4. Interests and Obligations Interests of physicians and drug companies CONVERGE in the desire to develop and prescribe products that benefit patients Obligations of physicians and drug companies DIVERGE Doctor Drug co. Coyle SL. Ann Intern Med 2002;136:396-402 Primary obligation of a drug company: to the SHAREHOLDERS: to generate profits by means of sale of products Primary obligation of a physician: to the PATIENT: to provide high quality care in line with the patient’s values and preferences
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9. Acad Med 2001;76:1271-7 Once they have finished their formal training, have no alternative but to rely on drug company detailing to learn about new drugs. Product information presented in a drug advertisement provides you with educational material about the drug. Drug company gifts to physicians do not significantly increase health care costs to patients. Drug company promotions are less likely to be about unique drugs than about drugs that are essentially similar to drugs made by other companies. When drug companies give physicians pens, calendars, or other non-educational materials, this biases the subsequent behavior of those physicians. When drug companies give physicians textbooks or other educational materials, this influences their subsequent behavior. When drug companies sponsor physicians to go to seminars at resort locations this biases the subsequent behavior of those physicians (e.g., they prescribe more of the company’s product). Strongly Disagree Disagree Neutral Agree Strongly Agree Statement
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17. The Parke-Davis Neurontin case enabled us to get a look at marketing and promotion plans that are ordinarily never made public. The strategies and tactics themselves were not illegal—only the promotion of off-label use was—and they are commonly used by all pharmaceutical manufacturers to promote new drugs to physician-prescribers.
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21. How Do Drug Companies Track the Effectiveness of Their Marketing Plans? Steinman MA et al Ann Intern Med 2006;145:284-93 Eichacker PQ et al. NEJM 2006;355:1640-2 Prescriptions for Neurontin per quarter from 1994-2000, by diagnostic category Sales of Xigris from years 2001-2006
22. Which Drugs Are Worth Marketing? Some Definitions from the FDA A brand name drug is a drug marketed under a proprietary, trademark-protected name. A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or " therapeutic equivalence ," of generic drugs on scientific evaluations. Patents are granted by the patent and trademark office and expire 20 years from the date of filing. Many factors affect patent duration. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition. www.fda.gov
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