A new study published March 7 by the Journal of the American Medical Association (JAMA) is sure to launch more debate in the already overheated world of opioids.
The randomized study examined how 240 patients in Veterans Affairs clinics with chronic back pain, hip or knee osteoarthritis, reacted to doses of opioids versus non-opioid medications in terms of their effectiveness in treating pain.
Following 12 months of treatment and research, the study concluded that the use of opioids did not give patients significantly better pain-related function, with the average age of patients in the study being 58. The study results showed that over-the-counter medications such as Tylenol, lidocaine and ibuprofen delivered more pain relief than opioid-based meds such as oxycodone, morphine and Vicodin.
"Overall, opioids did not demonstrate any advantage over non-opioid medications that could potentially outweigh their greater risk of harms," the report said.
The study showed that patients taking the opioids were more likely to experience side effects associated with those drugs, including opioid-induced constipation, physical dependence and nausea. The study was undertaken because of the growing opioid addiction crisis as well as more reports of overdose deaths across the country.
A report from the Centers for Disease Control and Prevention released the same day as the JAMA study echoes the concerns of the VA as the rate of opioid overdoses showing up in emergency rooms across the nation jumped from 14 to 18 per 100,000 ER visits. But those numbers are likely low since the CDC only tracks about 60% of the ER visits, and not all overdoses end up treated at an emergency room.
"This is a very difficult and fast-moving epidemic and there are no easy solutions," said Dr. Anne Schuchat, acting director of the CDC in a statement.
CDC data shows that opioid-related deaths in the U.S. now total 115 people a day. The crisis has resulted in cities, counties and states suing opioid manufactures for costs related to treatment and those deaths. A legal action in federal court in Cleveland has joined more than 400 of those lawsuits against companies that include Purdue Pharma, Janssen Pharmaceuticals, Teva Pharmaceutical Industries Ltd. (TEVA) , Action Alerts Plus holding Allergan (AGN) , McKesson (MCK) , Cardinal Health (CAH) , Endo International PLC (ENDP) and AmerisourceBergen Drug Corp. (ABC) .
The Trump administration has come under fire for its lethargic response to the opioid epidemic, having declared a national health emergency regarding opioids, but taking no action and making no funds available to tackle the crisis.
In recent days, the administration has tried to make up for lost time by announcing that the Justice Department intends to aid those bringing the actions in Cleveland by chasing down documents and making them available. The feds also will file a legal action so that if there is a financial settlement, Uncle Sam will get a cut to cover costs that Attorney General Jeff Sessions says have impacted the government.
In addition, Sessions has announced that the DOJ and the DEA intend to look at how opioid manufacturers and distributors have contributed to the opioid crisis.
Senator Claire McCaskill, D-MO, is not waiting for the federal government to dig in. Along with the Senate Homeland Security and Governmental Affairs Committee, she has gone after some opioid makers since last year to turn over documents showing how the drugs have been distributed and monitored.
But on March 7, McCaskill singled out Teva for what she says is its failure to turn over documents despite repeated requests and interaction with McCaskill's office. She charged that the Israeli company's "refusal to cooperate with Congressional requests strongly suggests they have something to hide."
Teva defended itself from the Senator's charges, saying it has ceased to promote all opioid products, worked to educate healthcare providers regarding prescription use and complied with all federal and state regulation regarding opioids.
A generic specialist, Teva has woes beyond McCaskill's probe, including opioid-related lawsuits, an ongoing restructuring and a weakened balance sheet. According to McCaskill, Teva responded to the Senator's office in a series of communications. But the Senator wanted more details than the pharma company wanted to furnish, telling the office that the requested documents could pose a problem for the company in pending litigation.