The Lessons of Experience: Selected Tidbits from a Mid-career Academic Pharmacoepidemiologist

• Introduction • Selected perspectives on pharmacoepidemiology • Advice for future pharmacoepidemiologists

CCEB

The Lessons of Experience: Selected Tidbits from a Mid-career Academic Pharmacoepidemiologist

• Introduction • Selected perspectives on pharmacoepidemiology • Advice for future pharmacoepidemiologists

CCEB Conflict of Interest Disclosure

• Funding from the National Institutes of Health; Agency for Healthcare Research and Quality (including CERT funding, DEcIDE [Developing Evidence to Inform Decisions about Effectiveness] funding, and patient safety funding; Pharmaceuticals; and Takeda Pharmaceuticals North America • Grants from Alza Corporation, Andrew W. Mellon Foundation, Asia Foundation, Bayer Corporation, Berlex Laboratories, the Burroughs Wellcome Company, Charles A. Dana Foundation, Ciba-Geigy Corporation, Health Information Designs, Inc., Hoechst-Roussel Pharmaceuticals, Hoffman-La Roche, Inc., Integrated Therapeutics, Inc., a subsidiary of Schering-Plough Corporation, International Clinical Epidemiology Network, Inc., International Formula Council, Joint Commission on Prescription Drug Use, Marion Merrell Dow, Inc., McNeil Consumer Products, McNeil Pharmaceuticals, Mead Johnson Pharmaceuticals, Merck and Company, Institute of Medicine of the National Academy of Sciences, Novartis Pharmaceuticals Corp., Pfizer Pharmaceuticals, PharMark Corp, A.H. Robins Company, Rockefeller Foundation, Rowell Laboratories, Sandoz Pharmaceuticals, Schering Corporation, Smith Kline and French Laboratories, Sterling Winthrop Inc., Syntex, Inc., Takeda Pharmaceuticals North America, the Company, US Agency for International Development, US Pharmacopeia, US Veterans Administration, -Ayerst Research • Pharmacoepidemiology training program support has been provided by NIH and from Alza Corporation, Aventis Pharmaceuticals, Inc., Bayer Corporation, Berlex Laboratories, Inc., Ciba-Geigy Corporation, , Inc., Hoechst- Marion-Roussel, Inc., Integrated Therapeutics Group, Inc., Johnson and Johnson, Merck and Company, Inc., McNeil Consumer Product Company, McNeil Consumer Healthcare, Novartis Pharmaceuticals Corporation, , Pfizer, Inc. , SmithKline Beecham Pharmaceuticals, Whitehall-Robins Healthcare, and Wyeth-Ayerst Research • US FDA Special Government Employee for serving on FDA advisory committees, and was a member of the FDA Drug Safety and Risk Management Advisory Committee • Consultant to: , Aetna, Alza Corporation, Astra-Merck, AstraZeneca LP, Aventis Pharmaceuticals, Bayer Corporation, Berlex Laboratories, Idec, Bracco Diagnostics, Inc., Bristol-Myers Squibb Company, Centocor, Inc., , Inc., Churchill Communications, Ciba-Geigy, Inc., Connaught Laboratories, CV Therapeutics, Cygnus Corporation, Inc. , Daiichi Pharmaceuticals UK, Ltd., Dupont-Merck, , , GlaxoSmithKline, Hoechst-Roussel Pharmaceuticals, Inc., Hoffman LaRoche, IBEX Technologies Corporation, IMS Health, Inflexxion, inc., Inveresk Research North Carolina, Inc., IOM/National Academies of Science, Janssen Pharmaceuticals, McNeil Consumer Products Company, Mikalix and Company, Novartis, Omnicare, Inc., Orchid Bioscience, Inc., Oscient Pharmaceutical Corp., Pfizer, Inc., PharMark Corporation, Quintiles Strategic Research and Safety/The Lewin Group, Inc, Rhone Poulenc Rorer Pharmaceuticals, Inc., Roche Laboratories, Inc., RW Johnson Pharmaceutical Research Institute, Sanofi Pasteur, Inc., Schering-Plough Research Institute, Science, Toxicology, and Technology Consultants, Searle, Shire Pharmaceuticals, Syntex,USA, Inc., Takeda, TAP Pharmaceuticals, Value Health Sciences, Warner Lambert, Wyeth Consumer Healthcare Division, and numerous law firms • Member of the Board of Directors of Medco Health Solutions, inc. CCEB • There was no funding support for this talk

Brian Strom’s Trainees 1980-2006

A. K. Dayal Robert O'Shea Ebbing Lautenbach David Turner John Farrar Jonathan Markowitz Supornchai Mikkael Sekeres Philippe Szapary Kongpatanakul Mindy Schuster Gregory Bisson Francois Chapuis David Margolis Worth Everett Patrick Brennan Robert Gross Vincent LoRe Sean Hennessy James Lewis Gregory Armstrong Stephen Kimmel Daniel Mines Christopher Rowan Shelley Sternberg Tommaso Staniscia Harry Seifert

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Other Penn Pharmacoepi Trainees 1992-2006

David Roth Elizabeth Hsia Joel Gelfand Lisa Kellar Ingi Lee Maria Leiva Scott Halpern Jon Burnham Priya Gor Eric Haas George Catherine Adriana Jesse Jeffrey Macones Bradley Izquierdo Pines Munson Susan Krug- Long-Long Athena Sharon Charles Gourley Gao Zuppa Meropol Leonard Mary Jonathan Kevin Haynes Diane Pamela Morrison Kantor Calello Fitch Liza O’Dowd Paul Esi DeWitt Jason Kim Brian McGovern Fisher Scott Kasner Yu Xiao Yang Samir Shah Eric Pifer Kelly Wade M. Soledad Theoklis Charalambos Tim Beu- Tracey Cepeda Zaoutis Andreadis kelman Wright Darren Linkin Kenneth Katz

CCEB The Lessons of Experience: Selected Tidbits from a Mid-career Academic Pharmacoepidemiologist

• Introduction • Selected perspectives on pharmacoepidemiology • Advice for future pharmacoepidemiologists

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•• “A“A desiredesire toto taketake medicationsmedications is,is, perhaps,perhaps, thethe greatestgreatest featurefeature whichwhich distinguishesdistinguishes manman fromfrom otherother animals.”animals.” Sir William Osler, 1891

CCEB •• “If“If thethe wholewhole materiamateria medicamedica,, asas nownow used,used, couldcould bebe sunksunk toto thethe bottombottom ofof thethe sea,sea, itit wouldwould bebe allall thethe betterbetter forfor mankindmankind ,, andand allall thethe worseworse forfor thethe fishes.”fishes.” Oliver Wendell Holmes Medical Essays, “Comments and Counter” Currents in Medical Science

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The Lessons of Experience: Selected Tidbits from a Mid-career Academic Pharmacoepidemiologist

• Introduction • Selected perspectives on pharmacoepidemiology • Advice for future pharmacoepidemiologists

CCEB

Tidbits From Paul Stolley

• Be a database user, not a builder • Your reputation is the most important thing you have • Don't forget the policy implications of the studies you are working on • Don't get so caught up in methodologic sophistication, that you lose sight of the real reasons why you are doing the work • Don't let methodologic perfection become the enemy of the feasible, especially when addressing questions of public health CCEB urgency Tidbits from Ken Melmon

• Surround yourself with great people, be sure they get appropriate support, and then stay out of their way

CCEB Selected Tidbits from John Eisenberg*

• Surround yourself with people who are fun to work with, personally

*and an unnamed faculty member who was not!

CCEB Selected Tidbits from Others

• Choose studies that are fun to address, important from a public health or clinical or policy point of view, and you can uniquely answer --Harry Selker

CCEB Selected, Less Tasty, Tidbits from Me-1

• Pay close attention to good methodology, and work to continually improve methodology, recognizing that this will lead inevitably to making mistakes along the way --those who were so eager to point out my errors along the way! • Having a career as a scientist is fun, but also is a privilege, supported by the public because of its perceived importance--never lose sight of that CCEB Selected, Less Tasty, Tidbits from Me-2

• Scientific rigor, honesty, and transparency must always be paramount. In the process, keep in mind that there are many forms of conflict of interest, besides just financial. • Careers are not straight line • The question is: “what is the question???” CCEB Key Problem of “Historical” Pharmacoepidemiology

• Adverse drug events are the most common iatrogenic causes of patient injuries • Most are the result of an exaggerated but otherwise usual pharmacological effect of the drug • Yet, historically these have been ignored by pharmacoepidemiology, as they do not represent a focus of commercial and regulatory interest

CCEB CCEB What Does the Field of Pharmacoepidemiology Need?

• Better science • Better scientists • More science • More scientists

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THANKS!!!THANKS!!!