NIH exposed for lax safety

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Updated: 11:20 PM EDT

NIH Target of Sexual Harassment Probe

Women Officers Tell of Intimidation and Lax Safety

 

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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 for 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

ensuring 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.

04/10/05 17:37 EDT