Farmaceuticas experimentando sin etica en el tercer mundo



-------- Original Message --------
Subject: Concealed NIH Review Substantiates Fired Expert's Concerns_AP
Date: 4 Jul 2005 11:17:19 -0500
From: "VERACARE" <veracare@xxxxxxxx>


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

FYI

The Associated Press reports that a 2004 internal report by the National
Institutes of Health validates the allegations by Dr. Jonathan Fishbeing,
the NIH ethics-safety expert who was fired for reporting unethical and
scientifically flawed AIDS resesrch in Africa.

The report also confirms that the NIH AIDS division "is a troubled
organization" and its managers have engaged in unnecessary feuding, sexually
explicit language and other inappropriate conduct that hampers its global
fight against the disease."

The August 2004 report seems to substantiate Dr. Fishbein's claim that he
was fired in retaliation for his well supported criticism--which makes it
illegal under federal whistleblowing protection.

The experiments that Dr. Fishbein criticized are the center of criticism of
US offshore research practices:

The Institute of Science in Society (UK) reports that the medical auditing
firm hired by the NIH AIDS division that investigated the Ugandan AIDS
testing sites found:
that many adverse events and perhaps a significant number of serious
adverse events for both mother and infant may not have been collected or
reported in a timely manner.

The adverse events included 14 deaths and thousands of severe reactions
that went undisclosed. The NIH subsequently recorded all deaths and the
majority of adverse reactions, but blamed them on the poor health of the
patients, not on nevirapine."
An article by South African journalist and lawyer Anthony Brink, The trouble
with nevirapine, "revealed that all the pregnant women were on either AZT
or nevirapine. There were no placebo groups. Brink saw the results of the
unblinded trials, which concluded with an official recommendation for
nevirapine. Side effects such as severe rash, pneumonia, blood cell-death ,
insufficient oxygen to tissues and blood , and tissue infection were
recorded at 20 percent in both the AZT and nevirapine groups . Thirty-eight
babies died; 22 in the AZT group and 16 in the nevirapine group. A further
16 deaths came to light in documents recently disclosed by Boerhingher
Ingelheim, mostly in the Nevirapine group. But nevirapine gained approval
because the rate of viral infection measured with PCR (a non - diagnostic
test) was 13.1 percent in newborns.
In light of consistent evidence of harm, it is difficult to understand why
Nevirapine was approved.
ISIS further reports that the South African government responded to the
earlier Associated Press revelations [See:
http://www.ahrp.org/infomail/04/12/13a.php ]
by accusing top US officials of treating Africans like guinea pigs and
telling lies to promote the sale of AIDS drugs [7].

When will Congress rein in the lawless culture NIH and senior NIH officials
whose conduct is harming both the integrity of research and the reputation
of US government research?
In the absence of enforcement of the rule of law, in the absence of severe
penalties for violators, the nation's leading scientific research
institutions are thumbing their noses at all professional standards of
conduct.

Contact: Vera Hassner Sharav
212-595-8974
veracare@xxxxxxxx

THE WASHINGTON POST
NIH Review Substantiates Fired Expert's Concerns

By John Solomon

The government's AIDS research agency "is a troubled organization" and its
managers have engaged in unnecessary feuding, sexually explicit language and
other inappropriate conduct that hampers its global fight against the
disease, an internal review found.

The review, for the National Institutes of Health director's office,
substantiates many of the concerns that whistle-blower Jonathan Fishbein
raised about the agency's AIDS research division and its senior managers.

The division suffers from "turf battles and rivalries between physicians
and Ph.D scientists" and the situation has been "rife for too long," the
report concluded.

NIH formally fired Fishbein on Friday, over the objections of several
members of Congress. The top Republican and Democrat on the Senate Finance
Committee are protesting, saying the firing is an example of whistle-blower
punishment.

"Retaliation against an employee for reporting misconduct or voicing
concerns is unacceptable, illegal and violates the Whistleblower Protection
Act," Sens. Charles E. Grassley (R-Iowa) and Max Baucus (D-Mont.), wrote
NIH late last week.

"Moreover, it would have a chilling effect on other NIH employees who might
makes truthful but critical comments about the NIH," the senators said.

Citing personnel privacy, NIH officials declined to address the senators'
letter or Fishbein's termination, except to say that his last day was
Friday. In the past, NIH officials have said they were terminating Fishbein
for poor job performance.

Fishbein, an accomplished private-sector safety expert, was hired by NIH
in 2003 to improve the safety of its AIDS research. He says he was let go
because he raised concerns about several studies and filed a formal
complaint against one of the division's managers alleging sexual harassment
and a hostile workplace.

An internal report, written on Aug. 9, 2004, by a special adviser to NIH
Director Elias A. Zerhouni but never made public, said efforts to fire
Fishbein gave the "appearance of reprisal."

The report says no documentation was provided to Fishbein suggesting poor
performance until after he complained about the safety in one sensitive AIDS
study and filed a formal complaint alleging that the division's deputy
director, Jonathan Kagan, was acting unprofessionally with subordinates.
After Fishbein complained, he was forced to begin reporting to Kagan, who
then went ahead with efforts to fire Fishbein.

The report says Kagan and the division's director, Edmund Tramont,
acknowledged that Kagan "uses sexually explicit and colorful language,
saying that no one ever complained until" Fishbein did.

The report says NIH should require sensitivity training for its senior
managers and provide instruction about "inappropriate personnel procedures."

The report also criticizes Fishbein, citing some of his supervisors'
statements that he did not take enough time to adapt to the "culture" of the
AIDS division before making changes to improve the agency's research safety.

"It seems apparent that both sides behaved badly, that a new senior
employee did not orient himself about the division and that the most senior
people engaged in inappropriate behavior," the report says.

) 2004 The Washington Post Company

http://www.i-sis.org.uk/NSADTMB.php
Institute of Science in Society (UK)
NIH-Sponsored AIDS Drugs Tests on Mothers and Babies
Deaths and adverse events in Uganda
The United States National Institutes of Health (NIH) began studies on
mother-to-child transmission of HIV in Uganda in 1997. A single dose of
nevirapine was given to labouring mothers and to their newborn child. Those
studies were reported to have lowered transmission of HIV by 50% [1].
But by 2002 , problems with the US-funded drug trials had been disclosed by
an NIH auditor, medical experts and Boehringer Ingelheim, the makers of
nevirapine [2].
The NIH hired Westat-Corp, a professional medical auditing firm to audit the
Ugandan testing sites. Westat- Corp's report stated [3], It appears likely
in fact, that many adverse events and perhaps a significant number of
serious adverse events for both mother and infant may not have been
collected or reported in a timely manner. The adverse events included 14
deaths and thousands of severe reactions that went undisclosed. The NIH
subsequently recorded all deaths and the majority of adverse reactions, but
blamed them on the poor health of the patients, not on nevirapine.
In December 2004 , the Associated Press claimed that the adverse events in
Uganda were censored and unknown to President Bush in 2002 when he announced
his $500 million plan to push nevirapine across Africa to a million women a
year. But before the plan went into effect, The NIH shut down the Ugandan
research until the summer of 2003 to review the science and to make the
necessary amends. They asked the National Academy of Sciences to investigate
the case and spent millions of dollars on improving record keeping and
safety monitoring. A top NIH disease official reviewing the case concluded
that the use of nevirapine even in single doses could confer instant drug
resistance to HIV - positive patients, which would prevent the use of any
other available antiretroviral drugs for future treatment. Therefore it was
unsuitable as a first drug of choice.
South African journalist and lawyer Anthony Brink published an article, The
trouble with nevirapine [4 ], which revealed that all the pregnant women
were on either AZT or nevirapine. There were no placebo groups. Brink saw
the results of the unblinded trials, which c oncluded with an official
recommendation for nevirapine. Side effects such as severe rash, pneumonia,
blood cell-death , insufficient oxygen to tissues and blood , and tissue
infection were recorded at 20 percent in both the AZT and nevirapine groups
.. Thirty-eight babies died; 22 in the AZT group and 16 in the nevirapine
group. A further 16 deaths came to light in documents recently disclosed by
Boerhingher Ingelheim, mostly in the Nevirapine group. But nevirapine gained
approval because the rate of viral infection measured with PCR (a non -
diagnostic test) was 13.1 percent in newborns.
Although all the women had tested positive for HIV, it is known that
pregnancy produces antibodies that can give a false positive test result. A
further anomaly noted by journalist Liam Scheff was that the newborn babies
were tested for HIV transmission at 6 weeks and 14 weeks using a PCR testing
kit called the amplicor HIV-1 monitor test, But PCR is not approved for
viral testing and the manufacturers specifically warn against using it for
the purpose of diagnosing HIV (Roche PCR HIV-1 Monitor Test). Furthermore,
eighteen months is considered the earliest age for testing mother to child
transmission of HIV [5].
In contrast, a study conducted on 561 expectant African mothers to assess
the rates of mother-to- child transmission of HIV using no drugs, pills or
placebos was 12 percent [6].
Boeringher Ingelheim had donated 411,000 doses of nevirapine to Africa, but
withdrew its application to the FDA for approval for use in single dose on
infants in America on the premise that better treatments have emerged.
Africans used as guinea pigs
The South African government responded to the Associated Press revelations
by carrying an article in the ANC online journal ANC Today on 17 December
2004, accusing top US officials of treating Africans like guinea pigs and
telling lies to promote the sale of AIDS drugs [7]. Jesse Jackson, the black
civil rights activist and official US envoy to Africa, called for an US
congressional investigation and demanded that nevirapine no longer be
distributed in Africa. He said, This was not a thoughtful and reasonable
decision, but a crime against humanity. Research standards and drug quality
that are unacceptable in the US and other Western countries must never be
pushed onto Africa [8]. (But see Guinea-pig kids, this series)
Some doctors in Africa support the use of the drug , however; saying that
without it many more babies would be born with HIV.
Kenyan study confirm s low effic a cy of nevirapine
A study on nevirapine in a hospital setting in Kenya examined the results of
172 breastfeeding women who presented their newborns for follow-up test
after receiving a single dose of the drug. Blood samples were taken from
babies at 6 weeks and 14 weeks after birth. Before the availability of
antiretrovirals, HIV mother to baby transmission rate at the Coast Province
General Hospital was 21.7 percent. After the use of nevirapine, the
transmission rate was similar at 18.1 percent. The overall prevalence of HIV
at the hospital is 14 percent, which has remained steady since 1995 [9].
The study concluded that the limited effect of nevirapine confirms the lack
of benefits for maternal health and justifies the concerns about drug
resistance. It also questions the enormous development of resources to
provide nevirapine and recommends that the true health gains of nevirapine
should be reconsidered.
Nevirapine tested on US mothers to be
But African mothers are not alone in being used as test subjects for
nevirapine. Nevirapine is known as viramune in the US. The NIH sponsored a
trial of viramune with expectant mothers in 2004 [10]. Joyce Halford was
persuaded to take part in the trial by her doctors because she had tested
HIV - positive during her pregnancy; otherwise she was a healthy 33 year-old
.. Some way into the trial, her doctors knew her liver was failing, but she
was kept on viramune and died two weeks later of drug - induced hepatitis.
Her child was cut from her in her dying moments. She and her family had not
been shown the explicit warning on the viramune label that specifically
states, Patients with signs or symptoms of hepatitis must discontinue
viramune and seek medical evaluation immediately.

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