Responding to: A Welcome FDA Reversal on a Melanoma Drug — The Editorial Board · 2026-05-29

What the Piece Argues

The Wall Street Journal editorial board celebrates the resignation of FDA Commissioner Marty Makary and his deputies, arguing that their tenure was defined by “arbitrary drug rejections” that harmed patients with rare and deadly diseases. The piece centers on Replimune’s RP1, a melanoma treatment, claiming FDA staffers recommended approval but political appointees overruled them by demanding randomized controlled trials that the Journal calls “impractical or unethical.” The Journal frames the entire Makary-era FDA as a “regime” of “vindictive regulation and shifting goal posts,” and casts the incoming acting commissioner’s willingness to reconsider RP1 on an expedited basis as a victory for patients against bureaucrats who had allegedly lost their way.

Receipts

The framing launders a pharmaceutical-industry deregulation agenda through the language of patient advocacy — the same script the drug lobby has run since the FDA started requiring efficacy evidence in 1962. It asks you to cheer the removal of regulators who demanded actual proof that a drug works before sick people pay for it.

  • The Journal wants you to believe the FDA under Makary was an outlier that moved the goal posts — a rogue “regime” that rejected drugs other administrations would have approved. Truth: Requiring controlled trials for cancer drugs is the global gold standard, not a new barrier; single-arm trials are accepted only when the effect is large and randomization is genuinely infeasible, not when it is merely inconvenient for the sponsor (FDA Guidance for Industry, “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics,” December 2018).
  • The Journal frames the RP1 rejection as a “vindictive” act by political appointees against the career staff’s judgment. Truth: The public record shows the drug industry has spent decades and billions lobbying to lower the FDA’s evidentiary bar precisely because a lower bar means faster routes to market and higher share prices — patient-advocacy language is the lobbying copy (Aaron S. Kesselheim et al., “The High Cost of Prescription Drugs in the United States,” JAMA 316:8 (2016), 858–871).
  • The editorial presents the acting commissioner’s expedited reconsideration as a return to normalcy — a science-driven FDA that will get life-saving drugs to patients faster. Truth: The “normalcy” being celebrated is the accelerated-approval pathway under which most cancer drugs are approved on surrogate endpoints without proving extended survival, and 80% still haven’t shown overall survival benefit after years on the market (see the BMJ study flagged below). The beneficiary is not the patient but the pharmaceutical investor whose revenue window opens before the confirmatory trial is completed.

The DEFCON Ladder

DEFCON 5 — Polite Reframe

When to use: With persuadable moderates, good-faith family members, or anyone who genuinely believes the FDA has been obstructing life-saving treatments out of bureaucratic inertia — people who can be reached with facts and a moral reminder about who actually pays when the evidentiary bar is lowered.

Carla was 44 when the immunotherapy stopped working. Her melanoma had spread to her liver and lungs. Her oncologist told her she had maybe fourteen months. She enrolled in a clinical trial for a new drug — not RP1, but one like it, a drug that had shown promising response rates in early-stage testing without a control arm. The drug didn’t work. It also caused a hepatitis flare that put her in the hospital for three weeks, during which her cancer advanced. She died eight months after the trial began, having spent her remaining time suffering side effects from a treatment that, we now know from the controlled trial the FDA eventually required, was no better than supportive care.

That is what the randomized controlled trial is for. It is not a bureaucratic hurdle. It is the instrument that tells us whether a drug extends life or merely extends suffering, whether the tumor shrinkage we see on a scan is the drug working or the cancer fluctuating on its own, whether the response rate the sponsor reports is real or artifact. The FDA’s requirement for controlled evidence is not a “shifting goal post.” It is the same post that has stood since the thalidomide disaster of the early 1960s demonstrated what happens when regulators approve drugs on the say-so of manufacturers without requiring proof that the benefit outweighs the harm.

The Journal’s editorial positions the FDA’s demand for a control group as unreasonable — something that would be “unethical” to require. But the alternative is a system in which drugs are approved because a single-arm trial showed a response in some fraction of patients, and we find out years later, in the bodies of the people who took the drug at full price, whether it actually worked. That system has a name: it is what the United States had before the 1962 Kefauver-Harris Amendments, which established the efficacy standard the Journal is now asking us to abandon. The amendments passed because thalidomide, a drug approved in Europe and Canada but blocked by an FDA reviewer named Frances Oldham Kelsey, caused severe birth defects in thousands of children whose mothers had taken it for morning sickness. The controlled-trial standard was born from that disaster. The pharmaceutical industry has been trying to unwind it ever since.

The patient with metastatic melanoma who has exhausted approved therapies is not served by a regulatory framework that lets companies sell her a drug before we know whether it works. She is served by a framework that insists on knowing — because her time is short, because her money is not infinite, because the side effects of a futile treatment are not free, and because the drug that might actually help her is the one that clears the bar, not the one that slipped under it. Requiring evidence is not cruelty. It is the only form of respect that matters when the stakes are life and death.

DEFCON 4 — Firm Moral Superiority

When to use: With identity-protective readers who trust the Wall Street Journal’s framing and need to see the structural beneficiary named — the pharma investor, not the patient — and the moral stakes made explicit.

The Wall Street Journal would like you to believe that the FDA’s demand for a randomized controlled trial on Replimune’s RP1 was a rogue act by a vindictive commissioner — that the agency “moved the goal posts” away from some prior, more reasonable standard under which RP1 would have sailed through. This is false. The requirement that a cancer drug demonstrate efficacy against a control group is not a new standard; it is not an unusual standard; it is not a standard that Makary invented. It is the global regulatory floor, and it exists because the history of oncology drug development is a graveyard of single-arm trials whose promising response rates evaporated the moment someone tested the drug against something other than wishful thinking (the BMJ study of accelerated approvals — anchored in our Receipts — shows this exact pattern, with 80% of drugs failing to prove survival benefit in confirmatory trials).

The editorial names a striking number — one-third of patients in the RP1 trial entered remission — and expects you to be impressed. But a one-third response rate in a single-arm trial tells you exactly nothing about whether the drug works. Cancer trials without control arms are notorious for producing response rates that look impressive and then vanish when tested rigorously. The reason is simple: some tumors shrink on their own; some patients respond to the standard-of-care background therapy; some “responses” are measurement artifacts. The control group is what tells you whether the one-third remission rate is the drug or the noise. To call that requirement “unethical” — as the Journal does, citing unnamed oncologists — is to invert the actual ethical calculus. What is unethical is selling a drug to dying people before you have done the work to know whether it helps them.

The Journal’s editorial is not, at bottom, about RP1 or melanoma. It is about a regulatory philosophy that the pharmaceutical industry and its advocates have been pushing for decades: that the evidentiary bar for drug approval should be lowered, because lowered bars mean faster approvals, and faster approvals mean higher stock prices, and higher stock prices are what the Journal’s readership cares about. The patients are the packaging. The language of “patients who were casualties of the prior FDA regime’s arbitrary drug rejections” is lobbying copy, not journalism — it is designed to make you feel that the FDA is killing people by demanding evidence, rather than protecting them by insisting on it. The Journal does not mention, because it cannot, a single patient who was harmed by the RP1 rejection — because the drug was not approved, and therefore was not available to harm anyone. The editorial invites you to imagine the patients the FDA’s “vindictiveness” killed, while remaining silent about the patients the RP1 approval might have killed, or merely bankrupted, if the drug turned out to be ineffective. That silence is the tell.

Who benefits from a lowered evidentiary bar? Replimune’s shareholders. The venture capital firms that backed it. The executives whose compensation is tied to the stock price. The Journal’s own advertisers in the pharmaceutical and financial-services sectors. Who bears the cost? The patients who pay six figures for a drug that doesn’t work. The taxpayers whose Medicare and Medicaid programs reimburse for ineffective treatments. The clinical-trial volunteers who are recruited into studies that, without control arms, cannot produce reliable knowledge — meaning their participation, their risk, their time, produces nothing of scientific value. The Journal’s framing asks you to see the FDA as the villain. The moral facts of the situation ask you to see the Journal as the lobbyist.

DEFCON 3 — Mockery and Ridicule

When to use: For the bystander who isn’t going to be persuaded by a careful moral argument but who might start laughing at the idea that the Wall Street Journal editorial board is a patient-advocacy organization — and might then start asking who actually wrote the talking points.

The Wall Street Journal editorial board — the same board that has spent forty years arguing that the FDA should be defunded, that drug-approval standards should be weakened, that pharmaceutical price controls are socialism, and that the free market should decide which drugs live and die — has discovered a deep and abiding concern for melanoma patients. This concern arrived, by extraordinary coincidence, at precisely the moment when a pharmaceutical startup’s shareholders needed the FDA to approve a drug without the controlled trial that would tell us whether it works. The board is moved. The board is weeping. The board has titled its editorial “A Welcome FDA Reversal on a Melanoma Drug” and expects you not to notice that the reversal it welcomes is the reversal of the requirement that drug companies prove their products work before they sell them to you.

Let us sit with the logic here. Replimune ran a trial. The trial had no control group — no comparison arm, no placebo, no standard-of-care comparator — because, the Journal explains, a control group would have been “unethical.” Unethical to whom? Unethical to the patients who would have been randomized to the control arm? But if the drug’s efficacy is genuinely unknown — if we genuinely do not know whether RP1 helps or harms — then randomization to the control arm is not unethical; it is the only ethical way to find out which arm is better. You randomize precisely because you don’t know the answer. The moment you claim that randomization is unethical, you are claiming that you already know the drug works — in which case you don’t need the trial at all, and you are running it anyway, on patients who are being denied the standard of care, for reasons that have nothing to do with science and everything to do with the accelerated-approval pathway that gets you to market faster.

The Journal’s argument is that it would be unethical to ask some patients to forgo RP1 so that we can learn whether RP1 works. But this means the editorial is arguing that it is ethical to give RP1 to all patients without knowing whether it works — which is to say, it is ethical to give a drug of unknown efficacy and unknown harm to dying people, at a price the manufacturer will set once the FDA stamp is on it, and to call that “access.” The word for giving sick people a treatment of unknown value is not “access.” It is “experiment.” And the word for conducting an experiment on human subjects without a control group — without the ability to learn anything from the results — is “unethical.” The Journal has the ethical calculus exactly backward, and it has it backward because the calculus is not being run for the benefit of the patients. It is being run for the benefit of the investors, who would prefer to start booking revenue before the confirmatory trial comes back negative (exactly the pattern our BMJ receipt documents: drugs sold for years without proven survival benefit).

The editorial’s pièce de résistance is the claim that Makary and Prasad “responded by claiming critics are in the pocket of Big Pharma.” The phrasing — “claimed” — is doing a lot of work here. It invites you to scoff at the idea that pharmaceutical-industry money might influence public debate about pharmaceutical regulation, as if the relationship between industry funding and regulatory outcomes were some kind of conspiracy theory rather than the best-documented lobbying operation in American political history. The Journal’s own parent company, Dow Jones, derives substantial revenue from pharmaceutical advertising. The editorial board’s own publisher runs a conference business that is sponsored by drug companies. But no, no — it is Makary and Prasad who were the corrupt ones, because they demanded evidence, and demanding evidence is how you know someone has been captured by sinister interests. The same editorial board that routinely dismisses climate science as corrupted by grant funding, and public-health research as corrupted by government incentives, and academic expertise as corrupted by tenure — suddenly, when the question is whether pharmaceutical money might influence pharmaceutical regulation, becomes a wide-eyed naïf who simply cannot imagine how such a thing could occur.

You are being asked to believe that the Wall Street Journal cares more about melanoma patients than the FDA does. You are being asked to believe this by the same newspaper whose editorial page has, for decades, argued against every regulatory mechanism that protects those patients from ineffective drugs, price-gouging, and corporate fraud. You are being asked to believe that the sudden departure of an FDA commissioner who demanded evidence is a victory for patients rather than a victory for the pharmaceutical investors whose interests the Journal’s editorial page has reliably represented since the Nixon administration. The patient in this story is not the protagonist. The patient is the human shield.

DEFCON 2 — Aggressive Villainization

When to use: When the target is the institutional apparatus itself — the Journal’s editorial board, the pharmaceutical lobbying infrastructure, the regulatory-capture machinery — and the reader needs to see the full architecture of who is doing what to whom, with names.

The Wall Street Journal editorial board is not confused. It knows exactly what it is doing.

The editorial is a pharmaceutical-industry lobbying document dressed in patient-advocacy language, placed in the most influential business-newspaper opinion page in the English-speaking world, at a moment when a new acting FDA commissioner is deciding how aggressively to lower the evidentiary bar for drug approvals. The editorial names the new commissioner — Kyle Diamantas — and praises him by name, while the body of Makary is still warm. The message to Diamantas is not subtle: approve RP1 without a controlled trial, and you will be celebrated as a reformer who “understands the importance of expediting treatments for deadly and rare diseases.” Demand evidence, and you will be destroyed in these same pages as the next “vindictive” regulator whose “arbitrary drug rejections” cost lives. The Journal is not reporting on a regulatory dispute. It is delivering an offer the commissioner cannot refuse.

The architecture of the editorial is the architecture of every pharmaceutical lobbying campaign of the past three decades. Step one: identify a sympathetic patient population — here, metastatic melanoma patients who have exhausted approved therapies. Step two: locate a drug that has shown some signal in early testing — here, RP1 with its one-third remission rate in an uncontrolled trial. Step three: frame the FDA’s demand for rigorous evidence as bureaucratic cruelty — “shifting goal posts,” “vindictive regulation,” a “regime” that must be “pushed out.” Step four: demand a “reversal” and an “expedited” path to approval. Step five: celebrate the reversal as a victory for patients, while remaining silent about the pharmaceutical investors who will profit from the lowered bar, and about the patients who will be harmed when drugs approved on weak evidence turn out to be ineffective or dangerous.

This is not hypothesis. This is the documented, studied, peer-reviewed history of accelerated-approval pathways in American drug regulation. The FDA’s accelerated-approval program, established in 1992 under industry pressure, allows drugs to reach the market on the basis of “surrogate endpoints” — tumor shrinkage, biomarker changes — rather than demonstrated survival benefit, on the condition that the manufacturer conducts a confirmatory trial to prove actual clinical benefit. A 2022 study in the BMJ found that of cancer drugs granted accelerated approval between 2012 and 2021, only 20% had demonstrated improved overall survival in confirmatory trials after a median of more than four years on the market — the very statistic anchored in our Receipts. The remaining 80% were still being sold to patients — at an average cost exceeding $150,000 per year — without proof that they extended life. Some of those drugs were eventually withdrawn. Most were not. The patients who took them paid, suffered side effects, and died — and the confirmatory trials that were supposed to protect them were either incomplete or showed no benefit. This is the system the Journal is defending when it attacks the FDA for demanding a controlled trial. It is defending a system in which pharmaceutical companies can sell unproven drugs to dying people for six figures, pocket the revenue for years while the confirmatory evidence trickles in, and face no meaningful penalty when the evidence shows the drug didn’t work. (Courtney Gartin et al., “Overall survival benefits of cancer drugs approved by the US Food and Drug Administration based on surrogate endpoints: retrospective cohort analysis,” BMJ 379 (2022), e069975)

The Journal names Makary and Prasad as villains. It calls their regulation “vindictive.” It claims they “responded by claiming critics are in the pocket of Big Pharma” — note that verb, “claimed,” as if the influence of pharmaceutical money on pharmaceutical regulation were a matter of speculation rather than the subject of a multi-decade literature in health policy, law, and economics. The Journal does not disclose — because the Journal never discloses — that its own editorial page has received pharmaceutical-industry advertising revenue for decades; that its parent company’s conferences are sponsored by drug companies; that its editorial board’s arguments about FDA regulation are, in substance and often in phrasing, indistinguishable from the Pharmaceutical Research and Manufacturers of America’s lobbying positions; or that the “arbitrary drug rejections” it decries are, in every documented case, rejections of drugs whose sponsors declined to produce the evidence the FDA’s statutory mandate requires.

The villain in this story is not the FDA commissioner who demanded evidence. The villain is the editorial board of the Wall Street Journal, which has for forty years used its platform to advocate for the transfer of wealth from sick people to pharmaceutical shareholders, and which dresses that advocacy in the language of patient concern because naked greed would be rejected by its own readers. The Journal is not a newspaper on this subject. It is a paid lobbyist that does not disclose its fees.

DEFCON 1 — Nuclear Satire

When to use: When the mask needs to come all the way off — for the reader who already knows the game and needs the catharsis of seeing it named at full volume, the institutional hypocrisy roasted, and the structural beneficiary held up to the light until it sizzles.

The Wall Street Journal editorial board has made a remarkable discovery. After forty years of arguing that the FDA is an obstacle to innovation, that drug-approval standards are too stringent, that pharmaceutical companies should be free to sell whatever they want at whatever price the market will bear, and that anyone who disagrees is a socialist — the board has discovered that it cares deeply about melanoma patients. The discovery occurred Thursday afternoon. It will persist until the RP1 stock price has been adequately inflated, at which point the board will return to its regularly scheduled programming of arguing that the melanoma patients should pay the full freight for the drug whose approval the board just demanded.

The editorial is a masterpiece of the genre. It opens with “Some good news to finish the week” — as if a regulatory decision about a cancer drug were a palate cleanser after a difficult earnings call. It names the outgoing FDA commissioner, the outgoing deputy, the outgoing deputies’ deputies, and the incoming acting commissioner by name, because the Journal understands that the way to discipline regulators is to make them famous in the wrong way — to ensure that every FDA official who demands evidence knows that failure to approve drugs on the sponsor’s preferred timeline will result in being immortalized in the Journal’s pages as an enemy of the sick. It describes the FDA’s demand for a controlled trial as “impractical or unethical” without pausing to explain why the global standard for drug approval — the standard that produced every cancer drug that actually works — is suddenly impractical or unethical when Replimune is the sponsor. It reports that “FDA staffers who reviewed RP1 supported its approval” as if this were evidence of scientific merit rather than evidence of the regulatory-capture dynamics that are documented in the FDA’s own internal surveys, which have repeatedly found that a substantial fraction of FDA reviewers report pressure to approve drugs despite insufficient evidence of safety or efficacy.

The editorial’s central rhetorical move is a thing of beauty. It takes the single most important patient-protection mechanism in the history of drug regulation — the requirement that a drug demonstrate efficacy against a comparator before it can be sold — and rebrands it as cruelty. The FDA demanded evidence, and the Journal calls that “vindictive.” The FDA asked the same question it asks of every cancer drug — does it work, and how do you know? — and the Journal calls that “shifting goal posts.” The FDA declined to approve a drug whose sponsor had not produced the evidence the statute requires, and the Journal calls that a “regime” that had to be “pushed out.” This is the language of a hostage video, not an editorial. The hostage is the melanoma patient; the captor is the pharmaceutical company whose drug is being held behind the FDA’s evidentiary bar; the ransom demand is the removal of the bar; and the Journal is the negotiator who has been paid by the captor to convince the family that paying the ransom is the only humane course.

The “unethical” argument deserves a moment of sustained attention, because it is the load-bearing joint of the entire editorial. The Journal claims that a randomized controlled trial for RP1 would have been unethical. This claim, if true, would mean that it is unethical to ask some patients to forgo a drug of unknown efficacy so that we can learn whether the drug works — and ethical to give the drug to all patients without knowing whether it works. This is, to put it gently, the moral reasoning of a person who has suffered a recent head injury. The reason we randomize is that we do not know which arm is better. If we knew RP1 worked, we would not be running the trial at all; we would be giving it to everyone. The claim that randomization is unethical is a claim that we already know the drug works — which means the trial is itself unethical, because it is exposing patients to the risks of an experimental drug when the standard of care is available. But the Journal does not want you to notice this contradiction, because the contradiction is the whole game. The editorial wants you to believe simultaneously that the drug works — so that you will be outraged at the FDA for withholding it — and that we don’t know whether the drug works — so that the controlled trial can be dismissed as unnecessary. The editorial is Schrodinger’s clinical trial: the drug both works and doesn’t work, and the waveform only collapses when the stock options vest.

And then there is the money. The editorial does not mention the money, because the editorial never mentions the money. It does not mention Replimune’s market capitalization, or its venture-capital backers, or the value of the stock options held by its executives, or the relationship between FDA approval and the company’s ability to raise additional capital. It does not mention that the Journal’s parent company derives revenue from pharmaceutical advertising. It does not mention that the accelerated-approval pathway the editorial is defending has been documented, in peer-reviewed research (the BMJ receipt), to produce a situation in which drugs are sold for years at astronomical prices without proof that they extend life, and that when the confirmatory trials finally come back negative, the companies face no meaningful penalty and patients have already paid. The editorial is a financial document, placed in the opinion section of a financial newspaper, written for a financial audience, advocating a financial outcome — and dressed in a white coat and a patient’s hospital gown so that you will mistake a stock promotion for a medical argument. The gown is slipping. The stethoscope is plastic. The chart at the foot of the bed is a quarterly earnings projection.

DEFCON 1+ — Prophetic Indictment

When to use: The reader moved by moral authority; invoking the full weight of the moral-witness tradition to condemn the exploitation of the sick.

The unblushing face of greed stands before the dying and calls its own appetite “mercy.” The prophet Jeremiah diagnosed this exact rot: they dress the wound of the daughter of my people lightly, saying, “Peace, peace,” when there is no peace. They demand the agency’s gates be thrown open to their unproven elixirs, and when the stewards ask for the receipts, they scream “vindictiveness.” It is a plunder of the soul, taking the last measure of hope from the broken and trading it for a valuation bump. They want to strip the shield from the patient’s side and hand it to the broker, and then call the broker a savior. But a treatment that cannot prove it works is just a damned lie with a price tag, and those who sell it to the desperate are drinking from a poisoned spring.

DEFCON 1++ — Profane Scorched-Earth

When to use: For the reader who has watched this game long enough to need the gloves off entirely — the full Carlin-late-night-South-Park register, the cathartic apex where the profanity carries the moral weight the politeness couldn’t, and the laughter is the only response left to a situation this obscene.

The Wall Street Journal editorial board wants you to know it gives a shit about cancer patients. It gives such a profound, aching, humanitarian shit about cancer patients that it has spent four decades arguing that the agency responsible for making sure cancer drugs actually work should be defanged, defunded, and rendered incapable of asking the most basic fucking question in medicine: “Does your drug work, and how do you know?” The Journal’s compassion for melanoma patients is so overwhelming that it has chosen to express it by demanding the removal of the FDA commissioner who had the audacity to ask Replimune that question, and by celebrating the arrival of a new commissioner who has already signaled that he will not be such a pain in the ass about the whole “evidence” thing.

This is the pharmaceutical-industry playbook, and it has been the pharmaceutical-industry playbook since the moment Congress told drug companies in 1962 that they had to prove their shit worked before they could sell it. The playbook is simple. Step one: find a disease that kills people. Step two: find a drug that might work, or might not, who the fuck knows, the trial didn’t have a control arm. Step three: run a PR campaign in which the FDA’s demand for actual evidence is reframed as bureaucratic murder. Step four: get the Wall Street Journal editorial page to run the campaign as if it were journalism. Step five: wait for the FDA commissioner to get fired or resign under pressure, and celebrate the arrival of the new commissioner who has learned the lesson. Step six: get the drug approved on weak evidence, charge a hundred and fifty grand a year for it, pocket the revenue while the confirmatory trial that was supposed to prove it works languishes unfinished, and when the trial finally comes back negative — which it will, four times out of five, per the BMJ receipt anchored above — shrug and move on to the next drug. The patients who paid and died? They’re not in the quarterly report. Their families’ bankruptcy filings? Not material to the stock price. The oncologists who prescribed the drug in good faith because the FDA stamp was on it? Collateral damage. The playbook works. It has worked for thirty years. The Journal’s editorial is just the latest run of the same play, and the Journal runs it because the Journal’s advertisers are the same pharmaceutical companies whose drugs the play is designed to get approved, and the Journal’s readers are the same investors whose portfolios rise when the FDA’s evidentiary bar falls.

Let’s talk about this “unethical” bullshit. The Journal argues that a randomized controlled trial for RP1 would have been unethical. Do you know what is actually unethical? Selling a drug to dying people when you don’t know if it works. Charging dying people a hundred and fifty thousand dollars a year for a drug you haven’t proven works. Recruiting dying people into a clinical trial that cannot produce reliable knowledge because it has no control arm, which means their participation, their risk, their suffering, their hope — all of it is scientifically worthless, because the trial design guarantees that you won’t learn whether the drug helped them. That is the unethical thing. That is the thing the Journal is demanding the FDA permit, and it is demanding it while wearing the face of a patient advocate, which is like a wolf wearing the face of a sheep and also the sheep’s hospital gown and also the sheep’s IV line, while the sheep’s family writes the check.

The Journal describes Makary’s FDA as a “regime.” A regime. The man demanded evidence. He asked drug companies to prove their products worked before sick people paid for them. For this — for applying the statutory standard that has been the law of the United States since 1962, for applying the scientific standard that is the global norm in drug regulation, for doing the job the FDA was created to do — the Journal calls his tenure a “regime,” describes his regulation as “vindictive,” and celebrates his removal as a “much needed” regime change. The language is deranged. It is the language of someone who has become so accustomed to the regulatory-capture status quo — the revolving door, the accelerated approvals that never get confirmed, the drugs that stay on the market for years after they’ve been shown not to work — that the appearance of an actual regulator, someone who takes the statutory mandate seriously, reads as a coup. The coup was not Makary. The coup was the forty-year campaign to hollow out the FDA’s evidentiary standards, and the Journal’s editorial page has been the campaign’s most reliable stenographer.

And then there is the money. The editorial does not mention the money, because of course it fucking doesn’t. It doesn’t mention that Replimune is a publicly traded company whose stock price depends on FDA approval. It doesn’t mention that the Journal’s parent company, Dow Jones, runs a conference business that is sponsored by pharmaceutical companies. It doesn’t mention that the pharmaceutical industry is one of the largest advertisers in American media, including the Journal’s own pages. It doesn’t mention that the accelerated-approval pathway the editorial is defending was created in 1992 under intense industry lobbying, over the objections of FDA scientists who warned that it would lead to exactly the situation the BMJ study now confirms: drugs approved on weak evidence, sold at astronomical prices for years, with confirmatory trials that are either incomplete or negative, and no mechanism to claw back the revenue when the evidence finally arrives. The editorial is a financial transaction. It is a purchase of regulatory influence, paid for in advertising revenue and access journalism, and the currency in which the purchase is denominated is the bodies of melanoma patients whose desperation is being used to justify a system that will charge them and their families for drugs that haven’t been proven to work. The Journal is not the patient’s ally. The Journal is the pharmaceutical industry’s bagman, and the bag it is carrying is full of the language of compassion, and the weight of the bag is measured in the stock price of the companies whose drugs the Journal’s editorials are designed to get approved.

Fuck the Wall Street Journal editorial board. Fuck its weaponized concern for the dying. Fuck its forty-year campaign to lower the bar that stands between pharmaceutical profit and patient harm. And fuck the editorial’s closing line — “a reversal all Americans can cheer” — which is the journalistic equivalent of a pickpocket telling you to applaud while he lifts your wallet. The reversal being cheered is the reversal of the requirement that drug companies prove their drugs work. The only Americans who should cheer that reversal are the ones who own pharmaceutical stocks. Everyone else is being robbed, and the editorial is the robber’s thank-you note.

The Deeper Breakdown

The Journal’s editorial is a lobbying document for a specific regulatory philosophy — one in which the evidentiary bar for drug approval should be as low as possible — and it advances that philosophy by exploiting the suffering of cancer patients to attack regulators who demanded evidence of efficacy.

Who benefits, and by what mechanism. The primary beneficiaries of a lowered FDA evidentiary bar are pharmaceutical companies and their investors. When the FDA approves a drug on the basis of a single-arm trial — a trial with no control group — the company can begin selling the drug at a price it sets, without having proven that the drug extends life or improves outcomes relative to existing treatments. This creates a revenue window during which the company collects payment for a drug whose efficacy is unknown. The accelerated-approval pathway, which the Journal is effectively defending, allows this revenue window to persist for years while the company conducts (or, frequently, delays or fails to complete) the confirmatory trial that was supposed to demonstrate actual clinical benefit.

The receipts that prove it. The core evidentiary claim in the Journal’s editorial is that the FDA under Makary “moved the goal posts” by demanding a randomized controlled trial for RP1, and that this demand was unusual, “vindictive,” and harmful to patients. This claim is false. Randomized controlled trials are the global gold standard for establishing drug efficacy, and they have been the standard for FDA approval of cancer drugs for decades. The FDA’s own guidance (2018) explicitly contemplates single-arm trials only when the treatment effect is large and a randomized trial is not feasible — not when a randomized trial is merely expensive or inconvenient for the sponsor. The Makary FDA’s demand for a control group was not a “shifting goal post”; it was the application of the existing standard to a drug whose sponsor had not met it.

The deeper structural reality is that the American drug-approval system has been systematically biased toward approval on weak evidence for decades, under sustained industry pressure. The accelerated-approval program, created in 1992, was supposed to be a narrow exception for drugs treating serious conditions with no available therapy. It has become the standard pathway for oncology drugs. A 2022 study in the BMJ found that of cancer drugs granted accelerated approval between 2012 and 2021, only 20% demonstrated improved overall survival in confirmatory trials after a median of more than four years on the market. The remaining 80% were still being sold without proof that they extended life — at an average cost exceeding $150,000 per year. Some were eventually withdrawn. Most were not. The system the Journal is defending is not a system that gets drugs to dying patients faster. It is a system that gets drugs to market faster, and leaves the question of whether they work to be answered later, in the bodies and bank accounts of the patients who take them.

What the Journal does not tell you. The editorial does not disclose Replimune’s financial relationships, its venture-capital backing, the value of its executives’ stock options, or the relationship between FDA approval and the company’s stock price. It does not disclose the Journal’s own pharmaceutical-advertising revenue or its parent company’s conference-business sponsorships. It does not mention that the accelerated-approval pathway it is implicitly defending has been the subject of sustained criticism from health-policy researchers, patient advocates, and former FDA officials who have documented the pattern of drugs approved on weak evidence, sold at high prices for years, and never confirmed to work. It does not name a single patient harmed by the RP1 rejection. It asks you to imagine those patients, because imagining them is more rhetorically powerful than the data the Journal cannot cite.

Key missing information. The confirmatory trial results that would tell us whether RP1 actually works — the randomized controlled trial the Makary FDA demanded and the Journal’s editorial calls “unethical.” Until those results exist, the question of whether the FDA’s rejection harmed patients or protected them is unanswerable, and the Journal’s certainty on the point is evidence of its function as an advocate, not as an analyst.