April 7, 2017
To tackle the opioid epidemic in the United States, Sen. Claire McCaskill of Missouri will be holding a congressional investigation on the top five big pharmaceutical opioid manufacturers, based on 2015 sales.
As the senior Democrat on the Senate’s Homeland Security and Governmental Affairs Committee (HSGAC), McCaskill launched letters on March 28, 2017, to Purdue, Johnson & Johnson, Insys, Mylan, and Depomed, asking about their sales, marketing, and education strategies for the past five years. These letters were posted on her website, along with a video statement about her mission:
“I think we can change this country for the better—when it comes to this killer, the heroin overdoses, the opioid prescription addiction—by doing the kind of investigation that will hold some people accountable [who] were trying to make a lot of money off a product that was being overprescribed and was eventually causing death,” said McCaskill in the video.
McCaskill Requests Documents from Top Five Opiate Manufacturers
McCaskill’s letters, which can be downloaded via this link, requested documents that show “internal estimates of the risk of misuse, abuse, addiction, overdose, diversion or death arising from the use of any opioid product or any estimates of these risks produced by a third-party contractors or vendors.”
The letters also asked for reports generated within the past five years that summarized their sales and marketing policies, business plans for direct-to-consumer and physician marketing, quotas for sales representatives dedicated to opioid products, any contributions to third party advocacy organizations, and reports issued to government agencies in accordance with corporate integrity agreements or other settlement agreements.
All of this leads up to the main point of McCaskill’s investigation: that the five pharmaceutical companies—Purdue, Johnson & Johnson, Insys, Mylan, and Depomed—may have used misleading methods to convince physicians to prescribe more opioid medications by downplaying the risk of addiction.
Big Pharma Sales Increase Coincides with Opioid Epidemic Rise
Though the letters request information for the past five years, McCaskill has been building a case with evidence dating back to the 1990s.
Just recently on March 5, 2017, before her announcements to push for an investigation on big pharma, McCaskill called for an investigation on the Drug Enforcement Administration to find out why the DEA “slowed enforcement efforts against pharmaceutical companies accused of violating laws designed to prevent pain pills from reaching the black market,” as reported in The Washington Post.
It was 10 years ago in 2007 when Purdue Pharma, a producer of OxyContin, was forced to pay $634.5 million in fines for false claims about opioids being less addictive than other pain medications.
In fact, while the US opioid epidemic was beginning to rise by the late 1990s, Purdue released its “I got my life back” OxyContin commercial in 1998:
Before the commercial release, Purdue Pharma sent a memo to sales representatives in August 1994 to remind them that “higher doses would lead to higher bonuses.” Sales reps were trained to claim that OxyContin’s risk of addiction was less than 1 percent and would avoid withdrawal symptoms, despite the FDA rejecting this information.
Yet, Purdue Pharma is not the only culprit. Other pharmaceutical companies, like Cephalon, were found setting quotas that would require physicians to prescribe opioids four times the recommended dosage or more.
In regards to their fentanyl spray, Subsys, which is intended for late-stage cancer pain, Insys allegedly pressured their sales reps to not target physicians with cancer patients as they “would die soon anyway” and instead follow their business model, described by one employee as, “Start them high and hope they don’t die.”
McCaskill’s Opioid Investigation Starts, Cooperation Pending
Four spokespeople have responded to McCaskill’s document request, each stating their companies will cooperate accordingly, reports The Kansas City Star.
John Puskar, the spokesman for Purdue Pharma, addressed the US opioid epidemic in his email statement as “among our nation’s top health challenges” and defended Purdue in mentioning its dedication to being part of the solution to the opioid epidemic by being “an industry leader in the development of abuse-deterrent technology and advocating for the use of prescription drug monitoring programs.”
Should any of the companies ultimately decide to not comply with the request, McCaskill will need Republican support from the HSGAC to be able to subpoena documents.
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