Month: September 2026

The Ubiquitous Claim That the “Gold Standard” for Testing the Safety and Efficacy of a Treatment Is a Randomized Controlled Trial

I am working on revising a paper that currently has the title “FDA-Mandated “Gold Standard” RCTs Hike Costs and Block Cures.” In the paper I state that a ubiquitous assertion is that “the gold standard” method for learning the safety and efficacy of a medical treatment is a randomized controlled trial (RCT). I have accumulated many examples to support my statement, but to save space in the paper, I am going to list the examples in this blog entry. As time permits, I will update this list as I encounter added examples.

This matters because I believe that calling RCTs “the gold standard,” functions to shut down any discussion of whether any other methods, such as well-done observational studies, might be cheaper, more ethical, or even more sound, than RCTs. (Calling RCTs “the gold standard” serves to locate such a discussion outside the Overton window of politely acceptable discourse.) Arguments and evidence are thus ignored that deserve to be heard and pondered.

Here are a few quotations supporting my claim that RCTs are ubiquitously viewed as the “gold standard” of medical research.

“Generations of medical students have been taught, quite rightly, that the double-blind, randomized [sic], placebo-controlled trial is the gold standard of evidence for new treatments” (Ritchie 2020, 110).

“The purists of evidence-based medicine demand data from randomized controlled trials (RCTs) before doing anything. Those trials are the gold standard of medical evidence, . . .” (Attia 2023, 50; italics in original).

“. . . the results of preliminary clinical trials, the gold standard in medicine, are compelling, despite the small sample sizes” (Whiteman 2023, 167).

“. . . a randomised [sic] clinical trial – medicine’s gold standard for sorting genuine treatments from quackery” (Yong 2016, 231).

“It was the only randomized controlled trial, the gold standard test of efficacy in medicine, ever done in iMCD” (Fajgenbaum 2019, 189).

“Some of these papers are randomized controlled trials (RCTs), which are considered “the gold standard” because they randomly separate people into a test and a control group. If the test group gets the effect and the control group doesn’t, it suggests a cause because the test food is the only difference” (Williams 2021, 204).

“The randomized controlled trial is the gold standard for evidence in clinical medicine” (Prasad and Cifu 2015, 119).

“First devised in the late 1940s (in a study of tuberculosis treatments), the RCT is arguably the most important medical technology of the 20th century. When large and well designed, it is the most powerful way to elucidate the truth in all of medical science. And though it cannot tell you about the mechanism of how a treatment works biologically, it can show conclusively whether a given intervention accomplishes a given goal. In medicine, it is the gold standard for proving a claim” (Prasad and Cifu, 2015, 124).

Without providing you the passages, here are some additional sources that support the ubiquity of the claim that RCTs are the “gold standard” of medical research: Bothwell et al. (2016); Concato and Horwitz (2018); Cook (2018); Hariton and Locascio (2018); Jones and Steel (2018); Mowat et al. (2018).

The full citations for the publications briefly cited above are:

Attia, P. 2023. Outlive: The Science and Art of Longevity. Harmony.

Bothwell, L. E., J. A. Greene, S. H. Podolsky, and D. S. Jones. 2016. “Assessing the Gold Standard — Lessons from the History of RCTs.” New England Journal of Medicine 374, no. 22 (June 2): 2175–81.

Concato, J., and R. I. Horwitz. 2018. “Randomized Trials and Evidence in Medicine: A Commentary on Deaton and Cartwright.” Social Science & Medicine 210 (Aug.): 32–36.

Cook, T. D. 2018. “Twenty-Six Assumptions That Have to Be Met If Single Random Assignment Experiments Are to Warrant “Gold Standard” Status: A Commentary on Deaton and Cartwright.” Social Science & Medicine 210 (Aug.): 37–40.

Fajgenbaum, D. 2019. Chasing My Cure: A Doctor’s Race to Turn Hope into Action; A Memoir. Ballantine Books.

Hariton, Eduardo, and Joseph J. Locascio. 2018. “Randomised Controlled Trials – the Gold Standard for Effectiveness Research: Study Design: Randomised Controlled Trials.” BJOG: an international journal of obstetrics and gynaecology 125, no. 13 (Dec.): 1716–16.

Jones, A., and D. Steel. 2018. “A Combined Theoretical and Empirical Approach to Evidence Quality Evaluation: A Commentary on Deaton and Cartwright.” Social Science & Medicine 210 (Aug.): 74–76.

Mowat, Ryan, S. V. Subramanian, and Ichiro Kawachi. 2018. “Randomized Controlled Trials and Evidence-Based Policy: A Multidisciplinary Dialogue.” Social Science & Medicine 210 (Aug.): 1.

Prasad, V. K., and A. S. Cifu. 2015. Ending Medical Reversal: Improving Outcomes, Saving Lives. Johns Hopkins University Press.

Ritchie, S. 2020. Science Fictions: How Fraud, Bias, Negligence, and Hype Undermine the Search for Truth. Metropolitan Books.

Whiteman, N. 2023. Most Delicious Poison: The Story of Nature’s Toxins—from Spices to Vices. Little, Brown Spark.

Williams, R. A. 2021. Fixing Food: An FDA Insider Unravels the Myths and the Solutions. Post Hill Press.

Yong, E. 2016. I Contain Multitudes: The Microbes within Us and a Grander View of Life. Ecco.

Aspire to Achieve the Hebrew Birthday Blessing

Peter Thiel and I praise the pursuit of what Jim Collins and Jerry Porras called “BHAGs” (big, hairy, audacious goals). One such BHAG would be to make lives of 120 years common.

“The Hebrew blessing on a birthday is that you should live to 120 (Moses’ age when he died in good shape with all of his marbles)” (Weiss 2026, A13). Jeanne Calment lived to 122, providing proof-of-concept that a life of 120 years is possible.

Longer lives would allow us to pursue more ambitious projects, and would give us more second and third chances when our first projects fail. The pursuit of ambitious goals is one path to a meaningful, fulfilling life. One such goal is to add many years to each of our lives.

The source of the Weiss quote is:

Lou Weiss. “When Your Friends All Turn 70.” The Wall Street Journal (Fri., July 10, 2026): A13.

(Note: the online version of the Weiss commentary has the date July 9, 2026, and has the same title as the print version.”)

The publications that I refer to in my first sentence are:

Collins, James C., and Jerry I. Porras. 1994. Built to Last: Successful Habits of Visionary Companies. HarperBusiness.

Diamond, Arthur M., Jr. 2019. Openness to Creative Destruction: Sustaining Innovative Dynamism. Oxford University Press.

Thiel, Peter, and Blake Masters. 2014. Zero to One: Notes on Startups, or How to Build the Future. Crown Business.

Humans and Non-Humans Can Adapt to Global Warming

In my Openness book (Diamond 2019, 122-123), and in an earlier paper (Diamond 2018, 246-248) I argue that environmentalists overestimate the harm from global warming, in part because they underestimate the ability of human and non-human life to adapt. I recently have run across, in The New York Times, four examples that support my argument.

If global warming increases the rate of calving of arctic glaciers into icebergs, the icebergs will contain “dropstones” that will drop to the bottom of the ocean as they melt, where they:

become an important part of the deep-sea ecosystem, providing a home for corals, sponges and other marine invertebrates that live by latching onto hard structures. Those populations then help support bottom-feeding shrimps and sea lilies, with whom they form symbiotic relationships. The researchers observed this flourishing deep-sea community using images from the HAUSGARTEN observatory.  . . .  The researchers hypothesize that, as dropstones continue to proliferate in the coming decades, the number of visible fauna and the level of biodiversity in the deep ocean will also increase. (Callaway 2026, A7).

In an extensive study of changes in butterfly habitats, believed mainly due to global warming, researchers found that “Eighty percent of the butterfly species the researchers studied expanded their ranges, establishing themselves in areas that had previously been unsuitable for them to inhabit” (Roth 2026, D5).

In the Canadian subarctic global warming is allowing many plants and animals, most impactfully the beaver, to move north. From Norimitsu Onishi’s account in The New York Times:

(p. A1) Until a few years ago, a small stream meandered down a long valley flanked by sheer ridges in Umiujaq, a subarctic village in northern Quebec. The waterway had pretty much hewed to that course since the earth’s crust rebounded after the last ice age.

Newcomers from the south, though, had other ideas.

A crew of bucktoothed, paddle-tailed beavers has erected five dams, the most impressive being as tall as a city bus and even longer. The sound of cascading water is heard half a mile away. Toads paddle inside the large ponds that now pockmark the valley, beneficiaries of the hydrological attenuation engineered by the recent arrivals.

. . .

(p. A7) To be sure, beavers aren’t the only transplants heading north. Across Canada’s Arctic, people report seeing new species of birds and sea mammals in their midst. On land, moose are branching out of their traditional range, following the northward spread of ever-taller shrubs across the tundra, a phenomenon scientists call the region’s “shrubification.”

But no southerner has had a greater impact on the north than the beaver. By building dams and ponds, beavers are rewiring Arctic hydrology, scientists say.

. . .

“Beavers change their environment so much that they even end up creating habitats that are favorable to other animal species — small birds like warblers that are able to nest in the bushes,” said Isabeau Pratte, a biologist for the Kativik Regional government, which oversees the Inuit communities in northern Quebec. (Onishi 2026)

In the eastern part of the Gobi desert in China, the Tongliao area was mostly arid, but global warming has made it much wetter. “Several decades ago, only 12 percent of Tongliao had grasslands or forests and the rest was desert, according to the local government. Now 64 percent of the area is covered with crops, grass or forests” (Bradsher 2026, B5). As a result, China has greatly expanded its production of corn and beef cattle.

The examples that I describe are documented in the following articles:

Keith Bradsher. “Climate Change Helps Raise Herds.” The New York Times (Fri., August 15, 2026): B1 & B5.

(Note: the online version of the above article has the date July 30, 2026, and has the title “How Climate Change and Tariffs Help China Raise More Cattle.”)

K. R. Callaway. “Some Deep-Sea Creatures Benefit as Planet Warms.” The New York Times (Fri., July 10, 2026): A7.

(Note: the online version of the above article has the date July 7, 2026, and has the title “As Ice Melts in the Arctic, Some Deep-Sea Creatures Are Thriving.”)

Norimitsu Onishi. “In Thawing Arctic, Beavers Invade and Renovate.” The New York Times (Sat., August 15, 2026): A1 & A7.

(Note: the online version of the above article was updated Aug. 14, 2026, and has the title “The Beavers Are Coming for Canada’s Arctic, One Dam at a Time.”)

Annie Roth. “Climate Change Spurs Butterfly Range Shifts.” The New York Times (Tues., August 11, 2026): D5.

(Note: the online version of the above article was updated Aug. 10, 2026, and has the title “Butterflies Take Flight in Face of Climate Change and Extreme Weather.”)

(Note: ellipses added.)

Academic papers supporting The New York Times articles by Roth and by Callaway are:

Chowdhury, Shawan, Upama Aich, Laura H. Antão et al. 2026. “Extensive Climate-Induced Range Shifts in Butterflies across the Globe.” Nature Ecology & Evolution (Aug. 5) https://doi.org/10.1038/s41559-026-03117-y.

Krumpen, Thomas, Kirstin S. Meyer-Kaiser, Claudia Wekerle, Lars Ackermann, Deonie Castle, Melanie Bergmann, Mario Hoppmann, Shfaqat A. Khan, Autun Purser and Holger Schmithüsen. 2026. “Amplified Arctic Iceberg Traffic Reshapes Benthic Biodiversity.” Nature 654 no. 8120 (June 25): 963–70. https://doi.org/10.1038/s41586-026-10630-4.

My own publications mentioned in my initial comments are:

Diamond, Arthur M., Jr. 2018. “Innovative Dynamism Improves the Environment.” Libertarian Papers 10, no. 2: 233–75.

Diamond, Arthur M., Jr. 2019. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press.

Regulatory Healthcare Price Caps Create Perverse Incentives With Unintended Consequences

Lorens Helmchen and Tony LaSasso’s op-ed in The New York Times argues that when regulators enforce price caps on medical treatments, they create perverse incentives for healthcare providers. For fragile patients with complicated maladies, the cost of treatment may exceed the price cap the regulators allow the healthcare provider to charge. In that case the healthcare provider has a perverse incentive either to deny the patient care, or to give the patient a lower, ineffective, level of care.

I argue elsewhere that there are better ways to reduce the too-high costs of healthcare, e.g., increase competition by repealing certificate of need requirements before opening new healthcare facilities, reduce practice restrictions on nurse practitioners, and eliminate the mandated Phase 3 RCTs required for FDA drug approval.

The Helmchen and LaSasso op-ed is:

Lorens Helmchen and Tony LoSasso. “Capping the Cost of Health Care Is a Mistake.” The New York Times (Tues., July 20, 2026): A23.

(Note: the online version of the op-ed has the date July 20, 2026, and has the title “This Is Not the Answer to Soaring Health Care Costs.”)