Industry Collaboration & Interactions With Health Professionals - Can Conflicts of Interest Be Properly Managed? FDA Regulatory and Compliance Symposium Harvard Annenberg Hall August 22, 2007

2 COI Issues Panel David Rothman, Ph.D. Associate Director, Prescription Project; President of the Institute on Medicine as a Profession and Bernard Schoenberg Professor of Social Medicine at Columbia College of Physicians & Surgeons Tom Stossel, M.D. American Cancer Society Professor, Department of Medicine, Harvard Medical School; Co-Director, Division of Hematology, Brigham and Women's Hospital Cathryn Clary, M.D., M.B.A. Vice-President, External Medical Affairs, Pfizer Jon Merz, M.B.A., J.D., Ph.D. Associate Professor, Bioethics, University of Pennsylvania; Associate Chair for Faculty Affairs in the Department of Medical Ethics in the School of Medicine, Senior Fellow in the Center for Bioethics, and Associate Scholar in the Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania. Marc Wilenzick, J.D. (moderator) Assistant General Counsel, Pfizer

3 Disclosures The views expressed by me and the panelists are mine and theirs, and aren’t necessarily the views of their employer(s) or any other group. Some relevant financial information is provided in the following chart.

4 Wilenzick Assistant General Counsel, Pfizer Inc; Stockholder in Pfizer, Inc. Stossel American Cancer Society Professor, Department of Medicine, Harvard Medical School; Co-Director, Division of Hematology, Brigham and Women's Hospital. Member of the Scientific Leadership Advisory Board of Merck, Member of the Boards of Directors For ZymeQuest and Critical Biologics to whom his employer, Brigham & Women's Hospital, has licensed, which may or may not result in milestone payments and royalties; prior service on the scientific advisory boards of Biogen and Dyax. Has spoken for IMS Health, Pfizer, Bristol Myers Squibb, Amgen. Published on COI Issues Rothman Bernard Schoenberg Professor of Social Medicine; President, Institute on Medicine as a Profession, Columbia University; Associate Director of the Prescription Project. Grants from IMAP, from Pew Charitable Trust, AG Oregon Prescription Drug Program. Published on COI in JAMA, Health Affairs JGIM Clary Vice-President, External Medical Affairs, Pfizer; Stockholder in Pfizer, Inc. Merz Associate Professor, Bioethics, University of Pennsylvania. Grants - Consumer Project on Tech. (now Knowledge Ecology International), NIH Ethics advisory boards for Wyeth, Schering Plough, and the Moffitt Cancer Center, Consultant to Wyeth and Schering, Honoraria from the NIH, ACRIN, Moffitt, WHO Am J Bioethics 2003; 3(3):39-46 Article on Gifts (funded in part by an unrestricted gift from Pfizer to the Penn Center for Bioethics).

Background

6 Dr. Brown says he gives two to three lectures a week advocating universal herpes testing for pregnant women, earning $1,000 to $2,500 per talk. He says his motive isn't money but a desire to reduce the number of babies born with herpes. Because his own university lacks the funds to pay for his lectures, he says, he has a relationship with Glaxo born of necessity. "I am using them and they are using me," he said recently as he waited to board a flight to Tennessee for a series of lectures at hospitals there. SJ_ html

The business of medical repping, although infrequently scrutinized, is invariably seen as a negative in the public eye, somewhere between legislative logrolling and subsidizing Big Sugar. The unethical influencing of our prescribing, the corruption of the sacred relationship between doctor and patient, allegations of bribery, unnecessarily increasing the price of health- care — these are on the rep's rap sheet. Yet it's a perfectly legal profession. Here are three reasons why. Unlike doctors, drug companies are truly and primarily businesses. They invest billions and come up with many great, new products which cannot be sold, whatsoever, without convincing doctors to prescribe them. * * Secondly, many doctors rely on reps for practical information. Someone has to show the doctors the new stuff they can prescribe, or the new procedures they can do using new medical equipment.

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11 * * The researchers said later they didn't believe their industry connections were relevant because the study of hip fractures didn't involve bone drugs and didn't recommend them. DeAngelis said she believes her journal is being unfairly scrutinized by The AP, which found the researchers' ties to drug companies through searches on the Internet and through a consumer database. "This has nothing to do with drugs," she said. "At what point do you say, come on, is this a witch hunt?" * * A close reading of JAMA's guidelines suggests the fracture study authors' ties to drug makers are "clearly relevant," said Dr. Michael Callaham, president of the World Association of Medical Editors. "It's a slam dunk," he said.

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Presentations

Issue Discussion - Panel

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Q & A with Panel