FDA Aims To Stifle Medical Innovation Again

By Ronald Bailey, Reason, April 2024.

Excerpt:

The Food and Drug Administration (FDA) that massively screwed up COVID-19 testing now wants to apply its vast bureaucratic acumen to all other laboratory developed tests (LDTs). By insisting on its recondite approval procedures, the FDA at the beginning of the pandemic stymied the rollout of COVID-19 tests developed by numerous academic and private laboratories. In contrast, public health authorities in South Korea greenlighted an effective COVID-19 test just one week (and many more in the weeks following) after asking representatives from 20 private medical companies to produce such tests.

LDTs are diagnostic in vitro tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide the treatment of breast cancer.

The FDA now wants to regulate these tests as medical devices that must undergo premarket agency vetting before clinicians and patients are allowed to use them. The FDA estimates that between 600 and 2,400 laboratories currently offer as many as 40,000 to 160,000 tests. Overall, some 3.3 billion in vitro tests are administered to patients annually.

Wow! The FDA plans to be even more detructive of human health than it has been.

How Capitalism Beat Communism in Vietnam

by Rainer Zitelmann, Reason, May 2024.

Excerpts:

The reforms adopted in the next couple of years included permission for private manufacturers to employ up to 10 workers (later increased), abolition of internal customs checkpoints, elimination of the state foreign-trade monopoly, reduced restrictions on private enterprise, elimination of virtually all direct subsidies and price controls, separation of central banking from commercial banking, dismantling major elements of the central planning and price bureaucracies, the return of businesses in the South that had been nationalized in 1975 to their former owners or their relatives, and the return of land seized in the ’70s collectivization campaign if it was “illegally or arbitrarily appropriated.”

And:

Vietnam’s gross domestic product grew by 7.9 percent a year from 1990 to 1996, faster than any other Asian country but China. Poverty fell sharply. By the World Bank’s standard for extreme poverty—living on less than $1.90 a day—52.3 percent of the Vietnamese population was living in extreme poverty in 1993. By 2008, the figure had fallen to 14.1 percent. By 2020, it was only 1 percent. That indicator was developed for “low-income economies,” though, and Vietnam has now moved to the “lower-middle-income” category, where poverty is defined as living on less than $3.20 a day. By that measure, the poverty rate dropped from 79.7 percent to just 5 percent.

Israel announces largest West Bank land seizure since 1993 during Blinken visit

by Cate Brown, Washington Post, March 22, 2024.

Palestinians have little ability to stop the land transfers. After the 1967 war, Israel issued a military order that stopped the process of land registration across the West Bank. Now families lack the paperwork to prove that they have private ownership over their land. And tax records, the only other evidence of West Bank property rights, are not accepted by Israeli authorities.

In June, the Knesset waived a long-standing legal precedent that required the prime minister and the defense minister to sign off on West Bank settlement construction at every phase. Smotrich enjoys near-total control over construction planning and approvals in the West Bank, and approved a record number of settlements in 2023.

“Israel has reached the conclusion that they could get away with this huge land grab because of the lack of international action,” said Sarit Michaeli, international advocacy lead at B’Tselem. “There have been individual economic U.S. sanctions placed on violent settlers, but the greater violence of the occupation is this colossal land theft.”

Steven Pinker: What Went Wrong at Harvard

by Nick Gillespie, Reason, March 27. 2024.

Excerpts:

Pinker: The first of the five-point plan was just consistent commitment to academic freedom. Because another reason that Claudine Gay got into such trouble is that when she was given what admittedly was a kind of a trap that she walked into—that is, if students called for genocide against Jews, would that be prohibited by Harvard’s code of conduct—she made a pretty hardcore [American Civil Liberties Union]-style free speech argument, which came across as hollow or worse, because we’ve had a lecturer who was driven out of Harvard for saying there are two sexes.

There was another professor whose course was canceled because he wanted to explore how counterinsurgency techniques could be used against gang warfare. We had a professor in the School of Public Health who had cosigned an amicus brief for the Obergefell Supreme Court case against a national policy allowing gay marriage. There were calls for his tenure to be revoked, for his classes to be boycotted. He had to undergo struggle sessions and restorative justice sessions and basically grovel in front of a mob. Given Harvard’s history of those cases and others, to all of a sudden say, “Well genocide, it’s just a matter of I disagree with what you say, but I defend it to the death your right to say it,” came off as a little bit hollow and hypocritical.

Pinker: I have nothing against diversity, equity, and inclusion. But as Voltaire said about the Holy Roman Empire: it was neither holy, nor Roman, nor an empire. Diversity, equity, and inclusion imposes an intellectual monoculture. It favors certain groups over others. It has a long list of offenses that mean you can be excluded. But it is a strange bureaucracy. It’s a culture that is kind of an independent stratum from the hierarchy of the universities themselves. The officers get hired or poached to move laterally from university to university. It’s with their own culture, their own mores, their own best practices. It’s just not clear who they report to, or who supervises them, or who allows them to implement policy.

Pinker: Yes. Not at Harvard, but at many universities. No one knew that we had this requirement. No one knew who implemented it. The faculty never voted on it. The president never said this is our policy going forward. A dean of arts and sciences must have signed off on it, but no one can remember who or when. But we just live with it. Likewise, freshman orientation consists of indoctrination sessions.

This is emblematic of a trend in universities, that this nomenklatura just got empowered and no one knows exactly how. What often happens is a dean gets into trouble because of some racial incident. They hire a bunch of staff, and that’s their way of getting out of the trouble. Then they’re there forever. And there is only one way that they’ve been changing and that’s upward.

I love the line “it was neither holy, nor Roman, nor an empire.” Aside from that, Mrs. Lincoln, how was the play?

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The covid pandemic decimated the supply chain. People needed goods — perhaps more than they ever had — but factories and warehouses struggled to keep up due to workers being sick and social distancing rules.

Truck drivers still did their jobs but, in many cases, the support systems they relied on were not operational. Rest stops and restaurants were closed and even finding an operating bathroom was a challenge.

Related: Discount retailer faces Chapter 11 bankruptcy or liquidation

It was a period that created some opportunity as the demands of the entire nation shifted, but it also increased costs. Trucks were waiting to be loaded, drivers were unable to hit the toad because they, or someone close to them, got sick, and the entire industry was under stress.

A number of regional carriers have since been driven into bankruptcy and, now, a major carrier has filed for Chapter 11 bankruptcy with parts of its filing falling under Chapter 15 of the bankruptcy code. That's a lesser-used type of bankruptcy designed to protect foreign companies operating in the United States.

"This chapter of the bankruptcy code allows for the recognition in the U.S. of foreign bankruptcy proceedings and access to domestic judicial proceedings by foreign representatives," the IRS shared on its website.

Family-owned trucking company struggles

Pride Group, a family-owned trucking company, has its headquarters in Canada, but operates in the U.S. as well.

"We are a privately held, diversified group whose subsidiaries and affiliates operate in a variety of industries including transportation, logistics, heavy-duty equipment dealerships, equipment leasing & rentals, real-estate holdings, and full-service fleet management. PGE operates and manages businesses in both Canada and the United States, employing over 500 people," the company shared on its website.

The company has struggled in recent months and has taken steps to restructure its business. This has included a bankruptcy filing, which the company explained on its website.

"Pride Group Holdings Inc. and other applicant companies (the “Applicants”) sought and obtained protection under the Companies’ Creditors Arrangement Act (the “CCAA”) pursuant to an Initial Order of the Ontario Superior Court of Justice (Commercial List) (the “Initial Order”). Other companies affiliated with the Applicants (the “Additional Stay Parties”, and together with Applicants, the “Pride Group”), although not applicants themselves, were granted a stay of proceedings as part of these proceedings under the CCAA (the “CCAA Proceedings”) for the duration of 10-days, subject to extension thereafter as the Court deems appropriate."

That's the Canadian version of bankruptcy, but there has also been a U.S. filing.

"Certain companies in the Pride Group will file cases under Chapter 15 of Title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware (the “Chapter 15 Cases”) seeking recognition of the CCAA Proceedings within the territorial jurisdiction of the United States and other related relief," the company shared.

Pride Group continues to operate

Pride Group has a complicated array of holdings that includes 16 transport companies, 45 real estate holding companies, and 10 other holding companies founded and controlled by Sulakhan “Sam” Johal, Truck News reported.

The company has roughly $2 billion in debt and the company blames the current freight market for its troubles.

“Spot freight prices, diesel prices, and interest rate trends were all initially favorable for the trucking industry following the onset of the Covid-19 pandemic. They have all deteriorated significantly since that time. The bottom-line result is made significantly worse by virtue of the increased trucking and logistics supply that was brought to market during the upturn, which is currently sitting as unused excess capacity in the market," according to a court filing.

The company, which controls 20,000 trucks,  was profitable until the pandemic, according to Johal.

 Pride Group filed for bankruptcy protection after it defaulted on debt owed to Mitsubishi HC Capital which had been personally guaranteed by Johal. More than 20 other lenders have filed claims against the company which does plan to continue operating. 

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