State Says OxyContin Maker “Conducted Uncontrolled Experiment On American Public”

The state of Washington and the City of Seattle filed separate lawsuits today against Purdue Pharma, maker of controversial opioid pain medication OxyContin, alleging that the drug company lied to doctors, regulators, and the public about the efficacy and safety of a drug that many place at the center of the ongoing opioid epidemic.

“In 2015, opioid overdoses killed 718 Washingtonians, more than either car accidents or firearms,” reads the complaint [PDF] filed today by Washington state Attorney General Bob Ferguson. “These deaths are attributable to a flood of prescription opioids into the state over the last two decades.”

The lawsuit, which involves other Purdue-made opioids in addition to Oxy, alleges that “Purdue aggressively marketed what was essentially an uncontrolled experiment on the American public,” and that the drug company lacked “reliable evidence that opioids are effective at relieving chronic pain in the long term.”

In fact, counters Ferguson, when Purdue began seeing evidence that opioids might be ineffective at treating chronic pain and that they could have deadly consequences, the company “offered half-solutions and half-truths as it continues to push its pills.”

The “Experiment”

Until two decades ago, opioids were not seen as a reliable and safe method to treat chronic pain. But then came arguments from some researchers like Dr. Richard Portenoy, who claimed that — based on evidence from just a handful of cancer patients treated with opioids — that the painkillers could also be used on more traditional pain patients.

Ferguson says Purdue took Portenoy’s research and ran with it, taking the doctor’s hypothetical assertions that opioids may be affective in treating chronic pain, and that there may be a slight likelihood of abuse and addiction, and presented them to the public as proven facts.

“Purdue’s decision to market opioids for long-term use despite the absence of clinical evidence and based on the hypothesis of a few cherry-picked doctors was a calculated gamble,” argues the complaint. “Purdue bet that the conventional medical wisdom was wrong and that the detrimental side effects of long-term opioid use could be acceptably managed.”

Of course, that gamble paid off for Purdue, and opioid makers in general. According to GBI Research, opioid sales in the U.S. totaled $11 billion in 2014, and were projected to continue growing in spite of the current epidemic. The complaint notes that Purdue has previously generated nearly $3 billion in a single year just from the sale of OxyContin.

Purdue’s Allegedly False Claims

As with the other lawsuits filed by Ohio and New Hampshire, the state argues that Purdue has been making false claims about the efficacy and safety of opioids for decades.

Not a 12-Hour Drug
OxyContin was marketed as a safe treatment because it was time-released over a 12-hour period. Fewer pills and more even distribution of the drug was supposed to not only provide steady relief from pain but also reduce the likelihood of abuse or addiction. However, it has repeatedly been shown that many Oxy patients do not enjoy the full 12 hours of relief.

Ferguson alleges that Purdue manipulated the visuals it presented in its marketing to make it appear as if Oxy was absorbed and a more steady and consistent rate than the actual rate.

“Purdue knew, according to its own research during the development of OxyContin and after, that the drug wears off in under 6 hours in one quarter of patients and in under 10 hours in more than half,” notes the complaint.

Managing Addiction
The state alleges, as the other states have previously claimed, that Purdue provided marketing materials that it knew contained inaccurate information about managing the risks of opioid addiction.

Publications published by Purdue-backed groups, and lectures from doctors paid by Purdue attempted to convince physicians that screening tools, urine tests, and patient agreements have the effect of preventing “overuse of prescriptions” and “overdose deaths.”

“Convincing prescribers that they could effectively manage risk and prevent addiction was essential to Purdue’s marketing strategy of increasing the number of prescriptions of opioids and its own branded drugs,” reads the complaint. “It was also unsubstantiated.”

Purdue: Opioids Are A Risk… When Made By Someone Else

In 2010, Purdue reformulated OxyContin, opening up the door to possible generic versions of the original drug. But in attempt to stave off this competition, Ferguson notes that Purdue petitioned the FDA in 2012 to deny generic applications because the drug poses a risk to public health.

Purdue’s argument was that the very drug it had been selling for over a decade should not be sold as a generic because the ‘abuse of extended release oxycodone could return to the levels experienced prior to the introduction of reformulated OxyContin.”

To Ferguson, this is an admission from Purdue that the company knowingly made billions selling a drug that it knew was being so widely abused as to constitute a public health risk.

Ultimately, Purdue decided to pull original OxyContin from the market under purported safety reasons, while continuing to sell the patent-protected reformulated version.

The state also accuses Purdue of violating a 2007 court order that was part of a settlement between the company and 26 states regarding allegations deceptive marketing of OxyContin.

As part of that deal, Purdue was barred from making misleading statements about OxyContin with regard to abuse, addiction or dependence. However, Ferguson contends that Purdue has continued to mislead the public about this drug.

Seattle’s Lawsuit

A separate complaint [PDF] was filed today by the City of Seattle against Purdue, and several other opioid drugmakers: Teva, Cephalon, Johnson & Johnson, Janssen; Endo; Actavis, and others.

The city’s complaint seeks compensation for much of the costs Seattle has had to absorb related to the opioid epidemic.

“Unlike earthquakes and hurricanes, this disaster is human-made,” said City Attorney Pete Holmes in a statement, adding that “Seattle has paid upfront” for all the additional expenses related to criminal justice, first-responders, public health and human services. “These are sums that, but for defendants’ conduct, Seattle could have devoted to other beneficial uses.”