Drugmakers push sale of 'risky' opioids
Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there’s little proof they reduce rates of overdoses or deaths.
More than prescriptions are at stake. Critics worry the drugmakers’ nationwide lobbying campaign is distracting from more productive solutions and delaying crucial efforts to steer physicians away from prescription opioids— addictive pain medications involved in the deaths of more than 165,000 Americans since 2000.
“If we’ve learned one lesson from the last 20 years on opioids, it’s that these products have very, very high inherent risks,” said Dr. Caleb Alexander, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “My concern is that they’ll contribute to a perception that there is a safe opioid, and there’s no such thing as a fully safe opioid.”
The latest drugs—known as abuse-deterrent formulations, or ADFs—are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industrysponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.
In the last two years, pharmaceutical companies have made a concerted under-theradar push for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the Food and Drug Administration (FDA) to replace older opioids with the new drugs.
The lobbying push features industry-funded advocacy groups and physicians, along with grieving family members, who rarely disclosed the drugmakers’ ties during their testimony in support of the drugs.
Besides the tamper-resistant pills, ADF opioids are being rolled out in other forms, including injectable drugs and pills that irritate users when they’re snorted or contain substances that counteract highs.
Making painkillers harder to abuse is a common-sense step. But it’s also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lowercost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills. The big companies hold multiple patents on the reformulated drugs, shielding them from competition for years—in some cases decades.
Though abuse-deterrent painkillers represented less than five percent of all opioids prescribed last year, they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion US market for the drugs, according to IMS Health. The field is dominated by Purdue Pharma’s Oxy Contin, patentprotected until 2030.
“We at Purdue make certain that prescribers and other stakeholders understand that opioids with abuse-deterrent properties won’t stop all prescription drug abuse, but they are an important part of the comprehensive approach needed to address this public health issue,” Purdue spokesman Robert Josephson said in a statement.
Like a spokeswoman for Pfizer Inc., Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.
“We need every tool that we can have in our toolbox,” said Kentucky state Rep. Addia Wuchner, a Republican who has worked on several bills to benefit reformulated opioids. “The extra steps are worth the effort in order to prevent this escalation of more addiction.”
The current industry campaign draws on the same 50-state strategy that painkiller manufacturers successfully deployed to help kill or weaken measures aimed at stemming the tide of prescription opioids, a playbook The Associated Press and Center for Public Integrity exposed in September.
The reporting detailed how opioid drugmakers and the nonprofits they help fund spent more than $880 million on lobbying and political contributions at the state and federal level over the past decade, eight times what the gun lobby reported for the same period. The money represents the drugmakers’ spending on all their legislative interests, including opioids.