Outrage of the Month: Newly Unsealed Court Documents Shine Light on How Purdue Planned to Mislead Doctors About the Risks of Oxycontin
Health Letter, January 2020
By Michael Carome, M.D.
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Purdue Pharma’s aggressive promotion of Oxycontin — the first long-acting version of the potent opioid analgesic oxycodone — after the drug was approved by the Food and Drug Administration (FDA) in 1995 was a major catalyst for the ongoing opioid overdose epidemic in the U.S. that began in the late 1990s. As a result, the company now faces more than 2,000 lawsuits brought by state and local governments around the country.
Secret documents held by a Kentucky court that were recently unsealed in response to a 2016 lawsuit filed by the media outlet STAT shed new light on the great lengths to which senior Purdue executives — including members of the billionaire Sackler family who founded and owns Purdue — went to downplay the drug’s risks of addiction and abuse. STAT reported that the Purdue documents had been gathered during the commonwealth of Kentucky’s lawsuit against the company for allegedly improper marketing of Oxycontin.
The unsealed documents obtained by STAT revealed that even before Oxycontin was approved by the FDA, the company brazenly planned to aggressively promote the opioid for noncancer patients with chronic pain, such as pain from osteoarthritis. For example, in December 1994 Michael Friedman — a Purdue sales and marketing executive who would later become the company’s CEO — sent an internal company memorandum labeled “VERY CONFIDENTIAL” to three members of the Sackler family that made the following points regarding the future marketing strategy for Oxycontin:
We have an existing franchise with those doctors that write MS Contin [oral morphine] prescriptions and since many of these physicians are [family practitioners/general practitioners] and [internal medicine physicians,] we know that they also use [schedule] II [opioids] and [schedule] III [opioid] combinations for a variety of other [diagnoses]/indications. The [family practitioners/general practitioners] and [internal medicine physicians] may be the bridge that we can use to expand the use of OxyContin beyond [c]ancer patients to chronic non-malignant pain…
We believe that the FDA will restrict our initial launch of OxyContin to the [c]ancer pain market. However, we also believe that physicians will perceive OxyContin as [c]ontrolled-release Percocet (without [a]cetaminophen) and expand its use. We do not want to position OxyContin in a way that will discourage physicians from using OxyContin for chronic non-malignant pain…
If price [does] not become a significant barrier, market expansion into chronic non-malignant pain could lead to the use of OxyContin in the 68.7 million prescription [schedule] III [opioid] market…
In summary, OxyContin will have the broadest range of use (from mild through severe pain) of any single-agent opioid and we must position it at launch in consideration of how this drug will be promoted and used in a variety of other markets.
In one particularly damning email chain from January 1997 that was highlighted by STAT, the Purdue sales team informed Dr. Richard Sackler that Merck-Medco, one of the largest pharmacy benefit managers in the U.S., had started to raise concerns with physicians about Oxycontin’s abuse potential in noncancer patients with chronic pain. In response, Sackler pushed back by proposing a plan to downplay Oxycontin’s risks of addiction and abuse, as reflected in the following excerpt:
Why don’t you guys plan a presentation about addiction that could be given first by RR or BK and eventually by our senior managed health care people.
I think that Paul has a good point, but we should consider that “addiction” may be a convenient way to “just say ‘NO’” and when this objection is obliterated, they will fall back on the question of cost.
Unless we can give a convincing presentation that [continued-release] products are less prone to addiction potential, abuse or diversion than [immediate-release] products. I think that this can be done, but I defer to BK and RR and other experts.
According to STAT, by the time this email exchange occurred, “Purdue sales representatives were falsely marketing [Oxycontin] to physicians as ‘less addictive and less subject to abuse and diversion,’ according to federal court records — conduct that would lead to Purdue pleading guilty in 2007 for the misleading way it sold OxyContin.”
These new details about Purdue’s efforts to mislead the medical community about Oxycontin’s risks of abuse and addiction highlight the key role that the company played in fueling the opioid overdose epidemic, which claimed nearly 400,000 lives from 1999 to 2017. Any final resolution of the thousands of ongoing state and local government lawsuits against Purdue and the Sackler family must result in the complete forfeiture of the ill-gotten billions in profits that came from the illegal marketing of Oxycontin.