Investigative reporting suggests regulator-opioid maker revolving door also helped grease the wheels.
- A Los Angeles Times report by Harriet Ryan, Lisa Girion, Scott Glover (16)
uncovers how Dr. Curtis Wright, the FDA bureaucrat who led its medical
review of Purdue Pharma's OxyContin application in 1995 left the FDA
shortly after it approved it and within 2 years began working for
Purdue.
- A piece in the Milwaukee Journal Sentinel by John Fauber suggests (see below from 17, emphasis mine) beefing
up pain advisory councils with opioid maker-friendly voices also helped
smooth the way in expanding usage of opioids in pain treatment,
'Federal
health industry regulators and executives of companies that make pain
drugs have held private meetings at expensive hotels at least once a
year since 2002 through an organization funded by the drug companies, according to emails obtained through public records requests and provided to the Journal Sentinel/MedPage Today.
Each
year a handful of drug companies have paid up to $35,000 each to send a
representative to meetings of IMMPACT, where they could discuss
clinical trial testing procedures with officials from the U.S. Food and
Drug Administration and other government agencies. IMMPACT's stated goal is to improve the design of clinical trials conducted to develop new pain treatments.’
- Such meetings appear to have favored opioid makers even as recently as 2013 (see below from 18, emphasis mine).
'The
Food and Drug Administration is under enormous pressure to change its
mind about a powerful new prescription painkiller. Forty-two public
health groups are urging the FDA to withdraw its support of Zohydro. The
drug is similar to Oxycontin, except it comes in significantly higher
doses. The FDA approved Zohydro last year, despite its own advisory panel voting against it. And critics are, among other things, raising questions about that approval process.’
- As
late in the US opioid crisis as January 2016, a federal government pain
advisory panel of 18 had at least 5 with financial ties to opioid
makers, connections that came to light (see below from 19),
'...after
the committee last month bashed a federal plan to recommend doctors
scale back on prescribing painkillers for chronic pain. The guidelines
by the Centers for Disease Control and Prevention are intended to curb
deadly overdoses tied to powerful but highly-addictive opioid drugs,
including Percocet and Vicodin.'
The
Center for Public Integrity - Wikipedia also uncovered evidence of opioid maker lobbying of Congress and state legislatures (
20),
efforts estimated by Mother Jones to be 8X that of the gun lobby and
200X that of those advocating stricter opioid prescription rules (
21).
Raw
numbers reflect the spectacular success of such unprecedented marketing
and lobbying. In 1996, annual OxyContin sales were $48 million. For
OxyContin's inaugural marketing alone, Purdue doubled its sales force to
600 and spent $207 million, so much so that already by 2000, OxyContin
sales grew 23-fold to ~$1.1 billion (
22).
Already
by 2001, OxyContin had become the most frequently prescribed brand name
opioid for treating moderate to severe pain in the US, with so much
overprescribing that the US GAO issued a 58-page report warning about it
all the way back in December 2003 (
23).
In recent years, other opioid makers such as Insys Therapeutics Inc. (
24) and Mallinckrodt Pharmaceuticals (
25)
have also come under the public spotlight for their aggressive sales
practices, tactics that also applied to antidote makers such as Reckitt
Benckiser (
26).
Like
a burst dam, such intense marketing and lobbying ended up transforming
how US doctors treat pain, replacing wholesale old true and tried
methods that erred on the side of caution to an approach where it
suddenly became acceptable to treat any and all pain with extremely
powerful opioids (
1,
5,
27,
28), a change that a 2016 study (
29) suggests had US family doctors and general practitioners at the forefront.
Could
one seriously argue that from the years 1996 onwards, physical pain
and/or existential angst increased so much among the US population as to
justify such an increase in opioid sales and consumption? Obviously
not. Instead, the US opioid epidemic is inextricably linked to an
unprecedented medical culture change in how US doctors were carefully
and relentlessly persuaded by opioid makers, their lobbyists and sales
reps to treat all manner of pain, not just terminal, late stage cancer
pain, with highly powerful opioids.
Problem
is so far opioid makers haven't been held accountable for their willful
recklessness (slaps on the wrist in the form of relatively piddling
monetary fines obviously don't count) even as they've saturated the US
market. Rather, a report in the
Los Angeles Times by by
Harriet Ryan,
Lisa Girion,
Scott Glover
suggests that as their profits in the US market start to dry up, their
ongoing intense lobbying around the world may end up replicating the US
opioid crisis in other countries as well (
30). For governments, policy makers and regulators the world over, how to avoid '
globalization of the prescription opioid epidemic' (31) thus becomes a matter of urgency.
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