As Americans nationwide deal with the ongoing opioid epidemic, which has also resulted in the resurrection of heroin in many parts of the country, the Ohio Attorney General is accusing five major pharmaceutical companies of misleading the public about the safety and benefits of opioid painkillers.
In a lawsuit [PDF] filed in Ross County, OH, Court of Common Pleas, Ohio Attorney General Mike DeWine accused Purdue Pharma (maker of OxyContin and others); Endo (Percocet); Teva (Fentora); Johnson & Johnson’s Janssen (Duragesic); and Allergan (Norco) of operating marketing campaigns that “falsely deny or trivialize the risks of opioids while overstating the benefits of using them for chronic pain.”
The pharma companies allegedly downplayed the risk of addiction posed by these drugs, and instead talked up the concept of “pseudoaddiction” — the notion that apparent symptoms of addiction may actually be signs of under-treatment.
The complaint cites a number of instances where the defendant companies allegedly put their support behind pseudoaddiction as a reason for prescribing more of a painkiller, like a 2007 book sponsored by both Purude and Teva subsidiary Cephalon, which allegedly stated that patients who request certain opioids by name, exhibit manipulative behavior, are hoarding or seeing multiple doctors may just be experiencing pseudoaddiction.
A 2009 website paid for by Janssen allegedly stated that pseudoaddiction “refers to patient behaviors that may occur when pain is under-treated,” and that it differs from true addiction “because such behaviors can be resolved with effective pain management.”
The lawsuit describes a Purdue-sponsored role-playing exercise wherein “a chronic pain patient with a history of drug abuse tells his doctor that he is taking twice as many hydrocodone pills as directed. The narrator notes that because of pseudoaddiction, the doctor should not assume the patient is addicted even if he persistently asks for a specific drug, seems desperate, hoards medicine, or ‘overindulges in unapproved escalating doses.’ The doctor treats this patient by prescribing a high-dose, long-acting opioid.”
AG DeWine also says the defendant drug companies exaggerated the effectiveness of screening tools to detect and prevent addiction in chronic pain patients. In marketing materials — taking the form of webinars, supplements, and conference presentations — the complaint notes that Purdue and Endo communicated to physicians that things like urine tests could be used to identify and weed out bad apple patients who were overusing opioids. However, opioid dispensing guidance from the Centers for Disease Control and Prevention say that current screening methods “show insufficient accuracy for classification of patients as at low or high risk for abuse or misuse.”
Drug companies also allegedly misled physicians and patients into believing that they could increase the dosage of their opioid medications without increased risk.
A 2007 pamphlet for Kadian acknowledged to patients that, “Over time, your body may become tolerant of your current dose. You may require a dose adjustment to get the right amount of pain relief. This is not addiction.”
A joint Cephalon/Purdue guide from that same year allegedly claims that some patients “need” a larger dose of an opioid, regardless of their current prescribed dosage, and that there is “no ceiling dose” for patients with severe pain.
“The ability to escalate dosages was critical to Defendants’ efforts to market opioids for long-term use to treat chronic pain,” contends the lawsuit. “[A]bsent this misrepresentation, doctors would have abandoned treatment when patients built up tolerance and lower dosages did not provide pain relief.”
DeWine claims that the drug makers downplayed the difficulty in managing opioid dependence and withdrawal to “make doctors feel more comfortable starting patients on opioids.” As noted by the CDC, opioid withdrawal symptoms run the gamut from anxiety, insomnia, abdominal pain to tremor and tachycardia (rapid heartbeat).
The AG’s office is asking for a jury to declare that the companies’ actions were illegal; for the court to grant an injunction to stop these marketing practices. It seeks damages to compensate the state for the additional costs of dealing with the ongoing epidemic, and refunds for Ohio consumers who allegedly paid for unnecessary opioid prescriptions for chronic pain.
“These drug manufacturers led prescribers to believe that opioids were not addictive, that addiction was an easy thing to overcome, or that addiction could actually be treated by taking even more opioids” says DeWine. “They knew they were wrong, but they did it anyway — and they continue to do it. Despite all evidence to the contrary about the addictive nature of these pain medications, they are doing precious little to take responsibility for their actions and to tell the public the truth.”
We’ve reached out to each of the defendant companies for comment; not all have responded.
A rep for Janssen maintains that the allegations in the lawsuit are “legally and factually unfounded,” and that the company has “acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications.”
Purdue says it shares DeWine’s concerns about the opioid crisis but did not address the lawsuit directly.
“OxyContin accounts for less than 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone — all important components for combating the opioid crisis,” reads the statement from Purdue.
In a statement to Consumerist, Teva says, “We are reviewing the complaint filed today by the Ohio Attorney General in the Ross County Court of Common Pleas. We have not completed review of the complaint and cannot yet provide comment.”
Allergan has declined to comment. We will update this story if we receive additional comment from Endo.