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Report
Testimony of Sidney Wolfe, M.D.
Health Research Group of Public Citizen
FDA Drug Safety and Risk Management
and Anesthetic and Analgesic Drug
Products Advisory Committees
Opioid Risk Mitigation: May 4, 2016
(I have no financial conflict of interest)
Is the rest of the world wrong, but the U.S.
right about massive opioid use?
Is it any wonder that the CDC has found “In 2014,
more than 14,000 people [in the U.S.] died from
overdoses involving prescription opioids.”
According to the UN-associated International
Narcotics Control Board’s 2015 report, Narcotic
Drugs (also source for data on the next slide),
the U.S. leads the world’s 168 countries in the
consumption of defined daily doses (DDD) of all
schedule II opioids per million people per day:
50,142 such doses/million population per day, more
than one daily dose for every 20 people in the U.S.
Narcotic Drugs: Publication of INCB, 2015: Table XIV.1.a
DDD of total Schedule II Opioids
(average for 2011-2014) for 168 Countries
• U.S.
50,142 DDD/million people/day (1 of 20)
With average ‘11-’14 U.S. Population 314 million,
average # of U.S opioid doses per day= 15.7 million
for entire population, though most don’t use opioids
----------------------------------------------------------------------• Canada 30,540 DDD/million people/day
• Germany 26,547
• 165
<25,000 all other EU countries (< 1 of 40)
141
< 5,000
(< 1 of 200)
• 129
< 2,500
(< 1 of 400)
Narcotic Drugs: Publication of INCB, 2015: Table XIV.1.a
International Changes in average total
annual DDD: 2001-03 to 2011-13
• Worldwide: increase of 4.33 billion, from 3.01 in
‘01-’03, to 7.35 billion total DDD/year in 2011-13
• U.S. : Increase of 2.74 billion, from 2.27 to 5.02
billion
• Thus, the interim increase in US opioid prescribing
is larger than the combined increases in the entire
rest of the world, making up 63% of the entire 10year world-wide increase.
Berterame, et al. Lancet 2016; 387: 1644–56
Age-Standardized Rates of Cancer (Cancer ASR)
Berterame, et al. Lancet 2016; 387: 1644–56
Conclusions from previous study
• “Much of increased usage that has occurred
in high-income countries is probably partly
due to long-term prescribing for non-cancer
pain.”
• “..the absence of real growth in use in most
of the world shows a continuing absence of
provision of these essential medicines.”
Berterame, et al. Lancet 2016; 387: 1644–56
July 2010 AC Meeting: Industry-Proposed Opioid REMS
• “the individual components of the REMS are
insufficient to address the misuse and abuse of ER
opioid analgesics.” (25/35 agreed)
• Members “stressed the need for appropriate and
adequate legislation to further the collaboration with
other federal agencies since voluntary training and
education efforts have not worked.”
• “the failure can be put at the feet of the continued
role of the drug companies in providing education
about pain management...many people around this
table were concerned that the educational
message was biased by the role of industry.”
Experiment to test physician choices as
a function of patient requests
• With increasing DTC advertising, even though
not for opioids, patients are more likely to
request other drugs as well, having been
generally “activated” by such advertising.
• 198 primary care physicians in six states were
shown videos of patients presenting with
sciatica, either passively requesting pain relief
or actively requesting oxycodone.
McKinlay et al. Med Care. 2014 April ; 52(4): 294–299
Effect of nature of patients’ pain med request-presenting with sciatica-on physicians’ choices of analgesic
McKinlay et al. Med Care. 2014 April ; 52(4): 294–299
Conclusions
• Key decision-makers in the unacceptable U.S epidemic
of opioid misprescribing, abuse and death are
physicians, too often influenced by opioid industryfunded “education” and promotion.
• Whereas many prescribers are appropriately cautious,
not contributing to the epidemic, too many are a
complicit cause.
• If opioids were no more dangerous than other drugs,
why do they require a narcotics license to prescribe?
• What more needs to be done? Mandatory training and
testing to get a narcotics license, with as little opioid
industry involvement as possible. Legislation is needed.

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