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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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      Biden promise to crack down on fentanyl trafficking divides experts

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      Biden promise to crack down on fentanyl trafficking divides expertsMeasures to combat overdose crisis include stiffer penalties but some worry it may signal a turn away from harm reduction Joe Biden’s call for stronger penalties to crack down on fentanyl trafficking during the his State of the Union address last week drew mixed responses from experts.On Tuesday, the president laid out a series of measures to combat the country’s overdose crisis including increased drug detection machines, cargo inspections and harsher penalties surrounding fentanyl trafficking.Biden also said that there was currently a “record number of personnel working to secure the border … seizing over 23,000 pounds of fentanyl in just the last several months”.Vending machines with lifesaving drug grow as opioid crisis rages in USRead moreExperts since then have leveled both criticism and praise at Biden. In 2021, when an estimated 107,000 people in the US died from drug overdoses, he became the first president whose administration launched a national plan prioritizing harm reduction policies – which include distributing strips that can detect the presence of fentanyl in substances and prevent overdoses – in attempts to prevent death and illness among drug users.Some harm reduction advocates worry that the Biden administration’s proposal of “strong penalties to crack down on fentanyl trafficking” may frame the crisis as a largely law enforcement and border patrol issue, as opposed to a nationwide public health problem.“Criminalization of drug use trafficking is the opposite of harm reduction,” the National Harm Reduction Coalition’s director of overdose prevention policy and strategy, Mary Sylla, said. “It’s kind of disheartening because President Biden did use the phrase ‘harm reduction’ last year in his State of the Union address and it was the first time harm reduction had ever been mentioned in the State of the Union address so we were excited to see that.”Sylla added that criminalizing drugs would have already reduced trafficking or overdoses if it was possible for such an action to do that. It hadn’t done that – or incentivized behavior change among drug users – because it can’t, she said.Sylla also said that putting people in jail for whatever reason increases their risk “of all kinds … [of] health problems” given the often crowded settings in lockups and prisons.Other harm reduction advocates argue that Biden’s call for greater penalties will further hit marginalized communities that have already been disproportionately affected by the failed “war on drugs”. They also believe it will allow for even more potent drugs to enter illegal markets.“His support for harsher penalties for fentanyl-related substances – which will result in broader application of mandatory minimum sentencing and disproportionately harm Black, Latinx and Indigenous communities – in the same breath is incredibly counterproductive and fails to recognize how we got to this place to begin with,” the Drug Policy Alliance’s director of the office of federal affairs, Maritza Perez Medina, said.Perez added: “The reason fentanyl-related substances have overtaken our drug supply at this point is because of the drug trade responding to harsh crackdowns and increased seizures of heroin and prescription opioids. And now that we are seeing harsher policies towards fentanyl, there are new and even more potent drugs, such as Xylazine and nitazenes popping up and beginning to overtake some markets.”Perez also criticized the Biden administration’s push for Congress to permanently categorize all fentanyl-related substances as schedule I drugs, a category reserved for drugs that have a high potential for abuse and can create severe psychological and physical dependence.Schedule I drugs currently include heroin, lysergic acid diethylamide (LSD) and marijuana. Medina said adding fentanyl-related substances to that list without fully testing or researching them is “creating the conditions for a riskier drug market and backtracking on his commitments to criminal justice reform” while also missing the opportunity to find more therapeutic treatments aimed at addressing the overdose epidemic.At least one therapeutic – naloxone – has already delivered promising results as a tool to reverse opioid overdoses, Medina said. But, Medina and others reiterated, there could be more.Meanwhile, other experts have praised the Biden administration’s approach to the overdose crisis, which includes disrupting the drug’s trafficking and sale while also expanding access to treatment, recovery and harm reduction tools such as sterilized needles and smoking equipment.“I think from a broad perspective, we’re on the right track,” Professor Erin Winstanley of West Virginia University – whose focuses include the opioid epidemic and substance use disorders – said.Winstanley said reducing the supply of dangerous and potent drugs like fentanyl has to be a dimension of any good drug policy. And she said the Biden White House’s list of recommendations to reduce illicit fentanyl-related substances, as submitted to Congress in 2021, took into consideration precisely how prone those drugs are to being abused and proposed their schedule accordingly.“It’s actually very rational,” Winstanley said. “Any criminal sentencing around fentanyl is linked to in part that research and also the schedule, so that looks quite progressive to me if that’s what ends up being the policy.”Nevertheless, Winstanley wants to see the Biden administration continue prioritizing science, especially by ensuring that research surrounding substance use disorders continues to have bipartisan support.“It’s something that we need to continue to ensure that there’s adequate funding so that we can find science-based solutions,” Winstanley added. “Since more deaths in the United States involve fentanyl and methamphetamine, we really need to see further advances in treatment for methamphetamine use disorder and … advancing more sophisticated approaches to managing overdoses involving potent synthetics like fentanyl.”TopicsOpioids crisisJoe BidenUS politicsfeaturesReuse this content 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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      Critics say Biden’s drug czar pick at odds with push for ‘harm reduction’ policies

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      Biden administrationCritics say Biden’s drug czar pick at odds with push for ‘harm reduction’ policiesConcern over role Rahul Gupta played in shutting down West Virginia’s largest syringe service program in the state’s capital Kyle Vass in West VirginiaFri 5 Nov 2021 05.00 EDTLast modified on Fri 5 Nov 2021 05.02 EDTJoe Biden is on record as the first US president to embrace a concept known as “harm reduction” – a public health approach that aims to mitigate harm done by drug use instead of the traditional just-say-no-ism of past administrations.Administration officials have said last week that the federal government will now support harm reduction concepts – like giving sterile syringes to people who inject drugs – in an effort to curb the transmission of infectious diseases.But the Biden administration has appointed Rahul Gupta as the nation’s new director of the Office of National Drug Control Policy despite the West Virginian having a controversial relationship to harm reduction policies in the past.The appointment of Gupta, a personal friend of Joe Manchin, the West Virginia senator, has sparked concern among some drug policy campaigners who see the move as at odds with the administration’s stated aims of a change in focus when it comes to harm reduction policies.The biggest criticism of the new “drug czar” comes from public health experts who recall the role he played in shutting down West Virginia’s largest syringe service program in the state’s capital of Charleston – now home to what the CDC has called “the most concerning HIV outbreak in the nation”.In the wake of the program’s shutdown, which Gupta supported, the state has formalized new legislation that is likely to shut down nearly all of its harm reduction programs despite facing multiple, new HIV clusters related to injection drug use.When Gupta began working as the director for the West Virginia bureau of public health in 2015, the state was entering a new phase of the opioid crisis. Prescription pill usage was trending down, but only because it was being replaced by people injecting heroin and fentanyl. The number of overdoses in West Virginia for that year more than doubled the number of people who had died in car accidents.Nationwide, the increase in injection drug use drove an uptick in new HIV cases, especially in small towns. In rural communities across the nation, where syringe possession without a prescription is often criminalized, people hooked on opioids still face two options: reuse (and perhaps share) already used needles or go into potentially fatal drug withdrawal.One community of 3,700 people in south-eastern Indiana went from having fewer than five HIV cases to 235 seemingly overnight in 2015. Surrounding local governments, desperate to find solutions, decided to buck small town conservatism and try an idea typically found in large cities, one grassroots outreach workers had been using for years: harm reduction.Although these governments couldn’t prevent people from using drugs, they could reduce the harm associated with their usage – especially the impact their usage had on public health. A syringe program was started in Scott county, Indiana, to provide people who inject drugs with sterile syringes. The results were staggering.In less than a year, there was an 88% drop in syringe sharing – a key victory in controlling the spread of HIV. Public health experts across the nation identified what was done in Indiana as the first step in preventing HIV transmission among people who inject drugs.Following the outbreak in Indiana, the CDC identified 220 counties across the US considered high-risk for HIV outbreaks associated with IV drug use. Of West Virginia’s 55 counties, 28 were on that list.Officials in West Virginia’s capital city, Charleston, started a syringe program through the local health department. The West Virginia bureau of public health, led at the time by Gupta, established statewide guidelines and the Kanawha Charleston health department sterile syringe program began operation.But in West Virginia, where Donald Trump’s brand of conservatism led to a state-record shattering 42.2% margin of victory in 2016, the rhetoric of giving people who use drugs syringes was a hard sell.The KCHD syringe program served nearly 25,000 people in the three years it operated. For a city of 49,000 residents, the program was meeting a massive demand for clean syringes. But, by 2018, conservative politicians and residents alike had successfully rallied against the program.An ugly public feud pitted former mayor Danny Jones and his supporters against the program and anyone who supported it. Jones, who in an interview had professed that people who use drugs should “be locked up until they’re clean”, enacted a series of changes on the program that include putting a police officer in charge of its design.The biggest criticism of Dr Gupta from his time as the state’s public health commissioner stems from an audit of the syringe program his office was asked to do by Jones. Flouting CDC recommendations that support lowering barriers to access and guidelines set up by his own office, Gupta’s audit called for a suspension of the syringe program because it didn’t require participants to first seek treatment for drug use before accessing clean syringes.Dr Robin Pollini, an epidemiologist at West Virginia University, and six other harm reduction experts nationwide wrote letters speaking out against Gupta’s findings saying his key criticism – that treatment options weren’t being prioritized above syringe access – showed he missed the point of harm reduction entirely.In an interview with the Guardian Pollini said: “The report was arbitrary in faulting the program for not adhering to practices that were not even required by the state certification guidelines” – guidelines written by Dr Gupta’s own office.When Gupta decided to leave West Virginia in 2018, Charleston and the surrounding county had fewer than five HIV cases related to IV drug use. Since then the number of new cases has gone up to 85, prompting the CDC to send in a team of disease intervention specialists.“They warned us there was going to be a massive HIV outbreak.” said April, who contracted HIV in Charleston last year from IV drug use and did not want her last name used. “I thought they were just trying to scare us into not using. But, they were right.”She added that she and people she had use drugs with didn’t have to share needles when the program was operational. “But as soon as it shut down, people started selling them just like they did dope.”But beyond the immediate public health crisis prompted by shutting down the state’s largest sterile syringe program, Gupta’s audit’s legacy lives on in the form of new legislation that has made it illegal for harm reduction programs in West Virginia to follow CDC guidelines.Proponents of the bill held up his report as an example of a public health official advocating for higher thresholds on syringe programs. As a result, three of the 28 counties in West Virginia originally identified as high-risk for HIV outbreaks have shut down their syringe programs, citing restrictions placed on their programs by the new law.Three years after the KCHD program was decertified by Gupta, people desperate for housing and access to medical supplies are not hard to find on the streets of Charleston. A man named Tommy said clean syringe access has completely dried up since the shutdown of the program.Desperate to reuse old needles, he described how people who are desperate to straighten out a used needle use the flint on matchbooks to reshape old needles which have been bent from use. He said the current market value for a clean syringe on the streets is around $5. Alternatively, people can get a used one for between $1 and $2.Seeing the devastation caused to her state’s public health by people who misunderstand or outright oppose harm reduction over the past few years, Dr Pollini is left with one question over the newly confirmed head of ONDCP. “Does he have a better understanding of these programs than he did three years ago?” Pollini asked.The White House was asked for comment but did not respond.TopicsBiden administrationUS politicsOpioids crisisnewsReuse this content More

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      Sacklers deny responsibility for opioid crisis and claim lawyers ‘invented false narrative’

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      A branch of the Sackler family has launched a website denying responsibility for the US opioid epidemic even after agreeing to pay billions of dollars to settle lawsuits over the crisis.The website, called Judge for Yourselves, claims that the family and the company it owns, Connecticut-based Purdue Pharma, are victims of a smear campaign by lawyers seeking to profit from a “strategically invented false narrative” that the firm’s high-strength prescription painkiller, OxyContin, drove an epidemic that has ultimately claimed more than 500,000 lives over the past two decades.It says the Sackler family regrets that the drug “unexpectedly became part of the opioid crisis” but that those members who ran Purdue “acted lawfully and ethically”.However, the site also downplays Purdue’s guilty pleas to federal crimes on two occasions, in 2007 and last year, over its huge marketing push to sell OxyContin to the masses, which included false claims that the drug was less addictive than other narcotic painkillers.It claims that the family is prepared to hand over a part of its fortune, even though it insists there was no wrongdoing, because it “does not want funds available for a public benefit to be consumed by attorneys’ fees”.The publicity campaign by the branch of the family descended from Raymond Sackler, one of two brothers who owned Purdue Pharma when the company entered the opioid painkiller market, comes amid accusations that it is misusing bankruptcy proceedings to keep hold of some of the billions of dollars the family made from OxyContin.Last week a judge approved a plan for the two branches of the Sackler family who have made their multibillion-dollar fortune from OxyContin to pay $4.5bn to settle more than 3,000 civil lawsuits. The plan would also turn Purdue Pharma into a non-profit company.But, in a highly unusual move, the deal would shield the Sacklers from further lawsuits, although not criminal prosecutions, and allow them to keep billions of dollars in profits from opioids even though the family itself has not sought bankruptcy.The publicity drive also follows publication of a damning biography of the family, Empire of Pain by the New Yorker writer, Patrick Radden Keefe.The Sacklers said the website was intended to counter “the many false allegations” by lawyers seeking to “vilify Purdue and the Sackler family”.At the core of the denial is a selective use of statistics to assert that OxyContin never accounted for more than 4% of prescription opioid sales in the US and therefore could not have been a cause of the epidemic.Analysts have called the claim “a legal and a public relations strategy” that cherry-picked data on the sales of individual pills without taking account of the impact of their high narcotic content or their leading role in creating addiction.When the amount of opioid in the drugs is taken into account, OxyContin accounted for about 20% of the market.The Sacklers’ claims are at odds with a wide body of studies into the roots of the epidemic.In 2017, Donald Trump’s presidential Commission on Combatting Drug Addiction and the Opioid Crisis said Purdue’s “aggressive promotion” of OxyContin, and its broader impact on the use of opioids for pain treatment, was a leading cause of the epidemic.Two years ago, the National Bureau of Economic Research released a study of the impact of OxyContin which concluded that “the introduction and marketing of OxyContin explain a substantial share of overdose deaths over the last two decades”.Purdue used its wealth to influence politicians and regulators, keeping open the floodgates to ever larger prescribing of opioids in the US, far beyond other developed countries, even as the evidence grew of a public health crisis in the making.The billionaire Sacklers face a struggle to restore the reputation of a family whose name is stamped on museums, art galleries and medical centres around the world thanks to their large donations from the profits of OxyContin.Raymond Sackler sat on Purdue’s board from 1990 until his death in 2017. His son, Richard Sackler, was the company’s head of marketing and ramped up sales of OxyContin while painting people who overdosed on the drug as criminals to blame for their own condition.At hearings last year, one member of Congress referred to the Sacklers who own Purdue as the “most evil family in America”, after Kathe Sackler, a powerful former member of Purdue’s board, drew scorn when she said that while “my heart breaks for the parents who have lost their children”, the company was not at fault.“There’s nothing that I can find that I would have done differently,” she said.Chris McGreal is the author of American Overdose, The Opioid Tragedy in Three Acts More

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      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

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      Walmart sued by US over alleged role in fuelling America's opioid crisis

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      The US Department of Justice filed a lawsuit against Walmart on Tuesday, alleging that the retail giant filled “thousands of invalid prescriptions” for powerful painkillers, helping fuel America’s opioid crisis.Walmart runs more than 5,000 pharmacies across the country. Until 2018, the chain was a wholesale distributor of controlled substances for its own pharmacies, giving it extensive reach into many communities.The civil complaint points to the role Walmart’s pharmacies may have played in the crisis by filling opioid prescriptions and by unlawfully distributing controlled substances to the pharmacies during the height of the opioid crisis.“As a nationwide dispenser and distributor of opioids, and given the sheer number of pharmacies it operates, Walmart was uniquely well positioned to prevent the illegal diversion of opioids,” the 160-page civil suit, filed in Delaware federal court, said.“Yet, for years, as the prescription drug abuse epidemic ravaged the country, Walmart abdicated those responsibilities,” the suit added.In response, Walmart said the suit was “riddled with factual inaccuracies”.The DoJ document said the company “knowingly violated well established rules requiring it to scrutinize controlled-substance prescriptions to ensure that they were valid – that is, issued by prescribers in a legitimate manner for legitimate purposes, not for purposes of abuse or other diversion,” the suit continued. While Walmart was legally required to check potential red flags, it “made little effort to ensure that it complied with them”.Instead, Walmart made it hard for pharmacists to abide by these regulations. Managers pressured pharmacists to fill high volumes of prescriptions as quickly as possible “while at the same time denying them the authority to categorically refuse to fill prescriptions issued by prescribers the pharmacists knew were continually issuing invalid prescriptions”, the complaint charged.Even though Walmart’s compliance arm had amassed extensive information showing that people were repeatedly trying to get invalid narcotic prescriptions filled, the unit kept that data from pharmacists, authorities also said.Walmart filled prescriptions from prescribers who its own pharmacists had “repeatedly reported were acting as egregious ‘pill mills’ – even when Walmart was alerted that other pharmacies were not filling prescriptions for those prescribers. In fact, some of those pill-mill prescribers specifically told their patients to fill their prescriptions at Walmart.”So intense were the pressures on pharmacists that managers told them to “[h]ustle to the customer, hustle from station to station” because completing prescriptions “is a battle of seconds”, federal authorities alleged.As early as 2013, Walmart adopted a plan that used the number of prescriptions processed by an employee’s store as a factor in determining if the pharmacy staffer “was entitled to monetary incentive awards”.The DoJ contends that Walmart has committed “hundreds of thousands of violations” of the Controlled Substances Act. If Walmart is found liable for violating this act, each unlawfully filled prescription could result in a $67,627 penalty. Each suspicious order that was not reported to authorities could result in a penalty of up to $15,691. Civil penalties could reach “billions”, the DoJ said.More than 232,000 people died in the US from opioid-involved overdoses between 1999 and 2018, according to the DoJ.In a statement, Walmart said that the DoJ’s investigation was “tainted by historical ethics violations, and this lawsuit invents a legal theory that unlawfully forces pharmacists to come between patients and their doctors, and is riddled with factual inaccuracies and cherry-picked documents taken out of context”.“Blaming pharmacists for not second-guessing the very doctors the Drug Enforcement Administration (DEA) approved to prescribe opioids is a transparent attempt to shift blame from DEA’s well-documented failures in keeping bad doctors from prescribing opioids in the first place,” the company said.Walmart recently sued the DoJ and DEA, alleging that authorities wrongly ascribed blame to the company. The retailer’s suit wants a federal judge to determine that the government doesn’t have grounds to pursue civil damages, according to the Associated Press. More

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      in US Politics

      'An evil family': Sacklers condemned as they refuse to apologize for role in opioid crisis

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      House committee is investigating Purdue Pharma and billionaire family’s role in epidemic that has killed almost 500,000 AmericansTwo members of the billionaire Sackler family that owns Purdue Pharma, the US pharmaceutical manufacturer of the prescription painkiller OxyContin, refused to apologize for their role in the opioids crisis that has killed almost half a million Americans, during a hearing in Washington on Thursday. Continue reading… More