Date post: | 26-Jan-2017 |
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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