[SSRI-Research] NIH Under Fire: Longtime Favorite of Congress-Wash Post / WSJ

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Sun, 27 Jun 2004 20:59:00 -0000

[sSRI-Research] NIH Under Fire: Longtime Favorite of Congress-Wash Post

/ WSJ

 

Under fire from Congress with evidence of NIH staff engaging in

secret outside contracts and consultancies, NIH Director, Dr. Elias

Zerhouni, turned a corner. He acknowledged the problem at a hearing

(June 22) of the House oversight subcommittee of the Energy and

Commerce Committee, and issued a series of reforms to bring NIH

researchers in line with government guidelines on outside activities

and remuneration. His predecessor, Dr. Harold Varmus, had waived

conflicts of interest guidelines, apparently believing that

scientists have special entitlements and are less given to greed and

temptation than other mortals.

 

The Congressional probe was prompted by an investigative report by

David Willman of the Los Angeles Times (December 7, 2003), who

uncovered conflicts of interest of unprecedented magnitude among 94%

of the highest paid scientist at institutes of the NIH. The article

also uncovered abuse of patients in clinical trials. See:

http://www.latimes.com/news/nationworld/nation/la-na-

nih7dec07,1,7108097.sto

ry?coll=la-home-headlines

 

The Washington Post reports about an example uncovered by the House

subcommittee investigation of a high NIH official who received secret

fees: " drug giant Pfizer Inc. reported that Trey Sunderland, a

researcher at the National Institute of Mental Health, was paid

$517,000 in fees, honoraria and expense reimbursements related to

consulting arrangements with the company over the past five years.

Greenwood said the information was not on Sunderland's financial

disclosure reports as required by federal ethics rules. An NIH

official said Sunderland was traveling abroad and could not be

contacted. "

 

Given the scope of the violations throughout NIH, it is doubtful that

Trey Sunderland is the only official at the NIMH who was involved in

secret financial deals with pharmaceutical companies. The Alliance

for Human Research Protection (AHRP) is concerned about recent

revelations involving concealed evidence of attempted suicides by

teens in antidepressant drug trials, and the role of NIMH in that

concealment. AHRP has twice submitted written letters of concern to

Dr. Thomas Insel, director of the NIMH (copies to Dr. Zerhouni)

questioning NIMH's role in the concealment of adverse clinical trial

data (April 30 and on June 23, 2004).

 

AHRP discovered in FDA documents that at least two teenagers enrolled

in an NIMH-sponsored Prozac trial, attempted suicide. The published

report of that trial failed to disclose any suicide attempts.

Additionally, AHRP discovered in FDA's medical review, that this

taxpayer funded trial was " part of [Eli Lilly's] pediatric

development program for fluoxetine " to gain FDA approval for

children. See: Food and Drug Administration (FDA). Center for Drug

Evaluation and Research (CDER). June 25,, 2001. Application number 18-

936/SE5-064. Medical Review by Andrew Mosholder, MD. Posted on FDA's

website Sept. 25, 2003: http://www.fda.gov/cder/approval/index.htm

 

We believe these revelations suggest the need for a thorough

investigation of NIMH officials' financial ties to drug companies--

and the agency's possible misappropriation of public funds. The Wall

Street Journal reports that lobbyists from academia and elsewhere

sense the chilly new atmosphere toward NIH. There is " NIH fatigue " on

Capitol Hill, one lobbyist says, and " lots of pushback " from once-

friendly members of Congress and their staffs. "

 

Oddly, The New York Times has not seen fit to report about the

corrupt practices that have tainted NIH's credibility. Yet, the Times

does report on its front page about the pervasive corrupting

influence of the pharmaceutical industry on individual physicians who

accept $10,000 kick-backs. See: As Doctors Write Prescriptions, Drug

Company Writes a Check, By Gardiner Harris

http://www.nytimes.com/2004/06/27/business/27DRUG.final.html?hp

 

The most damaging corrupting influence of the pharmaceutical industry

on the culture of medicine and the safety of prescription drugs, is

its influence on science and scientists at elite medical research

institutions. If scientists at prestigious institutions get away with

concealed financial deals with companies whose products they proclaim

to be " safe and effective " by reporting partial data, why would

anyone expect ordinary physicians who are under pressure from HMOs to

be less susceptible to pharmaceutical company bribes and kickbacks?

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

http://www.washingtonpost.com/ac2/wp-dyn/A61798-2004Jun22?

language=printer

 

Washington Post

NIH Scientists Broke Rules, Panel Says

Deals With Companies Went Unreported, Probe of Potential Conflicts of

Interest Finds By Rick Weiss Wednesday, June 23, 2004; Page A19

 

Researchers at the National Institutes of Health violated federal

rules by engaging in lucrative collaborations with pharmaceutical and

biotechnology companies and not reporting those arrangements to

ethics officials as required, according to documents released

yesterday as part of an escalating congressional investigation into

conflicts of interest at the agency. The House oversight subcommittee

had already identified several instances in which scientists engaged

in outside activities that posed at least the appearance of a

conflict of interest. But in those cases the arrangements had been

approved by top legal and ethics officials. Now, NIH officials said,

disciplinary actions may be needed.

 

Testimony yesterday also provided evidence that Lance A. Liotta, a

researcher at the National Cancer Institute, continued to receive

thousands of dollars in compensation from one such business

arrangement through May, despite his testimony under oath last month

that he had suspended the collaboration months before.

 

The subcommittee said Liotta and others used their government

computer systems to exchange e-mails relating to their private

consultancies, supporting some lawmakers' contention that some

government scientists have been illegally using federal resources for

personal gain. It remains to be seen how many of the subcommittee's

allegations will stand up to closer scrutiny as bona fide breaches of

ethics rules. Many details of the cases were still missing as of

yesterday, and key individuals could not be reached to comment after

the hard-hitting six-hour hearing came to a close.

 

But having learned of some of the new findings late last week, NIH Elias A. Zerhouni came before the subcommittee yesterday

with proposed revisions to NIH ethics rules more severe than those he

had recommended a month earlier. " I have reached the conclusion that

drastic changes are needed, " he said. The new allegations emerged as

part of the panel's expanding investigation into government

employees' consulting deals with private companies. Although House

members began by focusing on NIH, where top scientists' spare time is

in great demand by drug companies wishing to capitalize on their

expertise, they widened their probe last week to include 15 other

federal agencies. In letters sent to agency heads, the subcommittee

chairman, James C. Greenwood (R-Pa.), and House Energy and Commerce

Committee Chairman Joe Barton

(R-Tex.) asked that records of all such collaborations be provided to

them by July 2.

 

Yesterday's surprise disclosure that many NIH scientists may be

engaging in outside deals without the required agency reviews and

approvals grew from inquiries Greenwood made to 20 pharmaceutical

companies. Given the lack of a centralized NIH database of all

agency scientists' outside collaborations, Greenwood went directly to

the companies, asking them to reveal all the arrangements they had.

Of the 264 arrangements the companies reported, Greenwood

said, " about 100 " were apparently unknown to NIH officials. That

sampling has Congress wondering, " What else is out there?, " said Rep.

John D. Dingell (D-Mich.).

 

In one example detailed by Greenwood, drug giant Pfizer Inc. reported

that Trey Sunderland, a researcher at the National Institute of

Mental Health, was paid $517,000 in fees, honoraria and expense

reimbursements related to consulting arrangements with the company

over the past five years. Greenwood said the information was not on

Sunderland's financial disclosure reports as required by federal

ethics rules.

 

An NIH official said Sunderland was traveling abroad and could not be

contacted. In another highlighted arrangement, Alan Moshell of the

National Institute of Arthritis and Musculoskeletal and Skin Diseases

was retained as an expert witness in several private product-

liability lawsuits involving the drug Accutane at a rate of $600 per

hour -- and did so without required agency permission -- Greenwood

said. Those arrangements were described by Health and Human Services

general counsel Alex M. Azar II as particularly worrisome as Moshell

allegedly testified in those trials to the inadequacy of the

government's own warning label on the drug.

 

Moshell did not respond to calls and an e-mail late yesterday. The

subcommittee also provided new details regarding an alleged conflict

of interest outlined in a May hearing, in which cancer researcher

Liotta and an FDA scientist became paid consultants for a California

biotechnology company that is in competition with a Bethesda company

with which the two scientists and the Cancer Institute were already

collaborating. Liotta testified last month that by March of this year

he had suspended the California arrangement, pending a fresh ethics

review by agency officials who initially approved the deal but later

expressed regret at having done so.

 

Yesterday, Greenwood flashed on a giant screen copies of several

canceled checks from the company -- Biospect Inc. of South San

Francisco, recently renamed Predicant Biosciences -- made out to

Liotta. The latest check, for $3,125, was dated May 1. Greenwood also

showed evidence supplied by the company that it had paid Liotta a

total of $70,000, significantly more than the approximately $49,000

that Liotta reported to ethics officials.

 

A cancer institute spokesman said yesterday that Liotta had an

appointment and would not be able to respond to media queries.

Zerhouni has already imposed new tiers of ethics review for all

proposed outside consulting arrangements by NIH employees and greater

public disclosure of approved arrangements. Yesterday, he proposed

additional restrictions, including some that could be accomplished

internally and others that may require new legislation.

 

Among them: a ban on ownership of drug company or biotech stocks by

some key employees, and restricted stock ownership for all other

employees; no membership on corporate boards; creation of a

centralized registry of all outside arrangements and a public list of

the awards that employees may receive; and prohibition of all paid

consulting or speaking engagements at institutions that receive NIH

funding.

 

C 2004 The Washington Post Company

 

 

The Wall Street Journal

Bernard Wysocki Jr., National Institutes of Health Is Under Fire;

Longtime Favorite of Congress Grapples With Slim Funding Increases,

Conflicts Inquiry Wall Street Journal

Jun 22, 2004 p. A.4

 

Washington -- THE NATIONAL INSTITUTES of Health, long a sacred cow in

Washington, is coming under fire from the very Congress that once

showered it with funds. After doubling its annual budget to $28

billion in the past five years, Congress has given NIH tiny increases

this year, as large fiscal deficits force budget tightening.

Meanwhile, lawmakers are pressing agency officials to explain how

they spend all the money -- and why there isn't more bang for these

bucks. More ominously for the agency, congressional investigators

have launched a high-profile probe into the outside activities of NIH

scientists, many of whom already enjoy special exemptions from civil-

service salaries and command salaries of as much as $200,000 a year.

The congressional probe is delving into potential conflicts of

interest within NIH, following disclosures that scores of NIH

scientists enjoy lucrative consulting relationships, often with

pharmaceutical and biotechnology companies.

 

A House subcommittee will hold the third in a series of hearings on

these sometimes-lucrative outside activities today. Lawmakers are

expected to make public a list of 122 awards and prizes given to NIH

scientists and administrators since 1999, totaling about $575,000. In

34 cases, the House documents show, the money came from universities

and other institutions that get NIH grants, creating at least the

appearance of impropriety in some cases, House investigators say.

 

It is an unusual battering for NIH, whose 27 component institutes and

centers have long been admired as the crown jewel of America's

biomedical research effort. Several steps taken by Elias Zerhouni,

the director of NIH since 2002, to put some restrictions on outside

activities have failed to mollify lawmakers. " When people get awards

from a grantee, there's at least the appearance of conflict of

interest, " says Rep. Jim Greenwood (R., Pa.) chairman of the House

subcommittee. He said Dr. Zerhouni is expected to come before the

panel today and make proposals covering awards and outside

consulting. " In the main, they are pretty darn good. "

 

Some committee members have openly scoffed at the recommendations of

a blue-ribbon commission appointed by the 53-year-old NIH director.

This clearly caught Dr. Zerhouni, a former senior administrator at

Johns Hopkins University in Baltimore, off guard, since he believes

the blue-ribbon panel recommended " draconian " steps, including

limiting the size of consulting fees from industry and banning

outside consulting activity by high-ranking NIH officials.

 

NIH is in the spotlight for more than the conflict-of-interest

investigations. The huge increase in funding has prompted legislators

to demand high-profile results against diseases. The impatience crops

up repeatedly, as members of Congress often emphasize to NIH

officials that its vast research should ultimately translate into

treatment for diseases.

 

Further denting its image, lawmakers are using the NIH as a

springboard into a wider investigation of ethics in government.

Friday, the House Energy and Commerce Committee expanded the conflict-

of-interest inquiry beyond NIH to 15 federal agencies. " Our goal is

to learn whether the practices we have uncovered at NIH also exist in

other agencies, " Rep. Joe Barton (R., Texas) the committee chairman,

said Friday. Dr. Zerhouni in a recent interview said he had grave

misgivings about a complete ban on outside activities, particularly

on payments for writing and speaking. " If that's under attack, " he

said, " then we have a real issue. "

 

The NIH guidelines on outside activities were loosened by Dr.

Zerhouni's predecessor, Harold Varmus, in 1995, when, Dr. Varmus

says, NIH was having trouble recruiting top private-sector talent.

Dr. Varmus, now president of Memorial Sloan-Kettering Cancer Center

in New York, says a new NIH vaccine center couldn't have recruited 10

top scientists recently without the enticements of high pay and

outside income.

 

Gary Nabel, director of the vaccine center, says 80% of these

critical subordinates do outside speaking and writing, and about half

do outside industry consulting for pay. Dr. Nabel himself has

consulted on gene therapy in cardiovascular disease. It is an area of

expertise that he says doesn't conflict with his current job, which

is to oversee development of vaccines for the AIDS, Ebola and other

viruses. Dr. Nabel says he hasn't had any turnover among the top

people recruited over the past five years. However, he says, if a ban

on all outside activity is imposed, " the most talented people " would

be tempted to leave NIH.

 

Several members of the House subcommittee investigating NIH remain

skeptical. Rep. Diana DeGette (D., Colo.), has repeatedly questioned

Dr. Zerhouni about the need for outside compensation by scientists in

the civil service. She says she understands why interaction is

important but doesn't see the need for extra pay. While she hasn't

made up her mind on the issue for NIH scientists, Rep. DeGette

says, " I think it's very difficult to enforce conflict-of-interest

rules without an outright ban. "

 

One target of the probe by Congress is Richard Klausner, former

director of the National Cancer Institute. In 2002, shortly after he

stepped down, the cancer institute awarded a $40 million contract to

Harvard University for drug-discovery research. The lead scientist at

Harvard later formed a private company, made Dr. Klausner an officer

and awarded him stock in the enterprise. Dr. Klausner says he didn't

have any role in awarding the Harvard contract and joined with the

private company only after leaving government service. Currently, Dr.

Klausner is a senior official at the Bill & Melinda Gates Foundation,

which funds infectious-disease research.

 

In a separate case, several members of Congress lashed into two

officials, one of NIH, the other of the Food and Drug Administration,

who worked together in their official capacities with one biotech

company while moonlighting for a competitor. Both officials stopped

the moonlighting, after protests. More witnesses are expected to come

before the House panel this morning.

 

The agency's growing budget has brought it a different kind of

scrutiny. Some legislators see it as never satisfied. Sen. Pete

Domenici (R., N.M.) raised eyebrows this spring when he said NIH

has " turned into pigs. " A recent study by the Rand Corp., the

California think tank, found that nearly half of the federal research

and development budget is going to medical schools.

 

Lobbyists from academia and elsewhere sense the chilly new atmosphere

toward NIH. There is " NIH fatigue " on Capitol Hill, one lobbyist

says, and " lots of pushback " from once-friendly members of Congress

and their staffs.

 

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