Author Topic: The Politics of Health Care  (Read 694533 times)

Crafty_Dog

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ET: New Transplant Methods Raise Difficult Questions
« Reply #1850 on: November 14, 2022, 11:04:59 AM »
Strange New Organ Transplant Methods Raise Urgent Questions
New techniques use organs from partially resuscitated people and look toward genetically modified pigs
FEATUREDBIOTECHNOLOGY
Martha Rosenberg
Martha Rosenberg
Nov 12 2022

If you or a loved one has needed an organ transplant, you know the problem firsthand: There are not enough organs for those who need them and there is a long waiting period.

That desperate need, and potential profits, have fueled a Frankenstein-like effort to find or create organs to give recipients a longer lease on life.

The need for organs can be a matter of life or death. In the United States, more than 105,000 people sit on the national waiting list, and every nine minutes, a new name is added. Seventeen people die every day while waiting for an organ transplant in the United States, according to the government’s organ donor website.

The most common transplant operations are for hearts, kidneys, livers, pancreases, lungs, bone and bone marrow, skin, and intestines; some such transplants come from living donors, but most are obtained after a donor is deceased.

Different organs remain viable for different amounts of time after the patient has died, or after the organ has been taken from the deceased.

According to Donor Alliance, the liver can remain viable for transplant for up to 12 hours, and kidneys for up to 36 hours. But for other organs, such as the heart or lungs, that window is much shorter, in the range of 4 to 6 hours.

With so few organs available for so many in need, there’s tremendous pressure on scientists and industry to push the boundaries of medical ethics with products and procedures that can sound like mad science.

These vanguard developments raise fundamental questions about human life, the commodification of the human body, and the very definition of “human.”

Let’s put aside the obvious horrors of forced organ harvesting from prisoners of conscience in China, including Tibetans, Uyghurs, and, most notably, Falun Gong practitioners, “the primary victims of this cruel practice,” according to the U.S. Human Rights Commission.

Everyone can agree that this practice is abhorrent, but there are other new practices that raise more complex questions, including a new practice that some fear is being used to curb the dead donor rule.

That rule requires that a patient be dead, and often for several minutes, before their organs are taken. This ensures organs only come from the deceased.

Reviving the Dead—Partially
Doctors are using a relatively new procedure called NRP-cDCD (“normothermic regional perfusion with controlled donation after circulatory death”) to widen the window on organ transplants and make more organs available.

In this procedure, terminal patients are allowed to die and then be partially resurrected. Their blood is circulated with the help of machines that warm it, but the arteries that feed the brain are clamped off and starved.

Writing in the journal Cureus in 2022, pro-NRP researchers say that the method “is an emerging technology, a cost-effective alternative in donation after circulatory death (DCD), and will increase the pool of donors in heart transplantation.”

Among other advantages, NRP “restores heart function” and allows “continuous warm blood perfusion,” the researchers write.

Until now, transplant surgeons wouldn’t remove the organs of patients who are not brain dead, even if they couldn’t survive without life support. The procedure raises questions about what can be done with the body after death and how “death” itself is defined. Other procedures challenge the definition of the human body.

Transplants from Genetically Modified Animals

Scientists are in a race to develop genetically humanized animals for their organs. For example, scientists are currently trying to grow human organs in genetically altered pigs and other animals, and in 2017, the creation of what’s claimed to be the first part-human, part-pig hybrid was announced.

Xenotransplantation—using animal organ donors—is far from new. The first pig-to-human corneal transplant, for example, was performed in 1838, according to the journal EMBO Reports, but xenotransplantation was beset with failures until recently.

With the advent of CRISPR gene editing (clustered, regularly interspaced, short palindromic repeats) and stem cell science, an otherworldly new form of “chimeric” animals boasting human organs has made xenotransplantation viable.

Doctors had all but given up on such procedures after too many experiences like Dr. Keith Reemtsma’s in the 1960s.  Reemtsma, a transplant surgeon at Tulane University, inserted rhesus monkey and chimpanzee kidneys into humans, but the transplants all failed.

“An infant known as Baby Fae received a baboon heart at the Loma Linda University Medical Center in California in 1984 but died of rejection 21 days later,” wrote Dr. Joshua Mezrich, a transplant surgeon writing in The Wall Street Journal.

After more mishaps, transplant doctors stopped work with animal organs altogether, Mezrich wrote, and “only implantation of inert tissue from animals, such as heart valves, continued.”

A major risk with transplantation is the human immune system attacking and rejecting the newly transplanted organ as foreign.

According to the government health site MedlinePlus, “all [organ] recipients have some amount of acute rejection,” and if anti-rejection medicines are not used—risky unto themselves—”the body will almost always launch an immune response and destroy the foreign tissue.”

When transplants come from pigs—a preferred animal donor over primates because of size, breeding time, and public acceptance of their use—their intrinsic protein, alpha-gal, leads to rapid human rejection.

In 2020, the FDA approved a pig without alpha-gal, the first intentional genomic alteration. Some researchers and medical scientists want to use pigs that are genetically altered to prevent rejection of their organs in humans.

Issues With Transplantation Research

As the human body becomes more manipulatable by surgeons and scientists, the extent to which transplant research requires “living” human bodies also increases. This can complicate the mourning process for family members or play on the emotions of the organ recipients themselves.

In one example, earlier this year, scientists at NYU Langone Health in New York City announced the plan to study pig kidney behavior in brain-dead individuals for two to four weeks.

After a pig heart was transplanted into Alva Capuano, who was brain dead, as part of a study at Langone medical center, her husband, Richard Capuano, told The Wall Street Journal that the decision “was monumentally hard on the entire family.”

“Even though we realized she had already died and wasn’t coming back, there is still a respirator on and there is still a heartbeat. Psychologically it plays a game with you,” he said.

Many remember the recent saga of 57-year-old David Bennett, the first human recipient of a pig heart, who died weeks after his transplant, apparently from porcine cytomegalovirus (though human herpesvirus 6, which may cross-react with cytomegalovirus, was also found in Bennett).

According to a study published in The New England Journal of Medicine, the pigs used in recent failed human heart transplants at Langone, were significantly altered.

“The genetic modifications of the donor pig (including its heart) fell into two categories: those that inactivated pig genes and those that introduced human genes. In total, 10 different modifications were introduced, most to prevent graft rejection by the human immune system,” noted the journal.

The pig heart recipient, Bennett, had a criminal history and was denied a human heart because he was known to not follow medical guidance, raising other transplantation questions.

Scientific and Ethical Experts Weigh In
While many applaud scientific breakthroughs that allow more organs for human transplants (and these developments can certainly be lucrative), others question the direction in which we are going. In a 2021 statement, the American College of Physicians (ACP) raised serious concerns about NRP-cDCD.

The procedure, it said “is more accurately described as organ retrieval after cardiopulmonary arrest and the induction of brain death. It raises significant ethical concerns and questions regarding the dead donor rule, fundamental ethical obligations of respect, beneficence, and justice, and the imperative to never use one individual merely as a means to serve the ends of another, no matter how noble or good those ends may be.”

ACP is the largest medical-specialty society in the world, with 160,000 members internationally.

‘Humanized’ Animals
In a 2018 paper in the journal Embo Reports, authors worry that human stem cells transplanted into genetically altered pig embryos “will migrate to the animal’s brain and alter its behavior or cognitive state.” While such a brain presence could propel Alzheimer’s and Parkinson’s disease research, “there is no consensus on accurately assessing what it means to possess a human-like cognitive state,” wrote the researchers.

“Should personhood be defined as the percent of human brain cells expressed in a human-animal chimera…?” ask the researchers.

The U.S. National Institutes of Health has refused to support the transplantation of human-animal chimeras for this reason.

Moreover, could the advanced genetic technology we have today be used on “healthy human embryos to create designer babies for behavioral or cosmetic enhancements?” they asked.

Nita Farahany, a professor of law and philosophy at Duke Law School, agrees about the slippery slope that genetic engineering allows, she said in a recent interview with The Wall Street Journal. Scientists still don’t have a grasp on how insertion of human genes through gene editing affects animals’ cognitive capabilities, so “you’re starting to blur the line essentially between humans and non-human animals,” she says.

Disease Transmission

Research in the magazine Philosophy Now raises another ethical question: The possibility of disease transmission and future pandemics occasioned by transplantation.

“Diseases like HIV, Ebola, Hepatitis B, and, most recently, bird flu, originated in animals,” wrote co-author Laura Purdy in the magazine. “Pigs, where current xeno research is now focused, are thought to have been the vector of the devastating 1918 influenza epidemic.”

Known and unknown viruses are embedded in pigs’ DNA as they are in all mammals, says Purdy, and “currently harmless organisms, like the E. coli that lives in our guts, could pick up new, possibly harmful traits from the micro-organisms that came along for the ride on pig organs.”

Whether extreme NRP-cDCD surgery or the creation of pig-human chimeras, the race to harvest new organs has a dark side, according to experts.

“In some ways, the legal determination of death and medical practice are starting to diverge in ways that raise complex ethical and legal challenges we will increasingly face as a society,” Farahany of Duke University told The Epoch Times.

Beyond the moral issues of giving further intelligence to genetically modified pigs, or the health issues of inserting animal organs into people, there are fundamental questions about how we are commodifying the body and what it will mean for the sanctity of the body for future generations.

In a time when people can be fired or censured for not getting injected with a relatively new and unverified mRNA vaccine, which some describe as a gene therapy, these questions take on particular urgency.

And given that many of these organ failures are driven by preventable lifestyle factors, such as stress, diet, and a lack of natural movement, one has to wonder if we are putting scientific and commercial interests ahead of the human beings they are supposed to serve.

DougMacG

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Re: ET: New Transplant Methods Raise Difficult Questions
« Reply #1851 on: November 14, 2022, 11:16:03 AM »
It seems to me medical ethics used to put some kind of limits on what modern medicine could and should do in the manipulation of God's creation.

Now if you oppose genital removal of a minor you are a transphobe and if you oppose chopping the head off a fully developed fetus in the womb, you are a threat to 'women's rights'.

I don't claim to know where the limits should be but there ought to be some kind of limits on what we do with science and 'medicine' as our capabilities keep expanding.

Crafty_Dog

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WSJ $1M a pop for gene therapies?
« Reply #1852 on: December 26, 2022, 09:38:16 AM »
Drug Prices Reach New High—in the Millions
Several new drugs, most of them gene therapies, promise to cure or treat diseases in one course, but their price tags will test the health-insurance system

The most recent gene therapy approved in the U.S. set a price record: $3.5 million for CSL’s Hemgenix, a treatment for hemophilia B.
PHOTO: DARRIAN TRAYNOR/GETTY IMAGES
By Peter Loftus


Dec. 26, 2022 8:00 am ET

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A new era of expensive drugs has arrived: medicines priced in the millions of dollars a patient.

Since August, U.S. or European health regulators have approved four new products intended as one-time treatments for rare genetic diseases that carry list prices of at least $2 million a patient, including two from Bluebird Bio Inc.

The most recent one approved in the U.S. set a price record: $3.5 million for CSL Ltd.’s Hemgenix, a treatment for the blood disorder hemophilia B.

The price tags mark a new high for medicines, which drugmakers were once reluctant to charge more than six figures for but whose prices have been heading upward. The companies say the cost reflects the drugs’ potential to help patients in a single dose, but paying for it could challenge patients and health insurers.

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“It’s an innovation freight train headed toward an inflexible insurance wall,” said Steven Pearson, president of the Institute for Clinical and Economic Review, a nonprofit drug-pricing watchdog group. “The payers are not in a position to say no because there will be no other alternatives” for patients, he added.

Most of the multimillion-dollar treatments are gene therapies, a groundbreaking type of treatment that involves injecting a functional gene into a person to correct a faulty, disease-causing one.

Bluebird’s Skysona gene therapy for a rare neurological disease affecting children costs $3 million, while its Zynteglo for an inherited blood disorder is priced at $2.8 million.

Novartis AG’s Zolgensma gene therapy treating a muscle-wasting condition costs $2.1 million.

Drugmakers say gene therapies can make a difference to patients with rare genetic diseases, by either curing them or providing yearslong benefits through delivering a correct copy of a faulty gene, though there have been some safety concerns over the class.

Some of the new therapies could produce long-term savings, the companies say, by sparing patients from having to take older treatments repeatedly for the rest of their lives. Most of the gene therapies approved to date are for diseases with small patient populations, limiting their overall cost to health insurers’ budgets despite high per-patient prices.


A syringe containing Novartis’s genetic treatment Zolgensma, priced at $2.1 million.
PHOTO: PA WIRE/ZUMA PRESS
Yet health insurers say they aren’t set up to handle such big payouts. They are accustomed to paying for older, chronic treatments on a recurring basis over time, rather than paying a high price for a single treatment that could have lasting benefits.

The introduction of more high-price gene therapies could raise healthcare costs, especially once the drugs target bigger patient populations, health insurers say. That could lead to higher insurance premiums, before any long-term savings kick in.

McKinsey & Co. estimates that about 30 new gene therapies could be introduced in 2024 alone.

“When you think about hundreds of gene therapies under development, if we’re fortunate enough that they all work, there’s a concern about the collective budget impact,” said Michael Sherman, chief medical officer of Point32Health, which administers health-insurance plans primarily in New England. “Each time we see a new gene therapy they are at a higher price point.”

One-time therapies are on the horizon for diseases with bigger patient populations, including a more common form of hemophilia, as well as another blood disorder known as sickle-cell disease.

ccp

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Re: The Politics of Health Care
« Reply #1853 on: December 26, 2022, 10:13:33 AM »
to my knowledge there are no new classes of oral antibiotics being researched

occasionally an intravenous one for hospitals that can cost a lot

but nothing for most everyday use

as bacterial increasingly mutate to more resistant forms we are slowly running out of options


Crafty_Dog

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WSJ: The West's Drug-Price Self-Sabotage
« Reply #1854 on: January 23, 2023, 04:55:16 PM »
The West’s Drug-Price Self-Sabotage
A lesson from Europe for America on how price controls reduce access to treatments and cures.
By The Editorial BoardFollow
Jan. 23, 2023 6:35 pm ET

Democrats and even some Republicans want to import Europe’s drug price controls. So it’s worth observing how Europe’s raid on drug makers to bolster its ailing national health systems is reducing pharmaceutical investment and access to treatments.


The latest alarm came last week when AbbVie and Eli Lilly said they’re pulling out of a “voluntary” agreement with the U.K. government aimed at reducing drug spending. An AbbVie executive said the government’s policies are harming “our ability to operate sustainably in the UK.”

The British National Health Service (NHS) imposes price controls on drugs that reduce their cost on average by 60% versus America. U.K. law also requires drug makers to pay a 24.4% rebate on revenue from branded drugs. This levy on top of the NHS price controls discourages drug makers from selling treatments in the U.K.

The government and companies struck a deal in 2019 aimed at increasing access to innovative treatments, but this has turned out to be even more punitive. The agreement capped the government’s annual drug spending growth at 2%. Drug makers must pay the government rebate equal to their revenue above the cap.

Government spending on drugs has nonetheless continued to rise at a faster rate owing to Covid and delayed care for diseases such as cancer. As a result, companies this year must pay the government 26.5% of their brand drug revenue (about $4 billion), up from 15% last year and 5% in 2021. In short, drug companies are dunned more because more Brits are sick.

Eli Lilly and AbbVie last week withdrew from the 2019 agreement, and Bristol Myers Squibb has warned that the U.K. levies might cause it to divert investment. An executive at Germany’s Bayer last week said it is reducing its U.K. footprint and “deprioritising Europe to some degree.”

***
Governments across the continent are making it difficult for drug makers to earn a return on investment. Germany last fall increased mandatory drug discounts to 12% from 7% and extended a 2010 price freeze through 2026 that was supposed to expire in 2022.

Hard to believe, the U.K. and Germany are also still trying to attract pharmaceutical investment. But as Bayer’s pharmaceutical head Stefan Oelrich recently explained, “European governments are trying to create incentives for research investments, but they are making our lives miserable on the commercial side.” While Europe boasts a handful of pharmaceutical powerhouses, venture capital is flowing into biotech startups in the U.S. and China.

The result for Europe will be less investment and access to life-saving treatments. About 85% of new medicines launched between 2012 and 2021 were available in the U.S., compared to 61% in Germany, 59% in the U.K. and 52% in France and Italy. Bluebird bio in 2021 said it was unwinding operations in Europe and withdrawing gene therapies for rare diseases, citing the challenges of “achieving appropriate value recognition and market access.”

Generic drug firms also say Europe’s price controls, onerous regulation and rising energy costs are contributing to shortages of medicines and driving more production to China and India. Germany in December eased price controls on pediatric drugs in short supply because manufacturers were prioritizing countries with higher reimbursements.

According to a European Public Health Alliance survey in 2019, nearly half of patients reported that they or a family member couldn’t get a drug they needed. In France, 2,446 drug shortages were reported in 2020, up from 868 in 2018 and 44 in 2008. Two in three French oncologists say shortages of anti-cancer medicines can reduce survival odds.

But European governments refuse to pay more to ensure their citizens have access to treatments. Bureaucrats in Brussels are therefore now considering legislation that would reduce intellectual property protection for drugs that don’t launch in nearly all European Union markets. Such a deal: Accept price controls, or Europe will hand IP to the Chinese. Dealing with the Italian mob is easier.

***
The U.S. has drawn more pharmaceutical investment amid Europe’s war on drug makers, but this may not continue as progressives pound the industry. Democrats last year limited the price growth for drugs in Medicare to the rate of inflation and required the feds to dictate lower prices for dozens of drugs to finance climate spending.

Democrats also want the Health and Human Services Department to abrogate patents for higher-cost drugs such as prostate cancer treatment Xtandi that benefitted in part from government research. This would discourage cooperation between private industry and government, which helped produce life-saving Covid vaccines and therapies.

Pfizer CEO Albert Bourla warned last week that attacks on drug makers would leave the West more vulnerable to the next pandemic. “What was the big lesson from Covid? It was that thank god there was a thriving life-sciences industry that was predominantly fueled privately, but also supplemented by academia,” he said.

The novel mRNA vaccines didn’t turn out to protect as well against Covid infection as hoped, but they did save lives and helped the world return to normal. It makes no sense for governments to try to kill companies that came to their rescue.

Appeared in the January 24, 2023, print edition as 'The West’s Drug Self-Sabotage'

ccp

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Re: The Politics of Health Care
« Reply #1855 on: January 31, 2023, 07:15:24 AM »
from previous CD post :

"The West’s Drug-Price Self-Sabotage
A lesson from Europe for America on how price controls reduce access to treatments and cures.
By The Editorial BoardFollow
Jan. 23, 2023 6:35 pm ET"

of course WSJ thinks only of "profits "

but this is the down side of drug companies ripping us off. in the US :

https://www.nytimes.com/2023/01/28/business/humira-abbvie-monopoly.html

I am for price controls that the market itself would take

ie : competition

 2 things bother me:

 price fixing among drug companies - not clear they actually collude per se
but they do not seem to compete on pricing

when a similar drug comes out it seems to be priced like the earlier drug from another company

they see what the competition charges then charge the same but claim their drug is better (usually marginally etc ) and sell on that basis
but do not cut cost for consumers

the other problem is this legal patent scam
they make tiny differences in their drug
 and patent them to prevent competition
or as noted in the article simply pay off the generic manufacturer to not make the drug

THIS IMO needs regulation
folks we are being ripped off 
I am telling everyone


Crafty_Dog

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Re: The Politics of Health Care
« Reply #1856 on: January 31, 2023, 07:52:26 AM »
Some of what you describe is the inherent behavior of oligopolistic markets.

There is also the matter of markets dominated by insurance. 

ccp

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Re: The Politics of Health Care
« Reply #1857 on: January 31, 2023, 07:55:10 AM »
hey CD

CD responded with :

"Some of what you describe is the inherent behavior of oligopolistic markets.

There is also the matter of markets dominated by insurance. "

implying what ?

it is all ok and we should not confuse predatory behavior with free market forces ?

Crafty_Dog

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Re: The Politics of Health Care
« Reply #1858 on: January 31, 2023, 08:02:52 AM »
No, just seeking a good starting point for good diagnosis.

ccp

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Re: The Politics of Health Care
« Reply #1859 on: January 31, 2023, 08:29:28 AM »
"No, just seeking a good starting point for good diagnosis."

I am thinking
diagnosis is human nature

which is  sadly placing profit over morality .

Not inevitable but all too common .

I am not a regulation kind of guy
but sometimes protecting consumers and reducing health costs is legitimate cause for intervention

pros vs cons

IMveryHO

Crafty_Dog

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Re: The Politics of Health Care
« Reply #1860 on: January 31, 2023, 10:07:40 AM »
FWIW my starting orientation:

In the absence of coercion, the Free Market is most harmonious with human nature.

Insurance exists for good and proper reasons but has the consequence of separating the consumer and payor; the consumer is not constrained by price.   Once the insurance modality exceeds a certain portion of the market, the dynamics of a healthy free market are subverted.

IMHO Dr. Ben Carson had a serious proposal when he was running for President that I saw as being a very realistic and plausible way of returning the price mechanism to the health care market while still allowing for insurance for the cases that people could not be reasonably be held to be financially capable.