my God, we need to study this some more and then we can just prolong everything'? Oh yes."

• Difficulty in testing.

Because ALT levels in the population tended to vary from region to region, blood banks would have a hard time setting a nationwide rate that would signal dangerous donations.

But the working group that was appointed at the January 1981 meeting to write those guidelines never met. A national conference on ALT screening was scheduled by the government for June 1981, but it never happened either.

• Donors.

The numbers of lost donors would not be worth the infections that would be prevented. Of the donors who tested positive in the ALT test, for example, only a third might have hepatitis C.

The loss of so many other donors who weren't really infected would unnecessarily alarm the donors and also create a dangerous shortage of blood, leaders said.

Two extensive studies had estimated, however, that only 1.5 percent to 3 percent of all donors would be excluded.

• Partial solution.

Many thought a better test -- one actually triggered by the virus, not just by a liver enzyme -- would be worth waiting for because studies predicted the ALT test would prevent only a third of the infections.

But the January 1981 group knew a better test could be years away -- and, in fact, it was. Besides, said Pindyck, the former New York blood director, that debate just didn't make sense:

"If a group of firemen were outside a burning building and they could only save 30 percent of the people in the building, and they sat around and debated and said, `It's not worth our effort to do it,' what would happen?"

Voluntary testing

Only a few blood banks, including Pindyck's, bucked the industry.

After the January 1981 meeting, the Greater New York Blood Center, which had been part of the TTV study, decided to use the test. An independent committee of doctors, business leaders and others studied data for the blood center and concluded unanimously that the $2.77 cost of each test -- to cover the test itself and loss of donors -- was worth the drawbacks.

In fact, by 1983, Pindyck and a colleague had published an article that confronted some of the industry's objections. The ALT test was not difficult to conduct, and the center easily absorbed the loss of donors, Pindyck said.

The report's impact? "Nobody paid any attention," Pindyck said.

Ironically, even though the federal government didn't require the ALT test anywhere in the nation, it wanted to protect its own blood. The National Institutes of Health ordered ALT screening at its largest research hospital.

The FDA also took no position on another screening test, known as the hepatitis B core antibody test, which was available by 1983. Used together, it appeared, both tests could flag hepatitis C in more than 40 percent of the cases.

At the time, the value of the tests still seemed unproven and the costs in donors too high, said Jay Epstein, director of the FDA's Office of Blood Research and Review. And a better test still seemed near.

"On the other hand, the FDA did not discourage blood banks that elected voluntarily to implement those tests," Epstein said.

Indeed, blood banks finally did decide in 1986 to use the tests following an FDA blood advisory committee meeting. The committee heard about increasing reports that hepatitis C patients were dying.

"If we were the ones that caused their death with transfusion, I think that is something we should try to prevent," Harvey Alter, an NIH scientist credited as perhaps the nation's pre-eminent hepatitis C researcher, told the committee.

The Red Cross and other blood associations asked blood banks in 1986 to use the ALT test and the hepatitis B core antibody test. By 1987, most did, including the Community Blood Center in Kansas City.

As for the FDA, it never set guidelines or required the ALT test to be used.

As a result, some infected blood that would have been detected was used for transfusions, Mosley said.

Action in Canada

The years of delay have attracted little notice in the United States.

But in some countries, such as Canada and Australia, delays in hepatitis C testing have created a scandal, prompting public protests.

In fact, the Canadian Red Cross and its former top blood official were charged last year for not using available screening tests between 1986 and 1990, and for not warning the public that blood was unscreened. The charges are pending.

"This is a crime," said Mike McCarthy, a hepatitis C patient and until recently senior policy adviser to the ministry of health in the province of Ontario.

"People were harmed and people suffered egregious injuries and many people died."

Canada has paid millions of dollars in compensation to people infected with hepatitis C through transfusions. In fact, in 1994 Canada began searching for those people to make sure they knew they had received infected blood.

In the United States, however, hundreds of thousands of infected patients have never been notified.

And there is no compensation, despite prodding by a congressional committee and others. No strong lobby has ever formed around the disease to force the government to set up a fund.

And one American blood official doesn't believe there should be a fund. A lot of medical procedures are risky, and the blood industry did the best it could with hepatitis C, said Holland, former head of a government blood bank and now director of a Sacramento blood bank.

"It was really nobody's fault," Holland said. "Life is full of risks."

To reach Karen Dillon, projects reporter, call (816) 234-4430 or send e-mail to kdillon@kcstar.com. Database editor Gregory S. Reeves contributed to this report.