Jerry Avorn, "Drug Regulation, Promotion, and Advocacy in 2017"
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Transcript of Jerry Avorn, "Drug Regulation, Promotion, and Advocacy in 2017"
Drug regulation, promotion, and
advocacy in 2017 JERRY AVORN, M.D.
Professor of Medicine, Harvard Medical School Chief, Division of Pharmacoepidemiology &
Pharmacoeconomics Brigham and Women’s Hospital
Overview: A challenging time for evidence-based prescribing
and drug regulation
• 21st Century Cures Act • “Commercial free speech” attacks • New FDA Commissioner, climate • Whose risk is it, anyway? • What can help
The 21st Century Cures Act
passed December, 2016
A bad solution to a problem that barely exists
• A bogus meme: “FDA is so slow and makes such impossible demands that it keeps drugs from the American people and increases drug development costs higher prices.”
• The truth: not so. – NEJM papers from Krumholz-Ross group – 6 mo. for priority review – Very high approval rate – High prevalence of surrogate measures already
What the 21st Century Cures Act does • Some good things:
– Slightly more funding for NIH, maybe – But still not enough
• Kesselheim, Tan, Avorn: Health Affairs 2015
– Mental health $, opioid $
• New law encourages more approval based on biomarkers (“drug development tools”) – Good and bad aspects of biomarker-based approval – The eteplirsen cautionary example
• Ref: Kesselheim & Avorn, JAMA 2016 and JAMA 1/5/17
“Commercial free speech” vs. science
The 1st Amendment attack • Important background:
– Sorrel, ‘Citizens United’ cases
• Caronia, 2011 – Xyrem: narcolepsy vs. chronic pain, fibromyalgia,
chronic fatigue, use in children
• Amarin: Vascepta and triglycerides • FDA guidances and the future of drug
promotion • Ref: Avorn, Sarpatwari, Kesselheim, NEJM 2015
• Prognosis: grim
New sheriff(s) in town
A whole new world • “Government isn’t the solution to our problem,
government is the problem.” • Pres. Ronald Reagan, 1st Inaugural Address, January 1981
• Two of the finalists for FDA Commissioner job: – Jim O’Neill
• Venture capitalist, no science training • FDA should just make sure drugs are not toxic, then “let
people start using them at their own risk.”
– Scott Gottlieb, MD • American Enterprise Institute, de-regulator • Wrote WSJ article, “How the FDA could cost you your life.”
Patient advocacy groups and “Right to Try” laws
Grass roots, or Astroturf? Does it matter?
• The role of patient groups in drug approval – varied origins and funding – scientific legitimacy – roles: current and ideal
• Interesting overlaps across the law, clinical care, medical ethics, science policy, economics, and raw politics
Whose risk is it, anyway?
• Question is no longer as moot as it was last year. • The ethics of allowing use of (probably)
ineffective and (possibly) unsafe chemicals – semantics of access – who’s to pay?
• Practical impact on generating the data that current and all future patients (and society) need.
One solution: marketing real evidence in a post-fact world
• “Academic detailing” – rationale – ample RCT evidence of effectiveness – evolution
• Alosa Health
– progress – future
Can regulation support this kind of evidence-based education?
• Funding academic detailing outreach programs – state tax on manufacturers – license fees for pharma sales reps – settlement $ from litigation by AGs – tiny % of insurance premiums or care revenues
non-commercial educational programs
• Other regulatory strategies – Competency requirements for prescriber licensing
Acknowledgements
My talented colleagues in the PORTAL program of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham & Women’s Hospital and Harvard Medical School:
Aaron Kesselheim, MD, JD MPH Ameet Sarpatwari, JD, PhD Jonathan Darrow, JD, SJD, MBA
For more information:
www.DrugEpi.org www. AlosaHealth.org
Avorn, “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” www.PowerfulMedicines.org