Regulations – artdiamondblog.com

Father Spends 20 Years Researching to Cure His Children’s Type 1 Diabetes

The development of a new drug to cure Type 1 diabetes is big news, a triumph of medicine. The process of developing the medicine and bringing it to market interests me for several reasons. One is that Doug Melton spent 20 years of effort on it. His passion was due to having skin in the game: he has two children with the disease. Another is that it took so many years “of painstaking, repetitive, frustrating work.” I emphasize the common importance of trial-and-error in many major medical discoveries. Another is that the trial-and-error was to develop a “chemical cocktail to turn stem cells into islet cells.” Several major medical advances have required nimble and persistent trial-and-error to adjust drug cocktails, in terms of components and doses. Examples include HIV, Hodgkin’s lymphoma, and childhood leukemia.

A final reason I am interested in the case is that Melton selected the Vertex company to bring the drug to market. Vertex is an interesting case of a large firm struggling to keep the innovative culture of its startup roots. I read a book about its struggles called The Antidote. I intend to read an earlier book about its early years called The Billion Dollar Molecule.

(p. 17) A single infusion of a stem cell-based treatment may have cured 10 out of 12 people with the most severe form of type 1 diabetes. One year later, these 10 patients no longer need insulin. The other two patients need much lower doses.

The experimental treatment, called zimislecel and made by Vertex Pharmaceuticals of Boston, involves stem cells that scientists prodded to turn into pancreatic islet cells, which regulate blood glucose levels. The new islet cells were infused and reached the liver, where they took up residence.

The study was presented Friday evening [June 20, 2025] at the annual meeting of the American Diabetes Association and published online by The New England Journal of Medicine.

“It’s trailblazing work,” said Dr. Mark Anderson, professor and director of the diabetes center at the University of California in San Francisco. “Being free of insulin is life changing,” added Dr. Anderson, who was not involved in the study.

. . .

The treatment is the culmination of work that began more than 25 years ago when a Harvard researcher, Doug Melton, vowed to find a cure for type 1 diabetes. His 6-month-old baby boy developed the disease and, then, so did his adolescent daughter. His passion was to find a way to help them and other patients.

He began, he said, with an “unwavering belief that science can solve the most difficult problems.”

It took 20 years of painstaking, repetitive, frustrating work by Dr. Melton and a team of about 15 people to find the right chemical cocktail to turn stem cells into islet cells. He estimated that Harvard and others spent $50 million on the research.

Dr. Peter Butler, a professor of medicine at the University of California, Los Angeles and a consultant to Vertex, said he was awed by the achievement of the Harvard team.

“The fact that it worked at all is just freaking amazing to me,” he said. “I can guarantee there were a thousand negative experiments for every positive one.”

When Dr. Melton finally succeeded, he needed a company to take the discovery into the clinic. He joined Vertex, which took up the challenge.

For the full story see:

Gina Kolata. “People With Severe Diabetes May Have Been Cured in a Small Trial of a New Drug.” The New York Times, First Section (Sun., June 22, 2025): 17.

(Note: ellipsis, and bracketed date, added.)

(Note: the online version of the story was updated June 21, 2025, and has the title “People With Severe Diabetes Are Cured in Small Trial of New Drug.” The online version says that the article appeared on page 24 of the New York edition of the print version. But the article appeared on page 17 of my National edition.)

The NEJM academic article co-authored by Melton and mentioned above is:

Reichman, Trevor W., James F. Markmann, Jon Odorico, Piotr Witkowski, John J. Fung, Martin Wijkstrom, Fouad Kandeel, Eelco J.P. de Koning, Anne L. Peters, Chantal Mathieu, Leslie S. Kean, Bote G. Bruinsma, Chenkun Wang, Molly Mascia, Bastiano Sanna, Gautham Marigowda, Felicia Pagliuca, Doug Melton, Camillo Ricordi, and Michael R. Rickels. “Stem Cell–Derived, Fully Differentiated Islets for Type 1 Diabetes.” The New England Journal of Medicine (published online on June 20, 2025), DOI: 10.1056/NEJMoa2506549.

The books that I mentioned about Vertex are:

Werth, Barry. The Antidote: Inside the World of New Pharma. New York: Simon & Schuster, 2014.

Werth, Barry. The Billion-Dollar Molecule: One Company’s Quest for the Perfect Drug. New York: Simon & Schuster, 1994.

The Democratic Deep State Looked the Other Way as Fraudsters Stole 10 BILLION Healthcare Dollars

When DOGE fired federal workers we saw televised scenes where the fired workers expressed outrage at how taxpayers would be hurt by the loss of devoted civil servants. So where were the devoted civil servants in 2023? Were they doing their jobs to be alert to the Medicare, and personal identity, fraud that cost the public about 10 billion (that is “billion” with a “b”) dollars?

When Elon Musk’s DOGE uncovered myriad examples of major fraud, I saw Democrats on television complain that of course they were against fraud too, but it should be pursued more slowly and systematically, following traditional procedures. The Democrats were running the federal government in 2023. What procedure were the Democrats using, fast or slow, to protect taxpayers from the fraudulent loss of 10 billion (that is “billion” with a “b”) dollars?

Our jerry-rigged government-run-and-regulated health care system is rife with middlemen. In a true free-market healthcare system, patients would directly pay for healthcare, without middlemen. Patients would have the information, and the incentive to act on the information, to detect, report, and pursue fraudsters. Some fraud would exist under any system, but my hypothesis is that much less of it would exist under a free-market system.

(If you are concerned that patients would not have enough funds to pay for healthcare themselves, we could adopt the much better insurance system once proposed by Susan Feigenbaum, combined with deregulation that would reduce healthcare costs–like no longer mandating Phase 3 clinical trials.)

And my secondary hypothesis is that if we have to have a jerry-rigged government-run-and-regulated system, the Republicans, a party full of former bourgeois entrepreneurs and business managers, will usually do a marginally better job of detecting and pursuing fraud.

I wonder if these hypotheses have ever been researched by any of those noble economists studying the field of Public Choice?

(p. A18) When hundreds of thousands of people enrolled in Medicare were billed for expensive medical equipment they never asked for in 2023, it was part of a $10.6 billion fraud, among the largest such schemes in the program’s history, federal prosecutors said this week.

. . .

Those involved in the fraud bought dozens of companies that were accredited to submit claims to Medicare and the program’s supplemental insurers, prosecutors say.

Then, using personal information stolen from more than a million Americans, the defendants filed billions of dollars in claims for equipment that had not been ordered by people enrolled in Medicare and was not delivered to them, according to the indictment.

Of the $10.6 billion that was fraudulently billed, the indictment says, the defendants collected more than $900 million, most of it coming from private “Medigap” insurers and the rest from the Medicare program itself.

Even if the patients themselves did not pay for the phantom supplies, which included urinary catheters, braces and other durable medical equipment, such schemes can affect Medicare recipients by causing premium costs to rise.

. . .

In 2019, the Justice Department uncovered a scheme that it said had defrauded the program of more than $1 billion with phony claims for back and knee braces. In April 2023, prosecutors charged 18 defendants in a nearly $500 million scheme that involved false billing for Covid-19 tests that were never administered.

For the full story see:

Santul Nerkar. “11 Accused of Medicare Fraud In Scheme Based in Russia.” The New York Times (Sat., June 18, 2025): A18.

(Note: ellipses added.)

(Note: the online version of the story has the date June 27, 2025, and has the title “U.S. Charges 11 in Russia-Based Scheme to Bilk Medicare of $10.6 Billion.”)

The better healthcare insurance system proposed by Susan Feigenbaum was proposed in:

Feigenbaum, Susan. “Body Shop’ Economics: What’s Good for Our Cars May Be Good for Our Health.” Regulation 15, no. 4 (Fall 1992): 25-31.

One Third of Near-Death Multiple Myeloma Patients Are Cured by a New CAR-T Immunotherapy

Many consider immunotherapy to be the most promising current approach to curing cancer. One way to implement immunotherapy is to develop CAR-T cells. But there apparently are many ways to develop a CAR-T cell and which, if any, will work is a matter of trial-and-error.

It seems overly-cautious for regulators to require that the most innovative and promising therapies must first be tried on the patients nearest to death, and so least likely to respond. Why not allow patients at earlier stages to volunteer to try the new therapies earlier? They would be taking a bigger risk, but also would have the possibility of a bigger benefit. They would avoid the suffering from current treatments that are known to have major side-effects, and also are known to only extend life for short periods of time; and they would gain a shot at a real long-term cure.

(p. A18) A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.

They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.

They all got immunotherapy, in a study that was a last-ditch effort.

A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.

These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”

. . .

The new study, reported Tuesday [June 3, 2025] at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.

. . .

The Legend immunotherapy is a type known as CAR-T. It is delivered as an infusion of the patient’s own white blood cells that have been removed and engineered to attack the cancer. The treatment has revolutionized prospects for patients with other types of blood cancer, like leukemia.

Making CAR-T cells, though, is an art, with so many possible variables that it can be hard to hit on one that works.

. . .

The . . . study took on a . . . challenge — helping patients at the end of the line after years of treatments. Their immune systems were worn down. They were, as oncologists said, “heavily pretreated.” So even though CAR-T is designed to spur their immune systems to fight their cancer, it was not clear their immune systems were up to it.

Oncologists say that even though most patients did not clear their cancer, having a third who did was remarkable.

To see what the expected life span would be for these patients without the immunotherapy, Johnson & Johnson looked at data from patients in a registry who were like the ones in its study — they had failed every treatment. They lived about a year.

. . .

. . ., the hope is that perhaps by giving it earlier in the course of the disease, it could cure patients early on.

Johnson & Johnson is now testing that idea.

Dr. Kenneth Anderson, a myeloma expert at Dana-Farber Cancer Institute who was not involved with the study, said that if the treatment is used as a first-line treatment, “cure is now our realistic expectation.”

For the full story, see:

Gina Kolata. “From No Hope to Potential Cure for Deadly Blood Cancer, Study Shows.” The New York Times (Thurs., June 5, 2025): A18.

(Note: ellipses, and bracketed date, added.)

(Note: the online version of the story was updated June 5, 2025, and has the title “From No Hope to a Potential Cure for a Deadly Blood Cancer.”)

The academic article on the new cure is:

Jagannath, Sundar, Thomas G. Martin, Yi Lin, Adam D. Cohen, Noopur Raje, Myo Htut, Abhinav Deol, Mounzer Agha, Jesus G. Berdeja, Alexander M. Lesokhin, Jessica J. Liegel, Adriana Rossi, Alex Lieberman-Cribbin, Saad Z. Usmani, Binod Dhakal, Samir Parekh, Hui Li, Feng Wang, Rocio Montes de Oca, Vicki Plaks, Huabin Sun, Arnob Banerjee, Jordan M. Schecter, Nikoletta Lendvai, Deepu Madduri, Tamar Lengil, Jieqing Zhu, Mythili Koneru, Muhammad Akram, Nitin Patel, Octavio Costa Filho, Andrzej J. Jakubowiak, and Peter M. Voorhees. “Long-Term (≥5-Year) Remission and Survival after Treatment with Ciltacabtagene Autoleucel in Cartitude-1 Patients with Relapsed/Refractory Multiple Myeloma.” Journal of Clinical Oncology https://doi.org/10.1200/JCO-25-0076.

Public Should Beware of F.D.A.’s Lax Inspections of Drugs Made in India and China

On drug safety, the public puts its trust in the F.D.A. which frequently drops the ball. The public would be better off adopting caveat emptor, and seeking private means of assurance of safety. These would include certification (stamps of approval) from private organizations like the United States Pharmacopeial Convention (USP).

They might also choose to buy well-known name brands, since a well-known brand has more reputation capital to lose if they produce a bad batch, and thus can be expected to invest more in quality control. (Lester Telser made this argument–I need to seek where.)

(p. A10) A highly drug-resistant bacteria that was linked to eyedrops imported from India and that spread from person to person in a Connecticut long-term care center has prompted concerns that the strain could gain a foothold in U.S. health care settings, according to the Centers for Disease Control and Prevention.

. . .

The outbreak has renewed longstanding concerns about the quality and frequency of the F.D.A.’s overseas inspections.

In June 2020, Senator Chuck Grassley, Republican of Iowa, held an oversight hearing on the F.D.A.’s foreign inspection process, noting that the plants were given 12 weeks’ advance notice, “plenty of time to doctor up a facility to make sure that it passes inspection.” The agency has since received budget authority to conduct unannounced overseas inspections.

. . .

The F.D.A. paused overseas inspections during the height of the coronavirus pandemic, and the number of foreign inspections remained low last year, at 684 compared with 3,272 in 2019, according to agency data.

The F.D.A. has 4,000 overseas facilities to inspect, with about 20 percent in India; one of its six inspector positions in that country was vacant in late 2021, according to a report issued last year by the Government Accountability Office.

For over-the-counter drugs, the F.D.A. uses a system that essentially lists a medication recipe. Companies can make the products without express agency approval but are expected to follow agency rules for manufacturing quality products, said John Serio, a lawyer with Withers who has pharmaceutical clients.

“If you’re not out there inspecting facilities,” Mr. Serio said, “these sorts of problems will crop up because there’s no threat that if you’re out of compliance that the inspector will come knocking at your door.”

For the full story see:

Christina Jewett and Andrew Jacobs. “Drug-Resistant Bacteria Linked To Eyedrops Can Easily Spread.” The New York Times (Mon., April 3, 2023 [sic]): A10.

(Note: ellipses added.)

(Note: the online version of the story has the same date as the print version, and has the title “Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person.”)

The F.D.A.’s lax inspections of generic drugs made in India is documented in:

Eban, Katherine. Bottle of Lies: The Inside Story of the Generic Drug Boom. New York: Ecco, 2019.

Kennedy Defends Patients’ Freedom to Try “Experimental Therapies”

I agree with Kennedy that people with diseases or conditions that cannot be cured by mainstream medicine have the right try experimental therapies, and should be allowed what some are calling “health freedom.” For those who want certification of safety, private labels would emerge if the government exited from its role of allowing or banning. In the unregulated supplement business, multiple such organizations exist, e.g., the United States Pharmacopeial Convention (USP).

If the public decides the Kennedy/Diamond position is too radical, a step in the right direction would be for the government to provide informational certification of therapies or providers, but not to mandate that patients use only those therapies and providers.

(p. A1) Health Secretary Robert F. Kennedy Jr. recently declared that he wanted to expand access to experimental therapies but conceded that they could be risky or fraudulent.

In a podcast with Gary Brecka, who describes himself as a longevity expert, Mr. Kennedy vowed to end what he called the Food and Drug Administration’s war with alternative medicine. He said that would include stem cells, vitamins, peptides and chelation therapy, which involves removing heavy metals from the blood.

“If you want to take an experimental drug — you can do that, you ought to be able to do that,” Mr. Kennedy said.

“And of course you’re going to get a lot of charlatans, and you’re going to get people who have bad results,” he added. “And ultimately, you can’t prevent that either way. Leaving the whole thing in the hands of pharma is not working for us.”

Mr. Kennedy cited his own experience at a clinic in Antigua, where he said he received a stem cell treatment that “enormously” eased his neurological condition, spasmodic dysphonia, which affects his voice and has few treatment options.

. . .

(p. A11) Neither Mr. Kennedy nor the F.D.A. has released a formal plan to change agency standards for stem cell treatments, which have typically been reviewed by the agency as individual therapies to treat a specific disease.

Widening overall access could also happen informally if the agency decided to relax enforcement, an approach the F.D.A. used in the past to indicate that it wouldn’t crack down on unauthorized products. During the pandemic, for example, the agency allowed providers to retrofit infusion pumps and ventilators to treat hordes of sick patients.

. . .

Dr. Moreno and his colleagues found that the trials with funding from the red meat industry were nearly four times as likely to report favorable or neutral cardiovascular results after eating unprocessed red meat when compared with the studies with no such links.

. . .

“We don’t want to have the Wild West,” Mr. Kennedy said. “We want to make sure that information is out there. But we also want to respect the intelligence of the American people — the capacity of people who explore the outcomes that are going to benefit them the most.”

. . .

The field of stem cell treatments is so complex that the Harvard Medical School created a free course to help doctors navigate patient questions, said Insoo Hyun, the director of life sciences at the Museum of Science in Boston.

. . .

Some providers sidestep the costly, yearslong process of careful work that can lead to an F.D.A. approval. Among them is Dr. Chadwick Prodromos, a Chicago doctor who offers stem cell treatments in Antigua. Mr. Kennedy welcomed him warmly at the March meeting, Dr. Raizman recalled. Reached for comment, Dr. Prodromos’s office said that he was in Antigua doing treatments and was not available.

. . .

A website for Dr. Prodromos’s clinic says that he and colleagues offer injections in Antigua into the joints, back, neck, scalp, penis and pelvic floor for an array of conditions including autism, thinning hair and lupus. He uses AlloRX cells, which are derived from the umbilical cord, in a manner that in the United States would require an F.D.A.-cleared clinical trial.

People can seek out unregulated treatments using their own cells that are processed, purified and amplified in different ways. They can also find treatments using others’ cells that vary widely in quality and sterility.

Some low-quality clinics process cells in a back room, which is the opposite of a clinical-grade cell processing site. Dr. Hyun said he recently toured one in the Netherlands that used specialized air filtering, layers of gowns and a ban on bacteria-laden cellphones in their sterile area. “It’s kind of like you’re entering a space station,” he said.

For the full story see:

Christina Jewett. “‘Charlatans’ No Reason to Curb Untested Drugs, Kennedy Says.” The New York Times (Fri., June 6, 2025): A1 & A11.

(Note: ellipses added.)

(Note: the online version of the story has the date June 5, 2025, and has the title “Kennedy Says ‘Charlatans’ Are No Reason to Block Unproven Stem Cell Treatments.”)

Computer Chip Industrial Policy Subsidies Are an Unfair Waste of Taxpayer Funds

An “industrial policy” occurs when the federal government attempts to pick a technology that will be important in the future, and then subsidize it. T.J. Rodgers is an insider in the computer chip industry and has written a credible op-ed analyzing two attempts at industrial policy in his industry, the Sematech consortium in 1987, and the Chips and Science Act in 2022.

He makes a compelling case that Sematech did not work and that the Chips and Science Act is not working either.

Rodgers gives us more evidence that Secretary of the Treasury and Harvard President Larry Summers was right when he wrote “the government is a crappy venture capitalist.”

If the feds’ industrial policy on computer chips has failed, why do we think its industrial policy on cancer cures will succeed? (Nixon and Biden’s cancer “moonshots” amounted to picking, and then subsidizing, what they hoped would be cancer cures.)

By the way, when Rodgers stood up against welfare to his industry, he appears to have been an exemplar of Robert Nozick’s ideal CEO: maximizing profits subject to ethical side-constraints.

(p. A15) My mother was a fifth-grade teacher in Oshkosh, Wis. She earned $25,000 a year. Why should chip companies, some of the wealthiest corporations in the world, take money from her and other ordinary citizens? Today’s massive $280 billion Chips and Science Act of 2022, the latest semiconductor welfare program, is even less justified than Sematech was.

. . .

To my knowledge, Sematech contributed nothing of note to U.S. semiconductor technology. Its Final Report in 1997 served up platitudes about “catching up with Japan” and fostering “industry cooperation.”

Decades later, the Semiconductor Industry Association—now a group of lobbyists in Washington—began “saving” the chip industry again. This time the target is China, despite the fact that its best wafer foundry is SMIC, an also-ran in the foundry business. China is less a competitive threat today than Japan was in 1987.

. . .

Today, 100 high-performance computers can be put on one chip. The companies that know how to design 100-billion-transistor chips for a critical function such as artificial intelligence are much more valuable than the companies that carve commodity chips out of silicon wafers, like those in China. While the biggest chip-manufacturing company in China is worth $54 billion, a single U.S. chip company, Nvidia, is worth $3.4 trillion—58 times as much—and it doesn’t even make its own chips. Why are we doing this again?

For the full commentary see:

T.J. Rodgers. “Semiconductor Subsidies? Tried and Failed.” The Wall Street Journal (Weds., June 4, 2025): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 3, 2025, and has the same title as the print version.)

Robert Nozick discusses ethical side constraints in:

Nozick, Robert. Anarchy, State, and Utopia. New York: Basic Books, Inc., 1974.

“Flaws in the Peer Review System”

The flaws in the scientific journal peer review system undermine the argument that the freedom of individual patients should be subordinated to the judgements of “science.” A substantial, and not only recent, literature exposes a variety of flaws of the system. A recent impactful example is the failure of major medical journals to act in a timely manner to retract many Alzheimer’s studies where fraudulent images have been documented.

This impactful example is documented in painful detail in Charles Piller’s Doctored. The impact is that approaches to Alzheimer’s besides the mainstream’s amyloid hypothesis, have been suppressed, which may have slowed alternative effective therapies against the dread disease.

(p. C4) Suspicion of science journals was supercharged during the Covid pandemic, when most of them broadly supported mandates and lockdowns. Dr. Jay Bhattacharya, now the head of the National Institutes of Health, was among the most prominent critics of such policies. He gained attention as a co-author of the 2020 Great Barrington Declaration, which advocated letting Covid spread, conferring “herd immunity” on the population, only to see his work shunned by the major science journals.

. . .

The peer review system, in which a paper must go through scrutiny from experts, is intended as a form of quality control. But critics suggest that editors tilt the process toward papers that reflect their own favored results. In a May [2025] interview at the Hoover Institution, Bhattacharya said, “Folks think that if it is published in a top peer-reviewed journal, therefore it must be true, and that’s actually inaccurate.” In reality, he argued, “If I’m lucky the journal editor will send it out to two or three peer review editors, chosen by the editor. If they’re friendly with the editor, they’ll send it to friendly peer reviewers.”

Marty Makary, now the head of the Food and Drug Administration, was another prominent critic of science and medical journals during the pandemic. He said that some journals are captured by industry and others by groupthink. At NEJM and JAMA, “it’s clear that it was a group of like-minded friends, many of whom trained together or worked in the same hospital system,” Makary said. “Why should a small group of people be the gatekeepers of which research is read by most doctors in America?”

A 2023 paper in the journal PNAS on “scientific censorship by scientists” found flaws in the peer review system. A journal editor can quietly kill a submitted paper by sending it to hostile reviewers, who amplify minor methodological issues in order to reject a paper they disapprove of. “Many criteria that influence scientific decision-making, including novelty, interest, ‘fit,’ and even quality, are often ambiguous and subjective, which enables scholars to exaggerate flaws or make unreasonable demands to justify rejection of unpalatable findings,” the PNAS study found.

Often, part of what makes a paper “unpalatable” is its perceived politics. Science journals, like academia in general, have drawn increasing criticism for progressive bias. For example, in 2022 the journal Nature Human Behavior published an editorial stating that “considerations of harm can occasionally supersede the goal of seeking or sharing new knowledge,” including research that “may—inadvertently—stigmatize individuals or human groups” or be “discriminatory, racist, sexist, ableist or homophobic.”

“If anything gets published that doesn’t reflect the expected political view, then there is a public campaign to retract the paper,” said Luana Maroja, a professor of biology at Williams College. “Many times, they are successful.”

“I’ve received an anonymous peer review that said, ‘I’m afraid of what these findings will do for the laudable progressive moral agenda,’” said Cory Clark, a behavioral scientist at the University of Pennsylvania and lead author of the PNAS paper. Many researchers, she found, don’t bother asking questions that might lead to “wrong” answers, and if they do, they often don’t try to publish because they’ll only face resistance and blowback. Clark is now doing a study of journal editors, most of whom, she said, fear getting attacked or ostracized themselves.

. . .

Donald Trump’s campaign for president in 2016 spurred some science journals to make political endorsements for the first time. Nature, a U.K.-based journal, endorsed Hillary Clinton for president. Editorials in the Lancet referred to the first Trump administration as “anti-scientific” and called the 2020 election “a fight for the health of the nation.” In a pre-election editorial in 2020, the NEJM called the Trump administration “dangerously incompetent,” writing: “We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.”

For the full story see:

Pamela Paul. “How Scientific Journals Became MAGA’s Latest Target.” The Wall Street Journal (Sat., June 14, 2025): C1 & C4.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story has the date June 13, 2025, and has the same title as the print version.)

The PNAS article briefly summarized in a passage quoted above is:

Clark, Cory J., Lee Jussim, Komi Frey, Sean T. Stevens, Musa al-Gharbi, Karl Aquino, J. Michael Bailey, Nicole Barbaro, Roy F. Baumeister, April Bleske-Rechek, David Buss, Stephen Ceci, Marco Del Giudice, Peter H. Ditto, Joseph P. Forgas, David C. Geary, Glenn Geher, Sarah Haider, Nathan Honeycutt, Hrishikesh Joshi, Anna I. Krylov, Elizabeth Loftus, Glenn Loury, Louise Lu, Michael Macy, Chris C. Martin, John McWhorter, Geoffrey Miller, Pamela Paresky, Steven Pinker, Wilfred Reilly, Catherine Salmon, Steve Stewart-Williams, Philip E. Tetlock, Wendy M. Williams, Anne E. Wilson, Bo M. Winegard, George Yancey, and William von Hippel. “Prosocial Motives Underlie Scientific Censorship by Scientists: A Perspective and Research Agenda.” Proceedings of the National Academy of Sciences 120, no. 48 (Nov. 20, 2023): e2301642120.

Piller’s Doctored book that I mention in my introductory comments is:

Piller, Charles. Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer’s. New York: Atria/One Signal Publishers, 2025.

F.D.A. to Reduce Phase 3 Drug Trials from Two to One for Approval of Some Drugs

I have read and learned much from books by Marty Makary and Vinay Prasad, who are now high officials in the F.D.A. I also have suggested that patient freedom and drug innovation would both be served if the F.D.A. cut back regulations to only regulate for drug safety and leave drug efficacy to the judgement of physicians and patients.

Makary and Prasad have now announced that the F.D.A. will only require one clinical trial to satisfy the Phase 3 stage, instead of the currently common two trials. This is a partial, not a full, step toward my suggestion, but it is a step in the right direction. A modest step is better than no step at all.

I also support their announcement of the increased use of A.I. I believe that will increase efficiency, but doubt that it will soon “radically increase efficiency,” as they claim.

(p. A1) The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday [June 10, 2025] in JAMA.

. . . And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

“The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

. . .

(p. A16) For some cases, the F.D.A. officials proposed speeding major drug approvals by requiring only one major study in patients rather than two, a practice the agency has used in recent years. The pandemic provided a precedent, they said, for accelerating the process.

“We believe this is clear demonstration that rapid or instant reviews are possible,” Drs. Makary and Prasad wrote.

. . .

Last week, the agency introduced Elsa, an artificial intelligence large-language model similar to ChatGPT. The F.D.A. said it could be used to prioritize which food or drug facilities to inspect, to describe side effects in drug safety summaries and to perform other basic product-review tasks. The F.D.A. officials wrote that A.I. held the promise to “radically increase efficiency” in examining as many as 500,000 pages submitted for approval decisions.

For the full story see:

Christina Jewett. “F.D.A. to Seek Faster Process With A.I. Help.” The New York Times (Weds., June 11, 2025): A1 & A16.

(Note: ellipses, and bracketed date, added.)

(Note: the online version of the story has the date June 10, 2025, and has the title “F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’.”)

The JAMA article mentioned above is:

Makary, Martin A., and Vinay Prasad. “Priorities for a New FDA.” JAMA (2025) doi: 10.1001/jama.2025.10116.

During the Pandemic “Experts” Suppressed the Open Continual Inquiry That Is Science

The governmental violation of the basic rights of citizens, especially the right of free speech, is the most painful and lasting legacy of the Covid-19 pandemic. To flourish in the future, it is worth our time to remember what happened and defend those who protected free speech and the pursuit of true science, which is a method of continual inquiry, not a body of fixed beliefs.

(p. C7) “Science,” the great theoretical physicist Richard Feynman wrote, “is the belief in the ignorance of experts.” The incorrigibly curious Feynman knew that skepticism and a willingness to assimilate new evidence propel the scientific endeavor. Yet by 2020, in response to a global pandemic, the dominant part of America’s political and media class had turned the imperative to “follow the science” into an expression of almost religious reverence for the judgment of experts. Many educated and otherwise intelligent Americans, meanwhile, made a single, bespectacled government scientist their idol: “In Fauci We Trust” read their lawn signs and bumper stickers.

Their faith was misplaced. Credentialed experts, especially those in the fields of epidemiology and public health, had tied themselves to badly flawed theories, closed their minds to new evidence and thrown the mantle of “science” over value judgments for which they had no special competence.

“An Abundance of Caution,” by the journalist David Zweig, documents the poor evidentiary basis for the prolonged school closures and attendant follies such as masking requirements and social distancing. Mr. Zweig distinguished himself throughout the pandemic by his willingness to question the assumptions of self-identified “Covid hawks.” When he dug into the epidemiological modeling papers whose projections seemed decisively to rule out the safety of opening schools, he found “a never-ending matryoshka doll” of citations, resting ultimately on an assumption conceded to be “arbitrary” by its initial author.

Mr. Zweig shows how evidence emerged early on—in March 2020—that the virus did not pose a serious threat to children. American public-health professionals remained largely impervious to this fact.

. . .

“In Covid’s Wake,” by the Princeton political scientists Frances Lee and Stephen Macedo, mostly remains within the idiom of polite academic prose, but they state with disarming plainness that “elite institutions failed us” by giving in to panic. Ms. Lee and Mr. Macedo marvel at how consensus plans—none of which would have required extended lockdowns—were thrown out before Americans ever began dying, in part because public-health experts were entranced by China’s harsh restrictions. American policymakers had sound advice ready at hand, but most of them took the view that safety outweighed individual liberties, economic activity and quality of life.

Where Mr. Zweig emphasizes incuriosity, Ms. Lee and Mr. Macedo stress the willful suppression of reasonable debate, including the unfortunate tendency to paint critics of lockdowns and mask mandates as racists, quacks and conspiracy theorists. Such conduct was especially evident on the question of Covid-19’s origins, as top scientists vilified anyone suggesting the virus may have leaked from a lab in Wuhan, China. Credulous journalists, academics and other cultural arbiters, the authors remind us, embraced the effective censorship of those who questioned the official line.

. . .

Ms. Lee and Mr. Macedo catalog reams of data to show that, before the availability of vaccines, areas imposing the severest restrictions earned no discernible health benefits.

. . .

(p. C8) In 2024 the U.S. House’s Select Subcommittee on the Coronavirus Pandemic issued a genuinely impressive 500-page report, covering Covid-19’s origins, the fraud in pandemic-response programs and the effectiveness or otherwise of various interventions.

For the full review see:

Philip Wallach. “Failing the Pandemic Test.” The Wall Street Journal (Wednesday, April 19, 2025): C7-C8.

(Note: ellipses added.)

(Note: the online version of the review has the date April 18, 2025, and has the title “‘An Abundance of Caution’ and ‘In Covid’s Wake’: Failing the Pandemic Test.”)

The books under review are:

Macedo, Stephen, and Frances Lee. In Covid’s Wake: How Our Politics Failed Us. Princeton, NJ: Princeton University Press, 2025.

Zweig, David. An Abundance of Caution: American Schools, the Virus, and a Story of Bad Decisions. Cambridge, MA: The MIT Press, 2025.

The over-500-page 2024 report issued by the House’s Select Subcommittee on the Coronavirus Pandemic, and praised above, is:

Pandemic, Select Subcommittee on the Coronavirus. “After Action Review of the Covid-19 Pandemic: The Lessons Learned and a Path Forward.” U.S. House of Representatives. Washington, D.C., Dec. 4, 2024.

A Few More Months of Life Is Front Page News for Pancreatic Cancer Patients

For those with late stage pancreatic cancer, half live less than a year and half live longer than a year, according to the front page WSJ article quoted below. But the article seems to be celebrating a patient who has survived 17 months on a new drug. The patient has a feeling, perhaps because of a lesion that they radiated, that the drug may stop working soon.

So let’s say that without the drug she might have expected roughly a year of life, and now with the drug she has gotten roughly 17 months of life. Sure 17 months is better than 12 months.

But are our expectations so low and our cancer progress so slow, that an extra five months of life is front-page news?

(p. A1) Pranathi Perati was running out of time to treat her stage-four pancreatic cancer when she found out she would get another shot: a clinical trial testing a new experimental drug.

Perati’s odds were slim—3% of late-stage pancreatic-cancer patients are still alive after five years. And half of all pancreatic-cancer patients live for less than a year after their diagnosis. For Perati, the drug, daraxonrasib from Revolution Medicines, has helped keep her alive for 17 months and counting.

. . .

(p. A4) The pill has given her some fatigue and mouth ulcers, but she feels better than she did with chemo. A lesion in her lung started progressing this past winter and was radiated, but her disease has been stable otherwise.

“Seventeen months is a lot of good time to buy,” she said. Still, Perati worries that her time on the drug might soon run out. She has started looking for more options. Her son is set to graduate high school this summer.

For the full story see:

Brianna Abbott. “Treatments Offer Hope On Pancreatic Cancer.” The Wall Street Journal (Saturday, March 1, 2025): A1 & A4.

(Note: ellipsis added.)

(Note: the online version of the story has the date February 28, 2025, and has the title “New Treatments Give Hope to Patients With One of the Deadliest Cancers.”)

Nicholas Wade Highlighted That Early Email to Fauci Supported Lab-Leak Origin of Covid-19

Distinguished science journalist Nicholas Wade was one of the first and the few to early-on risk being canceled by providing evidence in favor of the lab-leak origin of Covid-19.

(p. A13) They told the world that the Covid-19 virus clearly couldn’t have been manipulated in the laboratory. But what they actually thought at first sight was that it had been.

The letter from five virologists published in Nature Medicine on March 17, 2020, was the single most influential statement in capturing the public narrative about the origin of SARS-CoV-2. Here was an authoritative statement from leading experts assuring the public that in terms of the virus’s origin “we do not believe that any type of laboratory-based scenario is plausible.”

But that’s the exact opposite of what these experts thought after taking their first look at the virus. A large batch of emails exchanged with Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was made available this week to BuzzFeed and the Washington Post under the Freedom of Information Act. For the most part the emails concern meeting arrangements or messages from cranks and have been redacted of any meaningful information. But one significant email escaped the censor’s black marker.

On Jan. 31, 2020, shortly after the SARS-CoV-2 genome had been decoded, Kristian Andersen, the five virologists’ leader, emailed Dr. Fauci that there were “unusual features” in the virus. These took up only a small percentage of the genome, so that “one has to look really closely at all the sequences to see that some of the features (potentially) look engineered.”

Mr. Andersen went on to note that he and his team “all find the genome inconsistent with expectations from evolutionary theory.” It isn’t clear exactly what he meant by this striking phrase. But anything inconsistent with an evolutionary origin has to be man-made.

For the full commentary see:

Nicholas Wade. “Fauci Email Bolsters the Lab-Leak Theory.” The Wall Street Journal (Monday, June 5, 2021 [sic]): A13.

(Note: the online version of the commentary has the date June 4, 2021 [sic], and has the same title as the print version.)