Right now – as in, at the very moment of publication – a group of economists and pharma-friendly policy types are sitting down to lunch, bankrolled by Pfizer (I was told privately), in Washington, D.C. to discuss a draft Executive Order (EO) that would hand the pharmaceutical industry everything it has ever wanted and then some.

I was invited to this lunch.

I sent my deepest regrets. I’m writing this instead.

The event is hosted by Unleash Prosperity Now, the think tank founded by Steve Forbes. The featured guests are Steve Moore (former presidential economic advisor) and Tomas Philipson (former Acting Chair of the Council of Economic Advisors, and apparently the academic health economist behind this draft EO).

Now you might be wondering why any of us should care what a roomful of think-tankers, Pharma bros and ex-Trump advisors say to each other over lunch on Pfizer’s dime.

The very real concern is that these aren’t cranks shouting into the void. The powerful people who show up in rooms like this are serious players with strong ties to senior officials at the White House, at HHS, and the president himself.

And those ties aren’t just hypothetical. A draft cooked up by outsiders becomes real policy when someone on the inside thinks it has merit, picks it up and runs with it. One day it’s being passed around a salon luncheon. The next, it’s got the president’s signature on it.

I know, because I have my own version of that story. It’s how price transparency came to be. Pointing out this method isn’t a knock on anyone. It’s how good policy gets made, too. The difference is what’s getting pushed. That one was a populist issue, despised by industry interests, that polled at 90 percent with voters. This one is a wish list for Big Pharma and Well-Connected Biotech. Paid for by Pfizer.

It’s billed as “an intimate salon luncheon” to discuss “the extraordinary economic promise of curing cancer” and “modernizing the FDA so that regulatory pathways keep pace with today’s scientific realities.” Who could be against curing cancer or keeping up with science? I know this language.

I’ve spoken this language. I know the free-marketeering policy that it is code for – which I very often have agreed with over the past couple decades in conservative policymaking. But the Shakespearean flaw of laissez-faire economics is its knee-jerk defense of private industry interests in health care – even when, as in the case of the past decade or so, that industry has become increasingly indefensible.

So I read what’s actually being proposed. Then I read it again, because I couldn’t believe my eyes.

And then I wrote 34 ranting comments in the margins.

The metadata of the draft EO lists Tomas as its author, which of course doesn’t mean he doesn’t have other collaborators. I worked alongside Tomas in the first Trump White House. He’s committed, credentialed, and about as laissez-faire as they come – a University of Chicago health economist who made his bones arguing for policies just like those in the draft EO – less and less FDA as the key to more and more Pharma products.

The draft EO was attached to the invitation to this lunch as the actual subject matter to be discussed. It has a name: Advancing Cost-Cutting Treatments and Diagnostics for Old-Age Populations through “Operation Warp Speed 2.0.”

(Paid subscribers can read it for yourselves here.)

Where to Even Begin

Before we get into the substance, the name alone will doom this proposal with public opinion.

The president gets booed at his own rallies, by his most diehard supporters, when he brings up Operation Warp Speed. There is no constituency in the United States – not Republican, not Democrat, not MAHA, not libertarian, not the guy who got the shot or the guy who didn’t – who is enthusiastic about resurrecting that program. Operation Warp Speed and all it delivered to the world is one of the most politically radioactive policy episodes of the last decade, and whoever suggested that branding either doesn’t read the news or wants the president’s polling to crater.

But the name is obviously just the first of many tone-deaf self-owns in this document. Let’s go section by section.

The Founding Myth

The EO’s opening premise is that medical innovation is the key to controlling the federal debt. If we just cure cancer and Alzheimer’s, the argument goes, we won’t have to cut Medicare – we’ll have a healthier population that doesn’t need as much of it.

This sounds good. And if we actually cured Alzheimer’s, cancer, and the other diseases consuming Medicare’s budget, it would be true. But pharmaceutical innovation and disease elimination are not the same thing.

We have had unfathomable medical innovation over the past century. More drugs, more devices, more diagnostics, more interventions than any previous civilization could have imagined. And what do we have to show for it on a population level? We are chronically sicker, fatter, more mentally ill, and more infertile than any previous generation in human history. The extinction-level chronic disease crisis that is actually bankrupting Medicare is not a failure of pharmaceutical innovation. It is the predictable outcome of dehumanized, unbiological lives – of industrial poisons masquerading as food, sedentary routines disconnected from nature, epidemic sleep deprivation, chemical exposures, and severed social bonds.

Medical innovation is not the answer to these problems. It is, at best, an increasingly expensive way to manage their consequences while the causes go unaddressed. Even if you concede that some drugs are keeping people with significant disease alive a little longer – which may be true – that would only perversely drive costs up, as these expensive new therapies generally manage or extend decline during the most expensive end-of-life years, but don’t cure.

And the dirty little secret is that “innovation” has become the industry’s word for obscene launch prices.

When a drug company insists that a new therapy deserves a $400,000 annual price tag, they justify it by saying – there was R&D involved, there were trials, there was a regulatory process. What they are not telling you is how much of that R&D was publicly funded, how taxpayers will be footing the bill for these products used by Medicare beneficiaries, and yet, how completely the profit is privatized once the product hits the market.

If the past is any preview of the future, there is no universe in which this dynamic controls the federal debt. It accelerates it.

The EO describes Operation Warp Speed (v.1.0) as an inspiration. I’d like to offer some alternative framings:

The tens of thousands of deaths attributed to the vaccines. The epidemic of myocarditis in young people. More than a million adverse events reported to government surveillance systems called V-safe and VAERS. The Pfizer trial in which there were more deaths in the vaccinated group than the unvaccinated group – and we approved the product anyway, because Warp Speed. The systematic delegitimization of existing treatments that might have helped people but were made of molecules too old to be profitable.

I’m not interested in re-litigating the entire COVID response here (though you can read more of my thoughts on it elsewhere). But if the lesson your team drew from that experience is “let’s do that again, but for cancer,” you’ve spent too much time in the faculty lounge.

The Structure – Who’s Running This Thing?

The EO would establish an Operation Warp Speed (OWS) 2.0 Steering Committee to be headed by Secretary Kennedy and his key agency heads.

Secretary Kennedy.

You know, Robert F. Kennedy, Jr.

Who literally wrote a book trashing OWS 1.0.

The Steering Committee gets better. It also explicitly includes pharmaceutical and biotechnology companies, among others, who would direct and oversee the OWS activities.

In other words, the regulated entities would sit on the committee telling the regulators what to do.

This isn’t a new idea. It is, in fact, the defining feature of regulatory capture – the thing that RFK Jr. has spent decades fighting, the thing that MAHA exists to dismantle, the thing that former Commissioner Marty Makary named as a foundational problem when he walked into the FDA, long before he was shown the door.

The EO summons another agency to the Steering Committee: BARDA, aka the Biomedical Advanced Research and Development Authority. You know, the shadowy, Pentagon-adjacent slush fund dressed up in public health clothing where sole-source contracts, guaranteed taxpayer pre-payment for unproven technologies, and relationships of unusual coziness with favored companies have determined who gets billions and who doesn’t.

What could possibly go wrong?

But the Operation Warp Speed (OWS) 2.0 Steering Committee isn’t the only committee this EO would establish.

The New “Advisory Committee on Expanding the FDA Mandate Beyond All Recognition”

Ok, that’s not really the name.

The EO would also create a permanent FDA Advisory Committee on Economic Innovation and Impact – a body of health economists, regulatory experts, industry representatives, biomedical entrepreneurs, and (for cover) patient advocates. The committee would be tasked with evaluating the economic consequences of FDA regulatory decisions and would require the FDA to respond in writing to any finding it declines to adopt.

Let me translate this: instead of asking whether a drug meets the scientific standard for approval, FDA would be pressured to ask whether enforcing that standard might hurt the industry’s (or anyone else’s) economic interests.

FDA’s statutory mandate from Congress is to protect the public from dangerous and ineffective products. Full stop. It is not to goose the GDP or pom-pom American biomedical competitiveness. It is not to weigh the complex economic ripple effects of its safety determinations. It is not to answer to industry representatives who are unhappy that their products didn’t get approved fast enough or that their garbage data were uncompelling.

The idea that an agency entirely organized around making scientific determinations about medical products has the institutional competence to accurately model all the downstream economic consequences of its licensure decisions is, charitably, delusional. No government agency could pull off such a sweeping set of mandates. And more to the point: we shouldn’t want it to try.

Picture the committee – stacked with regulated companies and their pals, now empowered to demand that their regulators consider the economic harm to their companies as part of the drug approval process. FDA’s independence has been in question for quite a while – in the last year, it’s been on life support. This would render it a complete fiction.

The draft EO reassures us that the committee members would be subject to “standard federal conflict-of-interest disclosure requirements.” But this is a joke – the committee is conflicted by design. The purpose of putting industry on the committee is to have industry’s interest overtly represented and to bully the FDA scientists with it.

Also worth imagining: this committee gets inherited by a future administration with completely different politics. Imagine President AOC, who decides that a drug’s anticipated launch price is itself grounds for withholding licensure. Because, economic impact. You’ve just built them the playbook – congratulations.

The Regulatory “Modernization” (Read: Weak-sauce Safety Trials)

Under the advice and oversight of all these committees, the draft EO would require:

• Creating fast-track pathways that cut development and approval costs by at least 50% while “maintaining standards of safety and efficacy.” You can’t cut the cost and time of safety evaluation by half and then claim you haven’t touched the standards. Sufficient follow-up time to detect safety signals IS the standard.

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Via https://www.katytalento.com/p/operation-warp-speed-20-is-happening