NIH Scolded Employee For Flagging Conflicts
7 CommentsBy Ed Silverman // October 22nd, 2008 // 1:21 pm
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 (please click on the letter at the left to enlarge).
What was the NIH’s reaction? Feder was reprimanded for signing his letters as an NIH employee (you can read the official reprimand here and numerous related documents here. Meanwhile, the NIH allegedly failed to address the underlying issue Feder wanted to correct - which the US Senate Finance Committee has been busy investigating for much of this year. Among the targets - several prominent academic psychiatrists at Stanford, Emory, Harvard and Brown universities, and a Columbia University cardiologist.
Remember that, since 1995, an NIH regulation has required scientists to report to their universities any “significant financial interests” they hold in research projects financed by the agency. Those are defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities, in turn, are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings (here are the rules).
We have asked the NIH to comment, but a spokesman says personnel matters can’t discussed. As to Feder, who retired from NIH two years ago and now works as a staff scientist at the Project on Government Oversight, a non-profit. “I’ve been pointing out these problems for years and, unfortunately, they ignored it,” he tells us. “I don’t feel bitter. I feel much less strongly about the reprimand than I do that they ignored my good advice.”
Doug Bremner MD
David Willman did a series of investigative news articles for the LA Times around that time on NIH scientists and doctors consulting for the pharmaceutical industry. Fact is it was pretty rife at the time, and undisclosed.
An FDA Reviewer
Reprimands are nothing. FDA is threatening reviewers children.
Jaynesday
An FDA Reviewer - Say what?
Blue Dog Dem
Reviewer and Jay:
It can’t be so… you must have mixed up your meds. Andy V. himself has said actions like those will not be tolerated.
“Let me assure you that I do not condone or tolerate intimidation or retaliation of any kind in this agency, and I will take every opportunity to reinforce that message.”
Andy V.
Philip Rudnick
Minewhile, at the FDA…
2006
VonEschenbach Orders Data on Ketek Suppressed, Threatens Staff
http://www.cbsnews.com/stories/2006/12/13/cbsnews_investigates/main2259865.shtml
…In an exclusive interview with CBS News, Ross, who reviewed Ketek’s safety for the FDA, says he warned his superiors that the drug was, in his words, a “time bomb,” and was shocked last summer when the acting head of the agency, Dr. Andrew Von Eschenbach, told employees to keep concerns about the drug in-house — and out of the press.
“He said, ‘If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,’” Ross says.
…Grassley’s letter to von Eschenbach:
http://www.cbsnews.com/htdocs/pdf/Letter_Eschenbach_Ketek.pdf
http://www.cbsnews.com/htdocs/pdf/Letter_Eschenbach_Ketek.pdf
http://ketek.martinandjones.com/
————————————–
Feb07
VonEschenbach - “Won’t Tolerate Whistleblowers”
http://www.ahrp.org/cms/content/view/483/28/
————————————-
November 2007
Senator Charles Grassley:
“We get press releases listing accomplishments rather than a meaningful revamping of the way things work inside the FDA. My staff investigators continue to hear from FDA employees who believe in their agency and … want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA’s work.”
http://www.newstarget.com/022282.html
Thom
Blue Dog Dem, well if Andy V. himself says it, then it must be true!
D
Although I wish NIDDK and NIH had paid more serious attention to Feder’s concerns I don’t see anything wrong in the reprimand letter. NIH said “go ahead and send as many letters as you want, just don’t use your NIH address and title”
Feder could have written a thousand letters as a private citizen using his home address.