Walter Block: Decriminalize Private, Competing FDA Alternatives Now!

The FDA is an Albatross

Competition brings about better results than monopoly. This is a basic premise of economics about which there is virtually no debate, at least not within this profession. Or, indeed, on the part of pretty much anyone else. It would be exceedingly rare to hear a discouraging word about the benefits of competition vis a vis monopoly from any quarter whatsoever. The competitive system lowers prices, increases quality, reliability, security, any other good thing anyone would care to mention. Monopoly, in contrast, leads in the very opposite direction.

A case in point has recently arisen. Amylyx Pharmaceuticals just created a drug to combat amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease. This horror is a progressive neurodegenerative disease that attacks nerve cells in the brain and spinal cord.

In its phase 2 trial, patients given this drug survived 8 to 11 months longer than those who were given a placebo; for a six-month trial period, they benefitted from a 25% slower rate of decline in their ability to breathe and chew food. The Food and Drug Administration (FDA) in its monopolistic wisdom, however, declined to allow patients suffering from this dread malady to try this new, unproven, cure. This government bureau is holding off approval pending the results of a phase 3 trial, which will not occur until late 2023 or early 2024. Why? The drug might not accomplish its task and might prove actually harmful. In the meantime, ALS patients, who would give their eye teeth and more to risk this Amylyx product, are left twisting in the wind.

How would a competitive free market system function in such a case? Simple. There would be several, perhaps dozens of firms which tested and rated new drugs, such as the one now under discussion. They would be companies and institutions such as the Harvard Medical School, M. D. Anderson, the Mayo Clinic, Cedars-Sinai Medical Center in Los Angeles and NYU Langone Hospitals. A privatized FDA might even join the scrum. They would all be certification agencies, approving or disapproving of drugs, sort of like Good Housekeeping Seals of Approval, the Better Business Bureau or Consumers’ Reports. The information garnered from such a system would presumably be of a higher quality than from present FDA monopoly arrangements.

As important and maybe even more so, there would be no licensing system in place. No one could legally prohibit anyone else from trying an unproven experimental drug, as at present with Amylyx. ALS patients would no longer be prevented from throwing the dice in an effort to save their lives. There is all the world of difference between licensing and certifying drugs. Only the latter is justified. Only certification is compatible with economic freedom.

Suppose these rating agencies disagreed with one another as to the safety, viability or effectiveness of a given drug. Would this be a flaw, vis a vis the present permit system? Not a bit of it. Whenever scientists are on the cutting edge of something or other, there are bound to be at least some disagreements. If there was unanimity, there would hardly be any need for certification in the first place.

But there was divergence of opinion, also, amongst the FDA staff in the present case. Their advisory committee voted only 6-4 against approval of this ALS drug. In the event, the FDA must speak with one voice. In contrast, many viewpoints can emerge from a certification industry. The major advantage, here, is that after the smoke clears, when more information become available, the market can reward those companies which were more accurate and penalize those that erred with loss of profit and even bankruptcy. This continual grinding down of firms which prove to be mistaken tends to render those remaining as the most successful.

The FDA can never go out of business no matter how many errors it commits. For example, approving of dangerous ineffective drugs or rejecting helpful and safe medication. However, they are subject to a bias in the direction of the latter. They cannot go broke, but are more subject to reputational loss when they commit the former error.

Take the thalidomide episode as a case in point. This drug was highly successful in alleviating vomiting and other debilities of morning sickness on the part of pregnant women, which typically occurred in the first trimester. However, horribly, it also led to miscarriages and serious birth defect deformities in a small but significant percentage of the progeny of women who utilized it.

How did the FDA perform in the face of this challenge? To be fair to this organization, it never did approve of this drug in the 1950s and 1960s when these tragedies occurred. (It later approved of it, but for leprosy, not for expectant women). On the other hand, it the FDA did not warn against it, did not forbid its usage, as it had the power to do, until long after these disasters took place. Was the FDA, then, a good watchdog, ensuring safety for the US populace? It is difficult to reach any such conclusion. In sharp contrast, were there a certification industry in place at the time, this calamity would have served as a litmus test. Some companies would have recommended in favor of it, some against it, and others, as in the case of the FDA, would have remained silent about it, during this crisis. Then, the free enterprise system would have rewarded those certification firms that warned against it.

End the FDA and substitute the benevolent free enterprise system for it!

This originally appeared on New English Review and was reprinted with the author’s permission.

From LRC, here.

Kiddush Hashem in Business: The Mensch of Malden Mills

Aaron Feuerstein, ‘Mensch of Malden Mills’ who paid his workers even after his factory burned down, dies at 95

(JTA) — Aaron Feuerstein, who became known as the “Mensch of Malden Mills” for continuing to pay his workers even after the textile factory he owned burned to the ground, died at 95 on Thursday.

The devout Orthodox businessman died at his home in Brookline, Massachusetts, after being injured in a fall several days earlier, The Boston Globe reported.

“He did not suffer,” Feuerstein’s son, Daniel Feuerstein, told Boston 25 News. “He lived a long, vibrant and exciting life. His community was everything to him; from his Jewish community in Brookline, and equally important was the manufacturing community in the Merrimack Valley [of Massachusetts].”

Malden Mills was a textile manufacturer in Lawrence, Massachusetts, best known for its line of synthetic fleece products called Polartec.

In December 1995, the company’s redbrick factory complex caught on fire, causing one of the largest blazes in Massachusetts history. Work for the factory’s 1,400 employees stopped but Feuerstein kept paying them.

Feuerstein also bucked the trend that saw industrial manufacturing leave the area by rebuilding the family-run factory.

At the time, the Globe quoted Feuerstein as saying, “I’m not throwing 3,000 people out of work two weeks before Christmas.” Feuerstein also explained after the fire that he was guided by Jewish tradition. “When all is moral chaos, this is the time for you to be a mensch,” he said.

Feuerstein’s grandfather, Henry Feuerstein, a Jewish immigrant from Hungary, founded Malden Mills in 1906, with grandson Aaron taking over in 1956. The company survived the fire of 1995, rebranded as Polartec, and stayed in the family’s hands until 2007. But by then the business had seen a downturn and Feuerstein took it into bankruptcy.

A private equity firm then bought the factory, shut down and moved the brand’s manufacturing to Tennessee. In 2019, industrial manufacturing company Milliken acquired Polartec.

A graduate of Yeshiva University, Feuerstein belonged to the Brookline congregation of Young Israel. Jewish teachings informed how he treated his workers.

“You are not permitted to oppress the working man, because he’s poor and he’s needy, amongst your brethren and amongst the non-Jew in your community,” he said on “60 Minutes” during an episode titled “The Mensch of Malden Hills” that aired in 2003.

Feuerstein’s wife Louise died in 2013. They are survived by their sons Daniel and Raphael and their daughter Joyce.

From JTA, here.

NYT’s Pacific COVID Unselfawareness…

New York Times Decides Lockdowns are Actually Draconian and Economically Destructive when China Does Them

“Many were fed up with Mr. Xi … and his ‘Zero-Covid’ policy, which continues to disrupt everyday life, hurt livelihoods and isolate the country,” writes the Times in pacific unselfawareness.

Three years ago, Zero Covid was the aspiration of public health bureaucrats and politicians across the West. Charlatan techbros like Tomas Pueyo appeared on national television to demand nationwide house arrest; leaders like Angela Merkel surrounded themselves with virus-eradicationist modellers and imposed unprecedented months-long closures upon their countries. When protests inevitably broke out, they were violently suppressed; the protesters were slandered as conspiracy theorists and fascists.

The New York Times played a leading role in this long and excruciating charade. In April 2020, they reported that “an informal coalition of influential conservative leaders and groups, some with close connections to the [Trump] White House” was responsible for “quietly working to nurture protests and apply … pressure to overturn state and local orders intended to stop the spread of the coronavirus.” In March 2021, they ran an obnoxious opinion piece about What Happened When Germany’s Far-Right Party Railed Against Lockdowns, which called German protesters “an amorphous mix of conspiracy theorists, shady organizations and outraged citizens” and appeared to accuse the right-populist party Alternativ für Deutschland of opportunism for joining their ranks.

What a difference a few years have made.

China Protests Break Out as Covid Cases Surge and Lockdowns Persist is a lead headline in today’s New York Times: “Strict Covid restrictions are hurting the country’s economy and angering members of the public, who are taking to the streets,” we read in the article that follows. Western anti-lockdown protesters are fascists and conspiracy theorists; Chinese anti-lockdown protesters, on the other hand, are ordinary people who are just fighting the power:

“Lift the lockdown,” the protesters screamed in a city in China’s far west. On the other side of the country, in Shanghai, demonstrators held up sheets of blank white paper, turning them into an implicit but powerful sign of defiance. One protester, who was later detained by the police, was carrying only flowers.

Over the weekend, protests against China’s strict Covid restrictions ricocheted across the country in a rare case of nationwide civil unrest. There had been signs of dissent, but the new wave of anger may pose a bigger challenge for the government.

Some demonstrators went so far as to call for the Communist Party and its leader, Xi Jinping, to step down. Many were fed up with Mr. Xi, who in October secured a precedent-defying third term as the party’s general secretary, and his “zero-Covid” policy, which continues to disrupt everyday life, hurt livelihoods and isolate the country.

Western lockdowns were necessary to save lives. Chinese lockdowns are the repressive tactic of an undemocratic regime.

The Chinese government on Monday blamed “forces with ulterior motives” for linking a deadly fire in the western Xinjiang region to strict Covid measures, a key driver as the protests spread across the country.

In much the same way, the New York Times blamed shadowy political actors with ties to Trump for anti-lockdown protests in 2020.

Outside China, the rest of the world has adapted to the virus and is near normalcy. Take soccer’s premier event, the World Cup. Thousands of people from across the globe have assembled in Qatar and are cheering on their teams, shoulder-to-shoulder, without masks, in packed stadiums.

China’s approach won praise during the beginning of the pandemic, and there is no doubt it has saved lives. But now that approach looks increasingly outdated. Almost three years after the coronavirus emerged, the contrast between China and the rest of the world couldn’t be starker.

Emphasis mine, because it’s probably the most amazing line in the whole piece. Here we have America’s foremost propaganda outlet, trying desperately to accuse China of unjust dictatorial repression, for the crime of implementing in a more organised and coherent way the very same Zero Covid policies that Times journalists spent nearly two years supporting. What’s actually wrong with the harsh Chinese lockdowns? Well, say the Times, who can’t say anything else – they’ve become unfashionable.

Continue reading here…

From Eugyppius, here.

Contraception Is a Question for a *Competent* Posek

How have we fallen! A reminder of the Torah-true view of having children

Too many have forgotten that birth control is assur in all forms al pi Torah. “Heterim” are for very extenuating circumstances. They are very bidieved and NOT meant to be dispensed like candy.

BS”D

As a follow up to our previous article, I wish to illustrate the correct Hashkafos regarding building a family, and the grave prohibition of contraception (unless it is for a serious medical need and has been approved by an expert Rav.)

To my great pain and surprise, I discovered that the phenomenon of very generous “child spacing” by means of birth control – for no medical reason – has become extremely widespread in many frum circles, and so has the practice of brand new couples “waiting” a year or two. It is incomprehensible to me that this is being condoned.

Here we see the terribly destructive effects at play, of the organization I mentioned in the previous article. They have normalized birth control across the spectrum of Klal Yisrael – not only to the general population, but also by having “educated” a new generation of young Rabbonim with their harmful ideas – and are preventing untold thousands of births for no good reason at all.

The pain over this terrible breach in our Mesora, and over the diminishment of Klal Yisrael, is intense. May Hashem set our nation back on track speedily, and undo the damage.

On the Torah view of bringing children into the world

Translated from Sefer Otzar Tahara by Rav Shlomo Dovid Klein (London)

(This excerpt includes most of the chapter. The PDFs attached below have the complete version.)

Part 1: Contraception – the seriousness of the prohibition

It is forbidden to take any action to prevent pregnancy, and this is a serious matter.(1)

Even when doctors advise this, there is usually no medical basis for it and it is merely based on their carefree attitude of these matters. Nevertheless, in cases of great need, there are methods that can be approved in certain circumstances, for example when a woman feels physically or emotionally weak after childbirth. One cannot set out general guidelines in these matters and a competent Moreh Horo’oh must be consulted. When contraception is permitted, one must clarify exactly which methods may be used, as some of them involve repeated serious issurim.

One cannot compare one case to another and may not rely on rulings supposedly given to others; it is essential that a Moreh Hora’ah is consulted in each individual case.(2)

Continue reading…

From Netzach Yisrael, here.