Sunday, October 26, 2008

NIH Management Reprimanded Scientific Review Administrator Who Advocated Transparency About Conflicts of Interest

In the "early days" of Health Care Renewal, i.e., in 2006, we posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked.

Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

More recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here, here, and here.) Sunderland pleaded guilty to "criminal conflict of interest," (see post here). We also posted about a "footloose and fancy-free" NIH institute director here.

Yet while all this was going on, it appears that NIH management was punishing not the conflicted, but those within the NIH who dared to complain about how the organization handled this conflicts. A few days ago, Ed Silverman reported on his blog PharmaLot about how a former NIH scientist who was reprimanded because he wrote letters to scholarly journals and newspapers advocating that the organization do better at disclosing conflicts of interest affecting its own personnel, and researchers who get NIH grants. As reported on PharmaLot,

Three years ago, Ned Feder began complaining publicly about what he perceived as the National Institutes of Health’s failure to monitor conflicts of interest involving academic researchers, who receive government grants for drug research while simultaneously getting paid by pharma for consulting, research or speaking.

And so the scientific review administrator, who at the time worked for the National Institute of Diabetes and Digestive and Kidney Diseases, began writing memos to NIH officials and then letters to various publications - Nature, The Scientist and The Los Angeles Times - to raise public awareness. “A proposal to require readily accessible financial disclosure will probably be fought tooth and nail by those who benefit from leaving things as they are: some university researchers and administrators, officials at the NIH and scientists in the industry,” Feder wrote in a September 2005 letter to Nature....

What was the NIH’s reaction? Feder was reprimanded for signing his letters as an NIH employee....

Looking at the document to which PharmaLot linked, Feder was reprimanded for "failure to follow management instructions." His specific offense was that he provided a "reference to your NIH affiliation in signature blocks for your personal publications." What apparently so troubled NIH management was, for example, some of the statements that follow

[There was] the embarrassing failure by the US National Institutes of Health (NIH), during the past year, to disclose information about NIH scientists serving as paid consultants to private companies. Having been a scientist at the NIH since 1967, as a physician, a cell biologist and now a science administrator, I must add that the habit of non-disclosure continues, making further embarrassments likely.

In articles published since December 2003, the Los Angeles Times has given ten specific examples of NIH scientists with financial conflicts of interest. However,
details of hundreds of others remain hidden, and the extent of the damage caused since 1995 is unknown.

He concluded,

The NIH’s defensive approach — one congressman called it stonewalling — has proved a disastrous miscalculation. If the NIH does not unflinchingly seek the facts and release them, they may come out anyhow in other ways. Then the NIH’s reputation, already at the lowest point in its history, will suffer further.

Note that the letter above [Feder N. NIH must tell whole truth about conflicts of interest. Nature 2005; 434: 271.]was written before the allegations about Sunderland, who eventually pleaded guilty, appeared.

Feder's second letter to Nature in 2005 [Feder N. Public disclosure could deter conflicts of interest. Nature 2005; 437: 620.] correctly predicted what would happen to Feder, himself

A proposal to require readily accessible financial disclosure will probably be fought tooth and nail by those who benefit from leaving things as they are: some university researchers and administrators, officials at the NIH and scientists in industry.

So while the conflicts on interest continued, those advocating transparency about financial relationships were punished.

Note that Feder's second 2005 letter was about how

NIH-funded researchers are required to provide details of any consulting arrangements to their universities, which in turn approve or veto the plans. This information is confidential and usually cannot be seen by the public.

What Feder advocated was that

The NIH could require grantees to make public disclosures of their paid arrangements with pharmaceutical, investment and other companies, as well as their ownership of stock and stock options, as a condition of having their medical research funded by the government.

So this letter from 2005 presaged the scandals of 2008, for example, how US Senator Charles Grassley has found that prominent researchers failed to disclose large payments from pharmaceutical companies that they received while doing NIH funded studies on drugs made by these same companies (see post here).

The unfortunate story of the punishment of Ned Feder is a reminder how deeply the culture of "get mine first" has infiltrated the culture of the leadership of our once most respected health care institutions. To promote research to serve science and the public rather than the needs of vested interests, we will have to make a big change in this corporate culture.

1 comment:

Anonymous said...

Medicine needs an enema.