Ned Feder, M.D.Tweet
Year Started at POGO: 2006
Areas of expertise: Misconduct in the funding of biomedical research; misconduct by biomedical researchers.
Dr. Ned Feder has examined and publicized instances of wrongdoing at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), which conduct health-related research and oversee the safety and effectiveness of medical products.
Before joining POGO in September 2006, Dr. Feder was a scientist at the NIH. He came to the NIH in 1967 as the head of a lab group that conducted basic research in cell biology. In the mid-1980s he and an NIH colleague, Walter Stewart, began to study professional misconduct among biomedical researchers and found that violations of ethical standards were common. Published reports on their controversial observations drew attention in academia, in the press, and on Capitol Hill. Over the years Dr. Feder has published articles in the scientific and lay press on a wide range of topics including histochemistry, cell biology, mycology, scientific misconduct, and conflicts of interest. He received an M.D. degree from Harvard Medical School in 1953 and was a faculty member of the Harvard Biology Department from 1961 to 1967.
Since joining POGO, Dr. Feder has investigated and written about threats to public health in programs of the Department of Health and Human Services. Several journals, including Nature, The Scientist, and New England Journal of Medicine have published his letters. Dr Feder has been quoted by the Associated Press, Washington Post, and other publications.
- Identified and wrote about NIH’s inadequate conflict-of-interest policies for biomedical researchers. The NIH later improved those policies, perhaps in part as a result of Dr. Feder’s efforts.
- Identified and wrote about FDA policies for ensuring the safety and effectiveness of medical devices. The policies may now be improving, perhaps in part as a result of Dr. Feder’s efforts.
Patients’ health is put at risk when outside experts advising the FDA have private financial interests that are undisclosed to the public. We propose specific ways to start correcting the problem. In short: POGO to FDA on conflicts of interest: Disclose them!
POGO questions if FDA is dealing well with conflicts of interest on FDA advisory committees.
We are writing about the failure by senior government officials to comply with an Executive Order that requires transparency in certain operations of the Office of Management and Budget (OMB) and the Office of Information and Regulatory Affairs (OIRA). The requirements for transparency, though spelled out clearly in the Executive Order, appear to have been systematically ignored, thus hiding the influence of competing interests on new regulations that affect the public health and welfare.
Since its creation thirty years ago, the Project On Government Oversight (POGO), a nonprofit, nonpartisan organization, has identified instances of financial conflicts of interest in the federal government and successfully pressed to correct them. We recently learned of industry ties among four members, including the acting chair, of a joint meeting last month of two FDA advisory committees—ties that were not disclosed to the public at the committee meeting.
The Project On Government Oversight is a nonpartisan independent watchdog that champions good government reforms. As such, we take a keen interest in the U.S. Food and Drug Administration (FDA), which receives around $4 billion a year in federal taxpayer dollars to regulate aspects of almost 25 percent of the U.S. economy.
An intrusion by the Office of Management and Budget (OMB) may be about to undermine the integrity of medical research supported by the National Institutes of Health (NIH). A new rule proposed by NIH will increase transparency in the financial arrangements of NIH funded researchers in medical schools and universities. However, the Project On Government Oversight (POGO) is concerned that OMB may weaken or block an important part of the proposed new rule.
In recent years the FDA’s Center for Devices and Radiological Health (CDRH) has improperly approved the marketing of medical devices that do not meet the FDA’s own standards for efficacy and safety. Some of the unlucky patients who received these defective devices have been seriously harmed by them.
Extramural investigators funded by the NIH may soon have their financial arrangements with industry disclosed on a public website.
We are writing to continue our correspondence on the possible use of statins to prevent influenza deaths.
We want to thank you for meeting with us two months ago to discuss the untenable situation in the FDA’s Center for Devices and Radiological Health (CDRH). During our July 17 meeting, it was apparent that you were dissatisfied and concerned about last year’s investigation of wrongdoing in CDRH conducted by the Inspector General’s Office of Investigations (OI). This investigation, which was triggered by whistleblowers' allegations of wrongdoing in CDRH, took place between May 2009 and December 2009 (the “2009 investigation”) and was completed a few months before you became director of OI.
Avandia, a drug made by GlaxoSmithKline for the treatment of diabetes, has been at the center of controversy for years, long before last month’s meeting of an FDA Advisory Committee charged with making recommendations on the marketing and labeling of this drug. The long-standing controversy was compounded by a problem that emerged soon after the meeting.
We ask that you arrange for Dr. Thomas Insel to step down as a leader of the NIH's effort to change its current rules on financial conflicts of interest. As we understand it, he is scheduled to remain in this position until the final rule is announced, which is likely to be several months from now.
I have received your letter of January 15 written in response to the October 30 letter to Secretary Sebelius from Danielle Brian and me. Unfortunately, your letter again avoids dealing with the issues we raised.
In an interview about six months ago you supported the idea of a database in which NIH grantees’ financial arrangements with outside organizations would be made public. We are writing to urge that you act forcefully on the implementation of this idea.
The Project On Government Oversight is dedicated to achieving a more effective, accountable, open, and ethical federal government. In articles and in communications with you and your predecessor as DHHS Secretary during the past 20 months, we have expressed concern about the lack of transparency in the pandemic flu vaccine program and about the risk that defects in the program, undisclosed and thus uncorrected, might lead to vaccine shortages in a pandemic. We regret that DHHS failed to act on our concerns. We now see a way in which prompt action by DHHS might benefit the country. In particular, we are writing about an unusual opportunity – a possible way to prevent many of the deaths caused by H1N1 influenza. It is an opportunity to establish whether these deaths can be prevented by treatment with a statin.
The vaccine shortage may be an inevitable result of DHHS's mistakes of the past. Those mistakes should be disclosed so they won't be repeated. The lack of disclosure is a problem that is easy and inexpensive to fix.
Thank you for your thoughtful response to our letter of June 6. We have carefully considered the plans you described in your letter of September 25 for dealing with the issues we raised. Because we believe these plans are inadequate, we are writing today to urge a specific alternative.
The shortage of H1N1 swine flu vaccine will persist for several months at least, and we believe that certain steps should be taken to deal with this issue. Some of the steps are described in the attached article, "Flu Vaccine Shortage: Why Did It Happen? How Can It Be Overcome?" which was posted today on POGO's website at http://www.pogo.org/pogo-files/alerts/public-health/ph-pfv-20090930.html. The article states:
We are writing again to request that you deal quickly with a pressing issue: ensuring full transparency in the government's program for producing H1N1 swine flu vaccine. While recognizing the demands of your time‑consuming focus on health care legislation, we nonetheless believe that the need for greater transparency in the vaccine program is urgent enough to require your prompt attention.
Those considering the amendment of regulations covered by NIH‑2008‑0002 should examine the passage below. It comes from a Letter to the Editor, "Public disclosure could deter conflicts of interest," published in Nature four years ago, before Senator Grassley discovered shocking financial conflicts of interest among NIH grantees.
This is a follow-up to our letter of March 17, 2009 (copy attached and also posted), a letter to which we have not received a reply. The main subject of the letter was the policy decision by CDRH to discontinue inspections of nonclinical laboratories – inspections covered by the Good Laboratory Practice regulation.
We are writing about a specific instance of regulatory failure in the Center for Devices and Radiological Health (CDRH) at the FDA: the case of AM2PAT, Inc., a small company that manufactured and sold syringes.
We are writing to ask about the failure of your office to disclose an action taken within CDRH: the decision to stop enforcing an important safety regulation.
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) oversees the safety of medical devices. Internal documents obtained by POGO reveal a decision made by senior CDRH officials that could put patients' lives at risk. Since 2006, the FDA is not ensuring that medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents are being tested according to good laboratory practices.
Hundreds have been sickened by salmonella-contaminated vegetables – victims of an under-funded Food and Drug Administration that once again has failed to ensure the safety of our food. Those recovering from their illness may be pleased to learn that the FDA is about to receive a long-overdue increase in its funding. But their pleasure will be short-lived when they realize the small size of the increase.
I am writing to confirm some comments made to me on the phone last week by Ms. Adrienne Burns, your Executive Assistant. On May 7 she said you and your associates were planning to respond to the letter of April 30 by Ms. Danielle Brian (Executive Director of POGO) and me.
We are writing about the apparent decision by the Center for Devices and Radiological Health not to enforce 21 CFR Part 58, the Good Laboratory Practice (GLP) regulations.
The U.S. is in a race to prepare for the mass production of a vaccine before the next influenza pandemic strikes. In a pandemic, there could be deaths in the hundreds of thousands in the U.S. and in the tens of millions worldwide. A vaccine will limit the harm caused by the influenza virus when it appears and spreads. Yet the current government plan for production of the vaccine for pandemic flu does not reflect the urgency of the problem nor the critical leadership it deserves. In addition, a lack of sufficient disclosure has beset the program to date.
The Oct. 30 news story "NIH's New Ethics Rules Lead Some to Ponder Jumping Ship" sounded the alarm that restrictions on outside income may cause the best and the brightest of the National Institutes of Health's researchers to retire or leave for academia, which has more lenient rules on moonlighting.
In his memo Feder challenges Director Zerhouni to correct serious deficiencies in the handling of conflicts of interest in the NIH’s intramural program.
The Food and Drug Administration has a brand-new policy bringing greater transparency regarding the agency's advisory committee members. The increased transparency will help address concerns over these members' conflicts of interest and the advice they give on drug and medical device approvals.