Concealed NIH Review Substantiates Fired Expert’s Concerns – AP

Concealed NIH Review Substantiates Fired Expert’s Concerns – AP

Mon, 4 Jul 2005

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

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 confirms low efficacy 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.”

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.