In a recent 5-4 decision, the U.S.Supreme Court rejected Purdue Pharma’s controversial bankruptcy settlement that protected the billionaire Sackler family from further liability for the opioid epidemic in the USA. The Harrington v. Purdue Pharma SCOTUS case blocks a ruling by a federal bankruptcy court in New York that was first rejected by a district court but later appealed before the US Department of Justice finally challenged it before the Supreme Court.

The original deal allowed Purdue, the Sackler owned pharmaceutical company behind the prescription opioid OxyContin, to restructure and protect Sackler billionaires without requiring them to declare personal bankruptcy. From the huge fortune they made from OxyContin the Sacklers agreed to contribute $6bn to the settlement from the vast fortune they made from OxyContin plus relinquish ownership in Purdue Pharma.

In a bankruptcy filing, a New York Times article,”The Sacklers Could Get Away With It,” reported, “debts are forgiven — “discharged,” in legal terms — after debtors commit the full value of all of their assets (with the exception of certain types of property, like a primary home) to pay their creditors. That is not, however, what the Sacklers want, and indeed the members of the family have not filed for bankruptcy themselves. What they proposed instead is to be shielded from all OxyContin lawsuits, protecting their tremendous personal wealth from victims’ claims against them. What’s more, a full liability release would provide the Sacklers with more immunity than they could ever obtain in a personal bankruptcy filing, which would not protect them from legal action for fraud, willful and malicious personal injury, or from punitive damages”.

CNBC Video: “Supreme Court blocks Purdue Pharma bankruptcy settlement”

By using the bankruptcy agreement, Purdue/Sackler wanted to resolve lawsuits, including those filed by state and local governments, alleging that Purdue Pharma caused a crisis killing half a million Americans when it asserted that OxyContin was non-addictive while it promoted massive over-prescribing via pill mills. Elizabeth Prelogar, U.S. solicitor general, argued that “the release of the Sacklers from future liability is not authorized by the bankruptcy code and constitutes an abuse of the bankruptcy system.”

PARAGONS OF GOOD WORKS

With charitable foundations on both sides of the Atlantic, the Sacklers, who are based in New York, have donated millions to the arts and sponsored faculty at Yale and many other universities. In each case, the family’s name is displayed prominently as the benefactor. Forbes listed the collective estimated worth of the 20 core family members at $14bn in 2015, partly derived from $35bn in sales revenue from OxyContin between 1995 and 2015. The name Sackler is displayed in the forecourt at the Victoria and Albert Museum in London and was noted in the Sackler Gallery at the Serpentine in 2013. The ancient Egyptian Temple of Dendur has a Sackler Wing in the Metropolitan Museum in New York. The Sackler Centre for Arts Education at the Guggenheim and many other arts institutions around the world have galleries or wings named after the Sackler family.

But few know Sackler wealth comes from Purdue Pharma, a private Connecticut company the family developed and wholly owns. In 1995, the company revolutionised the prescription painkiller market with the invention of OxyContin, a drug that is a legal, concentrated, chemical version of morphine or heroin. It was designed to be safe; when it first came to market, its slow-release formula was unique. After winning government approval it was hailed as a medical breakthrough, an illusion that many now refer to as “magical thinking”.

It was marketed to physicians, many of whom were taken on lavish junkets, given misleading information and paid to give talks on the drug . Patients were wrongly told the pills were a reliable long-term solution to chronic pain, and in some cases were offered coupons for a month’s free sample. DEA data says that the US has been flooded with about 10 billion pain pills a year. Most pain drugs were sold by a small number of pharmacies, with prescriptions for these drugs written by a small number of physicians at pill mill clinics that charged cash for prescriptions. Data has shown these clinics were good OxyContin customers for the Sacklers/Purdue Pharma. Launched in 1996, Purdues OxyContin sales strategy was highly successful for twenty years because it alleged concentrated aggressive OxyContin marketing programs on what Purdue labeled ‘supercore clinics’, i.e., pill mills.

PROFIT, PLUNDER, DEATH

The untimely overdosing death of famous singer Tom Petty can be traced to the Sackler family and Purdue Pharma according to many addiction specialists.The family of Tom Petty said that the singer’s death was caused by an accidental overdose with a cocktail of prescription drugs and pain pills, including oxycodone and fentanyl. Although prescriptions for opioids fell in response to the crisis, Americans didn’t shake the habit or seek rehab; they turned to heroin instead. Four out of five people in the US who try heroin today started with prescription painkillers, according to the American Society of Addiction Medicine. Alarmingly, street heroin started being secretly cut with the dangerous synthetic opioid fentanyl.

By misleading physicians about the safety of OxyContin in order to earn $35bn in sales revenue from the toxic pain drug between 1995 and 2015, many addiction specialists say that Purdue Pharma owners, the Sackler family, bear the lion’s share of the responsibility for many deaths and today’s opioid crisis. Legal experts, the NYT writes, conclude that “allowing the bankruptcy court to impose a global OxyContin settlement may at first appear to be an efficient way to resolve litigation that could drag on for years, the Sacklers will benefit from this expediency at the expense of victims. At stake is whether there will ever be a fair assessment of responsibility for America’s deadly prescription drug epidemic. Protection from all OxyContin liability for the Sackler family would be an end-run around the reckoning that justice requires”.

Just like all Big Pharma corporations, Sackler/Purdue pharma are dedicated to the bottom line of maximization of profit; everything else is of insignificant value compared to this. Their large and aggressive marketing campaign to sell the supposedly ‘safe’ pain drug OxyContin appears to have disregarded all boundaries and turned this dangerous drug into immense profit for themselves. There are always among us those self-serving and toxic individual and corporate predators who regard democracy/government regulation/community as an obstacle to their greed and avarice. The opioid epidemic is now burgeoning in the U.S. with millions of ruined lives, individuals, families. The Sacklers want to retreat back into their money and vast profiteering, and let other people clean up and pay for the overall and inevitable long-term suffering, death and destruction they allegedly created.

The SCOTUS decision recognizes plaintiff’s due process rights and the ability of plaintiffs to sue the Sacklers. The Sacklers, they argued, should not be rewarded for their contribution because they “created the need for that money” by taking it out of the company in the first place, setting up the situation where they would be protected from lawsuits “by piggybacking on the bankruptcy of their company.” In agreement with. SCOTUS, U.S. Attorney General Merrick B. Garland said in a statement, “The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family.”

( Tomdispatch.com) – Amid ongoing emergencies, including a would-be autocrat on his way to possibly regaining the American presidency and Israel’s war on Gaza (not to mention the flare-ups of global climate change), the U.S. has slipped quietly toward an assault on civil liberties as an answer to plummeting mental health. From coast to coast, state lawmakers of both parties are reaching for coercive treatment and involuntary commitment to address spiraling substance use and overdose crises — an approach that will only escalate despair and multiply otherwise preventable deaths while helping to choke the life out of America.

In December, we wrote about how loneliness has become a public-health crisis, according to the Surgeon General, and the ways in which it drives widespread substance use. We reach for substances to ease feelings of isolation and anguish — and when the two of us say “we,” we mean not just some hypothetical collective but the authors of this article. One of us, Sean, is a doctor living in long-term recovery from a substance-use disorder and the other, Mattea, is a writer who uses drugs.

And we’re anything but unique. Disconnection and loneliness aren’t just the maladies of a relatively few Americans, but the condition of the majority of us. Vast numbers of people are reaching for some tonic or other to manage difficult feelings, whether it’s weed, wine, work, television, or any mood- or mind-altering substance. These days, there’s scarcely a family in this country that’s been unscathed by problematic drug use.

Not surprisingly, under the circumstances, many elected officials feel increasing pressure to do something about this crisis — even as people who use drugs are widely considered to be social outcasts. In 2021, a survey of thousands of U.S.-based web users found that 7 in 10 Americans believed that most people view individuals who use drugs as non-community members. It matters little that the impulse to use such substances is driven by an urge to ease emotional pain or that the extremes of substance use are seen as a disease. As a society, we generally consider people who use drugs as rejects and look down on them. Curiously enough, however, such social stigma is not static. It waxes and wanes with the political currents of the moment.

“Stigma has risen its ugly head in almost every generation’s attempts to manage better these kinds of issues,” says Nancy Campbell, a historian at Rensselaer Polytechnic Institute and the author of OD: Naloxone and the Politics of Overdose. Campbell reports that she finds herself a target of what she calls “secondary stigma” in which others question why she even bothers to spend her time researching drug use.

Perhaps one reason to study such issues is to ensure that someone is paying attention when lawmakers of virtually every political stripe seek to answer a mental health crisis by forcing people into institutionalized treatment. Notably, such “treatment” can increase the odds of accidental death. Allow us to explain.

“Treatment” Can Be a Death Sentence

Across the country, the involuntary detainment and institutional commitment of people with mental illness — including those with a substance use disorder — is on the rise. Deploying the language of “helping” those in need, policymakers are reaching not for a band-aid but a club, with scant or even contradictory evidence that such an approach will benefit those who are in pain.

“The process can involve being strip-searched, restrained, secluded, having drugs forced on you, losing your credibility,” said UCLA professor of social welfare David Cohen in a 2020 statement about his research on involuntary commitment. He co-authored a study that found its use rose nationwide in the decade before the pandemic hit, even as there was a striking lack of transparency regarding when or how such coercion was used.

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Today, many states are expanding laws that authorize mandatory treatment for people experiencing mental-health crises, including addiction. According to the Action Lab at the Center for Health Policy and Law, 38 states currently authorize involuntary commitment for substance use. None of them require evidence-based treatment in all involuntary commitment settings and 16 of them allow facilities to engage in treatments of their choice without the individual’s consent. Nearly every state that ranked among the highest in overdose rates nationally has an involuntary commitment law in place.

In September, the California legislature passed a bill that grants police, mental healthcare providers, and crisis teams the power to detain people with “severe” substance use disorder. The Los Angeles County Board of Supervisors subsequently voted to postpone implementation of the law, with Board Chair Lindsey Hogarth noting the risk of civil rights violations as a reason for the delay. In October, Pennsylvania state legislators introduced a bill that would permit the involuntary commitment of people who have been revived following an overdose. While many mental health advocates acknowledge the good intentions of legislators, the potential for harm is incalculable.

New research shows that people who attended abstinence-based treatment programs were at least as likely, if not more likely, to die of a fatal overdose than people who had no treatment at all. By contrast, those who had access to medications like methadone or buprenorphine for opioid-use disorder were less likely to die. Those medications, however, are not considered “abstinence” and so are not uniformly provided in treatment settings. Though there is extensive evidence of the effectiveness of medications for opioid use disorder, abstinence still remains widely regarded as the morally upright and best path, even if it makes you more likely to die. The reason for the elevated risk of mortality following abstinence-based treatment is no mystery: abstinence reduces the body’s tolerance. If a person who has been abstinent resumes use, the ingestion of a typical dose is more likely to overwhelm his or her bodily system and so lead to death.

Disturbingly, both The Atlantic and the Wall Street Journal recently ran columns favoring mandatory treatment, with the Journal citing as evidence a 1960s study in which individuals fared well after 18 months of mandated residential treatment that included education and job training — a standard of care that’s virtually nonexistent today. The Atlantic referenced a study of 141 men mandated for treatment in the late 1990s whose outcomes were comparable to individuals who entered treatment voluntarily; the study’s own authors had, however, cautioned against generalizing the findings to other populations due to its limited scope — and since then, the potent opioid fentanyl has entered the drug supply and raised the risk of a fatal overdose following a period of abstinence.

Meanwhile, as policymakers turn to coerced treatment, consider this an irony of the first order: there are far too few treatment options for people who actually want help. “There is no place in this country where there is enough voluntary treatment. So why would you create involuntary commitment, involuntary treatment?” asks Campbell. The reason, she suggests, is the inclination of lawmakers not just to do something about an ongoing deadly crisis, but in no way to appear “soft on drugs.”

Just to put the strange world of drug treatment in context, imagine elected officials wanting to seem tough on constituents who have cancer or heart disease. The idea, of course, is ludicrous. But 7 in 10 Americans think society at large views addiction as “at least somewhat shameful” and people who use drugs as significantly responsible (that is, to blame) for their substance use. No surprise, then, that politicians would find it expedient to punish people who use drugs, even if such punishment only layers on still more shame, with research indicating that shame, in turn, exacerbates the pain and social isolation that drives people to use drugs in the first place. As Dr. Lewis Nelson, who directs programs in emergency medicine and toxicology at Rutgers New Jersey Medical School, pointed out to USA Today, the science of addiction and recovery is frequently overlooked because it’s inconsistent with ingrained social ideas about substance use.

“I Still Don’t Need Saving”

Punishing people for substance use worsens the pain and isolation that make drugs so appealing. So rather than punishment — and in our world today this will undoubtedly sound crazy — what if we treated people who use drugs as full and complete human beings like everyone else? Like, say, people with high blood pressure? What if we acknowledged that those who use drugs need the very same things that all people need, including love, support, and human connection, as well as stable employment and an affordable place to live?

Research on this, it turns out, suggests that human connection is particularly good medicine for the emotional pain that so often underlies substance use and addiction. Stronger social bonds — namely, having people to confide in and rely on — are associated with a positive recovery from a substance use disorder, while the absence of such social ties elevates the risk of further problematic drug use. Put another way, perhaps you won’t be surprised to learn that a powerful means of healing widespread mental distress is to connect with one another.

When people in distress have friends, attendant family, and healthcare providers who are genuinely there for them no matter what, their own self-perception improves. In other words, we help one another simply by being nonjudgmentally available.

Jordan Scott is a peer advocate for Recovery Link, which offers free digital peer support to people in Texas and Pennsylvania. She identifies as a person who uses drugs. “I felt like the message got reinforced that there was something wrong with me, that there was something broken with me,” she told us. “Anything that isn’t abstinence, or anything that doesn’t include total abstinence as a goal, is constantly positioned as less than.”

New research published in the journal Addiction draws a contrast between treatment focused exclusively on abstinence and a broader array of wellness strategies, including reducing drug use rather than eliminating it entirely. The study found that reduced use had clinical benefits and that health can distinctly improve even without total abstinence. Director of the National Institute on Drug Abuse Nora Volkow, for instance, supports a nuanced approach that includes many possible paths of recovery along with a shift away from the criminalization of drug-taking to a focus on overall health and wellbeing. And the Substance Abuse and Mental Health Services Administration, a branch of the U.S. Department of Health and Human Services, has identified four dimensions critical to recovery: health, home, purpose, and community.

Most important of all, a person doesn’t necessarily need to be abstinent in order to make gains in all four areas. This makes good sense when you remember that addiction or other problematic substance use is a symptom of underlying pain. Rather than exclusively treating the symptom — the drug use — addressing the underlying loneliness, trauma, or other distress can be a very effective approach. “Family can be a valid pathway to wellness,” Scott pointed out, while adding that her own path went from 12-step meetings like Alcoholics Anonymous to active civic engagement.

For someone else, quality time with his or her kids or even exercising and eating well might be a linchpin for staying mentally healthy. In other words, healing from the pain that underlies substance use disorder can look a lot like healing from any other health challenge.

Yet policymakers continue to call for intensifying the use of coercive treatment. “I think we’re going to see more [involuntary commitment] before we see less of it,” said Campbell, who studies historical patterns in the social response to drug use. There’s nothing new, she noted, in the move to “help” people by institutionalizing them — even if such a move constitutes an erosion of basic civil rights.

“I think most of the time people are genuine in wanting to help,” said Scott, who has been a target of such “help.” The problem, she explained, is the idea that there is a group of people considered “normal” and therefore superior, who think they’re in a position to save other members of society.

“I didn’t need saving. I am a drug user now. I still don’t need saving,” Scott told us. These days she’s focused on being a part of her community through volunteerism while drawing on a support network of people who respect her path.

As for the two of us writing this article, Sean is spending time with his children, staying connected with friends, practicing meditation and yoga, and has for years facilitated a group of physicians in recovery. Mattea has started a new habit of going to the gym with her uncle to ease her loneliness, while also confiding in close friends for support. And all of that truly does make a difference.

Copyright 2024 Sean Fogler and Mattea Kramer

Via Tomdispatch.com

HISTORY

Flying under the chaos of the Covid-19 pandemic, one of America’s richest families, the billionaire Sackler family who fully own Purdue Pharma and put themselves forward as the epitome of good works funded by the fruits of the capitalist system, are being held to account for allegedly earning their fortune at the expense of millions of people who are addicted. Although it’s shocking how long they have gotten away with it, legal proceedings against them, if carried out in full, may not, unfortunately, avoid the ‘justice delayed, justice denied’ conundrum. By seeking a ‘release from liability’ from the federal court handling Purdue’s bankruptcy case, the court could help them hold on to their wealth by releasing them from liability for the ravages of the opiod epidemic caused by OxyContin, and allow them to continue benefiting at the expense of victims.

In a bankruptcy filing, a New York Times article,”The Sacklers Could Get Away With It”, reported, “debts are forgiven — “discharged,” in legal terms — after debtors commit the full value of all of their assets (with the exception of certain types of property, like a primary home) to pay their creditors. That is not, however, what the Sacklers want, and indeed the members of the family have not filed for bankruptcy themselves. What they proposed instead is to be shielded from all OxyContin lawsuits, protecting their tremendous personal wealth from victims’ claims against them. What’s more, a full liability release would provide the Sacklers with more immunity than they could ever obtain in a personal bankruptcy filing, which would not protect them from legal action for fraud, willful and malicious personal injury, or from punitive damages”.

PROFIT, DEATH, DYING

The untimely overdosing death of famous singer Tom Petty can be traced to the Sackler family and Purdue Pharma according to many addiction specialists.The family of Tom Petty said that the singer’s death was caused by an accidental overdose with a cocktail of prescription drugs and pain pills, including oxycodone and fentanyl. Although prescriptions for opioids fell in response to the crisis, Americans didn’t shake the habit or seek rehab; they turned to heroin instead. Four out of five people in the US who try heroin today started with prescription painkillers, according to the American Society of Addiction Medicine. Alarmingly, street heroin started being secretly cut with the dangerous synthetic opioid fentanyl.

By misleading physicians about the safety of OxyContin in order to earn $35bn in sales revenue from the toxic pain drug between 1995 and 2015, many addiction specialists say that Purdue Pharma owners, the Sackler family, bear the lion’s share of the responsibility for many deaths and today’s opioid crisis.

EPITOMES OF GOOD WORKS?

With charitable foundations on both sides of the Atlantic, the Sacklers, who are based in New York, have donated millions to the arts and sponsored faculty at Yale and many other universities. In each case, the family’s name is displayed prominently as the benefactor. Forbes listed the collective estimated worth of the 20 core family members at $14bn in 2015, partly derived from $35bn in sales revenue from OxyContin between 1995 and 2015. The name Sackler is displayed in the forecourt at the Victoria and Albert Museum in London and was noted in the Sackler Gallery at the Serpentine in 2013. The ancient Egyptian Temple of Dendur has a Sackler Wing in the Metropolitan Museum in New York. The Sackler Centre for Arts Education at the Guggenheim and many other arts institutions around the world have galleries or wings named after the Sackler family.

But few know Sackler wealth comes from Purdue Pharma, a private Connecticut company the family developed and wholly owns. In 1995, the company revolutionised the prescription painkiller market with the invention of OxyContin, a drug that is a legal, concentrated, chemical version of morphine or heroin. It was designed to be safe; when it first came to market, its slow-release formula was unique. After winning government approval it was hailed as a medical breakthrough, an illusion that many now refer to as “magical thinking”.

It was marketed to physicians, many of whom were taken on lavish junkets, given misleading information and paid to give talks on the drug . Patients were wrongly told the pills were a reliable long-term solution to chronic pain, and in some cases were offered coupons for a month’s free sample. DEA data says that the US has been flooded with about 10 billion pain pills a year. Most pain drugs were sold by a small number of pharmacies, with prescriptions for these drugs written by a small number of physicians at pill mill clinics that charged cash for prescriptions. Data has shown these clinics were good OxyContin customers for the Sacklers/Purdue Pharma. Launched in 1996, Purdues OxyContin sales strategy was highly successful for twenty years because it allegedlconcentrated aggressive OxyContin marketing programs on what Purdue labeled ‘supercore clinics’, i.e., pill mills.

In a New Yorker Magazine expose, Allen Frances, M.D., former chair of psychiatry at Duke University school of medicine said, “Their name (Sackler/Purdue Pharma) has been pushed forward as the epitome of good works and of the fruits of the capitalist system. But, when it comes down to it, they’ve earned this fortune at the expense of millions of people who are addicted. It’s shocking how they have gotten away with it.” Long overdue, the Sacklers and Big Pharma are finally starting to pay for the opiod crisis.

Unfortunately,”the bankruptcy court has granted injunctions stopping proceedings in several hundred lawsuits charging that Sackler family members directed the aggressive marketing campaign for OxyContin; it and other opioids have been implicated in the addictions of millions of patients and the deaths of several hundred thousand.”

The Sacklers would walk away with an estimated several billion of OxyContin profits while leaving unresolved a crucial question asked by victims and their families: Did the Sacklers create and coordinate fraudulent marketing that helped make their best-selling drug a deadly national scourge? With that question left unanswered, many of those injured by OxyContin would feel victimized again.

Legal experts, the NYT writes, conclude that “allowing the bankruptcy court to impose a global OxyContin settlement may at first appear to be an efficient way to resolve litigation that could drag on for years, the Sacklers will benefit from this expediency at the expense of victims. At stake is whether there will ever be a fair assessment of responsibility for America’s deadly prescription drug epidemic. Protection from all OxyContin liability for the Sackler family would be an end-run around the reckoning that justice requires”.

Just like all Big Pharm corporations, Sackler/Purdue pharma are dedicated to the bottom line of maximization of profit; everything else is of insignificant value compared to this. Their large and aggressive marketing campaign to sell the supposedly ‘safe’ pain drug OxyContin appears to have disregarded all boundaries and turned this dangerous drug into immense profit for themselves. There are always among us those self-serving and toxic individual and corporate predators who regard democracy/government regulation/community as an obstacle to their greed and avarice. The opioid epidemic is now burgeoning in the U.S. with millions of ruined lives, individuals, families. The Sacklers want to retreat back into their money and vast profiteering, and let other people clean up and pay for the overall and inevitable long-term suffering, death and destruction they allegedly created.

JUDGE OVERTURNS PURDUE/SACKLER OPIOID SETTLEMENT

Judge McMahon agreed with lawyers for the U.S. Trustee who argued that shutting down the ability of plaintiffs to sue the Sacklers violated the plaintiffs’ due process rights. The Sacklers, they argued, should not be rewarded for their contribution because they “created the need for that money” by taking it out of the company in the first place, setting up the situation where they would be protected from lawsuits “by piggybacking on the bankruptcy of their company.” U.S. Attorney General Merrick B. Garland said in a statement, “The bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family.” Cheers and many thanks to Judge Colleen McMahon.

Trump ordered the CDC to prepare for mass immunizations beginning on November 1 — a breakneck speed that defies credulity. The timetable is too short for full safety analysis of any vaccine. Laurie Garrett, Pulitzer Prize winning author of The Coming Plague, says she won’t take a vaccine that comes out before election day. “Like most experts closely watching developments, I have no confidence that a safe, effective vaccine will be ready for use by then.”

Embed from Getty Images
Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images.

Desperate to take undeserved credit for a Covid cure to bolster sagging re-election prospects, Trump embraces the vaccination project because it appeals to his con man instincts for flashy salesmanship – branding it “Operation Warp Speed.” The federal government has funneled over nine billion tax payer dollars into private drug companies, scaled up manufacturing, and bought millions of doses well before a vaccine is proven viable. To be clear: no American or European putative vaccine against the coronavirus has completed Phase 3 clinical safety and efficacy trials, according to the New York Times’ Coronavirus Vaccine Tracker. Of the more than 150 vaccines in the world-wide research pipeline, only four American ones have even begun that final stage.

Most vaccines take years to develop and administer. Long-standing scientific protocols require massive testing of many thousands of people over a long period to ensure that a vaccine is safe, with minimal side effects, if any; and, effective, meaning it actually stops the disease, limits its spread or reduces its severity. Having a vaccine fully tested and ready for review on Oct. 22, when the FDA’s Vaccines and Related Biological Products Advisory Committee plans to meet will be next to impossible.

“Safety cannot be guaranteed,” says Garrett. “Life-threatening complications may not show up in a quick sampling of healthy adults.” That’s why vaccine clinical trials usually last for many months and involve far more volunteers than have been recruited for the Covid-19 products. Short-circuiting that process can be wasteful or even dangerous: a rushed vaccine for the swine flu in 1976 meant to help President Gerald Ford’s election campaign not only proved ineffective but also afflicted hundreds with a paralyzing side effect, Guillain-Barre syndrome, a rare neurological disorder.

Even if a vaccine looks safe and effective, rolling out a new one correctly is a major undertaking, requiring careful coordination across multiple state and federal agencies that play a pivotal role in evaluating the science behind it. Public trust is required. If millions of Americans are going to voluntarily agree to inject something to prevent a disease they don’t already have, they need to put faith in the agencies that endorse the effort and in the government that backs it. Since no one believes him, Trump will need Americans to trust the experts at the FDA and CDC — agencies he publicly denigrates or delegitimizes. Recent polling shows belief in a vaccine slipping: just over half of Americans now say they would take a vaccine if it were available today, a 21-point drop from earlier this year. That’s alarming since fewer people taking the vaccine dilutes its effectiveness.

Trump’s fixation on declaring victory just ahead of Election Day results in political pressure on the FDA and the CDC to provide scientific cover to his propaganda. The FDA is considering whether to allow a vaccine to be used on an emergency basis before its formal approval process is finished and the CDC has told states to be ready to distribute the vaccine two days before the election. But Trump’s unrelenting bashing of these two agencies has left their credibility in tatters such that their recommendations cannot be trusted.

Embed from Getty Images
A lab technician uses a multichannel pipette dropper during the immune response analysis process of the coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19. Photographer: Akos Stiller/Bloomberg via Getty Images.

As he did with other “miracle cures,” Trump has publicly pressured the FDA to move quickly on authorizing a vaccine, demanding that it use its powers to permit Emergency Use Authorization (EUA) of an unapproved and unproven vaccine. For example, a vaccine could generate antibodies to Covid — an immune response, but it might not prevent infection or serious illness. Further, long term side effects would remain unknown. This is a much lower bar than standard FDA approval. Rather than the usual process of consulting experts, the FDA chief alone can make this determination and Commissioner Stephen Hahn has already signaled that he is willing to do so.

Caving to White House pressure is not new to Hahn, who issued emergency use for two products that Trump misleadingly called “breakthroughs”: the malaria drug hydroxychloroquine, which the FDA later revoked as being ineffective and harmful, and convalescent plasm — blood plasma from recovered Covid-19 patients. Standing next to Trump at press briefing, Hahn made scientifically misleading claims about plasma’s medical benefits — a disastrous series of public mis-statements, which he later withdrew and about which he apologized.

“For the first time ever, I feel like official people at the FDA grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy at the University of Pittsburgh. This did widespread damage to the agency’s image in what was viewed by many as a trial run for its ability to manage Trump’s frenzied political pressure for a vaccine authorization.

Hoping to reassure a suspicious public about the government’s biggest public health decision in years, Hahn pledged to a Senate Panel, “Science will guide our decisions. The FDA will not permit any pressure from anyone to change that.” He prepared a proposal that set morestringent standards for a coronavirus vaccine EUA. Incensed that Hahn’s new safety guidelines will slow the process, Trump launched an all-out crusade against the FDA.He blew up Hahn’s carefully laid plans – attacking “deep state” agency staff for trying to hurt him politically and vowing to have final say over procedures for authorizing a Covid-19 vaccine.

This authoritarian move would follow the examples set by Russia and China — both of whom rushed out a limited use vaccine that experts call stupid and risky because they cut corners on rigorous scientific vetting that would be expected for FDA vaccine approval. In response to this, New York Gov. Andrew Cuomo announced his state would independently vet any vaccines before distribution.

After pressuring the FDA on the approval process, Trump clashed with the CDC, once considered the world’s premier public health agency. He publicly slapped down congressional testimony by the head of the CDC. Dr. Robert Redfield estimated that a vaccine will not be widely available to the public until the middle of 2021 at the earliest — echoing recent comments by Dr. Anthony Fauci. Redfield also praised wearing masks as “the most important, powerful public health tool we have in fighting the pandemic, even more important than a vaccine.” Lashing out at Redfield, the moronic, anti-mask Trump said of both remarks: “I think he made a mistake when he said that. I think he was confused. It’s just incorrect information.”

The CDC’s reputation has taken the biggest hit because of its undeniable and seemingly unassailable prestige. Even in pop culture, CDC doctors often play smart, courageous, selfless heroes such as in the movie Outbreak. The front-line agency was created to stop deadly pathogens. It battled malaria, polio and Ebola and helped eradicate smallpox. Over the course of seven decades, it became the world’s most admired disease-fighting agency with an elite workforce of the world’s foremost microbiologists, pathologists, and other scientists dispatched world-wide to investigate new and mysterious illnesses. Though successfully leading the country’s response to countless threats over decades — the deadly emergence of HIV, SARS, and the H1N1 flu pandemic, the CDC has been manipulated, sidelined and silenced by the Trump administration just as another virus rampages across the planet. Even by Trump’s low standards, this is unconscionable.

Unfortunately, the CDC was placed in unreliable hands. Dr. Robert Redfield is a right-wing darling with a checkered scientific past. His early AIDS research was inspired by the Christian right, who have been instrumental in driving a global AIDS strategy centered on abstinence. Redfield first came to public attention when he stood next to Trump, at CDC headquarters on March 7, and nodded approvingly as Trump said, in one of his most egregious Covid lies, “Anyone who wants a test can get a test.”

The CDC’s nationwide response to the pandemic has not been faultless. The stumbles started with the botched rollout of test kits suspected of being contaminated at a CDC lab in late January. Under Redfield, the agency took weeks to fix the flawed tests. But Trump’s concerns about the CDC are not about its efficacy, but about the facts that it reports about the pandemic — facts that show the president’s abject failure and that, like his “debate” performance, demonstrate that Trump is un-tethered from evidence, reality, and truth.

In order to change perceptions of Covid reality, Trump and his enablers try to suppress or alter CDC data and advice to mask the true scope of the epidemic. The agency has endured false accusations, criticism, and interference. White House officials pressured the CDC to align more closely with Trump’s message that the pandemic is largely over. Whether it’s getting the CDC to effectively lower the death count, muzzling officials, or forcing the agency to change guidelines — including on mask-wearing and the reopening of businesses, religious institutions, and schools. The CDC has experienced a loss of institutional integrity — eroded by blunders and Trump attacks — at a time when the nation desperately needs to trust it.

Embed from Getty Images
A lab technician wearing a full body protection suit handles a bottle containing growth media for virus production during coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19. Photographer: Akos Stiller/Bloomberg via Getty Images.

For example, in late August as the daily Covid death rate spiked, the CDC shockingly changed its testing guidelines andposted altered guidance, saying that asymptomatic people “do not necessarily need a test” even if they have come in close contact with someone infected by the virus. This was effectively a recommendation to test fewer people, soon after Trump said he had asked his people to “slow the testing down, please” because, he claimed, more tests revealed more coronavirus cases and made him look bad.

In his article “Ignore the CDC,” the former director of the National Institute of Health Harold Varmus attacks the agency for altering its guidelines and bowing to Trump’s bullying. “These changes will undermine efforts to end the pandemic,” wrote Varmus, “slow the return to normal, and increase the loss of lives.” The CDC later reversed the heavily criticized recommendation against asymptomatic testing. But the damage was done: its scientific credibility had been undermined again.

Last week, apparently under political pressure, the CDC removed language from its website that said the novel coronavirus spreads via airborne transmission, the latest example of the agency backtracking from its own guidance. Sudden flip-flops on public guidance is antithetical to the CDC’s own rules for crisis management spelled out in a 450-page manual. It requires US leaders and the CDC to avoid “mixed and conflicting messages from multiple sources,” “overly reassuring and unrealistic communication,” and “public conflicts and confusion.”

But that’s not happening. Trump creates a chaotic hurricane of misinformation that stokes confusion about what scientists know about the virus and the timetable for when most Americans will have access to a safe, effective vaccine. In fact, a major new study conducted by Cornell University researchers concluded that Trump is the world’s largest source of misinformation about Covid-19.

At Tuesdays’ debate — amid Trump’s sweat-soaked, rabid, racist, sociopathic behavior — he claimed that the vaccine would be available in “weeks.” His constant drumbeat for a vaccine before election day drowns out months of careful scientific work, reducing the vaccine hunt to yet another presidential litmus test. Given months of capitulation to Trump, there’s little reason to have confidence in FDA or CDC vaccine recommendations. Would anyone besides a MAGA zombie shoot a Trump vaccine into their arms? “We’ve sown the seeds of distrust in this vaccine,” says epidemiologist Dr. Michael Osterholm. “The politicization could give us, in a sense, what it would be like to have a very ineffective vaccine. Because nobody will take it.” A vaccine will succeed only if Americans across the political spectrum trust that it is the result of careful and cautious scientific work that will not be completed until long after the November election that defeats Trump.

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Bonus Video added by Informed Comment:

Realities Of Vaccine Testing Defy Trump Coronavirus Timeline | Rachel Maddow | MSNBC

While most countries are projected to experience a stark increase in lifespan, as much as 4 years, over the next two decades, the US will improve only slightly, plunging into a profound stagnation healthwise.

The US has switched places in the world rankings with China. You have to look closely at the Lancet Map to tell, but the US is very light blue like Brazil in 2040, and all of Europe, Canada, Australia, Japan, Singapore, China, and some of the Middle East (Saudi Arabia up to the Levant) will have healthier and longer-lived populations than the US in 2040. In Spain and Japan people will have a life expectancy of 85. That of the US will be several years shorter.

h/t The Lancet.

So the obvious question is what is causing this backwardness in US health prospects.

One big cause of going to an early grave is smoking tobacco. The US still lets tobacco companies spray extra nicotine on tobacco leaves so as to make them extra addicting. Since smoking will kill you, the people who try to hook youngsters on smoking are going to the very deepest and most painful level of hell. About 15.5 percent of Americans still smoke, about 38 million people, and all of them are at risk for heart and lung disease, hypertension, and lung cancer.

Tobacco is being promoted in the United States today because we don’t just have a capitalist system but have Barracuda Capitalism. Former speaker of the House John Boehner used actually to give out cash from Big Tobacco on the floor of the House of Representatives, and this was perfectly legal! The legal system has decided that as long as the cigarette sellers put those little warnings on the packet, you can’t sue them for killing people. The tobacco billionaires, none of whom smoke, are being coddled and allowed to create a public health crisis, just because it is lucrative to a small circle of executives.

I can’t go into all the other ways consumer capitalism is shortening our lives, but believe me, it is. Air pollution, mercury pollution from burning coal, radioactive waste, killing off insects with pesticides, and heat-trapping gases threatening our future– all of these have been unleashed by Trump.

Another reason we aren’t going to live longer as a nation is that we are getting fat! A high body mass index is correlated with all kinds of health problems, including heart attacks. 1 in 4 Americans get enough exercise. 1 in 10 eats enough fruits and vegetables.

Our billionaire class is fighting tooth and nail against medicare for all, some version of which most Europeans have. People can’t afford a doctor’s visit to get advice on weight, diet and exercise. Some states have global south levels of death in childbirth because working class mothers can’t afford doctor visits while pregnant. The US barracuda capitalists poisoned Flint’s water to save a few bucks.

As well, our poor diet and sedentary existence (75% of us!) are connected to things like capitalist television. The bandwidth for television is still limited, but the US government just gave that bandwidth away to a handful of media giants, who take the profit of advertising on the people’s airwaves.

Watching hours and hours of television instead of exercising will kill you dead, and, worse, the advertisements on television will encourage you to keep eating unhealthy food all day– food high in fat and salt and carbohydrates. Those activities will also make you depressed. The US media system, which is increasingly being exploited by far right fascist billionaires like Rupert Murdoch, is devastating the bodily and mental health of the American population. (It also gave us the Trump administration, which is a public health nightmare of cosmic proportions).

The US is becoming a more and more unequal society, with wealth concentrated at the top. Wealth transfer schemes like the mortgage bust of 2008-9 moved trillions from the middle class to the super-wealthy. People who lost their jobs and/or homes in the last crash turned to drugs. Initially it was meth. It is an unpleasant drug. It will make you skinny, give you sores, and make your teeth fall out. But for the most part it won’t kill you. The government with its eternal ‘war on drugs’ decided to crack down on meth. People were using sudafed over the counter to produce it, and it was restricted.

Then the devastated sections of the middle classes whom the grasping Bear Stearns and others had ruined with their unwise unsecured loans, turned to opioids. Bush’s wars have made these drugs more accessible for Americans, with poppy production spiking in chaotic Afghanistan.

But it is hard to gauge doses with opioids and very easy to overdose. And die.

American barracuda capitalism isn’t providing a living wage to large numbers of workers. The average wage of the average worker has been largely stagnant since 1970. Our peculiar system is, however, making a few people like Jeff Bezos fabulously wealthy. The three wealthiest billionaires own more than the poorer half of the country.

We don’t need to take our country back from the Chinese or Mexicans. We need to take it back from the Sheldon Adelsons of the world.

We need socialism.

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Bonus video:

David Pakman: “American Life Expectancy is DECLINING”

The committee is expected to make detailed recommendations based on an in-depth review in May 2018.

The main ingredient, Cannabidiol, CBD found in Marijuana is neither harmful nor addictive, a new World Health Organization, WHO report has confirmed.

CBD is a naturally occurring, non-psychoactive ingredient found in cannabis plants that has non-addictive relaxing properties and per WHO’s Expert Committee on Drug Dependence, ECDD, there lies “no evidence of public health-related problems associated with the use of pure CBD.” Also, the “current information does not justify scheduling of cannabidiol,” the report confirmed.

In fact, the natural component is known to help in treating epilepsy and several other medical conditions.

“Recent evidence from animal and human studies shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions,” WHO’s report confirmed.

Also clarifying, that it “does not say that WHO recommends the use of cannabidiol” but the substance need not be government-controlled or regulated at the international level, the report noted.

“Saying it should not be scheduled for international control means that it should not be prohibited, at the international level, to produce and supply it for specific purposes, such as medical treatment and research, given that WHO has not so far seen evidence of potential for abuse or harm from cannabidiol,” a spokesperson said, Newsweek reported.

“As to what is legal or illegal, that comes under national law, so it is up to countries to decide,” the report added.

“I’m ecstatic that these international health leaders agree that CBD is a substance that should not be scheduled and has therapeutic value for a variety of medical conditions,” Raul Elizalde, founder, and president of HempMeds Mexico told the Daily Mail. “It has changed our life.”

The U.S. Drug Enforcement Agency, DEA, which rarely allows research on Marijuana since it considers the substance as a Schedule I drug, in July released a statement saying the component is still considered illegal.

“Because ‘Charlotte’s Web’/CBD oil is not an FDA-approved drug…it is a schedule I controlled substance under the [Controlled Substances Act],” the statement concluded.

The committee is expected to make detailed recommendations based on an in-depth review in May 2018.

Via TeleSur

. . . The opioid overdose epidemic is . . . [the] gravest public health crisis since the emergence of HIV in the 1980s. With its roots in the over-prescription of high-potency painkillers, sparked by the contamination of the illicit drug supply with fentanyl and related drugs, the crisis has reached across demographic divides. Experts agree on the need for creative responses based in scientific evidence.

Could cannabis legalization be a part of this solution? Increasingly, this is what the latest scientific research indicates.

Fatal overdoses

The opioid crisis is a product of the medical system’s over-reliance on opioids for pain relief. Almost one in five Canadians live with some form of chronic pain. Twenty years ago, pharmaceutical companies began to develop slow-release formulations of opioids (e.g. OxyContin) and marketed them as safe and effective medications for the treatment of chronic non-cancer pain.

We know now that these drugs carry an extremely high risk of dependence and fatal overdose. Despite this, more than 20 million opioid prescriptions are filled each year in Canada. Drug overdoses are now the leading cause of death among Americans under the age of 50. And prescription opioids are involved in nearly half of these deaths. It is also becoming apparent that opioids might be less effective than initially thought in treating certain types of chronic non-cancer pain (e.g. neuropathic pain).

Cannabis, derived from the Cannabis sativa plant, contains several compounds. These include tetrahydrocannabinol (THC, the primary psychoactive component of cannabis) and cannabidiol (CBD). Beyond the well-known psychoactive effects of cannabinoids, new research has shown that they also interact with systems in the body involved in the regulation of pain.

This discovery has led researchers to investigate the potential for cannabis to treat various pain conditions for which opioids are currently first- or second-line therapies. High-quality clinical research involving cannabis has been stunted by its prohibited legal status. But a recent review of clinical studies involving cannabis-based medicines (including smoked or vapourized cannabis) found strong evidence for relief of chronic non-cancer pain.

Ground-breaking findings

The substitution effect is an idea from behavioural economics that describes how the use of one product might decrease when the availability of another increases. Substance use researchers have recently adapted this theory to understand the substitution potential between cannabis and opioids. In other words, does the use of opioids decrease with increasing access to cannabis?

In a landmark 2014 study, a team of researchers analzyed data from across the United States over a 10-year period. They found that states that had legalized medical cannabis saw 25 per cent fewer opioid-related deaths compared to states where medical cannabis remained illegal.

These findings broke ground for others in the field to find associations between U.S. medical cannabis laws and reduced state-level estimates of opioid use and dependence. But, because these population-level studies cannot observe individual-level changes in cannabis and opioid use, a closer look at these trends among different sub-populations of people affected by the opioid crisis is needed.

Not surprisingly, findings from surveys conducted among patients using medical cannabis across North America demonstrate a clear preference for cannabis over opioids. For example, roughly one-third of a sample of patients enrolled in Health Canada’s Marihuana for Medical Purposes Regulations (MMPR) program in B.C. report substituting cannabis for prescription opioids.

For chronic pain patients, this substitution effect appears even more pervasive, with cannabis substitution occurring in roughly two-thirds of a sample of former prescription opioid patients in Michigan who started using medical cannabis.

In the most recent study, 80 per cent of medical cannabis patients in California reported that taking cannabis alone was more effective at treating their medical condition than taking cannabis with opioids. More than 90 per cent agreed they would choose cannabis over opioids to treat their condition if it were readily available.

Illicit opioid use

But what about the relationship between cannabis and opioids among some of those most affected by the opioid crisis — people with long-term experience using illicit opioids?

Untreated pain and substance use have a high degree of overlap. Pain was reported by almost half of people who inject drugs surveyed in a recent San Francisco study. Research from our colleagues in Vancouver found that under-treatment of pain in this population is common. It results in self-management of pain by obtaining heroin or prescription opioids on the street.

This means there could be a role for cannabis even among individuals with extensive experience using illicit opioids. A study from California of people who inject drugs found that those who used cannabis used opioids less often. It’s still unclear if this difference is directly due to cannabis use and more research is needed.

Potential as anxiety treatment

Even without chronic pain, cannabis may prove an effective alternative among individuals wanting to reduce or stop their opioid use. There is growing evidence for the use of cannabis in treating opioid addiction. CBD, the non-psychoactive component of cannabis, is known to interact with several receptors involved in regulating fear and anxiety-related behaviours. It shows potential for the treatment of several anxiety disorders.

Research is also investigating CBD’s role in modulating cravings and relapses — behaviours that are tightly linked to anxiety — among individuals with opioid addiction. Recent preliminary studies suggest that CBD reduces opioid cravings. A larger clinical trial is now underway in the United States.

A bold response?

Canada will soon be the first country in the G-20 to introduce a legal framework regulating the use of cannabis by adults for non-medical purposes. This will create a country-wide natural experiment for the world to observe. Legalizing cannabis will break down traditional barriers to understanding the clinical and public health impacts of the drug.

This massive drug policy change could not come at a more desperate time. By increasing access to the drug for therapeutic and recreational purposes, we will have the opportunity to investigate substitution effects within different populations of people who use opioids.

Protection of youth and removal of organized crime aside, the Cannabis Act may just be the unintentionally bold government response to the opioid crisis that our country so desperately needs.

Stephanie Lake, PhD student in Population and Public Health, University of British Columbia and M-J Milloy, Research Scientist, BC Centre on Substance Use and Assistant Professor in the Division of AIDS, UBC Department of Medicine, University of British Columbia

This article was originally published on The Conversation. Read the original article.

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Related video added by Juan Cole:

AJ+ “Could Cannabis Be A Solution To The Opioid Crisis?”