Former Cancer Center director failed to disclose major financial conflicts of interest

Dr. Michele Carbone violated federal regulations when he failed to disclose both his additional annual income from expert testimony in asbestos litigation and the $4.3 million gift he received from a company involved in ongoing asbestos litigation that he is using in his mesothelioma research.

News Report
Will Caron

Dr. Michele Carbone—the former director of the University of Hawaii Cancer Center (UHCC) who was asked to resign in November of 2014 after evidence that he had grossly mismanaged the Manoa unit was publicized, and who was at the center of the power struggle that led to the controversial decision by the Board of Regents to remove former Manoa Chancellor Tom Apple—failed to disclose significant financial conflicts of interest to either the university (UH) or the National Institute of Health (NIH). A deposition from an asbestos litigation (Antonio Perez vs. ArvinMeritor, Inc.,et al.), obtained from the Kazan law firm in California, shows that Dr. Carbone admitted, under oath, to failing to disclose either his half-million dollar additional annual income from expert testimonies in asbestos litigations, or the multi-million donation he received for his genetic research on mesothelioma (cancer of the lining of the lungs caused by asbestos exposure) from a Fortune 100 company currently involved in ongoing asbestos litigations.

This income was collected during Dr. Carbone’s tenure as director of the UHCC (2009–14) and as a faculty member (2006–8 and 2013–present). Neglecting to disclose these significant financial relationships constitutes a serious violation of UH rules and federal NIH regulations on financial conflicts of interest. Carbone’s decision to hide his additional sources of income potentially exposes UH to devastating penalties, including the shut‐down of the $400 million federally‐funded research conducted at the Cancer Center.

In his deposition, Dr. Carbone admits to having received over 5 million dollars in consultant fees from asbestos companies for their asbestos‐mesothelioma litigations over nearly two decades. He also admits that he has never disclosed these relationships. In addition, in 2010 he sought and received for his research $4.3 million in gifts from Honeywell, a construction materials company involved in ongoing asbestos litigations. The company made its donation to Dr. Carbone’s research under the cover of anonymity through the University of Hawaii Foundation.

The current Manoa Chancellor, Robert Bley-Vroman, as well as the system Vice President for Research and Innovation, Vassilis L. Syrmos, confirmed to university faculty that they read this deposition in November of 2014 and that its content led to the decision to ask Dr. Carbone to resign as UHCC director at that time. The Manoa Faculty Senate recently learned from the Chancellor and the VPR that the ongoing investigation in the matter by the University of Hawaii is limited to Dr. Carbone’s outside employment and does not include his undisclosed financial conflicts of interest. According to UHCC faculty, it has become apparent that UH is in violation of NIH regulations about financial conflicts of interest and, in doing so, has exposed itself to a potential investigation by the NIH, and to potential penalties that could jeopardize federal research dollars at the university. The following is a summary of important evidence from within the deposition. The entire deposition can be read here.

1. As of November 7, 2014 (time of the deposition), Dr. Carbone had never reported as conflicts of interest to UH his consultation income from asbestos companies (p255–59).

2. His consultation income from asbestos companies in litigations has been over $500,000 per year for about 8 years prior to the deposition (i.e., about 2007 through 2014) and about half of that amount for prior years (p111–13, p50).

3. He charges $1,000 per hour for all his consultation activities (i.e., for review of pathology slides and medical records, testimonies, travel) for all his clients (p19, p49).

4. He usually charges about $10,000 per case, i.e. 10 hours per case (p49).

5. He typically takes about 50 cases per year (p25).

6. He used to charge $400 per hour for years up to about 8 years ago (p113).

7. He has served as an expert witness in asbestos‐mesothelioma litigations for over a decade, since around 1996–97 (p12, p50).

8. As a consultant for defendant asbestos companies, he disagrees with the mesothelioma diagnosis of the plaintiff patient’s treating doctor in about 10 percent of the cases (p45).

9. He sought and received a $4.3 million‐gift from Honeywell as an “anonymous gift” through the UH Foundation (p51–4, p260–61).

10. He actively sought the gift from Honeywell and he seeks similar gifts by speaking to defense lawyers at the Defense Research Institute meetings (p51–4).

11. He received the Honeywell gifts in 2010 through the UH Foundation as an “anonymous gift” (p260–61).

12. He did not disclose the Honeywell gifts until 2014 and has acknowledged the company in only two publications to date, out of ~35 publications since 2010: (1) “Germline BAP1 mutation and mesothelioma survival” (Baumann, Carbone et al. Carcinogenesis, 2015), (2) “Polyclonal origin of mesothelioma” (Comertpay, Carbone et al. Journal of Translational Medicine, 2014) (p264–65).

According to an NIH report, Dr. Carbone’s current R01 grant from the Department of Health and Human Services (DHHS) / NIH (July 2015–June 2020) is on “Germline BAP1 mutation and malignant mesothelioma: mechanisms and early detection.” Given the topic, any reliance on foundational work covered by the Honeywell moneys should have been disclosed at the time of the grant application and would now be subject to a retrospective review and to management plans as specified in the federal rules.

The federal Financial Conflict of Interest regulations require all DHHS research grant applicants and recipients to disclose all of their significant financial interests of above $5,000 per year that are related to any of their institutional responsibilities. The following are recent examples of federal sanctions for FCOI compliance violations (See weekly public announcements of scientific misconducts from NIH):

1. Columbia University Mesothelioma Center

2. NYU

3. Emory University

The BAP1 Defense

Dr. Carbone recently made headlines (September 2015, April 2015, March 2015) in law publications about his “BAP1 defense,” by which he claims that a certain genetic mutation may cause certain people to be more susceptible to mesothelioma. Even more extreme, Carbone testified in an ongoing mesothelioma lawsuit, Ortwein v Certainteed Corporation, that a person who possesses this mutation, called BAP1, can develop mesothelioma without any asbestos exposure.

“In other words, the BAP1 mutation, in and of itself, is capable of causing mesothelioma and many other cancers. However, asbestos exposure may increase the risk of developing mesothelioma in carriers of BAP1 mutations,” Carbone testified.

Companies like Certainteed, ArvinMeritor and Honeywell are using evidence provided by Dr. Carbone that this inherited mutation may be sufficient for a patient to develop mesothelioma without the presence of exposure to asbestos or other mineral fibers (p144–48) to try and get out of paying victims of mesothelioma who are, often, former employees of these companies exposed to large amounts of asbestos while on the job.

Dr. Joseph R. Testa, a geneticist and professor at the Fox Chase Cancer Center in Philadelphia, worked alongside Carbone to first discover that those with BAP1 mutations had a predisposition to mesothelioma. But he testified in the exact same case that a BAP1 mutation, on its own, is insufficient to cause cancer.

In the Ortwein case, plaintiff’s attorney Andrea Huston said she became aware that BAP1 might be used by as a defense strategy when her office received victim Holly Ortwein’s pathology slides from the defendants, which contained a report showing that “someone” within the University of Hawaii Cancer Center had done immunohistochemical staining for BAP1 protein expression.

“Companies that are being sued in mesothelioma litigation are trying to use this information as a defense to liability,” said Irena Kin, another attorney within the same law firm as Huston.

Meanwhile, Carbone still remains a tenured faculty member at the UHCC, on a $309,000 salary and with customized privileges, such as a bigger lab and office.