Lawyers for the city of Chicago are looking into marketing claims made by the makers of some narcotic painkillers in advance of a potential lawsuit against the drug makers.
The probe concerns if the drug maker overstated the medications’ benefits while downplaying risks, including that patients could become addicted to the drugs known as opioids, a court filing indicates, according to The New York Times.
If the inquiry reveals false claims, the city of Chicago would likely seek recovery of millions of dollars spent on the drugs that were used to treat city employees and retirees, according to the court filings, the Times reported. The investigation, which began this summer, seems to be in initial phases. A spokesman for the city’s law department confirmed the inquiry to the Times. “As part of its ongoing efforts to protect Chicago taxpayers, the city conducts reviews concerning allegations of misconduct on the part of city suppliers,” Roderick Drew, the spokesman, said in a statement. “This subpoena is part of those ongoing efforts,” he added, according to the Times.
Any lawsuit could face challenges given that the drugs were deemed safe and effective and received U.S. Food and Drug Administration (FDA) approval, the Times article indicated.
The investigation followed a filing made by the city in Cook County court in September. A copy of the filing was provided to the Times and shows that officials with the city asked a judge to enforce a previously issued subpoena to Janssen Pharmaceuticals over one of its prescription opioids. Janssen is a unit of Johnson & Johnson. The drug maker refused to release the requested records, which include marketing materials, citing a number of objections including the scope of the request and the involvement of a class action law firm, according to the filing.
“Janssen’s refusal to comply with the subpoena impedes the city’s authorized law enforcement investigation into potential misconduct by Janssen,” the city stated in its request. For its part, Janssen stated that it is working with the city. The filing, noted the Times, is specific to Janssen; however, the probe involves the entire industry.
The inquiry seeks to determine if drug makers were deceptive in the way in which they marketed opioids—as safe and effective for chronic pain such as arthritis and back pain, for example. There is minimal evidence to back up these claims, according to the Times. The inquiry also seeks to look at if opioid makers, which are known to have paid professional medical organizations and other groups to tout the drugs, might have understated opioids’ addiction risks and side effects.
The FDA recently announced safety labeling changes and directed that post-market studies be made on opioid analgesics. The labeling change involves the entire class of medications and the post-market study requirements include extended-release (ER) and long-acting (LA) opioid pain medications. “The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” FDA Commissioner Margaret A. Hamburg, M.D. said at the time.
The updated labeling states that ER/LA opioids are indicated for the management of pain that is severe enough to mandate daily, around-the-clock, long-term opioid treatment and for which other treatment options are not sufficient. The updated indication also clarifies that, because of addiction, abuse, and misuse risks, even at recommended doses, and because of increased overdose and death risks, these drugs should only be used in situations in which other options—non-opioid analgesics or immediate-release opioids—are not effective or tolerated or which would be insufficient to provide appropriate pain management. ER/LA opioid analgesics are not indicated for as-needed pain relief.
Although opioids were originally prescribed to patients in acute pain, such as what is seen in cancer patients, in the past 10 years, opioid use has expanded to more moderate pains, including arthritis and back pain, according to a prior The Washington Post report. The increased use has led to increased issues with addiction and the drugs’ illicit use. In fact, a 2009 National Survey on Drug Use and Health revealed that 2 million Americans were addicted to or abusing prescription pain relievers, much higher than for cocaine or heroin addictions.
A 2013 Centers for Disease Control and Prevention (CDC) report indicated that while overdose deaths consistently increased from 1999 to 2010, deaths tied to opioids increased five-fold in women and 3.6 times in men during the same period, according to The Washington Post.