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  • 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

  • #2
    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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