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.

WATCH this video on the obtained audio, or listen to the full audio here:


The Request

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.

READ THE LETTERS:

IMAGE: letter to opioid manufacturers

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.

READ THE LETTERS TO MALLINCKRODT, ENDO, TEVA, AND ALLERGAN

Letter to manufacturers about opioid diversion

READ THE LETTERS TO MCKESSON CORPORATION, AMERISOURCEBERGEN CORPORATION, AND CARDINAL HEALTH

Letter to distributors about opioid diversion


The History

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:

WATCH NOW: Purdue Pharma "I  got my life back" promotional video for OxyContin (1998)

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:


The Background

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.


Additional Resources

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