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Old 13th March 2006, 04:55 PM
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Default Help make world safe - FOR DRUGS

Date: Sun, 12 Mar 2006 23:34:18 -0800 (PST)
Subject: [SSRI-Research] Out of Control: AIDS & the Corruption of
Medical Science_Harper's

Out of Control: AIDS & the Corruption of Medical Science_Harper's

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org/cms/

FYI

For those who thought John LeCarre's 'fictional' Book / Movie, The
Constant
Gardner, was over the top in its depiction of a ruthless pharmaceutical
company and corrupt practices in AIDS drug research, read the
non-fictional
account, OUT OF CONTROL: AIDS and the corruption of medical science, By
Celia Farber in the current issue of Harper's magazine.

This riveting, informative article begins by describing the toxic
effect of
the AIDS drug, Nevriapine, and the rapid physical deterioration and
ultimate
death of, Joyce Ann Hafford, a 33-year old pregnant mother of a 13
year old
boy. As the facts of the case unfold, it seems that her life was
sacrificed
on the altar of AIDS research . Hafford was told she was HIV positive
on the
basis of a single screen which, unbeknown to her, is a test known to
have a
high rate of false-positives. [1] Though she was perfectly healthy and
showed no signs of any of the HIV markers, she agreed to participate in a
Phase III clinical trial (PACTG 1022) of nevirapine because she was
told it
would protect the baby she was carrying.

"The objective of the trial, PACTG 1022, was to compare the "treatment
limiting toxicities" of two anti-HIV drug regimens." However, women
in AIDS
drug experiments such as this are not informed that "Of the four drugs in
this study, three belong to the FDA's category "C," which means that
safety
to either mother or fetus has not been adequately established."

Hafford was enrolled in the trial and in early June, 2003, and "on June 18
took her first doses of the drugs." Her older sister, Rubbie King,
recalled:
"She felt very sick right away, within seventy-two hours, she had a
very bad
rash, welts all over her face, hands, and arms. That was the first
sign that
there was a problem. I told her to call her doctor and she did, but they
just told her to put hydrocortisone cream on it. I later learned that
a rash
is a very bad sign, but they didn't seem alarmed at all."

Hafford was on the drug regimen for thirty-eight days. "Her health started
to deteriorate from the moment she went on the drugs," says King. "She was
always in pain, constantly throwing up, and finally she got to the point
where all she could do was lie down."
"On July 16, at her scheduled exam, Hafford's doctor took note of the
rash,
which was "pruritic and macular- papular," and also noted that she was
suffering hyperpigmentation, as well as ongoing nausea, pain, and
vomiting.
By this time all she could keep down were cans of Ensure. Her blood was
drawn for lab tests, but she was not taken off the study drugs,
according to
legal documents and internal NIH memos. Eight days later, Hafford went to
the Regional Medical Center "fully symptomatic," with what legal documents
characterize as including: "yellow eyes, thirst, darkening of her arms,
tiredness, and nausea without vomiting."

She also had a rapid heartbeat and difficulty breathing. Labs were drawn,
and she was sent home, still on the drugs. The next day Hafford was
summoned
back to the hospital after her lab reports from nine days earlier were
finally reviewed. She was admitted to the hospital's ICU with "acute and
sub-acute necrosis of the liver, secondary to drug toxicity, acute renal
failure, anemia, septicemia, premature separation of the placenta," and
threatened "premature labor." She was finally taken off the drugs but was
already losing consciousness." The family could not afford the $3,000
for an
autopsy, so none was performed.

"There was a liver biopsy, however,which revealed, according to internal
communiqu�s of [NIH Division of AIDS] DAIDS staff, that Hafford had
died of
liver failure brought on by nevirapine toxicity.

What the family was told about the cause of Hafford's death:
"They told us how safe the drug was, they never attributed her death
to the
drug itself, at all. They said that her disease, AIDS, must have
progressed
rapidly."
But her sister realized something was very wrong: "'On the one hand
they're
telling us this drug is so safe, on the other hand they're telling us
they're going to monitor the other patients more closely. If her
disease was
progressing, they could have changed the medication.' I knew something was
wrong with their story, but I just could not put my finger on what it
was."

In fact, Farber reports, "Joyce Ann Hafford never had AIDS, or
anything even
on the diagnostic scale of AIDS." Of note: Nevirapine was one of the
experimental drugs tested in children and babies in foster care in
violation
of federal regulatory protections. [2] And many of the foster babies
in the
AIDS drug / vaccine trials did not have AIDS either.

"The conclusion of the PACTG 1022 study team was published in the journal
JAIDS in July of 2004. "The study was suspended because of greater than
expected toxicity and changes in nevirapine prescribing information." The
authors reported that within the nevirapine group, "one subject developed
fulminant hepatic liver failure and died, and another developed S t e
v e n
s -Johnson syndrome" (i.e. skin necrolysis-a severe toxic reaction that is
similar to internal third-degree burns, in which the skin detaches
from the
body).

Patients recruited for clinical trials in experiments that involve
high risk
and high financial stakes---particularly those from disadvantaged
populations-all too often encounter an arrogance bordering on
unconscionable
disregard for the rights and dignity of the subjects whose lives are
devalued by an elitist corps of powerful intersecting self-interest groups
who are not held accountable by anyone. Disadvantaged, members of a
minority
cannot possibly challenge powerful doctors who are shielded by powerful
institutions. They and subsequently their families have no leverage.

John Solomon, of the Associated Press, who first reported about the
controversy surrounding Nevirapine, and Joyce Ann Safford's death, noted
that Nevirapine had been hailed by the vested AIDS community as a "life
saving" drug and a "very important tool" to combat HIV in the Third World.
In fact, President Bush allocated $500 million for the drug to be given to
African nations as a "cheap solution" for protecting African babies from
AIDS. AP reported the President had not been informed by NIH
officials that
the drug had in fact been found to cause "thousands of severe reactions
including deaths." [3]
Farber sheds light on the apparent disconnect between what the
evidence from
clinical trials (PACTG 1022) and the highly publicized Nevirapine trials
conducted in Uganda (HIVNET 012) show, and the false claims made for
public
consumption.

When the drug's manufacturer, Boehringer Ingelheim inspected the Uganda
trial (HIVNET 012): "They were the first to discover what a shambles the
study was." According to Boehringer's pre-FDA inspection report, "serious
non-compliance with FDA regulations was found" in the specific
requirements
of reporting serious adverse events. Problems also were found in the
management of the trial drug and in informed-consent procedures."

Farber writes that the DAIDS then hired a private contractor, a company
named Westat, to go to Uganda and do another pre-FDA inspection. This time
the findings were even more alarming: the major problems that clearly
disqualified the trial included:
. "loss of critical records" including "one of two master logs" that
included follow-up data on adverse events, including deaths."
. "The records failed to make clear which mothers had gotten which
drug, when they'd gotten it, or even whether they were still alive at
various follow up points after the study."
. "Drugs were given to the wrong babies, documents were altered, and
there was infrequent follow-up."
. "The infants that did receive follow-up care were in many cases
small and underweight for their age. It was thought to be likely that
some,
perhaps many, of these infants had serious health problems."
. "The Westat auditors looked at a sample of forty-three such infants,
and all forty-three had "adverse events" at twelve months. Of these, only
eleven were said to be HIV positive."

Clearly, the Uganda trial failed to meet minimal safety and scientific
standards.
Yet, Farber reports, though the two inspections had now declared HIVNET to
be "a complete mess," and DAIDS officials were well aware of the
facts, "the
ways in which the various players were tethered together made it
impossible
for DAIDS to condemn the study without condemning itself." Thus, according
to DAIDS' public version of events, which was dutifully echoed in the AIDS
press, "the trouble with HIVNET was that it was unfairly assailed by
pedantic saboteurs who could not grasp the necessary difference
between U.S.
safety standards and the more lenient standards that a country like Uganda
deserved."

Framed another way, DAIDS trivializes Ugandans' human right to protections
ensured by minimal standards of safety and scientific validity in medical
experiments that they are asked to participate in. Within two weeks
of the
devastating report by Westat, DAIDS officials knowingly deceived the
public
by issuing the following patently false statement:
"There is no question about the validity [of the HIVNET results] . . . the
problems are in the rather arcane requirements in record keeping."

Farber then comments on the politics and undisclosed pervasive
conflicts of
interest that undermine the credulity of most claims made by vocal AIDS
activists about treatment success, noting the uncritical media that
broadcasts propaganda:
"So-called community AIDS activists were sprung like cuckoo birds from
grandfather clocks at the appointed hour to affirm the unwavering AIDS
cathechism: AI D S drugs save lives. To suggest otherwise is to endanger
millions of African babies. Front and center were organizations like the
Elizabeth Glaser Pediatric AIDS Foundation, which extolled the
importance of
nevirapine. Elizabeth Glaser's nevirapine defenders apparently didn't
encounter a single media professional who knew, or cared, that the
organization had received $1 million from nevirapine's maker, Boehringer
Ingelheim, in 2000."

"This was no scandal but simply part of a landscape. Pharmaceutical
companies fund AIDS organizations, which in turn are quoted
uncritically in
the media about how many lives their drugs save. This time the AIDS
organizations were joined by none other than the White House, which was in
the midst of promoting a major program to make nevirapine available across
Africa."

[note] "Africa, as the news media never tires of telling us, has become
ground zero of the AIDS epidemic. The clinical definition of AIDS in
Africa, however, is stunningly broad and generic, and was seemingly
designed
to be little other than a signal for funding. It is in no way
comparable to
Western definitions. The "Bangui definition" of AIDS was established
in the
city of Bangui in the Central African Republic, at a conference in
1985. The
definition requires neither a positive HIV test nor a low T-cell count, as
in the West, but only the presence of chronic diarrhea, fever, significant
weight loss, and asthenia, as well as other minor symptoms. These
happen to
be the symptoms of chronic malnutrition, malaria, parasitic
infections, and
other common African illnesses. "

AIDS advocates may be largely responsible legislation (1997 FDA
Modernization Act , FDAMA) that speeded up the drug approval process by
short circuiting safety tests. The unintended consequences are that
the bar
for drug safety has been lowered. Furthermore, their lobbying efforts have
undermined the sin quo non of medicine-which requires proof of safety and
effectiveness for treatments. This has set us back to the time when snake
oil purveyors roamed the countryside selling their, at best, worthless
potions, at worst, lethal ones.

The buzzword in AIDS (as well in psychiatry) is neither effectiveness nor
safety-it is "access," which has the advantage of short-circuiting the
question of whether the treatments actually work.

Prior to FDAMA, the burden of proof that a drug was safe and effective
rested on manufacturers. Since then, under pressure from manufacturers who
were emboldened by the AIDS activists' demand for speedy approval, the FDA
(in essence) presumes safety and efficacy unless someone proves otherwise.
Hence, we are again confronted with unsafe, lethal drugs such as Vioxx
being
approved without evidence of their safety.

While reading Farber's riveting account of the documented scientific facts
that emerged in clinical trials of the AIDS drug, Nevirapine-evidence that
belies the claims made by stakeholders in the AIDS drug enterprise--one is
struck by the similarity of the disconnect in psychiatry between the
scientific data and claims made. One is also struck by the similarity
between the politics of AIDS and psychiatry. In both there is a disconnect
between the scientific data and the ideology upon which practice
guidelines
rest. In both of these contentious fields the prevailing opinions rest on
theories, but no firm scientific knowledge. And most troubling of all, in
both fields there is an aversion for debate and intolerance of critics who
dare to challenge the prevailing ideology in AIDS and psychiatry--critics
are shunned as pariahs.

This sorry state of affairs--so antithetical to the essence of
academia and
the Socratic tradition--leads one to suspect that those in the seats of
power--in AIDS and psychiatry --are unable to refute any opposing
arguments.
Thus, they adopt a position akin to academic Stalinism or, if one prefers,
religious dogma that tolerates no dissent.
By abusing their power to stifle ideas that contradict their own for fear
their authority and the status quo would be toppled, they impose
intellectual stagnation that hinders discovery of new improved
paradigms of
care.

References:

1. Is a Positive Western Blot Proof of HIV Infection? Eleni
Papadopulos-Eleopulos, Valendar F. Turner and John M. Papadimitriou
BIO/TECHNOLOGY VOL.11 JUNE 1993
http://www.virusmyth.net/aids/data/epwbtest.htm ; see also,
http://www.virusmyth.net/aids/index/hivtests.htm

2. See, letters of determination by the Office of Human Research
Protections,
May, 2005: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf
February, 2006: http://www.ahrp.org/cms/content/view/82/31/

3. See: Woman Died During Aids Study
http://www.ahrp.org/infomail/04/12/16.php
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Old 15th March 2006, 04:06 PM
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Default Another American cockup

Six men in intensive care after drug trial goes wrong

Volunteers were testing treatment for arthritis
US company says adverse reaction is 'extremely rare'


Six men were in intensive care in a north London hospital last night after a pharmaceutical company's trial went wrong. Regulatory authorities have suspended the drug trial and are investigating in collaboration with the police.
The six were healthy volunteers, paid to take part in the earliest stage of human testing of a potential new medicine for inflammatory diseases such as rheumatoid arthritis and leukaemia. The volunteers were needed to establish whether there were any side effects or obvious problems with the drug before it was tested on people who have the conditions.
But on Monday, the first day of the trial, the Medicines and Healthcare Products Regulatory Authority (MHRA) said yesterday all six men became ill at the commercially run clinical trials unit at Northwick Park hospital, Harrow. One of the men reportedly had extreme breathing difficulties within three hours of taking the drug and his family was told his legs had turned purple, according to the Sun newspaper.
Two other men at the unit were enrolled in the trial but had been given a placebo and are unaffected.
Because the unit was in the hospital building, the sick men were rapidly given medical help and transferred to intensive care that evening. A spokeswoman for the MHRA said it was "very concerning" but "almost unheard of". The drug company, the German firm Te Genero, had submitted the results from animal safety tests, as it must do under the regulations, to get permission to run a trial on human beings. There had been no irregularities in the animal tests, the MHRA said. Investigators at the site will be looking at whether human error played a part in the incident, whether the product was contaminated or something went wrong with its storage.
The hospital said last night the men were seriously ill. "Although they were not part of an NHS trial, we were able to admit the patients very quickly to critical care and our full team has been treating them," said Ganesh Suntharalingam, clinical director of intensive care. "They are in a serious condition and receiving close monitoring and appropriate treatment. Their families are very concerned and we are keeping them closely informed."
The hospital emphasised that the clinical trials unit was a separate entity and that none of its doctors had anything to do with it. "It is run by an independent company and they are responsible for the trials," a hospital spokesman said.
The unit is run by the US company Parexel which contracts with drug companies to recruit patients and run trials all over the world. In a statement last night it said the volunteers had "an unexpected drug reaction" and that its staff had given them the right dosage.
"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Herman Scholtz, head of Parexel International Clinical Pharmacology. "We have a high-quality medical team in our Northwick Park unit. Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
The firm had operated entirely within clinical and research guidelines, he said. Parexel has run a 36-bed unit at Northwick Park since 1991. It advertises predominantly for healthy young men. Volunteers are told they must not have used any other medication or recreational drugs.
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