The corrupted world of AIDS medicine and research.

[Guest guest]

Exclusive: The Good Man at the NIH

http://www.gnn.tv/articles/2058/Exclusive_The_Good_Man_at_the_NIH

Mon, 30 Jan 2006 08:41:11 -0800

 

By Liam Scheff

 

(This article has been forwarded to me by a doctor)

 

Dr. Jonathan Fishbein's fight for medical ethics in AIDS medicine

Editor's note: In December 2005, GNN's Liam Scheff spoke with NIH whistleblower

Dr. Jonathan Fishbein. In an exclusive interview, Fishbein discusses the

controversial African AIDS drug trials he exposed, his firing and reinstatement

and how medical ethics and the public trust are violated when profit and

politics rule the day. - A.L.

 

" Science has become so severely politicized that one has to be skeptical of

nearly every research result that is reported. " Says Dr. Jonathan Fishbein, once

and future NIH employee.

 

He should know. Fishbein just fought a two-year battle with the nation's medical

authority, his former employer, the National Institutes of Health (NIH), for

what he feels was no less a goal than restoring integrity to science.

 

Dr. Fishbein had a nearly 20 year work history in medicine, specializing in

pharmaceutical safety and oversight, when he was hired at the NIH in July, 2003,

as Director of the Office for Policy in Clinical Research Operations. His job

was " to create, implement, and enforce research policy in the Division of AIDS, "

to ensure studies were being conducted according to ethical research standards.

 

The agency had some recent failures in maintaining ethical research guidelines,

both in the United States and abroad. In 2004, I broke a story of NIH clinical

trial abuse in a New York orphanage. The Associated Press took the investigation

national, and in 2005, Fishbein helped bring it to Congress.

 

But when Fishbein first arrived at the NIH, his attention was on an African drug

trial completed in 1999, called HIVNET 012 - a study of the drug Nevirapine in

pregnant women in Uganda.

 

Fishbein learned that the study was deeply flawed, the drug dangerous, and the

results had been covered-up. But all of this was an open secret. " The flaws were

common knowledge inside the division when I arrived, " Fishbein said. So why

hadn't they been corrected?

 

Fishbein says that within the Division of AIDS he encountered " a management

system guided more by politics than sound science, " and " an atmosphere of

intimidation " that made it impossible to properly address and correct the

institutional flaws that led to damaged study.

 

HIVNET 012 focused on finding a use for the troubled AIDS drug Nevirapine. The

drug had been around since the early 1990s, and had a bad reputation for

toxicity. By 1998 it had earned the FDA's black-box label, announcing its known

toxic potential, including the ability to cause organ failure and bloody skin

loss - both of which had resulted in death in patients taking the drug.

 

So why study a drug for use in poor, rural Africa that is known to be dangerous

here? The answers are fairly straightforward: profit, the illusion of progress,

and misplaced faith in the purity of big pharma's humanitarian motives by those

who care about poverty and illness in the developing world.

 

In 1998 in Kampala, Uganda, the Nevirapine study to prevent transmission of

HIV from mother to child was underway. The study put 645 expectant mothers

on the drug. The problems started immediately. First, the study was carried on

without a control group - everyone received one drug or another - AZT or

Nevirapine.

 

A 20 percent rate of " serious adverse events " was reported in newborns in both

the Nevirapine and AZT groups, including blood and tissue infection, pneumonia

and severe rash. Eighty percent of mothers exhibited laboratory and clinical

abnormalities. Twenty-two babies had grade 3 anemia.

 

Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT.

 

Nevertheless, Nevirapine found approval, and is being sold and distributed

throughout the developing world for use in pregnant women who test reactive on

HIV antibody tests.

 

How did this study get through?

 

Despite the toxicities, the HIVNET researchers concluded that fewer children

registered as HIV positive in the Nevirapine group, at 13.1%, than in the AZT

group, at 25.1%. It was decided that this potential benefit outweighted the

toxic burden. But, according to Fishbein, the research was so flawed as to

make the results meaningless.

 

" The [uganda] research was poorly conducted - record keeping was atrocious

and good clinical practice was not followed or was severely violated, " he

explained. " There were irregularities throughout the study - in safety

oversight, informed consent, and other human research protection issues. "

 

But the major flaw in the study had to do with the reporting of " serious adverse

events " in the trial population.

 

Kampala, Uganda, where the study took place, is an area with a high level of

serious endemic illness, including TB, cholera, sepsis, malaria and the general

effects of poverty and lack of access to food, clean water and basic medical

supplies.

 

" In a properly conducted clinical trial, all adverse events, regardless of

assumed relationship, are recorded, " Fishbein said,

 

But in the Ugandan study, " an assumption was made that the adverse events were

due to local endemic conditions. The people recording data were poorly trained

to assess these local conditions. They looked at the patients and said,

'whatever's going on is probably malaria, so I'm not going to write it down.' "

 

" You can't make determinations about drug safety this way, " said Fishbein.

" But that's what happened. "

 

According to Fishbein, this lack of careful reporting invalidated any data drawn

from the study.

 

But he wasn't the first at the Division of AIDS to notice the flaws. Dr. Betsy

Smith, a researcher in the division, reviewed the data in 2003, and had reached

the same conclusion. But Dr. Smith's concerns about the study had been buried.

 

In collecting the HIVNET data, Fishbein discovered that Smith's safety report

had been rewritten without her knowledge by AIDS Division director, Edmund

Tramont. According to Fishbein, Tramont's revisions shielded the investigators,

the study and the institute itself from urgent criticism and reform.

 

" In doing my job - creating clinical research policy - it was essential for me

to know the problems that occurred in HIVNET 012 and what had to be addressed to

improve oversight, research quality and integrity, " said Fishbein. " But during

the seven active months in the division, I met considerable resistance from both

division and scientific leadership to make reforms. "

 

Fishbein also found himself witness to grave professional misconduct by

high-ranking members of the Division of AIDS, including the sexual harrassment

of female employees and the bullying of researchers who disagreed with

department policy.

 

He voiced his concerns openly - and was quickly faced with a choice - back down,

or face an increasingly hostile work environment himself. Fishbein pursued the

issue and filed an official complaint with the division chief, Edmund Tramont.

Although he was lauded for his work in the division, even having his name

submitted for a cash performance award, On February 20, 2004, two weeks after

delivering his written complaint, Fishbein was demoted.Five days later he was

told his employment would be terminated.

 

He immediately filed appeals with Office of Management Assessment, NIAID

director Anthony Fauci, AIDS division head Edmund Tramont, NIH chief Elias A

Zerhouni, and Department of Health and Humand Services (HHS) Secretary

Tommy Thompson - but the appeals were ignored.

 

At that point, he filed an Equal Employment Opportunity Commission (EEOC)

complaint and a Whistleblower Complaint with the Office of Special Counsel.

Fishbein then brought the HIVNET data to Congressman James Greenwood

(R-PA), Chair of the House Energy and Commerce Committee, hoping for an new,

independent review.

 

Meanwhile, the NIH kept him on salary and on probation but with no ability to

return work or secure a job reference for over a year. It was understood that

at the end of the probation period, Fishbein would be able to file an appeal

with the Division. But they fired him a day before the probation was up, dashing

his hopes for a fair hearing.

 

During the same period, another AIDS drug scandal had been brewing involving

the use and abuse of orphans in NIH clinical trials in one of the poorest

boroughs of New York City.

 

In 2003, I began my investigation of the NIH trials conducted at the Incarnation

Children's Center (ICC) orphanage in Washington Heights, just north of Harlem.

Since the early 1990s, abandoned children, mostly of drug-addicted parents, were

being used to test dangerous and toxic drugs like Nevirapine and AZT for the

AIDS market.

 

ICC, a Catholic orphanage, is operated by Columbia University's Presbyterian

Medical center, which also runs extensive drug trials in conjunction with the

NIH.

 

I published my first report, " The House That AIDS Built " at altheal.org in

January 2004. The story was picked up by other investigators, and has appeared

in multiple outlets - The New York Post, NY Press, UK Observer, and as a BBC

documentary for which I provided research - but there has been no corrective

action from the city or state.

 

In May 2005, an Associated Press investigation revealed that the problem was

widespread - orphans and wards of the state were being used in clinical trials

with dangerous drugs nationwide - with little to no oversight.

 

Following the AP story, Dr. Fishbein wrote Daniel Levinson, the Inspector

General for the Department of Health and Human Services (HHS), asking that a

medical review and audit of study records be performed by the Inspector

General's office and that awarding of further research funds be withheld from

the site until completion of an investigation.

 

In June 2005, the HHS held a subcommittee meeting on the scandal. The committee

concluded that the protected rights of foster children had been violated in some

of the AIDS drug trials. The HHS cited Columbia Presbyterian, noting that the

hospital's " records demonstrate a failure . to obtain sufficient information

regarding such safeguards with respect to the enrollment of wards of the state

or foster children. "

 

The verdict looked good on paper, but nothing has changed at the ICC orphanage.

The drug regimen remains the same and is strictly enforced, despite negative

consequences in the children. Children in ICC who refuse to take the drugs by

mouth have them pumped through nasal or surgically-inserted gastric tubes.

Several children have died in recent years - one on Thalidomide, and one after a

stroke that left her blind, which occurred within three months of starting the

drugs1.

 

Fishbein says that he is unaware of any investigation into these matters.

 

" I went to the House Ways and Means human resources subcommittee hearing and

it appears that there is some interest in legislating better protections for

children in research, " he said. Fishbein cited a pointed comment from the

hearing, issued by Congressman Pete Stark (D-CA), " in drug trials, children

should at least be elevated to the level of protections we provide prisoners. "

 

In July 2005, The New York Times put out a front-page piece on the ICC

orphanage drug trial scandal, but painted my investigation as so much

internet hyperbole, excluding mention of the AP investigation or the

forced-drugging. The Times even colored AZT, one of the drugs tested on

the children, as a benign wonder-drug, but omitted any reference to it's

well-documented and often fatal toxicity.

 

Fishbein rebuffed the story; " The New York Times piece was not investigative

journalism at all, " he said. " The _Times_' big problem with the story was

that they didn't break it first! So they tried to make believe there was no

story. No surprise there. "

 

Back in the summer of 2004, Fishbein was still in the fight over HIVNET. He

had been looking for help in Congress and had already given the HIVNET data

to Congressmen Greenwood, " But when Greenwood suddenly announced his

retirement that summer to go work as the chief of the biotech lobby, I knew

he had no intent to hold NIH accountable, " Fishbein explained.

 

He again rebounded, and brought the evidence to Senator Charles Grassley

[R-Iowa], who as Chairman of the Senate Finance Committee was just launching

his investigation into the arthritis drug Vioxx, which was pulled from the

market after being linked to thousands of deaths.

 

" Grassley looked at it, and commenced his own investigation into HIVNET 012 -

and requested that the Inspector General of HHS do the same. " Fishbein said.

" That investigation is in progress. "

 

In January, 2005, Fishbein testified before the Institute of Medicine Committee

(a division of the National Academy of Sciences) that " gross violations of Good

Clinical Practice in the conduct of the HIVNET 012 study rendered the data

invalid. "

 

He spent the rest of the year fighting for his case before the EEOC. " I had

irrefutable evidence in my hands that substantiated the allegations I made, "

Fishbein said.

 

On December 12, 2005, after two years of battle over HIVNET 012, Dr.Jonathan

Fishbein was reinstated to the NIH.

 

Senator Grassely said: " Dr. Fishbein brought to light serious allegations of

systemic problems at the National Institutes of Health.As is typical, Dr.

Fishbein suffered mightily for being a whistleblower and for exposing the truth,

until now. "

 

But it's not a total victory; Fishbein's reinstatement is not to the Department

of AIDS. He is being given time to find another job within the NIH - begging the

question - how committed is the Department of AIDS to cleaning up its act?

 

But, Fishbein says, this is the very reason he looks forward to returning to

work.

 

" I hope to help the Agency achieve its mission and become a better environment

in which to work. I will, of course, continue to promote scientific integrity,

research safety, and protection of human research subjects, " he explained.

 

" I have never strayed from my desire to contribute to finding an end to the

epidemic and I still care a great deal about the NIH. I believe in its mission

and I believe in scientific integrity. " said the doctor. " That's really what

this fight was all about: scientific integrity. "

 

At the end of our conversation, Dr. Fishbein referred me to an apparently

unrelated story - the December 29, 2005 Wall Street Journal story on Perchlorate

- a chemical used in solid-rocket fuel that is at the center of an ongoing

battle between the Department of Defense (DOD) and the Environmental Protection

Agency (EPA).

 

The EPA says perchlorate causes neurological damage in fetuses in anything

over one part per billion; the DOD says that it's safe at much higher levels

than the EPA is allowing for - as much as 200 parts per billion.

 

Following the EPA guidelines could necessitate clean up of water sources in

35 states, including the massive Colorado River.

 

" The cleanup would bankrupt the DOD, " said Fishbein.

 

To settle the fight, the DOD took its case to the White House, who told the EPA

to halt any further action in the case. The White House then appointed its own

committee to come up with a ruling.

 

The result? Based on their committee's review, the allowable level of

perchlorate in drinking water is 24 parts per billion - 24 times that of the EPA

safety ecommendation.

 

" That's how political considerations get in the way of science, " said Dr.

Fishbein, the good man at the NIH.

 

Resources:

 

Dr. Jonathan Fishbein's official website and documents

 

Nevirapine (Viramune) Warning Label - 2005

 

The Trouble with Nevirapine by Anthony Brink, Treatment Information

Group 2001

 

AIDS drugs in Mothers and Children and AZT studies Alberta Reappraising

AIDS Society

 

The Fight to Limit Regulation of a Military Pollutant (Perchlorate)

Peter Waldman, Wall Street Journal, Dec 29, 2005

 

1 Inside Incarnation by Liam Scheff, NY Press, July/Aug 2005

 

 

Posted by Liam

Liam Scheff - writer on politics and culture, with a special focus on the

abuses of big pharma on the american underclass.

 

 

" Our ideal is not the spirituality that withdraws from life but the conquest

of life by the power of the spirit. " - Aurobindo.

 

 

 

 

 

 

 

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