Charles Bennett, an oncologist and cancer researcher whose work focuses on adverse events caused by pharmaceutical products, settled a federal complaint brought by a whistleblower alleging irregularities in the management of R01 research grants administered by Northwestern University.
Northwestern paid $2.93 million in 2013 to settle allegations of mismanaging five of Bennett’s R01 grants.
In an agreement made public Oct. 30, the government said it would dismiss its suit, filed under the False Claims Act, in exchange for a payment of $475,000 by Bennett. The deal, which was based on analysis of Bennett’s finances, allowed the parties to “avoid the delay, uncertainty, inconvenience, and expense of protracted litigation,” court documents state.
However, the announcement also included some parting shots: “Dr. Bennett expressly denies the allegations of the United States.”
Countering, the government “contends that it has certain civil claims against Dr. Bennett arising out of his improper submission of claims to Northwestern University for grant expenditures for: professional and consulting services, airfare and other transportation, conference registration fees, food, hotel, travel, meals, and other expenditures for items that were for the personal benefit of Dr. Bennett, his friends, and his family that were incurred in connection with certain grants as to which Dr. Bennett was a PI.”
The settlement agreement and the complaint are available on The Cancer Letter website.
Bennett made important contributions to describing adverse events associated with erythropoiesis-stimulating agents (The Cancer Letter, June 1, 2007; June 8, 2007; Feb. 29, 2008; March 21, 2008; Aug. 8, 2008; Oct. 3, 2008).
Bennett’s R01-funded research has resulted in multiple “Black Box” warnings from FDA. His supporters say his research has saved billions of dollars in expenditures by government agencies and private health insurers as well as thousands of lives, while making powerful enemies in the pharmaceutical industry. He continues to be supported with funding from NIH and has authored over 350 publications, many in top-tier medical journals.
Through much of his career, Bennett was on the faculty of Northwestern University’s Robert H. Lurie Comprehensive Center for Cancer.
A temporary employee hired by the Northwestern University Faculty Foundation in 2008 filed a whistleblower lawsuit claiming that he had improperly submitted reimbursement requests to Northwestern University for activities related to his NIH and NCI grants. In 2010, Bennett accepted an offer to be one of 47 SmartState endowed professors in South Carolina. He leads the only state-funded pharmaceutical safety program in the nation.
The Two Settlements
The government’s suit against Northwestern was unsealed last year, in conjunction with the university’s agreement to refund money to the federal government (The Cancer Letter, Aug. 9, 2013).
Northwestern’s settlement, which similarly didn’t acknowledge wrongdoing, left Bennett open to civil actions by the U.S. Department of Justice. Now, these actions have concluded, but Bennett may still be open to administrative sanctions.
“The settlement with the government is similar to the settlement agreement of Northwestern submitted on July 30, 2013, i.e. it contains an explicit denial by Dr. Bennett of the government’s allegations,” Bennett’s attorney James McGurk said to The Cancer Letter.
“The settlement was entered into by Dr. Bennett to avoid the expense and the drain of a trial,” McGurk said. “The grants which are the subject of the government’s complaint are, in some cases, 11 years old.
“Dr. Bennett has continued his work including recent significant publications in the New England Journal of Medicine on May 22 and a publication last week in the Journal of Clinical Oncology on Oct. 20.
“Dr. Bennett continues his work at the University of South Carolina,” McGurk said. “There has never been any suggestion that Dr. Bennett’s very significant scientific work was flawed or unsound in any way.”
Bennett’s supporters say that his work is first-rate.
“Charlie was a pioneer in tracing adverse drug reactions,” said Steven Rosen, former director of Northwestern’s cancer center who is now the provost, chief scientific officer and director of the cancer center at City of Hope. “His work had a profound effect on American medicine and lives were saved.”
At Northwestern, Bennett founded the Research on Adverse Drug Events and Reports (RADAR) project and, subsequently, at the University of South Carolina, he founded the Southern Network on Adverse Reactions (SONAR).
The two programs review physician queries, published and unpublished clinical trials, case reports, FDA databases and manufacturer sales figures to identify serious adverse drug and device reactions. According to a recent paper these programs have reported 50 serious ADRs. Data sources include case reports, registries, referral centers, and patients. SONAR, which is funded by NCI, has identified 20 ADRs.
The two programs flagged ticlopidine- and clopidogrel-associated thrombotic thrombocytopenic purpura, rituximab- and brentuximab vedotin-associated progressive multifocal leucoencephalopathy, erythropoietin- and darbepoetin-associated venous thromboembolism and mortality, erythropoietin-associated pure red cell aplasia, and thalidomide- and lenalidomide-associated venous thromboembolism.
Bennett was the first academic to jointly file a petition to the FDA with a state attorney general—Richard Blumenthal, who was then attorney general of Connecticut—requesting that a Black Box warning be added to the package label of a drug. This petition was granted in 2006.
The allegations against Bennett were made in a civil lawsuit filed under seal in 2009 by Melissa Theis, who came to Northwestern in 2007 and later became a purchasing coordinator for the Division of Hematology and Oncology at Northwestern’s Feinberg School of Medicine. She left the university in 2008.
The division, which is separate from the cancer center, administered all but one of the grants in question, the NIH database shows.
In actions of this sort, the individual plaintiff, called “relator,” is usually an insider who has worked for several years at a company and brings forward information the government couldn’t otherwise obtain. The relator is rewarded with a portion of recovered funds. Theis collected $498,100 from Northwestern’s settlement with the government and will collect $80,750 from Bennett’s.
The suit remained under seal until July 30, 2013, when it was released in conjunction with the memorandum of settlement between the prosecutors and Northwestern.
When the action and the settlement deal in the case against Northwestern were unsealed, documents showed that the relator also made allegations against then-center director Rosen. However, the final settlement document contains no allegations against Rosen.
Sources close to Rosen said that until the settlement he was unaware of having been a defendant in the sealed federal lawsuit.
Days before the settlement with Northwestern was announced, a former research administrator at the Division of Hematology and Oncology at the university’s medical school pled guilty to felony charges stemming from administration of Bennett’s NCI grants.
According to documents filed in the U.S. District Court for the Northern District of Illinois, Feyifunmi Sangoleye, the administrator for Bennett’s grants, set up an elaborate scheme to divert $86,000 to her personal accounts. The proceeds financed a wedding and a honeymoon in Europe, court documents say.
Legal experts said to The Cancer Letter that the final plea agreement between Sangoleye and the government would have weakened Northwestern’s position in negotiating the settlement. The final version of the plea agreement with Sangoleye was filed on July 25, 2013, five days prior to the announcement of the government’s settlement with Northwestern.
In 2005, Northwestern paid $5.75 million to settle similar allegations of grant mismanagement of NIH-funded projects, including one grant supporting the Pediatric Oncology Group.