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 campaign is distracting from more productive solutions and delaying efforts to steer physicians away from prescription opioids — 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.
The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when swallowed.
Pharmaceutical companies are making an under-the-radar push for bills benefiting the reformulated opioids in statehouses and in Congress, where proposed legislation would require the Food and Drug Administration 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.
Making painkillers harder to abuse is a common-sense step, but it's also a multibillion-dollar sales opportunity, allowing drugmakers to corner the market with their newly patented, higher-priced versions.
Abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year, but they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion U.S. market, according to IMS Health. The field is dominated by Purdue Pharma's OxyContin, patent-protected until 2030.
"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.
The Food and Drug Administration has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of abuse or death, and the evidence gap has led to diverging views among health authorities.
Whereas FDA regulators emphasize the potential promise of reformulated painkillers, other government officials stress that they contain the same heroin-like ingredients as traditional opioids. An estimated 78 Americans die from heroin and prescription opioid overdoses every day.
"'Abuse-deterrent' sounds to people sometimes like 'Oh, maybe it's not addictive.' But it's no less addictive," said Dr. Tom Frieden, head of the Centers for Disease Control and Prevention.
Survey results published this year in the Clinical Journal of Pain showed nearly half of U.S. physicians incorrectly believed that reformulated opioids are less addictive than their predecessors.
The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs.
The current industry campaign draws on the same 50-state lobbying strategy that painkiller manufacturers have successfully deployed for at least a decade.
In September, The Associated Press and Center for Public Integrity detailed their playbook, reporting that 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.
Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois' state capital to champion an unlikely cause — the revamped painkillers.
Bartlett's son Michael died after becoming hooked on Vicodin and later graduating to heroin. She didn't know then that she had been recruited into a wide-ranging lobbying campaign when she urged lawmakers last year to support a bill that would prioritize the new harder-to-crush pills. A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the measure, along with local sheriffs and fire chiefs.
The pharmaceutical industry's fingerprints are easy to spot. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 feature nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from Quorum, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.
Since 2012, at least 21 bills related to the drugs have become law, including five that require insurers to cover the more expensive drugs.
But drugmakers face fierce opposition from insurers and employers who would be on the hook for the far-more-expensive opioid variations. And federal health officials also have pushed back against mandates for the drugs, citing the "staggering" costs.
For example, a 30-day supply of abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by Truven Health Analytics, a company that tracks drug prices set by manufacturers.
The Department of Veterans Affairs' Dr. Bernie Good, who helps oversee medication safety, estimates that converting that health system to the new reformulations would increase opioid spending more than tenfold, to over $1.6 billion annually.
"Would the excess money to pay for abuse deterrent products — mostly to pay for it in cases where it wouldn't be necessary — be better spent for drug treatment centers?" he asked at a recent federal meeting on the drugs.
Federal estimates say at least 2.2 million Americans are addicted to prescription opioids or heroin, yet only one in five actually receives treatment, according to a Surgeon General's report published last month.
Meanwhile, the makers of abuse-deterrent drugs have spent more than $20 million on lobbying efforts that include support of a bill that would require the FDA to gradually replace current opioids with harder-to-abuse versions as they become available.
Though the bill has not received a vote in Congress, the FDA already has begun mapping out a process for removing older opioids from the market when newer versions are shown to be more effective at thwarting abuse.
The FDA has walked a careful line on the new drugs, promoting them as a promising approach to discouraging abuse while acknowledging their real-world benefits are still largely theoretical.
The agency has not yet concluded that any of the products have a "real-world impact" on measures like overdose deaths, according to Dr. Douglas Throckmorton, an agency deputy director. But he and other regulators predict that the reformulations will eventually translate into public health results.
"We stand by those predictions," Throckmorton said at a recent federal meeting.
Regulators acknowledge, however, that abusers continue to find ways around even the reformulated pills.
David Rook, a 40-year-old Henrico, Virginia, resident who now operates a recovery facility, was among them. Before entering treatment, he said, he would break down abuse-resistant pills using water, lemon juice and a microwave.
"The truth is an addict can find a way to abuse a medication one way or the other," he said.