National Institue AIDS Research–Professional Women Describe Sex Harassment – Conduct Unbecoming

National Institue AIDS Research–Professional Women Describe Sex Harassment – Conduct Unbecoming

Mon, 11 Apr 2005

Just when the NIH announced that it was in the clear – citing a report issued (April 6) by a panel of the Institute of Medicine "exonerating" NIH and rejecting the allegations by Dr. Jonathan Fishbein, who blew the whistle on the conduct of study HIVNET 012, a nevirapine AIDS drug experiment conducted in Uganda-See: http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=8118510

The Associated Press describes yet another dimension of the debasement of American academic medicine–institutional tolerance of conduct unbecoming:

“Women at the National Institutes of Health faced sexual intimidation and repeated disregard of their concerns for the welfare of patients in AIDS experiments, according to testimony by two senior female officers and documents gathered by investigators.”

“Documents obtained by the AP show that nearly a year ago, NIH managers were warned by the agency’s civil rights protection office in a letter that the deputy director of the AIDS division, Dr. Jonathan Kagan, had sent numerous e-mails containing “profanity and sexual innuendo” and “unprofessional and inappropriate statements.”

NIH administrators did nothing.

An investigation was undertaken by the Senate Finance Committee, “who interviewed some NIH employees, have obtained documents showing that safety concerns about AIDS studies were frequently overruled or delayed by supervisors.”

As the sordid evidence continues to unfold, it is ever clearer that the moral and professional standards at NIH have hit bottom. That raises serious doubts about the integrity of many of its claimed research findings which appear to b motivated by political expediency — rather than scientific evidence.

Professionals at the National Institute of Allegies and Infectious Disease (NIAIDS) are shown to have committed financial impropriety, scientific and ethical impropriety, as well as sexual impropriety.

Female medical officers have testified under oath about sexual harassment, intimidation, and a locker room culture of lewd intimidation: “One longtime medical officer at the government’s premier medical research agency alleges that the harassment and disregard for federal safety regulations are so widespread that employees are now afraid to hold up experiments even if they see a safety problem.”

“The two new witnesses testified in recent weeks to actions they alleged made the workplace intimidating. Examples included:

  • female workers receiving unwanted hugs, kisses or catcalls in the hallways.
  • a safety order on a major experiment delayed for nearly two years.;
  • safety conclusions changed or disregarded by supervisors.”

“I think the culture was certainly strong for a period of time that the ends could justify the means.’

According to the AP investigation, the women’s testimonies and e-mails “involving more staffers and several bosses, paint a picture of a sometimes raunchy, profane-language atmosphere inside an agency regarded for its pristine science.”

Dr. Fishbein–who was fired for blowing the whistle about ethical and scientific misconduct–was described by medical safety officers as “a strong advocate for improving safety for research participants and the effort to fire him is “a warning to other individuals.”

What will the public response to the abuse of public trust, misuse of public funds, and conduct unbecoming in any workplace environment?

The IOM-NIH whitewash of the HIVNET 012 nevirapine experiment is unlikely to stand the scrutiny of a credible investigation. Thus, NIH’s press release may be another sign of the agency being out of touch with reality:

“The IOM’s review is a true public service that allows us to settle any lingering concerns about the safety and efficacy of nevirapine,” adding, “Now we can once and for all put this issue to rest and focus our time and energy on the real issue of saving the lives of women and children in the developing world” April 7 http://www.nih.gov/news/pr/apr2005/od-07.htm

Dr. Fishbein didn’t have a ghost of a chance inasmuch as the IOM panel was stacked with stakeholders in the AIDS drug academic-industrial complex: Mark Kline, a pediatric AIDS specialist at Baylor College of Medicine and an IOM panel member stated: “Nevirapine really is the cornerstone of efforts to reduce mother-to-child transmission of HIV in poor countries around the world, particularly in Africa, so the concerns that have been raised about the study really have had a chilling effect on the use of this drug,” adding, “So we’re happy to report that the drug is efficacious and is safe because we would obviously like to do anything we possibly can do to help to provide tools for the prevention of mother-to-child transmission of HIV in poor settings around the world.” See: McAlary, VOA News, 4/7 http://www.voanews.com/english/2005-04-07-voa74.cfm With this latest IOM demonstration of its failure to be fair and objective underscores the inherent complicity of collegial “birds of a feather” who rally around their club mates against a whistleblower. See: Dr. Bernard Carroll, NATURE MEDICINE 2005; 11(4): 369 (April) (check www.ahrp.org)

The unraveling of NIH’s reputation and its failure to uphold even ordinary standards of conduct, is a demonstration of the corrupting effect of commercialism in the absence of independent checks and balances. A research institution that tolerates ethical corner cutting undermines the integrity of the research and the safety of research subjects. By waiving conflict of interest standards for NIH scientists, Dr. Harold Varmus, (then) director of NIH, sent a signal that NIH scientists need not be held to ethical standards. By waiving one standard he opened the door to professional misconduct at every level of NIH.

The AP report (below) was published on the website of The New York Times-but never made it into the print edition!! The Times has remained resolutely silent on the matter of professional misconduct by NIH scientists. Is this a way of attempting to trivializie the magnitude of the research misconduct and unacceptable personal conduct by the nation’s scientific leadership?

Contact: Vera Hassner Sharav
212-595-8974

THE NEW YORK TIMES
April 10, 2005
NIH Women Describe Sex Harassment
By John Solomon
THE ASSOCIATED PRESS
Filed at 1:17 p.m. ET

http://www.nytimes.com/aponline/national/AP-AIDS-Research-Safety.html

WASHINGTON (AP) — Women at the National Institutes of Health faced sexual intimidation and repeated disregard of their concerns for the welfare of patients in AIDS experiments, according to testimony by two senior female officers and documents gathered by investigators.

One longtime medical officer at the government’s premier medical research agency alleges that the harassment and disregard for federal safety regulations are so widespread that employees are now afraid to hold up experiments even if they see a safety problem.

Her sworn testimony and other documents were obtained by The Associated Press from a variety of sources inside and outside NIH.

“It can be fairly uncomfortable,” NIH medical officer Betsy Smith testified in a recent civil case deposition that has been turned over to federal and Senate investigators. “There are a number of things that you really don’t talk about.”

In such a work environment, “You don’t hold up any projects even if you feel there are safety issues for certain projects,” she said.

Testimony by Smith and the chief compliance officer for AIDS research, as well as e-mails involving more staffers and several bosses, paint a picture of a sometimes raunchy, profane-language atmosphere inside an agency regarded for its pristine science.

Documents tell of a supervisor sending a red bra to a former female subordinate and of women being hugged or kissed by bosses. In one instance, a supervisor invited a colleague to a West Coast rock concert and suggested they also visit an AIDS clinic there so the trip could be charged to taxpayers.

Smith and the top regulatory compliance officer in the NIH’s AIDS division, Mary Anne Luzar, stepped forward in interviews with investigators and in sworn depositions in recent weeks and expanded upon allegations made last year by an agency whistleblower, Dr. Jonathan Fishbein. Their videotaped testimony was given in Fishbein’s lawsuit against the agency.

Fishbein alleges he is in the process of being fired as the AIDS division’s chief of human research protection because he raised concerns about patient safety and shoddy science. The NIH says he was fired was poor performance.

The Senate and the inspector general at the Health and Human Services Department are investigating the allegations. In addition, officials told the AP, the NIH is conducting an internal investigation on sexual harassment.

NIH managers acknowledged in interviews that there are problems in their AIDS research program, which pays hundreds of millions of dollars for experiments across the globe. They said they could not address specific allegations because of the investigations, but were taking steps to end any sexual harassment and improve communication among employees when safety issues arise.

“We must be sure our staff works productively and in a timely fashion with our investigators to resolve any issues related to the conduct of our studies, with the highest priority paid to patient safety,” said Dr. H. Clifford Lane. He is deputy director of the National Institute of Allergy and Infectious Diseases, which oversees the AIDS research division.

Lane said “sexual harassment is not tolerated at NIH and we are committed to insuring that all employees are treated with dignity and respect.”

The two new witnesses testified in recent weeks to actions they alleged made the workplace intimidating. Examples included:

  • female workers receiving unwanted hugs, kisses or catcalls in the hallways.
  • a safety order on a major experiment delayed for nearly two years.;
  • safety conclusions changed or disregarded by supervisors.

Luzar, the AIDS division’s compliance officer, alleged that her bosses frequently sided with the front-line researchers they are financing, rather than with the agency’s safety and regulatory experts.

“I think we (safety officials) got in the way, and that we were an impediment to the science,” Luzar testified. She described the division managers as “totally unsupportive” of safety concerns and bending to “tremendous pressure” from drug companies and researchers in the name of trying to cure AIDS.

“I think the culture was certainly strong for a period of time that the ends could justify the means,” she testified.

Smith said Fishbein was a strong advocate for improving safety for research participants and the effort to fire him is “a warning to other individuals.”

She said after Fishbein was forced out, NIH held a meeting at which Fishbein and his allegations were attacked and a picture of one of Fishbein’s relatives was shown on a screen. Smith said the event was so intimidating that fellow safety and medical officers “called it scientific terrorism.”

Documents obtained by the AP show that nearly a year ago, NIH managers were warned by the agency’s civil rights protection office in a letter that the deputy director of the AIDS division, Dr. Jonathan Kagan, had sent numerous e-mails containing “profanity and sexual innuendo” and “unprofessional and inappropriate statements.”

The letter included e-mails showing Kagan sent to a male worker a picture of a bare-breasted woman with the caption “priceless” and sent a note jokingly instructing an employee to leave his pager behind and bring “bongs,” or drug paraphernalia, to an event. Kagan also used profane language in a variety of communications, the e-mails show.

NIH officials acknowledged they took no action after getting the letter last May. The investigation remains open, they said.

Luzar, who had disagreements with Kagan over her performance, testified that Kagan once hugged her inappropriately upon hearing her father had died, and routinely kept a mug on his desk with a phrase that included a four-letter expletive.

“I found it very intimidating to walk into Dr. Kagan’s office for a one-on-one and see this, the first, first thing you see on the left side as you walk in the door is the cup,” Luzar testified.

Alyza Lewin, Kagan’s lawyer, said her client occasionally hugged or kissed female subordinates, and used “earthy language” in some e-mails to workers. Lewin also said Kagan once had retrieved a red bra that had been a gag gift among women in the office and sent it to a woman who had been a subordinate and who had transferred from his office after a falling out with him.

Lewin said the NIH’s ombudsman talked with Kagan about the red bra incident but her client was never disciplined for any sexual harassment and never intended to offend women. She said the mug was bought from a popular Web news site and that he removed it from his desk once learning it bothered people.

“Dr. Kagan never sexually harassed any NIH employee,” she said. “It is noteworthy these allegations were not raised at the time the incidents allegedly occurred, but only now in connection with Dr. Fishbein’s employment action.”

Smith, the medical officer, testified that supervisors elsewhere inside the NIH behaved similarly. She recounted how one colleague had difficulty breaking off a sexual relationship with a branch chief and said that when others at the agency went on trips, they learned “the hotel only has one room so that the female scientist has to stay with her superior.

“I’m specifically describing individuals that don’t appear to be able to interact with females without having some amount of sexuality implied,” Smith testified. “Some sexual games. Sexual taunting. Sexual innuendo going on.”

Investigators from the Senate Finance Committee who interviewed some NIH employees have obtained documents showing that safety concerns about AIDS studies were frequently overruled or delayed by supervisors.

For instance:

  • Luzar testified that NIH failed for two years to comply with federal regulations and her demand — first made in April 2003 — to update the safety protocol and instruct researchers in the field to consider new warnings to patients in a $36 million AIDS drug trial after new side effects emerged, including suicidal tendencies.

    The NIH acknowledged the delay, but said patients were never in jeopardy because doctors were told about side effects as they became known.

    “It is clear we can do a better job in our communications within the division and our communications with our investigators,” said Lane, the NIH’s No. 2 infectious disease official. “We want to see all our processes take place in the quickest possible way, and two years is long time for any process.”

  • Smith detailed how a NIH supervisor delayed reporting for days the death of a patient in an experiment. The supervisor was “behaving as if she were a pharmaceutical company and did not clearly understand regulatory requirements for such a study,” Smith testified.

On the Net:
Documents gathered by The Associated Press are available at:
http://wid.ap.org/documents/nih/research.html
National Institutes of Health: http://www.nih.gov

Copyright 2005 The Associated Press

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