Health Supreme by Sepp Hasslberger

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December 30, 2003

Corrupting the research process - NIH officials paid as industry consultants

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

**************************************************************

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.

--------------------------------------------------------------
Can of worms deluxe
--------------------------------------------------------------

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.

--------------------------------------------------------------
Wait. It gets worse.
--------------------------------------------------------------

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.

--------------------------------------------------------------
Consulting we will go
--------------------------------------------------------------

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.

--------------------------------------------------------------
Once upon a time...
--------------------------------------------------------------

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?

**************************************************************

To start receiving your own copy of the HSI e-Alert, visit this page:

Or forward this e-mail to a friend so they can sign-up to receive their own copy of the HSI e-Alert.

**************************************************************

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

**************************************************************
If you'd like to participate in the HSI Forum, search past e-Alerts and products or you're an HSI member and would like to search past articles, visit http://www.hsibaltimore.com


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.

-----------------------------------------
Moving at the speed of bureaucracy
-----------------------------------------

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.

-----------------------------------------
That was then...
-----------------------------------------

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, secretary of the Department of Health and Human Services, AND the approval of the Office of Government Ethics (OGE). So now we've got THREE different bureaucracies involved. That ought to speed things up!

But here's the best part: Information about the proposed moratorium went out to NIH employees and the press on 9/24. And when was the proposal delivered to Secretary Thompson and the OGE? According to The Scientist magazine, as of 9/24, "NIH had
not submitted the proposal, officials said, and no date for doing so had been established."

These guys are something, aren't they?

In his 9/24 e-mail, Dr. Zerhouni stated, "We have identified vulnerabilities in our system that give us pause." The key word here: "pause." Those vulnerabilities didn't make them stop. Nope. They're pausing.

------------------------------------
Eye of the beholder
------------------------------------

Any amusement we may get from this bureaucracy's double-speak and snail-like pace disappears quickly when you consider the important work of the NIH. Last year, the NIH annual budget was nearly $28 billion. And many millions of that are devoted to vital research that includes complementary and alternative medicine.

Given that, I'm not sure which makes me angrier: the fact that NIH officials and scientists are so comfortable in accepting huge "consulting" fees from drug companies, or the fact that this proposed moratorium seems to be giving drug companies plenty of notice that they need to make sure consulting fees are spread liberally before any sort of ban actually takes effect.

According to The Scientist, Dr. Zerhouni told Congress last June that in retrospect, "there was not a sufficient safeguard against the perception of conflict of interest." Once again, when we read carefully, we can see that the concern was not over a conflict of interest, but the PERCEPTION of a conflict of interest.

It's almost as if Dr. Zerhouni were trying to tell us something.


See also related:


Book by Jeffrey Robinson Prescription Games: Life, Death and Money Inside the Global Pharmaceutical Industry

President Bush's administration distorts scientific findings and seeks to manipulate experts' advice to avoid information that runs counter to its political beliefs, a private organization of scientists asserted ...

Government Health Agency Plagued by Conflicts of Interest

Double Dipping at NIH

NIH to Set Stiff Restrictions on Outside Consulting

LA Times: The National Institutes of Health: Public Servant or Private Marketer?


February 2005:

A communication from the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)


The latest example of the corrupting influence of the pharmaceutical industry on health care policy is the composition of FDA's advisory panel that last week endorsed the marketing of lethal COX-2 pain killers. A front page article in today's New York Times (below) reports that 10 of the 32 panelists on FDA's advisory committee swung the votes last week in favor of allowing the continued marketing of painkillers that induce fatal heart attacks and strokes had ties with those drugs' manufacturers - Pfizer and Merck.

"If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return."
The 10 panelists were identified by Merril Goozner of The Center for Science in the Public Interest from disclosures in medical journals and other public documents. Other panelists may have similar conflicts that have not yet been identified.

Major, pervasive conflicts of interest among senior scientists at the National Institutes of Health were documented by the Los Angeles Times beginning with a major expose on December 7, 2003. The scope and severity of NIH scientists' conflicts of interest is staggering-94% of the top paid NIH scientists failed to report their financial deals with pharmaceutical companies. Several Congressional hearings were held in 2004, and a request by Congressional staff sent to just 20--out of several hundred pharmaceutical companies-yielded 100 names of NIH scientists with whom the companies had financial deals. These 100 represent the tip of an iceberg.

The scientists who receive the highest government salaries, continue to deny all and have embarked on a battle against restrictions on their supplemental income. Multiple investigations confirmed the evidence uncovered by the LA Times, leading Dr. Elias Zerhouni, director of NIH, to finally issue new conflict of interest regulations, effective Feb. 3, 2005. But as Dr. Zerhouni predicted, the hardest part is to change the culture at NIH:

"It's easy to come up with regulations. It's not easy to change a culture."

The new rules are meant to root out conflicts of interest and prevent major ethical abuses affecting the safety of patients and the integrity of medicine. The new rules will bring NIH staff scientists in line with federal legislation prohibiting government employees from having conflicts of interest or using insider information for self-enrichment.

But the NIH scientists are furious about a requirement that they divest themselves of pharmaceutical company stocks. Incredibly, they seem to have found support from apologists at the Washington Post. Earlier this week, a front page article, accompanied by an editorial, supported the disgruntled NIH scientists who had used their position and insider knowledge. Scientists at NIH have a sense of entitlement to be free to strike stock option deals with companies for whom they conducted clinical trials, to engage in lucrative lecture and consultancy deals--while drawing the highest level government salaries.

The Post reported that an NIH investigation found that: "as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators." However, as has been amply demonstrated, NIH self-investigations have no credibility. The editorial said the rules "went too far." "They threaten to harm the ability of the institutes to attract and retain top scientists..."
See: Washington Post article

This is an astonishing about face, from a July 5, 2004, editorial, "Double Dipping at NIH" which raised doubts whether Dr. Zerhouni's announcement that he would impose "drastic changes" to curtail conflicts of interest would be enough:

"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."
See: Washington Post's earlier article Whatever changed the editors' position?

Might this be a payoff for the few crumbs the Post receives from government officialdom?

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org



THE NEW YORK TIMES
February 25, 2005
10 Voters on Panel Backing Pain Pills Had Industry Ties
By GARDINER HARRIS and ALEX BERENSON

Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records. If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return. The votes of the 10 did not substantially influence the committee's decision on Celebrex because only one committee member voted that Celebrex should be withdrawn.


Washington Post
NIH Clears Most Researchers In Conflict-of-Interest Probe
By Rick Weiss
Wednesday, February 23, 2005; Page A01

Most of the 100 or so National Institutes of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, according to agency officials. The unexpected finding that as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni's recent decision to impose severe restrictions on the personal activities and finances of all of the agency's more than 5,000 employees, said scientists and NIH officials upset about the new rules.

LA Times - March 3, 2005
New Rules Will Cost Dissidents at NIH
A panel of scientists is fighting the agency's ban on consulting with drug firms. A third of them have profited from such deals in recent years.

 


posted by Sepp Hasslberger on Tuesday December 30 2003
updated on Friday December 10 2010

URL of this article:
http://www.communicationagents.com/sepp/2003/12/30/corrupting_the_research_process_nih_officials_paid_as_industry_consultants.htm

 


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Readers' Comments


This scenario of NIH officials acting as consultants to the drug industry is just as absurd as a hockey referee acting as a consultant to a specific team, or to a judge receiving a consulting fee from the accused.

How can this go on? Where is Justice?

Posted by: Mick L. on March 8, 2004 05:53 PM

 















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