The Business of Opioids...
As the most senior Democrat on the Senate's Homeland Security and Governmental Affairs Committee, Claire has launched a wide-ranging investigation into the business practices of the manufacturers of America’s top-five prescription opioid products. This investigation will explore whether pharmaceutical manufacturers—at the very beginning of the opioids pipeline—have contributed to the overutilization and overprescription of these drugs as the nation reels from a deadly crisis.
“[This epidemic] didn’t happen overnight—it happened one prescription and marketing program at a time. The vast majority of the employees, executives, sales representatives, scientists, and doctors involved with this industry are good people and responsible actors, but some are not," Claire said. "This investigation is about finding out whether the same practices that led to this epidemic still continue today, and if decisions are being made that harm the public health.”
LEARN MORE about Claire's fight against Missouri's opioid crisis at mccaskill.senate.gov/opioids
UPDATE: On September 6, 2017, Claire released "Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization," the first product from her opioid investigation. The report focused on the emphasis Insys Therapeutics placed on boosting approvals for one of its opioids (even for inappropriate, off-label uses) and details an audio recording in which an Insys sales representative misidentifies herself and uses language designed to circumvent the prior authorization process. The outcome of this particular deception was the death of a young woman, due to the "improper and excessive use" of Insys's product.
In letters sent to Purdue, Johnson & Johnson, Insys, Mylan, and Depomed in March 2017, Claire asked for information related to the sale, marketing, and education strategies these companies have employed to promote opioid use. This included:
- Documents showing any 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 third-party contractors or vendors.
- Any reports generated within the last five years summarizing or concerning compliance audits of sales and marketing policies.
- Marketing and business plans, including plans for direct-to-consumer and physician marketing, developed during the last five years.
- Quotas for sales representatives dedicated to opioid products concerning the recruitment of physicians for speakers programs during the last five years.
- Contributions to a variety of third party advocacy organizations:
- Any reports issued to government agencies during the last five years in accordance with corporate integrity agreements or other settlement agreements.
In July of 2017, Claire expanded her investigation to include four more manufacturers - Mallinckrodt, Endo, Teva, and Allergan - as well as three distributors - McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc. These requests focused on the distribution of opioids and the efforts companies have made to monitor, report, and investigate the diversion of drugs for illicit use, including through the black market.
Drug manufacturers are in a unique position to benefit financially off of the country's opioid crisis. Over the years, they have engaged in sales practices that indicate an enabling of addiction:
- Cephalon reportedly set sales quotas that could only be met by promoting the drug beyond its intended use and audience, and allegedly encouraged sales representatives to start patients at 4x the recommended dose.
- Purdue Pharma sent a memo to sales representatives in August 1994 reminding them that higher dosages would lead to higher bonuses. Purdue also trained its associates to claim that OxyContin's risk of addiction was less than 1% and that it's time-release formula would help avoid withdrawal symptoms and deter use among addicts. The Food and Drug Administration rejected these claims and it was found that OxyContin's tapering of pain control caused acute withdrawal in patients, which is a key motivator in taking additional drugs.
WATCH NOW: Purdue Pharma "I got my life back" promotional video for OxyContin (1998)
- Insys allegedly pressured its sales representatives to push Subsys, a fentanyl spray, far beyond its intended role, at times under threat of termination. Despite only being approved for breakthrough, late-stage cancer pain, one former Insys sales representative was told not to target physicians working with these patients, as they "would die soon anyway and couldn't [increase their dosage]." This business model was described by one employee as "Start them high and hope they don't die."
WATCH NOW: CNBC'S Nightly Business Report Investigates Insys's Sales Practices for Subsys
And they have used illegal kickbacks to encourage physicians and nurses to prescribe their products:
- Insys has reportedly hosted lavish social outting for doctors on a routine basis. One doctor was given "one of the best nights of his life," and began writing nearly 6x tmore Subsys prescriptions the very next week. Over the next three years, he also received more than a quarter of a million dollars in speaking fees from Insys.
- A registered nurse recently pleaded guilty to accepting $83,000 in kickbacks from Insys, in exchange for writing $1.6 million in Subsys prescriptions.
- A recent Harvard Medical School study published in the Journal of the American Medical Association (JAMA) found that doctors who received manufacturer-sponsored meals were more likely to prescribe brand-name drugs promoted during the dinners.
Opioid addiction is a national crisis. More Americans die from drug overdoses than car crashes each year. In 2015, more than 50,000 Americans were killed by a drug overdose—and one-third of those deaths were caused by prescription opioids, such as OxyContin, Subsys, Duragesic, Nucynta, and generic hydocodone. Since 1999, more than 183,000 people have died from prescription opioid overdoses.
Opioids are becoming more addictive, more deadly, and more plentiful. In Missouri, the rate of prescription opioid-related inpatient hospitalizations and emergency room visits more than doubled between 2005 and 2014.
Across the country, deaths involving prescription opioids increased by 4% between 2014 and 2015—for a total of 17,536 Americans killed. Opioid prescription sales nearly quadrupled between 1999 and 2014, despite no increase in how much pain Americans have reported.
- ONE-PAGER: Opioid epidemic and manufacturer business practices background material
- ONE-PAGER: Missouri's opioid crisis
- KANSAS CITY STAR OP-ED: More Resources Needed to Battle the Opioid Epidemic
WDAF: McCaskill Wants Explanation for Recent Price Changes on Lifesaving Opioid Drug
KMOV: McCaskill Launches New Opioid Resource Page
KMOV: McCaskill Continues Push for Resources to Fight Opioid Epidemic