Surgeon General-Nominee Murthy Would Bring Clinical Trial Experience To Post
This article was originally published in The Pink Sheet Daily
Executive Summary
A Harvard physician, Vivek Murthy also co-founded a pharmaceutical clinical trial operations company.
President Barack Obama’s new choice for U.S. Surgeon General, Vivek Murthy, brings some atypical expertise to the post, having run a new business that supports clinical trial operations and employs online tools to do so.
He is the co-founder and chairman of TrialNetworks, which is involved in 30 pharmaceutical trials with sponsors including Merck & Co. Inc., Biogen Inc., Infinity Pharmaceuticals Inc. and Ariad Pharmaceuticals Inc.While many recent Surgeons General have previously run academic medical institutions or led medical practices, they’ve not run commercial business nor organizations focused as directly on pharmaceuticals.
Murthy seems to have an interest as well in issues such as diversity in trial populations, having written a medical school thesis on “Participation of Minorities in Clinical Trials” and authored a 2004 Journal of the American Medical Association article on how well racial and ethnic minorities, the elderly and women are represented in National Cancer Institute-funded studies.
The HHS Office of the Surgeon General does not have regulatory or operational duties (other than overseeing the Public Health Service Commissioned Corps). But it offers a forum for weighing in on policy discussions as well as advising the HHS secretary and public on public health matters, through annual reports, calls to action and other vehicles. The most visibly activist Surgeon General in the modern era was C. Everett Koop, who spoke out candidly on the emerging HIV/AIDS crisis in the 1980s and waged a vigorous anti-smoking campaign.
The White House announced the president’s intention to nominate Murthy to the post on Nov. 14. The position requires Senate confirmation, following a review by the Senate Health, Labor and Pensions Committee. Murthy would succeed Regina Benjamin, who left HHS earlier this year.
The Senate HELP Committee has not yet scheduled a confirmation hearing. It is possible that Murthy’s nomination, like previous Obama administration nominees, could become entangled in political dust-ups over health care reform, although so far the nomination itself has not generated much negative reaction.
Murthy, who received both a medical degree and an MBA from Yale in 2003, is a hospitalist attending physician and instructor at Brigham and Women’s Hospital at Harvard Medical School.
He has advocated on a number of policy issues from his position as co-founder and president of Doctors for America, self-described as “national movement of physicians and medical students working together to improve the health of the nation and to ensure that everyone has access to affordable, high quality health care.”
The group has launched various media campaigns supporting the Affordable Care Act and offers an outreach tool kit with post cards, brochures and enrollment guides for members who want to work in their community to aid enrollment in health exchanges and expanded Medicaid programs. Other activities include advocating for reimbursement incentives for preventive health services. In January 2011, Murthy was appointed to the federal Advisory Group on Prevention, Health Promotion, and Integrative and Public Health.
But more on point for biopharma is TrialNetworks, which provides a cloud-based platform employing collaborative trial management apps and other tools to improve trial site feasibility studies and selection, patient recruitment and engagement, site and document management, and site closeout. Headquartered outside Boston and originally named Epernicus, the company was established in 2010 and launched its software platform the following year. The technology company usually contracts with the drug company and interacts with both the sponsor’s study team and the staff of the contract research organization, if one is used.
A case study involving an Infinity trial describes use of frequent multi-media contacts keep site staff actively involved in patient recruitment. It included a “gamification” strategy, where trial sites had 30-day challenges to increase enrollment and were awarded website badges and other virtual acknowledgements of progress.
A second case study involves an Ariad effort to improve site feasibility surveys for a planned pivotal trial. It includes an interactive checklist survey system for site coordinators, direct links to relevant documents, use of video and images to accompany questions, and custom alerts and other reminders.
While declining to name any candidate products, TrialNetworks Co-Founder and CEO Eric Silberstein said the company has been involved in studies ranging from early-phase trials to registration trials with more than 15,000 subjects. Most are global trials and some are expected soon to yield marketing applications.
If confirmed, Murthy will relinquish his CEO post and likely also his ownership of the company.