Inconsistent government oversight fuels opioid crisis, McCaskill report says

2018-07-12 | St. Louis Post-Dispatch

July 12--WASHINGTON -- Inconsistent government oversight and widely differing pharmaceutical industry compliance has contributed to a national opioid epidemic and to "significant" suspicious opioid shipments in parts of Missouri, a new report by investigators for Sen. Claire McCaskill, D-Mo., says.

A spokesman for the pharmaceutical industry pushed back, saying McCaskill relied on "debunked" information and did not focus enough on doctors' overprescribing the powerful painkillers.

McCaskill told the Post-Dispatch she suspects that high levels of suspicious shipments of opioids into Missouri counties to the south and southwest of St. Louis and along the Arkansas border were due to Missouri's being the only state to not monitor shipments of prescription drugs.

"These people coming over the border clearly from Arkansas or Kentucky or Tennessee or wherever they are coming from know that we have a welcome mat out for these drug dealers," McCaskill said.

Dr. Randall Williams, director of Missouri's Department of Health and Senior Services, said that the death rate from opioid abuse had gone down in the state, and that "we are increasingly focused on educating providers and the public about the risks of opioid misuse.

"While most providers prescribe appropriately, our increased surveillance efforts have resulted in a 25.4 percent increase of investigations and a 50 percent increase in referrals," he said.

The report, "Fueling an Epidemic," was issued through McCaskill's position as top Democrat on the Senate's Homeland Security and Governmental Affairs Committee. It comes with a partisan hue, because Sen. Ron Johnson, R-Wis., the committee chair, did not participate, and refused to issue subpoenas.

Investigators for McCaskill focused mostly on three pharmaceutical companies -- Cardinal Health, AmerisourceBergen, and McKesson -- that account for about 90 percent of drug distribution revenue in the United States.

Combined, these companies shipped about 1.6 billion doses to Missouri between 2012 and 2017, an average of 260 doses for every state resident, the report says.

Company reporting on potential "diversions" -- suspicious orders of opioids that may be diverted to illegal use -- varied widely between 2012 and 2017, McCaskill's report says.

McKesson and AmerisourceBergen, for example, both shipped about 650 million doses to Missouri in this five-year period, but McKesson reported 16,714 suspicious orders to the federal Drug Enforcement Administration while AmerisourceBergen reported only 224, the report said. Although Cardinal Health shipped fewer than half of the total opioid dosage units as AmerisourceBergen distributed during the same period, it reported 5,125 suspicious orders to the DEA.

McCaskill's report blames the DEA for providing unclear reporting guidelines and for loosening enforcement on potentially suspicious shipments. Pressured by pharmaceutical industry lobbyists, McCaskill said, the federal agency has since 2011 been reduced in its ability to intercept suspicious orders before they are delivered. She advocates a return to tougher pre-2011 enforcement standards.

"I blame DEA because they should be asking these questions," McCaskill said, referring to the wide disparity in reporting among companies. "It shouldn't be one senator from Missouri that is figuring this out."

McCaskill's report draws a grim picture of opioid abuse in Missouri.

"Over 3,400 Missouri residents died between 2012 and 2016 due to opioid-involved overdoses, and 664 Missourians died from prescription opioid overdoses in 2016 alone," it says. "From July 2016 through September 2017, Missouri also experienced a 21 percent increase in the rate of individuals visiting emergency departments as a result of opioid overdoses, and the number of quarterly Missouri resident non-heroin opioid deaths almost doubled from the first quarter of 2013 to the first quarter of 2017."

Missouri has the 14th-highest hydrocodone and oxycodone distribution rate among the 50 states, and in St. Louis County, "physicians prescribe enough painkillers per month to provide every resident with three pills," the report says.

Acting DEA Administrator Robert W. Patterson said that his agency's Diversion Control Division had "worked to improve communication and cooperation" with pharmaceutical companies. The agency "offers year-round training free of charge to pharmacists, distributors and manufacturers" on how to single out and report suspicious orders, he told McCaskill.

A spokeswoman for Pennsylvania-based AmerisourceBergen said that "as the Homeland Security and Governmental Affairs Committee statement indicates, we filed daily reports, providing DEA with detailed information about quantity, type and receiving pharmacy of each order of opioids, and we regularly flagged suspicious orders."

John Gray, president and CEO of the Healthcare Distribution Alliance, which represents the three companies mentioned, said McCaskill's report "relies on debunked, inaccurate statements without acknowledging the need for broader reforms across the pharmaceutical supply chain."

He said that "it is widely recognized and acknowledged that the decades-long trend of opioid overprescribing -- reinforced by federal policy -- was a leading factor in the start of the opioid crisis."

This report is the latest in a series on the drug industry issued by McCaskill. Her investigators are now turning their attention to drug pricing, she said.

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