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Saturday, June 1, 2019

J&J reps said to have blanketed Okla. docs with promos later called false, misleading

Promotional materials that the U.S. Food and Drug Administration would later label “false or misleading” were repeatedly used by Johnson & Johnson sales representatives to promote the company’s opioid Duragesic patch to Oklahoma doctors in the early 2000s.
That troubling fact was made clear Friday morning as an attorney for the state quizzed a Johnson & Johnson corporate representative for nearly three hours about the contents of call notes made by the sales representatives following more than 60 sales visits to physicians in offices scattered throughout Oklahoma.
The testimony came on Day 4 in a Cleveland County District Court trial in a case where Oklahoma Attorney General Mike Hunter has accused Johnson & Johnson and its subsidiaries of creating a public nuisance through false marketing that downplayed the risks of their opioid painkillers while overstating their benefits. The state has accused the companies of helping cause an opioid epidemic that has led to thousands of Oklahoma deaths and addictions.
A multitude of sales call notes from 2001 to early 2004 showed that in calls on Oklahoma doctors, Johnson & Johnson sales representatives repeatedly cited studies that their own company had funded.
Those later discredited studies purported to show Duragesic improved physical and social functioning, had demonstrated effectiveness in treating lower back pain and was less likely to be abused than many other forms of opioids.
The sales representatives also repeatedly cited emergency room admission data provided by the Drug Abuse Warning Network as showing that Duragesic had a lower addiction rate than other opioid drugs.
The FDA issued a stern warning to Johnson & Johnson in 2004 that criticized the studies and said there was a lack of evidence to back the claims.
Corporate Representative Kimberly Deem-Eshleman said her company didn’t agree with the FDA’s assessment of the studies, but agreed to pull the promotional materials it was using.
The call notes reveal that during the same sales calls where sales representatives were telling doctors that Duragesic was less subject to abuse, some doctors were telling the representatives about incidents in which the opioid patch was abused.
For example, following a September 23, 2003, sales call, Johnson & Johnson sales representative Holly Abraham reported that a Stillwater doctor had told her that “nurses were taking the old patches.”
Another doctor told a sales representative about a patient who was using more than one patch.

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