The Guardian: Aimee Dunkle and the Solace Foundation of Orange County

Ben Dunkle, who died of a heroin overdose, with his mother Aimee, who started Solace Foundation in southern California to distribute naloxone after his death. Photograph: Courtesy of the Dunkle family

Ben Dunkle died at the age of 20, abandoned in a car park by panicked friends who had no idea how to save his life as he overdosed on heroin.

“I’m certain that if they had been carrying naloxone, they wouldn’t have run away,” said his mother, Aimee Dunkle.

After Ben’s death, Aimee made it a mission to get naloxone, an antidote that can bring overdosing opioid users back from the brink of death within minutes, into the hands of as many people as she could. In February she founded the Solace Foundation in southern California to distribute naloxone among addicts, many of them homeless, as well as their relatives and friends. She says the group has saved at least 365 lives.

But Dunkle said she could have saved more if it were not for the surging cost of the drug which has prompted accusations of pharmaceutical companies profiteering from the US’s opioid epidemic. Costs for pre-filled syringes doubled in 2014 and are three times the price of 15 years ago, while auto-injectors, spring loaded syringes used to administer the drug, have seen their price increase more than fivefold in two years.

“More people are dead now than would have been otherwise,” said Dan Bigg, director of the Chicago Recovery Alliance, an important distributor of naloxone in the city. “How many is hard to count, but programmes that would have started didn’t because of the cost of naloxone. Programmes that would have expanded didn’t because of the price of naloxone. To the extent pricing is an impediment, it will prevent this being used as a lifesaving medicine.”

Deaths from opioid overdoses surged again last year to more than 30,000, driven by a sharp increase in the use of heroin and fentanyl.

Heroin deaths were up 23% on the previous year to 12,989, more than the number of lives claimed by guns used in murders, according to data released by the Centers for Disease Control and Prevention (CDC) on Thursday. The sharpest increase came from lives claimed by even more powerful synthetic opioids, such as fentanyl, the drug that killed Prince, which were up 73% to 9,580 deaths, although some of those deaths were in combination with heroin. But prescription opioid painkillers, containing drugs such as oxycodone, remained the biggest killers, taking 17,536 lives.

Medical studies say that most heroin users first become addicted to prescription drugs. It is how Ben Dunkle came to die.

Overdoses are so widespread that the National Center for Vital Statistics found drug-related deaths are dragging down life expectancy for white adults.

After 15 years of steadily rising deaths from opioids, what the CDC has called an epidemic, the issue has finally forced its way on to the political stage with $1bn in treatment and prevention legislation passed by Congress. It has also resulted in ever-widening access to naloxone as more police forces carry it and states liberalise access by making it available without a prescription. But increased demand for the antidote has coincided with a sharp rise in cost.

Naloxone is most commonly administered by injection or spray. Kaléo, a Virginia company, has increased the price of its naloxone auto-injectors, sold as Evzio, from $690 for a kit of two to $4,500 in less than two years. Amphastar of California nearly tripled the price of syringes pre-filled with naloxone.

“When we started in 1996, a 10cc vial of naloxone was $1.63. Now that 10cc vial is almost $300 at Walgreens here,” said Bigg. “Has the price been raised well beyond what it costs to make in an obscene way for such an important lifesaving drug? Yes.”

Robert Childs, director of the North Carolina Harm Reduction Coalition, one of the largest not-for-profit distributors of naloxone in the US, said his organisation had spent about $220,000 this year giving out more than 13,000 naloxone kits to police officers and others working with those at risk of overdose.

“If naloxone wasn’t the price it is, we would be able to buy a lot more and get a lot more out there to high-risk populations,” he said. “There’s a public health crisis with opiate and opioid-based drug overdoses, and the response has often been to increase the price, which is probably the worst response you can do.”

The increased demand and rising prices have resulted in a surge in income from naloxone for drug companies, up 400% since 2011 to $82m last year.

“It’s one thing to charge more for snow shovels when there’s a blizzard, but this is a public health emergency,” said Dr Andrew Kolodny, co-director for opioid policy research at Brandeis University. “When you have an epidemic of people dying of opioid overdoses, [this] should be readily available. We shouldn’t have pharmaceutical companies profiteering.”

Doctors writing in the New England Journal of Medicine called for government intervention to control the price of the drug, saying that cost is discouraging use of naloxone. They said that legislation has greatly expanded access to the antidote but that the price remains an obstacle.

“We believe that such policies should explicitly call on manufacturers to reduce the price of naloxone and increase transparency regarding their costs, particularly those related to the development of new formulations,” it said.

“The message to lawmakers is drug prices are an increasingly important problem for patients,” said one of the article’s coauthors, Dr Joseph Ross, an associate professor of public health at Yale University and a primary care physician.

Aimee Dunkle took one look at the young man slumped on a bench in a Santa Ana carpark three weeks ago and knew she had only minutes to act.

“The giveaway for me was he was drooling. He was breathing very shallowly. I recognised him and called his name. There was no response,” she said.

The man was overdosing on heroin and benzodiazepines, a lethal combination. Dunkle pumped a shot of naloxone – also known by the trade name Narcan – into him.

“I gave him the first shot of Narcan and no response. I gave him the second shot and he woke up. He was groggy, but he was up almost immediately. Someone had dialed 911 but before law enforcement arrived he was walking away,” she said. “It was exhilarating to save a life for the first time but then I realised this is how Ben died, sitting in a car, slumped over.”

Most of the manufacturers distribute a limited amount of free supplies to community groups and emergency services like Dunkle’s or sell naloxone at a discount. Dunkle said her group received free auto-injectors from Kaléo, but when they ran out she could not afford to buy more even at the discounted price for non-profits.

“There’s no way I can even contemplate buying it,” she said. “We sometimes get some financial donations. One time I had about $1,500 that had been donated and I bought $1,500 of Narcan. Then I had to select who to give it to. Not who was at most risk but who was most likely to witness an overdose. For a mother that’s lost a child, that’s a hellish decision to have to make: who gets the kits and who doesn’t.”

Supplies dried up for three weeks in September. Dunkle said that inevitably meant lives were lost.

“Our waitlist was over 70 people and that meant people died because we didn’t have it,” she said.

But financial donations mean she now has supplies to see her through the first half of 2017 distributing 70 naloxone kits a week. Still, that falls well short of demand.

“There’s never enough,” she said.

Source: "The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths", New England Journal of Medicine and Truven Health Analytics Graphic: Jan Diehm/The Guardian

The rising costs have drawn scrutiny in Congress. Senators Susan Collins and Claire McCaskill wrote to five pharmaceutical companies in June asking them to explain their pricing of naloxone.

A spokesman for McCaskill said that in meetings the companies defended the increases as necessary to cover the cost of new delivery systems. Naloxone, which has been on the market since 1971, is no longer covered by a patent and is cheap to produce. But pharmaceutical companies do have patents on how the drug is administered, such as by spray or auto-injector – a spring-loaded syringe.

“In meetings, generally speaking, the companies have argued that the price increases are due to new and more efficient delivery systems,” he said. “The question is, are these new bells and whistles effective?”

Manufacturers said the introductions of nasal sprays and auto-injectors were easier and safer to use than regular syringes. But Bigg questions whether those modifications justify the cost given that both means of delivery were already commonly used with other drugs.

An Irish company, Adapt Pharma, which makes a widely used naloxone nasal spray with a trade name of Narcan, denied that the patent was a means to price gouge. It said the spray “is designed, tested and approved so that anyone in the community can deliver a proper dose in non-medical conditions”.

“It’s not as simple as just putting naloxone into the device and selling it,” said Mike Kelly, president of Adapt’s US operations. “To obtain Food and Drug Administration approval, we must consistently meet the standards set by the FDA.”

The list price for the spray is $125 for the two shots typically administered to someone who overdoses on opioids, which Adapt notes is considerably cheaper than a rival, the Evzio auto-injector, with a retail price of $4,500 for a pack of two.

Kelly said the company discounts the cost for community groups and the police by 40% and that a majority of patients using a prescription can obtain it through health insurance for $10.

“We have made it our mission to provide more access and availability than ever before – including donating more than 50,000 doses of Narcan nasal spray to increase awareness and experience with the product and naloxone generally,” he said.

Mark Herzog, vice-president of corporate affairs at Kaléo, said the six-fold increase in the list price of Evzio was made in order to cover the cost of ensuring anyone with insurance and a prescription can obtain the drug cheap or free. The company responded to the senators’ letter by claiming that the real barrier to naloxone access is “lack of insurance coverage or unreasonable coverage restrictions”.

The company said it has donated more than 150,000 auto-injectors to public agencies and community groups. Other drug manufacturers did not respond to requests for comment, including one of the largest naloxone sellers, Hospira, which has raised the cost of a vial of the drug by 1,700%.

This article was amended on 17 December to correct a misstatement regarding which device increased more than five times in price in the last two years. It is an auto-injector manufactured by Kaléo, not the Narcan nasal spray.

Source: https://www.theguardian.com/society/2016/dec/16/opioid-overdose-naloxone-pharmaceutical-price-gouging