Corrupting the research process - NIH officials paid as industry consultants

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Pharma

NIH - The National Institutes of Health in the US, which comprises 27 individual institutes and has more than 18,000 employees was caught red handed with senior staff accepting drug industry "consultancy" fees to the tune of sometimes hundreds of thousands of dollars.

Jenny Thompson of the Baltimore Health Sciences Research Institute reports.

Bioethics centers are awfully silent in this regard. Maybe the following article can help us understand why: "The issue of corporate money has become something of an embarrassment within the bioethics community. Bioethicists have written for years about conflicts of interest in scientific research or patient care yet have paid little attention to the ones that might compromise bioethics itself."

Here is an important update:
LA Times - February 1, 2005: NIH to Ban Deals With Drug Firms
Federal researchers will no longer be able to accept fees to consult for companies, officials say. The lucrative pacts have sparked ethics probes.
Under a far-reaching reform to be announced today, all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings, officials said.
The new regulations — drawn up by administrators from the NIH, the Office of Government Ethics and the Department of Health and Human Services — are aimed at halting lucrative deals that have led to conflict-of-interest inquiries at the government's premier agency for medical research.

Health Sciences Institute e-Alert

December 29, 2003

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Back to the Island

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 David 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?

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Sources:
"Stealth Merger: Drug Companies and Government Medical Research" David Willman, the Los Angeles Times, 12/7/03, latimes.com
"Moonlighting Federal Watchdogs" CBS News, 12/8/03, cbsnews.com
"Stealth Merger: Drug Companies and Medical Research at NIH - LAT" Alliance for Human Research Protection, 12/7/03, ahrp.org

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Here is an update from Jenny Thompson of HSI Baltimore- October 2004:

Smoke and Mirrors

Health Sciences Institute e-Alert

October 05, 2004

Dear Reader,

Turn on the smoke and bring in the mirrors...

It must have made for a bummer of a Friday happy hour. On Friday, September 24th, an e-mail was sent out to all National Institutes of Health (NIH) employees announcing a proposed moratorium that would ban as many as 5,000 NIH scientists from accepting any consulting money from drug companies for at least a year.

Impressive! It seems like NIH administrators are getting tough on the unseemly cash-cow cahoots between researchers and the companies that develop drugs that are studied by those researchers. But let's take a peek between the lines for a reality check.

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Moving at the speed of bureaucracy
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In the e-Alert "Back to the Island" (12/29/03), I told you about a five-year investigation into the inner workings of the NIH by David Willman, a Pulitzer Prize winning reporter for the Los Angeles Times. Mr. Willman's painstaking reporting revealed that more than $2.5 million of drug company consulting fees had been paid to top NIH officials and scientists who oversee the clinical trials of drugs.

Uh oh. Not great news if you're an NIH honcho.

In his investigation, Mr. Willman found 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. A pretty sweet deal... until Congress got wind of it.

This past June, NIH director Elias A. Zerhouni, M.D., told a Congressional committee that he had finally seen the light! His conclusion: The NIH ethics rules and procedures needed "drastic changes."

So here's the timeline:

* December 2003: The LA Times drops the bomb and reveals all

* June 2004: Dr. Zerhouni confirms that the situation needs drastic
changes

* September 2004: NIH proposes a moratorium on drug company
consulting fees

Things aren't moving along too swiftly, are they? Well, this is, after all, a huge bureaucracy. It's easier for an ocean liner to make a u-turn than it is for a "national institute" to revise a key policy. Especially a beloved policy that's responsible for millions of dollars in perks.

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That was then...
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But things are moving along now, right?

Well... sort of. Notice that the moratorium is a "proposed" moratorium. Which means that before it can go into effect, it requires the approval of Tommy G. Thompson, secret