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Opioid industry draws scrutiny of Sen. Claire McCaskill of Missouri

Kansas City Star - 3/28/2017

March 28--U.S. Sen. Claire McCaskill of Missouri will lead a congressional probe of the opioid industry after executives from one of the nation's largest opioid manufacturers were charged in a federal racketeering case.

McCaskill, the ranking Democrat on the U.S. Senate Committee on Homeland Security and Government Affairs, sent letters Tuesday on behalf of the committee to the five largest prescription opioid manufacturers requesting documents that show internal estimates of the risk of misuse, abuse, addiction, overdose or death from opioid use.

The investigation will look at the methods companies used to persuade physicians to prescribe their products and whether the industry downplayed the risks of addiction.

In 2015, more than 15,000 people in the U.S. died from overdoses involving prescription opioids, according to the federal Centers for Disease Control and Prevention, which notes that is quadruple the rate of overdose deaths in 1999 and correlates with an increase in prescriptions. If illicit opioids are counted, the total number of overdose deaths from opioids in 2015 rises to more than 33,000, an increase of 4,400 from the year before.

"I think it's time to look at the manufacturers and find out what they knew about addiction," McCaskill said in a phone call Tuesday. "What marketing practices did they use to push these drugs?"

The U.S. Department of Justice brought charges in December against six former executives of Insys Therapeutics, one of the largest opioid manufacturers in the country, alleging that they engaged in a nationwide bribery scheme that led to doctors unnecessarily prescribing fentanyl-based pain medication.

For her investigation, McCaskill asked Insys and four other pharmaceutical companies for any reports generated within the last five years concerning compliance audits of sales and marketing policies, documents outlining marketing and business plans, and quotas for sales representatives concerning physician recruitment. Insys did not immediately respond to a request for comment about McCaskill's probe.

"We know anecdotally there are things that have occurred that are problematic, but we want to find out how widespread it is," McCaskill said.

She also asked for documentation of the companies' contribution to advocacy organizations and reports issued to government agencies in accordance with corporate integrity agreements or other settlement agreements.

The other companies that received the document request were Purdue Pharma, Depomed, Mylan and Janssen Pharmaceuticals, which is owned by Johnson & Johnson.

John Puskar, the spokesman for Purdue Pharman, which manufactures OxyContin, said in an email that the "the opioid crisis is among our nation's top health challenges, which is why our company has dedicated itself for years to being part of the solution. OxyContin accounts for only 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology and advocating for the use of prescription drug monitoring programs. We are reviewing Senator McCaskill's letter and will respond accordingly."

Jessica Castles Smith, the spokeswoman for Janssen, said that the company would address McCaskill's request. She said the company believes it has "acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label."

Christopher Keenan, the spokesman for Depomed, said the company has received McCaskill's letter "will cooperate accordingly."

U.S. Sen. Ron Johnson, the Wisconsin Republican who is chairman of the committee, has not signed on to McCaskill's minority investigation but she said she was hopeful he would participate in the investigation. The Washington Post reported earlier this week that President Donald Trump will tap New Jersey Gov. Chris Christie to be chairman of a commission focused on opioid abuse.

"This shouldn't be about whether this is coming from the White House, or a Republican, or a Democrat. People are dying," McCaskill said. "Something is wrong here. I welcome Governor Christie and I welcome the president."

McCaskill contended that opioids have been "handed out like candy" in recent years. She said that she had been prescribed opioids after knee surgery and when she had surgery for breast cancer, but that she flushed the pills down the toilet after a week.

"I was prescribed way more than I needed for the pain and I think that's another issue," McCaskill said. "How many pills is a person given when they have their wisdom teeth out?"

Bryan Lowry: 816-234-4077, @BryanLowry3

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