Drug makers push a profitable but unproven opioid solution – StatNews – Dec 2016
Drug makers are aggressively pushing their remedy to the problem [opioid overdoses]:
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.
The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, which the drug makers 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 industry-sponsored 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-the-radar push for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the Food and Drug Administration to replace older opioids with the new drugs.
Making painkillers harder to abuse is a common-sense step. But it’s also a multibillion-dollar sales opportunity, offering drug makers the potential to wipe out lower-cost 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 5 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 U.S. market for the drugs, according to IMS Health. The field is dominated by Purdue Pharma’s OxyContin, patent-protected until 2030.
Like a spokeswoman for Pfizer Inc., Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.
The FDA has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of addiction, abuse or death, and the evidence gap has led to diverging views among health authorities.
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.
This shows a shocking lack of knowledge and understanding.
Even without being explicitly informed, any doctor who knows what an opioid is would know that making the pills abuse deterrent has nothing to do with the function of the medicine (opioids) in the pill.
Many of us with chronic illness have impaired digestion and these pills are deliberately made hard to digest so they may not be as effective as generic pills. That’s been my experience.
But even they worry that some drug makers are overselling the technology. They stress that separate measures are needed for the majority of opioid abusers who ingest the pills orally
And the industry’s fingerprints are easy to spot in other areas.
Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured 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.
Drug makers have found fierce opposition to their ADF legislation from insurers and employers who would be on the hook for the far pricier opioid variations.
Federal health officials also have pushed back against requirements to cover the drugs, citing the “staggering” costs.
For example, a 30-day supply of Pfizer’s 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.
“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.
Finally, someone is making sense. Instead of focusing so narrowly on pain patients, why not focus on addiction instead and apply money and effort to treat the addicts that are so likely to overdose?
When critics raise alarms about higher costs and limited evidence, drug makers can rely on groups they support financially to argue their side, including the National Association of Drug Diversion Investigators, the Academy of Integrative Pain Management and the Partnership for Drug-Free Kids. Representatives from those groups have testified in favor of abuse-deterrent legislation in at least seven states.
And Bob Twillman, executive director of the Academy, said, “Increased use of abuse-deterrent opioids makes it more likely that those patients who need opiates to treat their pain will be able to get them.”
I think he means that pain patients won’t be suspected of abusing their drugs. I’m disgusted that things have gotten so bad that pain patients have to prove their innocence because they are always presumed to be guilty.
However, no matter how desirable they are, there’s no way our medical system can afford the price difference between the opioids used now and these “new and improved” ADF’s.
The pro-ADF playbook even includes a bit of political theater. In at least seven states, lawmakers or advocates have pounded the reformulated pills with hammers to demonstrate how difficult they are to smash.
‘An addict can find a way’
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 remain largely theoretical.
But the FDA has not yet concluded that any of the products have a “real-world impact” on measures like overdose or death, according to Dr. Douglas Throckmorton, an agency deputy director. He and other regulators predict, however, that the reformulations will eventually translate into public health results.
Dr. Lewis Nelson, who previously chaired an FDA panel on drug safety, notes that the drugs don’t deter the most common form of abuse: swallowing pills whole.
“The truth is an addict can find a way to abuse a medication one way or the other,” he said.
The lack of real-world data on reformulated opioids is the main reason some federal officials haven’t embraced them.
The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs. Why?
Frieden, the agency’s director, said his staff could not find any evidence showing the updated opioids actually reduce rates of addiction, overdoses or deaths.
They couldn’t find any evidence that opioids weren’t the more effective solution either, but that didn’t keep them from recommending against them.