Pharmaceuticals – Informed Comment https://www.juancole.com Thoughts on the Middle East, History and Religion Thu, 02 Nov 2023 16:09:59 +0000 en-US hourly 1 https://wordpress.org/?v=5.7.11 How a Big Pharma Company Stalled a Potentially Lifesaving Vaccine in Pursuit of Bigger Profits https://www.juancole.com/2023/11/company-potentially-lifesaving.html Sat, 04 Nov 2023 04:06:31 +0000 https://www.juancole.com/?p=215151 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 https://www.juancole.com/2023/10/intelligently-medicare-consumers.html Sun, 15 Oct 2023 04:04:34 +0000 https://www.juancole.com/?p=214856 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.

]]>
Post-Roe Abortion Bans force Pregnant People with Life-Threatening Complications to Travel Long Distances https://www.juancole.com/2023/05/threatening-complications-distances.html Wed, 10 May 2023 04:26:53 +0000 https://www.juancole.com/?p=211888

Idaho woman traveled to Oregon to terminate pregnancy with fatal fetal anomalies   

An ultrasound image of Jennifer Adkins’ 12-week-old fetus that was diagnosed with Turner syndrome and hydrops fetalis, two defects that are often fatal to the fetus and dangerous for the pregnant person to carry. Adkins had to seek an abortion in Oregon because, like 13 other states across the country, Idaho has a near-total ban on abortions without exceptions provided to preserve the health of the pregnant person. (Courtesy of Jennifer Adkins)

 
( Iowa Capital Dispatch ) – Jennifer Adkins’ first pregnancy was near-perfect.

 She sailed through her appointments and screenings with no complications, ticking every box and making lists of all the right questions to ask her medical professionals. By the time her unmedicated labor was over and the nurses placed her newborn son on her chest, Adkins felt like a superhero.

 So when she discovered she was pregnant again the day after Valentine’s Day, she was ready for another home run. The baby would be due on Halloween, and she and her husband affectionately referred to it as “Baby Spooky.” Maybe they’d find out the sex beforehand, maybe it would be a surprise. They hadn’t decided yet.  

 On April 21, Adkins saw her doctor for a routine screening by ultrasound to measure the collection of fluid behind the fetus’ neck. And even without a medical degree, she could tell by the picture on the ultrasound that something was wrong.

Sitting in the genetic counselor’s office that afternoon, Adkins learned her 12-week-old developing fetus likely had Turner syndrome, a chromosomal abnormality that ends in miscarriage in 99% of cases. Turner’s occurs when one of two X-chromosomes for a female is deleted, often from all cells. The few babies that do survive still have deletions in some cells that cause significant heart defects, fertility issues, kidney abnormalities and a range of other disabilities.

 The normal measurement is less than 3 millimeters, according to Dr. Maria Palmquist, a maternal-fetal medicine specialist at Saint Alphonsus Regional Medical Center in Boise, Idaho. Palmquist said Adkins’ fluid measured at 11.7 millimeters, with additional fluid accumulating under the skin and around the body of the fetus, known as edema. The combination of increased fluid and skin edema is a condition known as hydrops fetalis, a severe form of swelling that is often fatal.

“The doctor said basically, lightning struck this pregnancy, there’s nothing you can do,” Adkins said. “This just happens in 1% of all pregnancies.”

Following the U.S. Supreme Court’s decision in June 2022 to overturn Roe v. Wade and allow states to regulate abortion access, 14 states have enacted near-total or total abortion bans, while others continue to pass abortion ban laws that become tied up in state and federal court. The patchwork laws create reproductive health care deserts that can force pregnant people to travel as far as an eight-hour drive or a flight across the country.

That can bring great financial and often emotional costs, even if the termination of the pregnancy would prevent severe or potentially fatal health effects.

There are no abortion bans yet that criminalize the pregnant person. Instead, criminal penalties are focused on medical providers or others who help someone obtain an abortion. The charges in most states are felonies, with punishment ranging between two years and life in prison, and physicians face suspension or revocation of their medical licenses. 

Because Adkins lives in a state with an abortion ban, she faced one of two options: Either continue carrying the pregnancy knowing it would almost certainly end in miscarriage or stillbirth and jeopardize her own health in the process — or make a trip out of state for termination.

 

‘Do we try? But for what purpose?’

 

Idaho has a near-total ban on abortions that applies to any stage of pregnancy, with exceptions for cases of rape and incest with an accompanying police report during the first trimester or to save a patient’s life. Health care providers who violate the statute put their medical licenses at risk and face between two and five years in prison, along with civil penalties of $20,000 against individual providers if family members decide to sue.

Since Roe fell, residents in states with bans like Texas have to travel much farther to obtain an abortion. The Texas Observer reported the average number of miles a resident must travel increased from 44 miles to 497 miles. Texans often go to New Mexico, where some abortion providers fled and opened new clinics. Washington abortion providers have reported seeing patients from seven states around the country within one day.  

In the Southeast, where nearly every state has a highly restrictive ban, states such as Louisiana and Mississippi are hours away from the nearest abortion clinic. For many, the closest state is Florida, and the outcome of a Florida Supreme Court case over a law banning abortion at 15 weeks could determine whether a six-week ban signed in April by Republican Gov. Ron DeSantis will go into effect. If it does, the distance to access abortion for many residents in that region of the country will become much greater.

A study released in April conducted by international reproductive health care journal Contraception found that women who were forced to travel for abortion care described it as emotionally burdensome, saying it caused distress, anxiety and shame. 

“Because they had to travel, they were compelled to disclose their abortion to others and obtain care in an unfamiliar place and away from usual networks of support, which engendered emotional costs,” the study said. “Additionally, travel induced feelings of shame and exclusion because it stemmed from a law-based denial of in-state abortion care, which some experienced as marking them as deviant or abnormal.”


Photo by Devon Divine on Unsplash

Adkins said seeking care in another state made her feel like a criminal and a medical refugee of sorts, and she worried about what others would think of her for terminating her pregnancy. Another physician she saw for a separate issue wanted to keep the pregnancy out of her record, entirely as a precaution.

“They make this out to be like people that seek abortions are horrible, horrible people, and murderers, and all this stuff, and I’m like, that could not be further from the truth. This is a baby that we love with all of our heart and soul. And because we are loving parents, we are choosing this route, not only to be loving parents to that baby, but also to our living son, because I have to think about what’s in my best interest so that I can still be here and be healthy enough to take care of my son who needs me,” Adkins said.  

Idaho physicians have also stopped making referrals for patients in situations similar to Adkins’ in the wake of a legal opinion sent by Attorney General Raúl Labrador at the end of March. Until there is a decision in a lawsuit over the opinion, physicians and Planned Parenthood facilities in Idaho have said they will not make any referrals for abortion-related care outside of the state.

Adkins said if she wasn’t as informed about the state’s laws, she wouldn’t have understood what doctors were saying about her options.

“They said that I was welcome to leave the state on my own accord and seek health care outside of the state,” Adkins said. “It was a very odd experience because we were talking basically in code. … I understood the nuance, and I understood what they were implying, but it was a very surreal experience.”

A brief filed in the lawsuit on behalf of a health system in Idaho detailed a scenario nearly identical to Adkins’ on the same day she was diagnosed at a different facility. Like the case outlined in the brief, Adkins would be at risk for developing a condition called mirror syndrome, which causes the pregnant person to experience similar symptoms to that of the fetus. Dr. Palmquist told States Newsroom that it can lead to preeclampsia, a life-threatening state of high blood pressure in pregnant people that can cause seizures and organ damage.

 Knowing all of this, Adkins decided it was in the best interests of her family, including the nearly 2-year-old son she already had and the daughter she would never get to hold, to terminate the pregnancy.

 She hoped to miscarry within the following week so they wouldn’t have to make the emotional three-day trip. So she scheduled another ultrasound, but there was still a heartbeat. She was desperate to fix it — desperate to stop being a walking coffin for a dying dream. 

 “It’s hard knowing that my body and the fetus are trying so hard to hang on,” Adkins said. “And we had to make a really hard decision. Do we try? But for what purpose? There’s no sense in bringing a child into this world that’s not going to survive anyway or have severe complications. And it’s not fair to any of us.”

Maternal-fetal medicine doctors continue fleeing to other states

Idaho legislators made minor changes to the state’s abortion law toward the end of the legislative session in March to clarify that certain instances where the fetus has already died or ectopic or molar pregnancies would not fall under Idaho’s abortion ban, declining to proceed with an earlier iteration of the bill that included a clause exempting medical professionals from criminal liability. In that version, providers had to determine if an abortion was necessary “to prevent the death of the pregnant woman or to treat a physical condition of the woman that, if left untreated, would be life-threatening.” 

 Dr. John Werdel, an obstetrician-gynecologist at St. Luke’s in Boise, said he wasn’t sure if Adkins’ situation would have qualified under the health language in the original bill. She likely would have had to wait until the health effects were more severe, he said.

Many reproductive care physicians in states where abortions are banned have left to practice in other states in recent months, including one maternal-fetal medicine doctor in Tennessee who moved to Colorado in January after starting what she described as a dream job in Tennessee in August. 

 Idaho’s abortion laws caused Palmquist, one of three maternal-fetal medicine physicians at Saint Alphonsus, to take a job at Desert Perinatal in Las Vegas, Nevada. She is one of several specialists in the state to leave over the new laws since January. She was packing her belongings on Thursday, hoping the laws change soon and allow her to return. 

 “Since June, it’s just become so complicated to take care of pregnancy complications. Things before that were so straightforward now make us take an extra four to six hours and multiple meetings,” Palmquist said. “Making sure we’re protected by EMTALA, making sure this is an emergency medical condition. Does the hospital administration agree, does legal counsel agree? All of that.”

A recent study published in the Journal of General Internal Medicine found from a survey of more than 2,000 current and future physicians on social media that 82% preferred to work or train in states with preserved abortion access. More than 76% of respondents said they wouldn’t even apply to states with legal consequences for providing abortion care.

“At least monthly, we are faced with caring for moms with significant complications, and there’s no chance of a viable outcome. But with Idaho’s restrictions, there’s a lot of anxiety about essentially practicing the standard of care,” Palmquist said. “A year ago, it would’ve been just so straightforward, and now there’s all this caution and hesitancy.”

 The mounting costs

Adkins and her husband left their son with grandparents to make the trip to Oregon on a Thursday for her appointment the following morning. The Northwest Abortion Access Fund and Cascade Abortion Support Collective helped pay for a hotel room, a rental car and the surgical procedure, which was $850 by itself without insurance. Friends and family sent her Venmo donations for other expenses.

“I just started calling organizations because I was like, I don’t know what to do. And they said, ‘We’re here to help you.’ And it was so relieving but also absolutely heartbreaking to hear multiple times from multiple people, ‘You are not the only one. We get stories like yours all the time, every day,” Adkins said. “Every day.”

The Planned Parenthood clinic was supportive and professional, she said, and they honored her request to be deeply sedated for the procedure. When she told them why she needed to terminate the pregnancy, they offered to take ultrasound photos beforehand.

 “Everybody was like, ‘Oh my god, I’m so sorry you had to come all this way for this,’” Adkins said. “And they’re right. I shouldn’t have had to leave my son and travel hundreds of miles to do this.”

Since the procedure was performed in another state and at a Planned Parenthood clinic, Adkins had to ask the doctor to collect the remains of the fetus, the pregnancy tissue and the placenta and package them properly to be sent to a genetic testing clinic. She was also faced with rushing the package of remains to FedEx herself that same day.

 While she doesn’t regret the decision, Adkins said it was a painful experience that could have been much easier if she had been able to access care in her own state.

“I deserve better, and so does everybody else,” she said. “We can’t stop things from happening in pregnancy. That’s why we have modern medicine, to help guide us and protect the things we do have control over. So if we can’t stop those horrible things from happening … why make it even worse by making the worst experience someone has to go through — learning that they will not give birth to a happy, healthy baby — why do we make that even worse by saying, ‘We don’t value your life enough to try to save it or prevent something bad from happening to you in the meantime?’”

 
 
 
Kelcie Moseley-Morris
Kelcie Moseley-Morris

Kelcie Moseley-Morris is a reporter for the Idaho Capital Sun. She is an award-winning journalist who has covered many topics across Idaho since 2011. She has a bachelor’s degree in journalism from the University of Idaho and a master’s degree in public administration from Boise State University. Moseley-Morris started her journalism career at the Moscow-Pullman Daily News, followed by the Lewiston Tribune and the Idaho Press.

 

Via Iowa Capital Dispatch

Published under Creative Commons license CC BY-NC-ND 4.0.

]]>
No Amount of Fraud Deters Government Agencies When It Comes to Privatizing Medicare https://www.juancole.com/2023/02/government-agencies-privatizing.html Fri, 03 Feb 2023 05:04:44 +0000 https://www.juancole.com/?p=209840 By Ana Malinow and Kay Tillow | –

( Commondreams.org) – On January 17, the Center for Medicare and Medicaid Innovation (CMMI) announced 48 new model participants in a controversial pilot program called Accountable Care Organization: Realizing Equity, Access, and Community Health, better known as ACO REACH. CMMI, created by the Affordable Care Act, is supposed to test alternative payment models for Traditional Medicare to lower costs and improve, or at least not worsen, the care of 30 million seniors and people with disabilities.

Sadly, getting the fraudsters out of ACO REACH will not improve a program designed to enrich corporations and harm patients. This entire apple cart needs to be overturned.

The program, launched in the waning days of the Trump Administration as Direct Contracting, was greenlighted by the Biden Administration in 2021 and renamed ACO REACH in 2022. The model, which started with 53 contracting entities under Trump has grown to 132 participants with 131,772 health care practitioners and organizations providing care to over 2 million beneficiaries on Traditional Medicare under President Biden. Startling research found many of the ACO REACH participants have a history of Medicare fraud. Nevertheless, Medicare continues to sign contracts with them.

ACO REACH is a program designed to privatize what is left of public Medicare. Half of Medicare has been privatized through Medicare Advantage plans, which receive up-front “capitated” payments for Medicare beneficiaries from the Center for Medicare and Medicaid Services (CMS) and have the power to decide whether and how much of those Medicare dollars to spend on the beneficiaries who signed up for their plan. The Affordable Care Act allows Medicare Advantage plans to keep up to 15% of these Medicare dollars for administrative fees and profit (although they have clever ways to get around this restriction). To make these profits, Medicare Advantage plans create narrow networks for their beneficiaries, deny and delay care, and get overpaid by CMS, cashing in on billions of Medicare dollars.

What earthly reason would there be to exclude companies from ACO REACH but allow them to continue their plunder in Medicaid, Medicare Advantage, and subsidized on the ACA Exchanges?

ACO REACH uses similar tactics to those found in Medicare Advantage to profit from Medicare by overcharging Medicare, financially incentivizing providers to control healthcare costs for beneficiaries, and increasing the number of beneficiaries in their plans. But while some seniors “choose” to participate in Medicare Advantage, seniors and people with disabilities are auto-enrolled into an ACO REACH through their primary care physicians (PCPs). Thus, it is physicians and physician practices which are being lured into or forced to join the ACO REACH (Many physician practices are being swooped up by private equity or created whole-cloth). Physician practices, or their controllers, are enticed by the “shared savings” they will collect if they save money on their patients, shredding the trust between doctors and patients.

Once the PCP joins, their patients are automatically enrolled into the ACO REACH, without their informed knowledge or consent. While Medicare Advantage plans are allowed to keep 15% of the capitated fee for profits and administration, ACO REACH organizations, which include private equity and venture capital firms, as well as Medicare Advantage plans and insurance companies, can keep up to 40% of the capitated, up-front fees from Medicare as profit, guaranteeing themselves excessive payouts as they play out the eventual demise of the Medicare Trust Fund.

We were assured by CMMI that the new vetting process for all applicants was supposed to “ensure participants’ interests align with CMS’s vision.” They promised to protect beneficiaries and the model with “more participant vetting, monitoring, and greater transparency.” They pledged to employ “increased up-front screening… monitoring… and stronger protections against inappropriate coding and risk score growth.”

Yet, in a letter sent by Senator Elizabeth Warren (D-Mass.) and Congresswoman Pramila Jayapal (D-Wash.) to CMS Administrator Chiquita Brooks-LaSure in December 2022, they called on CMS to investigate nine organizations that had signed contracts to become an ACO REACH: Centene, Sutter Health, Clover Health, Adventist Health System/AdventHealth, Humana, Vively Health, Cigna/CareAllies, Bright Health/NeueHealth, and Nivano Physicians. The letter pointed out that all these organizations have been accused, investigated, settled claims, and/or sanctioned by governmental agencies for Medicare fraud and abuse.

Recently, CMMI Director Liz Fowler—a poster child for the revolving door in D.C.—was a guest speaker at the ACO REACH educational forum held by the California Public Employees Retirement System, the largest public pension fund in the country. When asked about private equity in ACO REACH, Fowler responded, “My personal opinion, you can’t say that private equity is inherently bad or good, but the way we viewed it, we want to make sure that the organizations in our program are in it for the right reasons.” And the right reasons for Fowler might very well be profit, given that six of the nine organizations identified by Warren and Jayapal are publicly traded in the stock market.

The entire apple cart needs to be overturned and replaced with a national, non-profit, single-payer healthcare system that covers everyone from birth to death…

Given Director Fowler’s personal opinion of private equity firms, it comes as no surprise that most of the Medicare fraudsters—including: Cigna/CareAllies, accused by the Justice Department of using a primary care program to defraud Medicare; Bright Health/NeueHealth, fined $1 million by the Colorado Division of Insurance for complaints from consumers and providers; Clover Health, which failed to let investors know it was under investigation by the DOJ as it was going public and even fined by CMS in 2016 for engaging in marketing activities that misled their beneficiaries; AdventHealth (formerly Adventist Health System), that paid $115 million to settle allegations of improper financial arrangements with referring physicians and for miscoding claims; Humana that overcharged Medicare by $200 million according to a federal audit; and Nivano Physicians, previously under a corrective action plan with the Department of Managed Health Care for lacking financial solvency—all made it through and became approved as ACO REACH.

Only three of the original nine identified in the Warren-Jayapal letter failed to get a contract with CMS: Centene, Sutter Health, and Vively Health. Fowler refuses to say whether these corporations pulled out on their own, or were rejected.

The Centene Corporation, with Medicaid contracts in 29 states, settled potential fraud claims in a dozen states to resolve Medicaid fraud claims for an estimated $1.25 billion. Sutter Health, a major California-based healthcare system, agreed to pay $90 million to settle allegations of knowingly submitting inaccurate information about the health of beneficiaries in the Sutter Medicare Advantage plans. DaVita HealthCare Partners Inc., one of the largest for-profit kidney dialysis providers and parent company of Vively Health, paid $450 million in 2015 to settle a whistleblower lawsuit, which accused DaVita of “intentionally wasting medications in order to overbill Medicare.”

What earthly reason would there be to exclude companies from ACO REACH but allow them to continue their plunder in Medicaid, Medicare Advantage, and subsidized on the ACA Exchanges?

The hypocrisy of CMS and CMMI is on full display. As is their collusion with the profiteers. Sadly, getting the fraudsters out of ACO REACH will not improve a program designed to enrich corporations and harm patients. The entire apple cart needs to be overturned and replaced with a national, non-profit, single-payer healthcare system that covers everyone from birth to death with all necessary medical services including long-term care, hearing, vision, dental, and prescription drugs. Only then can we stop worrying about the fraudsters.

Via Commondreams.org)

Licensed under Creative Commons ( CC BY-NC-ND 3.0). Feel free to republish and share widely.

]]>
Big Pharma spent more on Stock Buybacks and Dividends than on Research and Development even during COVID https://www.juancole.com/2023/01/buybacks-dividends-development.html Sun, 08 Jan 2023 05:02:07 +0000 https://www.juancole.com/?p=209315 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.

]]>
On Their 57th Anniversary, Medicare and Medicaid Remain Under Threat https://www.juancole.com/2022/07/anniversary-medicare-medicaid.html Fri, 29 Jul 2022 04:02:29 +0000 https://www.juancole.com/?p=206054 By Max Richter | –

( Commondreams.org ) –

You may wonder why former President Harry Truman is sitting close by while President Lyndon B. Johnson signs Medicare and Medicaid into law in the iconic 1965 photograph. Or why Harry Truman received the first-ever Medicare card. The reason is that Truman first proposed a Medicare-like system in 1945—but it took two decades, another Democratic president, and a Democratic supermajority in Congress to overcome opposition from political conservatives and the health industry. As we celebrate 57 years of Medicare and Medicaid successes on July 30th, it is vexing that these two vital programs continue to be in the cross-hairs of GOP opponents.

Democratic proposals to protect and expand Medicare and Medicaid have received almost ZERO support from the GOP, while proposals to privatize and cut benefits have originated with Republicans.

Today, elderly and low-income persons can truly say that—thanks to these two landmark programs—they are free from fear of not having health insurance.

Before Medicare was enacted, 56% of American seniors had no health insurance. Retirees were no longer covered by their employers. Private insurers considered them a “particularly bad risk” and rejected them as customers or charged premiums almost no one could afford. The uninsured elderly had to rely on family, friends, or charity to cover medical bills. More than one in four seniors went without medical care altogether.

Low-income Americans suffered a similar plight prior to the enactment of Medicaid. The poor had “limited access to healthcare, relying heavily on charity care and public hospitals,” according to Modern Healthcare. While those deemed the “deserving poor” might receive care through community and religious organizations, “able-bodied (low income) people needing healthcare were generally out of luck.”

A crowning achievement of LBJ’s Great Society, the enactment of Medicare and Medicaid affirmed that the federal government had a legitimate—and moral—obligation to ensure that the most vulnerable among us could obtain health coverage like everyone else. A truly Great Society would refuse to leave the poor and the old out in the cold when they needed care.

“No longer will older Americans be denied the healing miracle of modern medicine,” said President Johnson upon signing Medicare and Medicaid into law. “No longer will illness crush and destroy the savings that they have so carefully put away over a lifetime so that they might enjoy dignity in their later years.”

Unfortunately, Medicare and Medicaid faced opposition from a vast majority of Republican members of Congress from the beginning. None other than Ronald Reagan warned in a 1965 radio address that “one of the traditional methods of imposing… socialism on a people has been by way of medicine.” Reagan promised that if Medicare and Medicaid were enacted, “One of these days you and I are going to spend our sunset years telling our children… what it once was like in America when men were free.”

In fact, the opposite occurred. Today, elderly and low-income persons can truly say that—thanks to these two landmark programs—they are free from fear of not having health insurance. Neither program is perfect. Federal programs of this scope must continually be updated to reflect present realities. However, public support for Medicare and Medicaid is unequivocal. Here are some of the things that our volunteers and supporters have told us over the past few years:

“I had cancer. Without Medicare, I would have been dead.”

“As someone with several chronic conditions, I have a great peace of mind because Medicare and Medicare supplemental insurance pay my health care bills.”

“My son is a special-needs child. Medicaid was our saving grace in terms of having medical insurance.”

“My mother had an aneurysm. If she didn’t have Medicaid, she would not have been able to recover at home quickly and comfortably.”

Some 76 million Americans are covered by Medicaid, which not only provides health insurance for low-income people, but pays more than 60% of the cost of long-term care services and supports for seniors. Roughly 64 million Americans—most of them over 65 years of age—are enrolled in Medicare. That’s about 140 million examples of how Americans with chronic and acute health conditions—who otherwise might not be able to obtain private insurance—can get the health care they need thanks to the vision of President Lyndon Johnson and the U.S. Congress in 1965.

We all should applaud these achievements and the resulting health improvements and increased longevity of our oldest citizens—right? Instead of simply being able to celebrate this 57th anniversary, though, seniors’ advocates are having to fight to preserve these life-saving, poverty prevention programs. That’s because elite, well-funded, and powerful conservative interests who oppose Medicare and Medicaid continue their efforts to undermine both. During the Trump administration, Republicans renewed their calls to “block grant” Medicaid, which would have forced the states to slash benefits and trim their rolls of insured citizens. Democrats have been able to stop those efforts for now.

As for Medicare, instead of voicing outright opposition, adversaries now pay lip service to preserving Medicare. (President Trump famously promised “not to touch” Medicare but proposed to cut the program by billions of dollars in successive White House budgets.) Today, many conservatives focus on privatizing Medicare. The privatization effort got a running start through the Medicare Advantage (MA) program, which was created by the Medicare Modernization Act of 2003. (It’s the same law that forbade Medicare from negotiating prescription drug prices with Big Pharma.)

Medicare Advantage was supposed to save taxpayers money by providing more cost-effective care than the traditional Medicare program. Instead, MA insurers have benefitted handsomely from federal overpayments and fraudulent diagnostic “upcoding.” As multiple news reports and investigations have confirmed, Medicare Advantage insurers overbilled the government to the tune of $34 billion dollars in 2018-2019 alone. They’ve also increased profits by denying medically warranted pre-authorization requests and refusing to reimburse providers for valid claims.

Likewise, Part D prescription drug prices have continued to rise dramatically, hurting seniors on fixed incomes while Big Pharma profits climb ever higher. In 2021, major pharmaceutical CEOs raked in over $292.6 million while 2.3 million seniors were unable to afford at least one doctor-prescribed medication. How ironic that the fiscal conservatives who blast Medicare spending on seniors are at the same time shamefully silent while MA insurers and drug makers reap record profits from the program.

The reason you will likely only hear Democrats marking the anniversary of Medicare and Medicaid is that these programs began with them; they have endured because of them; and the future of both programs depends on electing members of Congress who will strive to continue them.

Meanwhile, private interests recently have gained a bigger foothold in the publicly-run, traditional Medicare program. When Accountable Care Organizations (ACOs) were established through the Affordable Care Act they were intended to improve coordination of care of chronic conditions by having Medicare contract directly with providers to improve quality of care. Over time, for-profit investor driven groups have insinuated themselves into the program. A new initiative begun during the Trump era (later rebranded as ACO/REACH by the Biden administration), provides substantially increased financial incentives for reducing costs. Seniors’ advocates are rightfully concerned that this will draw more private entities into traditional Medicare and could eventually lead to additional problems akin to what’s been taking place in the Medicare Advantage program.

For years, Democrats have been the only force behind expansion plans for traditional Medicare to cover basic hearing, vision, and dental care. President Biden included these in his initial Build Back Better plan, but vision and dental care were later dropped in Congressional negotiations. Hearing care coverage and expanded Medicaid home and community-based services also perished after Senator Joe Manchin withdrew his support. In an effort to salvage some of their expansion efforts, Congressional Democrats recently sent a letter to the Centers for Medicaid and Medicare Services (CMS) urging that the program broaden the rules for “medically necessary” dental care to cover seniors with various health conditions affecting their teeth.

As for Medicaid, the Biden administration continues to encourage states to expand their programs under the Affordable Care Act. About a dozen red states still refuse to expand their Medicaid programs, denying coverage to millions of uninsured, low-income residents—even though the federal government offers the states extra funding for expansion.

Let’s be very clear, Democratic proposals to protect and expand Medicare and Medicaid have received almost ZERO support from the GOP, while proposals to privatize and cut benefits have originated with Republicans. The reason you will likely only hear Democrats marking the anniversary of Medicare and Medicaid is that these programs began with them; they have endured because of them; and the future of both programs depends on electing members of Congress who will strive to continue them. Seniors who value these crucial, life-saving programs should bear this in mind when casting their votes in November. As we mark this 57th anniversary, let’s re-commit to protecting the two greatest pillars of the Great Society.

Max Richtman is president and CEO of the National Committee to Preserve Social Security and Medicare. He is former staff director at the United States Senate Special Committee on Aging.

Licensed under Creative Commons (CC BY-NC-ND 3.0).

Via Commondreams.org

Featured image: via Pixabay.

]]>
Abortion: The story of Suffering and Death behind Ireland’s Ban and subsequent Legalization https://www.juancole.com/2022/06/suffering-subsequent-legalization.html Tue, 28 Jun 2022 04:02:54 +0000 https://www.juancole.com/?p=205462 By Gretchen E. Ely, University of Tennessee | –

Now that the U.S. Supreme Court has overturned Roe v. Wade, the 1973 decision that legalized abortion in the U.S., the nation may find itself on a path similar to that trodden by the Irish people from 1983 to 2018.

Abortion was first prohibited in Ireland through what was called the Offenses Against the Person Act of 1861. That law became part of Irish law when Ireland gained independence from the U.K. in 1922. In the early 1980s, some anti-abortion Catholic activists noticed the liberalization of abortion laws in other Western democracies and worried the same might happen in Ireland.

Various Catholic organizations, including the Irish Catholic Doctors’ Guild, St. Joseph’s Young Priests Society and the St. Thomas More Society, combined to form the Pro Life Amendment Campaign. They began promoting the idea of making Ireland a model anti-abortion nation by enshrining an abortion ban not only in law but in the nation’s constitution.

As a result of that effort, a constitutional referendum passed in 1983, ending a bitter campaign where only 54% of eligible voters cast a ballot. Ireland’s eighth constitutional amendment “acknowledges the right to life of the unborn and [gave] due regard to the equal right to life of the mother.”

This religiously motivated anti-abortion measure is similar to religiously oriented anti-abortion laws already on the books in some U.S. states, including Texas, which has a ban after six weeks of pregnancy, and Kentucky, which limits private health insurance coverage of abortion.

What happened over the 35 years after the referendum passed in Ireland was a battle to legalize abortion. It included several court cases, proposed constitutional amendments and intense advocacy, ending in 2018 with another referendum, re-amending the Irish constitution to legalize abortion up to 12 weeks gestation.

Real-life consequences

Even before 1983, people who lived in Ireland who wanted a legal abortion were already traveling to England on what was known as the “abortion trail”, as abortion was also criminalized in Northern Ireland. In the wake of the Eighth Amendment, a 1986 Irish court ruling declared that even abortion counseling was prohibited.

A key test of the abortion law came in 1992. A 14-year-old rape victim, who became pregnant, told a court she was contemplating suicide because of being forced to carry her rapist’s baby. The judge ruled that the threat to her life was not so great as to justify granting permission for an abortion. That ruling barred her from leaving Ireland for nine months, effectively forcing her to carry the pregnancy to term.

On appeal, a higher court ruled that the young woman’s suicidal thoughts were in fact enough of a life threat to justify a legal termination. But before she could have an abortion, she miscarried.

The case prompted attempts to pass three more amendments to Ireland’s constitution. One, declaring that suicidal intentions were not grounds for an abortion, failed. The other two passed, allowing Irish people to travel to get an abortion, and allowing information to be distributed about legal abortion in other countries.

Emergency treatment

Even with these adjustments, the Eighth Amendment sometimes restricted the ability of medical professionals to offer patients life-saving care during a pregnancy-related emergency.

In 2012, Savita Halappanavar, age 31 and 17 weeks pregnant, went to a hospital in Galway, Ireland. Doctors there determined that she was having a miscarriage. However, because the fetus still had a detectable heartbeat, it was protected by the Eighth Amendment. Doctors could not intervene – in legal terms, ending its life – even to save the mother. So she was admitted to the hospital for pain management while awaiting the miscarriage to progress naturally.

Over the course of three days, as her pain increased and signs of infection grew, she and her husband pleaded with hospital officials to terminate the pregnancy because of the health risk. The request was denied because the fetus still had a heartbeat.

By the time the fetal heartbeat could no longer be detected, Halappanavar had developed a massive infection in her uterus, which spread to her blood. After suffering organ failure and four days in intensive care, she died.

This was likely not the only time someone had suffered, or even died, as a result of being denied abortion in Ireland. But the publicity surrounding the case prompted a new wave of activism aimed at repealing the Eighth Amendment. In 2013, the Protection of Life During Pregnancy Act was signed into law, which did not fully repeal the Eighth Amendment but legalized abortions that would protect the mother’s life.

It is estimated that about 170,000 people traveled from Ireland to seek a legal abortion between 1980 and 2018.

In 2018, a referendum repealing the Eighth Amendment passed overwhelmingly by a margin of 66% to 34%. As a result of the repeal, legal abortions are now allowed during the first trimester, with costs covered by the public health service.

A similar situation in the US

As a social work professor who researches reproductive health care, I see many parallels between what happened in Ireland between 1983 and 2018 and the present U.S. situation.

People in the U.S. are already traveling long distances, often to other states, in a manner similar to the Irish abortion trail.

In both the U.S. and Ireland, the people who need help paying for abortions are mostly single people in their 20s who already have an average of two children, according to research I conducted with some abortion funds, which are charitable organizations that help people cover often-unaffordable abortion expenses.

In contrast to the United States, Ireland is moving away from political control over private life. Now that Roe has been reversed and abortion may be illegal in much of the U.S., pregnant people could face forced pregnancy, suffering and even death – as was the case in Ireland prior to 2018.

This is an updated version of an article originally published May 16, 2022.The Conversation

Gretchen E. Ely, Professor of Social Work and Ph.D. Program Director, University of Tennessee

This article is republished from The Conversation under a Creative Commons license. Read the original article.

]]>
160 mn. Fell into Poverty during Pandemic as 10 Wealthiest Men doubled Wealth to $1.5 Trillion (Oxfam) https://www.juancole.com/2022/01/pandemic-wealthiest-trillion.html Wed, 19 Jan 2022 06:09:09 +0000 https://www.juancole.com/?p=202502 Ann Arbor (Informed Comment) – The charitable organization Oxfam reports this week that 160 million people fell into poverty during the past two years of pandemic, while the richest 10 men in the world doubled their wealth from $700 billion to $1.5 trillion. The authors of the report argued that this is not simply a matter of wealth inequality, but that the extreme wealth of the few is actually killing the poor. The United Nations defines poverty as living on less than about $2 a day and suffering from “hunger and malnutrition, limited access to education and other basic services, social discrimination and exclusion, as well as the lack of participation in decision-making.”

Here are some of Oxfam’s findings by the numbers:

1. The world’s top 10 wealthiest men own more than the poorest 3.1 billion persons.

2. The investment portfolios of the globe’s 2,755 billionaires grew more during the pandemic than they had during the previous 14 years — and those 14 years hadn’t been too shabby for them either.

3. They say that if you add up all the wealth held by all the women and girls in Latin America + the Caribbean and Africa, some 1 billion people, it comes to less than the wealth holdings of the richest 252 men.

4. Each day, they write, inequality is a contributing factor in the deaths of at least 21,300 people, or four deaths every second that might not occur if wealth were more equally distributed.

5. If they had the same life expectancy as whites, 3.4 million more African-Americans would be alive today. The disparity has worsened since the advent of Sars-CoV-2.

6. The richest 20 billionaires are responsible for 8,000 times more carbon dioxide emissions than the poorest billion people on earth.

7. Every 26 hours since the novel coronavirus arose, a new billionaire has been minted.

8. Of the 17 million estimated COVID-19 deaths globally, the biggest death toll since World War II, the poor have borne the brunt of the disease. During the second, delta variant wave of the coronavirus, people of Bangladeshi heritage in England died at a rate 5 times higher than English whites.

9. International Monetary Fund-backed austerity measures for 73 countries have exacerbated inequality. Women had been an average of 99 years behind, but are now as much as 135 years behind on gender parity.

10. The authors say, “This is the biggest annual increase in billionaire wealth since records began. It is taking place on every continent. It is enabled by skyrocketing stock market prices,28 a boom in unregulated entities, a surge in monopoly power,30 and privatization,31 alongside the erosion of individual corporate tax rates and regulations,32 and workers’ rights and wages — all aided by the weaponization of racism.” Just as alarming, they say, is the way in which the greed of the pharmaceutical billionaires has created a vaccine Apartheid, with citizens of the wealthier countries much more likely to be vaccinated. The horrible thing is that this means new variants can incubate in the poor global South, potentially prolonging the pandemic and its severe economic impact.

]]>
Opioid Crisis: Purdue Pharma/ Sackler Family Fails in End Run around Justice https://www.juancole.com/2021/12/opioid-sackler-justice.html Sat, 18 Dec 2021 05:02:56 +0000 https://www.juancole.com/?p=201850 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

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.

]]>