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    FDA approves overdose-reversing Narcan for sale without prescription

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    The US Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over counters in the US.It is a move some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.The best-known form of naloxone is Narcan, an approved branded nasal spray made by Emergent BioSolutions in Gaithersburg, Maryland. It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.Making naloxone available more widely is seen as a key strategy to control the US overdose crisis, which has been linked to more than 100,000 deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.Advocates believe it is important to get naloxone to people who are most likely to be around overdoses, including people who use drugs and their relatives. Police and other first responders often carry it.Emergent BioSolutions said Narcan would become available over-the-counter by late summer. Other brands of naloxone and injectable forms will not yet be available over the counter, but could be soon.Harm Reduction Therapeutics, a non-profit which has funding from the OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it. But not every pharmacy carries it. And buyers have to pay for the medication – either with an insurance co-pay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.The drug is also distributed by community organizations that serve people who use drugs, though it is not easily accessible to everyone who needs it.Emergent has not announced its price and it is not clear yet whether insurers will continue to cover it as a prescription drug if it is available over the counter.However, the FDA decision clears the way for Narcan to be made available in places without pharmacies, including convenience stores, supermarkets and online retailers.Jose Benitez, lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said over-the-counter access could help a lot for people who don’t seek help or who live in places where it is not available.Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they are getting it.“Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” he said.The US Centers for Medicaid and Medicare Services, which now covers prescription naloxone for people on government insurance programs, says coverage of over-the-counter naloxone would depend on the insurance program. It has not given any official guidance.Maya Doe-Simkins, a co-director of Remedy Alliance/For the People, which launched last year to provide low-cost and sometimes free naloxone to community organizations, said her group would continue to distribute injectable naloxone.One concern is whether people who buy Narcan over the counter will know how to use it, said Keith Humphreys, a Stanford University addiction expert, though the manufacturer is responsible for clear directions and online videos.One benefit of having pharmacists involved, Humphreys said, is that they can show buyers how to use it. Humphreys also said there are fears that if the drug is not profitable as an over-the-counter option, the drugmaker could stop producing it. More

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      Arresting Michael K Williams’ alleged drug dealers won’t solve the US addiction crisis | Akin Olla

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      Arresting Michael K Williams’ alleged drug dealers won’t solve the US addiction crisisAkin OllaAs a country we refuse to pursue policy reforms that might have saved the beloved actor and the many thousands of others who are dying of overdoses I cried the night Michael K Williams joined the over 100,000 Americans who died of an overdose in 2021. When I heard that Williams, the actor best known for his role as Omar, the queer, gun-toting rogue in The Wire, had suffered an accidental overdose in his apartment, I felt a deep sense of dread. The knowledge that another Black man not too dissimilar from myself had passed before his time mingled in my mind with my bitter memory of the moment when I learned that my best friend, Joseph Rodriguez, had overdosed at the age of 19.I am grateful, I suppose, that by the time Joe had died, in 2009, the public narrative around drug users had begun to evolve. Young suburban white kids had started dying, and the country quickly shifted to protect its most prized possessions. Teens were sent to rehab, and drug dealers, like those who allegedly sold Williams his final dose, were rounded up and blamed for what is clearly a broader societal issue.Last week four men in Brooklyn were charged with having sold fentanyl-laced heroin to Williams and others. This hollow act is part of the problem. The US has long chosen mass incarceration as the solution to substance abuse. Arresting people didn’t prevent Williams’ overdose, and arresting more now won’t prevent future ones. And given Williams’ stance on the war on drugs, it is doubtful he would have endorsed this action.There are many solutions that could have helped keep Williams alive. While it is unlikely that the US will rid itself of many of the underlying drivers of drug addiction – such as violence, systemic racism and the inequalities of capitalism – anytime soon, the country, and the federal government in particular, has long ignored policy reforms that could help address the worst of our current addiction epidemic. The most important reform, decriminalization, has gained steam in some places, like Oregon, but remains far away as a federal reform.Williams was a one-of-a-kind man and artist, but not unique in his struggles with drugs: according to the 2020 National Survey on Drug Use and Health, 14.5% of Americans – roughly 40.3 million people – had a substance use disorder in 2020. A couple hundred of those people die of an overdose every day. This is a long-term trend that continues to explode over time; while over 100,000 Americans died of an overdose last year, the number was roughly 17,000 in 2000. As someone who has been involved with drug policy reform since 2010, roughly a year after my friend died, it is difficult to maintain hope as the bodies pile up, especially as solution after solution is ignored by the federal government.There are an embarrassingly large number of policies that could be backed by the federal government and implemented nationwide to save lives and nudge addicted people towards healing. Rather than concentrating power in the police through criminalization, most of these policies involve treating drug users like human beings worthy of love and care. One of the simplest ways to save lives is to make drug testing kits easily available for drug users. Williams was reportedly poisoned by fentanyl, a synthetic opioid mixed into cocaine and heroin as a means for illicit manufacturers to increase profits. Drug testing kits, like fentanyl test strips, let consumers ensure that they know what they’re putting into their bodies. While these strips are available for free in some places, such as New York City, they are still illegal in many states because they’re considered drug paraphernalia.Another potentially life-saving intervention? Supervised consumption sites. These are locations where people can consume drugs safely, with the support of medical staff that can ensure the purity of what is being used while being on call to intervene in the event of accidental overdoses. These locations can also connect people with treatment services and safer alternative drugs. If this all feels unfamiliar, think of bars as a crude version of these sites: bartenders administer doses to clients and can cut them off if they are too intoxicated. If anyone drinks too much, bartenders can call an ambulance and have them hospitalized. Creating robust supervised consumption sites could save lives, and destigmatizing those sites could save even more.All of these interventions would be made more effective and possible if the federal government took the important leap to decriminalize the possession of small amounts of all drugs. Total decriminalization may seem extreme, but there is evidence that it could save lives, reduce drug use, and prevent more unnecessary incarceration and harassment of those who use drugs, particularly Black Americans. Living in New York City, Williams did have access to some harm reduction resources but, like many drug users, may have felt too much stigma to seek help.Portugal decriminalized all drugs, in small amounts, in 2001. The country has also radically expanded its capacity to treat substance use disorders. According to the US-based Drug Policy Alliance, overdose deaths in Portugal decreased by more than 80% after decriminalization. By contrast, in 2017, “there were more than 72,000 overdose deaths in the US. If the US overdose death rate were on par with Portugal’s, there would have been fewer than 800 overdose deaths that year.” By 2008, three-quarters of those suffering from substance use disorder in Portugal were in treatment.The deaths of Michael K Williams and Joseph Rodriguez were perfectly preventable if we’d wanted them to live. Addiction is inevitable in our present society. Capitalism is a system that necessarily involves the commodification of human beings and the reduction of the individual into a tiny cog that exists to work and create profit. This dehumanization, exacerbated by racism, is probably why there are strong relationships between poverty and addiction, and why Black men are now the people most likely to overdose and die.The reality is that there will be many more deaths like Williams’. I expect to lose more friends; it would be naive to think that I won’t. In recent years both Democrats and Republicans have slowly shifted closer to the kind of drug reforms that could save lives. But for some of the people I love it is too little, too late and, without a comprehensive federal plan that includes decriminalization, we may as well brace ourselves for more tearful phone calls and funerals.
      Akin Olla is a contributing opinion writer at the Guardian
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      in US Politics

      Empire of Pain review: the Sacklers, opioids and the sickening of America

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      By 2016, opioids had torn a piece out of Appalachia and the rust belt. The deep drop in life expectancy among white Americans without four-year degrees would no longer be ignored. OxyContin, Purdue Pharma’s highly addictive painkiller, helped elect Donald Trump.In Empire of Pain, Patrick Radden Keefe methodically and meticulously chronicles this tale of woe and crisis, indifference and corruption. His Secret History of the Sackler Dynasty lays bare the price exacted by the family’s drive for wealth and social mountaineering.The Sackler name came to dot the Metropolitan Museum of Art, the Smithsonian, Tate Modern and the Louvre. They rose – others paid dearly.Keefe is a veteran writer at the New Yorker. His 2019 bestseller, Say Nothing, chillingly examined the convergence of youth, zealotry and destruction in Northern Ireland. He even solved the mystery behind a disappearance.Like Say Nothing, Empire of Pain is drenched in misery, this time the byproduct of OxyContin, the go-to drug for Purdue. Since 1999, opioid-related deaths have risen more than fivefold. By the numbers, opioids have killed more than 450,000 in the US in two decades.Keefe’s book builds upon The Family that Built an Empire of Pain, a 2017 long read. Empire of Pain is filled with firsthand interviews and takeaways from confidential and original documents. It is a chilling and mesmerizing read, “substantially built on the family’s own words”. Which is what makes it so damning.The Sacklers did not cooperate. Indeed, they sought to derail publication. Keefe raises the possibility he was placed under surveillance, an attempt to intimidate him and his family. Nonetheless, the Sacklers’ indifference and smugness rise off the pages like steam from a sewer.In one 1996 email, Richard Sackler, Purdue’s chairman and president, demands the company become as feared as a “tiger with claws, teeth and balls”. Asked repeatedly at deposition years later if Purdue played any role in the opioid crisis, he steadfastly answers: “I don’t believe so.”A cousin, Kathe Sackler, actually boasts that OxyContin was a “very good medicine” and a “safe medicine”. She also claims credit for coming up with the “idea”. But she doesn’t end there.Confronted with the question, “Do you recognize that hundreds of thousands of Americans have become addicted to OxyContin?”, she can only muster: “I don’t know the answer to that.”The drumbeat surrounding the monster birthed by Purdue is as old as the century itself. Barry Meier, then of the New York Times, published Pain Killer: An Empire of Deceit and the Origin of America’s Opioid Epidemic, in 2003.Yet faced with pushback from Purdue and the Sacklers, the powers that be swept the crisis under the rug. Even the Times came down with a case a temporary case of cold feet.In 2007, under George W Bush, the US justice department only delivered a relative slap on the wrist. The Sacklers, major Republican donors, had unleashed a full-scale counter-attack starring Rudy Giuliani, Mary Jo White, formerly in charge of the southern district of New York and the Securities and Exchange Commission, and a bevy of high-priced legal talent.Strings were seemingly pulled, career prosecutors’ findings and recommendations discounted and binned. Purdue agreed to pay $600m to resolve a felony charge of misleading and defrauding physicians and consumers. Three executives entered guilty pleas and agreed to $34.5m in penalties. None of the individuals criminally charged were Sacklers.In the words of a former DoJ lawyer, this was “a political outcome that Purdue bought”. The company named its in-house law library after one of the designated-offenders and paid millions in post-employment compensation: a reward for taking a bullet for the team.Paul McNulty, then deputy attorney general, helped handcuff justice. John Brownlee, the federal prosecutor for the western district of Virginia, clashed with McNulty over the disposition of the case. Word spread that Brownlee’s job tenure was shaky. He resigned in April 2008. For the record, James Comey, McNulty’s predecessor as deputy AG, resisted Purdue’s entreaties.Among hundreds of interviews, Keefe spoke to Brownlee and Rick Mountcastle, the line prosecutor and career lawyer who handled the case. Still at DoJ, Mountcastle raises the possibility Purdue had an inside man at the Food and Drug Administration who enabled OxyContin in exchange for the prospect of future employment.Based on a 1995 email, Mountcastle began to suspect that Curtis Wright, then an FDA examiner, had turned a blind eye to the dangers posed by OxyContin. Purdue would later tap Wright to be an executive director. In 2003, Wright testified that he still believed addiction to OxyContin was “rare”.“I think there was a secret deal cut,” Mountcastle tells Keefe. “I can never prove it, so that’s just my personal opinion. But if you look at the whole circumstances, nothing else explains it.”Regardless, the FDA helped pave the way for an opioid epidemic. Dr David Kessler, FDA commissioner when OxyContin received the agency’s approval, acknowledged “certainly one of the worst medical mistakes”.Donald Trump spoke of the toll of the opioid crisis but in 2020, as election day loomed, his Department of Justice announced a “global resolution” of the government’s investigation into Purdue and the Sacklers. By then, the company was in bankruptcy and the target of a barrage of civil lawsuits.The Sacklers agreed to pay a $225m civil penalty, little more than the 2% they had taken from Purdue. But no one would be prosecuted. Asked why the government had not brought criminal charges against the Sacklers, Jeffrey Rosen, Bill Barr’s deputy attorney general, declined to say.The government, Keefe writes, was “so deferential toward the Sacklers that nobody even bothered to question them”. More