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A prominent UW-Madison cancer researcher has abruptly resigned after university officials began investigating a potential conflict of interest involving his outside business interests.

The case involving Dr. Minesh Mehta, an internationally recognized expert on human clinical cancer trials, comes amid heightened national scrutiny of doctors' ties to industry and the university's own attempts to better monitor such relationships.

In April, the UW-Madison committee responsible for protecting the rights and welfare of participants in research studies became aware of a potential conflict involving Mehta and his paid consulting work with TomoTherapy Inc., a Madison company that makes cancer treatment devices, according to documents obtained by the State Journal through an open records request.

For most of the last decade, Mehta has been the lead researcher of a federally funded clinical trial of a specialized radiation treatment for cancer patients known generically as tomotherapy. The device used to administer the radiation to a majority of participants in the study is made by TomoTherapy.

UW-Madison initiated a formal investigation, and participants in the clinical trial subsequently were told of the potential conflict, said Lisa Brunette, a UW Hospital spokeswoman.

In the notification letter to participants, a copy of which the State Journal obtained, UW-Madison says "information about this type of potential financial conflict of interest is ordinarily included in the consent form presented to potential research subjects."

Mehta, a professor of human oncology, notified the university of his resignation May 10, ending 22 years of employment, according to his resignation letter. His last day was June 4. Mehta's letter gives no reason for his resignation and doesn't mention an investigation.

In an e-mail message last week, Mehta told the State Journal he does not have another job lined up but is mulling several offers. He said he had been considering leaving UW-Madison since early 2009 and that his departure is "based on the unique and new opportunities that have presented themselves, which is very common in the academic field."

He said there is no conflict of interest involving his work.

TomoTherapy ties

Mehta notified the university in 2008 that he was reducing his university appointment by 10 percent to spend time as a consultant for TomoTherapy.

Last year, Mehta earned more than $20,000 in compensation and more than $10,000 in stock options from TomoTherapy for 20 days' worth of consulting work, according to records he filed with the university. (At the time, faculty members were required only to check broad ranges for outside income, with "more than $20,000" the highest category.)

Mehta's professional vitae says he was chairman of TomoTherapy's medical advisory board from 2001-08, and in a video posted on the company's website, he describes himself as having been "involved with the development and implementation of TomoTherapy."

The federal clinical trial involving the TomoTherapy device began in 2001 and is ongoing, although Mehta's role as lead researcher ended with his resignation, according to the university.

Mehta's explanation

Mehta told the State Journal he sought "formal and official clearance" from the university prior to initiating his consulting work with TomoTherapy.

Brunette, the UW Hospital spokeswoman, said there is no formal process for clearance, although some faculty members choose to submit a proposed contract to university officials for review. At press time, Brunette said the university could find no evidence of such correspondence from Mehta, although the search was ongoing.

Mehta has filed reports each year covering his outside business income as required by university policies.

As for the federal research study, Mehta said it has never been funded by any corporate support. More importantly, the study is designed to test a general principle — the maximum safe dose of radiation for lung cancer patients — not a particular device, he said.

Consequently, "there is no direct conflict," he said.

The notification letter to participants says that while it "is not believed that (Mehta's) participation in this research on the use of tomotherapy in any way compromised the results of the study or the safety of the people taking part in the study, we felt that participants in this study should be informed of Dr. Mehta's financial relationship."

The investigation into the potential conflict continues despite Mehta's departure, Brunette said.

Public scrutiny

Mehta's ties to TomoTherapy became much more public last November when Dr. Eli Glatstein, a University of Pennsylvania School of Medicine professor and a revered figure in oncology research circles, chastised Mehta in an editorial in the International Journal of Radiation Oncology Biology Physics.

Glatstein was irked that Mehta didn't reveal his ties to TomoTherapy when criticizing a TomoTherapy competitor in the pages of the same scholarly journal. In an e-mail message to the State Journal, Glatstein said his beef was not just with Mehta but with "a generation of people who don't seem to recognize a conflict of interest when it smashes them in the mouth."

Fred Robertson, CEO of TomoTherapy, said Mehta continues to work as a consultant for the company. He called Mehta a man of high integrity. "I think he's been very careful to disclose any conflicts of interest," Robertson said.

More oversight

Federal officials soon may tighten laws related to federal research — new rules under consideration would require researchers to report any outside income over $5,000, down from $10,000.

No mention is made of an association with TomoTherapy in Mehta's 2000 grant application to the National Institutes of Health, which is funding the trial. But Mehta's paid consulting work with TomoTherapy began only in 2008, according to Mehta. The State Journal has no information that NIH has any concerns about Mehta and potential conflicts of interest.

Meanwhile, the UW Medical Foundation approved stricter conflict-of-interest rules late last year. Doctors now must report the actual amount of outside money they earn to the nearest $1,000, as opposed to a broad range.

UW-Madison uses management plans to try to mitigate conflicts, and Mehta operated under three such plans in 2009, one each for his ties to Pharmacyclics, ProCertus Inc. and TomoTherapy.

The plans required Mehta to notify students and staff of any potential conflicts and disclose, when appropriate, his business ties when making presentations and publishing his research.

Management plans "are not unusual and not even negative," said Jim Wells, director of research policy for UW-Madison.

"There's an interest in having ideas get out of the labs and workshops and into the Wisconsin economy — and the world economy," Wells said. "So faculty members sometimes do get involved in that kind of outside activity."

Management plans and other safeguards rely on self-reporting, which generally works, Wells said. When it doesn't, a formal investigation such as the one involving Mehta is undertaken, although such investigations "are quite rare," he said.

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