September 20, 2005

Medical College Pays $4.4 Mil Settlement

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Weill Cornell Medical College paid a $4.4 million settlement this past June over allegations that it was using part of its $23 million research grant from the National Institutes of Health (NIH) for private patient care.

Like Harvard, Northwestern and three other institutions that have agreed to similar settlements since 2003, Cornell admitted no wrongdoing or liability in the lawsuit.

An assistant professor at the medical college with special NIH duties first brought the lawsuit against Cornell and 11 members of its senior faculty, including Dean Antonio Gotto, in fall 2003.

Weill Cornell recruited Kyriakie Sarafoglou in Aug. 2001 as the research subject advocate for its Children’s Clinical Research Center (CCRC). Salaried by the NIH, Sarafoglou was responsible for overseeing patient safety during research and reviewing the CCRC’s research protocols or projects. Six or seven months into her job, Sarafoglou said she discovered many discrepancies between how the CCRC operated and what it reported to the NIH.

When she attempted to bring her concerns to various university officials, the doctor said, they retaliated against her by excluding her from meetings, demoting her to general pediatrics and recommending her for a psychiatric evaluation, among other things.

During this period, Cornell conducted an internal investigation into Sarafoglou’s claims. Headed by Prof. Adam Asch, the investigation found “no evidence of financial impropriety.”

“Dr. Sarafoglou appears to have adopted a confrontational and accusatory posture in her dealings with colleagues and appears to have misinterpreted the scientific rationale for some of the studies,” the Asch report stated.

In Sept. 2003, Sarafoglou filed a qui tam lawsuit, brought by an individual on behalf of the government when misuse of government funds is alleged.

Alleged grant misuse

In her lawsuit, Sarafoglou alleged that Cornell overstated its projections for hospital days and outpatient visits in its grant proposal to the NIH to receive more money from the government organization.

The University estimated that a protocol to study children with congenital HIV would require 80 hospital days and 600 outpatient visits. Over the fiscal year, not a single patient was enrolled for the protocol, Sarafoglou stated.

She continued, “34 of the 37 protocols listed in the 2002 Grant Application failed to meet their projected inpatient and outpatient visits. Indeed, the 34 protocols failed to admit even half of the inpatient days and outpatient visits projected in the 2002 Grant Application.”

Likewise, for its 2002 and 2003 NIH grant applications, Cornell submitted the names and salaries of three nurses who had left in 2000, the doctor stated. The school also used NIH-funded nurses to treat private patients, according to her.

The medical school used funding for the NIH core lab, intended for research on children, towards standard care tests in its private laboratories, Sarafoglou stated in an email. The lawsuit alleged that in April 2002, Cornell performed 129 steroid profiles of private endocrine patients in the core lab. The University billed insurance carriers for these standard, non-research related tests, but did not refund money to NIH.

“Cornell made very little attempt to distinguish between research and private labs,” Sarafoglou wrote in her email.

Stephen Immelt, Cornell’s lead counsel in the lawsuit, told the Aug. 16 Wall Street Journal that many patients participating in NIH studies also receive standard treatment from the school. “The challenge is to create a system that catches an extra X-ray or a second blood sample and accounts for that correctly,” he said.

One of the 11 people named in the lawsuit was Dr. Maria New, chair of the pediatric department and program director of the CCRC.

“Dr. New dominated research in the pediatric center,” Sarafoglou told The Sun. “In pediatrics, [research] is supposed to be used by everyone. Not only one person benefits; not only one disease benefits.”

She said that Dr. New violated the NIH’s 33% guideline, which limits researchers to using at most a third of the funding.

In reviewing the school records, the US Attorney found that in 2003 Dr. New used 80% of inpatient resources and 67% of outpatient resources.

Dr. New’s lawyer, Kenneth Schacter, denied that she restricted any of her colleagues from accessing the research facilities.

What happened, Schacter said, was that “in certain years, the actual usage by other researchers at Cornell was lower than had been projected at the beginning of the year, with the result that Dr. New’s actual usage as a percentage of the total was actually higher than expected.”

For example, he said, in one year Dr. New might put in a request for 500 bed stays, while the other researchers combined might put down 1000 bed stays. If the researchers used less than their projected bed stays, then the percentage of Dr. New’s usage would go up.

For her part, Dr. New declined to comment, saying only that “much of what was written” in the earlier article by The Wall Street Journal “was untrue.”

The results

After investigating Sarafoglou’s claims, the US Attorney found Cornell to be in violation of a number of NIH regulations. Out of the $4.4 million settlement reached, Sarafoglou received $877,000 for her part in the suit.

Sarafoglou said that she had a difficult time finding a position at another university after the lawsuit.

“People were scared,” she recalled. “My options were very limited.”

She finally found a job as an assistant professor at the University of Minnesota Medical School, which had its own lawsuit in the early 1990s over misuse of grant money.

Besides paying a $32 million settlement, Minnesota was put under sanction by the NIH with strict restrictions on their spending and heavy oversight from government officials.

The NIH “gave us a huge volume of things we had to do,” said Winifred Schumi, assistant vice president for research at the university. Among the decrees were defining roles and responsibilities for everyone involved, establishing a training program for responsible conduct and research training and conducting random transaction reviews.

Schumi continued, “the NIH used us as an example, and now they have been doing proactive site visits” at other universities.

In the wake of multiple civil settlements, the NIH is mandating more regulatory controls at universities receiving its funding.

Weill Cornell, in addition to implementing a mandatory training program and random internal reviews, will establish a research compliance support team to work with investigators, its public affairs office said.

Sarafoglou is continuing to pursue litigation for broader claims the US Attorney did not cover, the doctor and her lawyer said.

Archived article by Xiaowei Cathy Tang
Sun Senior Editor