Sen. Grassley seeks independent review, answers to NIH subverting peer review pr

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Sen. Grassley seeks independent review, answers to NIH subverting

peer review process in awarding grants

PharmaLive.com (press release) - Newtown,PA*

http://www.medadnews.com/News/Index.cfm?articleid=531525

WASHINGTON, April 15, 2008 - Last summer, Senator Chuck Grassley

began an inquiry into allegations of mismanagement and ethical

lapses at the National Institutes of Environmental Health Sciences,

one of the 27 institutes operated by the National Institutes of

Health. His inquiry revealed allegations of missapropriated funds,

conflicts of interest and mismanagement by the Director of the

National Institutes of Environmental Health Sciences, Dr.

Schwartz. In response, the Director of the National Institutes of

Health, Dr. Elias Zerhouni, told Senator Grassley that he would

empanel a group of internal and external experts to conduct an

independent review of problems at the National Institutes of

Environmental Health Sciences.

Yesterday, Senator Grassley obtained a copy of that panel's report.

Today, Senator

Grassley is asking Dr. Zerhouni to respond to its findings that 45

grants were funded out of order

between 2005 and 2007 from the extramural program of the National

Institutes of Environmental

Health Sciences. Senator Grassley said he is also asking the

Inspector General for the

Department of Health and Human Services to investigate. Last fall,

Senator Grassley asked the

Government Accountability Office to conduct a review.

Senator Grassley said this activity is of concern because it

breaches the peer review

process, which provides an objective measure of grant applications.

When a grant request is

funded without having received a peer review that recommended

funding, then the decision to

fund the grant should be documented. In addition to 45 grants being

funded out of order,

according to the new report, Grassley said it appears that the

actions were undocumented. He

said he wants to know if this activity is also occurring at other

institutes of the National Institutes

of Health.

The text of the letter sent today from Senator Grassley to Dr.

Zerhouni is below. The

report of the panel and an email discussing approval of the NIEHS

director's outside activities

are posted at http://finance.senate.gov.

April 15, 2008

Elias A. Zerhouni, M.D.

Director

National Institutes of Health

9000 Rockville Pike

Bethesda, land 20892

Dear Director Zerhouni:

As a senior member of the United States Senate and the Ranking

Member of the

Committee on Finance (Committee), I have a duty under the

Constitution to conduct oversight

into the actions of executive branch agencies, including the

activities of the National Institutes of

Health (NIH/Agency). In this capacity, I must ensure that NIH

properly fulfills its mission to

advance the public's welfare and makes responsible use of the public

funding provided for

medical studies. This research often forms the basis for action

taken by the Medicare and

Medicaid programs.

Last year, I sent you several letters about serious mismanagement

problems plaguing the

National Institute of Environmental Health Sciences (NIEHS). In

particular, my investigation

demonstrated that the NIEHS director was giving expert testimony in

court cases regarding

asbestos while also leading the National Toxicology Program,

overspent his lab budget by

millions of dollars, used government staff for personal purposes,

and allegedly meddled in the

extramural funding process, among other things.

At that time NIEHS was being run by Dr. Schwartz, who will

depart NIEHS

shortly. In response to these letters, you graciously met with me

and my staff and informed us

that you were creating a panel to perform an independent and in-

depth assessment of problems at

the NIEHS.

A copy of that report was provided to my staff just a short time ago

by a government

employee (See attachment #1). The report is entitled: " Management

Review National Institute

of Environmental Health Science Office of Management Assessment

National Institute of Health

Department of Health and Human Services April 9, 2008: Final

Report. " (Report).

A review of this Report raises several issues of concern. First, I

am troubled that this

Report places blame for many of the NIEHS problems on the NIEHS

ethics office. While we do

not disagree that the NIEHS ethics office is understaffed and may

have some problems, that

office lacked general authority to approve Dr. Schwartz's outside

activities. Based upon a review

of the internal emails provided to me, it is apparent that Dr.

Schwartz had many of his outside

activities approved by Dr. Raynard Kington at the NIH rather than

the NIEHS ethics office (See

attachment #2: email from Dr. Kington to Dr. Schwartz). That fact is

not addressed in the

Report.

Second, I am very worried that there continue to be allegations that

Dr. Schwartz was

involved in selecting individuals/organizations for extramural

grants. Of the $700 million

appropriated to the NIEHS, around 80% of that money funds extramural

grants. Specifically, I

note that the Report found that " decisions to award extramural grant

applications out of rank

order are not properly documented, as required by NIH policy. "

The Report notes that between fiscal years (FY) 2005 to FY 2007-

2,516 grants were

funded through the NIEHS extramural program, and that " 45

applications that scored beyond the

payline were funded. " This seems to mean that Dr. Schwartz was

manipulating extramural

funding at the NIEHS and not properly documenting his decisions as

required.

I would also like to inform you that I have asked the Government

Accountability Office

to conduct an inquiry of the NIH oversight process. I am concerned

that many of the problems I

have uncovered at NIEHS, including meddling with extramural grants,

may be found at other

NIH institutes.

Further, I note that this Report also found:

1) Several grants to the NIEHS from outside organizations were not

documented;

2) Staff did not comply with NIH policy on travel and;

3) NIEHS managers showed intent to hire before receiving best

qualified lists.

To add to this final point, according to emails that I have

received, a husband and wife

were negotiating their combined salaries with NIEHS before the job

for the wife had even been

posted.

Therefore, and through this letter I am asking the Health and Human

Services Office of

the Inspector General to perform an audit of extramural grants and

all expenses coming out of

the NIEHS office of the director for the fiscal years 2005 to FY

2007.

Accordingly, I ask you to respond to the following requests for

information and

documents. In responding to each request, first repeat the

enumerated question followed by the

appropriate response.

1) Why did the Report fail to address the fact the Dr. Raynard

Kington approved many of

Dr. Schwartz's outside activities? In addition, and in light of this

fact, what action(s) will be

instituted, if any, against Dr. Kington?

2) I began my investigation, in part, because of allegations that

Dr. Schwartz was engaged

in outside activities that conflicted with his job as director of

the NIEHS. If the NIEHS ethics

office did not have final approval of Dr. Schwartz's outside

activities, then why was this not

identified in the Report?

3) I sent a letter to you on August 27, 2007; I identified several

problems with a report

completed on the NIEHS by the NIH Office of Management Assessment

(OMA). For instance,

OMA found that Dr. Schwartz had not used computer staff for his own

needs, but my

investigators found credible evidence to the contrary. Why was this

issue not addressed in this

recent report?

4) Please provide a list of all 45 grants that scored beyond the

payline, but were funded. For

each grant, provide the following information:

1. Grant title;

2. Brief description of the grant proposal;

3. Score of the grant and ranking in the payline;

4. Amount of funding for the grant;

5. Score of the last grant in the payline and its rank in the

payline;

6. Number of grants that were bumped to provide funding for this

particular grant and;

7. Rationale for funding those grants scoring below the payline.

I request your prompt attention to this matter and your continued

cooperation. I also

request that the response to this letter contain your personal

signature. Also, I am sending you a

copy of the Report that prompted this letter.

Sincerely,

E. Grassley

United States Senator

Ranking Member of the Committee on Finance

cc: The Honorable R. Levinson

Inspector General

U.S. Department of Health and Human Services

Attachment

Downloads

NIHMemo.pdf

NIHReport.pdf