BOOK REVIEW
Former Business Week writer Bruce Nussbaum has written a damning
critique of the "AIDS" research establishment in Good Intentions:
How Big Business and the Medical Establishment Are Corrupting the Fight
Against AIDS, Government scientists - like Sam Broder, Tony Fauci,
and Ellen Cooper - and university scientists like Margaret Fischl are depicted
as corrupt, power-hungry incompetents anxious to please greedy pharmaceutical
companies to collect their portion of the glory and the dough. And that's
just for starters.
"I didn't begin the book angry, but I did finish it that way,"
Nussbaum writes in the second sentence of the introduction. Plunging into
the world of "big-time" medical research, "the corruption,"
he found, "was startling."
Indeed, Good Intentions reads like a thriller; once started,
it is difficult to put down. The personalities leap off the page. Nussbaum
captures Broder whining about not getting the credit due him for "discovering"
AZT; Fauci's determination to grab media attention and his complete befuddlement
about how to conduct a clinical trial; Robert Gallo's arrogance; Burroughs
Wellcome's David Barry's shark-like progress through the Food and Drug
Administration approval process and the stooges in that agency who assisted
him; and much, much more.
"It is a polite fiction that scientists at the NIH and the drug
companies work for the public health," Nussbaum asserts. "They
really work for credit and cash."
Nussbaum chronicles how AZT was singled out a group of "maybe twenty"
anti-"AIDS" drugs for the development in the early 1980s. The
person most responsible for "ramming through a second-rate, mediocre
drug called AZT" was Sam Broder at the National Cancer Institute (NCI).
Broder's first real job was at NCI, where he joined the Commissioned
Corps of the Public Health Service in 1971. And, "with $20 billion
pouring in to cure cancer by the end of the decade," Nussbaum points
out, "... Broder never left."
As a young scientist, Broder cultivated a reputation as someone who
could work with even the most difficult of personalities, like Gallo. Nussbaum
describes Broder's early years at NCI as "an exercise in the care
and feeding of powerful, difficult men."
But it wasn't until "AIDS" that Broder came into his own.
The only question about "AIDS" for Broder was according to Nussbaum,
"Would it propel Broder to a higher station in life?"
The answer, apparently, was yes, and Nussbaum has done a painstaking
job of tracking the Byzantine path of AZT from manufacturer to patient:
from Burroughs Wellcome through Broder's drug-testing laboratory, via the
usurpation of clinical trials by Fauci, the drug's progress through the
FDA's approval process with a minimum of scrutiny, until it reached the
hapless, desperate "AIDS" patients it was foisted upon as an
effective treatment - which, according to Nussbaum AZT never was shown
to be.
The first mediocre, dangerous drug that Broder tried to push through
the system was the anti-viral Suramin, which appeared to block of the spread
of HIV in the test tube. In fact, Broder was so enthusiastic of Suramin
that his nickname around NCI during this period of time was "Mr. Suramin."
(It would later, of course, become "Mr. AZT.")
But while Broder enthusiastically pushed Suramin, a clinical trial of
the efficiacy of Suramin was showing that "the drug was not just a
little toxic, it was really toxic in AIDS patients."
So, when Suramin bit the dust, Broder began his search for another anti-viral.
But he learned a lot from the Suramin fiasco about gaining FDA approval
for a drug, according to Nussbaum: "Find a drug that had been tested
for a previous disease. Make sure it had a big corporate sugar daddy behind
it. Push the bureaucracy like hell to move it along. And talk it up. Talk
it up."
If Nussbaum portraits of Broder is unflattering, his depiction of Fauci
is horrifying.
Fauci couldn't bear the fact that NCI was conducting the "AIDS"
clinical trials in 1985 just because they had done the laboratory work;
clinical trials should be conducted by his agency, the National
Institute of Allergy and Infectious Diseases (NIAID). After all, "AIDS"
was an infectious disease not cancer, Fauci reasoned. After all, "It
was a matter of prestige," Nussbaum notes.
And so Fauci mounted a Machiavellian campaign to take control of "AIDS"
clinical trials, a campaign that Nussbaum captures in all its repellent
detail.
In 1985, when Congress appropriated $234 million for "AIDS"
research for the fiscal year 1986, Nussbaum writes, "To Dr. Anthony
Fauci the money spelled opportunity with a capital O."
Fauci assumed his position as director of NIAID in early 1984, supplanting
Dr. Richard Krause. And according to Nussbaum, "Tony Fauci was as
different from Richard Krause as shark is from goldfish."
The difference was typified by apparel. Jeans, running shoes, and "threadbare
dress shirts" under lab coats is the usual uniform at NIAID, according
to Nussbaum.
Fauci, however, "looked as if he had just stepped out of a limousine,"
Nussbaum writes. "... Fauci's tailored suits, cufflinked shirts, and
aviator glasses set him far apart from the rest of the scientists and administrators
at the NIH... Fauci stood out in sartorial splendour, even if he was a
bit short."
In keeping with his appearance, Fauci wasn't inclined to dirty his hands
with the details of laboratory work.
"In fact, Fauci hated details," Nussbaum points out. "...
He was, as one high ranking NIAID official puts it, 'a hit-the-front-page-every-day
kind of guy.'"
For Fauci, according to Nussbaum, "AIDS" was an opportunity
to increase the size and power of his institute. Not known for his brilliant
science, "This lacklustre scientist was about to find his true vocation
- empire building."
Nussbaum isn't being trivial in his criticism of Fauci: Fauci's actions
(and lack thereof) had wide-reaching impact on the health of the nation
in the late 1980s.
To transform NIAID from an institutional weakling into an NIH powerhouse,
Fauci had to fight for a bigger piece of the AIDS research pie. When Congress
began to appropriate big money in 1985, Fauci went about securing a large
portion of those funds for his own institute. He started the most important
bureaucratic battle in the history of the fight against AIDS. The outcome
of this single fight had enormous consequences for the live of thousands
of people. Had it turned out otherwise, many people who died might have
lived.
So Fauci began to do battle with Dr. Vincent DeVita, head of the NCI
- a battle which soon became grist for the rumor mill at NIH. "Lab
chiefs describing what was taking place in their little world were suddenly
making references to the old Godfather movies, which cracks about
'Don' DeVita and the new challenger, Fauci," Nussbaum recounts.
When the Mafia-esque manoeuvring was over, a deal was struck: NCI would
screen drugs and do the early clinical testing (Phase I safety trails).
NIAID, despite its lack of experience, personnel, and facilities, would
run the multi-center clinical trials to determine the efficacy of those
drugs.
"Fauci would build himself an entirely new trial system,"
Nussbaum writes. "Then he would learn how to run it."
Nussbaum describes how a small number of "PIs," Principal
Investigators in government lingo, control the direction of drug development
and testing. The PIs wanted to test AZT; why, Nussbaum inquired, did they
focus on this drug?
A researcher who would not allow his name to be used explained t this
way: "Clinical testing is all about money. Burroughs Wellcome, for
example, controls clinicians [investigators] by paying them money. If you
work for Wellcome, then you're not going to test other companies' drugs
because you're not being paid by other people."
What does this have to do with clinical trials conducted by the government?
As Nussbaum found out, "many of the Wellcome PIs came to dominate
NIAID's clinical trial system. They formed a web linking Wellcome, the
drug AZT, and the NIH. They came to sit on the institute's key drug selection
committee, and they voted on whether to give high or low priority to the
testing of each anti-AIDS drug, including those that might possibly compete
with AZT in the marketplace. The PIs were a power unto themselves. They
were, in fact, out of control."
Fauci's incompetence would lead to NIAID's clinical trials network earning
the nickname, "the HUD of the nineties."
"Money was spent, but trials went underenrolled, drug treatments
never seemed to emerge, and people with AIDS continued to get sick and
die," Nussbaum reports. "... In the end, Fauci barely survived
by handing over control of the government's only AIDS drug trial program
to a handful of PIs with close ties to Burroughs Wellcome and AZT."
It was one of these PIs who assigned by Fauci to do a small clinical
trial of AL721 - to "debunk" it, per Fauci's instructions - after
the AZT PIs voted AL721 such a low priority that it would not even be tested.
"No one saw any problems with conflict of interest," Nussbaum
points out.
The PIs were "accountable to no one except themselves" under
Fauci's non-management of the government's "AIDS" clinical trials.
"Where was Tony in all of this?" Nussbaum inquires. "Two
miles down the road, trying to be a 'hit-the-front-pages' kind of a guy...
And still nothing was coming out of the government to treat AIDS."
While AZT went through the FDA approval process, Ellen Cooper of the
FDA worked extremely closely with Burroughs Wellcome's David Barry. In
fact, according to Nussbaum, "Barry was able to negotiate a lower
amount of required data... Both Cooper and [FDA Commissioner Frank] Young
wanted AZT to succeed so much that they agreed to lower standards."
Cooper also masterminded the FDA hearing that resulted in approval of
AZT; it was a charade from the start to finish. As the meeting began, Cooper
criticized Burroughs Wellcome strongly for not being able to describe how
AZT worked and for having less than the normally acceptable amount of data;
she "made it clear that under normal circumstances, Wellcome would
never even have gotten a hearing of the FDA advisory committee."
"Unfortunately, none of the voting members of the committee knew
that Cooper was putting on a show for the record," Nussbaum asserts.
"They didn't know that Wellcome had worked everything out with the
FDA before stepping inside the room that morning."
Nussbaum describes how New York physician Dr. Joseph Sonnabend, an early
pioneer in "AIDS" treatment research, was edged out of the mainstream
because he didn't believe that HIV was the sole cause of "AIDS."
Sonnabend's early work was impetus for the formation of the AIDS Medical
Foundation (AMF), established by Dr. Mathilde Krim primarily to support
his work, according to Nussbaum.
But in 1985, Rock Hudson died of "AIDS," and that was when
really big money began to flow into non-profit organizations like
AMF, and Krim, like her government counterparts, was unable to resist the
lure of the power.
It was Sonnabend who pioneered community-based research, leading to
the formation of New York City's Community Research Initiative (CRI). "We
became convinced that it was perfectly feasible to do community research,"
Krim told Nussbaum. "Sonnabend led the way."
"Then Krim dumped Sonnabend for Liz Taylor," Nussbaum comments.
He reports that Krim dropped Sonnabend when AMF merged with a West Coast
foundation, resulting in the creation of the American Foundation for AIDS
Research, AmFAR.
"The new foundation would support AIDS research by giving grants
to scientists in established laboratories and by informing the public about
AIDS and its treatments, but it wouldn't do any clinical trials of its
own," Nussbaum recounts. "That was over. It would no longer support
Sonnabend's research."
Helping Sonnabend prove that community-based research was both possible
and effective was singer Michael Callen, who had been diagnosed with "AIDS"
in 1982. Callen was politically instrumental in the establishment of CRI
and Callen, like Sonnabend, was outspokenly critical of Fauci's lack of
progress.
In February 1989, Callen presented testimony to the FDA about a meeting
he and other "AIDS activists" had with Fauci in May 1987.
"We asked him - no, we begged him - to issue interim guidelines
urging physicians to prophylax those patients deemed at high risk for PCP,"
Callen told the assembled scientists, who had gathered to evaluate CRI's
data on the effectiveness of aerosolized pentamidine. Fauci had refused
to issue the guidelines; there wasn't enough data, he told Callen in May
1987.
So in February, Callen presented the FDA with data on prophylaxis using
aerosolized pentamidine that had been gathered in community-based clinical
trials in New York and San Francisco (which garnered FDA approval for the
drug). Fauci had yet to enrol a single person in a clinical trial of pentamidine,
Callen told the FDA.
"The community has rolled up its sleeves and done an end run around
federal incompetence and indifference," Callen told the FDA.
It was a comment that would come back to haunt Callen and Sonnabend
and the CRI; when the government decided to fund community-based research,
CRI, the prototype organization, received not a penny of government funding.
Fauci accomplished this by choosing Margaret Fischl, Chief PI for Burroughs
Wellcome's Phase II AZT trial, to be the chairperson of the committee that
decided whether to fund CRI. Sonnabend, in particular, had been scathingly
critical of the quality of Fischl's AZT research, a fact she was quite
aware of.
"In no way should she have been overseeing a peer review panel
that judged a proposal by CRI," Nussbaum points out. "It was
an institutional and personal conflict of interest."
"What goes around, comes around," Fauci is quoted as telling
PIs who voiced criticism of him. Callen and Sonnabend dared to criticize
Fauci; Fauci made sure they didn't get any federal funds.
The outrage uncovered by Nussbaum expose a morass of financial and ethical
impropriety. The role ACT UP played in influencing the speeding-up of drug
approval is recounted in great detail. Fauci and ACT UP began as bitter
enemies. But the wily Fauci figured out how to use ACT UP, how to seduce
them with power, if not money, as Nussbaum documents.
During the summer and autumn of 1989, "[Project Inform's] Martin
Delaney would spend many days talking with FDA Commissioner Frank Young
about how to relax the rules of drug regulation," Nussbaum writes.
"... Fauci himself would begin going to ACT UP meetings. He began
appointing [ACT UP members] Jim Eigo and Martin Delaney to AIDS committees
in NIAID."
Why should he bother?
"Fauci had spent hundreds of millions of dollars building drug-testing
network that didn't work... In an attempt to salvage his reputation, if
not his career, Fauci was now ready to change tack and adopt the AIDS medical
treatment agenda of AZT UP and the CRI."
Nussbaum points out in a final chapter that Sonnabend has never received
any government money to support his research on a multifactorial theory
about the cause of "AIDS," even though the NCI, "at Gallo's
urging, requested millions of dollars to investigate viruses that might
act as cofactors in AIDS. Each dollar was a redemptive nod to Sonnabend
for his original work on the cause of AIDS," writes Nussbaum.
Indeed, as Good Intention went to press, Nussbaum wrote that,
"The entire foundation of the scientific explanation of AIDS is actually
under attack." Researchers are finding KS without HIV, HIV without
KS, and no one can explain it; the Army's Dr. Shyh-Ching Lo has found a
new agent that may be a co-factor, or "may play a more fundamental
role, as Lo suggests."
A decade into the "AIDS" epidemic, AZT (and limited AZT analogues)
is still the only drug to come from the government's multi-billion dollar
research effort.
"Scientists who have made their entire careers in AZT have sat
on committees voting on potential commercial competitors. Scientists who
have had financial dealings with Burroughs Wellcome or other pharmaceutical
companies have come to dominate the government's entire clinical trails
network," Nussbaum points out.
"Scientists do what they do totally without oversight because Congress
and the public have accepted their argument that only they are knowledgeable
to police themselves," Nussbaum concludes. "The United States
has never accepted this kind of argument from its military; it should not
accept it from its biomedical establishment."
Good Intentions should be required reading for every United States
taxpayer. The "polite fiction" that government scientists work
to improve public health should be exposed, and Nussbaum has accomplished
a great deal towards this end. Sections of Good Intentions quoted here
are from uncorrected proofs supplied to Christopher Street and some may
change in the final publication. Hopefully, the teeth will not be pulled
from the hardbound edition of Nussbaum's biting investigation. *