The NXR Podcast - September 24, 2026


The Next Crusade - Calvin Robinson Breaks Down the FDA’s Century of Tombstone Regulation

Hosted by
Joel Webbon Harrison Smith Antonio Griffith Dale Partridge Wewsley Todd Calvin Robinson
Mentioned
Frances Kelsey Purdue Pharma David Graham Guillain-Barre Vioxx
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Episode Stats


Length

16 minutes

Words per minute

137.14

Word count

2,300

Sentence count

91


Transcript

Transcript generated with Whisper (turbo).
Hosts, guests, and mentioned names generated with spaCy (en_core_web_sm), reconciled against Wikidata.
00:00:00.000 Ever since moving to America, I've been shocked by just how little the average American cares
00:00:21.580 about what they eat, a behaviour I attribute to a blind and implicit trust in government
00:00:27.960 regulations. It's like Americans believe that somewhere in Washington, D.C. is a benevolent
00:00:34.440 guardian patiently sifting the safe from the dangerous foods, standing between the ordinary
00:00:40.280 citizen and the profiteer. The Food and Drug Administration has, for well over a century,
00:00:48.080 presented itself as precisely this guardian. And in fairness to it, there are moments in history
00:00:54.540 when it has fulfilled that image. But learning about the FDA's other moments,
00:01:00.000 the ones that the government doesn't advertise, really makes me understand why food in America
00:01:05.680 is almost entirely slop. The FDA's history is a record of catastrophes acknowledged
00:01:13.020 only after the coffins had been counted, of institutional habits that placed commerce
00:01:19.340 and convenience above the public that the agency has sworn to protect, and of a persistent
00:01:25.960 structural temptation to serve the very industry it was created to regulate.
00:01:32.380 To understand the pattern, we have to look at the start of it all. The first federal food and drug
00:01:38.040 law was passed in 1906, driven by public revulsion at the filthy conditions of the meatpacking trade.
00:01:46.080 But the agency as we recognise it today was devised in response to a tragedy.
00:01:52.720 In the autumn of 1937, a Tennessee firm, the S.E. Massengil Company,
00:01:59.460 marketed a liquid preparation of a popular new antibacterial drug.
00:02:04.020 To dissolve it into a sweet and palatable syrup, the company's chemist chose diethylene glycol,
00:02:10.360 a compound closely related to antifreeze and lethal to human beings.
00:02:14.920 No safety testing was required by law and none was performed
00:02:19.060 More than 100 people died in agony
00:02:21.700 A great many of them children whose parents had given them the medicine in good faith
00:02:26.560 This disaster produced the Federal Food, Drug and Cosmetic Act of 1938
00:02:33.060 Which for the first time obliged manufacturers to demonstrate that a product was safe before it could be sold
00:02:40.740 This was the beginning of the FDA's streak of tombstone regulation
00:02:47.540 The habit of the agency and the Congress behind it
00:02:51.320 To act decisively only once a sufficient number of citizens had already perished
00:02:56.680 The most celebrated chapter in the agency's history is the thalidomide affair
00:03:02.600 Which is to this day used as justification for everything the FDA does
00:03:06.800 In the late 1950s and early 1960s, thalidomide was prescribed across Europe as a sedative and a remedy for morning sickness, with appalling consequences.
00:03:19.760 Thousands of infants were born with severe malformations of the limbs.
00:03:24.000 A pharmacologist at the FDA named Frances Oldham Kelsey repeatedly refused to approve the drug
00:03:32.380 for the American market, unpersuaded by the data she was shown and unmoved by considerable pressure
00:03:38.820 from the manufacturer. Her caution spared the United States the worst of the calamity,
00:03:45.160 and she was rightly honoured for it. The popular telling, however, treats this as proof that the
00:03:51.520 agency has always been an unblemished hero and that impression is misleading. Even in America,
00:03:59.140 the drug was distributed to numerous patients under the guise of investigational samples
00:04:04.940 and a number of affected children were born as a result. What the near-miss truly accomplished was
00:04:11.380 legislative. The Kervor-Harris Amendment of 1962, which required manufacturers to prove not merely
00:04:19.980 that a drug was safe, but that it actually worked, and which tightened the conduct of clinical trials
00:04:26.200 and the taking of consent. The requirement to prove efficacy arrived too late to prevent another
00:04:32.600 quiet scandal. From the 1940s onward, a synthetic oestrogen known as diethylstilbestrol, or DES,
00:04:43.080 was prescribed to pregnant women in the belief that it would prevent miscarriage. It never did
00:04:49.220 any such thing. The evidence for its effectiveness was thin to the point of vanishing. Worse,
00:04:55.120 it was discovered years afterward that daughters exposed to the drug in the womb
00:04:59.860 suffered elevated rates of a rare cancer of the vagina and cervix, together with other
00:05:06.080 reproductive injuries. It took more than 30 years of suffering before the agency would
00:05:11.640 even advise against its use in pregnancy in 1971. The episode reminds us of two things,
00:05:20.580 that a treatment can be widely prescribed for decades without ever having been shown to work,
00:05:27.020 and that the gravest harms may be ignored for a generation before the damage is sufficient
00:05:32.160 to warrant even a warning. Around the same period, the limits of the agency's authority over
00:05:38.500 medical devices as distinct from drugs produced their own tragedy. The Dalkon Shield, an intra-uterine
00:05:47.840 contraceptive marketed from 1971, was associated with severe pelvic infections, septic miscarriages
00:05:55.980 and a number of deaths. Because devices were only lightly overseen before the medical device
00:06:02.700 amendments in 1976, the product reached the market and remained there with almost no scrutiny.
00:06:10.620 Once again, meaningful regulation followed the injuries rather than preventing them.
00:06:16.560 For the sake of accuracy, it's important to note that the FDA wasn't the only government agency
00:06:21.600 that is complicit in medical malpractice against the American people. Many people conflate every
00:06:26.740 failure of American public health with the FDA and the most notorious example of official cruelty
00:06:33.540 wasn't even carried out by them. The Tuskegee study of untreated syphilis, which ran from 1932
00:06:40.600 until 1972 in rural Alabama, was conducted not by the FDA but by the United States Public Health
00:06:48.580 Service. For four decades, hundreds of poor black men were deliberately left untreated so that the
00:06:56.020 natural cause of the disease could be observed, and they were denied penicillin even after it
00:07:01.860 had become the standard cure. When a whistleblower brought the study to the attention of the press
00:07:07.240 in 1972, the resulting outrage produced the National Research Act of 1974, and eventually
00:07:14.040 the framework of informed consent and ethical review that governs research today.
00:07:18.140 One need not be a theologian to grasp that
00:07:22.740 What was violated here
00:07:25.380 Though the Catholic tradition names it quite plainly
00:07:28.680 The inviolable dignity of the human person
00:07:33.080 Who may never be treated as a mere instrument of the ends of others
00:07:37.500 A principle set out with particular clarity
00:07:40.600 In the Church's teaching on the conduct of medicine
00:07:43.420 That such abusers were possible
00:07:46.460 within the apparatus of American public health should temper any naive faith in the benevolence
00:07:52.400 of institutions. Trust was eroded further in 1976 when an outbreak of a new influenza at a
00:08:00.440 New Jersey army base prompted fears of a repeat of the great pandemic of 1918.
00:08:06.500 A mass immunization program was launched with considerable political fanfare and some 45
00:08:12.220 million Americans were vaccinated. The dreaded pandemic never arrived, and the campaign became
00:08:18.920 associated with cases of a serious neurological condition. Guillain-Barre syndrome. The program
00:08:26.640 was suspended amid recrimination. It would be unfair to describe this as simple villainy.
00:08:33.440 Officials faced a genuinely difficult judgment under great uncertainty, and the honest lesson
00:08:38.420 is subtler than the cynical one. Still, the affair taught a wary public that the authorities
00:08:45.940 could be wrong, and that the government was glad to exercise as much control as they could
00:08:51.700 possibly justify, even if the justification was panic that they incited. This exact same
00:08:58.760 practice continues in recent memory, with the economic crash mandated by the tyrannical overreach
00:09:04.260 of mandating dress and restricting movement of innocent people, all justified by their mass
00:09:10.140 fear campaign. Consider the painkiller Vioxx, approved by the agency in 1991, approved to
00:09:17.400 many millions of arthritis sufferers before its manufacturer withdrew it in 2004 upon evidence
00:09:23.580 that it substantially raised the risk of heart attacks and strokes. A senior scientist within
00:09:29.840 the FDA itself, Dr. David Graham, testified before the Senate that the drug may have been
00:09:35.500 associated with somewhere between 88,000 and 139,000 excess cases of serious heart disease
00:09:46.120 in the United States, a large fraction of them fatal, and he described an institutional culture
00:09:52.060 that had made it extraordinarily difficult for safety concerns to be heard once a product had
00:09:57.640 been approved. For your sake, remember that the phrase FDA approved does not mean proven safe.
00:10:06.780 It means only that the agency has judged the benefits to outweigh the risks for a particular
00:10:11.660 use on the basis of the evidence available at the time. Rare or delayed harms often emerge only once
00:10:19.540 a drug is taken by vast numbers of people over years, and the ability to unapprove a medication
00:10:25.540 that past initial testing is much weaker than you'd hope. The most extreme failure of recent memory
00:10:31.880 and the one whose consequences are still being buried concerns opioids. In 1995, the agency
00:10:39.500 approved a powerful, long-acting formulation of oxycodone, marketed as oxycontin, by Purdue
00:10:47.520 Pharma. Its original laboring included the claim that the delayed absorption of the drug
00:10:52.920 was believed to reduce its potential for abuse, a statement for which the supporting evidence
00:10:58.880 was flimsy and which was later withdrawn. Armed in part by this reassurance, the manufacturer
00:11:06.020 pursued an aggressive marketing campaign, physicians prescribed the drug freely, and
00:11:11.560 donation was drawn into an epidemic of addiction and overdose that had claimed hundreds of thousands
00:11:16.240 of lives. The company would eventually plead guilty to criminal charges concerning the
00:11:20.900 misbranding of the drug, first in 2007 and again in 2020. The agency's willingness to sanction that
00:11:29.220 fateful language on the label remains one of the most heavily criticised regulatory decisions
00:11:34.140 in its history. Which brings us to the harder question the record forces upon us. Why should
00:11:41.420 an agency charged with protecting the public ever come to prioritise anything else? The answer lies
00:11:47.420 less in the wickedness of individuals than in the structure of incentives. Since the Prescription
00:11:54.080 Drug User Fee Act in 1992, a substantial and now majority share of the agency's budget for
00:12:01.220 reviewing new drugs has been paid not by the taxpayer but by the pharmaceutical companies
00:12:07.260 whose products it evaluates. Defenders argue that this arrangement sped up access to genuinely
00:12:13.360 needed treatments. Critics reply that a regulator financially dependent upon the industry it
00:12:18.420 regulates is placed in an impossible position, and that the pressure to approve quickly is thereby
00:12:25.460 built into the system itself. Economists have a name for the broader phenomenon,
00:12:32.340 regulatory capture, the tendency of an agency over time to serve the interests of the sector
00:12:37.680 it oversees rather than public it represents. That tendency is reinforced by the revolving
00:12:44.140 door, the movement of officials between the agency and the companies it regulates in both
00:12:49.160 directions. A practice that is entirely legal and entirely common, yet unavoidably raises
00:12:55.200 the amount of conflicting loyalties. When a recent commissioner departed and shortly
00:13:01.360 afterward joined the board of a major drug manufacturer, no law was broken, but the people
00:13:06.360 see that another government official has used their suspiciously good relationship to win a
00:13:12.040 six-figure salary with the company they're supposed to bring to heel. This isn't the only source of
00:13:18.180 corruption. The expert advisory committees that the agency relies on often includes members with
00:13:24.020 financial ties to the products under discussion. Patient advocacy groups, some of them funded by
00:13:30.960 industry campaign vigorously for faster approvals, and newer pathways permit drugs to be cleared on
00:13:38.000 the basis of surrogate measures, laboratory markers that stand in for actual clinical
00:13:43.820 benefits rather than proving it. The approval in 2021 of an expensive treatment for Alzheimer's
00:13:50.020 disease granted, despite the near-unanimous objection of the agency's own adversary panel,
00:13:55.700 from which several members resigned in protest and later the subject of a scathing congressional
00:14:01.920 inquiry showed how far this logic can be stretched. It is important to be fair and to understand that
00:14:09.320 the FDA isn't a failure 100% of the time. The agency has prevented genuine catastrophes that
00:14:16.260 its scientists have on occasion blown the whistle upon their own employer and the ordinary miracles
00:14:21.620 of modern medicine reach the public through its officers. The point is not that all medicine is
00:14:27.440 suspect, nor that the citizen should retreat into a paralysis of distrust. Two errors must be avoided
00:14:34.320 in equal measure. The naive faith that treats every approval as a guarantee, and the reflexive
00:14:41.000 cynicism that treats every regulator as a villain. The truth is, as always, more nuanced than a catchy
00:14:47.120 slogan. Recall also that the agency does not itself conduct the trials upon which it rules.
00:14:52.400 The manufacturers design and run the studies and submit the results, and the reviewer's task is to
00:14:57.740 interrogate another party's evidence, which leaves the FDA's hands tied in the face of corrupt
00:15:03.220 agencies. What the record demands then is neither reverence nor contempt but vigilance. The Catholic
00:15:11.600 social tradition holds that institutions and markets alike must be ordered towards the common
00:15:16.660 good, and that authority carries a particular duty to protect the vulnerable who cannot protect
00:15:22.240 themselves. An agency that forgets this, but comes to serve the balance sheet of an industry ahead
00:15:28.780 of the health of a people, betrays the very reason for its existence. The Guardian at the gate is a
00:15:35.140 fine and necessary thing, but history teaches that the Guardian too must be watched.
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