Price for drug that reverses opioid overdoses soars amid record deaths

Pfizer manufacturing problems leave nonprofits paying exorbitant prices for dwindling supplies of life-saving naloxone

As the United States faces an unprecedented surge in opioid overdoses, harm reduction groups are seeing shortages in naloxone, a usually affordable and easy-to-use medication that reverses overdoses and has been credited with saving many lives.

But it’s not because of a lack of supply; there’s actually plenty of naloxone out there. Instead, the dangerous shortage of naloxone is all about soaring prices.

Community groups working to prevent overdose deaths are now paying up to 30 times more for the life-saving medication – at a time when more Americans than ever are dying from overdoses.

The US Centers for Disease Control and Prevention said on Wednesday that nearly 100,000 people died of overdoses during the first year of the pandemic – a record high and a 30% increase from the year before. A majority of those deaths were caused by opioids, especially drugs tainted with fentanyl, an extremely dangerous substance that is 100 times more potent than morphine.

The simultaneous rise in overdoses and the lack of affordable naloxone is a “perfect storm”, Amanda Latimore, director of the Center for Addiction Research and Effective Solutions, told the Guardian.

“Not having this life-saving medication to reduce overdose deaths, during a time when we’re seeing the greatest increase we’ve ever seen, is a public health crisis. There hasn’t been a more important time than right now to have an overdose reversal drug available. And now that we’re seeing this shortage, we can expect even more fatal overdoses,” she said.

Opioid overdoses can often be reversed with naloxone, which is sold under brand names including Narcan and Nevzio, is safe and effective when administered quickly. The medication can be injected or inhaled.

Drug giant Pfizer reached a deal with the Opioid Safety and Naloxone Network (OSNN) Buyers Club in 2012 to provide its injectable medication at low cost for harm reduction groups, which work closely with people with substance abuse disorders to prevent overdose deaths. But Pfizer ran into problems in manufacturing doses of naloxone earlier this year, and the company temporarily stopped supplying the affordable medication to the community groups battling overdoses. The issues are now fixed, and Pfizer expects to be fully stocked again by the end of the year.

But meanwhile, thousands of people are dying from overdoses without enough medication to reverse them, as other drug firms have not responded to the supply problems by lowering their prices. The drug is now far more expensive for the very providers that need it the most.

“We are being asked to attend a lot more funerals than we ever have before,” said Nabarun Dasgupta, an epidemiologist at the University of North Carolina at Chapel Hill and an adviser for the OSNN Buyers Club.

“I estimated 12,000 to 18,000 excess deaths if we didn’t get the shortage handled, and I think a good chunk of those deaths have already happened,” he told the Guardian.

There is no reason other companies couldn’t cut their prices to help fill the gaps left by Pfizer’s manufacturing issues, Dasgupta said, except for one:

“Profit. There’s no other way to put it.”

But even if pharmaceutical companies dropped the price for harm reduction groups, he said, they were still “making their profit off institutional buyers”. Hospitals and other care systems can still buy the treatments at previously negotiated prices.

Harm reduction groups used to buy naloxone from Pfizer to create kits that cost about $2.50 each. Now they have to pay $37 for a different generic medication or $75 for Narcan – a 15- to 30-fold increase. They simply haven’t been able to afford enough kits to save everyone’s lives.

“To put it in stark terms, you could be saving one life or you could be saving 10 lives for the same price,” Leo Beletsky, a professor of law and health sciences at Northeastern University, told the Guardian.

Emergent BioSolutions, the company that produces Narcan, has not raised the price since the medication was launched in 2016, a spokesperson told the Guardian in an email, and “provides a discounted price to national, state, and local governmental health and safety entities closest to at-risk populations, including public health clinics, fire departments, and police departments”. But discounts are not offered to harm-reduction organizations.

One harm-reduction group in Colorado is almost out of supplies. “We’re experiencing a shortage in injectable Naloxone in CO and nasal Narcan is expensive at the moment,” the group tweeted this week, with a photo of the nearly empty drawer of medication. “We’re in the worst overdose crisis we’ve ever seen.”

The coronavirus pandemic has “really sparked a surge” and exacerbated existing disparities of who lives and who dies after an overdose, Beletsky said. “It is an absolute crisis.”

And the true extent of pandemic pressures and naloxone shortages is yet unclear. “It takes six months to a year for it to show up in some of the federal datasets,” Latimore said.

The experts wonder why other naloxone producers don’t drop their prices, even temporarily, to cover the gaps.

“For something that is so effective and so safe, there’s no reason why it shouldn’t be more affordable,” Latimore said.

Naloxone is an inexpensive medication that’s been around since the 1970s. Other life-saving medications such as insulin and EpiPens are also sold at prohibitively high costs.

“This is a symptom of broader dysfunction in the US pharmaceutical industry, where public health concerns are secondary to financial concerns,” Beletsky said.

But “it’s not enough to criticize the pharmaceutical industry,” he added. “We should be using the regulatory tools that we have to compel them to act in a different way.”

The federal government could step in to make the prices more affordable and consistent, “but that just hasn’t happened yet”, Latimore said.

Because there are no gaps in supply – only in price – the US Food and Drug Administration hasn’t declared a naloxone shortage.

One solution could be creating public benefit corporations – organizations that produce essential medications for low prices. Such a corporation was proposed in the Purdue Pharma settlement, Beletsky pointed out. The Biden administration could also invoke the Defense Production Act to compel private entities to prioritize manufacturing naloxone under the rationale that the opioid epidemic is a national crisis.

The pandemic may, in fact, pave the way for action. The Cares Act passed last year granted new powers to the FDA for making prescription drugs like naloxone available over the counter, which would significantly reduce ordering issues, Dasgupta said.

“Let me tell you what they’ve used it for: wart removers, anti-flatulence medications and ingrown toenails,” he said.

It’s not that leaders don’t care, Dasgupta said. “What’s been really fascinating in our conversations with federal officials has been not a lack of compassion, but a total blindness to how the system operates in practice,” he said. “​​There’s a huge disconnect between policy and what happens on the ground.”

Requiring pharmaceutical companies to lower prices for naloxone, or creating federally or philanthropically funded programs to buy the drugs, would be relatively inexpensive, he argued. Last year, the buyers club provided 1.3m doses.

“We’re talking about a couple million dollars,” Dasgupta said. “It’s just so small in terms of the [financial] impact around this. It’s really heartbreaking.”


Melody Schreiber

The GuardianTramp

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