Conflict of Interest Policies Joe Giffels Director, Research Integrity Office
Policy onProfessional External Activities • Responsibilities associated with faculty position must be fully satisfied • Prior approval by Dean or Dean’s Designee is required • Enhance professional standing or contribute to fulfillment of School’s mission • Report on activities each semester The University System of Maryland encourages its faculty to use its expertise in serving the economic and social interests of the community and the advancement of the academic disciplines.
Policies Supporting Professionalism and Education in Medicine • No gifts (including food and travel) • Carefully controlled access to faculty, students and patients • Industry involvement in CME managed by the CME Office • Industry-sponsored presentations and scholarships only under certain circumstances • No ghostwriting The UMB School of Medicine adopts the following policies so that the interactions of its faculty and students with representatives of industry associated with health care or medical education consistently reflect the principles of professional accountability and professionalism in all medical education settings.
Conflict of Interest Policy Maryland law encourages public senior higher education institutions such as UMB to promote State economic development and to increase their financial resources through arrangements with the private sector, including collaborative research and development, commercial application of institution-owned intellectual property, and provision of technical assistance to the business community. • Disclosure of financial relationships with commercial entities • Exemption (approval) of relationships is required, usually with conditions intended to manage the effects of the conflict of interest on academic activities
Intellectual Property (IP) Policy The primary mission of universities is to create, preserve, and disseminate knowledge. When that knowledge takes the form of intellectual property, a university must establish a clear and explicit policy that will protect the interests of both its creators and the university while ensuring that society benefits from the fair and full dissemination of that knowledge. • Ownership of IP rests with the University • Revenue from licensing shared with creators
August 5, 2009 Medical Papers by Ghostwriters Pushed Therapy By NATASHA SINGER Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
September 11, 2009 Ghostwriting Is Called Rife in Medical Journals By DUFF WILSON and NATASHA SINGER Six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association.
Surgeon's Royalties Bring Heat to a Medical School With a Strict Ethics Policy By PAUL BASKEN The University of Wisconsin enjoys a sterling reputation for policing the ethics of its medical school faculty and staff. "They're one of our stars," said Susan C. Chimonas of the Institute on Medicine as a Profession at Columbia University, which ranks institutions on the quality of their programs to avoid and disclose ethical conflicts of interest, like taking money from companies while treating patients with their products.
Some university officials were thus unpleasantly surprised by recent newspaper articles that detailed how Thomas A. Zdeblick, a renowned spine surgeon who is chairman of the university's department of orthopedics, collected $19.4 million between 2003 and 2007 from Medtronic, a medical-device supplier that sells spinal implants developed by Dr. Zdeblick. The university requires any researcher who collects $20,000 or more a year from outside parties to enter into a management plan that sets out various restrictions. Dr. Zdeblick did comply by entering such a plan. But the degree to which his outside income exceeded the $20,000 trigger is now raising questions about whether one of the nation's top-ranked conflict-of-interest policies is tough enough. And Medtronic announced this week that it would begin disclosing the names of physicians who receive at least $5,000 from the company.
Senator Grassley and his staff have been highlighting a series of such cases, in addition to that of Dr. Zdeblick, whose multimillion-dollar payments were first revealed publicly more than three years ago. Among the cases is one involving Charles B. Nemeroff, former chairman of the psychiatry department at Emory University, who faces a federal investigation into allegations he misled the National Institutes of Health about his paid consulting work for GlaxoSmithKline while conducting an NIH-funded study of Glaxo drugs for use as antidepressants (The Chronicle, December 29, 2008).
September 4, 2009 Company Says Research It Sponsored at Pitt and Hopkins Was Fraudulent By Goldie Blumenstyk Technology-transfer deals at universities can easily go sour, but rarely do they end up with the corporate partner suing an inventor and his institution for research fraud. The University of Pittsburgh and the Johns Hopkins University now find themselves in that unusual situation, as a company that says it spent millions of dollars sponsoring research by a prominent scientist, expecting to use his promising inventions as the basis for a new test for prostate cancer, is now accusing the professor and the institutions of falsifying his results. The company, Onconome Inc., says the professor, Robert H. Getzenberg, lied about his findings and progress from 2001 through 2008. Mr. Getzenberg has been a professor of urology and director of research at a urology institute at Johns Hopkins since 2005; previously he held similar posts at Pitt. He was also a paid scientific adviser to Onconome.
Conflict of Interest Policies Joe Giffels Director, Research Integrity Office JGiff001@umaryland.edu 410-706-1853 www.umaryland.edu/research_integrity/index.html