[Congressional Record Volume 140, Number 36 (Friday, March 25, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: March 25, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
           THE RAY FAMILY, HEMOPHILIA, AND THE AIDS EPIDEMIC

 Mr. GRAHAM. Mr. President, on December 13, 1992, Ricky Ray, a 
teenage boy in east Orange County, FL, died at home after his 6-year 
battle against AIDS and 15-year or lifelong battle with hemophilia. I 
attended Ricky's funeral later that week and read a letter from then 
President-elect Bill Clinton who, like I, was profoundly affected by 
this incredible human being and his family.
  This tragic story begins over 10 years earlier when the first case of 
immune deficiency linked to blood products was reported in a Floridian 
with hemophilia in January 1982. As documented in Randy Shilt's book 
``And the Band Played On: Politics, People, and the AIDS Epidemic,'' 
evidence grew over the year that others with hemophilia were being 
infected and at least two transfusion-related AIDS cases were also 
reported. In June 1982, the first warning was issued by the Centers for 
Disease Control [CDC] to clotting-concentrate manufacturers, other 
Federal health agencies and the National Hemophilia Foundation.
  According to Harvey M. Sapolsky and Stephen L. Boswell in ``The 
History of Transfusion AIDS: Practice and Policy Alternatives'',

       Weighing this evidence, the CDC epidemiologists began 
     warning representatives of the several blood-banking 
     organizations that the blood supply was possibly being 
     contaminated with AIDS. These discussions culminated in a 
     meeting in Atlanta in early January 1983, at which proposals 
     were presented to screen out from the blood donor pool 
     members of high-risk groups.

  Sapolsky and Boswell add,

       The opposition of the whole-blood collectors delayed 
     governmental action intended to reduce the risks of AIDS 
     transmission through transfusions. It was not until March 
     1983 that the Centers for Disease Control made public the 
     recommendations for widespread screening.

  Moreover, it was not until even February 1984 that manufacturers 
included warnings about AIDS on their blood products--over 18 months 
after CDC's original warning.
  Calls for blood testing for evidence of hepatitis B with a core 
antibody test were also being made during the period. According to 
Sapolsky and Boswell,

       The Food and Drug Administration's Blood Products Advisory 
     Committee studied the issues pertaining to screening the 
     blood supply in early 1984, concluding that surrogate 
     testing, and most specifically the hepatitis B core antibody 
     test, was not appropriate as a means of identifying those at 
     high risk for developing AIDS because it screened out too 
     much of the blood supply.

  While some testing did occur like that at Standord University Blood 
Bank, it was far from pervasive.
  In March 1985, the FDA licensed and put into place the first blood 
test for HIV antibodies. Meanwhile, due to the fact that clotting 
factors are made from pooled plasma lots composed of thousands of 
donors, approximately one-half of the estimated 20,000 Americans with 
hemophilia contracted AIDS. The result was, as Michael McLeod reports 
in his article ``Bad Blood'' which was printed in the Orlando Sentinel 
on December 19, 1993, ``a quite death march, caused by one of the worst 
medically induced calamities in history--one that has claimed more than 
1,600 Americans already, with at least 8,000 more sure to follow.'' 
Ricky Ray tested positive for HIV in 1986.
  In remembering Ricky, words such as perseverance and wisdom come to 
mind. Ricky and his family have, since that revelation in 1986, lived 
with the pain and questions caused by this horrible virus called AIDS. 
If that is not enough, there was also the pain of being banned from 
school in 1987, having their home burned down by an arsonist shortly 
thereafter, and spending a tremendous amount of time in court fighting 
with the DeSoto County School District and the pharmaceutical companies 
that sold the Ray family the contaminated blood products.
  Despite it all, Ricky was committed to teach others about his 
disease. His mother, Louise Ray, said of Ricky in a recent article 
written by Monica Davey at the St. Petersburg Times, ``He believed that 
his track in life was to educate people about a disease that nobody 
know about. He believed that was his purpose.'' His father Clifford 
added, ``Ricky was a very old soul. He had a wisdom about him.''
  Like others with hemophilia and AIDS, Ricky was interested in answers 
to the questions of why. Why did this happen and why was not more done 
to prevent this tragedy? If nothing else, we certainly owe it to the 
hemophilia community to find answers to these questions and to do 
everything possible to prevent further recurrences.
  As a result, I joined Senator Edward M. Kennedy and Congressman 
Porter Goss in requesting from Secretary Donna Shalala of the 
Department of Health and Human Services a thorough review of the 
transmission of HIV through blood products to approximately half of 
this Nation's hemophilia population and up to 90 percent among those 
with the most severe form of hemophilia. As Congressman Goss and I 
wrote in a letter to House Energy and Commerce Committee Chairman John 
Dingell, ``Our mission is twofold: first, it is critical to make sure 
the Nation's blood-supply and our supply of lifesaving blood clotting 
factors are now free on HIV contamination; second, we believe we owe it 
to those who were infected and their families to find out what went 
wrong.''

  Secretary Shalala requested the study to be conducted by the National 
Academy of Sciences. We are all hopeful for a thorough, yet speedy, 
review of these issues. However, with a person in the hemophilia 
community dying every day from AIDS, we cannot just patiently wait for 
their conclusions. We must continue to seek answers and move to protect 
others from similar fates.
  First, and foremost, we must ensure that our Nation's blood supply is 
truly safe for both the hemophilia community and all Americans who face 
the possibility that they may need a blood transfusion at some point in 
their lifetime.
  For example, the FDA has a catalog of Red Cross violations since 1988 
that is 500 pages long and has more than 3000 violations. In addition, 
according to a ``Dateline NBC'' report, there have been ``more than 
1,700 cases in the past 5 years in which blood had to be recalled from 
Red Cross and non-Red Cross blood banks across the country.'' The FDA, 
as a result, has resorted to suing the Red Cross, which is responsible 
for nearly half of the Nation's blood supply.
  Second, we should ensure that we assist those 10,000 HIV-infected 
people and their families with their primary needs. Whether this is 
addressed by Congress this year through the provision of universal 
health care coverage or not, we must adequately address the health and 
human needs of this population and others affected by AIDS.
  Third, as Harold L. Dalton, and editor of ``AIDS Law Today: A New 
Guide for the Public,'' writes:

       * * * we should remember that just as the law frames 
     society's response to the AIDS epidemic, the society as a 
     whole shapes the law. Like it or not, we must decide what 
     kind of society we will be: mean-spirited, shortsighted, and 
     judgmental or compassionate, clearheaded, and accepting. In 
     the end, society will determine where the burden of AIDS--
     social, financial, and emotional--will fall. We can make the 
     choice consciously and purposely, or we can make it by 
     indirection or default, but make it we will.

  When Ricky saw the headline that ``Ryan White loses battle with 
AIDS'', he was very upset. As quoted by McLeod, he said to his mother, 
``If I die, don't let them write that about me. Don't let them say that 
I lost. Just because you die, that doesn't mean you gave up. That 
doesn't mean you lost.'' Ricky is right because his call for answers, 
help for those with AIDS and fight for the safety of the blood supply 
lives on.
  Mr. President, I ask that additional information concerning this 
matter be printed in the Record.
  The material follows:

             [From the Philadelphia Inquirer, Feb. 4, 1994]

              AIDS A Big Factor In Deaths of Hemophiliacs

                          (By Gilbert M. Gaul)

       A new federal study documents the devastating effect of 
     AIDS on America's hemophiliacs.
       The death rate among hemophiliacs with the most common form 
     of the hereditary bleeding disorder, hemophilia A, tripled 
     between 1979-1989, chiefly because of AIDS, according to a 
     report in the February issue of the American Journal of 
     Hematology.
       During the same period, the median age at death for people 
     with hemophilia A plummeted from 57 years to 40 years, 
     researchers from the U.S. Centers for Disease Control 
     reported.
       The study found that 470 people with hemophilia A who died 
     between 1987 and 1989 had AIDS or HIV infection listed as the 
     cause of death. The 470 accounted for more than half of all 
     those with hemophilia A who died during that period.
       The president of the National Hemophilia Foundation, a New 
     York advocacy group, said the findings confirmed what 
     hemophiliacs and their families already knew.
       ``We have known that this devastation has been going on for 
     years.'' said Alan Brownstein. ``But for people who want to 
     see the numbers, their study displays the dramatic reversal 
     of all of the progress that had been made in the lifespan of 
     hemophiliacs in the 1970.''
       According to the foundation, about 17,000 Americans have 
     hemophilia A. More than 80 percent of people with severe 
     hemophilia A are believed to have been infected with AIDS in 
     the early to mid-1980s through the use of tainted blood-
     clotting medicine, called Factor VIII. The first case of AIDS 
     in hemophiliacs was reported in 1981.
       To date, about 4,000 people with hemophilia A are 
     officially listed as having been infected with AIDS according 
     to the CDC.
       ``It's safe to say that more than 2,000 people with 
     hemophilia A have died of AIDS.'' Brownstein said. Currently, 
     about 30 more people per month are dying, he said.
       The lifespan of hemophiliacs increased in the 1970s, but 
     then dropped dramatically in the late 1980s as hemophiliacs 
     started to die from AIDS. After peaking in 1983 to a median 
     lifespan of 64 years, the median age at death in hemophiliacs 
     fell to 40 in 1989, the study found. The lifespan of 
     hemophiliacs today now resembles what it was 20 years ago, 
     before modern treatments were available.
       According to the researchers, the risk of getting AIDS from 
     tainted blood products has been virtually eliminated since 
     1985 because of new screening procedures and safer clotting 
     medicines.
       In a related development, Brownstein yesterday said 
     foundation officials were competing draft legislation to 
     compensate AIDS-infected hemophiliacs and their families. 
     They hope to present it to Congress in March.
       Under the foundation's proposal, those hemophiliacs would 
     be eligible for financial help for medical bills and family 
     support from Medicare and Social Security. The legislation 
     would also create a special trust fund to meet the needs of 
     people who have been financially devastated by AIDS, 
     Brownstein said.
       ``We're pursuing this on the basis that the federal 
     government had a major responsibility in monitoring the 
     safety of the blood supply. We're not casting blame. We're 
     saying the system didn't work.''
                                  ____


                    [``Dateline NBC,'' Oct. 5, 1993]

                    Safety of America's Blood Supply

       Jane Pauley. A ten-year old in California. A carpenter in 
     Montana. They have something in common. Both acquired AIDS 
     from blood transfusions.
       Bob Jones. AIDS was the last thing on the face of this 
     Earth that I was worried about.
       Pauley. It happened long after blood screening began.
       Elizabeth Dole. American Red Cross blood is the safest it's 
     ever been. It's the safest in the world.
       Pauley. It's not always safe enough. Tonight, a Dateline 
     investigation into laboratories and blood banks.
       Stone Phillips. What does that say about the safety of the 
     blood supply?
       Dr. David Kessler. The risks are rare but they're real.
       Pauley. Do you know what you need to know about blood?
       Whether it's a surgical procedure or an accident, any one 
     of us could need a blood transfusion. That's why our first 
     story is so important: the safety of America's blood supply.
       The vast majority of blood transfusions are safe. And 
     nothing of what follows should cause you to reject blood if 
     you face a medical emergency. But what you're about to hear 
     is the untold story of the problems the Federal Government's 
     been finding at too many of the nation's blood banks.
       Stone Phillips. Problems so serious, the government took 
     the unprecedented step of suing the American Red Cross 
     earlier this year.
       Tonight, the results of a six-month Dateline investigation. 
     And for the first time on television, we'll show you the 
     scope of what the Food and Drug Administration described as a 
     continuing pattern of violations, violations that call into 
     question whether the blood supply is as safe as it can be. As 
     FDA Commissioner David Kessler told us, the risks are rare 
     but real.
       Jones. I was just totally shocked, stunned. You know, I 
     couldn't say a word, I couldn't think, I couldn't do 
     anything. AIDS was the last thing on the face of this Earth 
     that I was worried about.
       Phillips. Bob Jones is a 60-year-old carpenter living with 
     his wife, Shirley, in the mountains near Bozeman, Montana, 
     far removed from the urban neighborhoods that have become the 
     killing grounds of the AIDS epidemic.
       It's hard to imagine anybody being much further from the 
     highrisk groups for HIV infection than you.
       Shirley Jones. Right. That's what we thought. Absolutely.
       Jones. Well, apparently our high risk was accepting blood 
     from the blood bank.
       Phillips. Doctors say Bob Jones is slowly dying of AIDS. 
     What's surprising about his story is how he got it: through a 
     blood transfusion, a transfusion he received more than four 
     years after the government had approved a new test that was 
     supposed to screen blood for AIDS.
       In the early years of the AIDS epidemic, before scientists 
     knew much about it, thousands of people contracted AIDS from 
     blood transfusions, including celebrities like tennis star 
     Arthur Ashe.
       Woman. Today we are licensing a blood test . . .
       Phillips. But that changed in 1985 when officials announced 
     a new test that would screen the blood.
       There's no doubt the new test did dramatically improve 
     blood safety. Food and Drug Commissioner David Kessler says 
     today your chances of getting AIDS from a blood transfusion 
     are about the same as dying from an allergic reaction to 
     penicillin.
       Dr. Kessler. If you need blood tonight, I mean if you have 
     to be transfused, I can sit here and say that if you need 
     that transfusion, have that transfusion, because the benefits 
     outweigh that risk.
       Phillips. Even so, Kessler says the nation's blood system 
     is not as safe as it could be.
       Dr. Kessler. The risks are rare but they're real. And 
     unless it's your own blood, then the risks are out there.
       Phillips. Bob Jones says his case is evidence that the 
     risks are greater than most people realize. And as you'll 
     see, our own investigation points to the same disturbing 
     conclusion.
       Do you feel that you and your family were misled about the 
     safety of the blood supply?
       Jones. I feel not only my family, us and our family, I 
     think the whole world has been misled by it. You see these 
     advertisements on television, ``Blood is safer than it ever 
     was.'' Well, right. It is. They don't tell you how safe it 
     never was.
       Phillips. It was November 1989 when Bob Jones was rushed to 
     this hospital near Portland, Oregon. A blood vessel had 
     burst, causing severe internal bleeding. Surgery saved Bob's 
     life. But four months later he got a phone call from the head 
     of the Red Cross blood bank in Portland.
       Jones. He told me, he says, ``I hate to be the bearer of 
     bad news. But,'' he said, ``one of the donors has turned up 
     positive for HIV.''
       Phillips. What in the world went through your mind when you 
     heard that?
       Jones. I hate to see my family have to go through the next, 
     oh, three, four or five years, whatever it takes. I would 
     have much rather gone out right on the table.
       Phillips. You would have rather died in surgery than gone 
     through this.
       Jones. That's right.
       Phillips. How can contaminated blood get through the 
     screening process? And is it still happening today?
       When we started asking those questions, we found a blood 
     safety net which government officials say has potentially 
     dangerous holes. From big-city blood banks, where government 
     records show some critical testing and labeling violations 
     going on year after year, right into 1993; to government 
     computer files that document blood recalls, something we'd 
     never heard of, hundreds of them nationwide during the last 
     five years; and finally, to the headquarters of an 
     organization responsible for nearly half of the nation's 
     blood supply, whose record of repeated safety violations 
     recently landed it in federal court.
       When you took this job, did you ever imagine that your 
     biggest enforcement nightmare would be coming from an 
     organization called the American Red Cross?
       Dr. Kessler. It's the hardest thing that I have done. And 
     it had to be done in a way that got the job done and still 
     not scare the public.
       Phillips. In order to understand why FDA Commissioner David 
     Kessler has taken the Red Cross to court and how people as 
     unlikely as Bob Jones are still getting AIDS from blood 
     transfusions, we wanted to find out more about how blood is 
     tested for safety.
       Dr. Ed Engleman. This is the laboratory in which the blood 
     is tested.
       Phillips. Ed Engleman is a medical doctor, research 
     scientist, and director of the blood bank at Stanford 
     University. He's also testified as a paid expert in court 
     cases against the Red Cross. He says all blood must pass a 
     series of sophisticated tests, screening everything from 
     hepatitis to syphilis to the AIDS virus.
       Dr. Engleman. Each virus is different.
       Phillips. But even if every stop in the AIDS test is 
     followed to the letter, contaminated blood still can slip 
     through because the test has an inherent weakness, something 
     blood banks know but you may have heard little about The 
     problem is that the test doesn't actually look for the AIDS 
     virus itself, but for the immune system's response to it, the 
     antibodies.
       Dr. Engleman. And once a person is infected with the virus, 
     it takes time for the antibodies to form. It may take a few 
     weeks, it may take four or five months.
       Phillips. If a donor is recently infected, it may not show 
     up.
       Dr. Engleman. That's correct.
       Phillips. That means the test has a built-in blind spot. 
     And since each unit of blood usually is split into different 
     components, each component going to a different patient, one 
     bad unit could infect several people.
       In the case of Bob Jones, it turns out the donor had been 
     recently infected with the AIDS virus and the blood test 
     didn't catch it. But in a lawsuit, Bob Jones's attorney, 
     Monte Back, claimed the Red Cross in Portland overlooked what 
     should have been a clear warning.
       Each number on this computer printout represents a blood 
     sample taken and tested for AIDS. On the list, one stands 
     out. It's the blood that went to Bob Jones. Although not 
     above the cutoff that would have prevented its release, this 
     blood tested far higher than the other samples in the batch.
       Monte Beck. If you see an unusual test result that's five 
     times higher than anybody else on that test that day, that's 
     telling you something.
       Phillips. But if I'm the lab technician and I know what my 
     cutoff point is, I might not flag it.
       Beck. Well, you might not flag it, but you should.
       Phillips. Dr. Engleman agrees. He says although blood-
     testing equipment is better than ever, all lab technicians 
     need to be encouraged to use their judgment in close calls. 
     Often that's not the case, even in his own lab.
       Dr. Engleman. So if somebody comes up with a test that is 
     just below the cutoff, you've trained that individual to 
     ignore it.
       Phillips. This past March, just one day after these opening 
     arguments began in court, the Red Cross settled the Bob Jones 
     case, agreeing to pay him an undisclosed amount of money but 
     admitting no mistakes.
       Fred Kyle. We shouldn't imply that this was the fault of 
     the American Red Cross, because it was not.
       Phillips. Fred Kyle is in charge of Red Cross blood banks 
     nationwide.
       Kyle. The American Red Cross, in the case of the Jones 
     incident, followed every single procedure that we have to the 
     letter and every single procedure that the Food and Drug 
     Administration requires to the letter.
       Phillips. While the FDA did not find fault with the Red 
     Cross's handling of the Jones case, these government 
     inspection reports, obtained by Dateline through the Freedom 
     of Information Act, show the Red Cross does have a record of 
     repeatedly failing to follow blood test procedures, not only 
     for AIDS but for other potentially fatal diseases as well.
       In Portland, government inspectors reported in 1991 that 
     the Red Cross failed to properly calibrate its testing 
     equipment, failed to follow proper test procedures. And 
     record-keeping was so sloppy that during one inspection the 
     government found blood which had failed an AIDS test about to 
     be shipped out.
       Dr. Kessler. There was a great deal of concern.
       Phillips. And Kessler says the problems weren't just in 
     Portland, but at Red Cross blood banks all across the 
     country.
       In Waco, Texas, the Red Cross allowed blood to be 
     transfused from a donor with a history of failing AIDS tests. 
     In Farmington, Connecticut, the Red Cross mistakenly released 
     blood taken from known IV drug users. In Washington, D.C., 
     the blood bank failed to follow up on hundreds of cases in 
     which donors gave blood but later tested positive for AIDS.
       Dr. Kessler. It wasn't any one individual violation. What 
     it was was going in year-in and year-out and seeing the same 
     violations. That's what concerned us most.
       Elizabeth Dole [May 20, 1991]. There can be no higher trust 
     than the blood of life we distribute.
       Dr. Kessler. The government's findings came in spite of 
     repeated pledges, in 1988 and again in 1991, that the Red 
     Cross would upgrade its blood system.
       Dole. The key here is that we're going to make it as safe 
     as it can be made, or we're not going to collect blood.
       Phillips. Did you talk to Elizabeth Dole about this, head 
     of the Red Cross?
       Dr. Kessler. I spoke to the entire leadership of the 
     American Red Cross.
       Phillips. Unpersuaded their voluntary transformation 
     program to overhaul equipment and training would address the 
     problems quickly enough, Commissioner Kessler made what he 
     calls his most difficult and most important decision. In May 
     of this year, he took the American Red Cross to court, where 
     both sides agreed that if the improvements weren't made by 
     specific deadlines, the Red Cross would answer to a federal 
     judge.
       Kyle. I don't accept the fact or the allegation that the 
     American Red Cross has dragged its feet at all on maintaining 
     absolute safety in our operations.
       Phillips. Absolute safety?
       Kyle. Absolute confidence that we have maximum safety.
       Phillips. This is the FDA's catalog of Red Cross violations 
     since 1988. It's 500 pages, more than 3000 violations. I mean 
     that's a pretty sizable document.
       Kyle. It certainly is.
       Stone, I think that if we have rigorous regulatory 
     enforcement, which absolutely is necessary and we welcome it, 
     we are always going to have observations of how we can 
     improve our operations. But that's a different thing than 
     saying that there is a problem with the safety of the blood 
     supply, or the efficiency or safety of our operations. That's 
     two different things.
       Kessler. We were seeing too many units that were released 
     where there was just a breach in one of the levels of 
     protection. There were just too many unsuitable units being 
     shipped.
       Phillips. When we come back, blood recalls, trying to get 
     some of those unsuitable units back after they've been 
     shipped out. And more blood banks cited by the FDA. We'll 
     tell you which ones, why they got in trouble, and how in some 
     cases the government threatened to shut them down.
       Phillips. As we just heard, there is a blind spot in the 
     test used to screen blood for the AIDS virus, making it 
     inevitable that blood from some recently infected donors will 
     slip through. That's a problem both for Red Cross blood banks 
     and for private ones as well. But the question is, given 
     that, how should blood banks respond once they've learned 
     that one of their donors has tested positive for the virus? 
     What responsibilities do they have to notify patients who may 
     have received tainted blood? As we discovered, that's another 
     problem area for the FDA.
       Jessie Lee Fagan was hardly the picture of a child 
     struggling with cancer, perhaps because she beat it.
       Roger Fagan [father]. When we heard the word ``remission,'' 
     that was just the best news I've ever heard.
       Phillips. So why is Jessie in a California hospital bed 
     today? Well, it turns out in overcoming leukemia she received 
     dozens of blood transfusions. And somewhere along the way, 
     long after AIDS screening began, she apparently got blood 
     contaminated with the AIDS virus.
       Denise Fagan [mother]. I just thought, ``Oh, my God. How 
     did it happen.'' I thought this blood was safe.
       Phillips. Now, more than two years after she was diagnosed 
     with AIDS, doctors still don't know the source of the 
     contaminated blood, leaving open the possibility that an 
     infected donor may have given more tainted blood that slipped 
     through. And yet when local health officials tried to find 
     the donor, they say their efforts were actually thwarted by 
     the Los Angeles Chapter of the American Red Cross, which 
     provided much of Jessie's blood.
       This March 1992 letter about Jessie's case was sent by the 
     public health director in Kern County, California to the L.A. 
     Chapter of the Red Cross. It said, ``Your agency has refused 
     to provide us important information that would solve the 
     missing link and prevent further blood contamination and the 
     spread of AIDS.''
       The Red Cross says it was only trying to protect donor 
     confidentiality. But other documents obtained by Dateline 
     show that the Los Angeles Red Cross, in a number of cases, 
     has been slow to notify patients who may have received 
     contaminated blood.
       An AIDS transfusion case reported in October of 1991. The 
     blood donor isn't contacted until February of '92. And as of 
     May `92, more than six months later, the blood recipients 
     hadn't been contacted.
       Dr. Engleman. I think that's--I think that's criminal. I 
     think it's absolutely irresponsible. Because not only do you 
     have the blood donor who hasn't been contacted immediately, 
     now you have the recipients who are infected and capable of 
     infecting other people.
       Dr. Kessler. Was it sloppy? Was it the result of not 
     realizing that they had to adhere to rigid standards? Sure.
       Kyle. The L.A. center did not move as fast in the past as 
     we insist they move now.
       Phillips. And in fact, there was a failure to promptly try 
     to contact people who might have received contaminated blood.
       Kyle. In the past, they weren't moving as fast as we wanted 
     them to. Yeah.
       Phillips. The implications there are pretty serious. I mean 
     if people don't know that they may have been contaminated, 
     what's going to happen? They're going to go out and 
     contaminate others, potentially, with the virus.
       Dr. Kessler. It is very serious. And that's why we've taken 
     the actions that we've taken.
       Phillips. Although the Red Cross has been the focus of the 
     government's enforcement effort, Dateline discovered the 
     problems haven't been limited to that organization. Records 
     show that within the past year the government shut down a 
     non-Red Cross blood bank in Putnam County, Florida, and 
     one in Spokane, Washington, which was allowed to reopen 
     only after a management shakeup. And the FDA has 
     threatened to close down other blood banks, as well, for 
     AIDS and non-AIDS-related violations, including Life 
     Source, the largest blood bank in the Chicago area, cited 
     for failing to perform blood tests properly and not 
     keeping an accurate list of ineligible donors. The Irwin 
     Memorial Blood Center, the largest in San Francisco, cited 
     for failing to test blood correctly and failing to 
     properly investigate cases of possible AIDS-contaminated 
     transfusions. The Wobley (?) Blood Bank, the largest in 
     Dallas, cited for mistakenly allowing people who fail the 
     AIDS test to keep donating blood, some of it actually 
     distributed for transfusion.
       Dateline has learned that federal inspectors thought those 
     violations in Dallas were so serious, they considered 
     pursuing criminal charges because of the repeated release of 
     unsuitable blood, blood that wasn't adequately screened.
       All these blood centers were ultimately allowed to remain 
     open after convincing the FDA they were upgrading their 
     equipment and procedures.
       Dr. Kessler. What we're saying is that if there's not 
     immediate correction, we're going to close down and stop 
     allowing you to ship blood. I mean it's as serious as you 
     get.
       Phillips. And there's more. A Dateline analysis of 
     government computer records uncovered more than 1700 cases in 
     the past five years in which blood had to be recalled from 
     Red Cross and non-Red Cross blood banks across the country. 
     In more than 500 of those cases, records show the recalls 
     were because the blood had failed at least one of the safety 
     checks meant to screen out AIDS.
       This map shows the states, 36 of them plus the District of 
     Columbia, in which blood banks have reported AIDS-related 
     recalls since 1991.
       Now, a recall doesn't mean the blood was necessarily 
     infected, but it does mean there was a mistake in the safety 
     screening.
       What does that say about the safety of the blood supply?
       Dr. Kessler. It doesn't allow me to sleep very well at 
     night, knowing that, you know, that we have to recall blood.
       Phillips. Your staff has told us that only a very small 
     fraction of the blood that's recalled is actually recovered.
       Dr. Kessler. That's correct.
       Phillips. Well, doesn't that leave a very big unresolved 
     medical issue out there, blood that you don't know whether 
     it's contaminated or not contaminated?
       Dr. Kessler. Certainly, if there is a breach in a layer of 
     protection, there is no question that the blood poses risks.
       Kyle. I think we are doing a disservice, I truly do, if we 
     imply that the blood supply in this country is not safe. 
     Because it is safe.
       Phillips. In spite of the problems, the Red Cross and other 
     blood banks point to the following statistic as evidence that 
     the blood supply is extraordinary safe.
       Kyle. Since there was testing for the HIV virus in 1985, 
     there have, I believe, been in the United States 21 
     identified cases of transfusion-related HIV.
       Phillips. That figure comes from the Centers for Disease 
     Control, the CDC, and it's been repeated year after year to 
     reassure the public that the risk of getting AIDS from blood 
     transfusions is very low. The most recent CDC statistic is 
     actually 25 cases in the past eight years. That's an average 
     of just three a year out of millions of transfusions. But 
     Dateline discovered that number may not tell the whole story.
       Remember Bob Jones? His blood transfusion was in November 
     1989, but Dateline discovered that his case hasn't been 
     included yet in the CDC's numbers.
       Jones. I don't think they're telling us the truth on that, 
     because of my not being listed.
       Phillips. The government says it doesn't count cases like 
     Jone's until the patient develops full-blown AIDS. Experts 
     say that can take years, even after patients have tested 
     positive for the AIDS virus.
       How many uncounted cases are there? Nobody knows for sure. 
     But Commissioner Kessler told Dateline that instead of three 
     transfusion AIDS cases each year, the real number today could 
     range from 70 to several hundred.
       Dr. Kessler. You're dealing with, at most, I think, several 
     hundred cases a year. And when you recognize that there are 
     somewhere between 12 and 18 million units a year that are 
     transfused, the risk is small.
       Phillips. Several hundred per year is a lot more than 25 
     since 1985.
       Dr. Kessler. That's--Stone, that's the best estimate that I 
     have. That's the best number that I can give you today.
       Phillips. In the end, for people like Jessie Lee Fagan and 
     Bob Jones, it's no longer about estimates or numbers. It's 
     about doing everything possible to make an imperfect system 
     safer.
       Jones. I'd like to see them fix this up so's that my 
     grandkids and your grandkids aren't fighting this 20-30 years 
     from now, if there's anybody left.
       Phillips. The American Red Cross told us just last week 
     that instead of two or three cases, it now estimates there 
     may be as many as 89 cases each year of HIV contracted 
     through blood transfusions.
       So, what should you do?
       Well, first, you cannot get AIDS by donating. So don't be 
     afraid to give blood.
       Second, and we repeat, nothing you've heard tonight should 
     prevent you from accepting blood in a medical emergency. But 
     if you need surgery and it is not an emergency, FDA 
     Commissioner David Kessler urges everyone, if at all 
     possible, to set aside their own blood.
                                  ____


                     [Dateline NBC, Dec. 14, 1993]

          Hemophiliacs Not Told of Clotting Factor's AIDS Risk

       Jane Pauley. If only we knew then what we do now. But back 
     when the magnitude of the AIDS crises was only beginning to 
     be understood, one group of people at high risk slipped 
     between the cracks of what we knew and what we didn't yet 
     know. Thousands are dead or dying.
       Was this tragedy preventable?
       Stone Phillips. Our story goes back to the early 1980s, 
     when people with hemophilia began using a blood-clotting 
     agent known as factor. It was convenient and effective, but 
     it was often transmitting the AIDS virus.
       Tonight a six-month Dateline investigation shows that there 
     were people in authority who knew about the risks. So why 
     didn't their warnings reach more people?
       Here's Lea Thompson.
       [Clip of demonstration]
       Woman: Ten thousand people infected.
       Louise Ray: They should have at least given these people 
     word that every time you put that needle in your arm, you are 
     playing Russian roulette. I don't appreciate it that they 
     played God with my children's lives.
       Lea Thompson. Louise Ray's three sons are among the 
     thousands of hemophiliacs who got the AIDS virus by injecting 
     a blood product that was supposed to help them, not kill 
     them.
       This is Ricky, Robert and Randy Ray in 1987. They were all 
     born with hemophilia, a bleeding disorder among males that 
     prevents blood from clotting. Like most hemophiliacs, they 
     were treated with infusions of clotting factor, a concentrate 
     made from the blood of up to 20,000 donors.
       Mrs. Ray. The only thing that I knew about factor, that it 
     was this miracle drug that made it easier for hemophiliacs.
       Thompson. It was a miracle. Beginning in the '70s, instead 
     of having to go to the hospital for treatment, hemophiliacs 
     could finally treat themselves at home. And if swelling or 
     bleeding did occur, patients started using it even when it 
     wasn't absolutely necessary.
       Mrs. Ray. So we thought it was great, and we never 
     questioned it because we didn't know that we could.
       Thompson. The Rays say they never would have used factor 
     had they known the risks: that in the early '80s, just one 
     donor with AIDS could contaminate thousands of bottles of 
     clotting factor.
       Once they were infected, the Ray brothers paid a heavy 
     price. They were barred from school. Their house was burned 
     to the ground. Today one son, Ricky, is already dead. And 
     Louise knows that inevitably she will lose two more.
       Mrs. Ray. I have to wonder every morning when I get up, you 
     know, is this the day that they're going to get sick? Is this 
     the day that we're going to go down that road that I went 
     with with Ricky?
       Thompson. There were 20,000 hemophiliacs in the United 
     States in the early '80s. By 1985 drug companies had found a 
     way to heat factor to make it safe. But by then it was too 
     late. We now know over 12,000 people were infected with the 
     AIDS virus, nearly two out of every three hemophiliacs. 
     Almost an entire generation wiped out.
       Today hemophiliacs are outraged because they have 
     discovered most of those people didn't have to die, that it 
     could have been prevented.
       Man. Facts don't lie.
       [Applause]
       Thompson. Once silent, hemophiliacs are looking to place 
     blame.
       Man. Nail that son of a bitch.
       Thompson. In a strange twist, they're not only suing the 
     companies that made the factor, but the very organization 
     that claims to protect their interests, the National 
     Hemophilia Foundation, the NHF, which doctors and patients 
     trusted for information, not only about hemophilia but also 
     about AIDS.
       Man. They should have decided in favor of safety, and they 
     didn't.
       [Applause]
       Mrs. Ray. The National Hemophilia Foundation was supposed 
     to have been there as an advocate for us. They took away our 
     choice and our right to make a medically informed decision 
     for our children. And that's wrong.
       Thompson. Do you ever step back from this and say, ``Almost 
     everybody I represent is going to die?
       Alan Brownstein. I can't believe it. I can't believe it.
       Thompson. And this is the man that many hemophiliacs blame 
     the most. Alan Brownstein, the Executive Director of the NHF 
     since 1981.
       Hemophiliacs charge that because of the NHF's close ties to 
     drug companies, Brownstein and his former medical advisers 
     failed to adequately warn them.
       There are many people who say you just didn't do your job 
     in the early '80s, and as a result they're dying.
       Brownstein. We did all that we could. And I just wish we 
     had more information so that we could have made decisions 
     that could have saved more lives.
       Thompson. But as the nation's chief consumer advocate for 
     hemophiliacs, the NHF had plenty of information. What it did 
     with it was another matter.
       A six-month Dateline investigation has uncovered disturbing 
     evidence that at a time when factor was known to be 
     contaminated, the NHF continually downplayed the danger of 
     using it.
       In July of 1982, when little was known about AIDS, the 
     government Centers for Disease Control alerted the NHF that 
     for the first time three hemophiliacs had been discovered 
     with AIDS, and the CDC indicated all signs pointed to 
     clotting factor as the cause.
       Brownstein. We thought, first of all, that we had to get 
     the information out.
       Thompson. And several days later, the NHF did send out the 
     first of a series of newsletters. While it advised patients 
     to consult their doctors, it emphasized the risk of AIDS was 
     only minimal and that CDC was not advising a change in 
     treatment. In other words, keep using the factor.
       Dr. Donald Francis. The newsletter says that CDC does not 
     recommend changing treatment. That was just not true.
       Thompson. Dr. Donald Francis was one of the leading 
     scientists at the CDC during the outbreak of the AIDS 
     epidemic. Francis and his colleagues repeatedly warned the 
     NHF about the danger of injecting factor, and by the end of 
     1982, he says, the NHF should have seen what was going.
       Dr. Francis. We were already expressing at that time our 
     fear that half the hemophiliacs might die of this disease.
       Thompson. If half their members were doing to die of AIDS, 
     that fear did not seem to be reflected by the NHF.
       Dana Kuhn. They're the watchdog. And I felt like if there 
     was any problem with the product, they would make sure that 
     everybody knew about it.
       Thompson. On March 25th, 1983, Dana Kuhn, a minister and a 
     hemophiliac, broke his foot playing in a church basketball 
     game. At the hospital, even though his injury was not 
     serious, as a precaution they injected him with clotting 
     factor. It was his first and only injection.
       Is there a word that can explain how you feel?
       Kuhn. Betrayed.
       Thompson. And the reality is, is that you're living with a 
     disease that has no cure.
       Kuhn. Right. And my children are living with a nightmare, 
     that they don't know when their dad is going to develop 
     symptoms and die of AIDS.
       Thompson.  What Dana Kuhn never knew was three weeks before 
     he received what would be his fatal injection, the CDC issued 
     an even stronger statement: that blood product appeared to be 
     the cause of AIDS in hemophiliacs. But the NHF newsletter 
     five days later failed to mention that.
       Kuhn. Why weren't we getting warned when you had all this 
     information? That is when we should have been totally warned, 
     and it should have gone over the wire and people should have 
     had a choice.
       Thompson. It would be three years before Kuhn would 
     discover he had contracted the HIV virus. By then, he had 
     unknowingly passed it to his wife. Patricia Kuhn died 21 days 
     after she was diagnosed with AIDS.
       Did you ever dream that she would be the first to go?
       Kuhn. It just totally destroyed my life when she died. And 
     the toughest part was to tell my children. They didn't 
     understand why their mom died and they would say ``It's not 
     fair. It's not fair. Why did God let my mother die?''
       Thompson. And what's even harder to understand is why, 
     nearly a year after the CDC's first warning, the NHF sent out 
     this May 1983 bulletin with a headline, ``NHF Urges Clotting 
     Factor Use Be Maintained.'' By then, the death toll was 
     rising, and thousands who weren't already infected were still 
     at risk.
       Dr. Francis. Clotting factor was not an essential to the 
     survival of a hemophiliac. There were other options for 
     treatment. To say that NHF urges clotting factor use, at 
     least I feel at times, was a death sentence to lots of 
     people.
       Thompson.  Mr. Brownstein, what does the headline say?
       Brownstein. Oh. ``NHF Urges Clotting Factor Use Be 
     Maintained,'' because at that time the risk was minimal, from 
     what we knew. And keep in mind that the leading cause of 
     death in people with hemophilia was bleeding that was not 
     treated with clotting factor.
       Dr. Francis. He's clearly in error. It was clear that the 
     leading cause of death in hemophiliacs was not bleeding, but 
     already in January of 1983 the leading cause of death was 
     AIDS.
       Thompson. And Francis and others charge the NHF never 
     placed enough emphasis on the link between factor and AIDS.
       Dateline reviewed all of NHF's newsletters from 1982 to 
     1985. And although there were some references to potential 
     risks, not once could we find any clear warning not to use 
     factor because it could lead to AIDS.
       Tom Drees. And nobody, including my own company, issued a 
     warning.
       Thompson. Tom Drees is the former head of one of the 
     companies that makes factor. In the early '80s, Drees says, 
     he was fired for trying to make the factor safer. He claims 
     that while the companies put profits ahead of lives, the NHF 
     looked the other way.
       Why would the National Hemophilia Foundation side with the 
     pharmaceutical companies in an issue that it knew was killing 
     its very own people.
       Drees. Because it got a substantial amount of its income 
     from the pharmaceutical companies. And over the years, they 
     were always after us to make more contributions.
       Brownstein. They funded a project here and there, but the 
     actual operation of the foundation--zero.
       Thompson. They were doing things for you that wouldn't have 
     been done if they hadn't paid for them.
       Brownstein. That is correct. That is correct. And those--
     that is quite typical to get support, but it's also--we are 
     honor-bound to make sure that this support is done without 
     any strings whatsoever.
       Thompson. There was no conflict of interests.. . .
       Brownstein. Zero.
       Thompson. . . .in the early '80s with these pharmaceutical 
     companies.
       Brownstein. Zero.
       Thompson. But the drug companies certainly took advantage 
     of NHF newsletters.
       On May 11th of 1983, you put out this bulletin saying ``NHF 
     Urges Clotting Factor Use Be Maintained.''
       Brownstein. Un-huh.
       Thompson. Do you have any idea how the pharmaceutical 
     companies used this bulletin?
       Brownstein. No. I know how we use it and I know how we send 
     it to our physicians and to members of our community.
       Thompson. Here are two memos sent to sales forces.
       Dateline has obtained these two 1983 drug company memos 
     with that NHF newsletter attached urging patients to inject 
     factor. Doctors confirm that NHF information was used to push 
     sales.
       They took your bulletin and they took it to hospitals and 
     to doctors and said, ``This is what the NHF wants to go on. 
     Now please buy my product.''
                                  ____


  Bad Blood--Every Day, a Hemophiliac Dies of AIDS. It Didn't Have to 
                                 Happen

                          (By Michael McLeod)

       There's a pool on the third floor of the hotel, but Johnny 
     Kellar hasn't bothered to bring his swimsuit.
       At 13, he still has the face of a child, with curly brown 
     hair and a poutish over-bite. But he steers away from the 
     other kids at the convention, staying with the adults 
     instead--sitting in on their meetings, taking part in their 
     protest marches, wearing one of the buttons they've been 
     passing out.
       ``Cry Bloody Murder,'' it says.
       Johnny, of Clearwater, is wearing the button when he 
     accosts an executive from the National Hemophilia Foundation 
     in the lobby of the Indianapolis hotel.
       ``You thought I'd be dead by now, didn't you?'' Johnny 
     shouts. ``Well . . . I'm back!''
       Johnny's mother doesn't scold him after the outburst. Nor 
     do any of the other adults. No one even appears surprised. 
     The annual convention of the hemophilia foundation is the one 
     place Johnny Kellar and his anger fit right in.
       Like Johnny, many of the people at this convention are 
     dying. Like him, they are intent on speaking their minds, 
     knowing how slim the chances are that they will be back next 
     year to elaborate.
       Theirs is not a photogenic catastrophe, no space shuttle 
     blown to bits while millions watched. Until now it has been a 
     quiet death march, caused by one of the worst medically 
     induced calamities in history--one that has claimed more than 
     1,600 Americans already, with at least 8,000 more sure to 
     follow.
       They are among the more than 10,000 hemophiliacs in the 
     United States who contracted AIDS in the early 1980s from a 
     blood based clotting agent that pharmaceutical companies and 
     the National Hemophilia Foundation told them to continue 
     using even after government warnings that it was dangerous.
       Fearful of the stigma of AIDS, most hemophiliacs suffered 
     quietly as their numbers diminished. The only hemophiliacs 
     with AIDS who generated publicity were children who were 
     forced into confrontations--Ryan White in Indiana, the three 
     Ray brothers in Florida. Thousands of other hemophiliacs, 
     young and old, fought solitary battles--for hope, for legal 
     redress, for details about how their medicine had been 
     contaminated and why they were not warned.
       Lately that has begun to change. Hemophiliacs have banded 
     together, with their strongest bond not commiseration but 
     camaraderie.
       Motivated by the Ray family, they have sparked a 
     congressional inquiry into the catastrophe. The Rays, who 
     live in east Orlando, helped persuade U.S. Sens. Bob Graham 
     of Flordia and Edward M. Kennedy of Massachusetts to 
     spearhead the federal investigation soon after the death last 
     year of 15-year-old Ricky Ray, Ricky was the eldest of 
     Clifford and Louis Ray's three hemophiliac sons, all of whom 
     contracted the AIDS virus from the contaminated, blood-based 
     medicine.
       The 18-month inquiry by the National Academy of Sciences 
     will focus on the response of federal agencies and private 
     industry to the contamination.
       Hemophiliacs also have filed suit against four drug 
     companies and the National Hemophilia Foundation, asserting 
     that because of its close ties to industry the nonprofit 
     consumer group played down the danger of the medicine when it 
     should have been warning them about it.
       In that class-action suit filed in October, the drug 
     companies are accused on continuing to sell infected 
     medication even after top scientists, bureaucrats and company 
     executives knew or should have known that it was contaminated 
     with the AIDS virus.
       Whatever the results of the congressional inquiry and 
     related legal action, this much is clear following an 
     examination by Florida magazine of internal corporate 
     memorandums, transcripts of public health meetings, lawsuits, 
     government documents and more than 100 interviews with 
     victims and industry leaders:
       The imminent death from AIDS of more than half of the 
     hemophiliacs in the United States and thousands more abroad 
     could have been avoided. Questions about the safety of blood-
     based products emerged in the mid-1970s, long before the AIDS 
     crisis. And as early as 1980 the pharmaceutical industry 
     rejected proven cleansing processes that could have 
     eliminated viruses such as AIDS from the medicine.
       In 1982, people responsible for ensuring the safety of the 
     hemophiliac community were officially warned by the federal 
     Centers for Disease Control and Prevention that the blood-
     based medication was dangerous and probably fatal. Those 
     warnings, however, were not relayed in their entirety to 
     hemophiliacs and their doctors for a year and a half.
       Along with the CDC's warnings came two major safety 
     recommendations by the federal health agency that were 
     ignored by all but one of the pharmaceuticals. A 1983 memo 
     shows that three of the companies went further, suggesting 
     ``delaying tactics'' to evade those recommendations.
       Meanwhile, the federal Food and Drug Administration, which 
     oversees the safety of blood products, deferred many critical 
     decisions to the industry by exercising little regulatory 
     control.
       By the time the drug companies issued warnings and 
     perfected measures to purify the medicine, thousands in the 
     United States had been infected.
       Scientists such as Dr. Donald Francis look back with horror 
     on their futile attempts to persuade industry and government 
     leaders to take emergency action. To Francis, the 
     contamination of the hemophiliac community was a human-
     wrought catastrophe with all the classic trademarks: the 
     pressure of money, the illusion of invulnerability, the 
     warning voices that go unheard, the chances to change course 
     that slip by unheeded.
       ``It was like we were standing at a bend in the railroad 
     tracks, and you could hear the sound of an engine and you 
     could feel the tracks vibrating. And everyone was saying, 
     `No, you're wrong. There's no train coming,''' recalls 
     Francis, an epidemics specialist with the CDC in the 1980s.
       To Chicago lawyer Leonard Ring, one of the attorneys in the 
     class-action suit, the tragedy is nothing short of ``the 
     largest scandal in U.S. medical history.''
       Its boundaries actually extend even farther. The same 
     medicine that infected hemophiliacs in the United States was 
     exported to England, Canada, Japan and other countries. 
     Similar scandals involving blood concentrate took place in 
     Germany and in France, where it reached the level of a 
     Watergate, toppling a political party and sending two high-
     ranking government scientists to jail.
       And in Costa Rica, at least 15 hemophiliacs are infected 
     with AIDS because an American company, now called Miles Inc., 
     sent a tainted shipment of the medicine there in 1985, when 
     Miles already had crated an AIDS-free product through heat 
     treatment.
       To Miles and the other drug companies that produce the 
     blood concentrate--Rhone-Poulenc Rorer/Armour 
     Pharmaceuticals, Baxter Healthcare Corp. and Alpha 
     Therapeutic Corp.--the contamination of their product was 
     simply a terrible tragedy that was no one's fault.
       ``The villain here is not any person or company,'' says Don 
     Hyman, director of corporate communications for Miles Inc. in 
     New Haven, Conn. ``Isn't it possible that no one is to blame? 
     Isn't it possible that the villain here is simply a virus?''
       Several high-ranking hematologists support the position of 
     these drug companies that the infection of their product with 
     AIDS was no one's fault.
       ``Hindsight is great, but we had to make logical decisions 
     based on the information we had at the time,'' says Dr. Louis 
     Aledort, a key figure in the controversy as medical adviser 
     to the National Hemophilia Foundation when the AIDS crisis 
     began. ``People have short memories. They forget all the good 
     things we did for hemophiliacs before this happened.''
       Gainesville hematologist Craig Kitchens, who has testified 
     on behalf of the drug companies in lawsuits brought by 
     hemophiliacs, also feels that blame is being misplaced. 
     Kitchens says the scientists who voiced early warnings were 
     essentially just lucky.
       ``If you put 30 guys in a room, one of them is going to 
     predict who is going to win the World Series,'' he says.
       Yet it wasn't just a game of random numbers that doomed 
     thousands of hemophiliacs. Nor was it a single, viral 
     villain.
       It was a system of government and private enterprise that 
     failed them precisely when they needed its protection the 
     most.
       ``They lied to us,'' says Johnny Kellar. ``Do they think 
     we're stupid? It's so obvious. The whole thing was money, 
     money. Money was more important to them than our lives.''
       Johnny became friends with both Ricky Ray and Jason 
     Christopher, an 11-year-old Tampa hemophiliac who died of 
     AIDS two years ago. Last year, a jury awarded Jason's parents 
     $2 million in their milestone negligence lawsuit against 
     Armour. The jury decided that Armour knew enough in 1982 and 
     1983 to warn users of the AIDS risk--and that if such a 
     warning had come, Jason's doctor would have changed to a 
     safer treatment. Attorneys for Armour, who are appealing, 
     described the outcome as a ``sympathy verdict.''
       Dave Houston of Palm Harbor was the foreman of that jury. 
     ``There was no emotion involved'' in the decision, he said.
       ``We just felt that a company as big as that, a company 
     that supplies anything--food, medicine, whatever--if they 
     ever had the slightest doubt about the safety of anything, 
     they need to take it off the shelf. You may lose a few 
     million, but in the long run you'll save yourself money--and 
     you'll save people's lives.''
       The jury award was small consolation to Johnny Kellar, who 
     says he now has to fight ``the companies'' not only for 
     himself but for friends like Jason and Rickey.
       ``The way I see it, I don't have any chokce,'' he says. 
     ``They killed my friends. They gave me AIDS. And if I let 
     them get by with it, they're just going to do it again.''
       It was a golden age. It was a miracle cure.
       In Miami, Maxine Segal's two teenage boys, Doug and Scott, 
     had been in and out of the hospital so often that all their 
     crushes were on candy stripers. Now, instead of spending 
     their weekends hooked up to intravenous lines, they were 
     water-skiing and going to band practice.
       In Hershey, Pa., a retired night watchman named Gino 
     Cailone was able at last to take his dream trip to the old 
     country--to a rustic mountain village where indoor plumbing 
     was still a novelty. He came back home beaming, showing off 
     pictures of long-lost cousins pointing at their sinks.
       In Fort Pierce, a cattleman named Merlin Dawson had been 
     passing up chances to expand his business because of his 
     health. Now he was establishing herds in South America.
       And in Clearwater, the parents of Jason Christopher were 
     relieved that their infant son would grow up like a normal 
     boy.
       It was all because of a new, blood-based medicine that had 
     been developed to treat their illness, hemophilia.
       The standard misconception about hemophilia is that its 
     victims can bleed to death from a tiny scratch. That's not 
     true. But for many years, the reality was nearly as bad.
       Because of a single missing gene, the blood hemophiliacs 
     fails to clot properly. The main problem for hemophiliacs is 
     ``spontaneous'' internal bleeds that can start for no 
     apparent reason.
       Without clotting action, blood can seep into joints 
     repeatedly, eroding cartilage and even bone, causing painful 
     swelling and a form of arthritis. Before World War II, a 
     hemophiliac was usually on crutches or in a wheelchair by the 
     time he reached his teens.
       Transmitted by women, hemophilia causes symptoms almost 
     exclusively in males. Its hereditary nature helped to make it 
     a ``closet'' disease--a family secret. Mothers felt guilty 
     for giving it to their sons. Sons felt like sissies because 
     they were overprotected.
       Probably the most famous and overprotected hemophiliac in 
     history was Nicholas II of Russia, one of several aristocrats 
     who inherited the disease from Queen Victoria. But the 
     cloistered image of hemophilia would continue to haunt its 
     victims even into modern times.
       For years, the only treatment was an infusion of blood 
     plasma--the translucent, protein-laden part of blood that 
     remains when red blood cells are taken out. Plasma helped 
     save lives, but it did little to stop the crippling effect of 
     bleeds.
       Then, in 1964, Stanford University researcher Judith Poole 
     noticed a sediment, or ``cryoprecipitate,'' that accumulated 
     at the bottom of frozen plasma. She tested the substance and 
     discovered that it consisted mostly of the proteins that help 
     blood to clot. If hemophiliacs could be treated with the 
     sediment--Poole called it ``cryo'' for short--it would at 
     least be better than giving them whole plasma, which taxed 
     the circulatory system and involved long hospital sessions.
       Cryo was a turning point for hemophiliacs. Because it could 
     deliver clotting proteins quickly, there now was a way to 
     prevent the painful internal bleeds and joint damage.
       Yet it was still cumbersome. It had to be kept frozen, and 
     a doctor was needed to administer it. Then, in 1968, 
     researchers at the American Red Cross and Hyland Laboratories 
     developed a new product, which quickly became known as 
     clotting concentrate.
       It was mass-produced by pooling plasma in huge vats, then 
     drawing off the proteins that make blood clot--either Factor 
     VIII, the protein lacked by most hemophiliacs, or Factor IX, 
     another clotting protein. The clotting agent was then 
     stabilized, freeze-dried and bottled.
       Now hemophiliacs could treat themselves, thanks to the 
     small, vacuum-packed vials of white crystals--ready to be 
     dissolved in water and injected ``early and often,'' as 
     manufacturers advised.
       Patients were euphoric. Doctors basked in their gratitude. 
     A Gainesville hematologist remembers a whole family coming to 
     his office to hug him on their way to the Grand Canyon--the 
     first time they had dared take their hemophiliac son across 
     the Alachua County line.
       One physician called the mid-1970s ``the golden age of 
     hemophiliacs.'' A company that distributed clotting 
     concentrate came up with a cartoon super-hero mascot for it, 
     a caped crusader called ``Factor Man.'' If it sounded more 
     like a Saturday morning cartoon character than a medical 
     advance nobody was about to complain.
       Like most medications, clotting concentrate had a side 
     effect. Although the concentrate was treated to screen out 
     bacteria, viruses could slip through. Doctors knew that one 
     in particular was inevitable: viral hepatitis
       Because the plasma of an average of 20,000 different donors 
     was pooled in huge vats to make clotting concentrate, viral 
     hepatitis became statistically inevitable for hemophiliacs. 
     And doctors knew that a portion of those who contracted 
     hepatitis eventually would die from liver damage caused by 
     the disease.
       But it would take decades for viral hepatitis to kill 
     someone who contracted it from clotting concentrate. And 
     because concentrate was so convenient and effective, many 
     doctors, drug manufacturers, the FDA and hemophiliacs 
     themselves accepted the risk.
       Others didn't.
       Dr. Oscar Ratnoff had no particular inside track on the 
     manufacturing of concentrate. But the Cleveland hematologist 
     had done research into liver diseases. And one of the things 
     he remembered was the massive outbreak of hepatitis during 
     World War II, when soldiers were exposed to pooled plasma.
       The incident stuck in his mind as an example of just how 
     volatile plasma from thousands of donors could be. Ratnoff 
     wasn't so sure the trade-off between the convenience of 
     clotting concentrate and the risk of hepatitis was such a 
     good one. Why risk contracting a fatal disease for the sake 
     of convenience?
       Many of his colleagues thought Ratnoff was hopelessly old-
     fashioned and conservative. ``Oh,'' one would later say, 
     ``Oscar was always saying things like that.''
       But as Ratnoff knew, cryo was produced by local blood banks 
     with the plasma of only a dozen or so donors. With a pool 
     that small, chances were excellent that you could avoid 
     hepatitis altogether.
       Like any good doctor, Ratnoff decided to explain the risks 
     to his patients and give them a choice.
       Five patients chose cryo.
       Five shrugged of his warnings and kept using clotting 
     concentrate.
       ``You're messing with my lifestyle, Doc,'' said one of 
     them.
       There had been no telltale jolt, no sound of massive gears 
     locking in place. But a doomsday machine had begun churning 
     forward, and five more hemophiliacs had just taken their 
     places on board--alongside Jason Christopher, Gino Cialone, 
     Merlin Dawson, Doug and Scott Segal and 10,000 others.
       It was a holiday weekend, July 4, 1991, when Calvin Dawson 
     drove from Apopka to Fort Pierce to say goodbye to his 
     brother. By then, Merlin was emaciated. Confined to a 
     wheelchair, he was resigned to death. ``This thing is going 
     to kill me,'' he said. They prayed together. Merlin bound his 
     head, then looked at Calvin and said that he had accepted 
     Christ as his savior, that he wasn't afraid of death, that it 
     had to be better than the suffering he was going through.
       Then he swore Calvin to a promise.
       ``This is the damndest thing to happen to a group of 
     people,'' he said. ``If you do anything, Calvin, find out 
     what happened and why.''
       What happened is that hemophiliacs unknowingly became part 
     of what Peter Levine, a leading hemophilia researcher, calls 
     an ``unbelievable experiment.''
       That experiment--sanctioned by the FDA and carried out by 
     the pharmaceutical industry--would involve regular, week-
     after-week exposure to a product made from the bodily fluids 
     of thousands of people. Later, it would be equated to having 
     unprotected sex with 20,000 strangers every week.
       Unlike the plasma that was used in cryo, the plasma in 
     clotting concentrate came from blood that was bought and 
     sold--the basis of a loosely regulated, highly competitive $2 
     billion industry revolving around plasma products.
       The foundation of the plasma industry was a system of paid-
     donor centers, most of them located in impoverished, inner-
     city neighborhoods where people were paid $10 to $20 per 
     donation.
       Two of the companies that produced clotting concentrate for 
     hemophiliacs also had programs to draw plasma from inmates in 
     federal prisons. A string of plasma centers that catered to 
     migrant workers was located along the border between the 
     United States and Mexico. And between 1972 and 1977, a series 
     of American-run plasma centers was operating in Central and 
     South America, from Haiti to Argentina, where they could pay 
     for less per donation.
       Hemophiliacs were suddenly at the receiving end of what was 
     quite literally an international bloodstream.
       Three of the four companies that sold clotting concentrate 
     would soon become subsidiaries of foreign-owned 
     conglomerates--German, French and Japanese. In the 1970s, the 
     United States became the chief exporter of plasma and 
     clotting concentrate across the world.
       It was a profitable system. As everyone would later 
     realize, it was also ideal for spreading a worldwide 
     epidemic.
       There were two reasons. Plasma-product manufacturers were 
     now pooling the blood of thousands of people, exponentially 
     increasing the risk of contamination from disease. And plasma 
     centers were paying for the blood of high-risk donors--people 
     who were less likely to be healthy than volunteer donors.
       In the midst of the golden age, however, it was difficult 
     to shift the momentum of a multinational industry once its 
     course was set.
       As medical director for Hyland Pharmaceuticals, Dr. Edward 
     Shanbrom had overseen the original mass production of 
     clotting concentrate in 1974. He became concerned when 
     technicians who worked close to the huge vats of plasma 
     developed skin rashes and hepatitis.
       It was one thing to calculate, on paper, the risk-to-
     benefit ratio of clotting concentrate. It was another to see 
     people catch a serious disease simply because they came into 
     contact with invisible vapors from the pooling vats.
       Shaken, Shanbrom decided to develop a detergent-wash 
     process to make clotting concentrate virus-free. But it took 
     him five years. And when he tried to sell his cleansing 
     process to the drug companies in 1980, they turned him down. 
     A year later, the companies also ignored another kind of 
     cleansing process by a German company, which had tested its 
     new product on a group of 155 hemophiliacs. None of them 
     contracted hepatitis.
       Nor was anyone taking note of the warnings of Dr. J. 
     Garrett Allen, a Stanford University surgeon who had once run 
     a blood bank at the University of Chicago. Allen waged a long 
     and unsuccessful campaign to warn people about the dangers of 
     pooled plasma.
       ``Large pools are highly profitable, but they are medically 
     bankrupt,'' Allen said in 1987. ``This is not a recent 
     consensus. There was no valid reason to not have developed a 
     heat-treatment protocol . . . in the 1970s.''
       Articles in medical journals from that time were 
     documenting the progression of liver disease caused by 
     hepatitis, which had become the second-leading killer of 
     hemophiliacs, after bleeding. And in 1974, a U.S. Senate 
     subcommittee under Sen. Henry Jackson of Washington began 
     looking into the blood-plasma industry. The inquiry died 
     after Jackson lost his bid for the presidential nomination.
       Robert Massie Jr. was an investigator for Jackson at the 
     time. Massie, a hemophiliac with AIDS, is a professor in 
     business ethics at Harvard Divinity College.
       ``It was clear to anyone who looked at the system that it 
     was absolutely perverted, with little concern for safety, 
     driven by the search for cheap plasma and the desire to 
     maximize profit,'' he says.
       Yet apart from that brief investigation, few questioned the 
     collection methods of the plasma industry or the danger of 
     hepatitis.
       And fewer still stopped to wonder: If one virus could slip 
     through, who was to say that another one wouldn't?
       Make a wish, they said. The charitable organization that 
     set up dream trips for children with terminal diseases told 
     Johnny Kellar he could go anywhere, meet anyone.
       ``OK,'' said Johnny. ``I want to meet Arnold 
     Schwarzenegger.''
       So Johnny and his mother were flown to Hollywood. But when 
     he came face to face with Arnold, Johnny was too nervous to 
     talk. His mother had to relay the boy's request. He didn't 
     want an autograph. he didn't want a souvenir.
       ``My son says you're the Terminator, and he has a job for 
     you,'' Marge Kellar said. ``He says he wants you to terminate 
     the drug companies for him.''
       Dr. Donald Francis had spent years battling communicable 
     diseases in impoverished countries--from smallpox to exotic 
     African viruses.
       As early as 1981, when the notion still seemed outlandish 
     to many scientists, he suspected that AIDS was caused by a 
     new virus with a long incubation period. Independent and 
     mercurial, the young epidemics specialist was often impatient 
     with the ponderous CDC bureaucracy. He quickly became known 
     as a hothead--a reputation he bolstered by pounding on a 
     table during a key meeting between CDC scientists and balky 
     blood industry leaders during the early months of the AIDS 
     crisis, demanding: ``How many deaths do you need?''
       It was typical for Francis to get straight to the point, as 
     he did in a conversation with another CDC scientist, Dr. 
     Bruce Evatt, in 1982.
       ``If your children had hemophilia,'' Francis asked, ``would 
     you let them use clotting concentrate?''
       Unlike Francis, Evatt was courtly, soft-spoken. A good 
     listener and a diplomat, he had been around a federal agency 
     long enough to choose his words carefully.
       In this case, however, his response was unhesitating. 
     ``No,'' he said.
       Yet even though the danger was clear to the two 
     specialists, it would take a year and a half for their 
     warnings to get through to hemophiliacs.
       What stood in the way?
       Francis would later come up with a theory about that. He 
     calls it ``the erroneous consensus spiral,'' and he says he 
     may some day write a paper about it. His thesis would be that 
     thousands of Americans weren't killed by the AIDS virus. They 
     were victims of the status quo.
       Time after time, in the key crisis years of 1982 to 1984, 
     people and institutions who could have saved lives refused to 
     listen to the warnings of specialists.
       ``I had worked around the world in a variety of government 
     settings, including dictatorships and military regimes, and I 
     have never seen the sort of repression of the truth that I 
     was dealing with then,'' says Francis, who retired from the 
     CDC two years ago and in now working on an AIDS vaccine for a 
     private biotechnology firm. ``We told them what the danger 
     was. We told them what to do about it. And they ignored us.''
       Evatt, who is still with the CDC, says:
       ``You have to remember that, at the time, infectious 
     diseases weren't supposed to happen. We thought we had 
     conquered infectious diseases forever. They were supposed to 
     be a thing of the past.
       ``What happened--the disbelief, the way people reacted--
     that was just human nature. It's the sort of thing that 
     happens every day. Nobody wants to believe bad news. It's 
     just that in this case, the consequences were so immense.''
       It was in the spring of 1982 that Evatt, a divisional 
     director at the CDC, began seeing evidence that hemophiliacs 
     were falling ill from the same immune system collapse that 
     was killing gay men. Haitians and intravenous drug users.
       Evatt and other CDC scientists had feared it would happen. 
     Hemophiliacs were the canaries in the coal mine--harbingers 
     of a deadly infiltration. The thing--whatever it was--had 
     gotten into the blood supply, into blood plasma, into 
     clotting concentrates. One infected blood donor could taint 
     tens of thousands of units of clotting factor because of the 
     lethal exponentials of the pooling vats.
       Eventually, more than half of the nation's 20,000 
     hemophiliacs would contract a fatal disease through the 
     medicine they had thought of as their salvation. By the time 
     hemophiliacs understood the implications of the infection and 
     the nature of the disease, hundreds of their sexual partners 
     were also infected.
       But all those horrors still lay in the future when Evatt's 
     staff, in July 1982, presented evidence of three cases of the 
     mysterious new disease in hemophiliacs.
       Evatt knew that for many hemophiliacs, it already might be 
     too late. Thousands more were at grave risk.
       He and his staff quickly started working on a plan to alert 
     the blood industry, the FDA and other federal agencies.
       Though CDC scientists saw the danger in clotting 
     concentrate--and also in routine blood transfusions--they 
     could only make recommendations about how to deal with it. 
     The CDC wanted blood banks and plasma centers to begin 
     screening donors--that is, to stop taking blood and plasma 
     from homosexuals. That suggestion drew the ire of gay 
     activists, which helped to delay the screening.
       CDC doctors also wanted to test blood and plasma for 
     hepatitis and to discard all samples that came out positive. 
     Doing so would make blood products much safer, the CDC 
     reasoned, because eight out of 10 donors with AIDS also had 
     hepatitis.
       However, the agency had no authority to enforce those 
     recommendations. That action would have had to come from the 
     FDA or the drug companies themselves. Nor did CDC directly 
     warn hemophiliacs: That responsibility was assumed by the 
     National Hemophilia Foundation.
       So for CDC scientists, the critical first years of the AIDS 
     crisis would be like a macabre version of the parlor game in 
     which a whispered message, relayed through several people, 
     becomes muddled by the time it reaches the last in line.
       In July 1982, the CDC issued its first official warning 
     about hemophiliacs and AIDS, when Evatt wrote a letter to 
     other federal health agencies, blood banks, the four 
     pharmaceutical companies and Dr. Louis Aledort, the National 
     Hemophilia Foundation's medical director.
       ``We have been suspicious that it may be transmitted in a 
     manner similar to hepatitis, and thus creates a problem for 
     the users of blood products,'' Evatt wrote. ``Hemophiliacs 
     would be prime candidates to develop this syndrome.''
       Internal memos from the early months of the AIDS crisis, in 
     1982 and '83 show that the drug companies understood the 
     danger to hemophiliacs.
       In a 1982 memo, a doctor with Amour Pharmaceutical wrote: 
     ``Deficiency Syndrome [AIDS] is now a major issue. The cases 
     are doubling every six months, it is probably a transmissible 
     disease and may be found in all blood products. High risk 
     groups for Hepatitis B (which includes hemophiliacs) are also 
     high risk for AIDS.''
       In a deposition for Maryland hemophiliacs's lawsuit, Milton 
     Mozen, medical research director of Miles Inc., said his 
     company knew in October 1983 that the blood concentrate could 
     cause AIDS and that the entire supply of clotting concentrate 
     was contaminated.
       Even earlier, the company was aware of its responsibility 
     to warn consumers. In an internal memo sent to top 
     executives, dated Dec. 29, 1982, an attorney for a division 
     of Miles Inc. called Cutter Biological, sent this warning:
       ``It appears to me to be advisable to include an AIDS 
     warning in our literature . . . litigation is inevitable, and 
     we must demonstrate diligence in passing along whatever we do 
     know to the physicians who prescribe the product.''
       The company, however, did not issue those warnings for 
     another year and a half.
       Meanwhile, doctors and consumers were told the danger was 
     minimal.
       Three months after the internal Cutter memo, an article 
     appeared in a Cutter magazine for hemophiliacs.
       The article, titled ``What is Cutter Biological Doing to 
     Minimize the Risk of AIDS?'' claimed that Cutter was 
     ``launching an all-out campaign that includes strict 
     precautionary measures to make clotting concentrate safer.''
       Then it listed Cutter's blood-plasma collecting centers, 
     noting: ``There are no Cutter centers in New York, San 
     Francisco, Los Angeles or Miami, where the vast majority of 
     AIDS cases to date have been reported.''
       The prison where Cutter drew blood was not listed. And 
     anyone familiar with the West Coast might have paused at the 
     very first California city on Cutter's list: Berkeley.
       Besides being just a 10-minute subway ride from San 
     Francisco, Berkely is a college town with substantial 
     communities of gays and drug users--the population that 
     doctors knew was most at risk.
       And although it was true that Cutter has no plasma center 
     in Miami, it did have one in a run-down section of Fort 
     Lauderdale--a center that had been criticized for safety 
     violations by the FDA.
       ``That, to me--playing that game of misleading little 
     geographical games with your patients--that was just plain 
     callous,'' says Dr. Thomas Drees. ``That shows you the mind-
     set of some of these companies.''
       From 1973 to 1984, Drees was the president of Alpha 
     Therapeutics in Los Angeles, one of the companies that 
     produced clotting concentrate. He now works as a consultant 
     and is one of a few members of the plasma industry who is an 
     outspoken critic of the drug companies.
       Drees says he was aggressive in applying safety standards--
     and was fired specifically for that reason, when the company 
     was taken over by a Japanese conglomerate, Green Cross.
       An Alpha spokesperson declined comment.
       ``My attitude was, if you thought you had a problem, you 
     had a problem,'' says Drees. ``In terms of our safety 
     standards, we always tried to stay a step ahead of whatever 
     the FDA advised. Ethically, morally, that was the way I 
     thought we should do business.''
       That attitude was not necessarily shared by other clotting-
     concentrate manufacturers.
       One internal memo, dated December 1983, indicates that some 
     of the manufacturers--not including Cutter--were trying to 
     delay a recommendation to initiate plasma-screening measures 
     that the CDC had suggested a year earlier.
       ``Mike Rodell of Armour proposed a task force to deliberate 
     the details of the recommendation and provide further 
     information in three months,'' the memo reads. ``. . . The 
     general thrust of the task force is to provide a delaying 
     tactic for the implementation of further testings.''
       The FDA agreed to the formation of the task force, which 
     consisted of drug industry representatives. The task force 
     eventually recommended against the testing that the CDC 
     wanted.
       Instead, the drug companies began experimenting with heat-
     treated clotting concentrate, assuming that heat would kill 
     any fatal virus. By 1984, scientists had finally identified 
     the AIDS virus that destroys the immune system and confirmed 
     it was transmitted through blood products and bodily fluids.
       They eventually would learn that a combination of blood-
     donor screening and heat treating would eliminate the virus 
     from their blood product. By 1985, the clotting concentrate 
     was considered safe--three years after the CDC issued its 
     warning and recommended blood screening.
       Even then, hemophiliac activists say, one company continued 
     to use the old, unheated and unscreened clotting concentrate 
     rather than destroy it. Dallas attorney Charles Siegel says 
     he has proof.
       Cutter, he says, ``dumped'' unscreened, unheated and AIDS-
     tainted clotting concentrate into a foreign market, knowing 
     that it could be contaminated. Siegel is suing Miles Inc. on 
     behalf of 15 Costa Rican hemophiliacs who contracted AIDS 
     from the contaminated concentrate, which was shipped to Costa 
     Rica by Miles' Cutter subsidiary in March 1985. At the time, 
     Cutter had an AIDS-free product available.
       ``It's very difficult for someone outside of the U.S. to 
     sue a U.S. company,'' Siegel says. ``I honestly think that 
     Cutter just never believed in a million years that anyone 
     [from Costa Rica] would ever sue them over this, and that's 
     why they did it.''
       As an example of the company's unwillingness to destroy 
     products that might be tainted, Siegel points to a series of 
     Cutter memos recommending the sale of ``unscreened'' 
     product--meaning raw plasma drawn from donors who had not 
     been screened for AIDs.
       ``Put unscreened material into finished inventory as soon 
     as possible,'' reads one such memo, dated March 20, 1986. 
     ``Get word to distribution to move existing unscreened 
     finished goods inventory before we move screened material. . 
     . . From a production planning and inventory-control point of 
     view, this current policy is desired. We need the unscreened 
     inventory to meet our 1986 sales requirements and want to 
     avoid large writeoffs.''
       Siegel contends that such concern for profit was the reason 
     that his Costa Rican clients ended up with AIDS.
       Clotting concentrate is one of the most expensive medicines 
     ever made. Someone with severe hemophilia spends roughly 
     $150,000 a year on the treatment. By one estimate, the 
     pharmaceutical industry takes in $250 million a year from the 
     sale of the medicine.
       ``They had the technology available to make a safer product 
     and ship it to their customers,'' Siegal says. ``So they had 
     to make a choice: Do you sell the old stuff or throw it out? 
     They chose. They decided to just put it in the pipeline.''
       Donald Hyman, the spokesman for Miles Inc., calls criticism 
     such as Siegel's nothing but hyperbole.
       ``We reject categorically any allegation that we would put 
     profits over concern for human safety,'' he stated in a 
     recent news release. ``As in all such cases, tragedies such 
     as this create an urge in some people to seek a villain. And 
     the villain here is the AIDS virus.''
       Miles acted properly, ``based on the scientific knowledge 
     of the time, to procure safe and effective bloodclotting 
     products,'' he wrote. The company ``never sold products that 
     its scientists believed could transmit the AIDS virus.''
       In response to sending nonheat-treated concentrate to Costa 
     Rica, Hyman stated: ``Although we can now know the tremendous 
     benefits of heat-treated product, the company, the medical 
     community and regulatory agencies in the various countries 
     did not fully understand these benefits when it was first 
     introduced.''
       It was just a charity basketball game, something the church 
     had put together that spring in 1983. One of the players was 
     40-year-old Dana Kuhn, a father of two who was working as an 
     assistant for the church as part of his seminary studies.
       He went up for a rebound, came down off balance and wound 
     up breaking a bone in his foot. At the emergency room, he 
     told doctors that he was a mild hemophiliac--with such a 
     faint trace of the disease that he had never had to use 
     clotting concentrate.
       They suggested, just be on the safe side, that he should 
     get a shot of concentrate to stave off any bleeding problems 
     that the broken bone might cause.
       Kuhn was doubtful. He'd heard rumors that there was a 
     problem with AIDS in the concentrate. But the doctors, he 
     says, assured him it was safe.
       ``They probably have a way of screening the virus out of 
     this stuff,'' he remembers thinking as they gave him the 
     injection.
       It was the legal responsibility of the drug companies to 
     warn consumers about any danger caused by their products. But 
     there were two other lines of defense for hemophiliacs.
       One was the Food and Drug Administration, the federal 
     agency that regulates blood products. The other was the 
     National Hemophilia Foundation, the group with the most 
     direct line of communication to hemophiliacs.
       Why, then, did neither the FDA nor the foundation make sure 
     that the pharmaceuticals followed the blood-screening 
     recommendations and other precautions laid out by the CDC in 
     the early 1980s?
       At the time, both organizations had critical flaws that 
     hampered their ability to deal with an emergency.
       The FDA, during the Reagan deregulation years, left key 
     posts unfilled for years. Morale was low, with many 
     scientists shopping around for new jobs. Regulation also was 
     less than aggressive: In 1983, at the height of the crisis, 
     the FDA agreed to a blood-industry suggestion to cut down on 
     the number of its inspections of blood banks--from one per 
     year to one every other year.
       The FDA has been described in court cases as, by nature, a 
     ``passive'' agency--one that relies on manufacturers to stay 
     abreast of safety issues relating to their products. In a 
     series of hearings on drug-labeling regulations in 1978, an 
     FDA commissioner said that it was impossible, given staff and 
     funding limitations, for the FDA to operate any other way.
       Dr. Donald Francis, the CDC epidemics specialist, gives two 
     reasons why his agency's recommendations were not immediately 
     adopted: the FDA's complacency and resistance from blood 
     banks and pharmaceutical companies.
       ``They never really sat down and listened to us when we 
     warned them very clearly about what was happening,'' Francis 
     says. ``And now they all have to live with themselves. So, of 
     course, they're going to say that it wasn't their fault, that 
     they did everything they could. But that's simply not true. 
     The truth is that they killed a lot of people.''
       At a series of meetings of blood industry leaders and 
     federal officials, the CDC warnings and screening 
     recommendations were downplayed and derided.
       Where were their studies? How could they be so sure? 
     Weren't they exaggerating? Many at the agency, and within the 
     blood industry, saw the CDC's aggressiveness as the 
     beginnings of a turf war.
       ``We also agreed that the CDC was getting increasingly 
     involved in areas beyond their area of expertise,'' reads an 
     internal Cutter memo, dated January 1983.
       Among the doubters was Dr. Dennis Donahue, head of the 
     biologics division of the FDA, which was chiefly responsible 
     for overseeing the clotting-concentrate manufacturers.
       Like many FDA officials, Donahue had been in the blood-bank 
     industry himself. And an internal Cutter memo mentions that, 
     at the time of the AIDS crisis, Donahue was disillusioned 
     with the FDA and was looking for another job--in the blood 
     industry.
       Donahue thought the CDC's suggestion for a stopgap 
     screening test was ``absolute nonsense.'' A Cutter memo, 
     dated Dec. 27, 1982, notes that Donahue ``requested that we 
     send him some official notification of our plans so that he 
     could use this as ammunition that voluntary efforts of the 
     industry precluded the need for any further regulation.''
       In effect, decision making was left to blood bankers, drug 
     company executives and doctors whose careers revolved around 
     clotting concentrate--all people who had a vested interest in 
     the outcome.
       Donahue, who is retired, declined to comment, as did an FDA 
     spokeswoman in Washington, citing pending litigation.
       ``They were gambling that things wouldn't be as bad as the 
     CDC said,'' says Judy Kavanaugh, a Sarasota attorney who is 
     working on the class-action lawsuit against the 
     pharmaceuticals and the hemophilia foundation. ``The tragedy 
     is that they were gambling with people's lives.''
       Kavanaugh says that a ``revolving door'' was in operation 
     at the time between FDA officials and the private industry 
     they regulated.
       ``If you look at the documents, you see an incredible 
     chumminess--among the regulatory agency, the so-called 
     consumer advocacy group for hemophiliacs and the blood 
     industry,'' she says. ``People just seem to move around 
     freely from place to place within this inner circle. It's 
     like a little country club. Everybody has an angle. Everybody 
     has a reason to be pals with the other guy.''
       The foundation occupied a place in that inner circle. The 
     nonprofit group had come close to bankruptcy in the late 
     1970s and had discovered a way out: the coattails of the 
     clotting-concentrate manufacturers. Drug companies sponsored 
     foundation conventions and financed the foundation's mailings 
     to members. Internal foundation documents show what the 
     product manufacturers were getting in return for their 
     donations: publicity for their product.
       Kavanaugh believes that the foundation was hesitant in its 
     warnings because it didn't want to offend the drug companies.
       ``They weren't watchdogs,'' she says. ``They were more like 
     lap dogs.''
       Although the foundation did call for screening of blood 
     donors early in the crisis, its officials continued to 
     downplay the danger of AIDS.
       The foundation's executive director, Allan Brownstein, in a 
     speech to drug company representatives in 1983, criticized 
     ``scare tactics used by some of the media [that] have created 
     so much fear that . . . the use of product is down.''
       And even though the CDC continued to warn the blood 
     industry in an escalating series of letters and conferences, 
     the foundation's medical adviser, Dr. Louis Aledort, all but 
     scoffed at the notion that hemophiliacs were at risk.
       Aledort had been one of the heroes of the golden age--a key 
     figure in the science, the business and the politics of 
     hemophilia that evolved around clotting concentrate. He 
     successfully lobbied for federally funded centers that 
     offered greatly improved, comprehensive care to hemophiliacs.
       Besides acting as medical adviser to the hemophilia 
     foundation, Aledort frequently worked on research projects 
     about hemophilia paid for by one or more of the drug 
     companies that produced clotting concentrate. Drees, the 
     former Alpha president, says his company gave Aledort roughly 
     $25,000 a year.
       Aledort also was closely aligned with Cutter. He received 
     money for research from Cutter, helped solicit donations from 
     Cutter for the foundation and contributed articles to a 
     monthly newsletter that the company sent out to hemophiliacs.
       In the May 1983 edition of that newsletter, Aledort 
     downplayed the danger of AIDS. By then a dozen hemophiliacs 
     in the United States were known to have developed symptoms of 
     the disease.
       ``Let's put this in perspective,'' Aledort wrote. ``AIDS is 
     a dreadful, terrible disease that is frightening. 
     Hemophiliacs are frightened . . . but whether and if and how 
     it relates to their therapy [meaning clotting concentrate] is 
     completely unclear.'' The article continued: ``There is no 
     evidence to support that AIDS is transmitted in either 
     cryoprecipitate or concentrate, although it is possible.''
       Two months earlier, the CDC Morbidity & Mortality Weekly 
     Report had stated: ``Blood products . . . appear responsible 
     for AIDS among hemophiliacs who require clotting factor.''
       And at a meeting earlier that year, Dr. Ratnoff, the 
     Cleveland hematologist, had been invited to share his 
     research, which showed that those of his patients who are 
     using cryo rather than clotting concentrate were not showing 
     any symptoms of the immune disorder.
       ``There was evidence of what was happening. It wasn't just 
     from me, and it was very clear cut,'' Ratnoff says today. 
     ``But I can assure you it was antithetical to the prevailing 
     view, and there were very powerful forces aligned against 
     it.''
       Aledort was among the most outspoken of the high-ranking 
     doctors and blood industry leaders who were convinced that 
     the CDC was wrong and that Ratnoff's data were insignificant. 
     Aledort's own theory was that the growing number of 
     hemophiliacs with the immune disorder were only reacting to 
     antigens--bits of foreign protein that were known to be 
     transmitted by blood products.
       Aledort's position was that hemophiliacs should continue to 
     use concentrate, despite its possible danger. Several other 
     key hematologists agreed with him.
       Their oft-repeated logic was that the ``known risk'' of 
     hemorrhaging was greater than the ``unknown risk'' of 
     possible AIDS infection. At that time, scientists were still 
     uncertain whether people who became infected with the AIDS 
     virus would always develop symptoms of the disease. And they 
     also knew that a large percentage of hemophiliacs already had 
     been infected with the virus by the time the CDC issued the 
     warning about it. For them, it was already too late.
       But that still left thousands of hemophiliacs who might 
     have been able to avoid infection--perhaps by switching from 
     concentrate to cryo. Evatt himself estimates that roughly 
     half of the hemophiliacs who contracted the AIDS virus were 
     infected after his warning.
       The standard of public health is to err on the side of 
     caution. And a key principle of medical ethics is the notion 
     of informed consent: that the patient should be apprised of 
     any risk from treatment.
       That may be why Aledort's point of view so astonished one 
     FDA scientist that, at a key 1983 meeting, he asked Aledort 
     to repeat himself, saying, ``I just want to make sure I'm 
     hearing what I think I'm hearing.''
       And the foundation itself became disillusioned with 
     Aledort. In 1983, its executives decided to seek his 
     resignation as medical director. the minutes of an executive 
     committee meeting held in April 1983 spell out the reason:
       ``Dr. Aledort is not a team player. . . . Dr. Aledort's 
     medical brilliance is accompanied by personality traits which 
     take an excessive amount of time and effort to cope with. . . 
     . There have been isolated but real instances in which Dr. 
     Aledort has failed to properly implement NHF policies which 
     he has not agreed with, and, instead, has interposed a 
     personal position to delay or negate NHF policy.''
       Like many doctors who were mistaken about AIDS and 
     hemophilia, Aledort, now the director of the hemophilia 
     treatment center and a member of the board of directors at 
     Mount Sinai Hospital in New York, says that he would still do 
     the same thing again, given the information he had.
       ``We were wrong,'' he says. ``We didn't think it was a 
     virus, and we certainly didn't know it was 100 percent 
     lethal. There were uncertainties.''
       Aledort describes himself as a ``visionary'' and a 
     ``straight shooter'' and says of his dispute with the 
     hemophilia foundation: ``They expected me to say, `Recall all 
     Factor' [clotting concentrate]. They wanted me to say things 
     I disagreed with, and I wouldn't do it.'' He says he feared 
     that the CDC's warnings would panic hemophiliacs. ``All I was 
     saying was, let's stop the ticker tape.''
       He accuses CDC scientists like Dr. Donald Fancis of 
     ``creative recall.'' He complains bitterly about hemophiliacs 
     who have picketed banquets in his honor and who refer to him 
     as ``the Joseph Mengele of the hemophilia holocaust.''
       They want somebody's head to roll,'' says Aledort. ``It is 
     like a mob scene out of the French Revolution--`Let's knock 
     off everybody who ever treated us.' Well, that won't solve 
     anything. But this is a fan club country. It's like a 
     ballplayer who makes one bad play. You're remembered for your 
     last mistake, not all the good you did before.''
       Aledort says he didn't perceive himself as having a 
     conflict of interest. He says of all the studies that he did, 
     funded with drug company money: ``Who do you think profits 
     from all those studies? The hemophiliacs do.''
       But to many, Aledort has come to represent what one 
     hemophiliac advocate calls the ``incestuous relationship'' 
     among the foundation, the drug companies and the FDA.
       ``He could have blown the whistle and stopped the train,'' 
     says Calvin Dawson, whose brother Merlin died of AIDS from 
     the medicine a few weeks after his farewell visit. 
     ``Everybody would have listened to Lou Aledort.''
       Says Ricky Ray's mother, Louise: ``He played God with a lot 
     of people's lives. He was in a position to warn us, and he 
     didn't.''
       Jan Hamilton was a key member of the foundation's board of 
     directors during the early 1980s. She says that the board 
     simply believed what Aledort told them and went along with 
     his suggestions.
       ``I was at some of those meetings. I can remember getting 
     goose bumps, worrying abut what was going on. but they kept 
     telling us it was not that serious.
       ``He was the expert. We never thought he would mislead 
     us,'' she says.
       Last year, Hamilton and her husband, who is a pediatrician, 
     were shown for the first time some of the early warning 
     letters to Aledort from the CDC. She says they both began 
     crying.
       ``I was crying because I felt so bad and so angry and so 
     betrayed,'' she says. ``But I think my husband was crying for 
     a different reason. I think it was because he hates to see 
     people in his profession going against the Hippocratic 
     oath.''
       The newspaper clipping enraged Ricky Ray. It wasn't the 
     story. It was the headline:
       ``Ryan White loses battle with AIDS.''
       ``Mom,'' Ricky said, ``If I die, don't let them write that 
     about me. Don't let them say that I lost. Just because you 
     die, that doesn't mean you gave up. That doesn't mean you 
     lost.''
       In their final moments, the pilots of doomed airliners 
     rarely express fear.
       Instead, just before the crash, they are angry. They wonder 
     what is wrong with the machine, and they hate it for failing 
     them. They don't appeal to the hereafter. They curse the here 
     and now.
       It is something akin to that emotion that imbues the 1993 
     convention of the National Hemophilia Foundation.
       The meeting is not just for hemophiliacs but for health 
     professionals, and some of the seminars and meetings are 
     about promising developments for hemophiliacs. A cure 
     involving gene therapy is tantalizingly close. A new Kind of 
     clotting drug, produced in the lab instead of from human 
     plasma, is already available.
       Neither of those subjects comes up in the meetings--support 
     groups, legal seminars and town meetings--for hemophiliacs 
     with AIDS.
       Many of them have lost loved ones, and many have only 
     months to live themselves. But it isn't grief or fear that 
     drives them. It's a sense of betrayal best expressed by a 
     woman who stands up at one meeting and compares hemophiliacs 
     with AIDS to incest victims.
       ``We've gone through all the same stages,'' she says 
     through her tears. ``First disbelief and denial. You just 
     can't believe that someone who was supposed to be protecting 
     you did this to you. Then rage. And then, finally, what you 
     want most is just for the truth to come out, so that you can 
     heal.''
       Calvin Dawson is here. Dawson, who lives in Apopka, has 
     become a firebrand in the hemophiliac community. He keeps his 
     brother's wheelchair in his office as a reminder of the 
     deathbed promise he made to him to find out what happened and 
     why.
       Dana Kuhn is here. Kuhn is the minister who used clotting 
     concentrate just once in his life, after the charity 
     basketball game. The shot gave him the AIDS virus, which he 
     unwittingly transmitted to his wife, who died two years 
     later.
       Because his case was so clear-cut, he could have pursued an 
     individual, multi-million-dollar lawsuit. Instead, he became 
     one of the lead plaintiffs in the class-action suit, to give 
     it added credibility.
       Michael Druck is here. a 32-year-old Manhattan coin dealer, 
     he is among the leaders of a small group of hemophiliacs with 
     AIDS who have staged protests at testimonial dinners for 
     Aledort and other doctors involved in key decisionmaking 
     roles during the crisis. Like many men at the convention, 
     Druck has an immune system that is paper-thin. His T-cell 
     count--they are the immune cells that the AIDS virus 
     attacks--is measured in single digits. He jokes darkly about 
     talking to another AIDS-infected hemophiliac whose T-cell 
     count was even smaller.
       ``I offered,'' says Druck, ``to loan him one of mine until 
     Tuesday.''
       Michael Rosenberg is here. A former publisher, he is one of 
     the elder statesmen of the grass-roots activism among 
     hemophiliacs with AIDS. Everyone can see the change in 
     Rosenberg since last year's meeting. They've seen the same 
     signs before in all the others: the pallor, the way the 
     clothes no longer fit, the hollows in the face that begin to 
     show a little more clearly. Rosenberg is an inspired speaker, 
     but now there is a hesitation. People lean forward in their 
     seats, trying to finish his sentences for him.
       Bruce Evatt is here as well. Though he tells people, again 
     and again, that he saw his inability to warn them as ``a 
     personal failure,'' he is considered a hero by many 
     hemophiliacs. There is always a circle of people around him. 
     The CDC pays his expenses to come to the convention--unlike 
     the early years of the crisis when Evatt, traveling to speak 
     to various groups about the threat of AIDS, often had to 
     spend his own money or beg other government agencies for 
     travel funds.
       Pharmaceutical company representatives were once a 
     prominent presence at foundation conventions. They set up 
     display tables and ``infusion suites'' where people could go 
     for free injections.
       But there are only a few displays at this year's 
     convention, and those are usually unmanned, with just a 
     brochure or two and a scattering of free pens on the tables. 
     At last year's convention, Maxine Segal walked up to one 
     young man at the Miles Inc. table, took off her glasses and 
     leaned over within a few inches of him. ``I just wanted you 
     to see the face of the mother of two boys that your company 
     murdered,'' she said.
       AIDS has taken its fatal course a little more slowly with 
     hemophiliacs than with other victims, but time is running 
     out. One hemophiliac per day dies from AIDS in this country. 
     Those who survive are ``getting close to the far edge of the 
     curve,'' as one AIDS-infected conventioneer phrases it. A 
     mimeographed, homemade cartoon is making the rounds at the 
     convention, depicting a row of gravestones that read ``RIP 
     hemophiliac.'' A speaker at a lectern is addressing the 
     gravestones. ``It is with great pleasure we give an award to 
     the pharmaceutical companies and one to the government for 
     their never-tiring battle to find a cure for hemophilia,'' he 
     says.
       Johnny Kellar likes that cartoon a lot. He's been passing 
     it out to people. Though most of the time he stays to himself 
     or listens quietly, he hasn't always been such a loner.
       Like many young hemophiliacs with AIDS, he made friends 
     with other infected children, meeting them at camps and in 
     treatment centers--children with no future, drawn together in 
     a kinship that is difficult for adults to fathom.
       That was how he became best friends with Jason Christopher, 
     the Tampa youth whose parents won a $2 million lawsuit that 
     helped pave the way for the class-action suit.
       Two years ago, Jason and Johnny were being treated in a St. 
     Petersburg hospital, where they played tricks on the nurses--
     their favorite one being to rig a balloon-and-needle booby 
     trap to explode when the nurses lowered their beds.
       Jason was in the final stages of AIDS. But John's problem 
     was different. The doctors gave it a vague name: ``failure to 
     thrive.'' In truth, they could offer no particular physical 
     reason for his listlessness, his loss of appetite, his weight 
     loss. Though he had the AIDS virus, it was not in its active 
     stage. But it would be soon, the doctor warned Johnny's 
     mother, if his tailspin wasn't reversed.
       Then, a few months later, Jason died.
       And Marge Kellar was surprised when, soon after that, 
     Johnny perked up.
       He started eating again. He began speaking on behalf of an 
     AIDS awareness group and asking more questions about how his 
     medicine got contaminated with AIDS.
       He adopted a theme song: ``Beat It.'' He liked the lyrics: 
     They'll kick you and beat you and tell you it's fair . . . 
     just beat it.
       He visited Ricky Ray when Ricky was on his deathbed.
       ``Give 'em hell when I'm gone,'' Ricky told him.
       Like so many others, Johnny Kellar has the paper-thin 
     immune system, the single-digit T-cell count. Statistically, 
     he should be dead by now. His mother has come to believe that 
     the only thing keeping him alive is anger. It's as though the 
     raw fuel of adolescence has been drained out of him and 
     replaced by something else. She has begun calling him by a 
     wry nickname: ``Old Man.''
       On this night, the ``old man'' has left the adults meeting 
     upstairs and has headed for the awards dinner--the social 
     highlight of the convention.
       A jazz band is tuning up on stage. Allan Brownstein, 
     executive director of the hemophilia foundation, the man at 
     whom Johnny had shouted earlier, amuses everyone by sitting 
     down at the piano and playing ``Chopsticks.'' Waitresses 
     circle with crystal water pitchers while guests in semiformal 
     wear filter through the ballroom looking for their seats. In 
     all the refined commotion, nobody notices Johnny slip a 
     program off the table.
       Johnny glides out of the ballroom, stuffing the paper in 
     his pocket.
       ``Information,'' he mutters mysteriously. ``I pick up 
     things, here and there. You never know when it might come in 
     handy.''
       If he notices the slogan at the top of the program, he 
     doesn't say so. But there it is in black and white, the motto 
     that the National Hemophilia Foundation selected for this 
     year's convention: ``Securing our future . . . 
     together.''

                          ____________________