By Tom Bethell
Review 10 May 1993
the AIDS lobby know what it was doing when it pressed the government
to approve AZT?
was born in Petrosani, Rumania, in October 1990. She was adopted
by a Minneapolis couple, Cheryl and Steve Nagel, who brought her
back to the States later that year. Within a few weeks, they were
dismayed to find that she had tested positive for HIV. Although
she showed no symptoms of disease, the Nagels' doctor put her on
Retrovir syrup, otherwise known as AZT. In response to protests
by homosexual activists this drug had been hurriedly approved by
the FDA in 1987. "The government bends to AIDS victims' pleas,"
was the way U.S. News & World Report headlined a critical story
at the time.
Over the next
18 months Lindsey's general health declined. She became "hyperactive,"
as though "she did not feel comfortable in her body,"
according to her father. She did not eat properly, avoided milk,
and suffered from nausea and diarrhea. Then, in October 1992, things
took a turn for the worse. Night after night she woke up screaming.
Her parents would find her half sitting up in bed, clutching at
her knees and thighs. Sometimes this would happen twice a night.
A month or
so before this turn of events, the Nagels had read a couple of magazine
articles about Peter Duesberg, a virologist at UC Berkeley. Duesberg
says that HIV does not cause AIDS, and that AZT is toxic and not
a rational treatment for AIDS. The Nagels wanted to know more, so
they wrote and told him about the treatment their daughter was receiving.
her off AZT immediately if you want to see her live," Duesberg
wrote back. "Your daughter will die from it, like Kimberly
Bergalis, if you continue the treatment."
was believed to have been infected with HIV by her dentist in Florida.
She had a yeast infection, which is common among women, but it is
also one of the "indicator diseases" within the Centers
for Disease Control's ever-expanding definition of AIDS. (First
defined in 1982, AIDS was redefined more and more inclusively in
1984, 1985, 1987, and 1993.) With a yeast infection plus HIV, Miss
Bergalis became an AIDS patient by definition, and was duly prescribed
AZT. Within a year she was in a wheelchair (as was Rudolf Nureyev
toward the end of his life, and he, too, took AZT). Among its other
side-effects, AZT causes myopathy, or muscle atrophy. Miss Bergalis
died in 1991.
also took AZT. After his death, New York Daily News columnist Earl
Caldwell reported that Ashe had "wanted to" break away
from his treatment, but was worried about giving offense. "What
will I tell my doctors?" he said to a friend. Michael Callen,
the author of Surviving AIDS, claims that the only long-term AIDS
survivors are those who have not taken AZT. Larry Kramer, HIV-positive
gay playwright, and unremitting scourge of the government when it
doesn't seem to be doing enough, says that AZT is not for him.
AZT was designed
in 1964 as chemotherapy for cancer. But it was never approved, because
of its side-effects. With an AIDS cure much in demand, it was retrieved
from the storage room. After toxicity and efficacy trials seemed
to show that it did some good, at least in the short run, the FDA
gave the drug its seal of approval. "From a failed cancer medication
to the only fully approved AIDS treatment, AZT has made an astonishing
comeback," Discover reported in 1990.
prevents cells from dividing by fooling cellular DNA into accepting
a chain-terminator into the DNA chain. It's like putting a caboose
(with no rear coupling) into the middle of a freight train that
was supposed to incorporate many more cars. Now the train cannot
expand beyond the caboose because there's nothing to hook onto.
with chemotherapy is that it stops all cells from dividing, not
just cancer cells. Science hasn't been able to figure out a way
for it to zero in on the cancer exclusively. Cancer cells divide
rapidly, but so do stomach cells and bone-marrow cells and lots
of other cells. The formation of new DNA chains is stopped within
all of them. That's why long-term chemotherapy is very destructive.
The same problem
arises with AZT. The drug doesn't know how to find just the HIV-infected
cells (assuming, arguendo, that HIV really does cause AIDS). And
that's why Duesberg wrote in a recent article that AZT "must
be the most toxic drug ever approved for indefinite therapy in America."
Nonetheless, about 100,000 people are now taking it. One is Jeffrey
Schmalz, the New York Times reporter who has AIDS. Many people report
early beneficial effects from AZT. And Schmalz told me that the
drug had saved his life. "The problem is long range,"
he said, "because it begins to eat away at your system."
the efficacy and toxicity studies? Here I warn NR readers that I
shall make a "left wing" point, but I wouldn't bother
to do so if the news media had shown any interest in it. Surprisingly,
they have not. Many of the AZT studies have been funded by the company
that makes AZT, Burroughs Wellcome. This was true of the "double-blind,
placebo-controlled trials" in 1986 that led to FDA approval
of the drug. The results of these trials were published in The New
England Journal of Medicine in 1987.
I called Jerome
Kassirer, the editor-in-chief of The New England Journal of Medicine,
to ask him about "scientific etiquette" with respect to
publishing studies funded by the manufacturers of the thing studied.
He said that the NEJM's policy was very simple-disclosure. "We
disclose, typically on the cover page, what the relationship [of
the study] is to the company," he said. And indeed, with the
AZT toxicity study, it plainly says on the cover page: "Supported
by the Burroughs Wellcome Company....." Likewise the efficacy
study includes among its many co-authors "the AZT Collaborative
Working Group," which, if you read the fine print, also on
the cover page, includes five scientists from the Burroughs Wellcome
have a scientific study," Kassirer said, "we have to assume
that the data are the data."
Would The New
England Journal publish a smoking study funded by Philip Morris?
I asked. "In principle, we might publish it," he said.
"But it would have to pass the same kind of scientific standards
as any other study."
What are those
standards? When are the data not the data? Joan Shenton, who produced
a program critical of AZT shown in Britain last February, published
a letter in The Lancet claiming that "both the U.S. Food and
Drug Administration and trial investigators knew that the two trials
[mentioned above] had become unblinded." (FDA documents, obtained
through Freedom of Information procedure, had disclosed this information.)
The patients figured out who was receiving the drug and who was
receiving a placebo, and those receiving the drug shared it with
those who were not.
the trials, planned for 24 weeks, were ended "after an average
of only 17 weeks," according to Miss Shenton. It has since
come out that 30 (of 145) AZT recipients were kept alive by blood
transfusions to compensate for severe bone-marrow toxicity. Burroughs
Wellcome concedes "the drug has been studied for limited periods
of time and long-term safety and efficacy are not known." The
New Scientist reported in 1991 that "there are serious, unanswered
questions about its long-term effects."
In early April
came the results of a three-year European study of early use of
AZT with HIV-infected individuals-the Concorde trials. One group
was given AZT immediately; the other, not until they developed symptoms.
(It has not been reported how the subjects were chosen, but it is
a reasonable assumption that many were drug-users.) The study therefore
did not test the efficacy of AZT itself, because most subjects seem
to have ended up taking the drug. But early use was shown to have
no beneficial effects, and the fine print in The Lancet showed that
significantly more of the early users experienced anemia, low white-blood-cell
counts, nausea, and vomiting than the late-use group.
(in Britain and France) came under pressure to stop the study early-as
three out of four comparable U.S. studies have been. In Britain,
Lawrence K. Altman reported in the New York Times, "health
officials are less influenced by pressure from advocacy groups."
It's almost as though officials here don't want to know the truth.
Even more surprising is that gay activists should have so much faith
in government science. The very effectiveness of their protests
have shown just how easily government science can be politicized.
to young Lindsey? As soon as the Nagels received Duesberg' s letter,
they discontinued her AZT. Her condition immediately improved. "It
was dramatic, almost overnight," Cheryl Nagel told me. She
stopped crying out in the middle of the night. Her leg cramps ceased.
She became much calmer. Her food intake almost doubled. She happily
drank the milk that she used to reject. And since then she has gained
over five pounds. More recently her mother has spent a good deal
of time in the University of Minnesota's medical library, trying
to figure out why Lindsey was prescribed AZT in the first place.
The label published by Burroughs Wellcome does not "indicate"
the use of AZT with asymptomatic infants. At the end of March, the
Nagels filed a complaint with the Minnesota Board of Medical Practice,
but they do not expect that much will come of it. An FDA official
told them that once a drug has been approved by the FDA, "it
can be prescribed for dandruff." *
a National Review contributor, is Washington correspondent for The