Drugs – Informed Comment

The Sacklers may not Get away with Opioid Grift after all, as SCOTUS strikes Down Bankruptcy Settlement

F. Douglas Stephenson — Sun, 30 Jun 2024 04:15:12 +0000

Gainesville, Florida (Special to Informed Comment; Feature) – Allen Frances, M.D., distinguished former chair of psychiatry at Duke University school of medicine wrote in a Oct., 2017 New Yorker magazine expose, “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 opioid crisis.

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.”

We Deserve Medicare for All, But What We Get Is Medicare for Wall Street

Common Dreams — Sat, 06 Jan 2024 05:02:46 +0000

By Les Leopold | –

Creating a sane healthcare system will depend on building a massive common movement to free our economy from Wall Street’s wealth extraction.

( Commondreams.org ) – The United States health care system—more costly than any on earth—will become ever more so as Wall Street increasingly extracts money from it.

Private equity funds own approximately 9% of all private hospitals and 30% of all proprietary for-profit hospitals, including 34% that serve rural populations. They’ve also bought up nursing homes and doctors’ practices and are investing more year by year. The net impact? Medical costs to the government and to patients have gone up while patients have suffered more adverse medical results, according to two current studies.

The Journal of the American Medical Association (JAMA) recently published a paper which found:

Private equity acquisition was associated with increased hospital-acquired adverse events, including falls and central line–associated bloodstream infections, along with a larger but less statistically precise increase in surgical site infections.

This should not come as a surprise. Private equity firms in general operate as follows: They raise funds from investors to purchase enterprises using as much borrowed money as possible. That debt does not fall on the private equity firm or its investors, however. Instead, all of it is placed on the books of the purchased entity. If a private equity firm borrows money and buys up a nursing home or hospital chain, the debt goes on the books of these healthcare facilities in what is called a leveraged buyout.

To service the debt, the enterprise’s management, directed by their private equity ownership, must reduce costs, and increase its cash flow. The first and easiest way to reduce costs is by reducing the number of staff and by decreasing services. Of course, the quality of care then suffers. Meanwhile, the private equity firm charges the company fees in order to secure its own profits.

With so much taxpayer money sloshing around in the system, hedge funds also are cashing in.

An even larger study of private equity and health was completed this summer and published in the British Medical Journal (BMJ). After reviewing 1,778 studies it concluded that after private equity firms purchased healthcare facilities, health outcomes deteriorated, costs to patients or payers increased, and overall quality declined.

Photo by Towfiqu barbhuiya on Unsplash

One former executive at a private equity firm that owns an assisted-living facility near Boulder, Colorado, candidly described why the firm was refusing to hire and retain high-quality caregivers: “Their position was: We are trying to increase our profitability. Care is an ancillary part of the conversation.”

Medicare Advantage Creates Wall Street Advantages

Congress passed the Medicare Advantage program in 2003. Its proponents claimed it would encourage competition and greater efficiency in the provision of health insurance for seniors. At the time, privatization was all the rage as the Democratic and Republican parties competed to please Wall Street donors. It was argued that Medicare, which was actually much more efficient than private insurance companies, needed the iron fist of profit-making to improve its services. These new private plans were permitted to compete with Medicare Part C (Medigap) supplemental insurance.

In 2007, 19% of Medicare recipients enrolled in Medicare Advantage plans. By 2023 enrollment had risen to 51%. These heavily marketed plans are attractive because many don’t charge additional monthly premiums, and they often include dental, vision, and hearing coverage, which Medicare does not. And in some plans, other perks get thrown in, like gym memberships and preloaded over-the-counter debit cards for use in pharmacies for health items.

How is it possible for Medical Advantage to do all this and still make a profit?

According to a report by the Physicians for a National Health Program, it’s very simple—they overcharge the government, that is we, the taxpayers, “by a minimum of $88 billion per year.” The report says it could be as much as $140 billion.

In addition to inflating their bills to the government, these HMO plans don’t pay doctors outside of their networks, deny or slow needed coverage to patients, and delay legitimate payments. As Dr. Kenneth Williams, CEO of Alliance HealthCare, said of Medicare Advantage plans, “They don’t want to reimburse for anything — deny, deny, deny. They are taking over Medicare and they are taking advantage of elderly patients.”

Enter Hedge Funds

With so much taxpayer money sloshing around in the system, hedge funds also are cashing in. They have bought large quantities of stock in the healthcare companies that are milking the government through their Medicare Advantage programs. They then insist that these healthcare companies initiate stock buybacks, inflating the price of their stock and the financial return to the hedge funds. Stock buybacks are a simple way to transfer corporate money to the largest stock-sellers.

(A stock buyback is when a corporation repurchases its own stock. The stock price invariably goes up because the company’s earnings are spread over a smaller number of shares. Until they were deregulated in 1982, stock buybacks were essentially outlawed because they were considered a form of stock price manipulation.)

United Healthcare, for example, is the largest player in the Medicare Advantage market, accounting for 29% of all enrollments in 2023. It also has handsomely rewarded its hedge fund stock-sellers to the tune of $45 billion in stock buybacks since 2007, with a third of that coming since March 2020. Cigna, another big Medicare Advantage player, just announced a $10 billion stock buyback.

These repurchases are also extremely lucrative for United Healthcare’s top executives, who receive most of their compensation through stock incentives. CEO Andrew Witty, for example, hauled in $20.9 million in 2022 compensation, of which $16.4 million came from stock and stock option awards.

Those of us fighting for Medicare for All have much in common with every worker who is losing his or her job as a result of leveraged buyouts and stock buybacks.

A look at the pharmaceutical industry shows where all this is heading. Between 2012 and 2021, fourteen of the largest publicly traded pharmaceutical companies spent $747 billion on stock buybacks and dividends, more than the $660 billion they spent on research and development, according to a report by economists William Lazonick and Öner Tulum. Little wonder that drug prices are astronomically high in the U.S.

And so, the gravy train is loaded and rolling, delivering our tax dollars via Medicare Advantage reimbursements to companies like United Healthcare and Big Pharma, which pass it on to Wall Street private equity firms and hedge funds.

It’s Not Just Healthcare

In researching my book, Wall Street’s War on Workers, we found that private equity firms and hedge funds are undermining the working class through leveraged buyouts and stock buybacks. When private equity moves in, mass layoffs (just like healthcare staff cuts and shortages) almost always follow so that the companies can service their debt and private equity can extract profits. When hedge funds insist on stock repurchases, mass layoffs are used to free up cash in order to buy back their shares. As a result, between 1996 and today, we estimate that more than 30 million workers have gone through mass layoffs.

Meanwhile, stock buybacks have metastasized throughout the economy. In 1982, before deregulation, only about 2% of all corporate profits went to stock buybacks. Today, it is nearly 70%.

Those of us fighting for Medicare for All, therefore, have much in common with every worker who is losing his or her job as a result of leveraged buyouts and stock buybacks. Every fight to stop a mass layoff is a fight against the same Wall Street forces that are attacking Medicare and trying to privatize it. Creating a sane healthcare system, therefore, will depend on building a massive common movement to free our economy from Wall Street’s wealth extraction.

To take the wind out of Medicare Advantage and Wall Street’s rapacious sail through our healthcare system, we don’t need more studies. It’s time to outlaw leveraged buyouts and stock buybacks.

Our work is licensed under Creative Commons (CC BY-NC-ND 3.0). Feel free to republish and share widely.

How a Big Pharma Company Stalled a Potentially Lifesaving Vaccine in Pursuit of Bigger Profits

ProPublica — Sat, 04 Nov 2023 04:06:31 +0000

By Anna Maria Barry-Jester | –

( ProPublica) – Ever since he was a medical student, Dr. Neil Martinson has confronted the horrors of tuberculosis, the world’s oldest and deadliest pandemic. For more than 30 years, patients have streamed into the South African clinics where he has worked — migrant workers, malnourished children and pregnant women with HIV — coughing up blood. Some were so emaciated, he could see their ribs. They’d breathed in the contagious bacteria from a cough on a crowded bus or in the homes of loved ones who didn’t know they had TB. Once infected, their best option was to spend months swallowing pills that often carried terrible side effects. Many died.

So, when Martinson joined a call in April 2018, he was anxious for the verdict about a tuberculosis vaccine he’d helped test on hundreds of people.

The results blew him away: The shot prevented over half of those infected from getting sick; it was the biggest TB vaccine breakthrough in a century. He hung up, excited, and waited for the next step, a trial that would determine whether the shot was safe and effective enough to sell.

Weeks passed. Then months.

More than five years after the call, he’s still waiting, because the company that owns the vaccine decided to prioritize far more lucrative business.

Pharmaceutical giant GSK pulled back on its global public health work and leaned into serving the world’s most-profitable market, the United States, which CEO Emma Walmsley recently called its “top priority.” As the London-based company turned away from its vaccine for TB, a disease that kills 1.6 million mostly poor people each year, it went all in on a vaccine against shingles, a viral infection that comes with a painful rash. It afflicts mostly older people who, in the U.S., are largely covered by government insurance.

Importantly, the shingles vaccine shared a key ingredient with the TB shot, a component that enhanced the effectiveness of both but was in limited supply.

From a business standpoint, GSK’s decision made sense. Shingrix would become what the company calls a “crown jewel,” raking in more than $14 billion since 2018.

But the ability of a corporation to allow a potentially lifesaving vaccine to languish lays bare the distressing reality of public health vaccine creation. With limited resources, governments have long seen no other option but to team with Big Pharma to develop vaccines for global scourges. But after the governments pump taxpayer money and resources into the efforts, the companies get control of the products, locking up ownership and prioritizing their own gain.

That’s what GSK did with the TB vaccine. Decades ago, the U.S. Army brought in GSK to work on a malaria vaccine and helped develop the ingredient that would prove game-changing for the company. It was an adjuvant, a substance that primed the body’s immune system to successfully respond to a vaccine for malaria — and, the company would come to learn, a variety of other ailments.

GSK patented the adjuvant and took control of the supply of the ingredients in it. It accepted government and nonprofit funding to develop a TB vaccine using the adjuvant. But even though it isn’t carrying the vaccine to the finish line, it isn’t letting go of it entirely either, keeping a tight grip on that valuable ingredient.

As TB continued to rage around the globe, it took nearly two years for GSK to finalize an agreement with the nonprofit Bill & Melinda Gates Medical Research Institute, or Gates MRI, to continue to develop the vaccine. While the Gates organization agreed to pay to keep up the research, GSK reserved the right to sell the shot in wealthy countries.

The trial that will determine whether the vaccine is approved won’t begin until 2024, and isn’t expected to end until at least 2028. “We just can’t operate like that for a disease that is this urgent,” said Thomas Scriba, a South African scientist and TB expert who also worked on the study.

GSK pushes back against the premise that the company delayed the development of the TB vaccine and says it remains dedicated to researching diseases that plague underserved communities. “Any suggestion that our commitment to continued investment in global health has reduced, is fundamentally untrue,” Dr. Thomas Breuer, the company’s chief global health officer, wrote in a statement.

The company told ProPublica that it cannot do everything, and it now sees its role in global health as doing early development of products and then handing off the final clinical trials and manufacturing to others. It also said that a vaccine for TB is radically different from the company’s other vaccines because it can’t be sold at scale in wealthy countries.

Though a good TB vaccine would be used by tens of millions of people, it has, in the parlance of industry, “no market,” because those who buy it are mostly nonprofits and countries that can’t afford to spend much. It’s not that a TB vaccine couldn’t be profitable. It’s that it would never be as profitable as a product like the shingles vaccine that can be sold in the U.S. or Western Europe.

Experts say the story of GSK’s TB vaccine, and its roller coaster of hope and disappointment, highlights a broken system, which has for too long prioritized the needs of corporations over those of the sick and poor.

“We don’t ask for a fair deal from our pharma partners,” said Mike Frick, a director of the tuberculosis program at Treatment Action Group and a global expert on the TB vaccine pipeline. “We let them set the terms, but we don’t ask them to pick up the check. And I just find it frankly a little humiliating.”

Steven Reed, a co-inventor of the TB vaccine, brought his idea to GSK decades ago, believing that working with a pharmaceutical giant was essential to getting the shots to people who desperately needed them. He’s disillusioned that this hasn’t happened and now says that Big Pharma is not the path to saving lives with vaccines in much of the world. “You get a big company to take it forward? Bullshit,” he said. “That model is gone. It’s failed. It’s dead. We have to create a new one.”

Gaining Control

In the early 1980s, the U.S. Army was desperate for a way to keep troops safe from the parasite that causes malaria. Military scientists had some promising ideas but wanted to find a company that could help them develop and manufacture the antigen, the piece of a vaccine that triggers an immune response. They called on SmithKline Beckman, now part of GSK, which had a plant outside of Philadelphia committed to the exact type of antigen technology they were researching.

For the company’s part, working with the Army gave it access to new science and, importantly, the ability to conduct specialized research. The Army had laboratories for animal testing and ran clinical trial sites around the world. It’s also generally easier to get experimental products through regulatory approval when working with the government, and Army scientists were willing to be infected with malaria and run the first tests of the vaccine on themselves.

Col. Carl Alving, then an investigator at the Walter Reed Army Institute of Research, said he was the first person known to be injected with an ingredient called MPL, an adjuvant added to the vaccine. Today, we know that adjuvants are key to many modern vaccines. But at the time, only one adjuvant, alum, had ever been approved for use. Alving published promising results, showing that MPL boosted the shot’s success in the body.

Company scientists took note and began adding MPL to other ingredients. If one adjuvant was good, maybe two adjuvants together, stimulating different parts of the immune system, might be even better.

Image by Arek Socha from Pixabay

It was an exciting development, bringing the multiple adjuvants together, Alving said in an interview. But then he learned that the company scientists had filed a patent for the combinations in Europe, which put limits on what he and his colleagues could do with MPL. “The Army felt perhaps a little frustrated by that because we had introduced Glaxo to the field.”

Still, the Army wanted the malaria vaccine. Military personnel started comparing the adjuvant combinations on rhesus monkeys at an Army facility in Thailand and ran clinical trials that tested the most promising pairs in humans and devised dosing strategies.

The Army found that one of the combinations came out on top: MPL and an extract from the bark of a tree that grows in Chile. The bark extract was already used in veterinary vaccines, but a scientist at one of the world’s first biotech companies had recently discovered you could purify it into a material that makes it safe enough for use in humans.

Alving said that at the time, he didn’t patent the work he and his colleagues were doing or demand an exclusive license for MPL. “It’s a question of the Army being the Army, which is not a company,” Alving said. (This was actually the second time the government failed to secure its rights over MPL. Decades earlier, the ingredient was discovered and formulated by scientists working for the Department of Veterans Affairs and a National Institutes of Health lab in Montana. One of the scientists, frustrated that his bosses in Bethesda, Maryland, wouldn’t let him test the product in humans, quit and formed a company, taking the research with him. Though his company initially said it thought MPL was in the public domain and couldn’t be patented, he did manage to patent it.)

Experts say drug development in the U.S. is littered with such missed opportunities, which allow private companies to seize control of and profit off work done by publicly funded researchers. Governments, they say, need to be more aggressive about keeping such work in the public domain. Alving has since done just that, recently receiving his 30th patent owned by the military.

It’s an open secret in the pharmaceutical world that companies participate in global health research because it’s where they get to try out new technologies that can be applied to other, more lucrative diseases.

At an investor presentation in 2016, a GSK executive used the malaria vaccine example to explain the benefit of such work. “Of those of you who think this is just philanthropy, it is not,” Luc Debruyne, then president of vaccines at GSK, told the group. He explained that it was through the malaria work that the company invented the adjuvant that is now in its blockbuster shingles vaccine. And, he explained, vaccines are high-volume products that make a steady stream of money over time. “So doing good business, innovating and doing well for the world absolutely can get married.”

As the Army’s research on the combination of MPL and the bark extract evolved — and its market potential became clear — GSK moved to vacuum up the companies that owned the building blocks to the adjuvant.

In 2005, it bought the company that owned the rights to MPL for $300 million. In 2012, it struck a deal for the rights to a lion’s share of the supply of the Chilean tree bark extract.

The company was now in full control of the adjuvant.

Picking a Winner

GSK eagerly began to test its new adjuvant on a number of diseases — hepatitis, Lyme, HIV, influenza.

Steven Reed, a microbiologist and immunologist, had come to the company in 1994 with an idea for a tuberculosis vaccine. An estimated 2 billion people are infected with TB globally, but it’s mainly those with weakened immune systems who fall ill. A century-old vaccine called BCG protects young children, but immunity wanes over time, and that vaccine does little to shield people from the most common type of infection in the lungs.

Reed had just the background and resources to attempt a breakthrough: An adjunct professor at Cornell University’s medical school, he also ran a nonprofit research organization that worked on infectious diseases and had co-founded a biotech company to create and market products.

He and his colleagues were building a library of the proteins that make up the mycobacterium that causes TB. He also had access to a blood bank in Brazil, where TB was more prevalent, that he could screen the proteins against to determine which generated an immune response that prevented people from getting sick.

At the time Reed pitched the vaccine, the company’s decision over whether to take him up was made by researchers, said Michel De Wilde, a former vice president of research and development at the company that partnered with Reed and later became part of GSK. Today, across the industry, finance units play a much stronger role in deciding what a company works on, he said.

GSK signed on, asking Reed to add the company’s promising new adjuvant to his idea for a TB vaccine.

Reed and his colleagues used more than $2 million in federal money to conduct trials from 1995 to 2005. GSK also invested, but NIH money and resources were the key, Reed said. As the vaccine progressed into testing, the Bill & Melinda Gates Foundation pitched in, as did the governments of the United Kingdom, the Netherlands and Australia, among others.

Amid all that, in 2003, GSK started testing the adjuvant in its shingles vaccine, according to annual reports, but at a much faster speed. With TB, it performed a small proof-of-concept study to justify moving to a larger one. There’s no evidence it did so with shingles. By 2010, GSK’s shingles vaccine was in final trials; in 2017, the FDA approved it for use.

To employees and industry insiders, GSK was making its priorities clear. The company built a vaccine research facility in Rockville, Maryland, to be closer to the NIH and the Food and Drug Administration; at the same time, it was retreating from TB and other global public health projects, according to former employees of the vaccine division.

All the while, the adjuvant was limited. GSK struggled to ramp up production of MPL, according to former employees there; it relies on a cumbersome manufacturing process. And it wasn’t clear whether there was sufficient supply of the Chilean tree that is essential to both vaccines.

After researchers learned of the TB vaccine’s successful proof-of-concept results in 2018, GSK said nothing about what was next.

“You would have thought people would have said: ‘Oh shit, this is doable. Let’s double down, let’s quadruple down,’” said Dr. Tom Evans, former president and CEO of Aeras, a nonprofit that led and paid for half of the proof-of-concept study. “But that didn’t happen.”

Scriba, who was involved in the study in South Africa, said he never imagined that GSK wouldn’t continue the research. “To be honest it never occurred to us that they wouldn’t. The people we worked with at GSK were the TB team. They were passionate about TB,” Scriba said. “It’s extremely frustrating.”

But Reed said that when the shingles vaccine was approved, he had a gut feeling that GSK would abandon the tuberculosis work.

“The company that dropped it used similar technology to make billions of dollars on shingles, which doesn’t kill anyone,” Reed said.

Those in the field grew so concerned about the fate of the TB vaccine that the World Health Organization convened a series of meetings in 2019.

Breuer, then chief medical officer for GSK’s vaccine division, explained that the pharmaceutical giant was willing to hand off the vaccine to an organization or company that would cover the cost of future development, licensing, manufacturing and liability. If the next trial went well, they could sell the vaccine in the “developing world,” with GSK retaining the sales rights in wealthier countries.

GSK would, however, retain control of the adjuvant, Breuer said. And the company only had enough for its other vaccines, so whoever took over the TB vaccine’s development would need to pay GSK to ramp up production, which Breuer estimated would cost around $200 million.

Dr. Julio Croda was director of communicable diseases for Brazil at the time and attended the meeting. He said he was authorized to spend significant government funds on a tuberculosis vaccine trial but needed assurances that GSK would transfer technology and intellectual property if governments paid for its development. “But in the end of the meeting, we didn’t have an agreement,” he said.

Dr. Glenda Gray, a leading HIV vaccine expert who attended the meeting on behalf of South Africa, said she wasn’t able to get a straight answer about the availability of the adjuvant.

The year after the WHO meeting, after what a Gates representative described as “a lot of negotiation,” GSK licensed the vaccine to Gates MRI, a nonprofit created by the Gates Foundation to develop drugs and vaccines for global health issues that for-profit companies won’t tackle.

GSK told ProPublica that it did not receive upfront fees or royalties as part of the arrangement, but that Gates MRI paid it a small incentive to invest in the company’s global health endeavors. GSK and Gates MRI declined to comment on the amount.

Gates MRI tax documents show a payment designated as “royalties, license fees, and similar amounts that allow the organization to use intellectual property such as patents and copyrights” the year the agreement was finalized. Among available tax documents, that is the only year the organization has made a payment in that category.

The amount: $10 million.

An Uncertain Future

In June of this year, the Gates Foundation and the Wellcome Trust announced they were pledging $550 million to fund the phase 3 trial that will finally show whether the vaccine works. They’ve selected trial locations and are currently testing it on a smaller subset of patients, those with HIV.

Jeremy Farrar, chief scientist at the WHO, said he’s more optimistic than he’s ever been in his career that we’ll have a new TB vaccine this decade.

Gates MRI and GSK declined to say who had the rights to sell the vaccine in which countries, but Gates MRI said it will “work with partners to ensure the vaccine is accessible for people living in high TB-burden lower- and middle-income countries,” and GSK acknowledged that its rights extend to South America and Eastern Europe, two regions with significant pockets of TB.

As expected, Gates MRI will be reliant on GSK to supply the adjuvant, which concerns vaccine hopefuls because of the lack of transparency surrounding its availability. One of the key ingredients, the bark extract, comes from a tree whose harvest and export has been controlled by the Chilean government since the 1970s because of overexploitation. A megadrought and forest fires continue to threaten native forests today. The main exporter of the bark says it has resolved previous bottlenecks, and GSK said it is working on a synthetic version as part of its long-term plan.

In response to questions about why it retained control of the adjuvant, GSK said it was complicated to make, would not be economical to produce in more than one place, and was a very important component in many of the company’s vaccines, so it wasn’t willing to share the know-how.

The adjuvant is only growing in value to the company, as it adds yet another lucrative vaccine to its portfolio that requires it. In May, the FDA approved a GSK vaccine for the respiratory virus known as RSV. Analysts project that the shot will bring in $4 billion annually at its peak. GSK continues to study the adjuvant in additional vaccines.

GSK strongly insists that it has enough of the adjuvant to fulfill its forecasted needs for the RSV, shingles, malaria and TB vaccines through 2035.

The company and Gates MRI said their agreement includes enough adjuvant for research and the initial supply of the TB vaccine, if it is approved. The organizations declined, however, to specify how many people could be vaccinated. GSK also said it was willing to supply more adjuvant after that, but further negotiations would be necessary and Gates MRI would likely need to pay to increase adjuvant manufacturing capacity. For its part, Gates MRI said it is evaluating several strategies to ensure longer term supply.

Several experts said that Gates MRI should test other adjuvants with the vaccine’s antigen. That includes Farrar, who said it would be “very wise” to start looking for a new adjuvant. He is one of the few people who has seen the agreement between Gates MRI and GSK as a result of his previous role as director of the Wellcome Trust. Farrar is now helping to lead a new TB Vaccine Accelerator Council at the WHO and said he believes one of the group’s roles would be to find solutions to any future problems with the adjuvant.

Gates MRI declined to answer when asked if it was considering testing other adjuvants with the vaccine’s antigen. GSK, along with several other scientists and regulators that ProPublica spoke with, expressed that using a new adjuvant would require redoing all of the long and expensive clinical trials.

U.S. government officials, meanwhile, are working to identify adjuvants that aren’t already tied up by major pharmaceutical companies.

For a corporation, the primary concern is “what is this adjuvant doing for my bottom line,” said Wolfgang Leitner, who began his career working at Walter Reed Army Institute of Research on the malaria vaccine as a consultant for GSK. Now the chief of the innate immunity section at the National Institute of Allergy and Infectious Diseases, his job is to encourage the development of new adjuvants and to make sure that researchers have access to ones that aren’t tightly controlled by individual companies.

The WHO has also been helping to build a global network of vaccine manufacturers who can develop and supply vaccines to less wealthy countries outside of the shadow of Big Pharma; it is using a technology debuted during the COVID-19 pandemic called mRNA, which deploys snippets of genetic code to trigger an immune response. Reed, an inventor of GSK’s TB vaccine, co-founded the company at the center of that effort, Afrigen, after growing concerned about the fate of the vaccine he made for GSK.

Reed helped create a second TB vaccine, which Afrigen has the rights to manufacture for sale in Africa. But that vaccine has yet to start a proof-of-concept trial.

Over the past five years, an average of just $120 million a year has been spent on all TB vaccine research globally, including money from governments, pharmaceutical companies and philanthropic organizations, according to annual surveys conducted by the Treatment Action Group. For perspective, the U.S. alone spent more than $2 billion developing COVID-19 vaccines from 2020 to 2022. At a special UN meeting on tuberculosis in 2018, the nations of the world pledged to ensure $3 billion was spent on TB vaccine research and development over the next five years. Just 20% of that was handed out.

While that mRNA hub holds promise, it will be years before an mRNA TB vaccine enters a proof-of-concept trial, according to people involved. The pharmaceutical companies that made successful COVID-19 vaccines have refused to share the technology and manufacturing techniques that make mRNA vaccines work. One company, Moderna, has said it won’t enforce its patents on mRNA vaccines Afrigen creates for COVID-19, but it’s not clear what it’ll do if Afrigen applies those techniques to a disease like TB. (Paul Sagan, board chairman of ProPublica, is a member of Moderna’s board.)

To date, the GSK tuberculosis vaccine — which does not use mRNA technology — is the only one that meets a set of characteristics the WHO believes are necessary for a viable TB vaccine.

The phase 3 trial is set to begin early next year. In the time between the two trials, approximately 9 million people will have died from TB.

ProPublica

How to Enroll Intelligently in Medicare – A Consumers Guide 2024

F. Douglas Stephenson — Sun, 15 Oct 2023 04:04:34 +0000

Gainesville, FL (Special to Informed Comment)- Medicare open enrollment season begins October 15th, running through Dec.7, 2023. And very soon, everyone will be bombarded with new smarmy health insurance Medicare Advantage ads featuring healthy and happy-looking seniors playing tennis and telling us how wonderful their Medicare Advantage plan is and how much of a no-brainer it is to shun traditional Medicare and opt instead for a plan operated by a big private corporation like Humana and Cigna. We’ll hear insurers’ shills tell us about the extra benefits we’ll get, like discounts on gym memberships, $900 for groceries and some coverage for dental, vision, and hearing. They’ll be short on other details of course, and we’ll never hear that coverage for those extra things can be pretty meager.

By never mentioning the potentially deadly side effects of Medicare Advantage plans, insurers’ pitchmen—like ‘Broadway Joe’ Namath, Danny Glover and others—mislead everyone about what Medicare Advantage enrollees are really getting into . Leaving out important (Medicare Advantage) details we better know about before we sign on the dotted line is a recipe for disaster.

WHAT IS MEDICARE ADVANTAGE ?

Medicare Advantage is a program offering private health insurance industry plans as options to replace public traditional Medicare. Medicare Advantage plans differ from traditional Medicare in that they are paid with capitation (per member), they are required to limit enrollees’ out-of-pocket spending, and can offer extra benefits (e.g. gym memberships, $900 worth of groceries, dental benefits). They almost always offer prescription drug coverage and use a defined and often restricted network of providers that can require enrollees to pay more for out-of-network care. Utilization management techniques are used, such as prior authorization, and they can also fund special programs such as rewards for beneficiaries to encourage healthy behaviors. The hope is that these differences will lead to improved care at lower cost compared to Traditional Medicare.

In reality, “Medicare Dis-Advantage” is a better, more accurate name for the programs however, as insurance companies push Congress to corporatize all of Medicare, yet keep the name for the purposes of marketing, deception, and confusion.

HOW MEDICARE ADVANTAGE PLANS DIFFER FROM TRADITIONAL MEDICARE:

* They are owned and operated by for-profit, private insurance corporations;
* Unlike traditional Medicare, Medicare Advantage plans often refuse to pay for treatments and medications physicians prescribe;
* Unlike traditional Medicare, many physicians, other healthcare professionals, and hospitals will be off-limits to patients because Medicare Advantage companies create their own proprietary and often skimpy, managed care type “networks” of healthcare providers;
* If patients go out of network, they could be on the hook for thousands of dollars out of their own pocket; and
* They likely will have to pay extra—often a lot extra—for some of those extra benefits.

OVERCHARGING BY MEDICARE ADVANTAGE PLANS:

A). To put the sheer magnitude of overcharging in MA in perspective, a CBO analysis of a 2019 bill proposing to add dental, hearing, and vision benefits to Medicare and Medicaid estimated that in the most expensive year of its implementation, these benefits would cost a combined $84 billion.

B). Even by minimum estimates, private insurers receive more than enough surplus money to provide critically needed benefits to all Medicare and Medicaid beneficiaries.

C). Medicare Advantage is just another example of the endless greed of the insurance industry poisoning American health care, siphoning money from vulnerable patients while delaying and denying necessary and often life-saving treatment.

D). While there is obvious reason to fix these issues in MA and to expand Traditional Medicare for the sake of all beneficiaries, the deep structural problems with our health care system will only be fixed when we achieve “improved Medicare for All.”

ARE YOU CONSIDERING ENROLLMENT IN A MEDICARE ADVANTAGE PLAN?
! C A V E A T E M P T O R – B U Y E R. B E W A R E !

1). DON’T DO IT ! Stay with (or return) to traditional Medicare and buy a supplemental Medigap policy, because unfortunately, traditional Medicare has some big holes in it.

2). The trouble with Medicare Advantage plans is they look good while you’re healthy. But when you get sick, odds are high they will deny you.

3). Beware of another important factor: The door will have been slammed behind you if you have been in Medicare Advantage for more than six months and then decide you want to return /re-enroll in traditional Medicare.

4). With the exception of four states in this country, if you’re in Medicare Advantage for more than six months and decide you want to go back, and then buy a supplemental coverage, the insurance companies that sell you supplemental coverage can turn you down for supplemental coverage..

5) If they don’t like the look of your pre-existing conditions, they can also charge you a lot more money.

6). You need to make this decision in the next six months enrollment timeframe if you are still fairly new to MA.

7) The basic recommendation to everyone is: don’t even think about enrolling in Medicare Advantage in the first place!

DON’T ALLOW PRIVATE HEALTH INSURANCE INDUSTRY TO DISMANTLE TRADITIONAL MEDICARE: REJECT MA !

DISMANTLING MEDICARE WITH MEDICARE ADVANTAGE: Over 50% of Medicare beneficiaries have signed up and now have for-profit corporations in charge of their care through Medicare Advantage (MA). Insurance companies are paid handsomely for these plans, and much of that money goes to corporate profits instead of care. The companies running MA plans want to take over Medicare entirely, leaving patients with no option but to give their money to private insurers.

DENYING TREATMENT: Investigations into claim denials in MA found that insurers were inappropriately denying treatments and tests that should be covered under Medicare. Physician surveys show that these practices often cause patients to suffer unnecessarily, and can even be life-threatening. In some cases, MA insurers were found to spend just seconds on each claim, and even denied claims using artificial intelligence instead of medical experts.

DECEIVING PATIENTS AND TAXPAYERS: Reports from journalists, researchers, and government agencies have shown that health insurance companies like United Health and Cigna overcharge Medicare by giving patients exaggerated,upcoded or entirely false diagnoses. Several companies have been fined, or sued, and agreed to large settlements. MA insurers are taking citizens’ tax dollars for conditions they aren’t even treating.

Image by Arvi Pandey from Pixabay

BOTTOM LINE: Medicare Advantage is not the same Medicare program that Americans have come to know and love. The private insurance industry has spend millions on advertising in order to hide the ugly truth: Their MA plans raid taxpayer funds and routinely fail to deliver the care that patients expect and deserve.

TERMINATE MEDICARE ADVANTAGE: Physicians for a National Health Program (PNHP), concludes that the Center for Medicare Services (CMS) should terminate the Medicare Advantage program. It would be far more cost-effective for CMS to improve traditional Medicare by capping out-of-pocket costs and adding improved benefits within the Medicare fee-for-service system than to try to indirectly offer these improvements through private plans that require much higher overhead and introduce profiteers and perverse incentives into Medicare, enabling corporate fraud and abuse, raising cost to the Medicare Trust Fund, and worsening disparities in care. These problems are not correctable within the competitive private insurance business model, and the Medicare Advantage program should be terminated.

BIG INSURANCE MOTIVATED BY PROFIT:

Highly respected healthcare reform advocate, Wendall Potter, reports on the alarming scope of profiteering by Medicare Advantage plans:

1). Big Insurance revenues and profits have increased by 300% and 287% respectively since 2012 due to explosive growth in the insurance companies’ pharmacy benefit management (PBM) businesses and the Medicare replacement plans called Medicare Advantage.

2). The for-profits now control more than 70% of the Medicare Advantage market. In 2022, Big Insurance revenues reached $1.25 trillion and profits soared to $69.3 billion. That’s a 300% increase in revenue and a 287% increase in profits from 2012, when revenue was $412.9 billion and profits were $24 billion.

3). Big insurers’ revenues have grown dramatically over the past decade, the result of consolidation in the PBM business and taxpayer-supported Medicare and Medicaid programs.

4). What has changed dramatically over the decade is that the big insurers are now getting far more of their revenues from the pharmaceutical supply chain, Medicare, Medicaid, and from taxpayers as they have moved aggressively into government programs. This is especially true of Humana, Centene, and Molina, which now get, respectively, 85%, 88%, and 94% of their health-plan revenues from government programs.

5). The two biggest drivers are their fast-growing pharmacy benefit managers (PBMs), the relatively new and little-known middleman between patients and pharmaceutical drug manufacturers, and the privately owned and operated Medicare replacement plans marketed as Medicare Advantage.

6). Huge strides in privatizing both Medicare and Medicaid have been made. More than 90% of health-plan revenues at three of the health industry companies come from government programs as they continue to privatize both Medicare and Medicaid, through Medicare Advantage in particular. Enrollment in government-funded programs increased by 261% in 10 years.

TURNING PUBLIC MONEY INTO A BONANZA OF PRIVATE RICHES:

for the”BigInsurance/BigPharma/Congressional Complex”

Political support for private health insurance industry and Medicare Advantage exists because our government permits private health insurance companies to exact large profit from its citizens as Wall Street banks and investors who back Big Insurance turn public money into a bonanza of private riches. High health insurance costs are the result of a political decision to essentially allow Big Insurance to do what they want and charge whatever they want. It’s no wonder so many beholden members of Congress want to protect the interests of their donors, Big Insurance and Big Pharma, industries that spent $371 million on lobbying in 2017.

The website/blog The Lever reported that The Better Medicare Alliance, an advocacy group for Medicare Advantage plans, spent $570,000 lobbying Congress in the first quarter of this year, nearly double the $330,000 spent in the prior quarter. All told, the four major publicly traded health insurance companies that operate Medicare Advantage plans, as well as the insurance lobby America’s Health Insurance Plans, spent nearly $19 million on federal lobbying in the first quarter of 2023, a 66% increase from the prior quarter, according to a Lever analysis of data from OpenSecrets.

The USA is a country where health insurance for medical and mental healthcare is a function of socioeconomic status. Everyone knows that this inhumane system should have been corrected long ago. We must immediately end our moral crime of having one of the greatest health system in the world, but only for those who can afford it. We must support the common principles that healthcare is a human right, must be free from corporate profit, and must be achieved through national legislation.

Let’s never forget that universal Medicare for All is a solid investment in, not a cost for, all citizens of our country by simply promoting a social service for universal access to affordable healthcare insurance for all. Aren’t we a society that cares enough to see that everyone receive the healthcare they need? That’s the basic purpose of Medicare for All. The history of our most successful national health insurance program, Medicare, provides one of the best arguments for expanding the program to cover everyone. It’s time to end inadequate and dangerous health insurance programs like Medicare Advantage. Insist on real health insurance reform essential for individuals and families.

Contact your legislators asking them to oppose and end Medicare Advantage plans immediately. Most importantly, ask them to strongly support new legislation now filed in Congress, “The Medicare for All Act of 2023” House Bill (H.R. 3421) and Senate Bill (S. 1655) that would establish this badly needed reform.

Big Pharma spent more on Stock Buybacks and Dividends than on Research and Development even during COVID

F. Douglas Stephenson — Sun, 08 Jan 2023 05:02:07 +0000

Gainesville, Florida (Special to Informed Comment) – The 14 largest publicly-traded pharmaceutical companies spent $747 billion on stock buybacks and dividends from 2012 through 2021 — substantially more than the $660 billion they spent on research and development. So argue economists William Lazonick, professor emeritus of economics at University of Massachusetts, and Öner Tulum, a researcher at Brown University, in a new paper.

Recently Big Pharma bluntly and unashamedly announced price hikes in the United States on more than 350 drugs while continuing to brazenly insist that large price hikes are necessary for innovation. The Lazonick/Tulum research shows that the business model of America’s largest pharmaceutical companies involves far more spending on enriching shareholders and executives than on research and development.

Big business, Big Insurance and Big Pharma industries dominate our government with public health taking a back seat to the need for large private profit. Many government leaders from both political parties share the same ‘profits over public health’ ideology, even though the Covid-19 pandemic clearly showed how our economic system failed to serve our citizens by allowing these groups to privatize, sabotage, fragment and cripple our health, public health and other social services.

No greater disconnect exists between the public good and private interests than in the U.S. system of monopoly, for-profit Big Pharma.

Over forty years of profiteering by Big Pharma and oligarch control of our economy left the public totally exposed and ill-prepared to face the public health crisis of COVID-19. Because Big Pharma rarely invests in prevention, it has very little motivation to invest in preparedness for a public health crisis. Drugs for prevention do not contribute to share-holder value and profit. Instead, cures are designed once a public health crisis strikes.

The sicker we are the more profit they earn.

Opioid Crisis: Purdue Pharma/ Sackler Family Fails in End Run around Justice

F. Douglas Stephenson — Sat, 18 Dec 2021 05:02:56 +0000

Gainesville, Florida (Special to Informed Comment) – In a seismic victory for justice and accountability that re-opens the deeply flawed recent September, 2020 settlement of the Purdue pharma bankruptcy case, the Sackler family will be forced to confront the pain and devastation they have allegedly caused. Judge Colleen McMahon of the U.S. District Court for the Southern District of New York, ruled, Dec.16, 2021,that the settlement, part of a restructuring plan for Purdue approved in September by a bankruptcy judge, Robert Drain, U.S. Bankruptcy Court,White Plaines, N.Y., should not go forward because it releases the company’s owners, members of the billionaire Sackler family, from liability in civil opioid-related cases.

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

EPITOMES OF GOOD WORKS?

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.

Our Health depends on Indigenous Botanical Knowledge and Plants that are rapidly being Destroyed

John Buell — Mon, 11 Oct 2021 04:08:37 +0000

Southwest Harbor, Maine (Special to Informed Comment) – While mainstream media celebrate the remarkable development in record time of vaccines spectacularly effective against the Covid virus, knowledge that might contribute to other medical breakthroughs is being steadily undermined. This decline is not the result of some dramatic lawsuit or corporate takeover. It is one of the effects of the industrial modernization that is supposed to have brought increasing comfort, health and advanced knowledge into our lives. Economic growth has produced not only a climate emergency but a less publicized decline in the many efficacious forms of traditional knowledge and the bodiversity they sustain and are sustained by. In an email exchange I had with ethnobotanist PhD Kirsten Tripplett, she pointed out:

“the generally accepted understanding is that 12-25% of “Western” medicine is derived or based on plant molecules/chemical backbones…It depends who’s talking and what their agenda is. And that is JUST in Western medicine. There are other, much older and empirically-based medicinal systems out there that are incredibly effective, but most U.S. citizens are unaware or only dimly, of them. Not only is the loss of language directly linked to knowledge loss and potential medical/economic loss, but think of all of the practical and useful things that get lost, too.”

When Brazil President- Bolsanaroo encouraged more forestry development in the Amazon, global climate advocates worried about the lungs of the planet and the contribution to global warming. They might equally have been concerned with the indigenous knowledge going up in smoke..

Sibélia Zanon writing at nature site Mongabay reports:

Nor are medicines all that are lost. She adds,

“Every time a language disappears, a speaking voice also disappears, a way to make sense of reality disappears, a way to interact with nature disappears, a way to describe and name animals and plants disappears,” says Jordi Bascompte, researcher in the Department of Evolutional Biology and Environmental Studies at the University of Zurich.”

As indigenous peoples rely on the spoken word for intergenerational knowledge transfer, the disappearance of these languages will take with them a universe of information. The possible losses include fundamental neurological facts about the human brain. Jairus Grove, author of Savage Ecology, cites work by neurologists showing that each language contains a different cognitive map of the human brain. Sometimes the differences are very significant and open up important research potential. Grove cites work by linguist David Harrison on the Uririna people of Peru showing that some, though very few, languages place the object of the sentence at the beginning. Were it not for the continued existence of this people, neuroscientists would not even suspect or know that the human brain could be wired in such a way to make O-V-S sentences possible..

Grove points out that most Indo European languages have a active subject, verb, passive object form, but there are minority cultures that do not express that format. In a world beset by the dangerous exploitation of the natural world these minority cultures may teach us more about how to survive and thrive in this world. In this context Trip[let points out that agency is not confined to the human world The unwillingness to recognize and accept this fact could have increasingly dire consequences.

Dr. Kirsten Tripplett writes, “It’s a long leap conceptually to make, but if one accepts a premise that “language” isn’t just spoken, and that knowledge is transmitted through actions and lifeways, then loss of biological species and their exploitation to serve human interests, is a critical loss, too, for the same reasons as those cited above . . .”

Grove has similar worries: “Irreversible catastrophic changes are certain but extinction is unlikely. What we stand to lose as a species in this current apocalypse of homogenization is unimaginable , not because of the loss of life but because of the loss of difference. Who and what will be left on Earth to inspire and ally with us in our creative advance is uncertain. If the future is dominated by those who seek to establish the survival of the human species at all costs through technological mastery then whatever “we” manages to persist will likely live on or near a mean and lonely planet.”(Savage Ecology, p. 209)

Why this loss of cultural diversity? There is first the reductionist tendency to treat cultural diversity and biodiversity as separate issues rather than as continuously interacting. Zanon further quotes Jordi Bascompte: “We can’t ignore this network now and think only about the plants or only about the culture . . . We humans are very good at homogenizing culture and nature so that nature seems to be more or less the same everywhere.”

This homogenization process includes reduction of human labor to cogs in a corporate machine, to cookie cutter development to the planned obsolescence and corporate dominated consumer culture. Most important is a neoliberal financial system fostering increasing wealth gaps within and among nations. In this context it is especially important to preserve alternative ways of being in the world and their origins and history. Despite efforts to homogenize many indigenous cultures some retain their vitality. But their survival will depend on bottom- up activism and rules, laws, and practices negotiated across race, ethnicity, religion and class.

As Subhankar Banerjee argues, saving elephants in different states presents complex problems. More broadly biodiversity conservation is contextual. What works for one place and in a particular culture may not work for another place and in another culture. This is not, however, cultural relativism. Biodiversity advocates value most those cultures that seek space for difference and for a politics that celebrates that end.

Banerjee again: “”What makes biodiversity conservation so beautiful is that it is a pluriverse—so many ideas, so many practices, so many forms of human-nonhuman kinship that exist around the world, which in a different context, a quarter-century ago, Indian historian Ramachandra Guha and Spanish ecological-economist Juan Martinez-Alier called Varieties of Environmentalism.”

To help indigenous peoples worldwide preserve, revitalize and promote their languages, UNESCO has launched its Decade of Action for Indigenous Languages from 2022 to 203. This is a principle worthy of much more attention than it receives. For that situation to change more than proclamations of rights will be necessary, including political movements celebrating and willing to fight for economic justice and biological and cultural diversity.

—–

Bonus Video added by Informed Comment:

Euronews: “Inside the rainforest’s medicine cabinet”

Was ‘the War on Drugs’ always a White Nationalist Project?

Alfred W. McCoy — Thu, 08 Jul 2021 04:01:15 +0000

( Tomdispatch.com ) – Fifty years ago, on June 17, 1971, President Richard Nixon stood before the White House press corps, staffers at his side, to announce “a new, all-out offensive” against drug abuse, which he denounced as “America’s public enemy number one.” He called on Congress to contribute $350 million for a worldwide attack on “the sources of supply.” The first battle in this new drug war would be fought in South Vietnam where, Nixon said, “a number of young Americans have become addicts as they serve abroad.”

While the president was declaring his war on drugs, I was stepping off a trans-Pacific flight into the searing tropical heat of Saigon, the South Vietnamese capital, to report on the sources of supply for the drug abuse that was indeed sweeping through the ranks of American soldiers fighting this country’s war in Vietnam.

As I would soon discover, the situation was far worse than anything Nixon could have conveyed in his sparse words. Heroin vials littered the floors of Army barracks. Units legendary for their heroism in World War II like the 82nd Airborne were now known as the “jumping junkies.” A later survey found that more than a third of all GIs fighting the Vietnam War “commonly used” heroin. Desperate to defeat this invisible enemy, the White House was now about to throw millions of dollars at this overseas drug war, funding mass urinalysis screening for every homeward-bound GI and mandatory treatment for any who tested positive for drugs.

Even that formidable effort, however, couldn’t defeat the murky politics of heroin, marked by a nexus of crime and official collusion that made mass drug abuse among GIs possible. After all, in the rugged mountains of nearby Laos, Air America, a company run by the CIA, was transporting opium harvested by tribal farmers who were also serving as soldiers in its secret army. The commander of the Royal Lao Army, a close ally, then operated the world’s largest illicit lab, turning raw opium into refined heroin for the growing numbers of GI users in neighboring Vietnam. Senior South Vietnamese commanders colluded in the smuggling and distribution of such drugs to GIs in bars, in barracks, and at firebases. In both Laos and South Vietnam, American embassies ignored the corruption of their local allies that was helping to fuel the traffic.

Nixon’s Drug War

As sordid as Saigon’s heroin politics were, they would pale when compared to the cynical deals agreed to in Washington over the next 30 years that would turn the drug war of the Vietnam era into a political doomsday machine. Standing alongside the president on that day when America’s drug war officially began was John Erlichman, White House counsel and Nixon confidante.

As he would later bluntly tell a reporter,

“The Nixon White House had two enemies: the antiwar left and black people… We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news.”

And just in case anyone missed his point, Erlichman added, “Did we know we were lying about the drugs? Of course, we did.”

To grasp the full meaning of this admission, you need to begin with the basics: the drug war’s absolute, unqualified, irredeemable failure. Just three pairs of statistics can convey the depth of that failure and the scope of the damage the war has done to American society over the past half-century:

* Despite the drug war’s efforts to cut supplies, worldwide illicit opium production rose 10-fold — from 1,200 tons in 1971 to a record 10,300 tons in 2017.

* Reflecting its emphasis on punishment over treatment, the number of people jailed for drug offenses would also grow 10-fold from 40,900 in 1980 to 430,900 in 2019.

* Finally, instead of reducing domestic use, the drug war actually helped stimulate a 10-fold surge in the number of American heroin users from just 68,000 in 1970 to 745,000 in 2019.

In addition, the drug war has had a profound impact on American society by perpetuating, even institutionalizing, racial disparities through the raw power of the police and prisons. Remember that the Republican Party saw the Voting Rights Act of 1965, which ended decades of Jim Crow disenfranchisement for Blacks in the deep South, as a rare political opportunity. In response, Nixon and his men began developing a two-part strategy for winning over white voters in the South and blunting the Democratic advantage with Black voters nationwide.

First, in the 1970 midterm elections, the Republicans began pursuing a “Southern strategy” of courting disgruntled white-supremacist voters in the South in a successful attempt to capture that entire region politically. Three years later, they launched a relentless expansion of the drug war, policing, and prisons. In the process, they paved the way for the mass incarceration of African Americans, denying them the vote not just as convicts but, in 15 states, for life as ex-convicts. Pioneering this cunning strategy was New York’s Republican governor Nelson Rockefeller. The harsh mandatory penalties of 15 years to life for petty drug possession he got the state legislature to pass raised the number of people imprisoned on drug charges from 470 in 1970 to 8,500 in 1999, 90% of them African-American or Latinx.

Such mass incarceration moved voters from urban Democratic bailiwicks to rural prisons where they were counted in the census, but otherwise disenfranchised, giving a bit of additional help to the white Republican vote in upstate New York — a winning strategy Republicans elsewhere would soon follow. Not only did the drug war let conservatives shave opposition vote tallies in close elections, but it also dehumanized African Americans, justifying repressive policing and mass incarceration.

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None of this was pre-ordained but the result of a succession of political deals made during three presidencies — that of Nixon, who started it; of Ronald Reagan, whose administration enacted draconian punishments for drug possession; and of the Democrat Bill Clinton, who expanded the police and prisons to enforce those very drug laws. After remaining remarkably constant at about 100 prisoners per 100,000 population for more than 50 years, the U.S. incarceration rate started climbing relentlessly to 293 by the end of Reagan’s term in 1990 and 464 by the end of Clinton’s in 2000. It reached a peak of 760 by 2008 — with a racial bias that resulted in nothing less than the “mass incarceration” of African Americans.

Reagan Domesticates the Drug War

While Nixon fought his war largely on foreign battlefields trying, and failing, to stop narcotics at their source, the next Republican president, Ronald Reagan, fully domesticated the drug war through ever harsher penalties for personal use and a publicity campaign that made abstinence a moral virtue and indulgence a fiercely punishable vice. Meanwhile, he also signaled clearly that he was determined to pursue Nixon’s Southern strategy by staging a major 1980 election campaign rally in Neshoba County, Mississippi, where three civil rights workers had previously been murdered.

Taking office in 1981, Reagan found, to his surprise, that reviving the drug war at home had little public support, largely because the outgoing Democratic administration had focused successfully on drug treatment rather than punishment. So, First Lady Nancy Reagan began crisscrossing the country, while making TV appearances with choruses of cute kids wearing “Just Say No” T-shirts. Even after four years of the First Lady’s campaign and the simultaneous spread of crack cocaine and cocaine powder in cities and suburbs nationwide, only about 2% of the electorate felt that drug abuse was the nation’s “number one problem.”

Then personal tragedy provided Reagan with the perfect political opportunity. In June 1986, just a day after signing a multimillion-dollar contract with the NBA’s Boston Celtics, college basketball sensation Len Bias collapsed in his dorm at the University of Maryland from a fatal cocaine overdose. Five months later, President Reagan would sign the Anti-Drug Abuse Act, aka the “Len Bias Law.” It would lead to a quantum expansion of the domestic drug war, including a mandatory minimum sentence of five years just for the possession of five grams of cocaine and a revived federal death penalty for traffickers.

It also put into law a racial bias in imprisonment that would prove staggering: a 100:1 sentencing disparity between those convicted of possessing crack-cocaine (used mainly by inner-city Blacks) and those using cocaine powder (favored by suburban whites) — even though there was no medical difference between the two drugs. To enforce such tough penalties, the law also expanded the federal anti-drug budget to a massive $6.5 billion.

In signing that law, Reagan would pay special tribute to the first lady, calling her “the co-captain in our crusade for a drug-free America” and the fight against “the purveyors of this evil.” And the two of them had much to take credit for. After all, by 1989, an overwhelming 64% of Americans had come to feel that drugs were the nation’s “number one problem.” Meanwhile, thanks largely to the Anti-Drug Abuse Act, Americans jailed for nonviolent drug offenses soared from 50,000 in 1980 to 400,000 in 1997. Driven by drug arrests, in 1995 nearly one-third of all African-American males between 20 and 29 would either be in prison or on parole.

Clinton’s All-Too-Bipartisan Drug War

If those two Republican presidents were adept at portraying partisan anti-drug policies as moral imperatives, their Democratic successor, Bill Clinton, proved adept at getting himself reelected by picking up their seductive rhetoric. Under his administration, a racialized drug policy, with its disenfranchisement and denigration of African Americans, would become fully bipartisan.

In 1992, two years after being elected president, Clinton lost control of Congress to Republican conservatives led by House Speaker Newt Gingrich. Desperate for something he could call a legislative accomplishment, he tacked hard right to support the Violent Crime Control Act of 1994. It would prove the largest law-enforcement initiative in American history: nearly $19 billion dollars for 100,000 new cops to sweep the streets for drug offenders and a massive prison-expansion program to house those who would now be sentenced to life after three criminal convictions (“three strikes”).

A year later, when the non-partisan U.S. Sentencing Commission recommended that the 100:1 disparity in penalties for crack-cocaine and cocaine powder be abolished, along with its blatant racial bias, Clinton flatly rejected the advice, signing instead Republican-sponsored legislation that maintained those penalties. “I am not,” he insisted, “going to let anyone who peddles drugs get the idea that the cost of doing business is going down.”

The country’s Black political leaders were eloquent in their condemnation of this political betrayal. The Reverend Jesse Jackson, a former Democratic presidential candidate, claimed Clinton knew perfectly well that “crack is code for black” and labelled the president’s decision “a moral disgrace” by a man “willing to sacrifice young black youth for white fear.” The Congressional Black Caucus would similarly denounce the sentencing disparity as “a mockery of justice.”

As they predicted all too accurately, the relentless rise of Black incarceration only accelerated. In the five years following passage of Clinton’s omnibus crime bill, the country added 204 prisons and its inmate population shot up by a mind-boggling 28% to 1,305,300. Of those, nearly half (587,300) were Black, though African Americans made up only 13% of the country’s population.

Facing a tough reelection campaign in 1996, Clinton again worked with hard-right congressional Republicans to pass the Personal Responsibility Work Act, which, as he put it, brought an “end to welfare as we know it.” With that law’s work requirement for welfare, even as unemployment among Black residents of cities like Chicago (left behind by industry) hit 20% to 25%, youth in inner cities across America found that street-level drug dealing was fast becoming their only opportunity. In effect, the Clintons gained short-term political advantage by doing long-term social and economic damage to a core Democratic constituency, the African American community.

Reviving Jim Crow’s Racial Stereotypes

Nonetheless, during his 1996 reelection campaign, Clinton trumpeted such dubious legislative achievements. Speaking at a campaign rally in New Hampshire, for instance, Hillary Clinton celebrated her husband’s Violent Crime Control Act for taking back the streets from murderous minority teenagers. “They are often the kinds of kids that are called ‘super-predators,’” Clinton said. “No conscience, no empathy. We can talk about why they ended up that way, but first we have to bring them to heel.”

The term “super-predator” had, in fact, originated with a Princeton University political scientist, John Dilulio, who described his theory to the first couple during a 1995 White House working dinner on juvenile crime. In an article for a neo-conservative magazine that November, the academic trumpeted his apocalyptic analysis. Based solely on the spottiest of anecdotal evidence, he claimed that “black inner-city neighborhoods” would soon fall prey to such “super predators” — a new kind of juvenile criminal marked by “impulsive violence, the vacant stares, and the remorseless eyes.” Within five years, he predicted, there would be 30,000 “more murderers, rapists, and muggers on the streets” who would “place zero value on the lives of their victims, whom they reflexively dehumanize as just so much worthless ‘white trash.’” This rising demographic tide, he warned, would soon “spill over into upscale central-city districts, inner-ring suburbs, and even the rural heartland.”

By the way, the truly significant part of Hillary Clinton’s statement based on Dilulio’s “analysis” was that phrase about bringing super-predators to heel. A quick quiz. Who or what does one “bring to heel”: (a.) a woman, (b.) a man, or (c.) a child? Answer: (d.) None of the above.

That term is used colloquially for controlling a leashed dog. By implicitly referring to young Black males as predators and animals, Clinton was tapping into one of America’s most venerable and virulent ethnic stereotypes: the Black “buck” or “brute.” The Jim Crow Museum of Racist Memorabilia at Ferris State University in Michigan reports that “the brute caricature portrays black men as innately savage, animalistic, destructive, and criminal — deserving punishment, maybe death… Black brutes are depicted as hideous, terrifying predators.”

Indeed, Southern fiction of the Jim Crow era featured the “Black brute” as an animal predator whose natural prey was white women. In words strikingly similar to those Dilulio and Clinton would later use for their super-predator, Thomas Dixon’s influential 1905 novel The Clansman: A Historical Romance of the Ku Klux Klan described the Black brute as “half child, half animal… a being who, left to his will, roams at night and sleeps in the day, whose speech knows no word of love, whose passions, once aroused, are as the fury of the tiger.” When turned into a movie in 1915 as The Birth of a Nation (the first film ever screened in the White House), it depicted a Black man’s animalistic rape of a virtuous white woman and reveled in the Klan’s retribution by lynching.

In effect, the rhetoric about “super-predators” revived the most virulent stereotype from the Jim Crow lexicon. By the end of President Clinton’s term in 2000, nearly every state in the nation had stiffened its laws on juveniles, setting aside family courts and sending young, mainly minority, offenders directly to adult prisons for long sentences.

Of course, the predicted wave of 30,000 young super-predators never happened. Instead, violent juvenile crime was already declining when Hillary Clinton gave that speech. By the time President Clinton’s term ended in 2001, the juvenile homicide rate had fallen well below its level in 1985.

Amazingly, it would be another 20 years before Hillary Clinton was compelled to confront the meaning of those freighted words of hers. While she was speaking to a donors’ meeting in South Carolina during her 2016 presidential campaign, Ashley Williams, a young Black activist, stood up in the front row and unfurled a small banner that read: “We have to bring them to heel.” Speaking calmly, she asked: “Will you apologize to black people for mass incarceration?” And then she added, “I am not a super-predator, Hillary Clinton.”

When Clinton tried to talk over her, she insisted: “I know that you called black people super-predators in 1994.” As the Secret Service hurried that young woman out of the room amid taunts from the largely white audience, Clinton announced, with a palpable sense of relief, “Okay, back to the issues.”

In its report on the incident, the Washington Post asked Clinton for a comment. In response, she offered the most unapologetic of apologies, explaining that, back in 1994, she had been talking about “violent crime and vicious drug cartels and the particular danger they pose to children and families.”

“As an advocate, as first lady, as senator, I was a champion for children,” she added, though admitting as well that, “looking back, I shouldn’t have used those words.”

That was it. No mention of mass incarceration. No apology for using the power of the White House pulpit to propagate the most virulent of racial stereotypes. No promises to undo all the damage she and her husband had caused. Not surprisingly, in November 2016, the African-American turnout in 33 states — particularly in the critical swing states of Florida, Michigan, Pennsylvania, and Wisconsin — was markedly down, costing her the election.

The Burden of This Past

As much as both Republicans and Democrats might wish us to forget the costs of their deals, this tragic past is very much part of our present. In the 20 years since the drug war took final form under Clinton, politicians have made some relatively inconsequential reforms. In 2010, Congress made a modest cut in the sentencing disparity between the two kinds of cocaine that reduced the prison population by an estimated 1,550 inmates; Barack Obama pardoned 1,700 drug offenders; and Donald Trump signed the First Step Act that released 3,000 prisoners. Add up all those “reforms” and you end up with only 1.5% of those now in prison for drug offenses — just the tiniest drop of mercy in a vast ocean of misery.

So, even 50 years later, this country is still fighting a war on drugs and on non-violent drug users. Thanks to its laws, petty drug possession is still a felony with heavy penalties. As of 2019, this country’s prisons remained overcrowded with 430,900 people convicted of drug crimes, while drug offenders represented 46% of all those in federal penitentiaries. In addition, the U.S. still has the world’s highest incarceration rate at 639 prisoners per 100,000 population (nearly double Russia’s), with 1,380,400 people imprisoned, of whom 33% are Black.

So many decades later, the drug war’s mass incarceration still denies millions of African Americans the right to vote. As of 2020, 48 states refused their convicts the vote, while 34 states imposed a range of restrictions on ex-convicts, effectively denying suffrage to about 2.2 million Blacks, or 6.3% of all African-American adults.

Recent challenges have made more visible the drug war’s once largely invisible mechanisms for denying African Americans their rightful political power as a community. In a 2018 plebiscite, Florida voters restored electoral rights to that state’s 1.4 million ex-convicts, including 400,000 African Americans. Almost immediately, however, Republican governor Ron DeSantis required that 800,000 of those felons pay whatever court costs and fines they still owed before voting — a decision he successfully defended in federal court just before the 2020 presidential election. The effect of such determined Republican efforts meant that fewer than 8% of Florida’s ex-convicts were able to vote.

But above all, Black male drug users are still stigmatized as dangerous predators, as we all saw in the recent trial of Minneapolis police officer Derek Chauvin, who tried to defend kneeling on George Floyd’s neck for nine minutes because an autopsy found that the victim had opioids in his blood. And in March 2020, a paramilitary squad of Louisville police broke down an apartment door with a battering ram on a no-knock drug raid for a suspected Black drug dealer and wound up killing his sleeping ex-girlfriend, medical worker Breonna Taylor.

Maybe now, half a century later, it’s finally time to end the war on drug users — repeal the heavy penalties for possession; pardon the millions of nonviolent offenders; replace mass incarceration with mandatory drug treatment; restore voting rights to convicts and ex-convicts alike; and, above all, purge those persistent stereotypes of the dangerous Black male from our public discourse and private thoughts.

If only…

Follow TomDispatch on Twitter and join us on Facebook. Check out the newest Dispatch Books, John Feffer’s new dystopian novel, Songlands (the final one in his Splinterlands series), Beverly Gologorsky’s novel Every Body Has a Story, and Tom Engelhardt’s A Nation Unmade by War, as well as Alfred McCoy’s In the Shadows of the American Century: The Rise and Decline of U.S. Global Power and John Dower’s The Violent American Century: War and Terror Since World War II.

Via Tomdispatch.com