Category: Health

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.

Electricity May Be a Pellet in the “Magic Buckshot” Against Cancer

In a recent entry I claimed that the cure for many diseases may not be Paul Ehrlich’s one “magic bullet” but may instead be “magic buckshot.” A recent article in The Wall Street Journal suggests that one pellet in the magic buckshot against cancer is electricity. As proof of concept, the article claims that after surgery, radiation, and chemotherapy for a glioblastoma brain cancer, adding electrodes to the skull that deliver low-intensity electricity to the brain, will add a median of 4.9 months to the patient’s lifespan.

The Wall Street Journal article mentioned above is:

Brianna Abbott. “Next Hope in Treating Cancer: Electricity.” The Wall Street Journal (Tues., May 20, 2025): A10.

(Note: the online version of the article has the date May 16, 2025, and has the title “The Next Frontier to Treat Cancer: Electricity.”)

The Wall Street Journal article links to the following article in JAMA:

Stupp, Roger, Sophie Taillibert, Andrew Kanner, William Read, David M. Steinberg, Benoit Lhermitte, Steven Toms, Ahmed Idbaih, Manmeet S. Ahluwalia, Karen Fink, Francesco Di Meco, Frank Lieberman, Jay-Jiguang Zhu, Giuseppe Stragliotto, David D. Tran, Steven Brem, Andreas F. Hottinger, Eilon D. Kirson, Gitit Lavy-Shahaf, Uri Weinberg, Chae-Yong Kim, Sun-Ha Paek, Garth Nicholas, Jordi Bruna, Hal Hirte, Michael Weller, Yoram Palti, Monika E. Hegi, and Zvi Ram. “Effect of Tumor-Treating Fields Plus Maintenance Temozolomide Vs Maintenance Temozolomide Alone on Survival in Patients with Glioblastoma: A Randomized Clinical Trial.” JAMA 318, no. 23 (Dec. 19, 2017): 2306-16.

During Covid-19 “Bureaucratic Authorities Erred in Pretending . . . Certainty”

(p. A13) Adam Kucharski, a professor of epidemiology at the London School of Hygiene & Tropical Medicine, takes the reader on a fascinating tour of the history of what has counted as proof.

. . .

What should we do, . . ., when a mathematical proof of truth is unavailable, but we must nonetheless act?

This leads us to a discussion of probability and statistics, and of pioneers such as William Gosset, a brewer at Guinness who figured out how to quantify random errors in experiments, and Janet Lane-Claypon, an English scientist who first thought to investigate confounding factors while analyzing children’s health. Some innovations, though, have hardened into unhelpful dogma. The scientific notion of “statistical significance” relies, Mr. Kucharski explains, on a wholly arbitrary cutoff, which incentivizes researchers to massage their data. Such issues, he says, can be hard for scientists, let alone the laity, to understand.

Mr. Kucharski speaks from experience, since he was one of the experts first called upon by the British government for advice on the Covid-19 pandemic. He explains brilliantly the fragmentary and confusing nature of the data then available, and the provisional conclusions they led to. As a public face of this effort, Mr. Kucharski was bombarded daily with abusive and threatening messages from angry citizens who simply didn’t believe what they were being told.

The lesson Mr. Kucharski draws isn’t that he and his colleagues were right (though they largely were), but that bureaucratic authorities erred in pretending there was certainty when all that was possible at the time was messy and provisional. Notoriously, in March 2020 the World Health Organization tweeted “FACT: #COVID19 is NOT airbone.” (As it turns out, it was, and it is.) The author regrets, too, that politicians claimed to be “following the science,” because science can never tell you what you should do.

For the full review see:

Steven Poole. “Bookshelf; Finding Truth In Numbers.” The Wall Street Journal (Friday, June 6, 2025): A13.

(Note: ellipses added.)

(Note: the online version of the review has the date June 5, 2025, and has the title “Bookshelf; ‘Proof’: Finding Truth in Numbers.”)

The book under review is:

Kucharski, Adam. Proof: The Art and Science of Certainty. New York: Basic Books, 2025.

Dream of the Magic Buckshot

Paul Ehrlich in the early 1900s sought a “magic bullet” for each disease (including cancer). Given the alternatives at the time, when he found Salvarsan it could be considered a magic bullet against syphilis. Today Dr. Dale Bredesen has replaced “magic” with “silver” and “bullet” with “buckshot.” In his effort to cure Alzheimer’s “Bredesen believed in firing a “silver buckshot” (a reference to the sprayed pellets that come out of shotgun shells) by modifying 36 factors simultaneously” (Gellman, p. 18).

I have not investigated Dr. Bredesen’s “cure” for Alzheimer’s and express no opinion on it. I will express the opinion that I do not like the arrogantly dismissive tone of Lindsay Gellman’sThe New York Times article, bowing to “experts,” but calling Bredesen “Mr.” instead of the “Dr.” he has earned.

And I do like the idea that sometimes what is effective against a disease (including cancer) is not a single drug or therapy, but several taken together. For example, multi-drug cocktails have been effectively used against HIV, childhood leukemia, and Hodgkin’s lymphoma.

Ehrlich’s big dream was to find a magic bullet for each disease. But maybe it is mostly more promising to dream of the magic buckshot.

[N.B., the “Paul Ehrlich” I refer to is not the contemporary environmental alarmist “Paul Ehrlich” who famously lost his bet with the heroic heretic Julian Simon.]

The NYT article quoted above:

Lindsay Gellman. “Lifestyle to Reverse Alzheimer’s Carries High Costs and, Many Say, False Hope.” The New York Times, First Section (Sun., May 25, 2025): 1 & 18.

(Note: the online version of the NYT article was updated May 31, 2025, and has the title “An Expensive Alzheimer’s Lifestyle Plan Offers False Hope, Experts Say.”)

‘Getting Old Sucks, but It’s Still Preferable to Getting Cremated’

Apparently Billy Joel was unable to attend the celebration of a new documentary on the life of Billy Joel, since he had acquired a malady of the brain called “normal pressure hydrocephalus.” But Joel sent his greetings to the crowd: ‘Getting old sucks, but it’s still preferable to getting cremated’ (Zuckerman, p. C3).

“The audience roared in laughter” (Zuckerman, p. C3).

NYT article quoted above:

Esther Zuckerman. “When Billy Joel Started Singing Us Songs.” The New York Times (Sat., June 7, 2025): C3.

(Note: the online version of the NYT article has the date June 5, 2025, and has the title “‘And So It Goes’ Traces Billy Joel’s Dramatic Early Days: 5 Takeaways.”)

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.”)

“Gold Standard” RCT Studies Do Not Always Agree on Broad Issues

Randomized double-blind clinical trials (RCTs) are usually labeled the “gold standard” of medical evidence. But any given clinical trial can be done in an infinite number of ways. The length and duration of the RCT can vary. The eligibility requirements can vary. The definition of the placebo or comparison treatment can vary.

So on the broad issue of whether red meat is good for the heart, an RCT that compares the heart effects of red meat versus the heart effects of chicken, can yield different results than an RCT that compares the heart effects of red meat versus the heart effects of a plant-based diet.

Both RCTs might be competently done, involving no dishonesty or fraud.

We tend to overgeneralize the results of an RCT, for instance saying “red meat is heart healthy,” or “red meat is not heart healthy.” Whereas all we are justified in saying is “red meat is equally heart healthy as chicken” and “read meat is less heart healthy than a plant-based diet.”

Since RCTs are expensive and time-consuming, physicians and patients will often have to choose between treatments where no RCT has been done where the researchers made the choices that are most relevant to the patient’s situation.

And in an environment where RCT costs are high and funding is scarce, are researchers to be condemned if among the myriad varying ways of setting up the RCT, they choose the ways most likely to yield the results that will be appealing to their funder?

The article quoted below, in passages I did not quote, assumes this is only an issue with industry-funded research. But government funding review panels also have preferred outcomes. For example, Charles Piller in Doctored has recently documented that government funders have been more likely to fund RCTs that support the amyloid hypothesis of the cause of Alzheimer’s.

So is there hope for those who want to take effective action against dire disease? Yes, we can recognize that not all sound actionable evidence comes from RCTs. We can stop mandating Phase 3 trials, so that a more diverse assortment of plausible therapies can be explored. We can encourage diverse, decentralized funding sources.

(p. D6) In a review published last week in the American Journal of Clinical Nutrition, scientists came to a concerning conclusion. Red meat appeared healthier in studies that were funded by the red meat industry.

. . .

Past research funded by the sugar industry, for instance, has downplayed the relationship between sugar and health conditions like obesity and heart disease. And studies funded by the alcohol industry have suggested that moderate drinking could be part of a healthy diet.

Miguel López Moreno, a researcher at Francisco de Vitoria University in Spain who led the new analysis, said in an email that he wanted to know if similar issues were happening with the research on unprocessed red meat.

. . .

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.

. . .

These differing results may have stemmed from how the studies were set up in the first place, Dr. Tobias wrote in an editorial for the American Journal of Clinical Nutrition that accompanied the new study.

Individual nutrition studies can be good at showing how the health effects of certain foods compare with those of other specific foods. But to demonstrate whether a particular food, or food group like red meat, is good or bad for health in general, scientists must look at the results from many different studies that compare it to all possible food groups and diets.

The new review showed that, on the whole, the industry-funded red meat studies neglected to compare red meat to the full range of foods people might eat — including food we know to be good for the heart like whole grains or plant-based protein sources such as tofu, nuts or legumes. Instead, many of the studies compared unprocessed red meat to other types of animal protein like chicken or fish, or to carbohydrates like bagels, pasta or rice.

The independently funded studies, on the other hand, compared red meat to “the full spectrum” of different diets — including other types of meat, whole grains and heart-healthy plant foods like soy products, nuts and beans — Dr. Tobias said. This more comprehensive look offers a fuller picture of red meat’s risks or benefits, she said.

. . .

A spokeswoman for the National Cattlemen’s Beef Association said in an email that “beef farmers and ranchers support gold standard scientific research,” and that both animal and plant sources of protein can be part of a heart-healthy diet.

For the full story see:

Caroline Hopkins Legaspi. “Eyes on the Outcomes Of Red Meat Research.” The New York Times (Tues., May 27, 2025): D6.

(Note: ellipses added.)

(Note: the online version of the story has the date May 20, 2025, and has the title “Is Red Meat Bad for Your Heart? It May Depend on Who Funded the Study.”)

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

López-Moreno, Miguel, Ujué Fresán, Carlos Marchena-Giráldez, Gabriele Bertotti, and Alberto Roldán-Ruiz. “Industry Study Sponsorship and Conflicts of Interest on the Effect of Unprocessed Red Meat on Cardiovascular Disease Risk: A Systematic Review of Clinical Trials.” The American Journal of Clinical Nutrition 121, no. 6 (June 2025): 1246-57.

Some other articles discussing cases where industry funding is alleged to have funded biased research are:

Anahad O’Connor. “Sugar Backers Paid to Shift Blame to Fat.” The New York Times (Tues., Sept. 13, 2016): A1 & ?.

(Note: the online version of the story has the date Sept. 12, 2016, and has the title “How the Sugar Industry Shifted Blame to Fat.”)

Alice Callahan. “Is Fake Meat Superior to the Real Thing?” The New York Times (Tues., Feb. 18, 2025): D7.

(Note: the online version of the story has the date Feb. 17, 2025, and has the title “Is Fake Meat Better for You Than Real Meat?”)

Roni Caryn Rabin. “U.S. Wooed Alcohol Industry for a Drinking Study.” The New York Times, First Section (Sun., March 18, 2018): 1 & ??.

(Note: the online version of the story has the date March 17, 2018, and has the title “Federal Agency Courted Alcohol Industry to Fund Study on Benefits of Moderate Drinking.”)

Citizen Scientist Tim Friede Is Now “Director of Herpetology” at Centivax Startup

An earlier blog entry told the story, quoting The New York Times, of citizen scientist Tim Friede who injected himself with venom from multiple snakes, and allowed many to bite him, in order to develop antibodies that would protect him from all snake bites, and allow scientist Jacob Glanville to create a universal snakebite antivenom.

Now The Wall Street Journal has run a similar story, but adds a minor satisfying twist. The scientist Jacob Glanville has co-founded a startup called Centivax to develop the universal antivenom, and Friede is Centivax’s “director of herpetology.”

The Wall Street Journal article is:

Nidhi Subbaraman. “A Universal Antivenom, From a Man Bitten by Snakes 200 Times.” The Wall Street Journal (Sat., June 14, 2025): C5.

(Note: the online version of the WSJ article has the date June 10, 2025, and has the title “A Man Let Snakes Bite Him 200 Times. His Blood Inspired a Universal Antivenom.”)

“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.