The war against innovation and collaboration between physicians and industry has claimed another victim—and potentially thousands more in the form of patients—as a “prominent University of Wisconsin cancer researcher resigned last week after university officials began investigating a potential conflict of interest involving his outside business interests.” Fortunately, he is considering other positions that allow him the freedom and independence to work with anyone and everyone he wants.
What is disappointing about this case, which involves “Dr. Minesh Mehta, an internationally recognized expert on human clinical cancer trials,” and winner of the Ladies Home Journal Breakthrough in Innovation Award “comes amid heightened national scrutiny of doctors’ ties to industry and the university’s own attempts to better monitor such relationships.” In other words, there was no evidence of any harm or wrong doing on the part of Dr. Mehta. Instead, the atmosphere that has been created by media, critics and policymakers has made it almost impossible for researchers to work with industry to advance medicine and their training while still leading a normal career and life.
This case arose back in April, when “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 Wisconsin State Journal.”
The issue that came about surrounds the fact that Dr. Mehta has been the lead researcher of a federally funded clinical trial of a specialized radiation treatment for cancer patients known generically as tomotherapy over the past decade. According to UW-Madison, this created a potential conflict because “the device used to administer the radiation to a majority of participants in the study is made by TomoTherapy.”
Consequently, UW-Madison initiated a formal investigation, and participants in the clinical trial subsequently were told of the potential conflict. In the notification letter to participants, UW-Madison told participants 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.”
Dr. Mehta’s ties to TomoTherapy (the company called the same name as the treatment) also became 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.” Specifically, Dr. Glatstein accused him of not revealing his ties to TomoTherpay when Dr. Mehta criticized a TomoTherapy competitor in the pages of the same scholarly journal. This led Glatstein to group Dr. Mehta into “a generation of people who don’t seem to recognize a conflict of interest when it smashes them in the mouth.”
Amidst this controversy however, Dr. Mehta firmly maintains that there “is no conflict of interest involving his work.” Rather, he had “been considering leaving UW-Madison since early 2009 and based on the unique and new opportunities that have presented themselves, which is very common in the academic field.” After notifying the university of his resignation on May 10, he ended his 22 year career at UW on June 4.
Another reason why this case is so troubling is that even though Dr. Mehta followed all the necessary policies and he “filed reports each year covering his outside business income as required by university policies,” the university still used the “potential” for conflict to investigate his work. Despite the fact that he even “notified the university in 2008 that he was reducing his university appointment by 10 percent to spend time as a consultant for TomoTherapy,” this transparency was not enough.
Adding to this problem is the fact that media articles like this one cover the issue in a way that helps perpetuate criticism against physician-industry collaboration by focusing on his compensation last year, rather than the success TomoTherpay has provided to patients and the outcomes it has shown in clinical care.
Moreover, the fact that Mehta’s professional vitae shows he was chairman of TomoTherapy’s medical advisory board from 2001-08, and a video posted on the company’s website that describes “his involvement with the development and implementation of TomoTherapy,” should be reassuring, not problematic. Patients should want and in fact do want their physicians to have the most experience and training possible, especially when treating serious and life threatening diseases like cancer. The fact that this therapy is used through a device also constitutes a specific need for physicians like Dr. Mehta who have developed the device and know the designs, techniques, flaws, and best uses to help train other physicians accordingly.
But Dr. Mehta’s involvement with the development and implementation of the device does not create a potential for conflict for two simple reasons. First, the federal research study, which started in 2001, “has never been funded by any corporate support.” Second, the study is designed “to test a general principle — the maximum safe dose of radiation for lung cancer patients — not a particular device.” Those two factors, Dr. Mehta assert, clearly show “there is no direct conflict.”
Additionally, as CEO of TomoTherapy Fred Robertson put it, Dr. Mehta is “a man of high integrity who has been very careful to disclose any conflicts of interest.”
Consequently, the fact that the investigation into the potential conflict continues despite Mehta’s departure, is misguided. For instance, although Dr. Mehta has been receiving federal funding from NIH since his 2000 grant application, he only began receiving payment as a consultant for TomoTherapy in 2008, and NIH has not expressed any concern thus far of any potential conflicts. In addition, Dr. Mehta was already under three separate management plans, which according to Jim Wells, director of research policy for UW-Madison “generally work.” So if formal investigations are “quite rare,” then how is it that UW-Madison decided to conduct one on a professor who has filed all his annual reports and was following three management plans?
Ultimately, the fact that Dr. Mehta sought “formal and official clearance” from the university prior to initiating his consulting work with TomoTherapy demonstrates the high level integrity he has for working with patients while ensuring transparency. Since the UW-Madison has already expressed to participants that Dr. Mehta’s participation in this research on the use of tomotherapy did not in any way compromise the results of the study or the safety of the people taking part in the study, it is time to put this show to an end.
In the end, UW has already lost one important faculty member, and if we want to continue to attract physicians and researchers to academic medical centers, university policies and administrators would do better by patients and staff by moving away from such strict regulations that hinder innovation and chill physician willingness to participate and collaborate with industry.
Transparency is more than enough for now, at least until someone can show any kind of evidence that demonstrates what harm is done to a patient for a doctor to work with a company to help save patients lives.