Category: Regulations

F.D.A. Approves Vertex’s Nonaddictive Drug to Block Pain

Ann Case and Angus Deaton’s Deaths of Despair is a depressing but important book. I have read parts of it but plan to read it from cover to cover soon. They document and analyze a substantial group of Americans, mostly whites without college degrees, who die from alcohol, narcotics, or suicide. Starting in the 1990s their numbers grew. Part of the problem for some of the despairing is having jobs that give them hope for a better future, jobs that at least allow them to securely start and raise a family.

The growth in narcotics use is thoughtfully described in an earlier book, Dreamland by Sam Quinones. In some of the book Quinones writes about the same non-degree despairing whites as Case and Deaton, but he also in other parts of the book, discusses rising narcotics use among the better-off. His is a thoughtful complex narrative, involving diverse victims and diverse causes.

One component is that, from desire for euphoria, or to end pain, people start using narcotics that are addictive. Then they must fight, or succumb to, the addiction for the rest of their lives. For those drawn in by a desire to end pain, the news in the passages quoted below is important–the approval of suzetrigine, a drug that blocks some kinds of pain without being addictive. Quinones in his 2015 book reports his conversation with an expert who was pessimistic that such a drug would ever be possible (pp. 311-312).

A second reason suzetrigine is of interest is that it is being brought to market by Vertex, a firm that I have discussed in earlier blog entries, most recently here. Vertex was a once-small innovative mission-oriented start-up that got big. The continuing question is whether the big Vertex can sustain its earlier innovative culture.

(p. A11) The Food and Drug Administration approved a new medication Thursday [Jan. 30, 2025] to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.

That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.

Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.

To test the drug, Vertex, which is based in Boston, conducted two large clinical trials, each with approximately 1,000 patients who had pain from surgery. They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.

. . .

Suzetrigine eased pain as much as the combination opioid. Both were better than the placebo at relieving pain.

For the full story see:

Gina Kolata. “F.D.A. Approves a Non-Addictive Opioid.” The New York Times (Sat., February 1, 2025): A11.

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

(Note: the online version of the story has the date Jan. 30, 2025, and has the title “F.D.A. Approves Drug to Treat Pain Without Opioid Effects.”)

The Case and Deaton book, cited in my introductory comments, is:

Case, Anne, and Angus Deaton. Deaths of Despair and the Future of Capitalism. Princeton, N.J.: Princeton University Press, 2020. Reprint, pb 2021 (with new preface).

The Quinones book, cited in my introductory comments, is:

Quinones, Sam. Dreamland: The True Tale of America’s Opiate Epidemic. New York: Bloomsbury Press, 2015.

National Academy of Sciences Paper Warns Scientific “Fraud Is Growing Exponentially”

In previous blog entries I have cited evidence that top medical scientists have committed fraud in the areas of Alzheimer’s and cancer research. The research discussed in the passages quoted below reports a related but broader problem. In these accounts the fraud consisted mainly of doctored data and images, but did not mainly consist also of wholly fabricated text, which apparently is what new evidence reveals is being increasingly cranked out by paper mills.

The journals accepting these papers are presumably mainly the lower level, and less-cited, journals, and so this fraud arguably may be less damaging to the ongoing progress of science than the more sophisticated fraud carried out by top scientists and published in top journals. This argument assumes that scientists build on work published in the top journals. A problem with this argument is that many times, truly pathbreaking innovations are at first rejected by “top” journals and are only accepted by “lower” level journals. (For instance Hans Krebs’s paper on what is now known as the “Krebs cycle,” that must be memorized by all aspiring doctors, was rejected by the prestigious Nature and published by the much less prestigious Enzymologia (Lane 2022, p. 55).)

The newly revealed fraud reduces even further the credibility of those on the left who order ordinary citizens to “follow the science” rather than follow their own eyes and their own judgement.

(BTW, Dr. Elisabeth Bik who is quoted in a couple of passages quoted below, is also a prominent source in Charles Piller’s Doctored, that documented widespread high-level fraud in the Alzheimer’s research community.)

(p. D1) For years, whistle-blowers have warned that fake results are sneaking into the scientific literature at an increasing pace. A new statistical analysis backs up the concern.

A team of researchers found evidence of shady organizations churning out fake or low-quality studies on an industrial scale. And their output is rising fast, threatening the integrity of many fields.

“If these trends are not stopped, science is going to be destroyed,” said Luís A. Nunes Amaral, a data scientist at Northwestern University and an author of the study, which was published in the Proceedings of the National Academy of Sciences on Monday [Aug. 4, 2025].

. . .

“Science relies on trusting what others did, so you do not have to repeat everything,” Dr. Amaral said.

By the 2010s, journal editors and watchdog organizations were warning that this trust was under threat. They flagged a growing number of papers with fabricated data and doctored images. In the years that followed, the factors driving this increase grew more intense.

As more graduate students were trained in labs, the competition for a limited number of research jobs sharpened. High-profile papers became essential for success, not just for landing a job, but also for getting promotions and grants.

Academic publishers have responded to the demand by opening thousands of new scientific journals every year. “All of the incentives are for publishers to publish more and more,” said Dr. Ivan Oransky, the executive director of the Center for Scientific Integrity.

. . .

(p. D3) Elisabeth Bik, a California-based expert on scientific fraud who was not involved in the study, said that it confirmed her early suspicions. “It’s fantastic to see all the work we’ve done now solidified into a much higher-level analysis,” she said.

Dr. Amaral and his colleagues warn that fraud is growing exponentially. In their new study, they calculated that the number of suspicious new papers appearing each year was doubling every 1.5 years. That’s far faster than the increase of scientific papers overall, which is doubling every 15 years.

. . .

In an executive order in May on “gold-standard science,” President Trump drew attention to the problem of scientific fraud. “The falsification of data by leading researchers has led to high-profile retractions of federally funded research,” the order stated.

. . .

Dr. Bik proposed that scientific publishers dedicate more of their profits to monitoring manuscripts for fraud, similar to how credit card companies check for suspicious purchases.

. . .

Dr. Oransky said that the way scientists are rewarded for their work would have to change as well. “To paraphrase James Carville, it’s the incentives, stupid,” he said. “We need to stop making it profitable to game the system.”

For the full story see:

Carl Zimmer. “Fake Papers Found to Be Churned Out At Fast Pace.” The New York Times (Tues., August 5, 2025): D1 & D3.

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

(Note: the online version of the story has the date Aug. 4, 2025, and has the title “Fraudulent Scientific Papers Are Rapidly Increasing, Study Finds.” Where there was a minor difference in the wording between the online and print versions, the passages quoted above follow the online version.)

The academic paper documenting the substantial increase in scientific fraud is:

Richardson, Reese A. K., Spencer S. Hong, Jennifer A. Byrne, Thomas Stoeger, and Luís A. Nunes Amaral. “The Entities Enabling Scientific Fraud at Scale Are Large, Resilient, and Growing Rapidly.” Proceedings of the National Academy of Sciences 122, no. 32 (2025): e2420092122.

Nick Lane’s book, cited in my introductory comments, is:

Lane, Nick. Transformer: The Deep Chemistry of Life and Death. New York: W. W. Norton & Company, 2022.

“One Man’s Poison Is Another Man’s Cure”*

*The title “One Man’s Poison Is Another Man’s Cure” is a proverb that is widely attributed to the poet Lucretius. (I have not found a documented source.)

My commentary was posted on the Foundation for Economic Education (FEE) web site on Mon., Aug. 18, 2025.

Below are notes on sources supporting claims I make in the commentary.

https://www.1daysooner.org/ [website of group defending human challenge trials]

Attia, Peter. Outlive: The Science and Art of Longevity. New York: Harmony, 2023, pp. 78 & 84-86. [source of Attia’s views of rapamycin]

Bailey, Clifford J., and Caroline Day. “Metformin: Its Botanical Background.” Practical Diabetes International 21, no. 3 (April 2004): 115-17. [source on metformin]

Freeberg, Ernest. The Age of Edison: Electric Light and the Invention of Modern America, Penguin History American Life. New York: The Penguin Press, 2013, pp. 87 & 200-201. [source on electrification of New York faster than London]

Glanville, Jacob, Mark Bellin, Sergei Pletnev, Baoshan Zhang, Joel Christian Andrade, Sangil Kim, David Tsao, Raffaello Verardi, Rishi Bedi, Sindy Liao, Raymond Newland, Nicholas L. Bayless, Sawsan Youssef, Ena S. Tully, Tatsiana Bylund, Sujeong Kim, Hannah Hirou, Tracy Liu, and Peter D. Kwong. “Snake Venom Protection by a Cocktail of Varespladib and Broadly Neutralizing Human Antibodies.” Cell 188 (2025): 1-18. https://www.cell.com/cell/abstract/S0092-8674(25)00402-7

Harrison, David E., Randy Strong, Zelton Dave Sharp, James F. Nelson, Clinton M. Astle, Kevin Flurkey, Nancy L. Nadon, J. Erby Wilkinson, Krystyna Frenkel, Christy S. Carter, Marco Pahor, Martin A. Javors, Elizabeth Fernandez, and Richard A. Miller. “Rapamycin Fed Late in Life Extends Lifespan in Genetically Heterogeneous Mice.” Nature 460, no. 7253 (July 16, 2009): 392-95. https://www.nature.com/articles/nature08221

Ineichen, Benjamin V., Eva Furrer, Servan L. Grüninger, Wolfgang E. Zürrer, and Malcolm R. Macleod. “Analysis of Animal-to-Human Translation Shows That Only 5% of Animal-Tested Therapeutic Interventions Obtain Regulatory Approval for Human Applications.” PLOS Biology 22, no. 6 (2024): e3002667. [The title is misleading because the main message of the article is that “Notably, our meta-analysis showed an 86% concordance between positive results in animal and clinical studies.” The authors further explain: “We conclude that, contrary to widespread assertions, the rate of successful animal-to-human translation may be higher than previously reported. Nonetheless, the low rate of final approval indicates potential deficiencies in the design of both animal studies and early clinical trials.” (The quotations are both from the Abstract on p. 1) (See also: “How can we make sense of the fact that animal studies and early clinical trials seem to show promise, yet there is very limited official approval for these therapies? There are 2 possible explanations: One scenario is that the strict requirements of RCTs and regulatory approval are causing many potentially valuable treatments to be left behind. The other scenario is that both animal studies and early clinical trials may have limitations in their design, such as a lack of proper randomization and blinding, which affects their internal validity [45].” p. 12 https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3002667)]

Jewett, Christina. “Charlatans’ No Reason to Curb Untested Drugs, Kennedy Says.” The New York Times (Fri., June 6, 2025): A1 & A11. https://www.nytimes.com/2025/06/05/health/kennedy-stem-cells-experimental-treatments.html?searchResultPosition=1

Kinch, Michael. Between Hope and Fear: A History of Vaccines and Human Immunity. New York: Pegasus Books, 2018, pp. 33-34. [one source on Jesty]

Mandavilli, Apoorva. “Man of 200 Snake Bites May Be the Antivenom.” The New York Times (Sat., May 3, 2025): A1 & A19. https://www.nytimes.com/2025/05/02/health/snakes-universal-antivenom-tim-friede.html?searchResultPosition=1

Mannick, Joan B., Giuseppe Del Giudice, Maria Lattanzi, Nicholas M. Valiante, Jens Praestgaard, Baisong Huang, Michael A. Lonetto, Holden T. Maecker, John Kovarik, Simon Carson, David J. Glass, and Lloyd B. Klickstein. “mTOR Inhibition Improves Immune Function in the Elderly.” Science Translational Medicine 6, no. 268 (2014): doi:10.1126/scitranslmed.3009892. https://www.science.org/doi/abs/10.1126/scitranslmed.3009892?__hsfp=1773666937&__hstc=12316075.81f04695664b9dc054b5f524eb53b5a4.1525132803174.1525132803175.1525132803176.1&__hssc=12316075.1.1525132803177

Morgan, Kate. “Vaccine Protesters Find Winning Slogan: ‘Health Freedom.” The New York Times (Weds., Jan. 1, 2025): A11. https://www.nytimes.com/2024/12/28/well/health-freedom-medical-freedom-covid.html?searchResultPosition=1

Smith, Dana G. “Is the Secret to a Longer Life Hidden in a Transplant Drug?” The New York Times (Weds., Sept. 25, 2024): A1 & ?. https://www.nytimes.com/2024/09/24/well/live/rapamycin-aging-longevity-benefits-risks.html

Subbaraman, Nidhi. “A Universal Antivenom, from a Man Bitten by Snakes 200 Times.” The Wall Street Journal (Sat., June 14, 2025): C5. https://www.wsj.com/science/biology/snake-bite-blood-universal-antivenom-6de30fda?mod=Searchresults_pos1&page=1

Whiteman, Noah. Online notes to accompany Most Delicious Poison: The Story of Nature’s Toxins―from Spices to Vices. New York: Little, Brown Spark, 2023. [source of claim that 40% of drugs come from traditional medicine]

Zuckerman, Gregory. A Shot to Save the World: The inside Story of the Life-or-Death Race for a Covid-19 Vaccine. New York: Portfolio/Penguin, 2021, pp. 5-6. [one source on Jesty]

Healthcare Industry Now Top Employer in Most States

Source: the NYT article quoted and cited below.

Some argued that Obamacare would reduce the costs of healthcare in the U.S., but that has not happened. The government has failed us in multiple ways, by tolerating rampant fraud, by mandating voluminous red tape, and by reducing competition.

(p. A18) For years, the United States labor market has been undergoing a structural transformation. As jobs in manufacturing have receded, slowly but steadily, the health care industry has more than replaced them.

. . .

The nation’s corps of nurses, oncologists, lab technicians, anesthesiologists and other health-related workers has been growing steadily, through recession after recession, going from 9 percent of the total workforce in 2000 to 13 percent today.

. . .

. . . 20 percent or so of health care employment . . . is administrative.  . . .

David Cutler, a health care economist at Harvard University, cautions that while more people will be needed to deliver care in the future, the industry shouldn’t be seen as a jobs program. Costs have been rising for decades, placing a larger and larger burden on taxpayers and businesses — and to the extent possible, those resources should be redirected to other parts of the economy.

“Any person who’s employed in health care who we don’t need to be employed in health care, that’s a waste,” Dr. Cutler said. “That’s money in health care that costs people money when they’re sick, and that’s a person who could be doing a job somewhere else.”

For the full story see:

DePillis, Lydia, and Christine Zhang. “Health Care Industry Jobs Are Taking Over.” The New York Times (Sat., July 12, 2025): A18.

(Note: ellipses added.)

(Note: the online version of the story has the date July 3, 2025, and has the title “How Health Care Remade the U.S. Economy.”)

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.