Occasional Afternoon Rant, 8/14

Is the USA capable of providing for its own medical necessities?

Well, no.

J.J. Sefton, Ace and I have been providing updates on the illicit Chinese biotech lab in Reedley, California. More on that below. There have been other issues which have reminded us that the USA has been losing the capability to provide for its own medical necessities for a long time. For example, here's an update on:

The Infant Formula Crisis

This crisis extended from about this time in 2021 into this year. Imagine!

Background, City Journal, May 2022:

Parents of young infants have become alarmed by an ongoing shortage of baby formula--an essential food for non-breastfed infants under six months of age and some infants and children with medical needs. The shortage, which began unfolding in late summer 2021, worsened with Abbott Nutrition's recall on February 17 of three brands of formula possibly contaminated by Cronobacter bacteria. The tale of this crisis, however, goes beyond contaminated infant formula and the FDA's efforts to enforce its food-safety regulations and includes the FDA's mismanagement of its efforts to combat the infant-formula shortage.

The Food and Drug Administration's March 18 report of inspections over six weeks of Abbott Nutrition's facility in Sturgis, Michigan, noted findings of Cronobacter both in the processing environment and in finished formula. Surprisingly, the report, signed by a dozen FDA officials, noted that "Between 9/25/19 and 2/20/22, [Abbott Nutrition's] environmental samples and finished product testing confirmed the presence of Cronobacter," suggesting that the problem was long-standing and known to Abbot officials. Yet an FDA inspection of the same plant in September 2021 did not mention Cronobacter, though it noted violative practices including a failure to maintain the building in a clean and sanitary condition and lack of proper hand-washing. . . .

Recommendations are provided.

I heard an interview on NPR with the head of a start-up infant formula company in the USA who suggested that outmoded regulations by the FDA, requiring extensive clinical testing for new formulas, meant that infants in the USA were receiving sub-optimal nutrition. But he was very diplomatic in avoiding offense toward the government.

Anyway, it sounds like some of the manufacturing capacity remaining in the USA is not exactly up to snuff. A six week inspection.

Which, I think, does not mean that we should accept infant formula from China. Imagine the FDA doing inspections on a Chinese plant like the inspections they did at Abbott! And most pharmaceutical manufacturing capacity in the USA has just disappeared.

The FDA seized imported infant formula from Europe at the border, leaving parents with nothing. Reason reported in July of 2022 that the FDA had finally admitted that it was responsible for the crisis, and had begun steps to allow into the country some formula which was approved in European countries. Some of which probably have higher standards than the FDA at this point.

The FDA could keep infant formula out, but they couldn't keep toxic hand sanitizer out.

Rick Moran, March 2023:

Remember the baby formula shortage last year? A major manufacturer of infant formula, Abbott Labs, was forced to close its Michigan plant due to contamination by a deadly bacteria. The factory produced 40% of the nation's supply of infant formula, including most of the specialty formulas.

This led to massive shortages, empty grocery shelves, and panicked parents who went from store to store looking for food for their babies. To try and make up for the shortages, the Biden administration and Congress cut the tariffs that kept out foreign competition.

The result was soaring imports and an alleviation of the crisis. But on Jan. 1, 2023, the tariffs returned. And now, so have the shortages.

And quoting Reason as congressional hearings got underway:

The fact that the FDA has admitted it played a major role in creating the baby formula shortage in the first place but has steadfastly refused to hold anyone at the administration accountable for those mistakes should temper any expectations of positive changes. . .

Contaminated Artificial Tears

The contaminated artificial tears which caused at least 70 infections in the USA, including blindness and three deaths, were imported from India.

Who writes these headlines? "The bacterium Pseudomonas aeruginosa, which mutated over time to evade most treatments, had not been found in the U.S. until last year."

Not quite right. That strain of pseudomonas aeruginosa has not been found in the U.S. before. Prior strains could still make you blind. Don't scratch your eye with that old mascara wand.

Do you think that the FDA will be doing an Abbott-style inspection of the Indian plant? Here is the regulation on Water for Pharmaceutical Use from the FDA's guidelines for inspections, compliance, enforcement and criminal investigations/inspection.

There is zero tolerance for Pseudomonas in pharmaceutical water in the USA. Don't know about India. Might be even harder to do an inspection in China.

U.S. Health Authorities are well-respected in China. For sure.

Our NIH is very concerned about the over-use of antibiotics in China. April, 2022: Interventions to optimize the use of antibiotics in China: A scoping review of evidence from humans, animals, and the environment from a One Health perspective

Is there an official "One Health" perspective out there that I don't know about?

Objectives

The overuse and misuse of antibiotics has accelerated the rapid emergence of antibiotic resistance. The aim of the study was to review interventions conducted in China to optimize use of antibiotics in humans, animals, and the environment from a One Health perspective.

They did a literature review.

Conclusions

China has made major efforts on improving rational use of antibiotics in the past decades. Most policies or interventions, however, focused mainly on the human health aspect, less effort targeted toward the environment and animal health sectors. For further optimizing use of antibiotics, the cross-disciplinary and coordinated multi-faceted interventions guided by the One Health perspective should be developed and implemented. Meanwhile, the cross-departmental collaborative mechanism leading by the Chinese central government should be further strengthened to play a greater and more active role in fighting against antibiotic resistance wholly.

So, this is how we influence the CCP's policies? With literature reviews?

Meanwhile, Sean Durns reminded us last year in the New York Sun that:

One growing threat to American national security has largely gone under the radar -- the American military's reliance on pharmaceuticals manufactured by Communist China. America has offshored the manufacturing of key industries to China and elsewhere. Pharma, though, is seldom considered to be part of the nation's defense industrial base.

Today, though, there is, if belatedly, a growing awareness of the dangers of offshoring defense-related industries and products. . .

Even when pharmaceuticals aren't entirely manufactured in China, the materials required to make them are still sourced from the Middle Kingdom. China is the largest producer of active pharmaceutical ingredients, which are essential to the manufacturing of medicine. The USCC noted that China is now the second largest pharmaceutical market in the world by revenue.

Low production costs, a large consumer base, and breadth of expertise have enabled Beijing to supplant America. China's dominance is even greater as other manufacturing countries, such as India, are themselves reliant on Chinese-sourced active pharmaceutical ingredients. Some 80 percent of key ingredients for India's generic drug manufacturing come from China.

China's near monopoly on pharmaceuticals gives Beijing the ability to bring America to its knees, providing the ruling Chinese Communist Party with tremendous leverage. Time and again, the CCP has shown itself willing to wield its manufacturing capabilities to threaten countries as far removed from Communist China as Lithuania.

As one expert on Sino-American rivalry, Aaron Friedberg, a former U.S. deputy national security adviser, observed, the Chinese Communist party has "always regarded economic policy as a tool for enhancing China's power" over the United States and its allies. The CCP has already threatened to use its pharmaceutical manufacturing power.

Although the U.S. continues to hold an edge in the engineering of new drugs, China's dominance of the supply chain for generic medicine is particularly problematic. A senior advisor at the Hastings Center, Rosemary Gibson, author of the book on this crisis called "China Rx," has pointed out that America "can't even make penicillin anymore."

The United States, she warns, is almost entirely "dependent" on Beijing for the manufacturing of penicillin and other antibiotics to combat superbugs. Were China to "shut the door on exports, within months hospitals would cease to function." This danger applies to the American public writ large, but our military itself wouldn't be immune.

Policymakers need to plan accordingly. Historically, war brings not only death and destruction, but also disease.

Cheery!

Other Trends in Asia

China moves to shut out foreign medical equipment makers.

Maybe we should move to shut out Chinese medical equipment makers.

Life Sciences Trends to watch for in 2023, Asia Edition:

More partnerships between giant firms which develop new drugs and China.

China's dominance in CAR-T therapy

Biotech development in China

And more!

Brookings: Testimony on China's role in the fentanyl crisis.

Chinese Biotech Lab in Reedley

Our last update on this issue was Playing Kick the Can: The Chinese Biotech Lab in Reedley, which unfortunately became involved in last Saturday's "Lost in Space" episode on the blog. I have closed comments on this thread, the tech thread and the other threads affected. Some comments have been lost, so if you said something interesting, you might want to repeat it here.

Gentlemen, this is junta manifest, currently living in Japan, made a late comment to the effect that Gordon Chang, who has changed his position on China a few times, wrote a hair-on-fire analysis at Gatestone. I'm not linking it because it really is kind of urgent-sounding. Interesting that this type of commentary is starting to appear.

The feds might not want to be so reticent about this issue if they don't want the conspiracy theories to run wild. Because a lot of the details that are trickling out are perfect fodder for conspiracy theories. Or for theories of massive incompetence. Combined with greed and free money from our government (as noted in the comment).

Most of the information we are getting is coming from city, county and state sources. And press, often local. I can't say that all the information I have found fits together. Some of it may be wrong.

This is the facility in Reedley under discussion:

A huge facility which the Chinese lab moved into under cover of night, formerly used for packing fruit (VDH says he packed fruit there as a teenager) and then apparently as a furniture warehouse.

I don't know if the "cold storage" part still worked. It seems they brought in freezers and refrigerators. I don't think this crew was qualified to occupy a facility using ammonia refrigeration, given their earlier building code violations in Fresno.

Inspection reports from the city of Fresno show numerous electrical and storage safety dangers -- as well as chemicals stored outside the scope allowed -- for the company whose disease samples, biological waste, and lab mice would be found months later at a storage facility in Reedley.

It took two years for city inspectors to follow up on demands to correct safety violations, according to city records. City leadership attributed the lack of timely accountability to COVID-19.

Additionally, once the inspections were made, absent management at UMI made it hard for inspectors to see what exactly was being kept at Universal Meditech Inc.'s facility in south central Fresno.

Landlord's Complaints Prompted Inspectors to Check Out UMI

More at the link.

Are you surprised that they had an electrical fire in Fresno before secretly moving to Reedley?

State of California also granted a “Biowaste disposal permit”. Why did State and Federal authorities want this hidden? A reporter uncovered it two weeks ago. On 12/21/22 the City Msnager in Reedley CA was told to keep it quiet. pic.twitter.com/cpPHbBqav4

— Shelley (@ProudArmymom66) August 11, 2023

The feds and the state said they planned to investigate back in December of '22 and asked the city manager to keep quiet about the lab, as they knew that the outfit intended to move back to Fresno?

She reported the creepy findings in March of '23 to state and federal officials.

Also in the thread above, CDC plans no further action on this issue?

The City of Reedley drafted statements for public release much earlier than public statement were given, but was largely left in the dark by "higher authorities" about exactly how to respond.

Timeline, move from Tulare to Fresno to Reedley, experiences of an employee.

Who owns the property?

Philip Lenczycki wrote a detailed piece on the Reedley lab and China at Daily Caller. We linked it on Saturday. He also wrote a long thread on the attempts to connect people and medical firms in China to various labs in the USA. It is complex.

Some of the efforts to locate those responsible for the labs have been recorded in court documents.

How many American firms get away with hiding the identity of their owners?

Thought: Was there some reluctance to identify those in charge (both in the USA and China) because they were embarrassing the Chinese government?

Photo notes: Coco the Colobus Monkey (at the top of the post) lives at Zoo Atlanta. The conclave of Colobus Monkeys just above lives at Hogle Zoo.

posted by K.T. at 01:15 PM

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