Continuing Medical Education and the Marketing of Fentanyl for Breakthrough Pain: Marketing Messages in an Industry‐Funded CME Module on Breakthrough Pain

AuthorNicole Uliassi,Clare Marlin,Stephanie Waterhouse,Adriane Fugh‐Berman,Alicia Bell,Margaret Infeld
Published date01 March 2019
Date01 March 2019
Continuing Medical Education and the Marketing of
Fentanyl for Breakthrough Pain: Marketing Messages in
an Industry-Funded CME Module on Breakthrough Pain
Margaret Infeld, Alicia Bell, Clare Marlin, Stephanie Waterhouse,
Nicole Uliassi, and Adriane Fugh-Berman
In order to market transmucosal fentanyl products, industry-funded medical journal articles and
continuing medical education (CME) were used to persuade physicians that breakthrough pain
(BTP) was a separate entity, and that rapid onset opioids were an appropriate treatment. We
performed a pilot study on industry-funded online CME modules on BTP that used perceptions of
key points and text analysis to assess subtle bias. Thirty-eight participants were randomized to read
a non-industry publication or an industry-funded publication on opioids for managing pain.
Twenty-three participants were asked to assess key messages. A text analysis was also performed on
key words and phrases. Those who read the non-industry-funded article noted that the effectiveness
of opioids for chronic pain was unclear, whereas readers of the industry-funded article viewed
opioids more positively. Eight of twelve readers of the non-industry-funded article, compared to
three of twelve assigned to the industry-funded article, reported opioid abuse or addiction as a major
theme. “Breakthrough pain” was mentioned 55 times in the industry-funded article and once in the
non-industry-funded article. The non-industry-funded article mentioned “death” 26 times; the
industry-funded article never mentioned “death.” Our study provides a new method of identifying
subtle bias that may be useful for evaluating CME modules.
KEY WORDS: opioids, breakthrough pain, fentanyl, pharmaceutical marketing, condition branding,
continuing medical education
Prescribed opioids have fueled an epidemic of addiction and deaths; in 2017,
over 19,000 of about 49,000 opioid-related deaths involved a prescription opioid
(National Institute on Drug Abuse, 2018). Between 1996 and 2011, the medical use
of opioids increased 1,448 percent (Atluri, Gururau, & Manchikanti, 2014).
Opioids are appropriate for cancer pain and, short term, for some acute pain
conditions. However, industry-funded efforts expanded opioid use through a
campaign among physicians that emphasized the debilitating effects of chronic
World Medical & Health Policy, Vol. 11, No. 1, 2019
doi: 10.1002/wmh3.290
#2019 Policy Studies Organization
pain, cast pain as the “f‌ifth vital sign,” and battled “opiophobia,” which caused
the use of opioids for chronic noncancer pain to skyrocket in the 1990s (Atluri
et al., 2014).
Fentanyl, a particularly addictive opioid, was promoted for noncancer
“breakthrough pain” (Markman, 2008), a term that f‌irst appeared in the medical
literature in 1989, in an article funded by the manufacturer of a transmucosal
immediate-release fentanyl (TIRF)-containing lollipop, and, later, a reformulated
fentanyl “buccal tablet” (Portenoy & Hagen, 1989). In 1990, a paper by the same
authors (Portenoy & Hagen, 1990) reported that breakthrough pain (BTP)—
def‌ined as “a transitory increase in pain to greater than moderate intensity ...
which occurred on a baseline pain”—was a common, under-recognized condition
in cancer patients, deserving of specif‌ic treatment.
In 1998, the f‌irst TIRF, a lollipop placed between cheek and gum, was
approved by the FDA for BTP in cancer patients (U.S. Food and Drug
Administration, 2009). When the drug’s market exclusivity neared its end, the
manufacturer launched a buccal tablet (essentially a lozenge); the product was
approved in 2006.
In 2007, the TIRF buccal tablet manufacturer attempted and failed to obtain
an additional indication to treat noncancer pain. Regulatory approval, however, is
only one way to sell drugs. As a 2006 marketing report on BTP states: “A key
growth strategy will be to gain initial approval for cancer breakthrough pain and
then drive sales in additional indications through off-label use or regulatory
approval” (2006 Pipeline Insight: Breakthrough Pain).
In 2007, the TIRF buccal tablet was widely used off-label—and was only
rarely used for cancer pain. In 2008, the U.S. Department of Justice announced
that the manufacturers of the TIRF lollipop would pay a $425 million f‌ine to
resolve claims that it marketed the TIRF and two other drugs for unapproved
uses between 2001 and 2006. Although the TIRF was approved only for opioid-
tolerant cancer patients, the company’s mantra was “pain is pain,” and the
company instructed sales representatives to focus on general practitioners and
other physicians who were not oncologists. The TIRF was promoted off-label for
non-opioid-tolerant patients with migraines, sickle-cell pain crises, or injuries,
and patients who were undergoing wound dressing changes or radiation therapy
(U.S. Department of Justice, 2002).
In addition, the TIRF manufacturer “retained medical professionals to speak
to doctors...” and “funded continuing medical education (CME) programs ,
through millions of dollars in grants, to promote off-label uses of its drugs” (U.S.
Department of Justice, 2002, n.p.). In the United States, CME often features
industry-paid academic physicians that industry calls “key opinion leaders,” and
may be used to promote drugs for unproven uses without directly breaking laws
against off-label promotion (Fugh-Berman & Melnick, 2008). CME, required for
most physicians, is particularly important to industry for “creating disease-state
awareness and disease state signif‌icance” (Raichle, 1998, p. 84). We describe the
market positioning of fentanyl drugs through the promotion of BTP, and the use
of CME as indirect marketing for Actiq and Fentora. In an attempt to assess
44 World Medical & Health Policy, 11:1

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