- 7/24/2025
How the FDA and American Red Cross failed to safeguard the nation's blood supply from the AIDS virus in the early 1980s, and why some of America's largest blood banks are still not in full compliance with federal regulations on blood safety.
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00:00Last month there was panic in Germany when the government filed criminal charges against a blood
00:14products company for distributing blood contaminated with the AIDS virus. But it
00:21was too late for Hans Dieterhahn, who contracted the disease from a transfusion. He says it's a
00:28catastrophe, and people like him have been handed a death certificate.
00:35Tonight on Frontline, the decade-long story of how the AIDS virus entered this country's blood supply.
00:42No one in government accepted the responsibility of saying, hey, we've got to do something about this.
00:51Frontline investigates why warnings were ignored by regulators, blood banks, and doctors.
00:56Nobody had the decency to tell us.
01:00To tell us there was any risks involved.
01:02You know, it's my child.
01:04Tonight, AIDS, blood, and politics.
01:14Funding for Frontline is provided by the Corporation for Public Broadcasting.
01:18This program was co-produced with the Health Quarterly.
01:38Funding for the Health Quarterly is provided by a grant from the Robert Wood Johnson Foundation.
01:46Resources making a difference in the health care of Americans.
01:49May I ask, what type of relationship exists between FDA and state departments?
02:00This summer, in a congressional hearing room in Washington, the Federal Food and Drug Administration
02:05sounded a warning about the nation's blood supply.
02:07This industry is not assuming adequate responsibility for putting in place and then following the basic quality assurance programs
02:17required to assure the safety of the blood supply.
02:22As head of the FDA, Dr. David Kessler is responsible for blood safety.
02:26These were system-wide problems that were not being addressed at the national level of the American Red Cross.
02:33At the center of the FDA's recent action is the American Red Cross, which collects more than half of the nation's blood.
02:43Together with other independent blood banks and companies that collect blood products,
02:47it's a system that generates more than a billion dollars a year.
02:51But for the last decade, it has been an industry under siege.
02:58In September of this year, a lawsuit was filed against blood product companies
03:03on behalf of 10,000 hemophiliacs who were infected with the AIDS virus through the blood supply.
03:09It's been lies all the way down the line.
03:12And it's going to come out, hopefully with a congressional hearing, it's going to come out.
03:17And I hope the world knows the truth before I die.
03:21Because I'll tell you, I've got an appointment soon to die.
03:24It is now estimated that as many as 30,000 Americans were infected with AIDS through blood.
03:31It's a tragedy that has exposed critical weaknesses in the rules and practices of blood banking.
03:37It's also a story of missed opportunities, vested interests, and lax regulation,
03:46stretching back more than a decade to when a mysterious virus entered America's bloodstream.
03:52Even in San Francisco in 1981,
03:58the new disease that had appeared in the city's homosexual community was thought of as their problem.
04:04People called it gay cancer.
04:07The doctors had named the disease gay-related immune deficiency, or GRID.
04:12At the Centers for Disease Control in Atlanta,
04:16doctors were concerned about the spread of GRID.
04:20Donald Francis was an epidemiologist at the CDC.
04:24When I saw this situation occurring in humans that looked very much like feline leukemia,
04:31that is, the immunologic and cancer problems that AIDS patients have,
04:37I put it together very quickly, as did Max Essex,
04:41and we were on the phone immediately in 1981 talking about this as a possibility of being an infectious agent.
04:48Dr. Francis sent blood samples from people with GRID to Harvard's Cancer Biology Laboratory,
04:54run by Dr. Max Essex, one of the world's leading experts in retrovirology.
05:00Well, Don Francis and I both endorsed the hypothesis that this new disease was more likely to be an infectious disease.
05:11But not everyone agreed.
05:12Nobody at that time really knew what was causing the disease, of course,
05:18and probably the leading hypothesis was something to do with the gay male lifestyle.
05:27It would take the scientific establishment more than two years to recognize that Francis and Essex were right.
05:34GRID was, in fact, an infectious disease.
05:37It would spread rapidly among gay men through sexual contact.
05:43But it would also spread undetected through America's blood supply, infecting thousands.
05:49In the mid-1970s, gay men began donating blood as part of an effort to help find a vaccine against another disease,
06:03hepatitis B.
06:06Back then, the only way to make a vaccine was to draw blood from people who already had been infected with hepatitis B.
06:12And as many as three-quarters of the gay men in some cities were carrying the virus.
06:22Bruce Voller was the executive director of the National Gay Task Force in those years.
06:26Well, I remember a lot of people that I knew, in fact, we, you know, pushed for an array of gay organizations
06:35that this was a useful thing to do, that hepatitis was a major scourge for gay males,
06:40and that it would be a very important and valuable thing to find a solution
06:44and a way of dealing with this and preventing it.
06:47The American Red Cross operated blood collection centers in big cities,
06:54where they targeted blood drives in the homosexual community.
06:58Their strategy was successful.
07:01By the early 80s, gay men made up 15% of all Red Cross blood donors.
07:07But what none of them knew was that blood not only carried hepatitis,
07:11but also the new disease, GRID.
07:13Then, in 1982, at the CDC, there were reports of GRID-like symptoms appearing in another group,
07:23hemophiliacs.
07:25When the CD4 studies came forth from the hemophiliacs showing that, what was it,
07:3230% or more had abnormal immunologic tests,
07:37and the same thing was coming through with the gay community,
07:39then the issue was there's a huge, hidden chunk to this iceberg,
07:45and that we were in a far worse situation than we hadn't realized.
07:50Like gay men, hemophiliacs were chronically infected with hepatitis B.
07:56The virus was passed to them through injections of a blood product called Factor VIII,
08:01which they had to take to stop their uncontrolled bleeding.
08:04Factor VIII kept hemophiliacs alive and allowed them to live normal lives.
08:12When the first hemophiliacs died of the new disease,
08:16CDC called an emergency meeting in July 1982
08:19to warn that their clotting factor might be contaminated.
08:23The National Hemophilia Foundation made it very clear that this material revolutionized their lives
08:31and revolutionized their survival.
08:33And please do not take it away, even though it does have a risk.
08:37Dr. Louis Allodort, then medical advisor to the National Hemophilia Foundation,
08:42says he was unconvinced by the CDC's warning.
08:45Now, to look at what CDC was investigating in research at that time,
08:50to give you some idea of what people began to think about what caused this disease,
08:55they were injecting sperm into mice to see whether sperm caused HIV.
09:04But they didn't know. It wasn't called HIV.
09:06It wasn't anything that was causing this disease.
09:08Before the meeting, a key CDC scientist had written to Dr. Allodort
09:14suggesting the possibility that the causal agent is a virus producing immunosuppression
09:20transmitted in a manner similar to hepatitis.
09:25We were so unfamiliar with a retrovirus
09:29that it was beyond the ken of most people
09:32that you could have a disease based on something that happened years ago.
09:38The meeting ended with no consensus,
09:42except everyone knew it was no longer just a gay-related disease.
09:47It would be called Acquired Immune Deficiency Syndrome, AIDS.
09:51I made the only motion that got passed in that entire meeting.
09:55Every motion except my motion to change the name to AIDS got voted down.
10:01At the Stanford University Blood Center,
10:03Dr. Ed Engelman was one of the few blood bankers
10:06to take the CDC's warnings seriously.
10:09And it was quite surprising at that time
10:11that there was a tendency by the blood bankers and by the leadership
10:16to dissociate what happened to the hemophiliac patients
10:21with what might happen to recipients of blood transfusions.
10:24Somehow there was...
10:25Suddenly there was a big difference between receiving factors derived from blood
10:29and receiving the blood itself,
10:31which made absolutely no sense whatsoever
10:33because historically it was well known
10:36that the hemophiliacs were traditionally the first to get a new infectious agent.
10:43The reason hemophiliacs are vulnerable
10:46is that it takes plasma from as many as 20,000 different donors
10:50to extract one bottle of clotting factor.
10:53We were alarmed and we would have thought
10:59that anyone associated with blood banking
11:02or the transfusion industry would have been equally alarmed.
11:07Throughout 1982, the evidence continued to mount
11:11that AIDS was being transmitted by blood.
11:15Then the CDC announced an AIDS case
11:18that had nothing to do with gay men or hemophiliacs.
11:21By December came the blood-associated cases,
11:27especially the child in San Francisco
11:28who'd received platelets from a donor
11:32and both of them had developed AIDS.
11:34The baby was not known to have any other risk factor.
11:38That sounded like the type of event
11:40that had to be associated with acquisition of infectious agent
11:43and infectious agent transmitted in blood.
11:46The CDC presented this new evidence
11:49to a meeting of clotting factor producers
11:51in California.
11:52And I was literally knocked off my chair
11:55because he said,
11:57here's this new disease.
11:58It's blood-borne.
11:59It's a retrovirus, we think.
12:02It's doubling every six months
12:05and it's 100% fatal.
12:07Now, you don't have to be an epidemiologist or...
12:10If AIDS was making its way into his product,
12:13then Dries decided he had to do something about it.
12:17Human blood.
12:18I know.
12:19I'm Tom Dries,
12:20president of Alpha Therapeutic Corporation.
12:23He decided to screen out homosexual men
12:26from his plasma donors.
12:28Only six times a year.
12:29Like other commercial producers of Factor VIII,
12:32Alpha ran collection centers in poor neighborhoods
12:35where people could sell their plasma each week
12:37for up to $25.
12:40We adopted a very stringent screening program,
12:44which was to ask people verbally, face-to-face,
12:47not on a check-off card,
12:49which, have you ever had sex with a male,
12:51just to a male donor.
12:52The first two weeks,
12:53we had 308 donors get up and say,
12:58yes, I'm a homosexual
13:00or I've had a homosexual relationship with a man,
13:02and we'd say, thank you very much,
13:03and he left.
13:04We had another 500
13:05who didn't admit to anything,
13:07but got up and left.
13:09Other manufacturers of Factor VIII
13:11were reluctant to ask donors directly
13:14about homosexual practices.
13:16One group said to me,
13:17you're going to turn a donor down,
13:19he's going to walk out the door,
13:20he's going to walk down the street,
13:22come into my place,
13:23and we'll take him all day long.
13:24And you're a sucker.
13:25You're a jerk for doing this.
13:26Well, sorry.
13:27That's the way we see it.
13:30In Washington,
13:31the CDC presented the same evidence
13:33to the FDA's Blood Products Advisory Committee.
13:37But the committee made no recommendation
13:38to the FDA then,
13:40and its chairman, Dr. Joseph Bovey,
13:42would say that gays should not be prevented
13:44from donating blood.
13:46We have not been willing,
13:48because there's not enough evidence,
13:49to finger any population
13:51or subset of individuals
13:53and say,
13:54this group should not be allowed
13:56to donate blood.
13:58Screening out homosexuals
14:00was a policy Dr. Bovey
14:02and other blood bankers
14:03advising the FDA
14:04would strongly oppose
14:06in meetings with the CDC.
14:08They never listened.
14:10The blood bankers,
14:11the responsibility,
14:13frankly,
14:13the federal government
14:14was very limited in its resources,
14:16including the FDA and CDC,
14:17and the responsibility
14:18at that meeting
14:19was turned over
14:19to the blood bankers.
14:21And they were the only ones
14:22that could respond fast enough.
14:23The FDA could help them do it,
14:25but it was really their response.
14:26They had all the information.
14:27We spelled out
14:28that there was such thing
14:28as transfusion-associated AIDS,
14:30that it was associated
14:31with the donation
14:32of blood and plasma
14:33from gay men,
14:34and that you could identify that
14:36either from taking histories
14:37of individuals,
14:38which many of us
14:39had lots of experience
14:39in public health doing,
14:40or from testing the blood
14:42for a variety of tests.
14:44So we put the problem,
14:45and we gave them the solution,
14:46and they chose to ignore it.
14:49Well, Bovey, as I recall,
14:51was head of the blood bank
14:52at Yale University Medical Center.
14:57And so his motive, in my view,
15:00was let's keep the cost down,
15:03let's not upset the donor population.
15:07There was a problem.
15:07Greth saw another problem,
15:09a revolving door
15:10between the blood bankers
15:11and regulators at the FDA.
15:14There are people
15:15who put in 20 years in the FDA
15:17and then go across the street
15:18and work for the Red Cross,
15:19and people who do the work
15:21in the Red Cross for 20 years
15:23go to work for the FDA.
15:24So there is that,
15:25and plus the fact
15:26that it isn't just
15:27the Red Cross and the FDA.
15:29People work in the FDA
15:30and then come to work
15:31for the various plasma fraction
15:33manufacturers as well.
15:35On January 4th, 1983,
15:39in response to mounting pressure
15:41from the CDC,
15:43the U.S. Public Health Service
15:44called its first public meeting
15:46on transfusion-associated AIDS.
15:50Donald Drake,
15:51a medical reporter
15:52for the Philadelphia Inquirer,
15:54was one of the few journalists there.
15:56Well, there are four very long tables.
15:59I guess there are about 38 people,
16:01I remember,
16:02at the four tables.
16:04There was a great expanse
16:05of 20 yards
16:07from one side of the table
16:08to the other,
16:10and they would talk
16:11across this chasm
16:12at each other.
16:14Clearly, Don Francis
16:15was the most forceful person
16:17at the meeting,
16:18as I remember,
16:19and he was much stronger
16:21than any of the other CDC people
16:23in speaking out.
16:25That meeting was meant to say,
16:27yes, there was such a thing
16:29as transfusion-associated AIDS.
16:30That was the first thing,
16:31and it was laid out
16:32what the epidemiology was.
16:34I think we had five other cases
16:35besides the baby at that time,
16:37and that maybe half of those
16:39were investigated completely,
16:41and we found one donor
16:42and all the donors
16:43to these individuals
16:44who was a gay man,
16:46and one of which had gotten AIDS
16:48as the recipient had gotten AIDS.
16:50So it all looked very clear
16:51that there was such a thing.
16:53Second, that the thing
16:54was associated
16:55with the donation of blood
16:56from people who got AIDS,
16:59which at that time
17:00was about 75% gay,
17:02and intervenous drug users
17:03aren't big blood donors,
17:05and so it really was
17:06the donation from a gay man
17:07that was associated
17:08with the disease.
17:09So this is what,
17:10if there is such a thing,
17:11this is how it's transmitted.
17:13And then the recommendations,
17:14logically,
17:15we have to eliminate gay men
17:16from blood donation,
17:17or if they do donate blood,
17:20to eliminate their blood.
17:21They recommended
17:21that a series of tests,
17:23but the one that seemed easiest
17:24for us to implement
17:25was to do a surrogate test
17:28for hepatitis B core antibody,
17:32and they found
17:32an 88% correlation
17:34between that test
17:36and patients that had AIDS.
17:38When we made the recommendation
17:40for hepatitis B testing
17:42of the donors,
17:44we said that they would lose
17:455% of the donors,
17:46and we thought
17:47that was a reasonable cost
17:50to balance the benefits.
17:52The industry,
17:53the volunteer industry,
17:55was particularly strongly
17:56and adamantly opposed
17:57at those meetings
17:59to using the hepatitis B core
18:03antibody test
18:04as a surrogate test
18:05for screening out
18:06infected blood
18:08because of the cost.
18:09It was as simple as that.
18:11It was,
18:11from their point of view,
18:12that was going to add
18:14a great deal
18:14to their costs
18:17and the loss
18:17of their profits.
18:18Then the blood bank
18:20would get up
18:21and say,
18:23surrogate testing
18:24is very expensive
18:25and we can do it
18:28through screening.
18:29And then the gay community
18:31would come up
18:31and they'd say,
18:32as soon as you start screening,
18:33it will be counterproductive
18:35because gay men
18:37won't say they're gay
18:38and they'll continue
18:40to give blood.
18:41They were big blood donors,
18:42if you recall.
18:43very conscience-oriented people
18:47and community-oriented
18:49and gave lots of blood,
18:51the gay population
18:52went crazed.
18:53How could you single us out
18:55as people
18:56who shouldn't give blood?
18:57And it was a wild meeting.
19:01People were yelling
19:02and screaming,
19:03many of them at us
19:05because we,
19:06of our direct questioning
19:08of donors.
19:09Joe Bovian
19:10from the American Association
19:12of Blood Banks
19:13and Aaron Kellner
19:13from the New York Blood Center
19:14suddenly led this,
19:16almost a revolt
19:17to the whole concept
19:18that there was such a thing
19:20as transfusion-associated AIDS.
19:22So if there was no such thing
19:23as transfusion-associated AIDS,
19:25then you didn't have
19:26to do anything about it.
19:27The other people
19:28seemed to be saying,
19:29let's do something,
19:31but let's not do this
19:33because it's going to hurt
19:34our vested interest.
19:37Francis seemed to be saying,
19:38let's do something.
19:40Confident that there were
19:41going to be more cases
19:42because clearly
19:42they were coming in
19:43by the day.
19:44I said, let's just,
19:45if you people don't believe
19:46there's such a thing
19:47as transfusion-associated AIDS now,
19:49just give us a number.
19:50Give us a number.
19:51Is it 10?
19:51Is it 20?
19:52Is it 30?
19:52Is it 40?
19:53And say,
19:53when we get that threshold,
19:54then we will act.
19:56Okay, let's agree on that.
19:58Now, after you agree on that,
19:59then let's say
20:00what we're going to do
20:01when we act.
20:01So since we're all here
20:02together now,
20:03we can decide
20:03if we get there.
20:04If we don't get there,
20:04then we don't have to act.
20:05If we do get there,
20:06we will act.
20:07Well, that was a ploy
20:08that didn't work,
20:09obviously.
20:10It just increased
20:11their ire more
20:12and the meeting
20:14continued to go
20:15spiraling downhill.
20:18Tragic.
20:20Don Francis was never
20:21invited to another
20:22FDA blood products
20:23advisory meeting.
20:25He eventually resigned
20:26from the CDC.
20:28And this is
20:29an excellent example,
20:30I think,
20:32it's almost like
20:32a laboratory experiment,
20:34of when vested interests
20:36come into conflict
20:38with the bigger good,
20:41which side
20:42will people side with?
20:45And I think
20:46what we see
20:47is almost invariably
20:48they will side
20:49with the vested interest.
20:51The American Association
20:53of Blood Banks
20:54is the industry's
20:55trade group.
20:56Together with
20:57the American Red Cross,
20:58they quickly issued
20:59a joint statement.
21:01Direct or indirect
21:02questions about
21:03a donor's sexual preference
21:05are inappropriate.
21:07Dr. Paul Holland
21:08was a member
21:09of the AABB's
21:10executive board.
21:12So how could you
21:13screen out a high-risk donor
21:14if you didn't ask them
21:15if they were homosexual?
21:17Well, among the things
21:18that they were told
21:18at that meeting
21:19by these representatives
21:20of the gay community
21:21was it would be
21:21both inappropriate
21:22and counterproductive
21:23to directly confront people
21:25about their sexual preference.
21:27They said,
21:27if anything,
21:28it would make the blood supply
21:28less safe.
21:30Convinced their civil rights
21:32were at stake,
21:32gay activists
21:34were threatening
21:34the blood banks.
21:35Who was a major figure
21:36in the gay movement
21:37had in fact proposed that
21:40and argued that
21:41and I had called him
21:42and said
21:43that gays should just
21:45go and donate their blood
21:46and then later
21:47call up and say so
21:49and screw everything up
21:50as a way
21:52of blocking
21:55the attempt
21:56to utilize screening
21:57as a,
21:58that kind of screening
21:59as a way
22:00of dealing
22:02with the issue.
22:04Dr. Art Silverglide,
22:05president of the AABB,
22:07was the medical director
22:08of the San Bernardino
22:09blood bank
22:09at that time.
22:11We were not immune
22:12to their pressure
22:13and their pressure
22:14was that this would
22:15have been discriminatory.
22:16The Haitians
22:17applied a lot of pressure
22:19when blood from Haiti
22:20was being discriminated against
22:23and that question
22:24was removed
22:25for a while.
22:26There's a,
22:27you can't do everything
22:28in the society
22:28just because it's right
22:29even though you'd like to.
22:32The FDA went along
22:33with the blood industry
22:34adopting the AABB guidelines,
22:37rejecting the CDC
22:39scientists' recommendations.
22:42But the Stanford blood bank
22:44split with the rest
22:45of the industry.
22:47It became the first blood bank
22:49to institute a surrogate
22:50blood test for AIDS.
22:52But we estimate
22:53that we prevented
22:54somewhere between
22:5650 and 100 cases of AIDS
22:57in our medical center alone.
23:00And I would also point out
23:02to you that we had
23:02one individual
23:04that came in
23:04and donated here
23:05and tested positive
23:06in our tests
23:07and we did not use his blood.
23:09This individual donated
23:1015 times
23:11to other blood banks.
23:13And our estimate
23:14is that he probably
23:15transmitted AIDS
23:17to 50 or 100 people
23:18because each blood donation
23:20is separated
23:21into at least
23:21two or three components.
23:24Dr. Bovey remained
23:25skeptical
23:25that the AIDS virus
23:26had entered
23:27the blood supply.
23:30Clearly,
23:30there is some concern
23:31on the part
23:32of public health officials,
23:34physicians,
23:35blood bankers,
23:36and the public
23:36that AIDS,
23:38whatever it is,
23:39is into the blood supply.
23:41The evidence for this,
23:42in my view,
23:43is very weak
23:45and very early.
23:47We don't really
23:48have any proof yet
23:49that the nation's
23:50blood supply
23:50is contaminated.
23:52We're not screening people
23:53nor are we screening blood.
23:55There is no test.
23:57While he publicly
23:58downplayed the risks,
23:59three weeks before,
24:00he had written
24:01a confidential report
24:02to the board
24:03of the American Association
24:04of Blood Banks.
24:06In it,
24:07Dr. Bovey acknowledges
24:08the increased probability
24:09that AIDS may be spread
24:11by blood.
24:12I believe that the most
24:13we can do
24:14in this situation
24:15is by time,
24:16he wrote.
24:18There is little doubt
24:19in my mind
24:19that additional
24:20transfusion-related cases
24:22and additional cases
24:23in patients
24:23with hemophilia
24:24will surface.
24:26In fact,
24:27by that time,
24:29many hemophiliacs
24:30already had been
24:31infected with HIV.
24:33Well, we know,
24:34for instance,
24:35that in the hemophilia population,
24:36although the virus
24:37entered the system
24:38in 1978,
24:40the bulk
24:40of the virus
24:41really came between
24:4281 and 83,
24:44and 50% of our patients
24:45had zero-converted
24:46by January of 82
24:47before the first case.
24:49So more than 50%
24:51of our patient population
24:52were infected
24:53before we even saw
24:55the first case
24:56of AIDS
24:57in hemophiliac.
25:00Corey Dubin
25:01is a hemophiliac.
25:03It was really hard
25:04to face
25:05that the very product
25:07that had made
25:07my whole life
25:08better
25:09now potentially
25:11was going
25:11to take my life
25:12at a very early age.
25:14I remember
25:15asking my doctors,
25:16what do I do?
25:18You know,
25:18what's going on?
25:19And they'd say,
25:20we think it's okay.
25:21You've got to treat
25:22the bleeds.
25:23Corey Dubin
25:24is convinced
25:25that hemophiliacs
25:26were not warned
25:27clearly enough
25:28by their own
25:29medical advisors.
25:29if they had mailed
25:31out an 83 warning,
25:33we must talk,
25:34you must think
25:35about these issues.
25:37Of course not
25:38everybody would have
25:39responded.
25:39Of course some people
25:40would have stayed
25:41under the woodwork.
25:42But a lot of us
25:43would have walked
25:44into a meeting
25:45and sat down
25:46and said,
25:46what do we do?
25:47What do you think
25:48we do?
25:49Well, they claimed
25:49they sent notices
25:50to people.
25:52They didn't.
25:52I don't believe
25:53they did.
25:54There was no major effort.
25:56Look,
25:56they turned
25:57to the companies
25:57and they said,
25:59is there a problem?
26:00And the companies
26:01down the line said,
26:02don't worry,
26:03use the product.
26:05But there was
26:06a problem.
26:08According to
26:08Milton Mosen,
26:09the former
26:10medical research
26:11director of
26:11Cutter Laboratories,
26:13by the end of 1983,
26:15he knew that
26:16the hemophiliac's
26:17clotting factor
26:18could transmit AIDS
26:20and that virtually
26:22all lots of concentrate
26:23were contaminated
26:25with the AIDS virus.
26:29You'll never convince me
26:31that profit margins
26:33and fear of product liability
26:35and fear of losing
26:37a very lucrative business
26:39did not drive
26:41the CEOs
26:42and the leaders
26:43of these companies.
26:45Corey Dubin found out
26:46he was HIV positive
26:48in 1985.
26:50He is now part of
26:51a class action suit
26:52against the five manufacturers
26:54and the National Hemophilia Foundation.
26:56He believes they could have
26:58acted more urgently
26:59after 1983,
27:01not just for him,
27:03but for others.
27:04Clearly one of the greatest
27:04tragedies of the epidemic
27:06that in many ways
27:09were really brought up
27:10in that January meeting
27:12with the blood banks
27:13and the public health service
27:14all together
27:15were new hemophiliacs
27:17clearly being born
27:18into the society
27:20and there,
27:21there was such a thing
27:22as transfusion-associated AIDS.
27:24There were ways
27:25to avoid transfusion-associated AIDS
27:26and factor-8-associated AIDS.
27:28Why don't at least
27:29they get the benefits
27:30recognizing that
27:31some have already been infected
27:32and any new people
27:33coming into this group
27:34clearly should have not
27:36gotten HIV.
27:36On September 20th, 1983,
27:40at the Brigham and Women's Hospital
27:42in Boston,
27:43Maria Hannafant
27:44gave birth to her first child,
27:46Eddie Jr.
27:48Eddie was diagnosed
27:49as a factor-9 hemophiliac.
27:53I remember that
27:54it was very vague
27:56the way it was told to me.
27:57Of course,
27:57I was in a state of shock
27:58at the time, too.
27:59I was a brand-new mom
28:01to begin with.
28:02I had never heard
28:03the word hemophilia
28:04in my life
28:05till my son was diagnosed.
28:07And we were barely
28:08starting to hear
28:09things about HIV.
28:11The Hannafants
28:12had seen news reports
28:13on AIDS and hemophiliacs.
28:16They told their doctors
28:17that they were afraid
28:18of Eddie getting AIDS.
28:20We got introduced
28:21to a hematologist.
28:23And I asked her,
28:23because at the time
28:24there was information
28:25about HIV in the news.
28:27I said,
28:28what is this I'm reading
28:28in the paper
28:29about this HIV
28:30and this AIDS?
28:32And she says,
28:33well, that's something
28:33you shouldn't have
28:34to worry about.
28:35And, you know,
28:36because I always
28:36remember that.
28:38The Hannafants' fears
28:39were allayed.
28:42Also, because their son
28:43was a factor IX hemophiliac,
28:45and Eddie would only
28:47need the clotting factor
28:48rarely,
28:48as little as four times
28:50a year.
28:54Two months after
28:55Eddie was born,
28:56the FDA held a meeting
28:57with the major manufacturers
28:58manufacturers of clotting factor.
29:01By then,
29:02the number of hemophiliacs
29:03with AIDS
29:04had reached 21.
29:07The government
29:08was fully recognizing
29:10that there was
29:11a substantial problem
29:12of AIDS in the blood supply.
29:14And they invited
29:15participants from
29:17all over the blood industry,
29:18as well as academicians
29:19like myself,
29:21to come to this meeting
29:22and present our findings
29:24and our views.
29:25I presented,
29:26for example,
29:27the kind of testing
29:27that we were doing
29:28in our blood bank
29:29as a surrogate test
29:31to reduce the likelihood
29:32of AIDS in the blood supply.
29:34Others described
29:34their other tests.
29:36And the test
29:37that seemed to make
29:38the most sense
29:39economically
29:40and feasibility-wise
29:41was the antibody
29:42to hepatitis B corp.
29:44The night before that meeting,
29:47officials from the four
29:48major clotting factor producers,
29:51Alpha,
29:51Highland Baxter,
29:53Armour,
29:53and Cutter,
29:55held a private meeting
29:56in a suburban
29:57Washington hotel room.
29:59This Cutter memo
30:01describes how,
30:02at that meeting,
30:03the companies agreed
30:04to propose a task force
30:06to study the question
30:07of testing
30:08as a delaying tactic.
30:10The following morning,
30:14their proposal
30:15was adopted
30:16by the FDA.
30:18Several different
30:19surrogate tests
30:20would be considered
30:20and evaluated
30:21by the task force
30:23subcommittee.
30:25This committee
30:26didn't issue
30:27a report
30:27for six or eight months.
30:29And ultimately,
30:30a majority
30:31and minority report
30:32was issued
30:33with the majority
30:34favoring no testing
30:35and the minority
30:37favoring the institution
30:38of hepatitis B corp.
30:39So the ultimate
30:40outcome of that meeting
30:41was nothing.
30:43No testing.
30:45By the time
30:46he was three years old,
30:48Eddie Hannafant
30:48had been given
30:49only 12 injections
30:50of clotting factor.
30:52But by then,
30:53he was already
30:54showing early symptoms
30:55of HIV infection.
30:58I didn't see
30:59any danger in it
31:00because I didn't know.
31:02So any time
31:04that he got hurt,
31:05my thing was,
31:07you know,
31:07I'm going to take
31:10my kid
31:11and give him
31:11the factor
31:12to take good care
31:13of him
31:14because I thought
31:15that I would
31:16take care of him
31:16and he would be,
31:17you know,
31:18healthy.
31:20I didn't know.
31:21Sometimes I thought
31:22and I felt guilt
31:23over maybe
31:24one of those days
31:26that now
31:27maybe it didn't
31:29really maybe
31:29need the factor
31:30that badly.
31:31It could have gone
31:32maybe without
31:32the factor.
31:33or maybe
31:33that was
31:34the bottle
31:36that maybe
31:37gave him
31:38the HIV.
31:40And
31:41it really hurts.
31:45It really hurts.
31:46Eddie Hannafant
31:47is one of more
31:48than 800 children
31:49born with hemophilia
31:50in 1983
31:51and 1984.
31:54Estimates are
31:55that dozens
31:55of these children
31:56contracted the AIDS virus
31:58through their
31:59clotting factor.
32:0083 and 84
32:01were the lost years.
32:02and they were
32:04lost on the first
32:06year because of
32:07the Joe Bovee
32:09AABB
32:10Red Cross
32:10barrier
32:11head in the sand
32:12approach to AIDS.
32:13The first year
32:13they just kind of
32:14ignored it
32:14and then came
32:16the second year
32:18starting in January
32:19or December
32:20of 83
32:20going onwards
32:21where the
32:23Blood Product
32:23Advisory Committee
32:24said okay now
32:25we really do need
32:25to recommend
32:26hepatitis B
32:28testing at least
32:28and then
32:30they all voted
32:31well we need
32:32a task force
32:32to evaluate it
32:33and by the time
32:33the task force
32:34got to evaluate it
32:35then Margaret
32:37Heckler
32:37and Bob Gallo
32:38stood up
32:39and said
32:39now we're
32:39going to have
32:39a test
32:40and so a whole
32:41another year
32:41goes by
32:41and they still
32:42did nothing
32:43and so this
32:45combination of
32:45the first year
32:46of sticking your
32:46head in the sand
32:47and the second year
32:48having your
32:48expectations come
32:49that we have
32:49an HIV test
32:50around the corner
32:50when you knew
32:51it was going to
32:51take a long time
32:52just combined
32:54to kill
32:54tens of thousands
32:55of Americans
32:56finally there
33:01was a breakthrough
33:02in 1985
33:03the FDA
33:04announced a blood
33:05test
33:06this test
33:08adds a major
33:09dimension of
33:10protection
33:10to our present
33:11safeguards
33:12its use
33:14will keep our
33:14blood supply
33:15safe
33:15and indeed
33:16make them
33:17even safer
33:18the HIV antibody
33:20test
33:21called the ELISA
33:22test
33:22would help
33:23make the blood
33:24supply
33:24in large part
33:25safe
33:26but it came
33:28at a cost
33:29to the blood
33:29banks
33:29technicians
33:31had to be
33:31hired and
33:32trained
33:32donors checked
33:34and every new
33:35unit of blood
33:36tested
33:37and logged
33:38but astonishingly
33:41the blood banks
33:42were not required
33:43to go back
33:43to the inventory
33:44on their shelves
33:45and test the blood
33:47now in hindsight
33:49Dr. Art Silverglide
33:50at the American
33:51Association of Blood
33:52Banks
33:52says it was a mistake
33:54we test an inventory
33:55we didn't do it then
33:56I have no
33:57excuse
33:57and you're really
33:58telling us
34:00that that was
34:01an honest mistake
34:02and not motivated
34:03by things like
34:04not wanting to
34:05hire extra people
34:06not wanting to
34:07go to the inconvenience
34:08of having blood banks
34:10test all of their
34:10inventory
34:11I don't
34:12I can't get back
34:13ten years
34:14to tell you
34:15whether all those
34:16things played in
34:17but I really
34:17believe that
34:18it was an honest
34:19mistake
34:19the blood banks
34:20were used to
34:21doing things
34:21their own way
34:22they had even
34:24persuaded the FDA
34:25to reduce the
34:26number of
34:26inspections of
34:27blood banks
34:28Gilbert Gall
34:32is a reporter
34:32for the Philadelphia
34:33Inquirer
34:34I stumbled upon
34:36a document
34:37in which the
34:38blood banks
34:39were talking
34:39about how they
34:40had successfully
34:41lobbied
34:42the regulators
34:44to reduce the
34:46number of
34:47inspections
34:48to one every
34:49two years
34:49as opposed to
34:50one every year
34:50Investigating safety
34:52in the blood
34:52supply
34:53Gall found that
34:54the FDA reduced
34:55the number of
34:56inspections
34:57at the very time
34:58the AIDS virus
34:59was entering
35:00the system
35:01Even if you
35:02accept the idea
35:03that well we
35:04didn't know
35:05in 83 that
35:06AIDS was in
35:07the blood supply
35:08I mean we sure
35:08as hell knew
35:09that it was in
35:09the blood supply
35:10a year later
35:10and why
35:12wouldn't you
35:13have gone back
35:14at that point
35:15in time
35:15and increased
35:16your inspections
35:17so that you
35:19could police
35:20bad blood
35:21getting out
35:22the door
35:22but they
35:23didn't do it
35:23I mean that
35:24didn't come
35:24until 1988
35:25when all of a
35:26sudden everything
35:27exploded and
35:28the blood banks
35:28started having all
35:29these horrendous
35:30problems and all
35:30these recalls
35:31Gall discovered
35:32FDA reports of
35:34errors and
35:34accidents
35:35that between
35:371985 and
35:381987
35:38thousands of
35:40units of
35:41potentially
35:41contaminated
35:42blood had
35:43been released
35:44and then
35:44officially
35:45recalled
35:46Recalling blood
35:48that has been
35:49released for
35:49transfusion
35:50is a bit
35:51misleading
35:52because
35:53depending on
35:54when and
35:55how you're
35:56trying to
35:56recall it
35:57the chances
35:57of your being
35:58able to get
35:58it all back
35:59are almost
36:00zero
36:01because once
36:02it's released
36:03it's used
36:04Potentially
36:05contaminated
36:06blood had
36:07been used
36:08most of it
36:09quickly in
36:09emergency rooms
36:10the FDA
36:11had to take
36:12action
36:13in September
36:141988
36:15the FDA
36:16and the Red
36:17Cross
36:17entered into
36:18what is known
36:18as a voluntary
36:19agreement
36:20to comply
36:21with all
36:21FDA regulations
36:22from now on
36:24there would be
36:25yearly inspections
36:26Mary Carton
36:29was an
36:30experienced
36:30FDA field
36:31inspector
36:32FDA's job
36:33is twofold
36:34as I see it
36:35from my
36:35perspective
36:36the first
36:37part is
36:37that we
36:38should set
36:38a standard
36:38for them
36:39to meet
36:39and then
36:40the second
36:40part is
36:41to enforce
36:42that standard
36:42and over
36:44and over
36:45again
36:45while they
36:45will agree
36:46with us
36:46about the
36:47standard
36:47that we're
36:47setting
36:48when we
36:49come to
36:49enforce it
36:50they suddenly
36:50want to
36:51discuss with
36:52us maybe
36:53the merits
36:53of that
36:54standard
36:54Mary Carton
36:56was promoted
36:56and assigned
36:57to on-site
36:58inspections
36:58of Red
36:59Cross
36:59blood centers
37:00that previously
37:00had been cited
37:01for chronic
37:02safety violations
37:03this document
37:08shows the
37:09violations
37:09she found
37:10in Red
37:10Cross
37:10blood banks
37:11in Albany
37:12Charlotte
37:13Nashville
37:14Los Angeles
37:16St. Louis
37:16Tulsa
37:17and Washington
37:18D.C.
37:19where Carton
37:20found 230
37:21cases of
37:22possible
37:23transfusion
37:23associated
37:24AIDS
37:24none of
37:26these cases
37:26was ever
37:27reported
37:27to the
37:28FDA
37:28the bottom
37:30line was
37:31that the
37:31Red Cross
37:32didn't tell
37:33the FDA
37:33about those
37:34cases
37:35whether they
37:36were true
37:36transfusion
37:37associated
37:38cases or
37:38not
37:38and the
37:41FDA
37:41inspectors
37:42Mary Carton
37:43and others
37:43who went
37:44into National
37:44and went
37:45into the
37:45Washington
37:45region
37:46and looked
37:47at the
37:47files
37:48found out
37:49about these
37:49things
37:49and realized
37:50that they
37:50had not
37:50been reported
37:51to the
37:51FDA
37:52and they
37:53raised red
37:54flags about
37:55that issue
37:55I wrote
37:56the story
37:56and all
37:56hell broke
37:57loose
37:57questions
37:58about the
37:59Red Cross
37:59were raised
38:00by a
38:00congressional
38:01subcommittee
38:01on blood
38:02safety
38:02the Red Cross
38:04on July 10th
38:06Ms. Carton
38:06put out
38:07a statement
38:08and one of
38:08the things
38:09that they
38:09said
38:09talking about
38:10error and
38:10accident reports
38:11and I want to
38:13just quote to you
38:14they call them
38:15procedural errors
38:17which are corrected
38:17immediately at the
38:19local level
38:19and then routinely
38:21reported to
38:21national headquarters
38:22which in turn
38:23reports them
38:24to the FDA
38:25is that
38:27possibly a true
38:28statement
38:28not to my
38:30knowledge
38:30when Mary
38:33Carton
38:34and the
38:34FDA
38:34inspectors
38:35tried to
38:36get records
38:36from Red Cross
38:37national headquarters
38:38they were not
38:40forthcoming
38:40generally
38:41when I object
38:42to something
38:43during an
38:44inspection
38:44the firm
38:46is very
38:46prompt
38:46at trying
38:47to provide
38:48some information
38:49for me
38:49to show
38:50that they've
38:50already
38:50corrected
38:51the deficiency
38:52or are going
38:52to do
38:52the best
38:53they can
38:53in the
38:54case
38:54of this
38:55inspection
38:56of the
38:56American Red
38:57Cross
38:57at national
38:57headquarters
38:58that type
38:59of attitude
39:00did not
39:00prevail
39:01when
39:02Carton
39:02requested
39:03all of the
39:04case files
39:04Red Cross
39:05officials replied
39:06that the cases
39:07were in the
39:08office of their
39:09general counsel
39:09in case of
39:11litigation
39:11in November
39:19of 1989
39:20Bob Jones
39:22a carpenter
39:22from
39:23Wilsall
39:23Montana
39:24was in
39:25Portland
39:25Oregon
39:25visiting his
39:26son
39:27when he
39:27was rushed
39:28into emergency
39:29surgery
39:29with a
39:30burst
39:30artery
39:30Jones
39:33was transfused
39:34with blood
39:35from the
39:35Portland
39:35Red Cross
39:36blood bank
39:37a few
39:39months later
39:39he was
39:40called by
39:40the blood
39:41bank's
39:41director
39:41Dr.
39:42Franz
39:42Pitum
39:43and he
39:45said he
39:45was sorry
39:46to be
39:46the bearer
39:47of bad
39:47news
39:47but that
39:48I had
39:50been
39:51given
39:51a unit
39:53blood
39:54that was
39:55possibly
39:55that was
39:56contaminated
39:56with the
39:57HIV virus
39:58and I
40:00was just
40:01totally
40:01shocked
40:02I didn't
40:03believe that
40:03could happen
40:03so Shirley
40:06come boiling
40:07out then
40:08and she
40:08took the
40:08telephone
40:09and she
40:10talked to him
40:10but I was
40:11unable to talk
40:12I just
40:13couldn't
40:13understand that
40:14I asked
40:15Dr.
40:15Pitum
40:15about the
40:16donor
40:16and he
40:17said
40:18he
40:20wasn't at
40:21liberty
40:21to give
40:22details
40:23and I
40:23pressed for
40:24details
40:25and he
40:26finally said
40:26that he
40:26was
40:27homosexual
40:27and I
40:29asked him
40:29why
40:31they would
40:32take blood
40:33from a
40:33homosexual
40:34when they
40:34knew all
40:35this AIDS
40:36was out
40:36there in
40:37the
40:37homosexual
40:37community
40:38and he
40:40said
40:40well the
40:41donor
40:41had not
40:42disclosed
40:42that
40:43Dr.
40:44Pitum
40:44told me
40:45that I
40:45shouldn't
40:45tell anyone
40:46about this
40:47that
40:48it was
40:49none of
40:49their
40:50business
40:50and that
40:51family and
40:52friends
40:52might
40:53ostracize
40:53me
40:54if I
40:55did
40:55tell
40:57the
40:58Portland
40:58Red Cross
40:59has had
40:59its share
41:00of problems
41:00with the
41:01FDA
41:01a year
41:03after Dr.
41:04Pitum
41:04contacted
41:05Bob
41:06Jones
41:06Mary
41:07Cardin
41:07went to
41:07Portland
41:08to conduct
41:09a full
41:09inspection
41:09the
41:10Portland
41:10inspection
41:11of March
41:111991
41:12was just
41:14simply a
41:15routine
41:15inspection
41:16request
41:16Cardin's
41:17inspection
41:18revealed
41:18numerous
41:19significant
41:20violations
41:20including
41:21the release
41:22of blood
41:22improperly
41:23tested
41:24for
41:24hepatitis
41:25and HIV
41:25Portland
41:27was sent
41:28a notice
41:28of intent
41:29to revoke
41:29its license
41:30to test
41:30blood
41:31there was
41:33a notice
41:33of intent
41:34to revoke
41:34their license
41:34sent to
41:35the Portland
41:35Red Cross
41:36Mary
41:37Cardin
41:38had discovered
41:38that units
41:39of potentially
41:40contaminated
41:40blood
41:41had been
41:41released
41:42once more
41:44she testified
41:45before the
41:46congressional
41:46subcommittee
41:47do you know
41:49if in fact
41:50the blood
41:50was shipped
41:50or not
41:51I do not
41:52have all
41:53the records
41:53with me
41:53to indicate
41:54which of
41:55the products
41:55were distributed
41:56versus maybe
41:57expired in
41:59house
41:59but we do
42:00have records
42:00that they were
42:01shipped
42:01whether they
42:02were actually
42:02transfused
42:03we would have
42:04to go to the
42:04hospital
42:04and ask
42:07them that
42:07information
42:08in fact
42:09these records
42:10show that
42:10recalled
42:11blood
42:11units
42:12from the
42:12Portland
42:12blood
42:12center
42:13were
42:13transfused
42:14including
42:16units
42:16that had
42:17been
42:17incorrectly
42:18tested
42:18or had
42:19come
42:19from
42:19high
42:20risk
42:20donors
42:20at the
42:24time
42:25Dr.
42:25Pitoum
42:26insisted
42:26there was
42:27no danger
42:27no blood
42:29reached hospitals
42:30that we feel
42:30uncomfortable
42:31with
42:31no units
42:33have been
42:33released
42:34that were
42:34incompletely
42:35tested
42:36or were
42:36released
42:37with the
42:37wrong
42:37test results
42:38or were
42:39not tested
42:39at all
42:40and so
42:41this is
42:42just
42:42erroneous
42:43rather than
42:46have its
42:46license
42:47revoked
42:47by the
42:47FDA
42:48in July
42:491991
42:50the
42:50Portland
42:51Blood
42:51Bank
42:51voluntarily
42:52surrendered
42:53its
42:53license
42:53to
42:54test
42:54blood
42:54but
42:57seven
42:57months
42:57later
42:57Dr.
42:58Pitoum
42:59notified
42:59the
42:59FDA
43:00that
43:00Portland
43:01had
43:01resumed
43:02HIV
43:02testing
43:03without
43:03FDA
43:04official
43:05approval
43:05within
43:0724
43:07hours
43:08Mary
43:08Cardin
43:09arrived
43:09in
43:09Portland
43:10and
43:10closed
43:11the
43:11HIV
43:11testing
43:12unit
43:12down
43:12citing
43:13Portland
43:14for
43:14inadequate
43:14review
43:15of
43:15testing
43:15records
43:16inappropriate
43:17release
43:18of
43:18blood
43:18products
43:19and
43:19releasing
43:20blood
43:20even
43:20before
43:21receiving
43:21HIV
43:22test
43:22results
43:23we
43:26sent
43:26copies
43:27of
43:27the
43:27FDA
43:27inspection
43:28reports
43:28on
43:29Portland
43:29to
43:29Dr.
43:30Ed
43:30Engelman
43:31for
43:31his
43:31evaluation
43:32it's
43:32apparent
43:33to me
43:33that
43:33there
43:33are
43:34serious
43:34violations
43:35violations
43:35of
43:36conduct
43:37that
43:38would
43:39place
43:40recipients
43:40of
43:40blood
43:40transfusions
43:41at
43:41considerable
43:42risk
43:42example
43:44would
43:44be
43:44to
43:45release
43:45blood
43:45for
43:46transfusion
43:46blood
43:47that has
43:47been
43:47donated
43:48but
43:48has
43:48either
43:49not
43:49been
43:49tested
43:49tested
43:51for
43:51HIV
43:51for
43:52example
43:52or
43:52tested
43:53for
43:53hepatitis
43:53but
43:55released
43:55anyway
43:55for
43:55transfusion
43:56that
43:57to me
43:57represents
43:58a serious
43:58absolutely
43:59reprehensible
44:00breach
44:01of
44:02not only
44:04guidelines
44:04but
44:05common
44:05sense
44:05meanwhile
44:09back
44:10in
44:10Montana
44:10bob
44:11jones
44:11had
44:12hired
44:12local
44:12attorney
44:13monty
44:13beck
44:14whose
44:14first
44:14action
44:15was
44:15to
44:15go
44:15looking
44:16for
44:16the
44:16blood
44:16donor
44:17it
44:18wasn't
44:19easy
44:19he
44:20got
44:21no
44:21help
44:21from
44:21the
44:21portland
44:22red
44:22cross
44:22and
44:24when
44:24after
44:25months
44:25of
44:25investigation
44:26beck
44:27finally
44:27located
44:28the
44:28donor
44:28he
44:29did
44:29not
44:29fit
44:29the
44:30description
44:30dr
44:30pitum
44:31had
44:31given
44:31bob
44:32jones
44:32he
44:33wasn't
44:33a
44:33homosexual
44:34and
44:34he
44:34didn't
44:34lie
44:35he
44:36just
44:36simply
44:36wasn't
44:36asked
44:37the
44:37right
44:37questions
44:37and
44:38if
44:38he
44:38had
44:39been
44:39asked
44:39the
44:39right
44:39questions
44:40he
44:41flatly
44:41stated
44:41he
44:41wouldn't
44:42have
44:42given
44:42his
44:42blood
44:42it
44:43took
44:43three
44:44years
44:44for
44:44bob
44:45jones
44:45case
44:46to
44:46come
44:46to
44:46court
44:46the
44:48red
44:48cross
44:48lawyers
44:49argued
44:49that
44:49the
44:49blood
44:50he'd
44:50received
44:50had
44:51tested
44:51negative
44:51and
44:52that
44:52the
44:53Portland
44:53blood
44:53center
44:53screened
44:54the
44:54donor
44:54properly
44:55but
44:58then
44:58in
44:58a
44:58surprise
44:59move
44:59it
45:00just
45:00makes
45:01sense
45:01to
45:05before
45:06the
45:06donor
45:07could
45:07testify
45:07on
45:08bob
45:08jones
45:08behalf
45:09the
45:09red
45:10cross
45:10settled
45:10the
45:10case
45:11admitting
45:12no
45:12negligence
45:13and
45:13sealing
45:14the
45:14case
45:14records
45:15tom
45:18drees
45:18says
45:18there
45:18have
45:19been
45:19many
45:19other
45:19settlements
45:20of
45:20transfusion
45:21associated
45:21AIDS
45:22cases
45:22i saw
45:23some
45:23figures
45:24at
45:24the
45:24recent
45:25aabb
45:26meeting
45:26that
45:27court
45:27settlements
45:28not
45:28settlements
45:29outside
45:30but
45:30trial
45:31settlements
45:32have
45:32come up
45:33with
45:3365
45:34million
45:34dollars
45:35i mean
45:35that's
45:35serious
45:36money
45:37the
45:38highest
45:38numbers
45:38of
45:39transfusion
45:39associated
45:40AIDS
45:40cases
45:40occurred
45:41before
45:411985
45:42since
45:44the
45:44ELISA
45:45test
45:45there
45:45are
45:45far
45:46fewer
45:46of
45:46them
45:46but
45:48no
45:48one
45:48knows
45:48how
45:48many
45:49cases
45:49there
45:49are
45:50and
45:51blood
45:51banks
45:51are
45:51not
45:51required
45:52to
45:52report
45:53cases
45:53of
45:53HIV
45:54infection
45:54to
45:54the
45:55FDA
45:55or
45:56the
45:56CDC
45:56in
45:591992
46:00at
46:00the
46:00Los
46:01Angeles
46:01Red
46:01Cross
46:02FDA
46:03inspectors
46:04found nearly
46:04100
46:05cases
46:05where
46:06lookbacks
46:07notifying
46:08recipients
46:09of possible
46:09HIV
46:10infected
46:10blood
46:11had not
46:12been
46:12performed
46:13for
46:13several
46:14years
46:14it is
46:16the
46:16responsibility
46:16of the
46:17blood
46:17bank
46:17to go
46:18back
46:19to the
46:19recipients
46:20of those
46:21transfusions
46:21and make
46:22sure that
46:23they are
46:23aware
46:24that they
46:25may have
46:25become
46:26infected
46:27in this
46:27case
46:27an HIV
46:28infection
46:29and if
46:30one delays
46:31that
46:31lookback
46:32by
46:33weeks
46:34months
46:34years
46:35all you're
46:36doing
46:36is making
46:37it more
46:37likely
46:37that that
46:38recipient
46:38has
46:39suffered
46:40from AIDS
46:40without
46:41knowing
46:41it
46:41that that
46:42recipient
46:42has
46:43potentially
46:43transmitted
46:44AIDS
46:45to other
46:45individuals
46:47sexually
46:47and otherwise
46:48and so
46:49there is no
46:50good reason
46:50that I can
46:51think of
46:51to delay
46:52a look
46:53back
46:53finally
46:57in 1993
46:58FDA
46:59Commissioner
46:59Dr.
47:00David
47:00Kessler
47:01went to
47:01federal
47:02court
47:02and obtained
47:03an injunction
47:04against the
47:04Red Cross
47:05for failure
47:05to fulfill
47:06its promises
47:07under the
47:081988
47:08voluntary
47:09agreement
47:10we filed
47:11a complaint
47:12for injunctive
47:13relief
47:13in the
47:14district
47:14court
47:14and we
47:15obtained
47:16a consent
47:16decree
47:17in May
47:17of this
47:18year
47:18that put
47:19the
47:19American
47:19Red Cross
47:20under
47:21court
47:21supervision
47:22the injunction
47:23that applies
47:24to the
47:25American
47:25Red Cross
47:25applies to
47:26all the
47:27facilities
47:27throughout
47:28this country
47:28all American
47:29Red Cross
47:30blood banking
47:30facilities
47:31both in
47:31the field
47:31and in
47:32headquarters
47:32it doesn't
47:33apply to
47:34any one
47:34blood banking
47:36facility
47:36over another
47:37all facilities
47:38are covered
47:38by the
47:39injunction
47:39the complaint
47:42specifically
47:42cites safety
47:43violations
47:44in the
47:44Albany
47:45Charleston
47:46and Portland
47:47blood
47:47centers
47:48there were
47:49examples
47:49of the
47:50problems
47:50that we
47:50had seen
47:51and the
47:51reason why
47:51we went
47:52from a
47:52voluntary
47:52agreement
47:53that was
47:54signed
47:54in 1988
47:55to a
47:56court
47:56enforced
47:56injunction
47:57there
47:58are all
47:59these
48:00voluntary
48:01agreements
48:02between
48:02the FDA
48:03and
48:04these
48:04problem
48:05blood
48:05banks
48:06and
48:07it's like
48:08a consent
48:08decree
48:09the person
48:10who's
48:10signing
48:10the consent
48:11decree
48:11will always
48:12tell you
48:12that
48:12well I
48:13haven't been
48:13convicted
48:14of anything
48:14I haven't
48:15done
48:15anything
48:15wrong
48:16I'm
48:16just
48:16agreeing
48:17not to
48:17do
48:18this
48:18thing
48:18in the
48:19future
48:20and
48:21that's
48:21what
48:21the
48:22same
48:22spin
48:23that
48:23the
48:23blood
48:23banks
48:24put
48:24on it
48:24when they
48:25run afoul
48:26of the
48:28regulations
48:28they volunteer
48:30to fix
48:31these things
48:31of course
48:31when you go
48:32back and
48:32look later
48:33a year
48:34or more
48:34later
48:35whether those
48:35things were
48:36ever fixed
48:36from the
48:38examples
48:38that we've
48:39seen
48:39as often
48:41as not
48:42they've
48:42never been
48:42fixed
48:43they still
48:43have those
48:44kinds
48:44of
48:44problems
48:45Red Cross
48:47National
48:47Headquarters
48:48has been
48:48reluctant
48:49to discuss
48:50the details
48:50of its
48:51past
48:51problems
48:51but Fred
48:53Kyle
48:53who was
48:53hired
48:54less than
48:54two years
48:55ago
48:55as a
48:55senior
48:56executive
48:56did respond
48:58to the
48:58FDA's
48:59recent
48:59injunction
48:59so I
49:00think
49:00what
49:01gives
49:01them
49:01comfort
49:02is
49:03yes
49:04there
49:04is
49:04some
49:05formality
49:05and
49:05legality
49:06to
49:07this
49:08arrangement
49:08they
49:08didn't
49:08have
49:09before
49:09they
49:10were
49:10disappointed
49:11in the
49:12Red Cross
49:12response
49:13to the
49:13voluntary
49:13agreement
49:14that it
49:15wasn't as
49:15quick
49:15as they
49:16thought
49:16and so
49:17this
49:17perhaps
49:17gives them
49:17more
49:17assurance
49:18and I'm
49:19not saying
49:20I'm happy
49:20with that
49:20but I
49:21understand
49:21that
49:21right
49:22well
49:22Dr. Kessler
49:23puts it
49:24another way
49:24he says
49:25he needs
49:26the courts
49:26to get
49:27the Red Cross
49:28to fix
49:29the violations
49:30that it
49:31refuses to
49:32fix
49:32he knows
49:32I disagree
49:33with him
49:33on that
49:34Dr. Kessler
49:36doesn't have
49:37as much
49:38faith as
49:38I do
49:39in the
49:40management
49:40control
49:40that we
49:41absolutely
49:41have in
49:42this
49:42organization
49:42and we
49:43will exercise
49:44during the
49:45last 18
49:46months
49:46while we
49:46have made
49:47a lot
49:47of progress
49:47we have
49:48also had
49:49mistakes
49:49we have
49:50had false
49:50starts
49:51we've had
49:51to do
49:52things over
49:52again
49:52the Red Cross
49:54claims that
49:54it is spending
49:55148 million
49:56dollars on a
49:57transformation
49:58program to
49:59improve the
50:00standards of its
50:00blood centers
50:01continue to do
50:02but we have to
50:03remember this is a
50:04big job
50:05we are changing
50:06the tires on the
50:07truck as we're
50:07going down the
50:08highway
50:08and we've never
50:10done this before
50:11Kyle insists the
50:13transformation program
50:14is not connected to
50:15the Red Cross's
50:16recent problems
50:17with the FDA
50:18we shouldn't be
50:20relating this to
50:21current safety
50:23or the AIDS
50:24problem
50:25or HIV
50:26this is a
50:27future related
50:28system to make
50:29us able to
50:31deal with any
50:32challenges that we
50:33might have in
50:34the 21st century
50:35or later in
50:36the 1990s
50:37this is a
50:38forward-looking
50:39program to
50:40change the way
50:41we run the
50:42blood system
50:42but the blood
50:44system that we're
50:44running now
50:45Carol is
50:46indeed as
50:48safe as it
50:48can be made
50:49and I think
50:51the numbers we
50:51have
50:52demonstrate
50:53that
50:53each part of
50:56the blood
50:56industry seems
50:57to have its own
50:58numbers about
50:58how many cases
50:59of HIV infection
51:00have happened
51:01since 1985
51:03from blood
51:03transfusions
51:04from the blood
51:06bankers
51:07to the CDC
51:08to the FDA
51:09there is no
51:10central system
51:11for gathering
51:12that information
51:1312 million
51:14units
51:15are
51:16donated
51:17every year
51:19and so
51:20when asked
51:21Dr. Kessler
51:21has to guess
51:22how many cases
51:23there are
51:24annually
51:24that translates
51:26into somewhere
51:28between 90
51:29and 450
51:30460 cases
51:32if my memory
51:33serves me
51:34correct
51:35for Gilbert
51:36Gall
51:37who won a Pulitzer
51:38in 1990
51:38for his reporting
51:39it sounds like
51:41an old story
51:42the numbers
51:43were suspect
51:44to some extent
51:46they're still suspect
51:47I don't have
51:50a whole lot
51:50of faith
51:51in them
51:52flipping it
51:54that's not to say
51:55that the blood
51:57supply
51:58is just
51:59incredibly unsafe
52:00and just full
52:01of AIDS
52:01nobody's saying
52:02that
52:03nobody's even
52:03suggesting that
52:04but
52:05God
52:07we ought to have
52:08at least
52:08better data
52:09and we ought to have
52:11the top public
52:13officials in this
52:14country
52:14speaking honestly
52:17with the American
52:18public
52:18about the risks
52:20now FDA
52:22Commissioner Kessler
52:23is sending
52:23a clear message
52:24to the blood industry
52:25this was
52:27one of the strongest
52:29enforcement actions
52:30that I have taken
52:32during my tenure
52:33as Commissioner
52:33of FDA
52:34and we followed it
52:36by strengthening
52:37our enforcement
52:37activities across
52:39the entire blood industry
52:40but his challenge
52:42is whether his field inspectors
52:44can bring the problem
52:45blood banks
52:46into compliance
52:47earlier this year
52:50at the Portland Red Cross
52:51we found that the blood bank
52:53had resumed HIV testing
52:55Heidi Patterson
52:58is the technical director
52:59and when did you start
53:01up again
53:02January of 93
53:04okay
53:05January of 93
53:06and that was based
53:09on a letter
53:11from the FDA
53:12saying that
53:13your license is
53:14been amended
53:14to resume testing
53:15in Portland Oregon
53:16okay
53:17and since then
53:19anybody from the FDA
53:22ever show up here
53:23to inspect
53:24not in the center
53:26to my knowledge
53:26we asked Dr. Kessler
53:32about the letter
53:33and why
53:34after all its problems
53:35the FDA
53:36hadn't been back
53:37to re-inspect
53:38the Portland blood bank
53:39there have been
53:40there are real problems
53:42we have seen
53:43violations
53:44throughout
53:46this industry
53:48and that's the reason
53:50why we went
53:50I mean to an injunction
53:52I mean it was
53:53a very strong action
53:54it's not something
53:55that we did lightly
53:56it was something
53:57that
53:58look
53:59why hasn't anybody
54:00been back to Portland
54:01to do a full inspection
54:03in two years
54:04and four months
54:05is my question
54:06and on what grounds
54:08are they performing
54:08this test
54:09I'd like to get an answer
54:11because
54:11when was the last
54:12Portland inspection
54:13well I can't tell you
54:14the specifics
54:15of each and every
54:15inspection
54:16that's been conducted
54:17in Portland
54:17and some of the
54:19issues there are not
54:20are unresolved issues
54:21that I'd prefer
54:22not to address
54:23what chances are
54:25when was the last time
54:25Portland was inspected
54:26soon after this interview
54:28in July 1993
54:30FDA inspectors
54:32went to Portland
54:33for the first
54:34full inspection
54:35in over two years
54:36the inspection
54:38cited 35 violations
54:40during the month
54:41of January 1993
54:42including
54:44failure to properly
54:46perform
54:47the ELISA test
54:48the ELISA test
54:50for
56:11For the documentary consortium by WGBH Boston, which is solely responsible for its content.
56:22This program was co-produced with the Health Quarterly.
56:27Funding for the Health Quarterly is provided by a grant from the Robert Wood Johnson Foundation.
56:33Resources making a difference in the health care of Americans.
56:44This is PBS.
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