Duke agrees to pay $112.5 million to settle allegation it fraudulently obtained federal research funding

Seth Thomas Gulledge
Triangle Business Journal
Originally posted March 25, 2019

Duke University has agreed to pay $112.5 million to settle a suit with the federal government over allegations the university submitted false research reports to receive federal research dollars.

This week, the university reached a settlement over allegations brought forward by whistleblower Joseph Thomas – a former Duke employee – who alleged that during his time working as a lab research analyst in the pulmonary, asthma and critical care division of Duke University Health Systems, the clinical research coordinator, Erin Potts-Kant, manipulated and falsified studies to receive grant funding.

The case also contends that the university and its office of research support, upon discovering the fraud, knowingly concealed it from the government.

According to court documents, Duke was accused of submitting claims to the National Institute of Health (NIH) and Environmental Protection Agency (EPA) between 2006-2018 that contained "false or fabricated data" cause the two agencies to pay out grant funds they "otherwise would not have." Those fraudulent submissions, the case claims, netted the university nearly $200 million in federal research funding.

“Taxpayers expect and deserve that federal grant dollars will be used efficiently and honestly. Individuals and institutions that receive research funding from the federal government must be scrupulous in conducting research for the common good and rigorous in rooting out fraud,” said Matthew Martin, U.S. attorney for the Middle District of North Carolina in a statement announcing the settlement. “May this serve as a lesson that the use of false or fabricated data in grant applications or reports is completely unacceptable.”

The info is here.

Series of ethical stumbles tests NIH’s reliance on private sector for research funding

Lev Facher
STAT News
Originally published August 1, 2018

Here is an excerpt:

Now, the NIH is seeking to bounce back from the hit to its reputation — and to demonstrate that the failures of recent years are isolated incidents and not emblematic of a broader cultural problem. At the same time, some congressional aides have hinted at more aggressive oversight of the foundation through which the NIH takes on many of its partnerships.

NIH officials told STAT this week the agency is completing a plan to ensure better ethical compliance and better delineate the actual process for private-sector collaboration. The officials said the plan will be presented to an advisory committee in December.

Already, as STAT reported in April, the NIH proactively nixed a long-touted plan to accept roughly $200 million from pharmaceutical manufacturers to pursue research on pain and addiction treatment, with an explicit acknowledgement that involving companies being sued for their role in the crisis could taint the perception of the research.

NIH Director Francis Collins acknowledged the setbacks in an interview with STAT this week, but defended his staff’s efforts.

The info is here.

NIH adopts new rules on human research, worrying behavioral scientists

William Wan
The Washington Post
Originally posted January 24, 2018

Last year, the National Institutes of Health announced plans to tighten its rules for all research involving humans — including new requirements for scientists studying human behavior — and touched off a panic.

Some of the country’s biggest scientific associations, including the American Psychological Association and Federation of Associations in Behavioral and Brain Sciences, penned impassioned letters over the summer warning that the new policies could slow scientific progress, increase red tape and present obstacles for researchers working in smaller labs with less financial and administrative resources to deal with the added requirements. More than 3,500 scientists signed an open letter to NIH director Francis Collins.

The new rules are scheduled to take effect Thursday. They will have a big impact on how research is conducted, especially in fields like psychology and neuroscience. NIH distributes more than $32 billion each year, making it the largest public funder of biomedical and health research in the world, and the rules apply to any NIH-supported work that studies human subjects and is evaluating the effects of interventions on health or behavior.

The article is here.

Amid a Sea of False Findings, the NIH Tries Reform; Science needs to get its house in order, says Francis Collins, director of the NIH

By Paul Voosen
Chronicle of Higher Education
Originally published March 16, 2015

How do you change an entire scientific culture?

It may sound grandiose, but that is the loaded question now facing the National Institutes of Health, the federal agency that oversees and finances U.S. biomedical research.

While the public remains relatively unaware of the problem, it is now a truism in the scientific establishment that many preclinical biomedical studies, when subjected to additional scrutiny, turn out to be false.

Many researchers believe that if scientists set out to reproduce preclinical work published over the past decade, a majority would fail.

(cut)

The NIH, if it was at first reluctant to consider the problem, is now taking it seriously. Just over a year ago, the agency's director, Francis S. Collins, and his chief deputy, Lawrence A. Tabak, announced actions the agency would take to improve the research it finances.

Science needs to get its house in order, Dr. Collins said in a recent interview with The Chronicle.

The entire article is here.

U.S. high court won't review federal embryonic stem cell funds

By Terry Baynes
Reuters
Originally posted on January 7, 2013

The U.S. Supreme Court on Monday refused to review a challenge to federal funding of human embryonic stem cell research brought by two researchers who said the U.S. National Institutes of Health rules on such studies violate federal law.

The decision brings an end to a lawsuit that had threatened to hamper stem cell research after a district court judge blocked the taxpayer funding in 2010. But some observers expected the Supreme Court would decline the take the case after an appeals court ruled that the funding could continue.

U.S. law prohibits the NIH from funding the creation of human embryos for research or research in which human embryos are destroyed, but leaves room for debate over whether that includes work with human embryonic stem cells.

Opponents of such research, including many religious conservatives, have argued that it is unacceptable because it destroys human embryos.

Scientists hope to be able to use stem cells to find treatments for spinal cord injuries, cancer, diabetes and diseases such as Alzheimer's and Parkinson's.

The entire story is here.

Sanctioned Psychiatrist Gets First NIH Grant in 3 Years

by Jocelyn Kaiser
ScienceInsider
May 22, 2012

Dr. Nemeroff

A psychiatrist whose failure to disclose drug company income contributed to a furor over conflicts of interest in biomedical research has just received his first National Institutes of Health (NIH) grant in 3 years.

Charles Nemeroff's lax reporting of at least $1.2 million in drug company payments to his employer, Emory University, and similar payments to other academic psychiatrists prompted a 2007 Senate investigation.

Nemeroff stepped down as chair of psychiatry at Emory, and NIH suspended a $9-million grant he held for a depression study. In December 2008, Emory barred him from applying for NIH funding for 2 years.

The rest of the story is here.

A prior blog post about Dr. Nemeroff can be found here.

Health Guideline Panels Struggle with Conflicts of Interest

By Duff Wilson
The New York Times
Money and Policy

All 16 members of the United States Preventive Services Task Force were vetted to ensure they had no financial conflicts that would prohibit them from voting, according to the panel’s vice chairman, Dr. Albert L. Siu.

But three other federal panels that are quietly developing major public health guidelines on the leading causes of cardiovascular disease — hypertension, cholesterol and obesity — operate under less stringent ethics recommendations.

And one potential conflict after another has surfaced among the members, with some receiving speakers’ fees from drug companies, others consulting for pay and others doing company-financed research.
In all, about 20 of the three panels’ members, including some co-chairmen, have been advised that they should not vote on crucial issues as they prepare to issue the health guidelines next year — because they are too closely connected to industries with a keen interest in the panels’ recommendations.

Nearly a decade ago, the work of similar panels was so marred by charges of industry bias that the National Institutes of Health extensively heightened the scrutiny for individual panelists. But the decline in federal financing for medical research continued to pose problems, leaving many researchers to rely more heavily on private industry support. Specific new rules have been adopted to reduce the impact of conflicts of interest on guideline-writing panels.

But the N.I.H. groups, which meet behind closed doors, partly to avoid outside influence, had already been appointed when some of those rules were issued. Their finished work could wield a powerful influence on medical care, insurance and lifelong treatment for hypertension, obesity and cholesterol.

The entire article can be found here.

How An Ethically Challenged Researcher Found A Home at the University of Miami

By Paul Thacker

Forbes

Dr. Charles Nemeroff

Three weeks ago, the National Institutes of Health announced new rules to govern federally-funded researchers and their financial conflicts of interest. Three years in the making, the policy will affect over 38,000 scientists at 2000 organizations as the NIH attempts to ensure that biomedical research, paid with taxpayer dollars, remains objective.  (See our prior blog post.)

But none of these changes might have happened were it not for Dr. Charles Nemeroff.

A renowned chairman of psychiatry at Emory University, Nemeroff was a proponent for drugs sold by GlaxoSmithKline, such as the antidepressant Paxil. While earning hundreds of thousands of dollars jetting around the country and giving talks about Paxil to doctors at fancy restaurants, Nemeroff also managed a multi-million dollar grant from the NIH to research drugs under development by Glaxo.

The ensuing scandal became central to an investigation by Senator Charles Grassley into undisclosed payments from companies to prominent physicians—a practice that puts patients at risk and drives up healthcare costs. As Grassley’s lead investigator on the matter, I had a ringside seat as arguably the most powerful psychiatrist in the country was forced from prominence, eventually leaving Emory.

At my new job with the Project On Government Oversight (POGO), a government watchdog, I have continued to study the cozy relationships between physicians and corporations.  I also observed as Nemeroff left Emory for a new job at the University of Miami which has a medical school operating under financial strain. But why would this school snatch up a physician with such a history?

According to new emails and other materials shown to me, UM officials had serious concerns about Nemeroff’s history of ethical blunders. However, these emails suggest that Nemeroff’s perceived ability to raise money trumped those concerns. At one point while negotiating with UM for a job, Nemeroff even dangled the possibility of a new funder for the school if he was hired. These emails imply that, despite new federal rules, the public must remain vigilant to ensure that medicine is practiced with the highest regard for ethics and patient safety.

Officials at UM did not respond to detailed and repeated questions about the emails, which include communications by UM President Donna Shalala, who is now facing public scrutiny over a separate ethics scandal involving UM’s football program.

The entire story can be found here.

NIH Finalizes Financial Conflict of Interest Rules

By Brian Vastag

The Washington Post

Published: August 23

The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies.

The rules, which will affect more than 40,000 researchers, come after a string of high profile cases in which federally funded researchers failed to disclose millions of dollars from companies with a financial interest in the outcome of their work.

Researchers who receive more than $5,000 in income from drug or device companies must disclose the payments. Universities or other institutions employing the researchers must collect the data and provide for public access to it.

But in an about-face from proposed rules announced last year, institutions will not be forced to disclose conflict-of-interest information online. (See our prior blog post).  Instead, they may maintain the data offline and provide it only when requested.

This change reduces the administrative burden of the proposed public disclosure rule for institutions employing federally funded researchers, said Sally Rockey, the NIH’s deputy director for extramural research.

Universities also will be required to develop plans to manage the financial conflicts of individual researchers, but the plans do not have to be made public.

Praising the “vast majority of researchers” as ethical and sensitive to conflicts of interest, NIH Director Francis S. Collins called the new rules “an insurance plan against potential trouble downstream.”

Collins added that the rules will ensure that government-funded researchers can continue working with private companies.

The rest of the story can be read here.

Conflict disclosure plan dropped

The NIH will not require universities to create websites detailing researchers' financial ties.

Meredith Wadman

Francis Collins hailed it as a "new era of clarity and transparency in the management of financial conflicts of interest" (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers.

Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped. "They have pulled the rug out from under this," says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer-protection organization based in Washington DC. "It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH." It will also make it more difficult for "scholars to study the effects of conflicts of interest in universities", adds Sheldon Krimsky, who studies science ethics at Tufts University School of Medicine in Boston, Massachusetts.

The NIH's parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research. The DHHS called the proposed websites "an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust". Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, "that could directly and significantly affect the design, conduct, or reporting" of the research. The institutions would post the details online, where they would stay for at least five years.

But a government official with knowledge of the ongoing negotiations on the rule says that the institutions will now be allowed to choose how to disclose this information, and will not be obliged to post it online. This is likely to make it much harder for members of the public to find these details, says Ned Feder, a senior staff scientist with the Project on Government Oversight. The watchdog group, based in Washington DC, wrote last month to the White House Office of Management and Budget (OMB) urging that the website requirement be protected. The OMB must sign off on the finalized form of the rule before it is published.

The entire story can be found here.
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