Onions:  "quercetin absorption from onions is double that [of] tea and three times that [of] apples."

I have eaten garlic medicinally.  What that means is that whenever I feel sick or anxiety I take a clove of garlic at bed.  I crush the clove so garlic's chemicals can be released and made easier for absorbtion.  The result is spectacular.  My blood vessels get dilated, and the benefits are more energy.  Love it.  And the following day I feel sturdier.  

But sometimes the garlic can work adversely on my stomach.  Still, I know that garlic and other root vegetables or onions, allium vegetables, are good for the heart.  Least that's what I've heard and read.  My dad once told me that he eats onions "because they're good for the heart."  In fact, he used to make his own sandwiches and always add a wedge of onion and a few peppers to it and take that to work. Don't know how he got around the smell at work.  Funny. Remember, too, how on long vacation drives he would wrap up sandwiches and always, always I'd find a wedge of onion wrapped in the tin foil in which he kept his sandwich. So he knew. This is not news.  Just an important reminder. Eat your onions.  Eat them raw. 

A little side note on onions: 

Onions have been cultivated for thousands of years and originated in the Near East and Central Asia. They were grown not only for use in cooking, but for their antiseptic qualities. In Egypt, onions were used in mummification. The most familiar allium is the common, or bulb, onion of the species Allium cepa, which may have a yellow, white, red, or purple skin. While onions may be fresh, they are most commonly purchased dried. Fresh, also called “sweet”, onions have a milder taste. Dry, also called “storage,” onions, have a stronger flavor. Dry onions have thick, paper-like skins. The vast majority of onions purchased at the supermarket are yellow storage onions. Pungent yellow onions are the best “keepers” and are great additions to soups and stews, while red onions are very sweet, but a poor choice for long-term storage. Red onions are good sliced and eaten raw in salads or sandwiches, or for topping a veggie burger. Common mild onions include Bermuda and Spanish varieties. Pearl onions -- which are most often white -- are the tiniest of the bulb onions, and are the top choice for boiling or pickling.  

WHY ARE ONIONS GOOD FOR YOU?

In a word, quercetin.  Quercetin is a flavonoid, chemicals that give the fruit or vegetable its flavor.  Onions are also a disease-fighting food.  Dr. Joseph Mercola explains that 

Quercetin is a powerful antioxidant with anti-inflammatory properties that may help fight chronic diseases like heart disease and cancer.  In lab studies, quercetin was shown to prevent histamine release (histaminese are the chemicals that cause allergic reactions.  This makes quercetin-rich foods like onions "natural anti-histamines."  

I knew that apples and onions contained quercetin; I just didn't know the extent of quercetin's benefits.  I mean almost since the term anti-oxidants gained traction in the public discourse, that seems that that's all we hear about.  But anti-oxidants are not created equal, nor do they function equally. 

Mercola adds that 

While apples and tea also contain quercetin, onions appear to be a particularly good source.  Research from Wageningen Agricultural University in the Netherlands showed quercetin absorption from onions is double that from tea and three times that from apples.

Research from the University also showed consuming onions leads to increased quercetin concentrations in the blood.  As reported by The World's Healthiest Foods

". . . On an ounce-for-ounce basis, onions rank in the top of commonly eaten vegetables in their quercetin content.  The flavonoid content of onions can vary widely, depending on the exact variety and growing conditions.

Although the average onion is likely to contain less than 100 milligrams of quercetin per 3-1/2 ounces, some onions do provide this amount.  

And while 100 milligrams may not sound like a lot, in the United States, moderate vegetable eaters average only twice this amount for all flavonoids (not just quercetin) from all vegetables per day." 

ONIONS or QUERCETIN SUPPLEMENTS?

Mercola answers this question too.  In the context of concentration, it is hard to beat food remedies.  

Quercetin is available in supplement form, but there are a couple of reasons why getting this flavonoid from onions makes more sense.  

*  One animal study found that animals received greater protection against oxidative stress when they consumed yellow onion in their diet as opposed to consuming quercetin extracts.  

*  Quercetin is not degraded by low-heat cooking, such as simmering.  When preparing a soup with onions, the quercetin will be transferred into the brother of the soup, making onion soup an easy-to-make superfood.  

Good to know.  

I started eating more onions, raw, to address some digestion discomfort.  Turns out that onions are really good for the colon.

Organosulfur compounds [in onions] such as diallyl disulfide (DDS), S-allylcysteine (SAC), and S-methylcysteine (SMC) have been shown to inhibit colon and renal carcinogenesis.  

That has to sit well with almost every reader even those who don't like onions.  

Onions contain sulfur, too, as you know.  And Mercola explains its benefits when you consume onions.  

The sulfur compounds in onions, for instance, are thought to have anti-clotting properties as well as help to lower cholesterol and triglycerides.  The allium and allyl disulphide in onions have also been found to decrease blood vessel stiffness by releasing nitric oxide.  

I have first-hand experience with that.  He adds that . . .  

This may reduce blood pressure (always a good thing, no?) inhibit platelet clot formation and help decrease the risk of coronary artery disease, peripheral vascular diseases and stroke. [Amazing!]  The quercetin in onions is also beneficial, offering both anti-oxidant and anti-inflammatory properties that may boost heart health.  

All I can say is wow.

Anti-Psychotic Drugs: A Substitute for Staff?

"Phony Diagnoses Hide High Rates of Drugging at Nursing Homes," at DNYUZ

Thank you to Lew Rockwell. 

The handwritten doctor’s order was just eight words long, but it solved a problem for Dundee Manor, a nursing home in rural South Carolina struggling to handle a new resident with severe dementia.

David Blakeney, 63, was restless and agitated. The home’s doctor wanted him on an antipsychotic medication called Haldol, a powerful sedative.

“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”

But there was no evidence that Mr. Blakeney actually had schizophrenia.

Antipsychotic drugs — which for decades have faced criticism as "chemical straitjackets"—are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents.

The risks to patients treated with antipsychotics are so high that nursing homes must report to the government how many of their residents are on these potent medications. But there is an important caveat: The government doesn’t publicly divulge the use of antipsychotics given to residents with schizophrenia or two other conditions.

With the doctor’s new diagnosis, Mr. Blakeney’s antipsychotic prescription disappeared from Dundee Manor’s public record.

Eight months following his admission with a long list of ailments — and after round-the-clock sedation, devastating weight loss, pneumonia and severe bedsores that required one of his feet to be amputated — Mr. Blakeney was dead.

A New York Times investigation found a similar pattern of questionable diagnoses nationwide. The result: The government and the industry are obscuring the true rate of antipsychotic drug use on vulnerable residents.

The share of residents with a schizophrenia diagnosis has soared 70 percent since 2012, according to an analysis of Medicare data. That was the year the federal government, concerned with the overuse of antipsychotic drugs, began publicly disclosing such prescriptions by individual nursing homes.

Today, one in nine residents has received a schizophrenia diagnosis. In the general population, the disorder, which has strong genetic roots, afflicts roughly one in 150 people.

Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.

“People don’t just wake up with schizophrenia when they are elderly,” said Dr. Michael Wasserman, a geriatrician and former nursing home executive who has become a critic of the industry. “It’s used to skirt the rules.”

Some portion of the rise in schizophrenia diagnoses reflects the fact that nursing homes, like prisons, have become a refuge of last resort for people with the disorder, after large psychiatric hospitals closed decades ago.

But unfounded diagnoses are also driving the increase. In May, a report by a federal oversight agency said nearly one-third of long-term nursing home residents with schizophrenia diagnoses in 2018 had no Medicare record of being treated for the condition.

For nursing homes, money is on the line. High rates of antipsychotic drug use can hurt a home’s public image and the star rating it gets from the government. Medicare designed the ratings system to help patients and their families evaluate facilities using objective data; a low rating can have major financial consequences. Many facilities have found ways to hide serious problems — like inadequate staffing and haphazard care — from government audits and inspectors.

One result of the inaccurate diagnoses is that the government is understating how many of the country’s 1.1 million nursing home residents are on antipsychotic medications.

According to Medicare’s web page that tracks the effort to reduce the use of antipsychotics, fewer than 15 percent of nursing home residents are on such medications. But that figure excludes patients with schizophrenia diagnoses.

To determine the full number of residents being drugged nationally and at specific homes, The Times obtained unfiltered data that was posted on another, little-known Medicare web page, as well as facility-by-facility data that a patient advocacy group got from Medicare via an open records request and shared with The Times.

The figures showed that at least 21 percent of nursing home residents — about 225,000 people — are on antipsychotics.

The Centers for Medicare and Medicaid Services, which oversees nursing homes, is “concerned about this practice as a way to circumvent the protections these regulations afford,” said Catherine Howden, a spokeswoman for the agency, which is known as C.M.S.

“It is unacceptable for a facility to inappropriately classify a resident’s diagnosis to improve their performance measures,” she said. “We will continue to identify facilities which do so and hold them accountable.”

Representatives for nursing homes said doctors who diagnose patients and write the prescriptions to treat them are to blame, even though those doctors often work in partnership with the nursing homes.

“If physicians are improperly diagnosing individuals with serious mental health issues in order to continue an antipsychotic regimen, they should be reported and investigated,” Dr. David Gifford, the chief medical officer at the American Health Care Association, which represents for-profit nursing homes, said in a statement.

Medicare and industry groups also said they had made real progress toward reducing antipsychotic use in nursing homes, pointing to a significant drop since 2012 in the share of residents on the drugs.

But when residents with diagnoses like schizophrenia are included, the decline is less than half what the government and industry claim. And when the pandemic hit in 2020, the trend reversed and antipsychotic drug use increased.

A DOUBLED RISK OF DEATH

For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.

In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.

But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.

In 2005, the Food and Drug Administration required manufacturers to put a label on the drugs warning that they increased the risk of death for patients with dementia.

Seven years later, with antipsychotics still widely used, nursing homes were required to report to Medicare how many residents were getting the drugs. That data is posted online and becomes part of a facility’s “quality of resident care” score, one of three major categories that contribute to a home’s star rating.

The only catch: Antipsychotic prescriptions for residents with any of three uncommon conditions — schizophrenia, Tourette’s syndrome and Huntington’s disease — would not be included in a facility’s public tally. The theory was that since the drugs were approved to treat patients with those conditions, nursing homes shouldn’t be penalized.

The loophole was opened. Since 2012, the share of residents classified as having schizophrenia has gone up to 11% from less than 7%, records show.

The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4% from 6%.

A SUBSTITUTE FOR STAFF

Caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.

Studies have found that the worse a home’s staffing situation, the greater its use of antipsychotic drugs. That suggests that some homes are using the powerful drugs to subdue patients and avoid having to hire extra staff. (Homes with staffing shortages are also the most likely to understate the number of residents on antipsychotics, according to the Times’s analysis of Medicare data.)

The pandemic has battered the industry. Nursing home employment is down more than 200,000 since early last year and is at its lowest level since 1994.

As staffing dropped, the use of antipsychotics rose.

Even some of the country’s leading experts on elder care have been taken aback by the frequency of false diagnoses and the overuse of antipsychotics.

Barbara Coulter Edwards, a senior Medicaid official in the Obama administration, said she had discovered that her father was given an incorrect diagnosis of psychosis in the nursing home where he lived even though he had dementia.

“I just was shocked,” Ms. Edwards said. “And the first thing that flashed through my head was this covers a lot of ills for this nursing home if they want to give him drugs.”

Homes that violate the rules face few consequences.

In 2019 and 2021, Medicare said it planned to conduct targeted inspections to examine the issue of false schizophrenia diagnoses, but those plans were repeatedly put on hold because of the pandemic.

In an analysis of government inspection reports, The Times found about 5,600 instances of inspectors citing nursing homes for misusing antipsychotic medications. Nursing home officials told inspectors that they were dispensing the powerful drugs to frail patients for reasons that ranged from “health maintenance” to efforts to deal with residents who were “whining” or “asking for help.”

In more than 99 percent of the cases, inspectors concluded that the violations represented only “potential,” not “actual,” harm to patients. That means the findings are unlikely to hurt the homes’ ratings.

‘HE WAS SO LITTLE’

Mr. Blakeney’s wife of four decades and one of his adult daughters said in interviews that he had never exhibited any mental health problems. Then he developed dementia, and his behavior became difficult to manage. His wife, Yvonne Blakeney, found that she could no longer care for him.

Over the next several months, Mr. Blakeney was in and out of medical facilities, where he was treated for problems including a urinary tract infection. He became increasingly confused and upset.

In April 2016, he went to the Lancaster Convalescent Center, a nursing home in Lancaster, S.C., where a doctor labeled him with schizophrenia on a form that authorized the use of antipsychotic drugs. That diagnosis, however, did not appear on his subsequent hospital records.

Lancaster’s administrator declined to comment.

Six months later, Mr. Blakeney arrived at Dundee Manor, a 110-bed home in Bennettsville, S.C. At the time, it received only one out of five stars in Medicare’s rating system. The low score reflected poor marks from government inspectors who had visited the facility. It was also penalized for inadequate staffing.

When Mr. Blakeney was admitted, schizophrenia did not appear in his long list of ailments, which included high blood pressure, pneumonia and advanced dementia, according to medical records disclosed in a lawsuit that his widow later filed against the home.

Two weeks after his arrival, Dundee Manor’s medical director, Dr. Stephen L. Smith, instructed the home to add the schizophrenia diagnosis so that Mr. Blakeney could continue to receive Haldol. He was also prescribed Zyprexa, as well as the sleeping pill Ambien and trazodone, which is often given to help patients sleep.

Ms. Blakeney’s lawyer, Matthew Christian, said he had not seen any evidence that anyone conducted a psychiatric evaluation of Mr. Blakeney.

Mr. Blakeney, who had worked for decades as a farmhand, was once tall and muscular. But the drugs left him confined to his bed or wheelchair, exhausted. When his wife and sister visited, they couldn’t wake him, even when they brought his favorite meal of fried chicken. Over eight months, his weight dropped from 205 to 128 pounds.

“I cried because he was so little,” Ms. Blakeney said. “You could see his rib cage, just sticking out.”

Mr. Blakeney’s medical records show that several people warned that he was too sedated and receiving too many drugs.

Three weeks after he arrived at Dundee Manor, a physical therapist noted his extreme lethargy, even when she washed his hands and face. In mid-November, after Mr. Blakeney lost 12 pounds in a single week, a dietitian left a note for the doctor. “Consider medication adjustment,” she wrote, adding that he was “sleeping all day and through meals.”

That month, an outside pharmacist filled out a form recommending that Mr. Blakeney’s doses of Haldol and Zyprexa be reduced to comply with federal guidelines that require nursing homes to gradually reduce doses of antipsychotics.

On a form with Dr. Smith’s name and signature, a box labeled “disagree” was checked. “Staff feels need” for the continued doses, the form noted.

It was exactly the sort of decision — prescribing powerful drugs to help the nursing home and its staff, not the patient — that the 1987 law was supposed to ban.

Dr. Smith declined to comment. Dundee Manor didn’t respond to requests for comment.

According to Medicare’s public database of nursing home ratings, only 7 percent of Dundee Manor’s long-term residents were getting antipsychotic drugs in the third quarter of 2018. That put the nursing home in a good light; the national average was roughly double.

But Dundee Manor’s relatively low figure was a mirage created by the large number of residents who were diagnosed with conditions like schizophrenia. In reality, The Times found, 29 percent of Dundee Manor’s residents were on antipsychotics at the time, according to unpublished Medicare data obtained through public records requests by California Advocates for Nursing Home Reform.

FIVE-STAR PROBLEMS

False schizophrenia diagnoses are not confined to low-rated homes. In May, the inspector general of the Department of Health and Human Services, for example, identified 52 nursing homes where at least 20 percent of all residents had an unsupported diagnosis. Medicare rated more than half of those homes with at least four of the maximum five stars. (The inspector general’s report didn’t identify the nursing homes. The Times obtained their identities through a public-records request.)

One was the Hialeah Shores Nursing and Rehabilitation Center in Miami, a 106-bed home bordered by palm trees and a white painted fence. It is a five-star facility that, according to the official statistics, prescribed antipsychotics to about 10 percent of its long-term residents in 2018.

That was a severe understatement. In fact, 31 percent of Hialeah Shores residents were on antipsychotics, The Times found.

In 2018, a state inspector cited Hialeah Shores for giving a false schizophrenia diagnosis to a woman. She was so heavily dosed with antipsychotics that the inspector was unable to rouse her on three consecutive days.

There was no evidence that the woman had been experiencing the delusions common in people with schizophrenia, the inspector found. Instead, staff at the nursing home said she had been “resistive and noncooperative with care.”

Dr. Jonathan Evans, a medical director for nursing homes in Virginia who reviewed the inspector’s findings for The Times, described the woman’s fear and resistance as “classic dementia behavior.”

“This wasn’t five-star care,” said Dr. Evans, who previously was president of a group that represents medical staff in nursing homes. He said he was alarmed that the inspector had decided the violation caused only “minimal harm or potential for harm” to the patient, despite her heavy sedation. As a result, he said, “there’s nothing about this that would deter this facility from doing this again.”

Representatives of Hialeah Shores declined to comment.

Seven of the 52 homes on the inspector general’s list were owned by a large Texas company, Daybreak Venture. At four of those homes, the official rate of antipsychotic drug use for long-term residents was zero, while the actual rate was much higher, according to the Times analysis comparing official C.M.S. figures with unpublished data obtained by the California advocacy group.

More than 39 percent of residents at Daybreak’s Countryside Nursing and Rehabilitation, for example, were receiving an antipsychotic drug in 2018, even though the official figure was zero.

A lawyer for Daybreak, Charles A. Mallard, said the company could not comment because it had sold its homes and was shutting its business.

A SPRINKLE OF DEPAKOTE

As the U.S. government has tried to limit the use of antipsychotic drugs, nursing homes have turned to other chemical restraints.

Depakote, a medication to treat epilepsy and bipolar disorder, is one increasingly popular choice. The drug can make people drowsy and increases the risk of falls. Peer-reviewed studies have shown that it does not help with dementia, and the government has not approved it for that use.

But prescriptions of Depakote and similar anti-seizure drugs have accelerated since the government started publicly reporting nursing homes’ use of antipsychotics.

Between 2015 and 2018, the most recent data available, the use of anti-seizure drugs rose 15 percent in nursing home residents with dementia, according to an analysis of Medicare insurance claims that researchers at the University of Michigan prepared for The Times.

And while Depakote’s use rose, antipsychotic prescriptions fell 16 percent.

“The prescribing is far higher than you would expect based on the actual amount of epilepsy in the population,” said Dr. Donovan Maust, a geriatric psychiatrist at the University of Michigan who conducted the research.

About half the complaints that California Advocates for Nursing Home Reform receives about inappropriate drugging of residents involve Depakote, said Anthony Chicotel, the group’s top lawyer. It comes in a “sprinkle” form that makes it easy to slip into food undetected.

“It’s a drug that’s tailor-made to chemically restrain residents without anybody knowing,” he said.

In the early 2000s, Depakote’s manufacturer, Abbott Laboratories, began falsely pitching the drug to nursing homes as a way to sidestep the 1987 law prohibiting facilities from using drugs as “chemical restraints,” according to a federal whistle-blower lawsuit filed by a former Abbott saleswoman.

According to the lawsuit, Abbott’s representatives told pharmacists and nurses that Depakote would “fly under the radar screen” of federal regulations.

Abbott settled the lawsuit in 2012, agreeing to pay the government $1.5 billion to resolve allegations that it had improperly marketed the drugs, including to nursing homes.

Nursing homes are required to report to federal regulators how many of their patients take a wide variety of psychotropic drugs — not just antipsychotics but also anti-anxiety medications, antidepressants, and sleeping pills. But homes do not have to report Depakote or similar drugs to the federal government.

“It is like an arrow pointing to that class of medications, like ‘Use us, use us!’” Dr. Maust said. “No one is keeping track of this.”

LOBBYING FOR MORE

In 2019, the main lobbying group for for-profit nursing homes, the American Health Care Association, published a brochure titled “Nursing Homes: Times have changed.”

“Nursing homes have replaced restraints and antipsychotic medications with robust activity programs, religious services, social workers and resident councils so that residents can be mentally, physically and socially engaged,” the colorful two-page leaflet boasted.

Last year, though, the industry teamed up with drug companies and others to push Congress and federal regulators to broaden the list of conditions under which antipsychotics don’t need to be publicly disclosed.

“There is specific and compelling evidence that psychotropics are underutilized in treating dementia and it is time for C.M.S. to re-evaluate its regulations,” wrote Jim Scott, the chairman of the Alliance for Aging Research, which is coordinating the campaign.

The lobbying was financed by drug companies including Avanir Pharmaceuticals and Acadia Pharmaceuticals. Both have tried — and so far failed — to get their drugs approved for treating patients with dementia. (In 2019, Avanir agreed to pay $108 million to settle charges that it had inappropriately marketed its drug for use in dementia patients in nursing homes.)

‘HOLD HIS HALDOL’

Ms. Blakeney said that only after hiring a lawyer to sue Dundee Manor for her husband’s death did she learn he had been on Haldol and other powerful drugs. (Dundee Manor has denied Ms. Blakeney’s claims in court filings.)

During her visits, though, Ms. Blakeney noticed that many residents were sleeping most of the time. A pair of women, in particular, always caught her attention. “There were two of them, laying in the same room, like they were dead,” she said.

In his first few months at Dundee Manor, Mr. Blakeney was in and out of the hospital, for bedsores, pneumonia and dehydration. During one hospital visit in December, a doctor noted that Mr. Blakeney was unable to communicate and could no longer walk.

“Hold the patient’s Ambien, trazodone and Zyprexa because of his mental status changes,” the doctor wrote. “Hold his Haldol.”

Mr. Blakeney continued to be prescribed the drugs after he returned to Dundee Manor. By April 2017, the bedsore on his right heel — a result, in part, of his rarely getting out of bed or his wheelchair — required the foot to be amputated.

In June, after weeks of fruitless searching for another nursing home, Ms. Blakeney found one and transferred him there. Later that month, he died.

“I tried to get him out — I tried and tried and tried,” his wife said. “But when I did get him out, it was too late.”

The post Phony Diagnoses Hide High Rates of Drugging at Nursing Homes appeared first on New York Times.

The PREP Act allows the government and the DoD to bypass the normal regulatory frameworks and consumer safeguards,

https://t.co/PhzRwfXZba

— St. Michael, the Archangel (@aveng_angel) June 16, 2023

HERE IS THE VIDEO.  WATCH IT.  LATYPOVA'S REMARKS BEGIN AT THE 5:50 MARK.

PREP Act was a law launched in 2002, and amended in 2005 that allows the HHS Secretary to issue a declaration to expand this liability shield for using unapproved medical interventions, devices, pharmaceuticals, all sorts of things, diagnostics, therapeutics, anything, using the Emergency Use Authorization essential to bypassing the normal regulatory frameworks and consumer safeguards, which are quite extensive today for very good reasons because we want to make sure that the medications are being used as safe.  So this is a shield essentially that the government uses and now, specifically, the DoD is using extensively to shield themselves and anyone that they hire for the task from any liability from using these poorly tested, untested, experimental, and completely black box, devices, and technologies.

8:50  Dr. Meryl Nass.  The Defense Department has been accustomed to doing whatever it wants and has a history of using untested products on soldiers.  In the Gulf War, they got a memorandum of understanding with the FDA that allowed them to use products that were unapproved and unevaluated by the FDA and at other times in the past also.  The DoD is kind of a law unto itself.  So for them, this was nothing new.  It was just happening on a larger scale.  It wasn't just 2 million soldiers, but it was also 134 million Americans.  But then this method was shipped out to the rest of the world, so 8 billion people.  

9:42  Polly Tommey.  Why have we called this program, "Willful Misconduct"?  What is the purpose behind that?  

9:48  Latypova.  I think it's because of the George Watts case v. Lloyd J. Austin, III, in other words, the DoD.  His estate is suing the Dept. of Defense for his death.  The only basis that we have to break this liability shield, a very extensive one, is based on willful misconduct.  So the case complaint was that the willful misconduct was essentially a bait-and-switch scheme that the Department of Defense and Health and Human Services, HHS, ran on the American public.  

11.  PREP provides blanket immunity for covered persons such as the DOD with a sole exception for willful misconduct the enumerated sovereign immunity for the United States and an agency such as the DOD (42 U.S.C. 247d-6d(f)) is unconstitutional since for closing all redress violates due process enshrined in the 5th Amendment and it's central promise and assurance that all levels of American government must abide by the law and provide fair procedures particularly in instances such as this where Mr Wash was "deprived of life."  The enumerated sovereign immunity for the United States and an agency such as the DOD has is also an unconstitutional taking in violation of the Fifth Amendment.  A "legal cause of action is property within the meaning of the Fifth Amendment." 

So, now we have a death of a civilian from disregard for safety and using this PREP Act liability shield, and his attorneys are stating that "Well because this was willful misconduct because knowingly the Department of Defense administered, distributed the experimental product while telling everyone it was FDA approved.  And that was the lie that they perpetrated on this young man who died as a result of it.  

11:00  Dr. Meryl Nass.  The way that the PREP Act is written, there are almost no requirements for safety or efficacy.  What it requires is that the FDA, and the FDA issues it, simply believe, with or without evidence, that the benefits are going to be greater than the risks.  But it does say that the FDA needs to disclose the known significant risks.  And the FDA did not do that.  So the FDA was hiding many of the known risks.  But the other thing that happened was a bait-and-switch.  So in August of 2021, the Federal government announced all these mandates but only at the time that FDA approved a license for the Pfizer vaccine.  So on August 23, the FDA issued a license for the Pfizer vaccine for adults, but none of that product was made available in the United States.  So every body continued to get the Emergency Use product with a huge liability shield and the only potential way to litigate against them was to prove willful misconduct which was they knew they were doing something wrong but they hid it.  So what we're saying is, yes, they knew that the product being administered to George Watt and to everybody else in the country was not licensed, but the FDA, the DoD, and the rest of the Federal government pretended that it was.  

12:32  Tommey.  And this is Children's Healt Care case, correct?  Yep.

And the reason you're on here is because your lawyer can't talk about it. 

12:50  Latypova.  I think it's a great case because, finally, in my opinion, a correct defendent is named, in other words, which is the DoD and Lloyd J. Austin, III, the U.S. Secretary of Defense, who were the head of the operation, while the pharmaceutical companies are complicit and knowingly administered poisons because they are experts and they understand exactly what they are doing and know what consumer safeguards have been subverted. But they are operating under the Department of Defense who was heading Operation Warp Speed, OWS, now it's been renamed to Acceleration of Countermeasures, another name but essentially the same thing.  

[Huh.  The federal government is notorious for renaming projects and programs.  Remember when the Iraq invasion was initially named Operation Iraqi Liberation with the acronym of O.I.L.?  They're always trying to show how clever they are when in reality they're stupid monsters.]

This was at the time that these shots were rolled out and relevant to George Watts' case this was headed by the Department of Defense, Chief Operation Officer was General Gustave F. Perna, reporting directly to President Trump.  Structurally, the same reporting system reporting to Biden.  The Dept. of Defense leadership represents about 2/3 of Operation Warp Speed, most of them without any health care experience.  So this was all orchestrated from there, using several legal framework of several laws, so the PREP Act is one of them.   But there are others, such as Public Health Emergency Declaration to begin with, and the Emergency Use Authorization

How Government Killed the Medical Profession

This article appeared in the May 2013 Issue of Reason.

by Jeffrey Singer

I am a general surgeon with more than three decades in private clinical practice. And I am fed up. Since the late 1970s, I have witnessed remarkable technological revolutions in medicine, from CT scans to robot-assisted surgery. But I have also watched as medicine slowly evolved into the domain of technicians, bookkeepers, and clerks.

Government interventions over the past four decades have yielded a cascade of perverse incentives, bureaucratic diktats, and economic pressures that together are forcing doctors to sacrifice their independent professional medical judgment, and their integrity. The consequence is clear: Many doctors from my generation are exiting the field. Others are seeing their private practices threatened with bankruptcy, or are giving up their autonomy for the life of a shift-working hospital employee. Governments and hospital administrators hold all the power, while doctors—and worse still, patients—hold none.

The Coding Revolution

At first, the decay was subtle. In the 1980s, Medicare imposed price controls upon physicians who treated anyone over 65. Any provider wishing to get compensated was required to use International Statistical Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes to describe the service when submitting a bill. The designers of these systems believed that standardized classifications would lead to more accurate adjudication of Medicare claims.

What it actually did was force doctors to wedge their patients and their services into predetermined, ill-fitting categories. This approach resembled the command-and-control models used in the Soviet bloc and the People’s Republic of China, models that were already failing spectacularly by the end of the 1980s.

Before long, these codes were attached to a fee schedule based upon the amount of time a medical professional had to devote to each patient, a concept perilously close to another Marxist relic: the labor theory of value. Named the Resource-Based Relative Value System (RBRVS), each procedure code was assigned a specific value, by a panel of experts, based supposedly upon the amount of time and labor it required. It didn’t matter if an operation was being performed by a renowned surgical expert—perhaps the inventor of the procedure—or by a doctor just out of residency doing the operation for the first time. They both got paid the same.

Hospitals’ reimbursements for their Medicare-patient treatments were based on another coding system: the Diagnosis Related Group (DRG). Each diagnostic code is assigned a specific monetary value, and the hospital is paid based on one or a combination of diagnostic codes used to describe the reason for a patient’s hospitalization. If, say, the diagnosis is pneumonia, then the hospital is given a flat amount for that diagnosis, regardless of the amount of equipment, staffing, and days used to treat a particular patient.

As a result, the hospital is incentivized to attach as many adjunct diagnostic codes as possible to try to increase the Medicare payday. It is common for hospital coders to contact the attending physicians and try to coax them into adding a few more diagnoses into the hospital record.

Medicare has used these two price-setting systems (RBRVS for doctors, DRG for hospitals) to maintain its price control system for more than 20 years. Doctors and their advocacy associations cooperated, trading their professional latitude for the lure of maintaining monopoly control of the ICD and CPT codes that determine their payday. The goal of setting their own prices has proved elusive, though—every year the industry’s biggest trade group, the American Medical Association, squabbles with various medical specialty associations and the Centers for Medicare and Medicaid Services (CMS) over fees.

As goes Medicare, so goes the private insurance industry. Insurers, starting in the late 1980s, began the practice of using the Medicare fee schedule to serve as the basis for negotiation of compensation with the doctors and hospitals on their preferred provider lists. An insurance company might offer a hospital 130 percent of Medicare’s reimbursement for a specific procedure code, for instance.

The coding system was supposed to improve the accuracy of adjudicating claims submitted by doctors and hospitals to Medicare, and later to non-Medicare insurance companies. Instead, it gave doctors and hospitals an incentive to find ways of describing procedures and services with the cluster of codes that would yield the biggest payment. Sometimes this required the assistance of consulting firms. A cottage industry of fee-maximizing advisors and seminars bloomed.

I recall more than one occasion when I discovered at such a seminar that I was “undercoding” for procedures I routinely perform; a small tweak meant a bigger check for me. That fact encouraged me to keep one eye on the codes at all times, leaving less attention for my patients. Today, most doctors in private practice employ coding specialists, a relatively new occupation, to oversee their billing departments.

Another goal of the coding system was to provide Medicare, regulatory agencies, research organizations, and insurance companies with a standardized method of collecting epidemiological data—the information medical professionals use to track ailments across different regions and populations. However, the developers of the coding system did not anticipate the unintended consequence of linking the laudable goal of epidemiologic data mining with a system of financial reward.

This coding system leads inevitably to distortions in epidemiological data. Because doctors are required to come up with a diagnostic code on each bill submitted in order to get paid, they pick the code that comes closest to describing the patient’s problem while yielding maximum remuneration. The same process plays out when it comes to submitting procedure codes on bills. As a result, the accuracy of the data collected since the advent of compensation coding is suspect.

Command and Control

Coding was one of the earliest manifestations of the cancer consuming the medical profession, but the disease is much more broad-based and systemic. The root of the problem is that patients are not payers. Through myriad tax and regulatory policies adopted on the federal and state level, the system rarely sees a direct interaction between a consumer and a provider of a health care good or service. Instead, a third party—either a private insurance company or a government payer, such as Medicare or Medicaid—covers almost all the costs. According to the National Center for Policy Analysis, on average, the consumer pays only 12 percent of the total health care bill directly out of pocket. There is no incentive, through a market system with transparent prices, for either the provider or the consumer to be cost-effective.

As the third party payment system led health care costs to escalate, the people footing the bill have attempted to rein in costs with yet more command-and-control solutions. In the 1990s, private insurance carriers did this through a form of health plan called a health maintenance organization, or HMO. Strict oversight, rationing, and practice protocols were imposed on both physicians and patients. Both groups protested loudly. Eventually, most of these top-down regulations were set aside, and many HMOs were watered down into little more than expensive prepaid health plans.

Then, as the 1990s gave way to the 21st century, demographic reality caught up with Medicare and Medicaid, the two principal drivers of federal health care spending.

Twenty years after the fall of the Iron Curtain, protocols and regimentation were imposed on America’s physicians through a centralized bureaucracy. Using so-called “evidence-based medicine,” algorithms and protocols were based on statistically generalized, rather than individualized, outcomes in large population groups.

While all physicians appreciate the development of general approaches to the work-up and treatment of various illnesses and disorders, we also realize that everyone is an individual—that every protocol or algorithm is based on the average, typical case. We want to be able to use our knowledge, years of experience, and sometimes even our intuition to deal with each patient as a unique person while bearing in mind what the data and research reveal.

Being pressured into following a pre-determined set of protocols inhibits clinical judgment, especially when it comes to atypical problems. Some medical educators are concerned that excessive reliance on these protocols could make students less likely to recognize and deal with complicated clinical presentations that don’t follow standard patterns. It is easy to standardize treatment protocols. But it is difficult to standardize patients.

What began as guidelines eventually grew into requirements. In order for hospitals to maintain their Medicare certification, the Centers for Medicare and Medicaid Services began to require their medical staff to follow these protocols or face financial retribution.

Once again, the medical profession cooperated. The American College of Surgeons helped develop Surgical Care Improvement Project (SCIP) protocols, directing surgeons as to what antibiotics they may use and the day-to-day post-operative decisions they must make. If a surgeon deviates from the guidelines, he is usually required to document in the medical record an acceptable justification for that decision.

These requirements have consequences. On more than one occasion I have seen patients develop dramatic postoperative bruising and bleeding because of protocol-mandated therapies aimed at preventing the development of blood clots in the legs after surgery. Had these therapies been left up to the clinical judgment of the surgeon, many of these patients might not have had the complication.

Operating room and endoscopy suites now must follow protocols developed by the global World Health Organization—an even more remote agency. There are protocols for cardiac catheterization, stenting, and respirator management, just to name a few.

Patients should worry about doctors trying to make symptoms fit into a standardized clinical model and ignoring the vital nuances of their complaints. Even more, they should be alarmed that the protocols being used don’t provide any measurable health benefits. Most were designed and implemented before any objective evidence existed as to their effectiveness.

A large Veterans Administration study released in March 2011 showed that SCIP protocols led to no improvement in surgical-site infection rate. If past is prologue, we should not expect the SCIP protocols to be repealed, just “improved”—or expanded, adding to the already existing glut.

These rules are being bred into the system. Young doctors and medical students are being trained to follow protocol. To them, command and control is normal. But to older physicians who have lived through the decline of medical culture, this only contributes to our angst.

One of my colleagues, a noted pulmonologist with over 30 years’ experience, fears that teaching young physicians to follow guidelines and practice protocols discourages creative medical thinking and may lead to a decrease in diagnostic and therapeutic excellence. He laments that “ ‘evidence-based’ means you are not interested in listening to anyone.” Another colleague, a North Phoenix orthopedist of many years, decries the “cookie-cutter” approach mandated by protocols.

A noted gastroenterologist who has practiced more than 35 years has a more cynical take on things. He believes that the increased regimentation and regularization of medicine is a prelude to the replacement of physicians by nurse practitioners and physician-assistants, and that these people will be even more likely to follow the directives proclaimed by regulatory bureaus. It is true that, in many cases, routine medical problems can be handled more cheaply and efficiently by paraprofessionals. But these practitioners are also limited by depth of knowledge, understanding, and experience. Patients should be able to decide for themselves if they want to be seen by a doctor. It is increasingly rare that patients are given a choice about such things.

The partners in my practice all believe that protocols and guidelines will accomplish nothing more than giving us more work to do and more rules to comply with. But they implore me to keep my mouth shut—rather than risk angering hospital administrators, insurance company executives, and the other powerful entities that control our fates.

Electronic Records and Financial Burdens

When Congress passed the stimulus, a.k.a. the American Reinvestment and Recovery Act of 2009, it included a requirement that all physicians and hospitals convert to electronic medical records (EMR) by 2014 or face Medicare reimbursement penalties. There has never been a peer-reviewed study clearly demonstrating that requiring all doctors and hospitals to switch to electronic records will decrease error and increase efficiency, but that didn’t stop Washington policymakers from repeating that claim over and over again in advance of the stimulus.

Some institutions, such as Kaiser Permanente Health Systems, the Mayo Clinic, and the Veterans Administration Hospitals, have seen big benefits after going digital voluntarily. But if the same benefits could reasonably be expected to play out universally, government coercion would not be needed.

Instead, Congress made that business decision on behalf of thousands of doctors and hospitals, who must now spend huge sums on the purchase of EMR systems and take staff off other important jobs to task them with entering thousands of old-style paper medical records into the new database. For a period of weeks or months after the new system is in place, doctors must see fewer patients as they adapt to the demands of the technology.

The persistence of price controls has coincided with a steady ratcheting down of fees for doctors. As a result, private insurance payments, which are typically pegged to Medicare payment schedules, have been ratcheting down as well. Meanwhile, Medicare’s regulatory burdens on physician practices continue to increase, adding on compliance costs. Medicare continues to demand that specific coded services be redefined and subdivided into ever-increasing levels of complexity. Harsh penalties are imposed on providers who accidentally use the wrong level code to bill for a service. Sometimes—as in the case of John Natale of Arlington, Illinois, who began a 10-month sentence in November because he miscoded bills on five patients upon whom he repaired complicated abdominal aortic aneurysms—the penalty can even include prison.

For many physicians in private practice, the EMR requirement is the final straw. Doctors are increasingly selling their practices to hospitals, thus becoming hospital employees. This allows them to offload the high costs of regulatory compliance and converting to EMR.

As doctors become shift workers, they work less intensely and watch the clock much more than they did when they were in private practice. Additionally, the doctor-patient relationship is adversely affected as doctors come to increasingly view their customers as the hospitals’ patients rather than their own.

In 2011, The New England Journal of Medicine reported that fully 50 percent of the nation’s doctors had become employees—either of hospitals, corporations, insurance companies, or the government. Just six years earlier, in 2005, more than two-thirds of doctors were in private practice. As economic pressures on the sustainability of private clinical practice continue to mount, we can expect this trend to continue.

Accountable Care Organizations

For the next 19 years, an average of 10,000 Americans will turn 65 every day, increasing the fiscal strain on Medicare. Bureaucrats are trying to deal with this partly by reinstating an old concept under a new name: Accountable Care Organization, or ACO, which harkens back to the infamous HMO system of the early 1990s.

In a nutshell, hospitals, clinics, and health care providers have been given incentives to organize into teams that will get assigned groups of 5,000 or more Medicare patients. They will be expected to follow practice guidelines and protocols approved by Medicare. If they achieve certain benchmarks established by Medicare with respect to cost, length of hospital stay, re-admissions, and other measures, they will get to share a portion of Medicare’s savings. If the reverse happens, there will be economic penalties.

Naturally, private insurance companies are following suit with non-Medicare versions of the ACO, intended primarily for new markets created by ObamaCare. In this model, an ACO is given a lump sum, or bundled payment, by the insurance company. That chunk of money is intended to cover the cost of all the care for a large group of insurance beneficiaries. The private ACOs are expected to follow the same Medicare-approved practice protocols, but all of the financial risks are assumed by the ACOs. If the ACOs keep costs down, the team of providers and hospitals reap the financial reward: surplus from the lump sum payment. If they lose money, the providers and hospitals eat the loss.

In both the Medicare and non-Medicare varieties of the ACO, cost control and compliance with centrally planned practice guidelines are the primary goal.

ACOs are meant to replace a fee-for-service payment model that critics argue encourages providers to perform more services and procedures on patients than they otherwise would do. This assumes that all providers are unethical, motivated only by the desire for money. But the salaried and prepaid models of provider-reimbursement are also subject to unethical behavior in our current system. There is no reward for increased productivity with the salary model. With the prepaid model there is actually an incentive to maximize profit by withholding services.

Each of these models has its pros and cons. In a true market-based system, where competition rewards positive results, the consumer would be free to choose among the various competing compensation arrangements.

With increasing numbers of health care providers becoming salaried employees of hospitals, that’s not likely. Instead, we’ll see greater bureaucratization. Hospitals might be able to get ACOs to work better than their ancestor HMOs, because hospital administrators will have more control over their medical staff. If doctors don’t follow the protocols and guidelines, and desired outcomes are not reached, hospitals can replace the “problem” doctors.

Doctors Going Galt? 

Once free to be creative and innovative in their own practices, doctors are becoming more like assembly-line workers, constrained by rules and regulations aimed to systemize their craft. It’s no surprise that retirement is starting to look more attractive. The advent of the Affordable Care Act of 2010, which put the medical profession’s already bad trajectory on steroids, has for many doctors become the straw that broke the camel’s back.

A June 2012 survey of 36,000 doctors in active clinical practice by the Doctors and Patients Medical Association found 90 percent of doctors believe the medical system is “on the wrong track” and 83 percent are thinking about quitting. Another 85 percent said “the medical profession is in a tailspin.” 65 percent say that “government involvement is most to blame for current problems.” In addition, 2 out of 3 physicians surveyed in private clinical practice stated they were “just squeaking by or in the red financially.”

A separate survey of 2,218 physicians, conducted online by the national health care recruiter Jackson Healthcare, found that 34 percent of physicians plan to leave the field over the next decade. What’s more, 16 percent said they would retire or move to part-time in 2012. “Of those physicians who said they plan to retire or leave medicine this year,” the study noted, “56% cited economic factors and 51% cited health reform as among the major factors. Of those physicians who said they are strongly considering leaving medicine in 2012, 55% or 97 physicians, were under age 55.”

Interestingly, these surveys were completed two years after a pre-ObamaCare survey reported in The New England Journal of Medicine found 46.3 percent of primary care physicians stated passage of the new health law would “either force them out of medicine or make them want to leave medicine.”

It has certainly affected my plans. Starting in 2012, I cut back on my general surgery practice. As co-founder of my private group surgical practice in 1986, I reached an arrangement with my partners freeing me from taking night calls, weekend calls, or emergency daytime calls. I now work 40 hours per week, down from 60 or 70. While I had originally planned to practice at least another 12 to 14 years, I am now heading for an exit—and a career change—in the next four years. I didn’t sign up for the kind of medical profession that awaits me a few years from now.

Many of my generational peers in medicine have made similar arrangements, taken early retirement, or quit practice and gone to work for hospitals or as consultants to insurance companies. Some of my colleagues who practice primary care are starting cash-only “concierge” medical practices, in which they accept no Medicare, Medicaid, or any private insurance.

As old-school independent-thinking doctors leave, they are replaced by protocol-followers. Medicine in just one generation is transforming from a craft to just another rote occupation.

Medicine in the Future

In the not-too-distant future, a small but healthy market will arise for cash-only, personalized, private care. For those who can afford it, there will always be competitive, market-driven clinics, hospitals, surgicenters, and other arrangements—including “medical tourism,” whereby health care packages are offered at competitive rates in overseas medical centers. Similar healthy markets already exist in areas such as Lasik eye surgery and cosmetic procedures. The medical profession will survive and even thrive in these small private niches.

In other words, we’re about to experience the two-tiered system that already exists in most parts of the world that provide “universal coverage.” Those who have the financial means will still be able to get prompt, courteous, personalized, state-of-the-art health care from providers who consider themselves professionals. But the majority can expect long lines, mediocre and impersonal care from shift-working providers, subtle but definite rationing, and slowly deteriorating outcomes.

We already see this in Canada, where cash-only clinics are beginning to spring up, and the United Kingdom, where a small but healthy private system exists side-by-side with the National Health Service, providing high-end, fee-for-service, private health care, with little or no waiting.

Ayn Rand’s philosophical novel Atlas Shrugged describes a dystopian near-future America. One of its characters is Dr. Thomas Hendricks, a prominent and innovative neurosurgeon who one day just disappears. He could no longer be a part of a medical system that denied him autonomy and dignity. Dr. Hendricks’ warning deserves repeating:

Let them discover the kind of doctors that their system will now produce. Let them discover, in their operating rooms and hospital wards, that it is not safe to place their lives in the hands of a man whose life they have throttled. It is not safe, if he is the sort of man who resents it—and still less safe, if he is the sort who doesn’t.

Jeffrey Singer practices general surgery in Phoenix, Arizona, writes for Arizona Medicine, the journal of the Arizona Medical Association, is an adjunct scholar at the Cato Institute, and is treasurer of the U.S. Health Freedom Coalition.