Double Dipping at NIH: the Gaming Must End_Editorial WashPost

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> Tue, 6 Jul 2004 12:27:22 EDT

> Fwd: Double Dipping at NIH: " the Gaming

> Must End " _Editorial WashPost

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> " veracare " <veracare

> " Elias Zerhouni " <ez26y, " Tommy

> Thompson " <hhsmail

>

> Double Dipping at NIH: " the Gaming Must

> End " _Editorial WashPost

> Tue, 6 Jul 2004 12:24:51 -0400

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> Monday's Washington Post editorial took a critical

> of the corrupting

> influence of the pharmaceutical industry on

> scientists at the National

> Institutes of Health. The agency's " lax ethics

> rules, laxly enforced " has

> resulted in scientists " pocketing] fat consulting

> fees, at times for work

> that overlapped, or even conflicted, with their

> government jobs. "

>

> These revelations were first uncovered by David

> Willman of The Los Angeles

> Times who reported on December 7, 2003 that the

> former director of the NIH,

> Dr. Harold Varmus, had lifted the enforcement of

> government ethics rules for

> NIH staff, leading " more than 94% of the agency's

> top-paid employees to keep

> their consulting income confidential. "

>

> Following questioning by the House subcommittee on

> oversight and

> investigations (May 13, 2004), NIH director Dr.

> Elias Zerhouni, convened a

> panel that conducted nothing but a whitewash

> investigation. Committee

> chair, James Greenwood, called the NIH ethics

> policy, " the option of

> corruption, " and convened an investigation of his

> own. When NIH officials

> failed to hand over documents requested by the

> committee, Greenwood went

> directly to the pharmaceutical companies, uncovering

> additional evidence of

> corruption.

>

> One example involved a high ranking official at the

> National Institute of

> Mental Health-which the LA Times did not

> investigate. The Washington Post

> reported that: " drug giant Pfizer Inc. reported that

> Trey Sunderland, a

> researcher at the [NIMH], 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. "

>

> Only after he was confronted with additional

> evidence-and criticism around

> the country--did Dr. Zerhouni revise his original,

> unacceptable

> recommendations for reform, and seriously address

> the malaise by laying down

> restrictions on outside consultancies, requiring

> full disclosure of any that

> are engaged in.

>

> The Washington Post editorial wistfully suggests

> that the new restrictions

> " may turn out not to be strong enough medicine. "

> The Post acknowledges

> that:

> " It's a legitimate question whether any outside

> consulting at all should be

> allowed. "

>

> The Alliance for Human Research Protection (AHRP)

> notes the deafening

> silence in the pages of the New York Times

> throughout the public disclosure

> proceedings in which a body of evidence unfolded,

> laying bare evidence of

> secret cash payments to top NIH scientists. The

> Times did not see fit to

> report these matters to its readers. One is led to

> wonder, why evidence of

> institutional corruption at the nation's

> prestigious medical research

> center, one that set the tone for the medical

> community-is not " fit to

> print, " but examples of corruption by individual

> practitioner-hustlers are

> " fit to print? "

> See: Medical Marketing : Treatment by Incentive; As

> Doctor Writes

> Prescription, Drug Company Writes a Check By

> GARDINER HARRIS, Section 1 ,

> Page 1 , Column 1

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

http://www.washingtonpost.com/ac2/wp-dyn/A28128-2004Jul4?language=printer

> THE WASHINGTON POST

> Double Dipping at NIH

> Monday, July 5, 2004; Page A16

>

> THE NATIONAL Institutes of Health in recent years

> has suffered from a set of

> lax ethics rules, laxly enforced. Freed in 1995 from

> regulations that had

> limited their outside income, some senior NIH

> scientists pocketed fat

> consulting fees, at times for work that overlapped,

> or even conflicted, with

> their government jobs.

>

> In one instance recently uncovered by congressional

> investigators, a

> researcher at the National Institute of Mental

> Health, one of the NIH's 27

> components, was paid $517,000 by the drug company

> Pfizer over five years;

> the money wasn't cleared with agency officials or

> reported on his financial

> disclosure form. In another, a National Cancer

> Institute lab chief, along

> with a colleague from the Food and Drug

> Administration, was assigned to

> collaborate with a private company to develop cancer

> testing; the pair then

> signed a consulting deal with one of the firm's

> competitors. The skin

> diseases branch chief at the National Institute of

> Arthritis was retained to

> testify as an expert witness on the acne drug

> Accutane, at a reported hourly

> rate of $600; among his points was the alleged

> inadequacy of

> government-approved warnings on the drug.

>

> " I've reached the conclusion that drastic changes

> are needed, " NIH director

> Elias Zerhouni told a House committee. Dr.

> Zerhouni's prescription, which

> goes beyond his original recommendations, may turn

> out not to be strong

> enough medicine. It's a legitimate question whether

> any outside consulting

> at all should be allowed. But given the unusual role

> of the NIH -- its

> scientists are more comparable to academic

> researchers than to government

> regulators like those at the FDA -- the Zerhouni

> approach is worth a try.

>

> Senior employees wouldn't be allowed to do outside

> consulting. Those allowed

> to engage in consulting work would be limited to 400

> hours annually; their

> pay couldn't amount to more than a quarter of their

> government salary (and

> no more than half could come from any one source).

> None of the consulting

> work could involve their government duties. All

> consulting would have to be

> publicly disclosed. NIH employees couldn't serve on

> corporate boards or

> accept stock or stock options as compensation; they

> couldn't hold more than

> $5,000 worth of stock in any pharmaceutical or

> biotechnology firm. And no

> consulting deals would be allowed with universities

> that get NIH funding.

>

> One of the arguments in favor of allowing continued

> outside consulting work

> is not to inhibit the NIH's ability to recruit and

> retain top-tier

> scientists, who could command higher pay in the

> private sector. Another

> sneaky way around the pay disparity has been for the

> NIH to exploit a

> loophole designed to let the government hire

> " special consultants " above the

> usual federal pay rates. This exception has been

> used widely at the NIH,

> with 21 of 27 institute and center directors paid as

> special consultants, at

> salaries of up to $235,000. Nearly one-third of NIH

> employees hired last

> year were brought on using this inartful dodge.

>

> As with the Securities and Exchange Commission,

> which has been granted

> exemptions from regular government pay scales

> because of difficulties in

> competing with the private sector to attract lawyers

> and accountants, we

> don't begrudge giving the NIH some flexibility in

> setting salaries. But this

> can't be taken too far: There are rewards to working

> at the NIH that

> alleviate the pay differential. And salaries ought

> to be set in an

> above-board manner. As Rep. James C. Greenwood

> (R-Pa.), who has overseen the

> congressional probe of the NIH as chair of the

> Energy and Commerce

> subcommittee on oversight and investigations, put

> it, " The gaming must end. "

>

>

> C 2004 The Washington Post Company

>