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Presenting Truthful Information to Doctors

Presenting Truthful Information to Doctors. Aaron S. Kesselheim, M.D., J.D. Brigham and Women ’ s Hospital Harvard School of Public Health Boston, Massachusetts National State Attorney General Program at Columbia Law School May 11, 2007 akesselheim@partners.org. Today ’ s Agenda.

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Presenting Truthful Information to Doctors

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  1. Presenting Truthful Information to Doctors Aaron S. Kesselheim, M.D., J.D. Brigham and Women’s Hospital Harvard School of Public Health Boston, Massachusetts National State Attorney General Program at Columbia Law School May 11, 2007 akesselheim@partners.org

  2. Today’s Agenda • I. How physicians learn about drug products • II. How litigation influences the information available and the way it is communicated • III. Ways to continue to promote dissemination of accurate information to prescribers

  3. Presenting Information to Physicians • Commercial sources • Advertisements • Manufacturer-funded CME • Detailers • Strong, consistent, specific, and independent association between physicians’ behaviors and their exposure to detailers

  4. Presenting Information to Physicians • Deficiencies in information presented • Withheld as trade secret • Ex: duloxetine for urinary incontinence • Presenting to the FDA fulfills manufacturer duty • Ex: cerivastatin rhabdomyolysis side effect • Protracted negotiations regarding label wording • Ex: cisapride and five-year delay • Obscure truth in promotion to physicians • Ex: rofecoxib and cardiovascular risks • Inaccurate

  5. The Role of Litigation • Improve quality of information about drug risks • 1. Uncover important and previously unavailable data • Lead to reassessment of drug products • Ex.: paroxetine and suicidality

  6. The Role of Litigation • 2. Reveal manufacturer policies regarding presenting information to physicians • Delays in revealing data, attempts to minimize severity • Improper marketing practices • Ex.: Serostim, Neurontin litigation • Misrepresenting price information • Ex.: AWP litigation

  7. The Role of Litigation • 3. Shed light on deficiencies in US regulatory process • Change FDA’s official position on specific drug products • Ex.: paroxetine and withdrawal side effects • Expose limitations in FDA information collection and dissemination procedures • Ex.: cerivastatin and reporting side effects

  8. Promoting Dissemination of Accurate Information to Prescribers • Numerous systems aimed to promote rational use of drugs • Ex. #1: Independent Drug Information Service

  9. Balanced data about medicationswww.RxFacts.org

  10. Promoting Dissemination of Accurate Information to Prescribers • Optimize medication therapy • Can involve educating about generic alternatives • Educational materials provide clinical and cost data • Goal: Lower cost by providing better medicine. Emphasis on quality of care, not just cost

  11. Promoting Dissemination of Accurate Information to Prescribers • Materials prepared by clinicians at Harvard Medical School • Evidence documents – review all recent literature • “Un-advertisements” • Patient scenarios • Physician reference cards • Patient education materials – help facilitate prescribing change

  12. Promoting Dissemination of Accurate Information to Prescribers • Ex. #2: Using monetary recovery from Neurontin litigation to educate physicians • Provide clinicians with basic tools for: • Weighing drug data • Immunizing practitioners from problematic aspects of drug marketing • Providing greater understanding of drug development and approval process

  13. Promoting Dissemination of Accurate Information to Prescribers • Preemption • Jan 2006: FDA inserted into comment made on discussion of largely unrelated federal regulation • Would absolve mfrs of adequately evaluating or reporting risks associated with their products • Four courts have used this comment to hold litigation preempted by FDA approval • The issue: whether state AGs may be deprived of jurisdiction over the adequacy of messages transmitted to consumers within their borders by pharmaceutical manufacturers

  14. FDA Approval is Just The Beginning • Manufacturers’ message to physicians can overstate the benefits and understate the risks of approved products • Attorney General investigations: • Promote disclosure of information • Promote appropriate manufacturer behavior • Promote better understanding among physicians of how messages can affect their prescribing practices

  15. Thanks to… • Jerry Avorn, M.D. • Michelle Mello, J.D., Ph.D.

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