NIH Officials serve as Consultants to Drug Companies-Conflicts often waived

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Subj:FEES GO TO N.I.H. OFFICIALS

Date:12/30/2003 8:54:26 AM Eastern Standard Time

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Date: Tue, 30 Dec 2003 06:54:46 EST

From: Gould018______

Subject: FEES GO TO NIH OFFICIALS

Back to the Island

Health Sciences Institute e-Alert

December 29, 2003

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Dear Reader,

They did it again. Just when I get to the point where I think I've seen it

all, they raise the bar to a new height of absurdity.

" They " in this case is the mainstream medical establishment in general, and

the drug industry specifically. And this time it's a doozy. If you think drug

company influence has a long reach, wait till you hear this one.

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Can of worms deluxe

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When you see the terms " secret consultancy fees " and " drug companies "

mentioned in the same article, you know it's time to fasten your seat belts. But

this

time it goes way beyond fees paid to individual doctors. This time the fee

recipients are highly placed officials with the National Institutes of Health

(NIH).

Hats off to Willman, a two-time Pulitzer Prize winning reporter for the

Los Angeles Times, who recently concluded a five-year investigation of the

inner workings of the NIH. Mr. Willman's article reveals that hundreds of

thousands of dollars of drug company consulting fees have been paid to top NIH

officials who oversee the clinical trials of drugs.

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Wait. It gets worse.

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Willman cites a 1998 legal opinion that provides a loophole by which more

than 90 percent of NIH officials are allowed to keep their consulting income

confidential. In addition, many of them sign confidentiality agreements with the

companies from whom they receive fees and corporate stock options.

If there were ever a situation tailor-made for conflict of interest, this

would be it.

An LA Times survey of more than 30 other federal agencies revealed that the

NIH had the lowest percentage of employees filing reports of " consulting "

income. In many of those agencies

ALL of the most well paid officials submitted public reports. Mr. Willman

concludes that in the area of financial disclosures,

the NIH is " one of the most secretive agencies in the federal government. "

But wait. It gets even worse.

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Consulting we will go

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To understand the trust that has been violated by the NIH's easy-does-it

attitude toward consulting fees, Mr. Willman highlights one case in particular.

In an NIH study of a drug to treat kidney inflammation related to lupus, one

of the subjects receiving the drug died of a complication that was believed to

be related to the drug. But the senior NIH official connected to the study

didn't stop the study, nor did he attempt to warn the medical community of the

potential danger of the drug.

That official was a paid consultant for the company that produced the drug.

And in the past 10 years, he received well over half a million dollars in

consulting fees from various drug

companies and biomedical firms.

And he wasn't alone. According to the LA Times article, among his many

colleagues who provided consulting services, one of them has accepted almost

$1.5

million in fees.

Gee. He must be a REALLY good consultant.

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Once upon a time...

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During the Reagan era, Margaret Heckler (the secretary of Health and Human

Services, which is the agency that oversees NIH) called NIH " an island of

objective and pristine research, untainted by the influences of

commercialization. "

Ah, those were the days!

In 2003 the NIH comprises 27 individual institutes, more than 18,000

employees, an annual budget of almost $28 billion this fiscal year, and a very

protective bureaucracy.

When Dr. Ruth L. Kirschstein (the NIH deputy director who approved many of

the consulting arrangements) was asked about the results of the Willman

investigation, she told the LA Times that NIH staff members are " highly ethical "

and

have " enormous integrity. " She admitted that systems can be " tightened up, " and

said that, " perhaps, based on this, we will do so. "

Wow. Sounds like Dr. Kirschstein is going to go all out!

And last month, NIH Director Elias A. Zerhouni announced that he

would study the situation by forming a committee.

Well, well, well... a committee! Now that IS impressive! What next? A memo?