By Debbie Cenziper, ProPublica; Michael D. Sallah, Michael Korsh and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Monica Sager, Northwestern University

Tainted continuous positive airway pressure (CPAP) machines and ventilators went to children, the elderly and at least 700,000 veterans despite internal warnings. Company insiders said the devices posed an “unacceptable” risk.

The first complaints landed at the offices of Philips Respironics in 2010, soon after the company made a fateful decision to redesign its bestselling breathing machines used in homes and hospitals around the world.

To silence the irritating rattle that kept users awake at night, Philips packed the devices with industrial foam — the same kind used in sofas and mattresses. It quickly became clear that something had gone terribly wrong.

The reports coming into Philips described “black particles” or “dirt and dust” inside machines that pump air to those who struggle to breathe. One noted an “oily-like” substance. Others simply warned of “contamination.”

The complaints targeted some of the company’s most celebrated devices built in two factories near Pittsburgh, including ventilators for the sick and dying and the popular DreamStation for patients who suffer from sleep apnea, a chronic disorder that causes breathing to stop and start through the night.

Yet Philips withheld the vast majority of the warnings from the U.S. Food and Drug Administration (FDA), even as their numbers grew from dozens to hundreds to thousands and became more alarming each year.

“Black shavings in the chamber,” said one 2011 report that was kept from the government.

“Contaminated with unknown sticky substance,” noted another three years later.

By 2015, the year Philips launched the DreamStation, the company had amassed at least 25 complaints that pointed to a specific cause — the foam was falling apart.

In June 2021, more than a decade after the first reports, Philips announced a recall of millions of machines that had been delivered to nearly every corner of the U.S. and dozens of other countries.

The company acknowledged that the foam it had chosen could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats and lungs of users.

In a series of statements, the industry giant said it acted as soon as it learned of the “potential significance” of the problem.

But an investigation by ProPublica and the Pittsburgh Post-Gazette of the 11 years between the first complaints and the recall reveals a different story — one of a company that sought to protect its marquee products as stock prices soared to the highest levels in decades.

Again and again, previously undisclosed records and interviews with company insiders show, that Philips suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive.

Federal law requires device makers to turn over to the government within 30 days all reports of patient injuries, deaths and malfunctions that have the potential to cause harm and to take action to investigate them.

A ProPublica and Post-Gazette analysis of tens of thousands of reports shows that Philips withheld more than 3,700 complaints over 11 years from the FDA, which oversees medical devices.

The company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests for the company found that the foam was degrading.

Instead, as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam.

The sales pitch worked: The devices went to infants, the elderly and at least 700,000 veterans. The company also promoted machines meant for some of the sickest people in the country, rolling out a new ventilator filled with the foam in the early months of the COVID-19 pandemic.

Philips didn’t stop even after the company learned the foam was breaking down in its ventilators in Japan and had to be replaced — and after tests in the U.S. revealed that the material released chemicals at dangerous levels.

Among them: formaldehyde, a compound used in fertilizer, dyes and glues that has been tied to respiratory problems and certain cancers.

In 2018, the company called more than a dozen engineers and safety supervisors to a series of urgent meetings in Pittsburgh to investigate the problem in what eventually became known to insiders as Project Uno.

Still, the public was not warned.

All the while, people using Philips machines were suffering from illnesses that no one could explain: vomiting, dizziness and headaches, along with newly diagnosed cancers of the lungs, throat, sinuses and esophagus.

One man in Philadelphia coughed so hard that he broke his ribs, and a Florida woman with a hacking cough was hospitalized for days and placed on oxygen.

[…]

To examine what happened at Philips, reporters interviewed more than 200 former company supervisors, doctors, toxicologists, patients and the relatives of those who died and obtained company records that show officials knew about the dangers but continued to sell machines that the FDA had since said are capable of causing severe illness or death.

Reporters also reviewed thousands of complaints submitted to the company and government describing device malfunction and injuries, including more than 370 reports of deaths.

As part of the investigation, the news organizations collaborated with Mediahuis NRC, the publisher of one of the largest newspapers in the Netherlands, where Philips’ parent company is located.

In a statement to the news organizations, Philips said its top priority is patient safety and that it regretted “the distress and concern” caused by the recall.

“We deeply apologize for that and continue to work hard to resolve this,” the company said.

Philips said complaints about the foam were limited in the years before the recall and that the reports were evaluated on a case-by-case basis. The company added that it became aware of the potential significance of the problem in early 2021 and launched the recall shortly after that.

Former company engineers and safety supervisors, who spoke on the condition of anonymity because they still work in the industry, said top officials at Philips repeatedly dismissed a dangerous breakdown that ultimately set off a worldwide health crisis involving as many as 15 million devices.

“It was a catastrophic series of errors,” said a former compliance supervisor. “There were people who knew and knew for a long time.”

In the months since the recall, the company has walked back its initial acknowledgment of the health risks posed by the degrading foam, saying tests on the DreamStation and similar devices show the chemicals released by the material fall within safety thresholds.

“The whole product complies with safety norms,” Roy Jakobs, chief executive officer of parent company Royal Philips, said last year.

ProPublica and the Post-Gazette obtained copies of four tests carried out in 2021 that were solicited by Philips. Three experts who reviewed the results for the news organizations dispute the company’s claim and point to another finding that they say is even more alarming.

The foam tested positive multiple times for genotoxicity — the ability of a chemical to cause cells to mutate, a process that can lead to cancer.

“You’re basically changing cells,” said one engineer who was familiar with the testing. “I don’t even know if we really scratched the surface of how bad this really is.”

In New York, 58-year-old retired music teacher and father of three Mark Edwards said he’ll spend the rest of his life fearing that a sleep apnea machine caused years of respiratory infections and two benign tumors in his throat.

Edwards brought home a DreamStation in 2017 and set it up next to his bed, where he sleeps with his rescued German shepherd, Tyson. He continued using it even after he said he began to spot black particles in his mask.

[…]

A competitive edge

[…]

Throughout the 1980s, McGinnis invented a series of breathing masks and ultimately developed the nation’s first mass-produced continuous positive airway pressure, or CPAP machine, sold under the banner of his growing company, Respironics.

During a scientific renaissance that transformed Pittsburgh from a steel town into a hub for medical innovation, the company became a dominant player in a thriving industry that would change the lives of those struggling with sleep apnea.

[…]

Locked in a race to make its breathing machines quieter, the company inserted the foam to muffle the sound. The change was a triumph in the world of sleep apnea, a way to quiet the humming, vibrating machines that disturbed patients and their partners as they slept.

[…]

It was a risky move. Studies published in scholarly journals showed the foam broke apart in heat and moisture. The company used it anyway, even though the machines send air for hours at a time into the lungs of users.

“Anybody who has half a brain cell in chemistry knows that this was a stupid idea,” said the engineer who was familiar with the recent testing.

Soon, alarming reports began to surface.

In June 2010, Philips found that a machine sent back to the company by a customer was contaminated with “foam particles,” FDA records show.

Rather than alerting the government as federal law required, records reveal that the company kept the report about the problem in-house for the next decade.

[…]

By the end of 2014 — about six years after Philips started using the foam — more than 500 reports from healthcare workers, patients and others had flooded the company in a pattern that would not be revealed to the government or the public for years, the records show.

[…]

Philips received more than 3,700 reports about foam problems before recalling machines

For more than a decade, the company used polyester-based polyurethane foam in its ventilators and CPAP machines to reduce noise. In that time, it received thousands of complaints about “dust contamination,” “black particles” and “foam degradation.”

[…]

Mounting Injuries

[…]

The company alerted the FDA but said nothing to its customers — news reports at the time were largely limited to the company’s positive earnings. Over the next six weeks, more complaints came in, one after another:

[…]

Philips withheld thousands of complaints about foam problems from the FDA

After Philips issued a recall in 2021, the company turned complaints over to federal regulators, including more than 2,500 that it had withheld for more than two years.

[…]

The true extent of the crisis may not be known for years.

As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government.

The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.

[…]

Via https://childrenshealthdefense.org/defender/philips-respironics-ventilators-children-elderly/

Remarkable as it may seem, 99% of the proteins, carbohydrates, fats, minerals, vitamins and other biochemical scomponents making up whole food are a complete mystery. So how can scientists replicate those components in lab food? And what are we missing in our diets if those components aren’t all there?

Story at a glance:

• An estimated 99% of the components making up whole food are a complete mystery. The U.S. Department of Agriculture’s (USDA) National Nutrient Database for Standard Reference details 188 nutritional components of food, including 38 flavonoids, yet scientists estimate there are more than 26,000 different biochemicals in our food.
• We know even less about the constituents of processed foods and synthetic foods, which falsely claim to be “equivalents” to whole foods, such as “animal-free meats” or “animal-free milk.”
• Scientists cannot create equivalence when they don’t even know what 85% or more of the whole food they’re trying to replicate consists of.
• A paper published in the April issue of Animal Frontiers warns that cultured products are not nutritionally equivalent to the meats they’re intended to replace.
• A May report by the Food and Agriculture Organization concluded there are at least 53 potential health hazards associated with lab-grown meat, including the possibility of contamination with heavy metals, microplastics, nanoplastics and chemicals, allergenic additives, toxic components, antibiotics and prions.

Do you know what’s in the food you eat? Remarkable as it may seem, 99% of the components making up whole food are a complete mystery.

As reported by New Scientist in July 2020:

“We know next to nothing about the vast majority of compounds in our diet … ‘Our understanding of how diet affects health is limited to 150 key nutritional components,’ says Albert-László Barabási at Harvard Medical School, who coined the term nutritional dark matter.

“‘But these represent only a small fraction of the biochemicals present in our food’ … The idea that food is a rich and complex mix of biochemicals is hardly news.

“Even the well-known macronutrients — proteins, carbohydrates and fats — are hugely diverse. There’s also a vast supporting cast of micronutrients: minerals, vitamins and other biochemicals, many of which are only present in minuscule quantities, but which can still have profound health effects.”

The official source of nutritional information is the USDA’s National Nutrient Database for Standard Reference.

It lists the composition of hundreds of thousands of foods, but it’s not as detailed as you might imagine.

In all, it details only 188 nutritional components, including 38 flavonoids, yet scientists estimate there are more than 26,000 different biochemicals in our food.

As noted by New Scientist: “With the USDA as your guide, 99.5% of the components in food are a mystery,” and as noted by Barabási, “It would be foolish to dismiss 99.5% of the compounds we eat as unimportant … We will not really understand how we get sick if we don’t solve this puzzle.”

Searching for nutritional ‘dark matter’

Disturbed by the information gap, an international team of researchers started working on a more comprehensive database a decade ago called FooDB, which as of 2020 contained information on some 70,000 nutritional compounds.

Yet even this database still has a long way to go. An estimated 85% of the nutritional components listed remain unquantified, meaning they know a food contains a particular component, but they don’t know how much.

The health implications of most compounds also remain largely unknown.

New Scientist notes:

“This is also true of individual micronutrients. ‘Consider beta-carotene,’ says Barabási. ‘It tends to be positively associated with heart disease, according to epidemiological studies, but studies adding beta-carotene to the diet do not show health benefits. One potential reason is that beta-carotene never comes alone in plants; about 400 molecules are always present with it. So epidemiology may be detecting the health implications of some other molecule.’

“Another probable cause is the effect of the microbiome on dark nutrients, says [FooDB founder David] Wishart. ‘Most dark nutrients are chemically transformed by your gut bacteria.’

“That’s probably why studies on the benefits of different foods give relatively ambiguous results. We don’t properly control for the variation in gut microflora, or our innate metabolism, which means different people get different doses of metabolites from their food.”

Processed foods are an even greater mystery

The reason I started with that background is because we know even less about the constituents of processed foods and synthetic foods that ignorantly claim to be “equivalents” to whole foods, such as “animal-free meats” or “animal-free milk.”

Food processing alone will often alter the composition of bioactive molecules in a food and hence the food’s impact on health, but today, processed foods also contain a wide array of synthetic chemicals that, prior to the modern era, were never part of the human diet.

As such, they pose incredible risks to long-term health and well-being. Processed foods may also have intergenerational effects.

“How can scientists create equivalence when they don’t even know what 85% or more of the whole food they’re trying to replicate consists of?”

In recent years, the idea that we can simply replace whole foods with synthetic, genetically modified or lab-grown alternatives that are wholly equivalent to the original food has taken root. In reality, that’s simply impossible.

How can scientists create equivalence when they don’t even know what 85% or more of the whole food they’re trying to replicate consists of?

Common sense will tell you they can’t. It might look, smell and even taste similar, but the micronutrient composition will be entirely different, and as a result, the health effects will be incomparable as well.

Animal-free equivalence is a PR fraud

Take cultured meat, for example. It’s said to be equivalent to real animal meat because it’s grown from animal cells. The cells are then grown in a nutrient solution inside a bioreactor until they become a meat-like slab.

Similarly, Bored Cow animal-free milk is a dairy alternative made with whey protein obtained through a fermentation process, plant-based fats (in lieu of milk fats), citrus fiber (for creaminess) and added vitamins and minerals.

Defenders of cultured meat insist that this product is not “fake meat” but “actual meat,”

the only difference is that no animal had to be slaughtered to create it.

Cultured meat and other synthetic foods are also said to be more environmentally friendly. But nothing could be further from the truth.

Their impact is far more akin to that of the pharmaceutical industry than the food industry.

According to a recent “cradle-to-gate life cycle” analysis, the lab-grown meat industry produces anywhere from four to 25 times more CO2 than traditional animal husbandry.

Based on this assessment, each kilo of cultured meat produces anywhere from 542 pounds (246 kilos) to 3,325 pounds (1,508 kg) of carbon dioxide emissions, making the climate impact of cultured meat four to 25 times greater than that of conventional beef.

And this information is only provided to refute those who believe the global warming fallacy.

As noted by the authors, investors have poured billions of dollars into the animal cell-based meat sector based on the theory that cultured meat is more environmentally friendly than beef.

However, according to these researchers, that hype is based on flawed analyses of carbon emissions.

Cultured meat is also the epitome of ultra-processed food and therefore likely to cause health problems like those caused by other ultra-processed foods, such as obesity, cardiovascular diseases, Type-2 diabetes, metabolic syndrome, irritable bowel syndrome, cancer, mental health problems and increased all-cause mortality.

A paper published in the April issue of Animal Frontiers also warned that there are several implications of cell-based meat that need to be considered but aren’t, including the fact that cultured products are not nutritionally equivalent to the meats they’re intended to replace.

The claim that no animals are killed in the process is also false. At present, most cultured or cell-based meats are created by growing animal cells in a solution of fetal bovine serum, which is made from the blood of unborn calves.

In short, pregnant cows are slaughtered to drain the unborn fetus of its blood.

Is it safe to eat tumors?

There are also many unanswered questions surrounding safety. For example, to get the cell cultures to grow, some companies are using immortalized cells, which technically speaking are precancerous and/or fully cancerous.

(Other companies use embryonic stem cells or cells from living animals.)

The reason for using immortalized cells is that normally behaving cells cannot divide forever. Most cells will only multiply a few dozen times before they become senescent (old) and die.

This won’t work when your intention is to grow thousands of pounds of tissue from a small number of cells, hence they use immortalized cells that have no off switch for their replication and can divide indefinitely.

Meat substitutes cultured in this way could therefore be thought of as tumors, seeing how the flesh is entirely made up of precancerous or cancerous cells. Is it safe to eat tumors? We don’t know.

Massachusetts Institute of Technology biologist Robert Weinberg, Ph.D., has proposed that humans can’t get cancer from these cells because they’re not human cells and therefore cannot replicate inside your body.

However, there’s no long-term research to back this theory.

Dietary headaches to come

It’s also important to realize that the nutritional composition and safety of synthetic foods will vary depending on the brand.

When you’re dealing with beef, for example, the meat from one cow will be relatively identical to that of any other cow (one major exception being the way they’re raised and fed).

One wild-caught salmon is comparable to any other wild-caught salmon and each russet potato is more or less identical to every other russet potato.

However since each synthetic food brand uses proprietary ingredients and processes, no two will have identical composition or safety, so even if one is eventually proven safe and nutritious, those results cannot be applied to any other brand.

This variance has the potential to create major problems in the future when all sorts of foods have been replaced with synthetic non-equivalents.

How do you determine which cultured beef, chicken or salmon brand might be best for you? How will you devise a sensible diet plan when every food comes in myriad variations of varying composition and safety?

Synthetic foods pose unique food-safety hazards

Many synthetic food proponents claim lab-created food will bypass a host of food-safety problems, but the converse is far more likely to be true.

Sure, beef, for example, can be contaminated during processing, packaging, transport or storage, or during the cooking process.

But in cultured meat, every ingredient and processing step brings with it the potential of contamination and any of the hundreds of ingredients could have toxic effects, alone or in synergy.

Indeed, an in-depth analysis of the available evidence by the Food and Agriculture Organization of the United Nations and a World Health Organization expert panel, published in May, concluded there are at least 53 potential health hazards associated with lab-grown meat.

Among them are the possibility of contamination with heavy metals, microplastics, nanoplastics and chemicals, allergenic additives, toxic components, antibiotics and prions.

What’s more, some of the ingredients that go into synthetic biology like cultured meat are regulated as “non-detectable manufacturing aids,” and you won’t even know what they are. Israeli startup Profuse Technology, for example, has developed a growth media supplement that massively encourages protein growth.

As reported by Food Navigator Europe in an article titled, “Cultivated Meat ‘Breakthrough’: Media Supplement Achieves Full Muscle Maturation on Scaffold Within 48 Hours,” the supplement reduces the time to grow filets and steaks by 80% and augments the protein in the final product by a factor of five.

[…]

Via https://childrenshealthdefense.org/defender/lab-grown-synthetic-food-dangerous-cola/

by Brian Shilhavy
Editor, Health Impact News

Today, October 3, 2023, is a historical day in the United States, as chaos now reigns in America’s political and financial sectors.

In the U.S. Congress, Speaker of the House of Representatives Kevin McCarthy was removed from his position by a vote of his fellow members of the House of Representatives, something that has never happened in the history of the United States until today.

Shortly before McCarthy lost his position as Speaker of the House of Representatives, the U.S. Stock Market closed with the Dow Jones Industrial Average losing over 400 points, its highest loss since the banking collapses back in March, giving up all of its gains on the year.

The huge loss in the Stock Market today is being blamed on rising Treasury yields.

Major U.S. stock indexes closed sharply lower on Tuesday as a surge in Treasury yields continued, pushing long-term benchmark rates to their highest level since the fall of 2007.

The Dow Jones Industrial Average shed about 430 points, or 1.3%, ending near 33,003, according to preliminary FactSet data. That marked the blue-chip index’s biggest daily drop since the March banking crisis, according to Dow Jones Market Data. It also erased the Dow’s yearly gain, with the index now down 0.4% in 2023.

Other equity gauges also skid Tuesday, with the S&P 500 index ending down 1.4% and the Nasdaq Composite Index closing 1.9% lower. Stocks have been under pressures from the continued climb in longer 10-year and 30-year Treasury yields since the Federal Reserve signaled rates could stay high through 2024 and beyond at its September meeting. (Source.)

Pam Martens of Wall Street on Parade issued a dire warning in her newsletter today:

The Fed’s problem and the U.S. Treasury’s problem just became the problem of every American who has their retirement savings stuffed in the stock market via 401(k) plans or direct holdings.

[S]tocks do not like yields on the 10-year U.S. Treasury note rising to a level that is competitive with the return on stocks – especially since the principal on the Treasury note is guaranteed at maturity while the principal in the stock market is guaranteed to take one’s stomach on a roller coaster ride.

Last evening, the 10-year U.S. Treasury note had spiked to a yield of 4.682 percent, its highest yield since 2007. As of early this morning, its yield had spiked even higher, to 4.738 percent, making a 5 percent handle increasingly possible.

In response to the competition from Treasury securities and chaos in running the U.S. government, stocks have sold off in 8 of the last 10 trading sessions through Monday.

On September 21, the U.S. Treasury’s Assistant Secretary for Financial Markets, Josh Frost, delivered a speech in which he indicated that “we expect that further gradual increases in coupon auctions sizes will likely be necessary in future quarters.”

Frost also indicated that the Treasury is, apparently, going to join the thinking of the wizards at the Wall Street mega banks who prop up their banks’ share prices by spending tens of billions of dollars a year buying back their own stock.

The Fed, as you might recall, called its Treasury buyback program Quantitative Easing or QE for short. The Fed is now attempting to whittle itself out of the $9 trillion mess to its balance sheet that resulted from that radical experiment by shrinking its balance sheet. So far, it’s whittled away about $1 trillion.

Which means that a new buyer of last resort for Treasury securities is needed. But should that really be the same entity that is issuing the debt in the first place? If the Treasury has the money to buy back its debt, why is it issuing the debt? (Full article.)

One analyst wrote that one major source of rising U.S. bond yields is China, who has sold $300 billion worth of US Treasurys since 2021, including $40 billion since April 2023.*

As to who is going to replace McCarthy as Speaker of the House of Representatives, who is second in line to take over as President of the United States, after the Vice President, is anybody’s guess at this point.

As rumors spread over the weekend that McCarthy could lose his position as Speaker of the House, no names had surfaced yet as to who his replacement could be as of today. It took 15 rounds of voting back in January to install McCarthy as Speaker of the House, and Donald Trump’s name started showing up in the latter ballots cast. Could we see a stronger effort this time to bring back Trump?

But it would also not be surprising to see some of the older Republicans reach out across the aisle to Democrats, which could even result in a Democrat taking over as the House Speaker, such are the crazy times we now live in.

Whatever happens, we are much closer today to a total economic and societal collapse here in the United States, than we were yesterday. More banks collapsing seems like a certainty at this point.

[…]

Via https://healthimpactnews.com/2023/economic-and-political-chaos-descends-upon-the-united-states/

*Both China and Japan (now the largest holder of US treasury bonds) are selling off. Japan’s holdings of $1.1 trillion represent 4.4% of the total, while China’s $835 billion is equal to 3.4%, according to the most recent Treasury data from the end of June. See https://asia.nikkei.com/Business/Markets/Bonds/Japan-China-pare-U.S.-Treasury-holdings-as-currencies-hit-new-lows#:~:text=Japan’s%20holdings%20of%20%241.1%20trillion,from%20the%20end%20of%20June.