On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals.

In its lawsuit, the FTC said that if it allowed Amgen’s $27.8 billion purchase to go through, Amgen could pressure the companies that manage access to prescription drugs — pharmacy benefit managers, or PBMs — to boost the two extremely expensive Horizon products in a way that would inhibit any competition.

The suit, the first time since 2009 that the FTC has tried to block a drug company merger, reflects Chair Lina Khan’s strong interest in antitrust action. In announcing the suit, the agency said that by fighting monopoly powers it aimed to tame prices and improve patients’ access to cheaper products.

The FTC’s action is a “shot across the bow for the pharmaceutical industry,” said Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco. David Balto, a former FTC official and attorney who fought the 2019 Bristol-Myers Squibb-Celgene and 2020 AbbVie-Allergan mergers, said FTC’s action was long overdue.

The Horizon-Amgen merger would “cost consumers in higher prices, less choice, and innovation,” he said. “The merger would have given Amgen even more tools to exploit consumers and harm competition.”

The FTC also announced an expansion of a yearlong investigation of the PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services. Critics claim the PBMs set up these companies to conceal profits.

When Amgen announced its purchase of Horizon in December — the biggest biopharma transaction in 2022 — it showed particular interest in Horizon’s drugs for thyroid eye disease (Tepezza) and severe gout (Krystexxa), for which the company was charging up to $350,000 and $650,000, respectively, for a year of treatment. The complaint said the merger would disadvantage biotech rivals that have similar products in advanced clinical testing.

Amgen could promote the Horizon drugs through “cross-market bundling,” the FTC said. That means requiring PBMs to promote some of Amgen’s less popular drugs — the Horizon products, in this case — in exchange for Amgen offering the PBMs large rebates for its blockbusters. Amgen has nine drugs that each earned more than $1 billion last year, according to the complaint, the most popular being Enbrel, which treats rheumatoid arthritis and other diseases.

The three biggest PBMs negotiate prices and access to 80% of prescription drugs in the U.S., giving them enormous bargaining power. Their ability to influence which drugs Americans can get, and at what price, enables the PBMs to obtain billions in rebates from drug manufacturers.

“The prospect that Amgen could leverage its portfolio of blockbuster drugs to gain advantages over potential rivals is not hypothetical,” the FTC complaint states. “Amgen has deployed this very strategy to extract favorable terms from payers to protect sales of Amgen’s struggling drugs.”

The complaint noted that biotech Regeneron last year sued Amgen, alleging that the latter’s rebating strategy harmed Regeneron’s ability to sell its competing cholesterol drug, Praluent. Amgen’s Repatha generated $1.3 billion in global revenue in 2022.

It “may be effectively impossible” for smaller rivals to “match the value of bundled rebates that Amgen would be able to offer” as it leverages placement of the Horizon drugs on health plan formularies, the complaint states.

Business analysts were skeptical that the FTC action would succeed. Until now the commission and the Department of Justice have shied away from challenging pharmaceutical mergers, a precedent that will be hard to overcome.

Research on the impact of mergers has shown that they often benefit shareholders by increasing stock prices, but hurt innovation in drug development by trimming research projects and staffing.

Waves of consolidation shrank the field of leading pharma companies from 60 to 10 from 1995 to 2015. Most of the mergers in recent years have involved “big fish buying up lots of little fish,” such as biotech companies with promising drugs, Feldman said.

The giant Amgen-Horizon merger is an obvious exception, and therefore a good opportunity for the FTC to demonstrate a “theory of harm” around drug industry bundling maneuvers with PBMs, said Aaron Glick, a mergers analyst with Cowen & Co.

But that doesn’t mean the FTC will win.

Amgen may or may not engage in anti-competitive practices, but “a separate question is, how does this lawsuit fit under current antitrust laws and precedent?” Glick said. “The way the law is set up today, it seems unlikely it will hold up in court.”

The FTC’s argument about Amgen’s behavior with Horizon products is hypothetical. The pending Regeneron suit against Amgen, as well as other, successful lawsuits, suggests that rules are in place to suppress this kind of anti-competitive behavior when it occurs, Glick said.

The judge presiding over the case in U.S. District Court in Illinois is John Kness, who was appointed by then-President Donald Trump and is a former member of the Federalist Society, whose membership tends to be skeptical of antitrust efforts. The case is likely to be settled by Dec. 12, the deadline for the merger to go through under current terms.

Amgen sought to undercut the government’s case by agreeing not to bundle Horizon products in future negotiations with pharmacy benefit managers. That promise, while hard to enforce, might get a sympathetic hearing in court, Glick said.

Still, even a loss would enable the FTC to shed light on a problem in the industry and what it sees as a deficiency in antitrust laws that it wants Congress to correct, he said.

The day after suing to stop the merger, the FTC announced it was pushing further into an investigation of pharmacy benefit managers that it began last June. The agency demanded information from Ascent and Zinc, the two so-called rebate aggregators — drug purchasing organizations set up by PBMs Express Scripts and CVS Caremark.

At a May 10 hearing, Eli Lilly & Co. CEO Dave Ricks said that most of the $8 billion in rebate checks his company paid last year went to rebate aggregators, rather than to the PBMs directly. A “big chunk” of the $8 billion went overseas, he said. Ascent is based in Switzerland, while Emisar Pharma Services, an aggregator established by PBM OptumRx, is headquartered in Ireland. Zinc Health Services is registered in the U.S.

Critics say the aggregators enable PBMs to obscure the size and destination of rebates and other fees they charge as intermediaries in the drug business.

The PBMs say their efforts reduce prices at the pharmaceutical counter. Testimony in Congress and in FTC hearings over the past year indicate that, at least in some instances, they actually increase them.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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El 16 de mayo, la FTC interpuso una demanda para bloquear la fusión de las farmacéuticas Amgen y Horizon Therapeutics, alegando que la enmarañada red de acuerdos de la industria  permitiría a Amgen aprovechar el poder monopolístico de dos de los principales medicamentos de Horizon que no tienen rivales.

En su demanda, la FTC alegó que si se permitía la compra que pretende Amgen por $27,800 millones, Amgen podría presionar a las empresas que gestionan el acceso a los medicamentos con receta —los gestores de beneficios de farmacia, o PBM— para que impongan los dos productos extremadamente caros de Horizon de una manera que eliminaría cualquier competencia.

Es la primera vez desde 2009 que la FTC intenta bloquear una fusión de empresas farmacéuticas, y esta demanda refleja el gran interés de la presidenta Lina Khan por las medidas antimonopolio. Al anunciar la demanda, la agencia declaró que al luchar contra los poderes monopolísticos pretendía controlar los precios y mejorar el acceso de los pacientes a productos más baratos.

Para Robin Feldman, profesor y experto en la industria farmacéutica de la Facultad de Derecho de la Universidad de California en San Francisco, la actuación de la FTC es “un golpe frontal a la industria farmacéutica”. David Balto, ex funcionario de la FTC y abogado que luchó contra las fusiones Bristol-Myers Squibb-Celgene en 2019 y AbbVie-Allergan en 2020, dijo que la acción de la FTC era necesaria desde hace mucho tiempo.

La fusión Horizon-Amgen “costaría a los consumidores precios más altos, menos opciones e innovación”, señaló. “La fusión habría dado a Amgen aún más herramientas para explotar a los consumidores y dañar la competencia”.

La FTC también anunció la ampliación de una investigación de un año sobre los PBM, indicando que se investigaban dos gigantescas empresas de compra de medicamentos, Ascent Health Services y Zinc Health Services. Los críticos afirman que los PBM crearon estas empresas para ocultar beneficios.

Cuando Amgen anunció la compra de Horizon en diciembre —la mayor operación biofarmacéutica de 2022— mostró especial interés por los medicamentos de Horizon para la enfermedad tiroidea ocular (Tepezza) y la gota grave (Krystexxa), por los que la empresa cobraba hasta $350,000 y $650,000, respectivamente, por un año de tratamiento. Según la demanda, la fusión perjudicaría a rivales biotecnológicos que tienen productos similares en fase avanzada de pruebas clínicas.

Según la FTC, Amgen podría promocionar los fármacos de Horizon a través de la “venta cruzada”. Esto significa exigir a los PBM que promocionen algunos de los medicamentos menos populares de Amgen —los productos Horizon, en este caso— a cambio de que Amgen ofrezca a los PBM grandes descuentos por sus superventas. Según la denuncia, Amgen tiene nueve medicamentos que el año pasado generaron más de $1,000 millones cada uno. El más popular es Enbrel, que trata la artritis reumatoide y otras enfermedades.

Los tres mayores PBM negocian los precios y el acceso al 80% de los medicamentos recetados en Estados Unidos, lo que les confiere un enorme poder de negociación. Su capacidad para influir en los medicamentos a los que tienen acceso los estadounidenses, y a qué precio, les permite obtener miles de millones en descuentos de los fabricantes.

“La posibilidad de que Amgen pudiera aprovechar su cartera de medicamentos superventas para obtener ventajas sobre sus rivales potenciales no es hipotética”, afirma la denuncia de la FTC. “Amgen ha desplegado esta misma estrategia para conseguir condiciones favorables de los pagadores y proteger así las ventas de los medicamentos de Amgen en dificultades”.

La denuncia señaló que la biotecnológica Regeneron demandó el año pasado a Amgen, alegando que la estrategia de reembolso de esta última perjudicó la capacidad de Regeneron para vender su medicamento competidor contra el colesterol, Praluent. Repatha, de Amgen, generó unos ingresos mundiales de $1,300 millones en 2022.

Según la demanda, “puede resultar completamente imposible” para los rivales más pequeños “igualar el valor de los reembolsos agrupados que Amgen podría ofrecer”, ya que aprovecha la colocación de los medicamentos de Horizon en los formularios de los planes de salud.

Los analistas de la industria se mostraron escépticos sobre el éxito de la acción de la FTC. Hasta ahora, la Comisión y el Departamento de Justicia han evitado cuestionar las fusiones farmacéuticas, un precedente difícil de superar.

Las investigaciones sobre el impacto de las fusiones han demostrado que a menudo benefician a los accionistas al aumentar el precio de las acciones; pero perjudican la innovación en el desarrollo de fármacos al recortar los proyectos de investigación y el personal.

Las olas de consolidación redujeron el número de empresas farmacéuticas líderes de 60 a 10 entre 1995 y 2015. Según Feldman, la mayoría de las fusiones de los últimos años se han producido entre “peces gordos que adquieren muchos peces pequeños”, como empresas de biotecnología con fármacos prometedores.

La gigantesca fusión Amgen-Horizon es una excepción obvia y, por tanto, una buena oportunidad para que la FTC demuestre la “teoría del daño” en las maniobras de consolidación de la industria farmacéutica con los PBM, dijo Aaron Glick, analista de fusiones de Cowen & Co.

Pero eso no significa que la FTC vaya a ganar.

Amgen puede incurrir o no en prácticas anticompetitivas, pero “otra cuestión es cómo encaja esta demanda en las leyes antimonopolio y los precedentes actuales”, señaló Glick. “Tal y como está configurada la ley hoy, parece poco probable que se sostenga en los tribunales”.

El argumento de la FTC sobre el comportamiento de Amgen con los productos Horizon es hipotético. La demanda pendiente de Regeneron contra Amgen, así como otras demandas que han prosperado, sugiere que existen normas para suprimir este tipo de comportamiento anticompetitivo cuando se produce, añadió Glick.

El juez que preside el caso en el Tribunal de Distrito de Estados Unidos en Illinois es John Kness, quien fue nombrado por el entonces presidente Donald Trump y es un ex miembro de la Federalist Society, cuyos miembros tienden a ser escépticos sobre los esfuerzos antimonopolio.

Es probable que el caso se resuelva antes del 12 de diciembre, fecha límite para que la fusión se lleve a cabo en los términos actuales.

Amgen trató de socavar los argumentos del Gobierno comprometiéndose a no agrupar los productos de Horizon en futuras negociaciones con los gestores de beneficios farmacéuticos (PBM). Esta promesa, aunque difícil de hacer cumplir, podría obtener una audiencia favorable en corte, apuntó Glick.

Sin embargo, incluso una derrota permitiría a la FTC arrojar luz sobre un problema en la industria y lo que considera una deficiencia en las leyes antimonopolio que quiere que el Congreso corrija, explicó.

Al día siguiente de ir a corte para detener la fusión, la FTC anunció que profundizaba en una investigación sobre los gestores de beneficios farmacéuticos que inició el pasado mes de junio. La agencia solicitó información a Ascent y Zinc, los dos llamados agregadores de reembolsos, organizaciones de compra de medicamentos creadas por los PBM Express Scripts y CVS Caremark.

En una audiencia celebrada el 10 de mayo, el CEO de Eli Lilly & Co., Dave Ricks, afirmó que la mayor parte de los $8,000 millones en cheques de reembolso que su empresa pagó el año pasado fueron a parar a los agregadores de reembolsos, en lugar de directamente a los PBM. Una “gran parte” de los $8,000 millones fue a parar al extranjero, indicó Ricks. Ascent tiene su sede en Suiza, mientras que Emisar Pharma Services, un agregador establecido por PBM OptumRx, tiene su sede en Irlanda. Zinc Health Services está registrada en Estados Unidos.

Los críticos afirman que los agregadores permiten a los PBM ocultar la cuantía y el destino de los reembolsos y otras comisiones que cobran como intermediarios en el negocio de los medicamentos.

Por su parte, los PBM aseguran que sus esfuerzos reducen los precios en el mostrador de la farmacia. Los testimonios en el Congreso y en las audiencias de la FTC del año pasado indican que, al menos en algunos casos, en realidad los aumentan.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.

Read the rest…

At issue is a maneuver called alternative funding, which a growing number of drugmakers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help patients obtain the medicines for free from patient assistance programs run by drug makers or foundations.

Continue to STAT+ to read the full story…

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The formal end May 11 of the national public health emergency for covid-19 will usher in lots of changes in the way Americans get vaccines, treatment, and testing for the coronavirus. It will also change the way some people get their health insurance, with millions likely to lose coverage altogether.

Meanwhile, two FDA advisory committees voted unanimously this week to allow the over-the-counter sale of a specific birth control pill. Advocates of making the pill easier to get say it could remove significant barriers to the use of effective contraception and prevent thousands of unplanned pregnancies every year. The FDA, however, must still formally approve the change, and some of its staff scientists have expressed concerns about whether teenagers and low-literacy adults will be able to follow the directions without the direct involvement of a medical professional.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Tami Luhby of CNN, and Margot Sanger-Katz of The New York Times.

Panelists

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Tami Luhby
CNN

@luhby

Read Tami's stories

Margot Sanger-Katz
The New York Times

@sangerkatz

Read Margot's stories

Among the takeaways from this week’s episode:

• The formal public health emergency may be over, but covid definitely is not. More than 1,000 people in the United States died of the virus between April 19 and April 26, according to the Centers for Disease Control and Prevention. While most Americans have put covid in their rearview mirrors, it remains a risk around the country.
• The Senate Finance Committee held a hearing on “ghost networks,” lists of health professionals distributed by insurance companies who are not taking new patients or are not actually in the insurance company’s network. Ghost networks are a particular problem in mental health care, where few providers take health insurance at all.
• Another trend in the business of health care is primary care practices being bought by hospitals, insurance companies, and even Amazon. This strategy was popular in the 1990s, as health systems sought to “vertically integrate.” But now the larger entities may have other reasons for having their own networks of doctors, including using their patients to create revenue streams.
• Court battles continue over the fate of the abortion pill mifepristone, as a federal appeals court in New Orleans prepares to hear arguments about a lower-court judge’s ruling that would effectively cancel the drug’s approval by the FDA. In West Virginia, the maker of the generic version of the drug is challenging the right of the state to ban medication approved by federal officials. At the same time, a group of independent abortion clinics from various states is suing the FDA to drop restrictions on how mifepristone can be prescribed, joining mostly Democratic-led states seeking to ensure access to the drug.

Plus for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: Slate’s “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern.

Joanne Kenen: The Baltimore Banner’s “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million,” by Hallie Miller and Adam Willis.

Tami Luhby: CNN’s “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa.

Margot Sanger-Katz: The New Yorker’s “The Problem With Planned Parenthood,” by Eyal Press.

Also mentioned in this week’s episode:

• CNN’s “Here’s How the End of the Covid-19 Public Health Emergency Affects You,” by Tami Luhby and Alex Leeds Matthews.
• The New York Times’ “Corporate Giants Buy Up Primary Care Practices at Rapid Pace,” by Reed Abelson.
• Vox’s “Independents Back Abortion Rights. They’re Less Sure Democrats Do,” by Rachel M. Cohen.

Click to open the transcript

Transcript: The Crisis Is Officially Ending, but Covid Confusion Lives On

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, May 11, at 10:30 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Tami Luhby, of CNN.

Tami Luhby: Hello.

Rovner: Margot Sanger Katz, The New York Times.

Sanger-Katz: Good morning.

Rovner: And Joanne Kenen, of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Rovner: So the news on the debt ceiling standoff, just so you know, is that there is no news. Congressional leaders and White House officials are meeting again on Friday, and we still expect to not see this settled until the last possible minute. But there was plenty of other health news. We will start with the official end of the U.S. public health emergency for covid. We have talked at some length about the Medicaid unwinding that’s now happening and a potential to end some telehealth service reimbursement. But there’s a lot more that’s going away after May 11. Tami, you’ve been working to compile everything that’s about to change. What are the high points here?

Luhby: Well, there are a lot of changes depending on what type of insurance you have and whether we’re talking about testing, treatment, or vaccines. So I can give you a quick rundown. We wrote a visual story on this today. If you go to CNN.com, you’ll find it on the homepage right now.

Rovner: I will link to it in the show notes for the podcast.

Luhby: Basically, many people will be paying more for treatments and for tests. However, vaccines will generally remain free for almost everyone. And basically, if you look at our story, you’ll see the color-coded guide as to how it may impact you. But basically, testing — at-home tests are no longer guaranteed to be free. So if you’ve been going to your CVS or somewhere else to pick up your eight tests a month, your insurer may opt to continue providing it for free, but I don’t think many will. And then for lab tests, again, it really depends. But if you have Medicaid, all tests will be free through 2024. However, if you have private insurance or Medicare, you will probably have to start paying out-of-pocket for tests that are ordered by your provider. Those deductibles, those pesky deductibles, and copays or coinsurance will start kicking in again. And for treatments, it’s a little bit different again. The cost will vary by treatment if you have Medicare or private insurance. However, Paxlovid and treatments that are purchased by the federal government, such as Paxlovid, will be free as long as supplies last. Now, also, if you’re uninsured, there is a whole different situation. It’ll be somewhat more difficult for them. But there are still options. And, you know, the White House has been working to provide free treatments and vaccines for them.

Rovner: So if you get covid, get it soon.

Luhby: Like today. Right, exactly. Yeah, but with vaccines, even though, again, they’re free as long as the federal supplies last — but because of the Affordable Care Act, the CARES Act, and the Inflation Reduction Act, people with private insurance, Medicare, and Medicaid will actually continue to be able to get free vaccines after the federal supplies run out.

Rovner: After May 11.

Luhby: It’s very confusing.

Rovner: It is very confusing. That’s why you did a whole graphic. Joanne, you wanted to add something.

Kenen: And the confusion is the problem. We have lots of problems, but, like, last week, we talked a little bit about this. You know, are we still in an emergency? We’re not in an emergency the way we were in 2020, 2021, but it’s not gone. We all know it’s much, much better, but it’s not gone. And it could get worse again, particularly if people are confused, if people don’t know how to test, if people don’t know that they can still get things. The four of us are professionals, and, like, Tami’s having to read this complicated color-coded chart — you know, you get this until September 2024, but this goes away in 2023. And, you know, if you have purple insurance, you get this. And if you have purple polka-dotted insurance, you get that. And the lack of clarity is dangerous, because if people don’t get what they’re eligible for because they hear “emergency over, everything — nothing’s free anymore” — we’re already having trouble with uptake. We don’t have enough people getting boosters. People don’t know that they can get Paxlovid and that it’s free and that it works. We are still in this very inadequate response. We’re not in the terrifying emergency of three years ago, but it’s not copacetic. You know, it’s not perfect. And this confusion is really part of what really worries me the most. And the people who are most likely to be hurt are the people who are always most likely to be hurt: the people who are poor, the people who are in underserved communities, the people who are less educated, and it’s disproportionately people in minority communities. We’ve seen this show before, and that’s part of what I worry about — that there’s a data issue that we’ll get to whenever Julie decides to get to it, right?

Rovner: Yeah, I mean, and that’s the thing. With so much of the emergency going away, we’re not really going to know as much as we have before.

Sanger-Katz: In some ways, how you feel about this transition really reflects how you feel about the way that our health care system works in general. You know, what happened for covid is —and I’m oversimplifying a little bit — is we sort of set up a single-payer system just for one disease. So everyone had access to all of the vaccines, everyone had access to all of the tests, everyone had access to all of the treatments basically for free. And we also created this huge expansion of Medicaid coverage by no longer allowing the states to kick people out if they no longer seem to be eligible. So we had the kind of system that I think a lot of people on the left would like to see, not just for one disease but for every disease, where you have kind of more universal coverage and where the cost of obtaining important treatments and prevention is zero to very low. And this is definitely going to be a bumpy transition, but it’s basically a transition to the way our health care system works for every other disease. So if you are someone who had some other kind of infectious disease or a chronic disease like cancer, rheumatoid arthritis, whatever, you’ve been sort of dealing with all of this stuff the whole time — that you have to pay for your drugs; that, you know, that testing is expensive; that it’s confusing where you get things; that, you know, there’s a lot of complexity and hoops you have to jump through; that a lot depends on what kind of insurance you have; that what kind of insurance you can get depends on your income and other demographic characteristics. And so I find this transition to be pretty interesting because it seems like it would be weird for the United States to just forever have one system for this disease and another system for every other disease. And of course, we do have this for people who are experiencing kidney disease: They get Medicare, they get the government system, regardless of whether they would otherwise be eligible for Medicare.

Rovner: We should point out that Congress did that in 1972. They haven’t really done it since.

Kenen: And when it was much more rare than it was today.

Rovner: And when people didn’t live very long with it mostly.

Kenen: We didn’t have as much diabetes either.

Sanger-Katz: But anyway, I just think this transition kind of just gives us a moment to reflect on, How does the system work in general? How do we feel about how the system works in general? Are these things good or bad? And I agree with everything that Joanne said, that the confusion around this is going to have public health impacts as relates to covid. But we have lots of other diseases where we just basically have the standard system, and now we’re going to have the standard system for covid, too.

Kenen: You could have gone to the hospital with the bad pneumonia and needed oxygen, needed a ventilator, and when they tested you, if you had covid, it was all free. And if you had, you know, regular old-fashioned pneumonia, you got a bill. I agree with everything Margot said, but it’s even that silly. You could have had the same symptoms in your same lungs and you had two different health care systems and financing systems. None of us have ever thought anything made sense.

Rovner: Yes, well, I actually —

Kenen: That’s why we have a podcast. Otherwise, you know —

Sanger-Katz: And also the way that the drugs and vaccines were developed was also totally different, right? With the government deeply involved in the technology and development, you know, funding the research, purchasing large quantities of these drugs in bulk in advance. I mean, this is just not the way that our system really works for other diseases. It’s been a very interesting sort of experiment, and I do wonder whether it will be replicated in the future.

Luhby: Right. But it was also clear that this is not the beginning of the pushback. I mean, Congress has not wanted to allocate more money, you know, and there’s been a lot of arguments and conflicts over the whole course of this so-called single-payer system, or this more flexible system. So the U.S.’ approach to health care has been pushing its way in for many months.

Rovner: I naively, at the beginning of the pandemic, when we first did this and when the Republicans all voted for it, it’s like, let’s have the federal government pay the hospitals for whatever care they’re providing and make everything free at point of service to the patient — and I thought, Wow, are we going to get used to this and maybe move on? And I think the answer is exactly the opposite. It’s like, let’s get rid of it as fast as we possibly can.

Kenen: There’s money that the government has put in. I believe it is $5 billion into the next generation of vaccines and treatments, because the vaccine we have has certainly saved many lives. But as we all know, it’s not perfect. You know, it’s preventing death, but not infection. It’s not ending circulation of the disease. So we need something better. This debt ceiling fight, if the people in the government could spend all $5 billion today — like we were joking, if you want to get covid, if you’re going to get covid, get it today — I mean, if they could, they would spend all $5 billion of it today, too, because that could be clawed back. I mean, that’s — it’s going to be part of the coming fight.

Luhby: But the question is, even if they develop it, will anyone take it, or will enough people take it? That’s another issue.

Rovner: Well, since we’re sort of on the subject, I’m going to skip ahead to what I was going to bring up towards the end, which I’m calling “This Week in Our Dysfunctional Health System.”

Kenen: We could call it that way every week.

Rovner: Yes, that’s true. But this is particularly about how our health system doesn’t work. First up is “ghost networks.” Those are where insurers provide lists of health care providers who are not, in fact, available to those patients. A quote “secret shopper survey” by the staff of the Senate Finance Committee found that more than 80% of mental health providers found in insurance directories in 12 plans from six states were unreachable, not accepting new patients, or not actually in network. This is not a new problem. We’ve been hearing about it for years and years. Why does it persist? One would think that you could clean up your provider directory. That would be possible, right?

Kenen: Didn’t they legislate that, though? Didn’t they say a few years ago you have to clean it up? I mean, there are going to be some mistakes because there’s, you know, many, many providers and people will make changes or leave practices or … [unintelligible] …  jobs or whatever. But I thought that they had supposedly, theoretically, taken care of this a couple years ago in one of the annual regulations for ACA or something.

Rovner: They supposedly, theoretically, took care of the hospitals reporting their prices in a way that consumers can understand, too. So we’ve discovered in our dysfunctional health care system that Congress passing legislation or HHS [the Department of Health and Human Services] putting out rules doesn’t necessarily make things so.

Kenen: Really?

Rovner: Yeah. I just — this was one that I had thought, Oh, boy, I have a whole file on that from like the 1990s.

Sanger-Katz: It’s a huge problem, though. I mean —

Rovner: Oh, it is.

Sanger-Katz: You know, we have a system where, for large groups of Americans, you are expected to shop for a health insurance plan. If you’re purchasing a marketplace plan for yourself, if you are purchasing a Medicare Advantage plan when you become eligible for Medicare, and in many cases, if you have a choice of employer plans, you know, you’re supposed to pick the plan that’s best for you. And we have a system that tells people that having those kinds of choices is good and maximizes the benefits to people, to be able to pick the best plan. But for a lot of people, being able to have the doctors and hospitals that they use or to have a choice of a wide range of doctors for various problems, including mental health services, is a huge selling point of one plan versus another. And again, you have these ghost networks, when you have this lack of transparency and accuracy of this information, it just causes people to be unable to make those good choices and it undermines the whole system of market competition that underpins all of this policy design. I think you can argue that there are not a million gazillion people who are actually shopping on the basis of this. But I do think that knowing whether your medical providers are covered when you’re choosing a new health care plan is actually something that a lot of people do look into when they are choosing a health insurance plan. And discovering that a doctor that you’ve been seeing for a long time and whose relationship you really value and whose care has been important to you is suddenly dishonestly represented as a part of an insurance plan that you’ve selected is just, you know, it’s a huge disappointment. It causes huge disruptions in people’s care. And I think the other thing that this study highlighted is that health insurance coverage for mental health services continues to be a very large problem. There has been quite a lot of legislation and regulation trying to expand coverage for mental health care. But there are these kind of lingering problems where a lot of mental health care providers simply don’t accept insurance or don’t accept very many patients who have insurance. And so I think that this report did a good job of highlighting that place where I think these problems are even worse than they are with the health care system at large. It’s just very hard to find mental health care providers who will take your insurance.

Rovner: And I would say, when you’re in mental health distress or you have a relative who’s in mental health distress, the last thing you need is to have to call 200 different providers to find one who can help you.

Kenen: A lot of the ones that are taking insurance are these online companies, and the good thing is that they’re taking insurance and that there may be convenience factors for people, although there’s also privacy and other factors on the downside. But there have been reports about, your data is not private, and I have no idea how you find out which company is a good actor in that department and which company is just selling identifiable data. I mean, I think it was The Washington Post that had a story about that a couple of weeks ago. You know, you click in on something — straight to the data broker. So, yeah, you get insurance coverage, but at a different price.

Rovner: Well, overlaid over all of this is consolidation, this time at the primary care level of health care. Margot, your colleague Reed Abelson had a big story this week on primary care practices being bought up by various larger players in the health care industry, including hospitals, insurance companies, pharmacy chains, and even Amazon. These larger entities say this can act as a move towards more coordinated, value-based care, which is what we say we all want. But there’s also the very real possibility that these giant, vertical, mega medical organizations can just start to name their own price. I mean, this is something that the FTC [Federal Trade Commission] in theory could go after but has been kind of loath to and that Congress could go after but has also been kind of loath to.

Sanger-Katz: Yeah, in some ways we’ve seen this movie before. There was a big wave of primary care acquisitions that happened, I think, in the 1990s by hospitals. And the hospitals learned pretty quickly that primary care doctors are kind of a money-losing proposition, and they divested a lot. But I think what Reed documented so nicely is that the entities that are buying primary care now are more diverse and they have different business strategies. So it’s not just hospitals who are sort of trying to get more patients referred to their higher-profit specialists, but it’s also Medicare Advantage insurers who benefit from being able to tell the primary care doctors to diagnose their patients with lots of diseases that generate profits for the plan, and it’s other kinds of groups that see primary care as kind of the front door to other services that can be revenue-generating. And it’s very — it will be very interesting to see what the effects of these will be and whether these will turn out to be good business decisions for these new entities and of course also whether it will turn out to be good for patient care.

Rovner: Yeah, I remember in the 1990s when hospitals were buying up doctor practices, the doctors ended up hating it because they were asked to work much harder, see patients for a shorter period of time, and some of them actually — because they were now on salary rather than being paid for each patient — were cutting back on, you know, in general, on the amount of care they were providing. And that was what I think ended up with a lot of these hospitals divesting. It didn’t work out the way the hospitals hoped it would. But as you point out, Margot, this is completely different, so we will — we will see how this moves on. All right. Let’s go back a little bit. We’re going to talk about abortion in a minute. But first, something that could prevent a lot of unintended pregnancies: On Wednesday, an advisory committee for the Food and Drug Administration — actually two advisory committees — unanimously recommended that the agency approve an over-the-counter birth control pill. This has been a long time coming here in the U.S., even though pills like these are available without prescription in much of Europe and have been for years. But while the FDA usually follows the recommendations of its advisory committees, we know that some FDA scientists have expressed concerns about over-the-counter availability. So what’s the problem with giving women easier access to something that so many depend on?

Kenen: There are trade-offs. And there are — some of the scientists at the FDA are more conservative than others about, What if the woman doesn’t understand how to take the pill properly? Things like that. I mean, obviously, if we go the over-the-counter route, as other countries are doing, there have to be very simple, easy-to-understand explanations in multiple languages. Pharmacists should be able to explain it like, you know, “You have to take it every day, and you have to take it at approximately the same time every day,” and things like that. So, you know, obviously not taking it right doesn’t protect you as much as taking it right. But there are a lot of people who will be able to get it. You know, getting a prescription is not always the easiest thing in the world. Or if you’re lucky, you just click on something and somebody calls your doctor and gets you a refill. But that doesn’t always work and not everybody has access to that, and you have to still see your doctor sometimes for renewals. So if you’re a working person who doesn’t have sick leave and you have to take time off from work every three months to get a refill or you have to hire child care or you have to take three buses — you know, it takes a whole day, and then you sit in a waiting room at a clinic. I mean, our health system is not patient-friendly.

Rovner: I was going to say, to go back to what Tami was talking about earlier — if pills are available over the counter, it’s going to depend on, you know, what your insurance is like, whether you would get it covered.

Kenen: The cost.

Rovner: That’s right. And it could end up being —

Kenen: But I don’t think the FDA is concerned about that.

Rovner: No, they’re not. That’s not their job.

Kenen: The pill is pretty safe, and these are lower-dose ones than the pills that were invented, you know, 50 years ago. These are lower-dose, safer drugs with fewer side effects. But I mean, there’s concern about the rare side effect, there’s concern about people not knowing how to take it, all that kind of stuff. But Julie just mentioned the cost of coverage is a separate issue because under the ACA it’s covered. And if it becomes over the counter, the mechanism for getting that covered is, at this point, unclear.

Sanger-Katz: But we do have a system now where, for a lot of women, obtaining birth control pills depends on being able to get a doctor’s appointment on a regular basis. I think, you know, this is not standard practice, but I do think that there are a lot of OB-GYNs who basically won’t write you for a birth control pill unless you come in on a regular basis to receive other kinds of health screenings. And I think many of them do that with good intentions because they want to make sure that people are getting Pap smears and other kinds of preventive health services. But on the other hand, it does mean that there are a lot of women who, if they don’t have time or they can’t afford to come in for regular doctor’s appointments, lose access to birth control. And I think over-the-counter pills is one way of counteracting that particular problem.

Rovner: And I think that’s exactly why so many of the medical groups are urging this. During the more than a decade-long fight over making the morning-after pill over the counter, the big hang-up was what to do about minors. Even President Obama, a major backer of women’s reproductive health rights, seemed unhappy at the idea of his then-barely teenage daughters being able to get birth control so easily and without notifying either parent. It seems unimaginable that we’re not going to have that same fight here. I mean, literally, we spent six years trying to figure out what age teens could be to safely buy morning-after pills, which are high doses of basically these birth control pills. I’m actually surprised that we haven’t really seen the minor fight yet.

Kenen: I think everyone’s waiting for somebody else to do it first. I mean, like Julie, I wasn’t expecting to hear more about age limitations, and that’ll probably come up when the FDA acts, because I think the advisory committee just wanted to — they were pretty strong saying, “Yeah, make this OTC.”

Sanger-Katz: I also think the politics around emergency contraception are a little bit different because I think that, while physicians understand that those pills are basically just high-dose birth control pills and that they work in just the same way as typical contraception, I think there’s a perception among many members of the public that because you can take them after unprotected sex, that they might be something closer to an abortion. Now, that is not true, but because I think that is a common misperception, it does lead to more discomfort around the availability of those pills, whereas birth control pills — while I think there are some people who object to their wide dissemination and certainly some who are concerned about them in the hands of children, I think they are more broadly accepted in our society.

Rovner: We obviously are going to see, and we’ll probably see fairly soon. We’re expecting, I guess, a decision from the FDA this summer, although with the morning-after pill we expected a decision from FDA that lingered on for many months, in some cases many years.

Kenen: And I think it’s at least hypothetically possible that states will not do what the FDA says. Say the FDA says they can be over the counter with no age limitations. I can see that becoming a fight in conservative states. I mean, I don’t know exactly the mechanism for how that would fall, but I could certainly think that somebody is going to dream up a mechanism so that a 12-year-old can’t get this over the counter.

Rovner: I want to move to abortion because first up is the continuing question over the fate of the abortion pill, which we get to say at this point: not the same as the emergency contraceptive pill, which, as Margot said, is just high-dosage regular birth control pills. Needless to say, that’s the one that we’re having the current court action over. And there was even more action this week, although not from that original case, which will be heard by the Court of Appeals later in this month. In West Virginia, a judge declined to throw out a case brought by GenBioPro. They are the maker of the generic version of mifepristone, the abortion pill. That generic, which accounts for more than half the market, would be rendered unapproved even under the compromise position of the Court of Appeals because it was approved after the 2016 cutoff period. Remember, the Court of Appeals said, We don’t want to cancel the approval, but we want to roll it back to the date when FDA started to loosen the restrictions on it. So, in theory, there would be no generic allowed, but that’s actually not even what the West Virginia lawsuit is about; it’s about challenging the state’s total abortion ban as violating the federal supremacy of the FDA over state laws. Joanne, that’s what sort of you were talking about now with contraceptives, too. And this is the big unanswered question: Can states basically overrule the FDA’s approval and the FDA’s approval for even an age limit?

Kenen: Well, I mean, I’m not saying they can, but I am saying that I don’t know where the question will come down. Go back to the regular birth control; I can certainly see conservative states trying to put age limits on it. And I don’t know how that’ll play out legally. But this is a different issue, and this is why the abortion pill lawsuits are not just about the abortion pill. They’re about drug safety and drug regulation in this country. The FDA is the agency we charge with deciding whether drugs are safe and good for human beings, and not the system of politicians and state legislators in 50 different states replacing their judgment. So obviously, it’s more complicated, because it’s abortion, but one of several bottom lines in this case is who gets to decide: the FDA or state legislature.

Rovner: And right: Do states get to overrule what the federal Food and Drug Administration says? Well, I —

Kenen: Remember, some states have had — you know, California’s had stricter regulations on several health things, you know, and that’s been allowed that you could have higher ceilings for various health — you know, carcinogenics and so forth. But they haven’t fundamentally challenged the authority of the FDA.

Rovner: Yet. Well, since confusion is our theme of the week, also this week a group of independent abortion clinics led by Whole Woman’s Health, which operates in several states, filed suit against the FDA, basically trying to add Virginia, Kansas, and Montana to the other 18 states that sued to force FDA to further reduce the agency’s current restrictions on mifepristone. A federal judge in Washington state ruled — the same day that Texas judge did that mifepristone should have its approval removed — judge in Washington said the drug should become even more easily available. In the real world, though, this is just sowing so much confusion that nobody knows what’s allowed and what isn’t, which I think is kind of the point for opponents, right? They just want to make everybody as confused as possible, if they can’t actually ban it.

Sanger-Katz: I think they actually want to ban it. I mean, I think that’s their primary goal. I’m sure there are some that will settle for confusion as a secondary outcome. I think just this whole mess of cases really highlights what a weird moment we are, where we’re having individual judges and individual jurisdictions making determinations about whether or not the FDA can or can’t approve the safety and efficacy of drugs. You know, as Joanne said, we’ve just had a system in this country since the foundation of the FDA where they are the scientific experts and they make determinations and those determinations affect drug availability and legal status around the country. And this is a very unusual situation where we’re seeing federal courts in different jurisdictions making their own judgments about what the FDA should do. And I think the Texas judge that struck down the approval of mifepristone, at least temporarily, has come in for a lot of criticism. But what the judge in Washington state did is sort of a flavor of the same thing. It’s telling the FDA, you know, how they should do their business. And it’s a weird thing.

Rovner: It is. Well, one last thing this week, since we’re talking about confusion, and the public is definitely confused, according to two different polls that are out this week — on the one hand, a Washington Post-ABC News poll found that a full two-thirds of respondents say mifepristone, the abortion pill, should stay on the market, and more than half say they disagree with the Supreme Court’s overturn of Roe v. Wade, including 70% of independents and more than a third of Republicans. Yet, in focus groups in April, more than a third of independents couldn’t differentiate Democrats’ position on abortion from Republicans’. As reported by Vox, one participant said, quote, “I really haven’t basically heard anything about which party is leaning toward it and which one isn’t.” When pressed, she said, “If I had to guess, I would say Democrat would probably be against it and Republican would probably be for it.” Another participant said she thought that Joe Biden helped get the Supreme Court judges who overturned Roe. We really do live in a bubble, don’t we? I think that was sort of the most mind-blowing thing I’ve read since — all the months since Roe got overturned, that there are people who care about this issue who have no idea where anybody stands.

Sanger-Katz: I think it’s just a truth about our political system that there are a lot of Americans who are what the political scientists call low-information voters. These are people who are just not following the news very closely and not following politics very closely. And they may have a certain set of opinions about issues of the day, but I think it is a big challenge to get those people aware of where candidates stand on issues of concern to them and to get them activated. And it doesn’t really surprise me that independent voters are the ones who seem to be confused about where the parties are, because they’re probably the least plugged into politics generally. And so, for Democrats, it does seem like this lack of information is potentially an opportunity for them, because it seems like when you ask voters what they want on abortion, they want things that are more aligned with Democratic politicians’ preferences than Republicans’. And so it strikes me that perhaps some of those people in the focus group who didn’t know who stood for what, maybe those are gettable voters for the Democratic Party. But I think — you know, we’re about to go into a very heated campaign season, you know, as we go into the presidential primaries and then the general election in which there are going to be a lot of ads, a lot of news coverage. And, you know, I think abortion is very likely to be a prominent issue during the campaigns. And I think it is almost certainly going to be a major goal of the Biden presidential reelection campaign to try to make sure that these people know where Biden stands relative to abortion, because it is an issue that so many voters agree with him on.

Rovner: And it makes you see, I mean, there’s a lot of Republicans who are trying to sort of finesse this issue now and say, you know, “Oh, well, we’re going to restrict it, but we’re not going to ban it,” or, “We have all these exceptions” that are, of course, in practice, you can’t use. Obviously, these are the kinds of voters who might be attracted to that. So we will obviously see this as it goes on.

Kenen: But Julie, do you remember whether they were actually voters? Because I had the same reaction to you: like, of all the things to not be sure of, that one was pretty surprising. But we also know that in places like Kansas where, you know, where there are not that many Democrats, these referenda won. Voters have supported abortion rights in the 2022 elections and in these state referenda. So independents must be voting with the —

Rovner: I was going to say, I think if you’re doing —

Kenen: Something isn’t totally — something is not totally adding up there.

Rovner: If you’re doing a focus group for politics, one presumes that you get voters. So, I mean, I think that was — that was the point of the focus group. But yeah, it’s —

Kenen: Or people who say they’re voters.

Rovner: Or people who say they’re voters. That is a different issue. All right. Well, something not that confusing: Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Tami, why don’t you go first this week?

Luhby: OK. Well, I picked a story from CNN by my colleagues on the health team. It’s titled “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa. And I have to say that when I first read this story, I couldn’t get through it, because it was so upsetting. And then when I selected it as an extra credit, I had to read it in full. But it’s about a family in Florida whose son was born without kidneys. They knew that he was going to die. And it’s about all of the effects from everything from, you know, the mother, Deborah Dorbert, on her physically and emotionally. But it also, you know, talked about the family and, you know, the effect on the marriage and the effect — which was just so upsetting — was on the 4-year-old son, who became very attached. I don’t think they even knew — well, it wasn’t a girl. It was actually a boy. But for some reason, this older son felt that it was a girl and just kept saying, like, “My sister is going to do X, Y, Z.” And, you know, how did the parents break it to him? Because he saw that his mother was, you know, pregnant and getting larger. And, you know, it was just figuring out how to break it to him that no baby was coming home. So the details are heart-wrenching. The quotes in the third paragraph: “‘He gasped for air a couple of times when I held him,’ said Dorbert. ‘I watched my child take his first breath, and I held him as he took his last one.’” So, you know, these are things that, you know — and we just talked about how the states are arguing over what exceptions there should be, if any, you know, and these are the stories that the legislators don’t think about when they pass these laws.

Rovner: I think I said this before because we’ve had a story like this almost every week. This one was particularly wrenching. But I think the one thing that all these stories are doing is helping people understand, particularly men, that there are complications in pregnancy, that they’re not that rare, that, you know, that they sort of throw off and say, “Oh, well, that’s, you know, one in a million,” — It’s not one in a million. It’s like one in a thousand. That’s a lot of people. So I mean, that’s why there are a lot of these stories, because there are a lot of pregnancies that don’t go as expected.

Luhby: Right. And it really shows the chilling effect on doctors because, you know, you would say, “Oh, it’s simple: life of the mother or, you know, life of the fetus” or something like that. That seems pretty straightforward, but it isn’t. And these doctors, in cases where, you know, other cases where it is the life of the mother, which seem, again, very straightforward, the doctors are not willing to do anything because they’re afraid.

Rovner: I know. Joanne.

Kenen: This is a story from The Baltimore Banner that has a very long title. It’s by Hallie Miller and Adam Willis, and it’s called “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million.” Baltimore is not that big a city. $650 million is a lot of curbs and barriers. And there’s also a lot of gun violence in Baltimore. If you drive around Baltimore, and I work there a few days a week, you see lots of people on walkers and scooters and wheelchairs because many of them are survivors of gun violence. And you see them struggling. And there were quotes from people saying they, you know, were afraid walking near the harbor that they would fall in because there wasn’t a path for them. It is not invisible, but we treat it like it’s invisible. And it’s been many years since the Americans with Disabilities Act was passed, and we still don’t have it right. It’s a — this one isn’t confusion like everything else we talked about today. I loved Margot’s phrase about confusion as a secondary outcome. I think you should write a novel with that title. But it’s — this isn’t confusion. This is just not doing the right thing for people who are — we’re just not protecting or valuing.

Rovner: And I’d say for whom there are laws that this should be happening. Margot.

Sanger-Katz: I had another story about abortion. This one was in The New Yorker, called “The Problem With Planned Parenthood,” by Eyal Press. The story sort of looked at Planned Parenthood, you know, which is kind of the largest abortion provider in the country. It’s — I mean, it’s really a network of providers. They have all these affiliates. They’re often seen as being more monolithic than perhaps they are. But this story argued that people who were operating independent abortion clinics, who do represent a lot of the abortion providers in the country as well, have felt that Planned Parenthood has been too cautious legally, too afraid of running afoul of state laws, and so that has led them to be very conservative and also too conservative from the perspective of business, and that there is a view that Planned Parenthood is not serving the role that it could be by expanding into areas where abortion is less available. I thought it was just interesting to hear these criticisms and hoped to understand that the community of abortion providers are, you know, they’re diverse and they have different perspectives on how abortion access should work and what kinds of services should be provided in different settings. And they also view each other as business competition in some cases. I mean, a lot of the complaints in this article had to do with Planned Parenthood opening clinics near to independent clinics and kind of taking away the business from them, making it harder for them to survive and operate. Anyway, I thought it was a very interesting window into these debates, and it did mesh with some of my reporting experience, particularly around the legal cautiousness. I did a story before the Dobbs decision came down from the Supreme Court where Planned Parenthood in several states had just stopped offering abortions even before the court had ruled, because they anticipated that the court would rule and they just didn’t want to make any mistake about running afoul of these laws such that, you know, women were denied care that was still legal in the days leading up to the Supreme Court decision.

Rovner: Yeah, it’s a really good story. Well, my story is kind of tangentially about abortion. It’s from Slate, and it’s called “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern. And it’s about a case from Texas, of course, that we talked about a couple of weeks ago, where an ex-husband is suing two friends of his ex-wife for wrongful death, for helping her get an abortion. Well, now the two friends have filed a countersuit claiming that the ex-husband knew his wife was going to have an abortion beforehand because he found the pill in her purse and he put it back so that he could use the threat of a lawsuit to force her to stay with him. It feels like a soap opera, except it is happening in real life. And my first thought when I read this is that it’s going to make some great episode of “Dateline” or “20/20.” That is our show, as always.

Kenen: Or, not “The Bachelor.”

Rovner: Yeah, but not “The Bachelor.” That is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m at @jrovner. Joanne?

Kenen: @JoanneKenen.

Rovner: Tami.

Luhby: @Luhby.

Rovner: Margot.

Sanger-Katz: @sangerkatz.

Rovner: We will be back in your feed next week, hopefully with a little less confusion. Until then, be healthy.

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taxes, according to a memo by a U.S. Senate Committee.

Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.

Continue to STAT+ to read the full story…

When the first Humira biosimilar — essentially a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommended option No. 2: the more expensive version.

As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermediaries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, undermining the whole rationale for generic drugs.

The Optum-Amgen announcements perfectly elucidated why, after years of thundering against drugmakers, Congress and the administration have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceutical executives Wednesday in preparation for a vote on PBM legislation, expected Thursday.

The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescription drug sales in America and are the most profitable parts of the health conglomerates in which they’re nestled. CVS Health, the fourth-largest U.S. corporation by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHealth Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporations also own the highest-grossing specialty drug and mail-order pharmacies.

“John D. Rockefeller would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”

Drug manufacturers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independent pharmacists say PBMs are driving them out of business. Physicians blame them for unpredictable, clinically invalid prescribing decisions. And patients complain that PBMs’ choices drain their pocketbooks.

With PBMs driving prices, competition has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitors than for those that didn’t.

All this makes the PBMs ripe targets for politicians of both parties. Yet the complexity and obscurity of their role in the drug marketplace have skeptics wondering whether legislation advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.

“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.

The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescription decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.

Several congressional bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.

But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproportionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participating hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.

Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-of-pocket costs their covered members will pay.

In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortable for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.

 PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduces medical underwriting” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northwestern’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.

“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.

PBMs Evolve From Minnows to Whales

In 1967, a year before the first PBM was founded, spending on prescription drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiating power to keep rising drug prices in check.

The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitors and merge with insurers during the Bush and Obama administrations on the grounds that bolstering their powers might rein in prices. The FTC fought state investigations of anti-competitive behavior, saying that pressure on PBMs would benefit consumers.

The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigation of the PBMs last June.

It came partly at the request of independent pharmacists, who rely on PBM reimbursements for the drugs they purchase and provide consumers. Thousands of pharmacists complained to the FTC that PBMs force them to accept unfairly low reimbursements — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacists returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.

During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescription because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodate a patient delayed getting to the store.

And her reimbursements are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiating anything,” she said. “It’s take it or leave it.”

PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceutical Care Management Association, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufacturers and pharmacists.”

PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularies baffling, with dozens of variations depending on a patient’s health plan.

When Philadelphia-area internist Amy Davis writes a prescription, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorization. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.

“We physicians are completely in the dark,” she said. “And it’s designed that way.”

The PBMs’ growing use of proprietary pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-year-old restaurant manager and mother of six in Mount Juliet, Tennessee.

In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescription be filled by Accredo, the mail-order pharmacy it owns.

In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”

After St. Clair started the four-pills-twice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medications didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”

The pharmacy attached to her oncology practice straightened out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrences in her practice.

“The problem with the PBMs and the specialty pharmacies they own is that they are so complicated and intertwined it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucratic stuff is a distraction and takes away from things I could be doing, like asking Jasmine about her kids.”

What’s the Remedy?

Bipartisan House and Senate bills would require PBMs to reimburse pharmacies serving Medicaid patients based on an authorized price list, rather than using standards that allegedly allow PBMs to lowball pharmacies. The Congressional Budget Office has estimated the bills would save the federal government $1 billion over 10 years. Another Senate bill would require PBMs to report more of their earnings to the FTC, and would ban deceptive and unfair fees.

But PBMs have shown themselves adept at finding ways around regulation. A federal rule scheduled to take effect next year would curtail PBM “clawbacks” on independent pharmacies. But PBM contracts sent out to pharmacies in recent weeks get around that by lowering reimbursement fees and putting a percentage of their payments to pharmacies into a kind of escrow, said Douglas Hoey, CEO of the National Community Pharmacists Association.

When the Trump administration considered banning brand-name drug rebates in 2017, PBMs set up companies in Ireland and Switzerland to take over the negotiations and purchases. Doing so offered a tax advantage and allowed the PBMs to avoid scrutiny of the quantity and nature of those deals. Recently, Express Scripts set up another company to purchase generic drugs, in the Cayman Islands.

And PBMs appear adept at moving money from one pocket to another. “Yesterday’s rebates are today’s fees and potentially tomorrow’s something else,” said John O’Brien, CEO of the pharmaceutical industry-funded research group, the National Pharmaceutical Council.

Every arrangement that PBMs make with manufacturers, employers, and insurers is secret and proprietary, said Barak Richman, a Duke University Law School professor. This makes it nearly impossible to examine what kind of deals PBMs are making.

Antitrust law could be brought to bear on the PBMs, Richman said. And the Biden administration has shown an eagerness to possibly reverse mergers that have increased PBM clout. The Justice Department has taken similar steps.

But federal officials will have to move fast to slow the PBMs. Insurers that don’t have PBMs as part of their business have been shrinking in recent years because of the growing clout and buying power of the companies.

“I predict that any health insurer that doesn’t have a PBM is going to disappear in 10 years,” said Neeraj Sood, a professor at the University of Southern California Sol Price School of Public Policy. “Otherwise, there is no way to compete with the big three.”

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Mike Lee no se arrepintió de su carrera. Había sido uno de los mejores boxeadores profesionales del mundo en su categoría. Tenía marca de 21-1, y peleó en el Madison Square Garden y frente a millones en la televisión.

Pero habían pasado más de dos años desde que pisó un ring, y cada día era un recordatorio del costo. En un momento, Lee estaba tomando ocho medicamentos recetados, todos para tratar de sobrellevar la situación.

Contó que, en su momento más bajo, en una noche en que estaba en lo más profundo de una adicción a los analgésicos, pensó en chocar su auto contra la valla de una autopista de Chicago a 140 mph.

Estaba dispuesto a hacer cualquier cosa para escapar del infierno en el que se sentía atrapado.

El impulso se desvaneció, pero el dolor permaneció.

Estaba perdido.

“Cuando tienes dolor y estás atrapado, harás cualquier cosa para salir de eso”, dijo Lee.

Ahora, había llegado a una jungla verde al final de un camino de tierra en la mitad de una montaña.

Esperaba que los hongos psicodélicos pudieran cambiar su vida.

Lee era parte de un pequeño grupo, muchos de ellos atletas retirados, que viajaron a Jamaica en marzo de 2022 para un retiro que costó hasta $5500. Cada uno de ellos había venido a Good Hope Estate, una plantación de azúcar convertida en centro turístico exclusivo, con la esperanza de librarse de la depresión, la ansiedad y el dolor crónico que habían experimentado durante años.

Dos ceremonias con hongos psicodélicos y dos sesiones de terapia les esperaban en el retiro dirigido por una empresa canadiense llamada Wake Network. Los participantes estaban nerviosos, pero también esperanzados.

Junto con Lee, había un jugador profesional de fútbol americano que estaba considerando retirarse y una ex estrella de hockey que tenía múltiples conmociones cerebrales.

Venían de todas partes de América del Norte, de diferentes orígenes y diferentes deportes, pero tenían algunas cosas en común: eran vulnerables y sentían que los medicamentos recetados les habían fallado. No sabían qué esperar, si el tratamiento funcionaría, si regresarían a casa con una solución o simplemente con otra decepción.

Lee se enteró del retiro por un amigo de la infancia que trabaja como médico en Wake. Otros habían sido reclutados por Riley Cote, un ex ejecutor de los Philadelphia Flyers y ahora un evangelista psicodélico que es asesor de Wake con una participación accionaria.

Alguna vez, Cote fue como Lee. Le encantaba golpear a la gente en la cara. Amaba la forma en que su mano aterrizaba con un ruido sordo cuando sus nudillos se conectaban con la carne y el hueso a una velocidad violenta. Romper la cabeza de alguien hacía que Cote se sintiera vivo.

“Luché contra todos. Escogía al tipo más grande que pudiera encontrar y lo desafiaba. Así fue como sobreviví, cómo me hice un nombre. Me estaba infligiendo todo este dolor e inflamación, siempre recibiendo puñetazos en la cara, y tenía que mantener este tipo de personalidad machista, como, ‘Oh, no puedes lastimarme. No puedes lastimarme’”.

Ya no era esa persona. Le daba escalofríos pensar en el hombre que alguna vez fue, alguien que bebía en exceso y usaba analgésicos para adormecer su cerebro. Hubo un tiempo en que él, como Lee, estaba en un lugar oscuro, pero con el transcurso de varios años, los hongos psicodélicos, cree Cote, lo ayudaron a regresar a la luz.

“El mundo está en una crisis, una crisis de salud mental, una crisis espiritual”, dijo Cote. “Y creo que estas son medicinas espirituales, y siento que es el camino correcto para mí. No lo considero más que mi deber, mi propósito en este planeta es compartir la verdad sobre la medicina natural”.

Durante años, han circulado rumores sobre una red clandestina de atletas, principalmente ex atletas, que usan psilocibina, el compuesto de los hongos mágicos, para tratar lesiones cerebrales traumáticas, ansiedad y depresión.

Muchos de ellos, como Cote, ven a los psicodélicos como una cura milagrosa, lo único que pudieron encontrar que podría ayudar a romper un ciclo de analgésicos y abuso de sustancias. Se reunían en pequeños grupos para ingerir hongos en privado o viajaban a países como Jamaica donde los hongos psicodélicos no están prohibidos.

Ahora, el uso de hongos psicodélicos está ganando terreno en los Estados Unidos. Varias ciudades han despenalizado la posesión de psilocibina, y los votantes de Oregon y Colorado aprobaron medidas electorales para legalizar los hongos mágicos bajo uso supervisado. Muchos investigadores predicen que la Administración de Drogas y Alimentos (FDA) aprobará un tratamiento psicodélico en los próximos cinco años.

Pero muchos de esos mismos investigadores advierten que la intensa promoción de los psicodélicos está superando a la ciencia, y que el tratamiento conlleva riesgos significativos para algunos pacientes. Temen que, a menos que la investigación se lleve a cabo de forma metódica y ética, el uso generalizado de la psilocibina podría resultar en una reacción negativa del público, como sucedió en la década de 1960, relegando un tratamiento prometedor al basurero de las sustancias prohibidas.

Están instando a las entidades corporativas como Wake, que ya se están posicionando para aprovechar la posible legalización de los psicodélicos, a que avancen lentamente, se aseguren de que la investigación se realice de la manera correcta y permitan que la ciencia se ponga al día.

“Si no haces esto de manera segura, la gente saldrá lastimada”, dijo Matthew Johnson, profesor de psiquiatría e investigador de psicodélicos en la Universidad Johns Hopkins.

Pero muchos, incluidos los ex atletas profesionales con cuerpos y cerebros maltratados, no quieren esperar el lento avance de la investigación clínica. Necesitan ayuda ahora.

Los analgésicos, los antidepresivos, las innumerables píldoras diferentes que les recetaron a lo largo de los años no han ayudado. En sus mentes, las historias de sus compañeros atletas que dicen que se han beneficiado de los psicodélicos superan cualquier incertidumbre científica.

“Cuando piensas en hongos mágicos, piensas en los hippies de Woodstock bailando al ritmo de la música”, dijo Lee. “Pensar que tienes algunos de los mejores atletas del mundo aquí que están lidiando con algunas cosas y las están tomando, te hace sentir más cómodo. Me hace sentir como, ‘Está bien, tal vez estoy haciendo lo correcto’. Es una medicina curativa; no es solo una droga de fiesta”.

***

Cote, ahora de 41 años, era un patinador de hockey decente que creció en Winnipeg, Manitoba, tenaz de punta a punta y un trabajador incansable, pero bastante promedio en el manejo del disco.

No anotó suficientes goles para ascender en el hockey junior como lo hicieron algunos prospectos. Sin embargo, a medida que crecía, a los entrenadores no les importaba tanto. Tenía hombros anchos y un largo alcance. En una era del hockey en la cual la violencia todavía era moneda corriente, había encontrado su boleto dorado para la NHL: Cote golpeaba a la gente y recibía golpes a cambio.

Como miembro de los Flyers, vio que era su deber mantener las tradiciones de los Broad Street Bullies, un grupo de jugadores de la década de 1970 que fueron celebrados por la prensa por jugar y festejar fuerte.

Se abrió camino a través de la NHL durante partes de cuatro temporadas, acumulando más de 400 minutos de penalización en su carrera y anotando solo un gol. La mayoría de sus peleas fueron situaciones brutales, bárbaras. Sus destacados muestran a un gigante corpulento, con los ojos llenos de violencia, el tipo de matón que podría romperte la mandíbula y reír como un maníaco después, la sangre goteando de su rostro y cayendo al hielo.

“Fue algo que disfruté hacer, y creo que era solo un elemento de competencia para mí”, dijo Cote. “Y probablemente también era algo que estaba haciendo por miedo: miedo de no vivir mi sueño de la infancia o de decepcionar a mis padres o a la gente”.

Dijo que se medicaba por su dolor casi todos los días con alcohol. Las cervezas eran un aperitivo de camino a los shots en la barra. Después, venían drogas duras. Él y sus compañeros de equipo se quedaban fuera hasta las 3 am, a veces más tarde, y luego intentaban sudar el veneno al día siguiente durante la práctica.

Después de unos años, su cerebro comenzó a empañarse. Se hizo más grande y más fuerte a través del levantamiento de pesas, y parecía un monstruo en el hielo, pero cada una de sus habilidades de hockey se deterioró, salvo las peleas. A medida que su carrera terminaba, dijo, se sentía como si la oscuridad se acercara sigilosamente. Se deprimió. Tenía miedo de en lo que se había convertido.

Hoy, Cote se parece poco a aquel ejecutor de los videos. Más delgado y tranquilo, imparte clases de yoga en un estudio de Delaware tres veces por semana. Con el pelo hasta los hombros, tatuajes en los brazos y el pecho, habla con una suave voz de barítono. Parece más un monje que un monstruo.

“Miro hacia atrás y tal vez solo muestra lo confundido que estaba y la realidad que estaba buscando, que supuestamente era la felicidad y la satisfacción de perseguir el sueño de mi infancia”, dijo Cote. “Pero es difícil para mí entender que estoy haciendo eso ahora, simplemente sabiendo quién soy ahora y dándome cuenta de que se necesita mucha oscuridad para hacer lo que hice”.

Cote dijo que tomó hongos de forma recreativa durante sus 20 años, pero nunca en un entorno terapéutico o con el entendimiento de que podrían ayudarlo a procesar su trauma físico y emocional. “Era solo parte de la escena o parte de la fiesta”, dijo.

Pero cuando se jubiló en 2010, sintió que estaba enfrentando una crisis de identidad. Había sido un luchador durante tanto tiempo que pensó que eso era todo lo que era. ¿Cómo podría un ejecutor fracasado criar a dos hijas?

Empezó a leer. Lo que aprendió lo sorprendió.

Los investigadores habían revivido silenciosamente el estudio sobre los hongos psicodélicos como tratamiento médico en el año 2000, y los primeros hallazgos sugirieron que la psilocibina a menudo tenía beneficios notables para las personas diagnosticadas con ansiedad y depresión. Ayudó a algunos pacientes a deshacerse de sus adicciones a las drogas o al alcohol.

Otra investigación sugirió que la psilocibina en realidad puede ser capaz de remodelar la anatomía del cerebro, restaurar las vías neurológicas y ayudar a curar lesiones cerebrales traumáticas.

Para Cote, a quien le diagnosticaron al menos tres conmociones cerebrales en su carrera de hockey y probablemente sufrió muchas más, fue transformador.

Cote ahora recluta clientes para Wake, que organiza retiros inmersivos de psilocibina fuera de los Estados Unidos.

“Algunas personas vienen a estos eventos y están al borde del suicidio”, dijo Tyler Macleod, cofundador de Wake y su director de experiencia. “No se arreglan después de una ceremonia, pero ya no están atascados en la oscuridad. Se despiertan y dicen: ‘Oh, puedo navegar de nuevo una relación con mis hijos'”.

Todos los ex atletas que asisten a estos retiros están luchando con algo, dijo Cote. Necesitan ayuda. En muchos casos, sienten que han probado todo lo demás. Les pregunta por qué tienen que esperar cuando tantos estudios y anécdotas indican resultados positivos.

“Es como con el cannabis: ¿cuántas historias tuvimos que contarnos antes de tener un programa médico?”, apuntó Cote. “Simplemente ha estado bloqueado durante tanto tiempo”.

***

En 1970, el presidente Richard Nixon promulgó la Ley de Sustancias Controladas, legislación que dividía las drogas en cinco niveles, clasificándolas en gran medida según su potencial de abuso. Los hongos mágicos se clasificaron como sustancias de la Lista 1, junto con la heroína y la marihuana, lo que significa que el gobierno creía que no tenían ningún beneficio médico y que tenían un alto potencial de generar adicción. (La cocaína, la oxicodona y la metanfetamina se clasificaron como drogas de la Lista 2).

Esas decisiones, que el asesor de Nixon, John Ehrlichman, dijo más tarde que tenían motivaciones políticas, continúan teniendo un efecto dominó en la actualidad. La investigación sobre tratamientos psicodélicos se suspendió durante 30 años.

Si bien los estudios recientes han tenido un alcance pequeño, han mostrado efectos notables. Los medicamentos recetados aprobados para afecciones como la ansiedad o la depresión ayudan, en el mejor de los casos, a entre el 40% y el 60% de los pacientes. En los primeros ensayos, los psicodélicos han alcanzado tasas de eficacia de más del 70%.

Y, a diferencia de la mayoría de los medicamentos recetados, que dejan de funcionar poco después de que los pacientes dejan de tomarlos, uno o dos tratamientos de psilocibina pueden tener efectos terapéuticos por seis meses, un año o incluso más, según un estudio de Johns Hopkins.

Con un riesgo mínimo de adicción o sobredosis y siglos de uso por parte de las culturas indígenas, muchos investigadores consideran que la psilocibina es un tratamiento innovador potencial con grandes beneficios y pocos riesgos.

Scott Aaronson, director de programas de investigación clínica en Sheppard Pratt, un hospital psiquiátrico sin fines de lucro en las afueras de Baltimore, ha estado estudiando los trastornos del estado de ánimo difíciles de tratar durante 40 años, comenzando con algunos de los primeros estudios sobre Prozac.

“Soy un ser humano cínico, escéptico y sarcástico”, dijo Aaronson. “Y te diré, nunca he visto algo así en todos mis años”.

Pero la psilocibina no está exenta de riesgos. Puede exacerbar problemas cardíacos y desencadenar esquizofrenia en personas con una predisposición genética, y la combinación de psilocibina y litio puede causar convulsiones.

Los ensayos clínicos generalmente han descartado a los pacientes en riesgo de tales complicaciones. Aún así, una parte significativa de quienes consumen psilocibina, incluso sin ninguna de esas preocupaciones, tienen una experiencia negativa.

“En una dosis alta, alrededor de un tercio de las personas en nuestros estudios, incluso en estas condiciones ideales, pueden tener lo que se llamaría un mal viaje, algún grado de ansiedad o miedo sustancial”, dijo Johnson, investigador de Johns Hopkins. “Una persona puede ser muy vulnerable psicológicamente. Puede sentirse como si estuvieran muriendo”.

Sin embargo, a veces, incluso esos “malos viajes” pueden conducir a la ayuda con la depresión u otros problemas, según han descubierto investigadores, especialmente con la ayuda de seguimiento de un terapeuta para procesar la experiencia.

Los efectos psicodélicos de la psilocibina también pueden desconectar a una persona de la realidad, lo que puede llevar a las personas a hacer cosas peligrosas, como correr hacia el tráfico o saltar por una ventana.

“La percepción misma de la realidad y de ellos mismos en la realidad, como quiénes son, estas cosas pueden cambiar profundamente y no es una buena receta para interactuar en público”, dijo Johnson.

Los investigadores también describen casos en los que la psilocibina pone a las personas con problemas psicológicos no resueltos en estado de angustia a largo plazo.

Es por eso que los investigadores insisten en que la psilocibina debe administrarse en un entorno clínico con terapeutas capacitados que puedan guiar a las personas a través de la experiencia, lidiar con los resultados negativos cuando surjan, y ayudarlas a procesar e integrar sus experiencias.

Los ensayos clínicos de psilocibina se han basado en protocolos estrictos, que incluyen una o más sesiones antes del tratamiento para ayudar a los participantes a comprender qué esperar. El consumo de los hongos se hace a menudo en un solo día, con uno o dos terapeutas disponibles.

En los días siguientes, la persona regresa para lo que se conoce como integración, generalmente una sesión de terapia individual para ayudar a procesar la experiencia y comenzar el camino hacia la curación. Algunos ensayos agregan un día adicional de terapia entre dos tratamientos.

A diferencia de un medicamento típico, nose envía a los pacientes a casa con un frasco de píldoras. Todo el protocolo se parece más a un procedimiento médico.

Pero es un error pensar que es la medicina psicodélica la que hace todo el trabajo, no la terapia que viene después, dijo Jeffrey LaPratt, psicólogo e investigador de psilocibina con Sheppard Pratt. “Es un trabajo muy duro y requiere vulnerabilidad. Se necesita coraje. Puede ser realmente doloroso”.

***

El ex jugador de la NHL Steve Downie sintió como si algo en él se hubiera roto cuando lo invitaron al retiro de Wake en Jamaica. Sus días estaban llenos de niebla. Vivía con depresión, a menudo incapaz de salir de su casa.

“Me cansé de ir a esos médicos y me cansé de hablar con ellos”, dijo Downie. “No me malinterpreten, no digo que los médicos sean malos. Solo digo que, en mi experiencia personal, lo que viví no fue positivo. Y llega un punto en el que tienes que probar algo nuevo, y es por eso que estoy aquí”.

También tuvo un trauma en su vida que nunca había enfrentado realmente. Cuando Downie tenía 8 años, su padre murió en un accidente automovilístico que lo llevó a practicar hockey. Lanzarse profundamente en el deporte fue su única forma de sobrellevar la muerte de su padre. Al igual que Cote, su compañero de equipo en los Flyers durante dos años, jugó de manera imprudente imprudente, lanzándose a colisiones violentas que lo dejaban a él y a sus oponentes ensangrentados.

Después de una carrera juvenil empañada por una controversia de novatos, Downie comenzó su primera temporada en la NHL, en 2007, con una suspensión de 20 juegos por un brutal control en las tablas en un competencia de pretemporada que envió a su oponente fuera del hielo en camilla.

Sigue siendo una de las suspensiones más largas jamás emitidas por la liga. En la prensa de hockey, fue etiquetado como un villano, un matón y un psicótico extremo. Las palabras le dolieron un poco, incluso cuando trató de reírse de ellas.

“No tengo dientes y soy pequeño, así que no pueden estar tan equivocados”, dijo Downie. “¿Bien? Al final del día, era un trabajo. Hice lo que me pidieron”.

Durante sus nueve temporadas jugando para cinco equipos de la NHL, sufrió más conmociones cerebrales de las que podía recordar. Sordo de un oído, al borde de las lágrimas todos los días y bastante seguro de que estaba bebiendo demasiado, Downie, que ahora tiene 36 años, se miraba en el espejo algunos días y se preguntaba si estaría muerto en seis meses.

No sabía nada sobre psicodélicos, solo que Cote le había dicho que lo ayudaría cuando Downie estuviera listo.

“Llamé a Riley y le dije: ‘Necesito algo, hombre’. Me cansé de ir a los médicos y hablar con ellos”, dijo Downie. “Muchas de las pastillas que te dan, te comen el cerebro. Realmente no te ayudan”.

Justin Renfrow, un jugador de línea de 33 años que jugó en la NFL y en Canadá, llegó en busca de claridad. Estaba considerando retirarse del fútbol profesional, algo que lo asustaba y lo emocionaba. Había estado jugando durante la mitad de su vida, y el juego era una gran parte de su identidad. Fue la última conexión que tuvo con su abuela, una de las personas más importantes de su vida. Ella fue la que iba a los viajes de reclutamiento con él. Después de su muerte en 2021, Renfrow sintió que una parte de ella todavía estaba con él mientras jugara.

Pero después de una década de jugar profesionalmente, el cuerpo de Renfrow estaba maltratado. Le dolía una de las rodillas. Había llegado a odiar las drogas farmacéuticas. Dijo que los médicos del equipo le habían recetado tantos medicamentos diferentes, incluidos los que cubren el estómago y los bloqueadores de los nervios para que pudiera tomar más analgésicos, que su cuerpo comenzó a experimentar terribles efectos secundarios.

Dijo que una vez tuvo una reacción tan mala a una combinación de analgésicos que le habían dado que necesitó atención médica después de sudar a través de su ropa y tener problemas para respirar.

“Es solo, ‘Necesitamos llegar a los playoffs, así que toma esto'”, dijo Renfrow. “Lanzó mi cuerpo en picada”.

Había usado hongos psicodélicos en numerosas ocasiones, principalmente como una forma de lidiar con el dolor provocado por el fútbol americano, pero nunca los había usado como parte de una ceremonia o para meditar. En este viaje, buscó claridad. ¿Era hora de alejarse del fútbol? Le apasionaba la cocina y estaba pensando en iniciar su propio programa en YouTube. Tal vez era hora de cambiar su enfoque y dejar que el fútbol se desvaneciera.

“Tengo muchas personas que dependen de mí todos los días”, dijo Renfrow.

Los atletas esperaban que la ceremonia los ayudara a obtener respuestas.

La investigación sobre psicodélicos es prometedora y emocionante, pero la efectividad de los hongos como tratamiento no está del todo establecida. Pero incluso si la psilocibina y otros psicodélicos resultan ser nada más que un placebo, lo que algunos investigadores dicen que es posible, muchos atletas juran que están encontrando un alivio real de la ansiedad, la depresión y otros traumas persistentes de sus días de juego.

Con un mercado global potencial multimillonario, también hay un gran incentivo financiero. Wake es solo una de un número creciente de nuevas empresas con fines de lucro respaldadas por dinero de inversión privada que buscan una parte del tratamiento psicodélico.

Eventualmente, ellos y otros esperan abrir centros de tratamiento o vender las drogas en los Estados Unidos y Canadá. En Canadá, la producción, venta o posesión de hongos psicodélicos son ilegales.

Durante el retiro de Jamaica, los líderes de Wake dieron una presentación a los participantes sobre cómo podrían invertir en la empresa.

Macleod dijo que se interesó en la terapia psicodélica no como una oportunidad comercial, sino después de que perdió a su hermana, Heather, hace seis años por suicidio.

Perderla lo llevó a buscar respuestas. Su hermana había sido esquiadora competitiva en Canadá, pero una serie de caídas le provocaron múltiples conmociones cerebrales y durante su vida adulta tuvo ansiedad y depresión. La medicina tradicional le falló repetidamente, dijo Macleod. Cada semana, se encuentra deseando haber sabido lo que sabe ahora y haberlo usado para intentar salvarla.

“No puedo decirte cuántas personas vienen a mí que están luchando como mi hermana”, dijo. “Dios, desearía que ella pudiera estar aquí. Sé que ella nos estaría animando. La veo a veces mirándonos desde arriba y diciendo: ‘Ayuda a otras personas que estaban atrapadas donde yo estaba'”.

Ansiosas por llevar los tratamientos psicodélicos a los consumidores, las empresas corporativas a menudo extrapolan los resultados de la investigación de ensayos clínicos estrictamente controlados con pacientes cuidadosamente seleccionados para promover un uso más amplio por parte de la población general en casi cualquier entorno.

“La presión por los psicodélicos generalmente está siendo impulsada por personas que quieren ganar dinero, mucho más que por científicos”, dijo Kevin Sabet, ex asesor principal de la Oficina de Política Nacional de Control de Drogas de la Casa Blanca, y ahora presidente y director ejecutivo de Smart Approaches to Marijuana, un grupo político que se opone a la legalización de la marihuana.

“¿Por qué dejaríamos que los inversionistas de Wall Street, que son realmente los que están aquí tratando de ganar dinero, lideren la conversación?”, agregó.

La comercialización podría ser tanto buena como mala para los psicodélicos. Por un lado, podría proporcionar financiación para la investigación; por otro, el deseo de rentabilizar esa inversión podría influir indebidamente en los resultados y poner en riesgo a los pacientes.

“Tu modelo de negocio no va a funcionar bien cuando alguien salta por la ventana y aparece en la portada de The New York Times”, dijo Johnson, el investigador de Johns Hopkins.

La investigación clínica también debe superar la imagen del hongo como una droga de fiesta, algo que los hippies comparten en bolsas de plástico en las últimas filas de los conciertos.

Para cambiar esa narrativa, dicen Wake y otras compañías, se están inclinando mucho hacia la ciencia. Esto no es una búsqueda de emociones, dicen, sino una medicina legítima que trata condiciones psiquiátricas reales.

Es el mismo argumento que hicieron los defensores de la legalización de la marihuana, ya sea que lo creyeran o lo estuvieran usando como un medio para un fin: presionar para legalizar el cannabis como medicina antes de abrir las puertas al uso recreativo sin restricciones.

Los líderes de Wake, como la mayoría de los ejecutivos en el universo psicodélico, han dicho que están comprometidos a ayudar en la investigación para demostrar a los reguladores federales que la psilocibina es segura y efectiva. Las muestras de sangre y saliva que recolectó un médico en el retiro de Wake, dijeron, se usarían para identificar marcadores genéticos que podrían predecir quién responderá al tratamiento con psilocibina.

El equipo de Wake hizo que los participantes usaran un casco que contenía tecnología de imágenes experimentales que se había utilizado en ensayos clínicos para rastrear la actividad cerebral antes, durante y después de las experiencias psicodélicas. Como parte de la investigación, los participantes usaron el casco mientras jugaban juegos de palabras.

Muchos investigadores académicos se preguntan si algunas empresas simplemente están aplicando un barniz de ciencia a un esfuerzo por hacer dinero, lo que muchos escépticos denominan “teatro placebo”.

De hecho, Aaronson teme que el campo pronto pueda estar “lleno de vendedores ambulantes”.

“El problema que tienes es que, como era de esperar, las redes sociales y las comunicaciones funcionan mucho más rápido que la ciencia”, dijo. “Entonces, todos están tratando de tener en sus manos estas cosas porque creen que será increíble”.

Aaronson ha diseñado protocolos de ensayos clínicos para Compass Pathways, una empresa competidora con fines de lucro que busca comercializar tratamientos con psilocibina, y ha rechazado a otras empresas que buscan crear una huella en el espacio psicodélico. (Aaronson recibe fondos de Compass para respaldar su investigación, pero dijo que no tiene ningún interés financiero directo en la empresa).

“Me preocupa quién respalda el juego de algunas de estas compañías y trato de averiguar qué es lo que realmente busca alguien”, dijo. “Hablas con la gente y ves si hay un plan real para investigar o si hay un plan real para vender algo”.

***

Un murmullo de tensión nerviosa perduraba en el aire mientras los atletas se preparaban para la ceremonia. En el desayuno, no hubo muchas conversaciones triviales. Los asistentes se arremolinaron y se registraron con el personal médico de Wake para ofrecer sus muestras de sangre y saliva. Algunos participaron en una clase de yoga en un estudio al aire libre con vista a la jungla.

Wake había contratado a una chamán jamaicana, una mujer llamada Sherece Cowan, una empresaria de comida vegana que fue finalista de Miss Universe Jamaica 2012, para dirigir a los atletas en la ceremonia. Pidió que la llamaran Sita y se refirió a sí misma como facilitadora de medicina natural.

Habló lenta y deliberadamente, agitando el humo de una urna mientras instaba a los participantes a reunirse en círculo en el césped de la finca. Después de beber una dosis de 3 a 5 gramos de psilocibina, que había sido molida en polvo y mezclada con jugo de naranja, los atletas cayeron en un estado de sueño durante las próximas cuatro a seis horas.

“Espero que obtengas todo lo que necesitas. Puede que no sea todo lo que estás pidiendo, pero espero que recibas todo lo que necesitas”, dijo Cowan. “Bendiciones en tu viaje”.

Un músico local comenzó a tocar, sus tambores y campanas pretendían realzar el viaje. La mayoría de los atletas yacían sobre colchonetas, como si durmieran. Cote se sentó en una pose de yoga. Nick Murray, director ejecutivo de Wake, le había pedido a Cote que usara un casco especial, un dispositivo de electroencefalografía más pequeño que el otro casco, para medir su actividad cerebral.

Excepto por los tambores y las campanas del músico, todo estaba en silencio. De vez en cuando, el viento agitaba las hojas de los árboles en el límite de la propiedad, pero durante las siguientes seis horas, dentro del círculo, el tiempo casi se detuvo.

Dos horas después de la ceremonia, después de que el psicodélico había hecho efecto, lo que estaba ocurriendo pasaba dentro de las cabezas de los atletas. Cote, sorprendentemente, seguía manteniendo su postura de yoga.

El silencio se rompió cuando Renfrow se levantó de su estera después de tres horas. Llevaba una sudadera en la ceremonia con sus iniciales, JR, estampadas en el pecho. Se quitó la camisa de su cuerpo con frustración y la arrojó a un lado.

Las lágrimas se derramaron por su rostro.

Cuando la ceremonia terminó, los atletas comenzaron a sentarse y algunos charlaron en voz baja.

La mayoría no estaba seguro de cómo describir la experiencia. Para algunos, se sintió como un descenso a los rincones de la mente, con colores y emociones mezclándose. Otros dijeron que enfrentaron traumas que pensaron que habían enterrado o emociones que querían reprimir. Dijeron sentir una conexión con las otras personas en el círculo.

“Es el último asesino del ego porque, al menos para mí, te da una empatía increíble que nunca antes habías sentido”, dijo Lee. “Cuando estás haciendo un viaje con otras personas, te ves a tí mismo en ellos. Es casi como si estuvieras caminando frente a un espejo, diferentes espejos. Ves partes de tí mismo en todos y te das cuenta de que todos estamos conectados y todos estamos pasando por algo, todos tenemos algún tipo de dolor, y eso te vuelve humilde”.

La mayoría de los atletas se quedaron solos para poder anotar sus pensamientos en un diario, siguiendo las instrucciones del personal de Wake. Habría una sesión de terapia comunitaria a la mañana siguiente.

A cada uno se le pediría que compartiera algo de su viaje.

***

Al final, la mayoría de los curiosos sobre la psilocibina simplemente quieren saber: ¿Funciona? Y, ¿cómo funciona? Los científicos dicen que esas son preguntas difíciles de responder en este momento.

Investigadores han descubierto que los psicodélicos clásicos, como la psilocibina y el LSD, actúan sobre el receptor de serotonina 2A, el mismo receptor al que se apuntan los antidepresivos más comunes del mercado. Pero más allá de eso, la comprensión de cómo funcionan para ayudar a las personas es, en este punto, más teoría o conjetura que hecho científico.

Johnson, el investigador de Johns Hopkins, dijo que la psilocibina ayuda a aumentar la apertura en las personas, permitiéndoles salir de su visión de quiénes son. Alguien que se resigna a ser un fumador que no puede dejar de fumar o una persona con depresión que no puede encontrar la felicidad puede, bajo la influencia de los psicodélicos, verse a sí mismo de una manera diferente, explicó.

“Una vez que están fuera de la trampa mental, se vuelve tan obvio para las personas con estos diferentes trastornos que, ‘¿Sabes qué? Puedo simplemente decidir dejar de fumar. Puedo dejar de lado mi tristeza’”, dijo Johnson.

Estudios con ratas muestran que los psicodélicos también parecen aumentar la conectividad neuronal en el cerebro, incluso después de una sola dosis. Eso podría ayudar al cerebro a recuperarse de lesiones traumáticas o conmociones cerebrales, encontrando nuevos caminos alrededor de las áreas dañadas.

La teoría predominante de cómo la psilocibina y otros psicodélicos podrían ayudar a tratar la salud mental es que reprimen la actividad en la red de modo predeterminado del cerebro. Es un conjunto de regiones del cerebro que se activan cuando las personas reflexionan sobre algo, y una de las pocas partes que está hiperactiva en las personas con depresión.

A menudo revisan los errores que cometieron una y otra vez o se castigan continuamente por ellos, dijo LaPratt, el investigador de Sheppard Pratt. Esa hiperactividad en la red de modo predeterminado conduce a patrones repetitivos de pensamientos negativos. ¿Qué me pasa? ¿Por qué soy tan infeliz? De los cuales la persona no puede escapar.

Las personas con depresión suelen reflexionar sobre el pasado; personas con ansiedad, sobre el futuro.

“Es posible que surja algo y luego el cerebro comience a pensar, y nuevamente, como ese disco rayado”, dijo LaPratt. “Puede ser muy fácil comenzar a pensar en cómo todo podría salir mal y comenzar a dramatizar”.

Ese pensamiento repetitivo también prevalece en personas con otras afecciones, incluido el trastorno obsesivo compulsivo y el trastorno por estrés postraumático. Comienza a afectar el sentido de quiénes son; se definen a sí mismos por su condición.

Pero los psicodélicos parecen ayudar a las personas a examinar viejos traumas sin volver a caer en el mismo ciclo destructivo. Pueden ayudar a las personas a sentirse más conectadas con los demás. La depresión y la ansiedad no se borran simplemente, dijo LaPratt, sino que las personas pueden obtener una nueva perspectiva de sus problemas y comenzar a sentir, tal vez por primera vez, que pueden deshacerse de ellos.

“Vemos una mayor apertura y cierta motivación para cambiar los comportamientos”, dijo.

La mayoría de los psicodélicos están fuera del sistema de una persona a la mañana siguiente, pero, según los investigadores, esa mayor apertura puede durar semanas o meses sin dosis adicionales, lo que brinda una ventana durante la cual pueden comenzar a abordar sus problemas.

“Quizás estemos ayudando a las personas a llegar al punto de poder aceptar las cosas que no pueden cambiar y cambiar las cosas que sí pueden”, dijo Aaronson, haciéndose eco de la Oración de la serenidad, que a menudo se usa en los ejercicios de 12 pasos de los programas de recuperación. “Se les quita autonomía personal a las personas con depresión. No sienten que puedan operar en su mejor interés. Se ven atrapados en un conflicto interno. Y creo que esto les ayuda a ir más allá de eso”.

Por la mañana, los atletas se reunieron en un patio para una forma de terapia de grupo llamada integración. Estaba previsto que durara al menos dos horas. Macleod explicó que era una parte esencial para comprender el viaje de la psilocibina. Todos los asistentes tuvieron la oportunidad de compartir algo de su experiencia, ya fuera esclarecedor, confuso, edificante o una mezcla de muchas emociones.

Lee habló sobre su ansiedad, sobre tratar de entender cuál sería su identidad ahora que no era boxeador. Al alejarse del ring, temía estar decepcionando a todas las personas que lo apoyaron cuando eligió una carrera de boxeo en lugar de un trabajo en finanzas después de graduarse de Notre Dame.

Pero ahora había llegado a comprender que esas eran sus propias inseguridades. Podía seguir su propio camino. Podría ayudar a las personas que experimentan un dolor físico y emocional similar.

Renfrow respiró hondo varias veces mientras buscaba las palabras. Durante la mayor parte de su vida, se había visto a sí mismo como un jugador de fútbol americano. Pero en su viaje de psilocibina, sintió como si los miembros de su familia le dijeran que estaba bien dejarlo ir. Cuando se puso de pie durante la ceremonia y se quitó la camisa con sus iniciales, dijo que, simbólicamente, estaba soltando algo.

“Está bien dejar de perseguir el viaje del fútbol”, dijo Renfrow. “No voy a vestirme bien este año y eso está bien para mí. Seré capaz de resolverlo.

Al decir adiós al fútbol, dijo, se estaba despidiendo de su abuela.

“El fútbol era ella”, dijo Renfrow, y comenzó a llorar. “Fuimos a todos mis viajes de reclutamiento. Así que tuve que dejarla ir dejando ir al fútbol. Y ese fue un gran momento cuando me puse de pie. Tuve que dejarla ir. Así que fue difícil, pero tenía que hacerlo”.

Cuando fue el turno de Downie, trató de calmar la tensión bromeando, diciendo que era hora de ir a comer. No quería abrirse al grupo, dijo. Había escrito algunas notas en una hoja de papel. Sus manos temblaban mientras trataba de leerlas.

“No estaba bebiendo y no estaba consumiendo drogas por diversión”, dijo Downie con voz temblorosa. “Estaba adormeciendo mi cerebro porque estaba jodido. No pude salir de mi camino de entrada durante un año. Me senté en cuartos oscuros y recurrí a las drogas y el alcohol”.

Pero dijo que en el viaje psicodélico pudo conectarse con su pasado. “Estoy sentado allí y estoy repasando mi cerebro, estoy hablando con mi papá, estoy hablando con los miembros de mi familia. He pedido perdón a todos los que podría pedir perdón”, dijo. “Me hizo llorar. Me hizo sentir bien”.

Se dio cuenta, a través del viaje, que quería ser un mejor hombre. Su voz temblaba mientras trataba de pronunciar las palabras.

“Al final de todo esto, creo que lo que he aprendido es cómo controlar lo que sucede. yo tengo el control. Puedo controlar esto”, dijo. “Me iré a casa y me identificaré y ejecutaré y seré un mejor padre y me quedaré para mis hijos, lidiaré con mis conmociones cerebrales lo mejor que pueda”.

Se giró para mirar directamente a Cote, las lágrimas corrían por sus mejillas detrás de sus gafas de sol.

“Quiero decir esto, hermano, cuando digo que me salvaste la vida”.

Cuando las palabras de Downie dieron paso al silencio, Lee se levantó de su silla. Cruzó el círculo, se acercó a Downie y abrió los brazos. Los dos luchadores, que llegaron a Jamaica tristes y destrozados, se abrazaron.

***

Si bien los estudios han encontrado que la psilocibina junto con la terapia es más efectiva que la terapia sola, no está claro si la psilocibina sola, sin el trabajo preparatorio o la integración posterior, tiene algún efecto.

“Hay una razón por la cual las personas que van a raves y toman psilocibina no se curan”, dijo Aaronson. “La psilocibina no es un antidepresivo”.

Incluso dentro de los estrictos protocolos de ensayos clínicos, la pregunta sigue siendo si la terapia asistida por psilocibina funciona. Los estudios preliminares han sido prometedores, pero el número de sujetos de prueba ha sido pequeño. Se necesitan estudios mucho más amplios para determinar tanto la seguridad como la eficacia.

Aún así, eso no ha impedido que los defensores de la psilocibina promocionen la investigación hasta la fecha, lo que implica que es más definitiva de lo que es. Además, muchos evangelistas de los hongos atribuyen los efectos positivos de los ensayos clínicos al consumo de psilocibina en general, descartando los protocolos utilizados en los estudios.

En el retiro de Wake en Jamaica, por ejemplo, los atletas tomaron psilocibina en ceremonias grupales guiadas por Cowan, la chamán local, mientras que las sesiones de integración grupal fueron dirigidas por un médico osteópata. Ninguno de los dos era un psicoterapeuta autorizado, dijo Murray. No está claro si los beneficios de la terapia con psilocibina sugeridos por la investigación clínica se aplicarían a un entorno grupal, para la dosificación o la integración.

Murray, director ejecutivo de Wake, dijo que si bien la investigación clínica se esfuerza por eliminar cualquier variable, como las interacciones entre los participantes, los líderes de Wake sienten que el entorno grupal ofrece beneficios a sus clientes.

“Es ese grupo que siente que, ‘Estamos juntos en esto. Mi divorcio es como tu divorcio. Perdí a un hermano’”, dijo. “Eso es difícil de poner en un ensayo clínico”.

Wake se había registrado para realizar un ensayo clínico en Jamaica, pero Murray dijo que la compañía finalmente decidió no continuar, centrándose, en cambio, en ofrecer tratamiento.

Aún así, Murray dijo que Wake está contribuyendo a la investigación científica: recolectaron muestras de sangre y saliva, y se les pidió a los participantes que completaran cuestionarios antes y después del retiro para ayudar a evaluar si el tratamiento había funcionado.

Murray dijo que Wake usa los mismos cuestionarios validados clínicamente que se usan en el consultorio de un psiquiatra.

“Entonces, no es teatro. Estas son las herramientas reales que se utilizan”, dijo. Sin embargo, sería difícil con el enfoque de Wake analizar si los hongos y la integración ayudaron a los participantes u otras influencias, como estar de vacaciones en Jamaica, estar entre un grupo de compañeros de apoyo o la marihuana que muchos de ellos fumaban regularmente durante el retiro.

“Al menos tienes que escuchar y tomarlo en serio. Hay anécdotas de personas que dicen que se habrían suicidado”, dijo Johnson. “A veces ves solo la experiencia de ‘full monty’, donde esta persona está allí en una trayectoria oscura, oscura y toda su vida cambia. Sospecho que esto es real. Algo está pasando con estos atletas que hacen estos informes”.

Las anécdotas brillantes, particularmente cuando provienen de atletas o celebridades de alto perfil, tienen peso entre el público y ayudan a impulsar medidas como las de Oregon y Colorado que están estableciendo vías para el tratamiento con psilocibina, independientemente de lo que piensen los investigadores o los reguladores.

“Cuando las personas están molestas y no satisfacemos sus necesidades, van a probar cosas”, dijo Atheir Abbas, profesor asistente de neurociencia del comportamiento en la Oregon Health & Science University. “Con suerte, los científicos pueden ponerse al día para comprender por qué las personas piensan que esto es realmente útil. Y tal vez sea útil, pero tratemos de averiguar si lo es y cómo”.

Pero existe el peligro de tomar estas historias, sin importar cuán convincentes sean, y extrapolar su seguridad o eficacia.

“La parte difícil es que el plural de anécdota no son datos”, dijo Sabet, el CEO de Smart Approaches to Marijuana. “Y los datos aún no están allí”.

***

Un año después del retiro, Downie, Renfrow y Lee dijeron que creían que su viaje con la psilocibina los había ayudado. No solucionó mágicamente todos sus problemas, pero cada uno lo consideró una experiencia positiva.

Downie ya no siente que está atrapado en un lugar oscuro. Dijo que cuando regresó a Ontario, su familia notó una diferencia de inmediato.

“Ese viaje me dio mucha claridad”, dijo Downie. “Te da direcciones. Te da respuestas internamente. Es algo único que experimenté. Mi año fue definitivamente mejor que el año anterior, eso es seguro… ¿Creo que podría ayudar a otras personas? Yo diría que sí. ¿Me ayudó? Absolutamente”.

Sin sentirse más como un prisionero en su casa, Downie comenzó un campamento de motos de nieve que lleva a los adultos en aventuras guiadas por Moosonee, cerca de James Bay. Es algo que solía hacer con su familia antes de que despegara su carrera en el hockey.

“No es mucho de lo que presumir, pero es lo más al norte al que puedes ir en una moto de nieve en Ontario”, dijo Downie. “Vienen muchos adultos de todas partes. Es una experiencia genial. Siempre ha sido una de mis pasiones”.

Todavía tiene problemas persistentes por sus conmociones cerebrales y sospecha que siempre los tendrá.

“Es lo que es”, dijo. “¿Diría que está mejorando? Es un proceso”.

El resultado más positivo ha sido la alegría que ha encontrado en ser padre.

“Mi pequeño está empezando a enamorarse del hockey, que es algo que he estado esperando”, dijo Downie.

Aunque Downie no ha realizado otro viaje con psilocibina, dijo que estaría abierto a hacerlo.

Renfrow salió de la ceremonia con la intención de retirarse del fútbol profesional, pero tres meses después volvió a firmar con Edmonton Elks de la Canadian Football League. Este año, se unió a los Jacksonville Sharks de la National Arena League, en parte para estar más cerca de su hijo.

“En ese momento, pensé que iba a dejar el fútbol”, dijo.

Pero se siente cómodo donde está y dice que está cumpliendo sus objetivos, incluido presentar ese programa de cocina en YouTube que esperaba hacer. Y dijo que se está divirtiendo de nuevo. Ahora recurre a los hongos cada vez que tiene que tomar una gran decisión.

“Creo de todo corazón en eso y en todo el tipo de orientación que me ha dado”, dijo. “No podrías pedir algo mejor, haber seguido la guía de un viaje con hongos”.

Lee se mudó de California a Austin, Texas, y ahora dirige un negocio de CBD con su hermana. Encontrar su identidad posterior al boxeo sigue siendo un proceso. En sus viajes psicodélicos en el retiro de Wake, dijo Lee, nunca pensó en deportes o boxeo. Sus visiones eran todas sobre la familia, Dios, el universo.

“Simplemente me hace darme cuenta de la importancia que le estoy dando a algo que a mi subconsciente ni siquiera le importa”, dijo. “A mi subconsciente no le importa que sea boxeador, que fui luchador e hice esto y aquello. Es todo tipo de ego”.

La experiencia, dijo, lo ayudó a comprender cuán poderosa puede ser la mente, que puede ser un amigo o un enemigo.

“Salí de eso dándome cuenta de que tengo todas las herramientas para curarme a mí mismo”, dijo. “Eso es enorme. Porque, especialmente para los muchachos que han tenido conmociones cerebrales o atletas o lo que sea, te sientes un poco aislado, te sientes solo, te sientes sin esperanza. Así que te da un sentido de esperanza”.

Le permitió ir más allá de la necesidad de probarse a sí mismo, en el ring o fuera de él, para dejar de medir su valor por sus logros. Se ha obsesionado con actividades mucho más tranquilas y no violentas: el surf y el pickleball.

“Puedo apagar mi cerebro como en el boxeo”, dijo. “Pero al mismo tiempo, es más fácil para mi cuerpo y simplemente, no sé, más satisfactorio. No tengo que probar nada”.

El viaje a Jamaica le está permitiendo salir adelante, hacer el trabajo necesario para sanar.

“Una parte de mí entró con la esperanza de que todos mis problemas se resolvieran, pero poner esas expectativas puede ser difícil”, dijo. “¿Estoy curado? No. ¿Pero realmente ayudó? ¿Y fue como una de las experiencias más profundas de mi vida?

“Yo diría que sí”.

Este artículo fue producido y escrito por Markian Hawryluk de KFF Health News y Kevin Van Valkenburg de ESPN. El investigador John Mastroberardino colaboró con la historia.

Si tu mismo o alguien que conoces puede estar experimentando una crisis de salud mental, llama o envía un mensaje de texto a la Línea de vida de crisis y suicidio al 988 o a la Línea de texto de crisis enviando un mensaje de texto con “HOME” al 741741. En Canadá, llama a Talk Suicide Canada al 1-833- 456-4566 o envía un mensaje de texto al 45645 de 4 pm a medianoche ET.

[Nota del editor: como parte del reportaje de este artículo, algunos miembros del equipo de reporteros de ESPN, bajo la guía del personal de Wake Network, usaron psilocibina. Wake Network fue compensado, pero no por ESPN.]

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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WAKEFIELD, Jamaica — The boxer felt broken. Every day, he was waking up in pain. Some days, it was debilitating headaches. Other times, it was his back. Or his fists. His ribs. His nose. On top of that, he had mood swings. Depression. Anxiety.

Mike Lee didn’t regret his career. He had been one of the best professional fighters in the world in his weight class. He’d gone 21-1 professionally and fought in Madison Square Garden and in front of millions on TV.

But it had been more than two years since he’d been inside a ring, and every day was a reminder of the cost. At one point, Lee was taking eight prescription medications, all of them trying to help him cope. In his lowest moment, on a night when he was in the depths of an addiction to painkillers, he said, he contemplated driving his car into the median of a Chicago freeway at 140 mph. He was willing to do anything to escape the hell he felt trapped in.

The impulse faded, but the pain remained.

He was lost.

“When you’re in pain and you’re stuck in a corner, you’ll do anything to get out of it,” Lee said.

Now, he had come to a verdant jungle at the end of a dirt road halfway up a mountain.

Psychedelic mushrooms, he hoped, could change his life.

Lee was part of a small group — many of them retired athletes — who’d traveled to Jamaica in March 2022 for a retreat costing as much as $5,500. They each had come to the Good Hope Estate, a sugar plantation turned exclusive resort, hoping to rid themselves of depression, anxiety, and chronic pain they had experienced for years.

Two psychedelic mushroom ceremonies and two therapy sessions awaited them at the retreat run by a Canadian company called Wake Network. The participants were nervous, but also hopeful.

Along with Lee, there was a professional football player considering retirement and a former hockey star who had multiple concussions. They’d come from all over North America, from different backgrounds and different sports, but they had a few things in common: They were vulnerable, and they felt that prescription medications had failed them. They didn’t know what to expect, whether the treatment would work, whether they’d return home with a solution or just more disappointment.

Lee had learned about the retreat from a childhood friend who works as a doctor for Wake. Others had been recruited by Riley Cote, a former enforcer with the Philadelphia Flyers and now a psychedelics evangelist who is an adviser to Wake with an equity stake.

Cote was once just like Lee. He used to love punching people in the face. He loved the way his hand landed with a thud when his knuckles connected with flesh and bone at a violent speed. Snapping someone’s head back made Cote feel alive.

“I fought everyone and their brother in my career,” Cote said. “I would pick out the biggest guy I could find and challenge him. It was how I survived, how I made a name for myself. I was inflicting all this pain and inflammation on myself, always getting punched in the face, and I had to keep up with this macho type of personality, like, ‘Oh, you can’t hurt me. You can’t hurt me.’”

He was no longer that person. It made him cringe to think about the man he once was, someone who drank excessively and used painkillers to numb his brain. There was a time when he, like Lee, was in a dark place, but over the course of several years, psychedelic mushrooms, Cote believes, helped bring him back into the light.

“The world is in a crisis, a mental health crisis, a spiritual crisis,” Cote said. “And I think these are spiritual medicines, and I just feel like it’s the right path for me. I don’t think of it as anything more than my duty, my purpose on this planet is to be sharing the truth around natural medicine.”

For years, whispers have circulated about an underground network of athletes — primarily ex-athletes — using psilocybin, the compound in magic mushrooms, to treat traumatic brain injuries, anxiety, and depression. Many of them, like Cote, view psychedelics as a miracle cure, the one thing they’d been able to find that could help break a cycle of pharmaceutical painkillers and substance abuse. They gathered in small groups to ingest mushrooms in private or traveled to countries such as Jamaica where psychedelic mushrooms aren’t prohibited.

Now the use of psychedelic mushrooms is gaining traction in the United States. A number of cities have decriminalized possession of psilocybin, and Oregon and Colorado voters passed ballot measures to legalize magic mushrooms under supervised use. Many researchers predict FDA approval of a psychedelic treatment will come within the next five years.

But many of those same researchers warn the hype over psychedelics is outpacing the science — and that the treatment comes with significant risks for some patients. They fear that, unless research is conducted methodically and ethically, widespread use of psilocybin could result in a public backlash, as it did in the 1960s, relegating a promising treatment to the dustheap of banned substances.

They are urging corporate entities like Wake, which are already positioning themselves to take advantage of the potential legalization of psychedelics, to go slowly, ensure the research is done the right way, and allow the science to catch up.

“If you don’t do this safely, people are going to get hurt,” said Matthew Johnson, a psychiatry professor and psychedelics researcher at Johns Hopkins University.

But many — including former pro athletes with battered bodies and brains — don’t want to wait for the slow grind of clinical research. They need help now. The painkillers, the antidepressants, the countless different pills they were prescribed over the years haven’t helped. In their minds, the stories told by fellow athletes who say they have benefited from psychedelics outweigh any scientific uncertainty.

“When you think of magic mushrooms, you think of hippies at Woodstock dancing around to music,” Lee said. “To think about you’ve got some of the best athletes in the world here that are dealing with some stuff and they’re taking it, it makes you feel more comfortable. It makes me feel like, ‘OK, maybe I’m doing the right thing.’ It’s a healing medicine; it’s not just a party drug.”

***

Cote, now 41, was a decent hockey skater growing up in Winnipeg, Manitoba, tenacious as hell from end to end and a tireless worker, but fairly average at handling the puck. He didn’t score enough goals to rise through junior hockey the way some prospects did. Yet as he got older, coaches didn’t mind as much. He had broad shoulders and a long reach. In an era of hockey where violence was still currency, he had found his golden ticket to the NHL: Cote would beat on people and get beat on in return. As a member of the Flyers, he saw it as his duty to uphold the traditions of the Broad Street Bullies, a group of players from the 1970s who were celebrated by the press for playing — and partying — hard.

He fought his way through the NHL for portions of four seasons, accumulating more than 400 career penalty minutes while scoring just one goal. Most of his fights were brutal, barbaric affairs. His highlight reel shows a hulking giant, his eyes filled with violence, the kind of goon who could break your jaw and laugh maniacally in the aftermath, blood dripping from his face down onto the ice.

“It was something I enjoyed doing, and I think it was just an element of competition for me,” Cote said. “And it was also probably something I was doing out of fear — fear of not living my childhood dream or letting my parents down or people down.”

He said he medicated his pain nearly every day with booze. Beers were an appetizer on the way to doing shots at the bar. Shots often led to harder drugs. He and his teammates would stay out until 3 a.m., sometimes later, then try to sweat out the poison the next day during practice.

After a few years, his brain started to fog. He got bigger and stronger through weightlifting, and he looked like a monster on the ice, but every hockey skill except his fighting deteriorated. As his career wound down, he said, it felt as if darkness was creeping in. He grew depressed. He was afraid of what he’d become.

Today, Cote bears little resemblance to that enforcer in the videos. Thinner and calmer, he teaches yoga classes in a Delaware studio three times a week. With shoulder-length hair, tattoos on his arms and chest, he speaks with a soft baritone voice. He seems more monk than monster.

“I look back and it just shows maybe how confused I was and what reality I was seeking, which was supposedly happiness and fulfillment within chasing my childhood dream,” Cote said. “But it’s hard for me to wrap my head around me doing that now, just knowing who I am now, and realizing it takes a lot of darkness to do what I did.”

Cote said he took mushrooms recreationally throughout his 20s, but never in a therapeutic setting or with the understanding they might help him process both his physical and emotional trauma. “It was just part of the scene or part of the party,” he said.

But when he retired in 2010, he felt like he was facing an identity crisis. He had been a fighter for so long, he thought that’s all he was. How could a washed-up enforcer raise two daughters?

He started reading. What he learned shocked him.

Researchers had quietly revived the study of psychedelics as a medical treatment in 2000, and early findings suggested psilocybin often had noticeable benefits for people diagnosed with anxiety and depression. It helped some patients shed their addictions to drugs or alcohol. Other research suggested that psilocybin may actually be capable of reshaping the anatomy of the brain, restoring neuropathways, and helping heal traumatic brain injuries.

For Cote, who was diagnosed with at least three concussions in his hockey career and probably incurred many more, it was transformative.

Cote now recruits clients for Wake, which hosts immersive psilocybin retreats outside the U.S.

“Some people come to these events and they’re borderline suicidal,” said Tyler Macleod, a Wake co-founder and its chief experience officer. “They’re not fixed after one ceremony, but they’re not stuck in the dark anymore. They wake up and they’re like, ‘Oh, I can navigate a relationship with my kids again.’”

The ex-athletes who attend these retreats are all struggling with something, Cote said. They need help. In many cases, they feel as if they have tried everything else. He asks why they need to wait when so many studies and anecdotes indicate positive results?

“It’s like with cannabis: How many stories did we have to be told before we had a medical program?” Cote said. “It’s just been roadblocked for so long.”

***

In 1970, President Richard Nixon signed into law the Controlled Substances Act, legislation that divided drugs into five levels, ranking them based largely on their potential for abuse. Magic mushrooms were categorized as Schedule 1 substances, alongside heroin and marijuana, meaning the government believed they had no medical benefit as well as high potential for abuse. (Cocaine, oxycodone, and methamphetamine were all classified as Schedule 2 drugs.)

Those decisions — which Nixon adviser John Ehrlichman later said were politically motivated — continue to have a ripple effect today. Research into psychedelic treatments was put on hold for 30 years.

While the recent studies have been small in scope, they have shown remarkable effects. Prescription drugs approved for conditions such as anxiety or depression help at best 40% to 60% of patients. In early trials, psychedelics have reached efficacy rates of more than 70%.

And unlike most prescribed medications, which stop working soon after patients quit taking them, one or two treatments of psilocybin can have lasting effects of six months, a year, or even longer, according to one Johns Hopkins study. With minimal risk of addiction or overdose and centuries of use by Indigenous cultures, psilocybin is seen by many researchers as a potential breakthrough treatment with great benefits and few risks.

Scott Aaronson, director of clinical research programs at Sheppard Pratt, a nonprofit psychiatric hospital outside Baltimore, has been studying difficult-to-treat mood disorders for 40 years, starting with some of the early studies on Prozac.

“I’m a cynical, skeptical, sarcastic human being,” Aaronson said. “And I will tell you, I have never seen anything like it in all my years.”

But psilocybin is not without risks. It can exacerbate heart problems and trigger schizophrenia in those with a genetic predisposition, and the combination of psilocybin and lithium may cause seizures. Clinical trials have generally screened out patients at risk for such complications. Still, a significant portion of those who consume psilocybin, even without any of those concerns, have a negative experience.

“At a high dose, about a third of people in our studies, even under these ideal conditions, can have what would be called a bad trip, some degree of substantial anxiety or fear,” said Johnson, the Johns Hopkins researcher. “A person can be very psychologically vulnerable. It can feel like they’re dying.”

Sometimes, though, even those “bad trips” can lead to help with depression or other issues, researchers have found, especially with follow-up help from a therapist to process the experience.

The psychedelic effects of psilocybin can also disconnect a person from reality, which can lead people to do dangerous things, like running out into traffic or jumping out a window.

“The very conception of reality and themselves in reality, like who they are — these things can be profoundly changed and it’s not a good recipe for interacting in public,” Johnson said.

Researchers also describe cases where psilocybin puts people with unresolved psychological issues into long-term distress.

That’s why researchers are adamant that psilocybin should be administered in a clinical setting with trained therapists who can guide people through the experience, deal with negative outcomes when they emerge, and help people process and integrate their experiences.

Clinical trials of psilocybin have relied on strict protocols, involving one or more sessions before the treatment to help the test subjects understand what to expect. The ingestion of the mushrooms is often done in a single day, with one or two therapists on hand. In the following days, the person returns for what’s known as integration, typically a one-on-one therapy session to help process the experience and to begin the journey toward healing. Some trials add an extra day of therapy in between two treatments.

Unlike with a typical medication, patients aren’t sent home with a bottle of pills.The entire protocol is more like a medical procedure.

But it’s a misconception that it’s the psychedelic medicine doing all the work, not the therapy that comes afterward, said Jeffrey LaPratt, a psychologist and psilocybin researcher with Sheppard Pratt. “It’s really hard work and it takes vulnerability. It takes courage. It can be really painful.”

***

Former NHL player Steve Downie felt as if something in him was broken when he was invited to the Wake retreat in Jamaica. His days were filled with fog. He was living with depression, often unable to leave his home.

“I got tired of going to those doctors and tired of talking to them,” Downie said. “Don’t get me wrong — I’m not saying doctors are bad. I’m just saying, in my personal experience, what I went through, it wasn’t positive. And it just comes to a point where you got to try something new, and that’s why I’m here.”

He also had trauma in his life he’d never truly confronted. When Downie was 8 years old, his father died in a car crash driving him to hockey practice. Throwing himself deep into the sport was his only way of coping with his father’s death. Like Cote, his teammate on the Flyers for two years, he played the game with reckless abandon, launching himself into violent collisions that left both him and his opponents bloodied.

After a junior career marred by a hazing controversy, Downie started his first NHL season, in 2007, with a 20-game suspension for a brutal check into the boards in a preseason contest that sent his opponent off the ice on a stretcher. It remains one of the longest suspensions ever issued by the league. In the hockey press, he was labeled a villain, a thug, a goon, and borderline psychotic. The words stung a little, even when he tried to laugh them off.

“I got no teeth, and I am small, so they can’t be all that wrong,” Downie said. “Right? End of the day, it was a job. I did what I was asked.”

Over his nine seasons playing for five NHL teams, he endured more concussions than he could remember. Deaf in one ear, on the verge of tears every day, and fairly certain he was drinking too much, Downie, now 36, would look in the mirror some days and wonder if he would be dead in six months. He didn’t know anything about psychedelics, just that Cote had told him he would help when Downie was ready.

“I called Riley and I said, ‘I need something, man.’ I got tired of going to doctors and talking to them,” Downie said. “A lot of the pills they give you, they eat at your brain. They don’t really help you.”

Justin Renfrow, a 33-year-old lineman who played in the NFL and in Canada, came seeking clarity. He was considering retiring from professional football, something that both scared and excited him. He’d been playing for half his life, and the game was a huge part of his identity. It was the last connection he had to his grandmother, one of the most important people in his life. She was the one who went on recruiting trips with him. After she died in 2021, Renfrow felt that a part of her was still with him as long as he played the game.

But after a decade of playing professionally, Renfrow’s body was battered. One of his knees was aching. He had come to loathe pharmaceutical drugs. He said he’d been prescribed so many different drugs by team doctors — including stomach coaters and nerve blockers so he could take more painkillers — that his body started to experience terrible side effects. Once, he said, he had such a bad reaction to a combination of painkillers he’d been given, he needed medical attention after he sweated through his clothes and began to have trouble breathing.

“It’s just, ‘We need to make the playoffs, so take this,’” Renfrow said. “It threw my body into a tailspin.”

He’d used psychedelic mushrooms numerous times, mainly as a way to cope with the pain brought on by football, but he’d never used them as part of a ceremony or to be meditative. On this trip, he sought clarity. Was it time to walk away from football? He was passionate about cooking and thinking of starting his own show on YouTube. Maybe it was time to shift his focus and let football fade away.

“I’ve got a lot of people who depend on me every day,” Renfrow said.

The ceremony, the athletes hoped, would guide them toward some answers.

***

The research into psychedelics is promising and exciting, but the effectiveness of mushrooms as a treatment isn’t fully settled. But even if psilocybin and other psychedelics prove to be nothing more than a placebo — which some researchers say is possible — many athletes swear they are finding real relief from the anxiety, depression, and other traumas lingering from their playing days.

With a potential multibillion-dollar global market, there’s also a huge financial incentive. Wake is just one of a growing number of for-profit startups backed by private investment money staking a claim in the psychedelic treatment space. They and others hope to open treatment centers or sell the drugs in the U.S. and Canada eventually. Magic mushrooms are illegal to produce, sell, or possess in Canada.

During the Jamaica retreat, Wake leaders gave a presentation to participants on how they could invest in the company.

Macleod said he grew interested in psychedelic therapy not as a business opportunity but after he lost his sister, Heather, six years ago to suicide. Losing her drove him to search for answers. His sister had been a competitive skier in Canada, but a series of falls led to multiple concussions, and throughout her adult life she had anxiety and depression. Traditional medicine repeatedly failed her, Macleod said. Every week, he finds himself wishing he’d known then what he knows now and used it to try to save her.

“I can’t tell you how many people come to me who are struggling like my sister was,” he said. “God, I wish she could be here. I know that she’d be cheering us on. I see her sometimes looking down on us and saying, ‘Help other people who were stuck where I was.’”

Eager to bring psychedelic treatments to consumers, corporate firms often extrapolate research findings from tightly controlled clinical trials with carefully selected patients to promote broader use by the general population in almost any setting.

“The push for psychedelics generally is being driven by people that want to make money, much more than it is about scientists,” said Kevin Sabet, a former White House Office of National Drug Control Policy senior adviser who’s now president and CEO of Smart Approaches to Marijuana, a political group opposed to marijuana legalization. “Why would we let the Wall Street investors, who are really the ones here trying to make money, be driving the conversation?”

Commercialization could be both good and bad for psychedelics. On the one hand, it could provide funding for research; on the other, the desire for a return on that investment could improperly influence the results and put patients at risk.

“Your business model isn’t going to work well when someone’s jumped out of a window and it’s on the front page of The New York Times,” said Johnson, the Johns Hopkins researcher.

Clinical research must also overcome the mushroom’s image as a party drug, something hippies share out of plastic baggies in the back rows of concerts. To change that narrative, Wake and other companies say, they are leaning hard into the science. This isn’t thrill-seeking, they say, but legitimate medicine treating real psychiatric conditions. It’s the same argument proponents of marijuana legalization made, whether they believed it or were using it as a means to an end — pushing to legalize cannabis as medicine before opening the floodgates to unfettered recreational use.

Wake leaders, like most executives in the psychedelic space, have said they are committed to assisting research to prove to federal regulators that psilocybin is safe and effective. Blood and saliva samples a doctor collected at the Wake retreat, they said, would be used to identify genetic markers that could predict who will respond to psilocybin treatment.

Wake’s team had participants use a helmet containing experimental imaging technology that had been used in clinical trials to track brain activity before, during, and after psychedelic experiences. As part of the research, participants wore the helmet while playing games of Wordle.

Many academic researchers wonder whether some companies are simply applying a veneer of science to a moneymaking endeavor, what many skeptics refer to as “placebo theater.”

Indeed, Aaronson fears the field could soon be “full of hucksters.”

“The problem you’ve got is that, not surprisingly, social media and communications works much faster than science does,” he said. “So everybody’s trying to get their hands on this stuff because they think it’s going to be incredible.”

Aaronson has designed clinical trial protocols for Compass Pathways, a competing for-profit company seeking to market psilocybin treatments, and has turned down other firms looking to create a footprint in the psychedelic space. (Aaronson receives funding from Compass to support his research but said he has no direct financial interest in the company.)

“I worry about who’s backing the play from some of these companies and try to figure out what somebody is really after,” he said. “You talk to people and you see whether there’s a real plan to do research or there’s a real plan to sell something.”

***

A hum of nervous tension lingered in the air as the athletes prepared for the ceremony. At breakfast, there wasn’t a lot of small talk. The attendees milled about, checking in with Wake’s medical personnel to offer up their blood and saliva samples. Some participated in a yoga class in an outdoor studio that overlooked the jungle.

Wake had hired a Jamaican shaman — a woman named Sherece Cowan, a vegan food entrepreneur who was a 2012 Miss Universe Jamaica runner-up — to lead the athletes in the ceremony. She asked to be called Sita and referred to herself as a plant medicine facilitator.

She spoke slowly and deliberately, waving smoke from an urn as she urged participants to gather in a circle on the lawn of the estate. After drinking a 3- to 5-gram dose of psilocybin, which had been ground into a powder and mixed with orange juice, the athletes would slip into a dream state for the next four to six hours.

“I hope that you get all that you need. It may not be all that you’re asking for, but I hope you receive all that you need,” Cowan said. “Blessings on your journey.”

A local musician began to play, his drums and chimes intended to enhance the journey. Most of the athletes lay on mats, as if sleeping. Cote sat in a yoga pose. Nick Murray, Wake’s CEO, had asked Cote to wear special headgear — an electroencephalography device smaller than the other helmet — to measure his brain activity. Except for the musician’s drums and chimes, it was quiet. The wind occasionally rustled the leaves on the trees at the edge of the property, but for the next six hours, inside the circle, time mostly stood still.

Two hours into the ceremony, after the psychedelic had kicked in, whatever was taking place was occurring inside the athletes’ heads. Cote, remarkably, was still holding his yoga pose.

The stillness was broken when Renfrow stood up from his mat after three hours. He’d worn a sweatshirt to the ceremony with his initials, JR, emblazoned across the chest. He peeled the shirt off his body in frustration and tossed it aside.

Tears spilled down his face.

As the ceremony wound down, the athletes began sitting up, and a few chatted quietly.

Most weren’t sure how to describe the experience. For some, it felt like a descent into the recesses of the mind, with colors and emotions swirling together. Others said they confronted traumas they thought they’d buried, or emotions they wanted to suppress. They expressed feeling a connection to the other people in the circle.

“It’s the ultimate ego killer because, for me at least, it gives you incredible empathy that you’ve never felt before,” Lee said. “When you’re doing a journey with other people, you see yourself in them. It’s almost like you’re walking past a mirror, different mirrors. You see parts of yourself in everybody and you realize that we’re all connected and we’re all going through something, we’re all in some sort of pain, and it humbles you.”

Most of the athletes drifted off to be alone so they could scribble down their thoughts in a journal, per instructions from Wake staffers. There would be a communal therapy session the next morning.

Each would be asked to share something from their journey.

***

In the end, most of those curious about psilocybin simply want to know: Does it work? And how does it work? Scientists say those are difficult questions to answer right now.

Researchers have discovered that classic psychedelics, like psilocybin and LSD, act on the serotonin 2A receptor, the same receptor targeted by the most common antidepressants on the market. But beyond that, the understanding of how they work to help people is, at this point, more theory or conjecture than scientific fact.

Johnson, the Johns Hopkins researcher, said psilocybin helps increase openness in people, allowing them to step outside of their vision of who they are. Someone who is resigned to being a smoker who can’t quit or a person with depression who can’t find happiness can, under the influence of psychedelics, view themselves in a different way, he said.

“Once they’re outside of the mental trap, it just becomes so obvious to people with these different disorders that, ‘You know what? I can just decide to quit smoking. I can cast aside my sadness,’” Johnson said.

Studies with rats show that psychedelics also appear to increase neuronal connectivity in the brain, even after a single dose. That could help the brain recover from traumatic injuries or concussions, finding new pathways around damaged areas.

The prevailing theory of how psilocybin and other psychedelics might help treat mental health is that they tamp down activity in the brain’s default mode network. It’s a set of regions in the brain that are engaged when people are ruminating about something and one of the few parts that is overactive in people with depression.

They often revisit mistakes they’ve made over and over again or continually beat themselves up about them, said LaPratt, the Sheppard Pratt researcher. That overactivity in the default mode network leads to repetitive patterns of negative thoughts — What’s wrong with me? Why am I so unhappy? — from which the person cannot escape.

People with depression often ruminate about the past; people with anxiety, about the future.

“You may have something coming up and then the brain starts thinking, and again, like that broken record,” LaPratt said. “It can be very easy to start thinking about how everything might go wrong and start catastrophizing.”

That repetitive thinking prevails in people with other conditions, too, including obsessive compulsive disorder and post-traumatic stress disorder. It begins to affect their sense of who they are; they define themselves as their condition.

But psychedelics seem to help people examine old traumas without falling back into the same kind of destructive loop. They can help people feel more connected to others. Depression and anxiety aren’t simply erased, LaPratt said, but people can gain a new perspective on their problems and start to feel, maybe for the first time, that they can shake them off.

“We see increased openness and some motivation for changing behaviors,” he said.

Psychedelics are mostly out of a person’s system by the next morning, but, according to researchers, that increased openness can last for weeks or months without additional doses, providing a window during which they can begin to address their problems.

“It is maybe that we’re helping people get to the point of being able to accept the things they can’t change and to change the things that they can,” Aaronson said, echoing the Serenity Prayer, often used in 12-step recovery programs. “Personal autonomy is taken away from people with depression. They don’t feel like they can operate in their own best interest. They get caught in internal conflict. And I think this helps them get beyond that.”

***

In the morning, the athletes gathered on a patio for a form of group therapy called integration. It was scheduled to last at least two hours. Macleod explained it was an essential part of understanding a psilocybin journey. Every attendee had an opportunity to share something from their experience, whether it was enlightening, confusing, uplifting, or a mixture of many emotions.

Lee spoke about his anxiety, about trying to understand what his identity would be now that he wasn’t a boxer. By walking away from the ring, he feared he was letting down all the people who supported him when he chose a boxing career instead of a job in finance after he graduated from Notre Dame. But now he’d come to understand those were his own insecurities. He could walk his own path. He could help people experiencing similar physical and emotional pain.

Renfrow took several deep breaths as he searched for words. For most of his life, he’d viewed himself as a football player. But on his psilocybin journey, he felt as if members of his family told him it was OK to let go. When he stood up during the ceremony and peeled off his shirt with his initials, he said, he was symbolically letting go of something.

“It’s OK to stop chasing the football journey,” Renfrow said. “I’m not going to suit up this year and that’s cool with me. I’ll be able to figure it out.”

In saying goodbye to football, he said, he was saying goodbye to his grandmother.

“Football was her,” Renfrow said, and he began crying. “We went on all my recruiting trips. So I had to let her go with letting football go. And that was a big moment when I stood up. I had to let her go. So it was tough, but I had to do it.”

When it was Downie’s turn, he tried to defuse the tension by joking that it was time to go eat. He didn’t want to open up to the group, he said. He’d written some notes on a sheet of paper. His hands shook as he tried to read them.

“I wasn’t drinking and I wasn’t doing drugs for fun,” Downie said, his voice trembling. “I was numbing my brain because it was f—ed. I couldn’t turn out of my driveway for a year. I sat in dark rooms and I turned to drugs and alcohol.”

But on the psychedelic trip, he said, he was able to connect with his past. “I’m sitting there and I’m going through my brain, I’m talking to my dad, I’m talking to my family members. I’ve said sorry to everyone I could possibly say sorry to,” he said. “It made me cry. It made me feel good.”

He realized, through the journey, he wanted to be a better man. His voice was shaking as he tried to get the words out.

“At the end of all this, I think what I’ve learned is how to control what goes on. I do have control. I can control this,” he said. “I’m going to go home and I’m going to identify and execute and be a better father and stay around for my kids, deal with my concussion problems as best I can.”

He turned to look directly at Cote, tears streaming down his cheeks from behind his sunglasses.

“I mean this, bro, when I say you saved my life.”

As Downie’s words gave way to silence, Lee stood up from his chair. He crossed the circle, walked over to Downie, and opened his arms wide. The two fighters, who came to Jamaica sad and broken, embraced.

***

While studies have found that psilocybin plus therapy is more effective than therapy alone, it’s unclear whether psilocybin alone, without the preparatory work or the integration afterward, has any effect.

“There’s a reason why people who go to raves and take psilocybin don’t get cured,” Aaronson said. “Psilocybin is not an antidepressant.”

Even within strict clinical trial protocols, the question remains whether psilocybin-assisted therapy works. Preliminary studies have been promising, but the numbers of test subjects have been small. Much larger studies are needed to determine both safety and efficacy.

Still, that hasn’t stopped psilocybin advocates from touting the research to date, implying it is more definitive than it is. Moreover, many mushroom evangelists attribute the positive effects from clinical trials to taking psilocybin in general, discounting the protocols used in the studies.

The Wake retreat in Jamaica, for example, had the athletes take psilocybin in group ceremonies guided by Cowan, the local shaman, while the group integration sessions were led by an osteopathic physician. Neither was a licensed psychotherapist, Murray said. It’s unclear whether the benefits of psilocybin therapy suggested by clinical research would apply to a group setting — for the dosing or the integration.

Murray, Wake’s CEO, said that while clinical research strives to remove any variables, such as interactions between test subjects, Wake leaders feel the group setting offers benefits to its clients.

“It’s that group feeling that, ‘We’re in this together. My divorce is like your divorce. I lost a brother,’” he said. “That’s tough to put into a clinical trial.”

Wake had registered to hold a clinical trial in Jamaica, but Murray said the company ultimately decided not to pursue it, focusing on offering treatment instead.

Still, Murray said Wake is contributing to scientific research: They collected the blood and saliva samples, and participants were asked to fill out questionnaires before and after the retreat to help assess whether the treatment worked.

Murray said Wake uses the same clinically validated questionnaires used in a psychiatrist’s office. “So, it’s not theater. These are the actual tools that are used,” he said. It would be hard with Wake’s approach, however, to parse whether participants were helped by the mushrooms and integration or by other influences, such as being on vacation in Jamaica, being among a supportive peer group, or the marijuana many of them smoked regularly during the retreat.

“You’ve got to at least listen and take it seriously. There’s anecdotes of people saying they would have killed themselves,” Johnson said. “Sometimes you do see just the ‘full monty’ experience, where this person is just there on a dark, dark trajectory and their whole life changes. I suspect this is real. Something’s happening with these athletes making these reports.”

Glowing anecdotes, particularly when they come from high-profile athletes or celebrities, carry weight with the public and help spur measures like those in Oregon and Colorado that are establishing pathways to psilocybin treatment regardless of what researchers or regulators think.

“When people are upset and we’re not meeting their needs, they’re going to try things out,” said Atheir Abbas, an assistant professor of behavioral neuroscience at Oregon Health & Science University. “Hopefully, scientists can catch up to understanding why people think this is really helpful. And maybe it is helpful, but let’s try to figure out if it is and how.”

But there’s a danger in taking these stories, no matter how compelling, and extrapolating safety or efficacy from them.

“The hard part is the plural of anecdote is not data,” said Sabet, the Smart Approaches to Marijuana CEO. “And the data isn’t there yet.”

***

A year after the retreat, Downie, Renfrow, and Lee said they believed their psilocybin journey had helped them. It did not magically fix all their issues, but each considered it a positive experience.

Downie no longer feels that he is stuck in a dark place. When he returned to Ontario, he said, his family noticed a difference right away.

“That trip gave me a lot of clarity,” Downie said. “It gives you directions. It kind of gives you answers internally. It’s a unique thing I experienced. My year was definitely better than the previous year, that’s for sure. … Do I think it could help other people? I would say yes. Did it help me? Absolutely.”

No longer feeling like a prisoner in his house, Downie started a snowmobile camp that takes adults on guided adventures around Moosonee, near James Bay. It’s something he used to do with his family before his hockey career took off.

“It’s not much to brag about, but it’s the most northern you can go in Ontario in a snowmobile,” Downie said. “A lot of adults come from all over. It’s a pretty cool experience. It’s always been a passion of mine.”

He still has lingering issues from his concussions and suspects he always will.

“It is what it is,” he said. “Would I say it’s getting better? It’s a process.”

The most positive outcome has been the joy he’s found in being a father.

“My little guy is starting to fall in love with hockey, which is something I’ve been waiting for,” Downie said.

Although Downie hasn’t taken another psilocybin journey, he said he would be open to it.

Renfrow emerged from the ceremony intent on retiring from professional football but three months later re-signed with the Canadian Football League’s Edmonton Elks. This year, he joined the National Arena League’s Jacksonville Sharks, in part to be closer to his son.

“At that time, I thought I was going to quit football,” he said.

But he feels comfortable where he is and says he’s fulfilling his goals, including hosting that cooking show on YouTube he’d hoped to do. And he said he’s having fun again. He now turns to mushrooms whenever he has a big decision to make.

“I wholehearted believe in that and all the kind of guidance it’s given me,” he said. “You couldn’t ask for a better thing, to have followed guidance from a mushroom journey.”

Lee moved from California to Austin, Texas, and now runs a CBD business with his sister. Finding his post-boxing identity has remained a process. In his psychedelic journeys at the Wake retreat, Lee said, he was never thinking about sports or boxing. His visions were all about family, God, the universe.

“It kind of just makes me realize how much importance I’m putting on something that my subconscious doesn’t even care about,” he said. “My subconscious doesn’t care that I’m a boxer, that I was a fighter and did this and did that. It’s all kind of ego.”

The experience, he said, helped him understand how powerful the mind can be — that it can be a friend or a foe.

“I came away from it kind of realizing that I have all the tools to heal myself,” he said. “That’s huge. Because, especially for guys who have had concussions or athletes or what have you, you feel kind of isolated, you feel alone, you feel hopeless. So it kind of gives you a sense of hope.”

It allowed him to move beyond the need to prove himself, in the ring or outside it, to stop measuring his worth by his accomplishments. He’s become obsessed with much calmer, nonviolent pursuits: surfing and pickleball.

“I can turn my brain off just like in boxing,” he said. “But at the same time, it’s easier on my body and just, I don’t know, more fulfilling. I don’t have to prove anything.”

The Jamaican trip is allowing him to move forward, to do the work necessary to heal.

“Part of me went into it hoping that all my problems would be solved, but putting those expectations on it can be difficult,” he said. “Am I cured? No. But did it really help? And was it, like, one of the most profound experiences of my life?

“I’d say yes.”

This article was reported and written by KFF Health News’ Markian Hawryluk and ESPN’s Kevin Van Valkenburg. Researcher John Mastroberardino contributed to this report.

[Editor’s note: As part of the reporting of this article, some members of ESPN’s reporting team, under the guidance of Wake Network staff, used psilocybin. Wake Network was compensated, but not by ESPN.]

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Mary Agnes Carey, Partnerships Editor and Senior Correspondent, oversees placement of KFF Health News content in publications nationwide. She has covered health care policy and politics for KFF Health News, CQ, Dow Jones Newswires, and other news outlets.

Supreme Court justices could act at any moment on access to the abortion pill mifepristone. Beyond reproductive health, their ruling could carry significant implications for states’ rights and FDA independence and integrity. For now, though, observers are unsure what the court will do — or what exactly prompted justices to again delay their decision this week.

At the Capitol, lawmakers grumbled, scoffed, and bickered this week as House Speaker Kevin McCarthy revealed the Republican proposal to cut government spending. The package would be dead-on-arrival in the Democratic-controlled Senate. But of note is the pushback from within McCarthy’s own caucus, with some hard-right conservatives pressing to go further by demanding the repeal of the Inflation Reduction Act in exchange for raising the debt ceiling.

And President Joe Biden pursued new efforts to grant legal status to young immigrants living in the country illegally who were brought here as children, sometimes called “Dreamers,” as his administration announced a plan to grant them access to government-funded health coverage.

This week’s panelists are Mary Agnes Carey of KFF Health News, Rachel Cohrs of Stat, Sandhya Raman of CQ Roll Call, and Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Among the takeaways from this week’s episode:

• The Supreme Court extended its stay on the use of mifepristone through Friday, giving justices longer to act on a major, complicated case with nationwide implications for reproductive health. It is unclear what the court will do, though there are several actions it could take — including sending the case back to the lower courts or again extending the stay and buying justices even more time to come to agreement or pen dissents.
• GenBioPro, which produces the generic version of mifepristone, sued the FDA on Wednesday, attempting to preserve access to the drug. About two-thirds of the mifepristone currently used in the United States is generic.
• In congressional news, House Speaker McCarthy released what is effectively Republicans’ opening offer in the fight over raising the debt ceiling. The package includes GOP health priorities that would not garner needed support in the Senate, like work requirements for Medicaid and the clawback of unspent covid-19 pandemic funds.
• While health costs are high across government programs, Medicaid takes the big hit in the Republican proposal to cut federal spending. Republicans have embraced work requirements for government assistance since at least the 1980s, yet in Arkansas — a state that implemented work rules for Medicaid — it has proved challenging to verify that enrollees are meeting those requirements.
• The Senate Finance Committee, which has jurisdiction over much of federal health spending, revealed a package this week to tackle drug pricing. While the proposal is in the early stages, it seeks to incorporate bipartisan measures touching pharmacy benefit managers, insulin users, and more.
• And on the coverage front, the Biden administration announced that immigrant kids brought to the United States who remain here under the Deferred Action for Childhood Arrivals program will be able to apply for Medicaid and Affordable Care Act coverage. This eligibility expansion comes as states prepare to disenroll those who no longer qualify for Medicaid as the public health emergency’s coverage protections expire. Expect a fight from some states as they resist being forced to cover insurance for individuals living in the U.S. without legal permission.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Mary Agnes Carey: The New York Times’ “A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement,” by Anna Kodé

Joanne Kenen: The New York Times’ “My Transplanted Heart and I Will Die Soon,” by Amy Silverstein

Sandhya Raman: ABC News’ “Puerto Rico’s Water Supply Is Being Depleted, Contaminated by Manufacturing Industry on the Island, Experts Say,” by Jessie DiMartino, Lilia Geho, and Julia Jacobo

Rachel Cohrs: The Wall Street Journal’s “‘I Hate You, Kathie Lee Gifford!’ Ozempic Users Report Bizarre Dreams,” by Peter Loftus

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Transcript: Will They or Won’t They (Block the Abortion Pill)?

KFF Health News’ ‘What the Health?’Episode Title: Will They or Won’t They (Block the Abortion Pill)?Episode Number: 294Published: April 20, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Mary Agnes Carey: Hello and welcome back to “What the Health?” I’m Mary Agnes Carey, partnerships editor for KFF Health News. I’m filling in this week for Julie Rovner, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, April 20, at 10 a.m. Eastern. As always, news happens fast and things might have changed by the time you hear this. So here we go. Joining us today by video conference are Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Carey: Rachel Cohrs of Stat.

Cohrs: Morning, everyone.

Carey: And Sandhya Raman of CQ Roll Call.

Raman: Good morning.

Carey: Let’s start with the current court action on mifepristone. The Supreme Court was scheduled to rule yesterday on a decision from the U.S. Court of Appeals for the 5th Circuit that rolled back FDA action since 2016, allowing patients to get mifepristone through the mail, authorizing prescriptions by medical professionals other than doctors, and approving the drug’s use up to 10 weeks into a pregnancy instead of seven. Supreme Court Justice Samuel Alito Jr, who’d previously set Wednesday as the deadline for the court to act, extended that stay until Friday, and the justices could certainly act before they choose to —hopefully not while we’re taping. But I wanted to get everyone’s thoughts on why do you think the court didn’t act yesterday? Joanne, can I start with you?

Kenen: I mean, presumably they’re still hashing it out. There’re probably two or three judges who are still thinking about it or discussing it with their colleagues, or colleagues who want to think they can persuade them to their side. I mean, there’s something internal. On the other hand, I mean, they didn’t originally give themselves a lot of time to consider a complicated and historic case. We know there’s an anti-abortion majority. We know they’re not crazy about medical abortions any more than they are about surgical abortions. But this has large implications about states’ rights and about the sort of integrity of the FDA. So they may just wanted to sleep on it. They’re human, but the two sides are battling for two or three in the middle.

Carey: So what does this signal about how they might rule? I mean, to your point about the split, the battle, what are the options? What do you — Sandhya, what do you think about what they might —

Kenen: Well, if it was slam dunk, we’d have had it.

Carey: That is true. That is true. It is not a slam dunk.

Raman: And everyone that I have talked to in the last few weeks on this is just that there are so many different options, different permutations, that it’s difficult even for people that are experts on FDA policy, like expert lawyers, experts on abortion policy, to just kind of like predict the nuances. You know, they could let the stay expire. They could send it back to the 5th Circuit. They could decide to hold arguments and let it expire or not expire. They could decide something different than the 5th Circuit. You know, there’s so many different ways that things could happen that I think it makes it difficult. And then yesterday, the other manufacturer of mifepristone, GenBioPro, also filed suit against the FDA. So now we have, since Dobbs, like five different lawsuits related to mifepristone and three of them, post-Dobbs, are related to the FDA in particular. And I think it just gets very, very complicated to make a decision, even if ideologically some people might align with one way versus the other, given all of these different permutations and that we still have that Washington case that is attacking another part of this. So it’s just complicated to get people to do something. And the fact that this case has been moving so, so quickly.

Carey: Could we be in the same place on Friday? Could we get another stay? Could the justices certainly ask for more time, and are there any thoughts about the probability of that actually happening? Rachel, what are your thoughts?

Cohrs: I think they can do what they want.

Carey: That’s true.

Cohrs: They gave themselves time once more, and I think obviously there’s a benefit to having some certainty and predictability for people, for providers, but certainly they could stay again.

Carey: So, Sandhya, you just mentioned the Washington state case. So while this Texas ruling is before the Supreme Court, a federal district judge in Washington state issued a ruling in a separate case that instructed the FDA to not alter the current availability of the drug in 17 states and the District of Columbia. And as you just mentioned, a manufacturer of the generic version of the drug — the company’s name is GenBioPro; they make the generic version of mifepristone — they’re arguing that if the FDA implements a court order suspending approval of the drug, the agency would deprive the company of its rights to market the drug without due process of law. And as I understand, this company is a major manufacturer of the generic version of the drug, right? So let’s talk a bit more about this confusion of these split rulings. I mean, what is the public to make of it? What’s the reaction with facilities that are providing this medication or doctors who want to prescribe it or just the general public? The person who might be interested in this situation is very confused. I mean, talk a little bit about how people sort through it and what this means for them.

Raman: So the suit that was filed yesterday about the generic, they make two-thirds of the mifepristone that is used in the U.S. So if they were unable to be manufacturing theirs based on a ruling that only allowed the name-brand version of the drug, that’s a huge percentage of the market that is gone, and more than half of abortions are done through medication abortion. So that’s one thorn in it. And I think that another is that we have all of these states that have been stockpiling the drugs — several that have been, you know, in case they don’t know what is happening with the ruling. Washington is one of them. And there’s still not clarity depending on what happens with these cases of, you know, will they be able to use what that they have stockpiled? And then we have other states like New York and I think California that have been stockpiling misoprostol as another way to — in case there’s a court ruling that doesn’t go in their favor — to just give patients in their states access to medication abortion. I think that there are so many different permutations that it’s very difficult for even folks that are confident that the rule may go a different way to know what to predict, just because we’re in such uncertain territory, from all of the different former FDA officials that have said, “You know, this is a very different situation. We don’t even know, after decades of experience at the FDA, like, how this would play out, what it would mean, whether we’d have to pull everything off the market.” How it would play out, it’s just a lot of unknown territory given all of the different things going on.

Kenen: Well, also, whatever they do now isn’t necessarily the end of the story, right? I mean, if the court issues a stay, it will still go through the courts and it presumably ends up at the Supreme Court again. If they issue a stay pending full hearing of the case, it’ll be going on for months more. But either they issue a stay saying the 5th Circuit ruling, which did not totally — the lower federal court banned the use of the pill; the appeals court limited it to seven weeks instead of the FDA has ruled it’s for 10 weeks. So if they uphold the 5th Circuit Court of Appeals, there would still be use, but it would be limited. If they put a stay saying, “Yes, it can stay legal in the states that allow it for now,” then it would still be legal in those states but we’d still be back discussing what is the Supreme Court going to do a couple of months from now.

Carey: And how — where is the drug industry on this? I mean, this would have sweeping ramifications.

Kenen: They’re horrified. One of you might know the number — was it like 250 companies signed the brief that you’re going to have a court decide what drug is safe and what drug is not safe, rather than the FDA? I mean, the pharmaceutical company fights with the FDA all the time, but they need the FDA and they know they need the FDA and they admit they need the FDA. You know, you have one voice in this country saying a drug is safe or a drug is not safe or a drug is safe under the following conditions.

Raman: There have been hundreds of the drug companies that have spoken out against it, and PhRMA [Pharmaceutical Research and Manufacturers of America] more recently also finally came out against it. It’s been pretty uniform in a way that I have not really seen in the past where there have been, you know, the drug companies, the various people that have been regulators, the folks that are in favor of abortion rights, then just advocates — and just very unified in this response.

Carey: Rachel, what is the impact of the drug industry’s weighing in in this manner? How could that shape the decision? Was there anything surprising in how they worked together on this? I know you’ve done some reporting on this area.

Cohrs: Yes. Yeah. So I think certainly them actually filing briefs with the court will kind of help drive home the ramifications of this, just on a much larger scale. I mean, we’re not just talking about abortion now. We’re talking about any medication that could be at all controversial. You know, we’re talking PrEP for HIV. You know, there are so many areas where companies genuinely are concerned about lawsuits and about judges who aren’t experts. So I think this uniform voice will drive home the larger impacts here beyond this one issue. And also, I think, the drug industry has significant resources to invest. And I think, it took a little while, but the trade groups PhRMA and BIO [Biotechnology Innovation Organization] have said that they are willing to invest, and they haven’t made any specific commitments, but certainly I think down the line there could be legal challenges. And now that they have put themselves out there, they certainly are a significant player in the space, with resources.

Raman: The drug industry is also a huge player in, you know, donating to various campaigns and lobbying on the Hill. And it’s definitely going to be — put increasingly different folks in a tight spot if they are receiving a lot of backing from the pharmaceutical industry and if they’ve spoken out in favor of restricting the drug. And it’ll be interesting to see kind of as it goes on what happens there with some of these folks.

Carey: Sure. Well that’s a perfect segue way because we have lawmakers on Capitol Hill are also weighing in on this. About 150 Republicans are urging the Supreme Court to uphold the 5th Circuit’s ruling, while more than 250 Democrats have urged the court to not prevent access to mifepristone. Are Republicans taking a political risk here speaking out? Because I know it’s been talked about on the podcast before, about the abortion rights opponents have some splits on how far to go on some of these restrictions on abortion. You know, Republicans didn’t really seem eager to engage when the decision came out, but now they are. What does that mean? What do you make of it?

Raman: We’ve had that delay first that, you know, a lot of Republicans did not even comment on the case, which was kind of interesting, given that, you know, after a lot of these decisions, we see a lot from both sides kind of weighing in. And I think when you look at some of these briefs, they say a lot of the similar talking points as before, which is something that you can kind of look to. But I mean, the conversation is still moving, even on the Hill. Yesterday, Robert Califf from the FDA was facing questions about mifepristone from different Republicans, from Cindy Hyde-Smith, who had agreed with the lower court decision, from Susan Collins, who was kind of against the decision as one of the Republicans who generally supports abortion rights. And I think it’ll be very interesting if this gets taken up by a committee that has jurisdiction over the FDA, which we have not really seen a commitment to. Energy and Commerce [Committee] Democrats have asked for something on this to come up. But, you know, under Republican leadership, I don’t know that that would necessarily happen. The only committee that is really committed to looking at this issue has been, like, Senate Judiciary, which with Democratic control is going to look a different way. And they don’t really have the jurisdiction over FDA in the same way as some of the other committees do. So I think that’ll be interesting to look at if that changes.

Kenen: There is a divide in the Republican Party about how far to go. I mean, some are for rape and incest exceptions, some are not. Some are for six weeks, some are for 15 weeks, some are for zero weeks. This is reflecting those divisions. It also depends on the individual lawmaker’s district. You know, if you come from an extremely conservative district and you are an anti-abortion absolutist, then you’re going to speak out on this. But we’ve noted they don’t really want to antagonize pharma either. So you’ve seen, I guess it’s 150ish — you haven’t seen all of them. It’s a complicated issue for some of them, given the competing interests, you know. Is abolishing all abortions in the United States of America your top goal? In which case you’re going to want to support the lower court. If you have a more nuanced view, where you’re worried about precedent for overriding the FDA, you have competing — I mean, there are very few abortion rights Republicans, but they don’t all want to draw the line in the same place.

Carey: So while we’re on the subject of Capitol Hill, let’s talk about the debt ceiling. We have a little bit of action there this week. Speaker of the House Kevin McCarthy unveiled his plan to raise the debt ceiling. McCarthy and many Republicans have said they don’t want to raise the debt ceiling without spending cuts. President Biden and many Democrats are pushing for a clean debt ceiling increase. So among its provisions, Speaker McCarthy’s plan would cut federal spending by roughly $130 billion, and that would take spending back to fiscal 2022 levels. Health-related provisions include new work requirements for Medicaid and food stamp recipients, and the package would also claw back unspent covid aid funds. And there’s a bit of a twist on the work requirement proposals of the past: States could opt to keep those that don’t comply with the work rules covered under Medicaid, keep them on the rolls. But if they do, the state would bear the full cost of that coverage and forgo the federal money for those enrollees, right? The proposal also requires states to make use of existing resources like payroll databases, state health and human service agencies, to verify compliance with a work rule when possible. There’s a lot to unpack here. It’s pretty clear that, I mean, House Democrats aren’t going to vote for this. Does the speaker even have enough votes in his own caucus to pass it? I think he can only lose like four.

Kenen: TBD. But I don’t think the conventional wisdom is that he has the votes. You know, it’s a starting offer, but they can change, you know, has to go Rules [Committee]. They’ll change — you know, they could change things.

Carey: It is a starting offer. But your vote is next week and it’s Thursday. OK. Rachel, what’s your take on this?

Cohrs: Yeah, I think it was a bit of a roller coaster this week, as some members of the Freedom Caucus were demanding wholesale repeal of the Inflation Reduction Act around midweek, and they certainly backed off from that, especially the health care portion. So I think that is worth noting, at least right now. Again, unclear if he has the votes, or if the speaker has the votes, and then obviously Senate Democrats aren’t going to go for it and President Biden isn’t going to go for this. So I think, like Joanne said, it is kind of an opening offer here. And again, there isn’t a lot on Medicare in here. So I think we just, you know, finally, after so much rhetoric and so much back-and-forth, have some sort of tangible starting point from Republicans here, which is significant.

Kenen: But, you know, as soon as they made that pledge that we’re not going to touch Medicare, meaning traditional Medicare actually, and we’re not going to touch Social Security, we all knew that, Oh, that means that it’s all going to go to Medicaid. So this is a big Medicaid hit. And work rules have been something the Republicans have embraced at least since the Reagan era, maybe even before, but certainly since the 1980s. A few states tried them or at least said they were going to impose them under the Obama administration. At that point, the administration didn’t approve them and the courts didn’t uphold them. But we have a different court now. So I think this court would uphold; that’s likely. But this is not acceptable for Democrats, nor is it meant to be.

Raman: And when we had the various states propose these and in some cases implement them during the Trump administration, every single one of them was struck down by the court once, sometimes twice. You know, we had Arkansas, we had New Hampshire, we had Kentucky, we had Michigan. Every single time the judge at hand was, you know, “This is going against the function of Medicaid,” which — historically we’ve had work requirements in some of the other programs, but the way the Medicaid statute is written, it has been difficult to find a way to keep those in place. So if they were able to get that past, I mean, even the House, which seems like is a, is a question mark, I mean — whatever could get through would absolutely face court battles from some of the same folks that challenged them during the Trump administration.

Kenen: But I think the only one that actually went into effect was Arkansas. And in addition to it being thrown out by a court, it also just didn’t work. The mechanism didn’t work. It became really hard for people. The verification that you’re working, which this proposal actually addresses, that Mary Agnes just alluded to that, the verification was extraordinarily cumbersome. I mean, you had like lots of poor people in Arkansas — and rural Arkansas don’t have access to Internet — and you only had a few hours a day where you could use the portal and you have to leave work to go to the local library to prove that you were working. I mean, it was just — forget the ideology of it — the mechanics didn’t work, and people were thrown off even though they were compliant. And but this [is] just like a deep philosophical divide between the two parties, and they have compromised, and back in the Clinton years they compromised on welfare, what’s now called TANF [Temporary Assistance for Needy Families]. There’s work requirements for SNAP, for what we used to call food stamps. But Medicaid has been a red line for Democrats, that this is an entitlement based on health; it’s not like you deserve — some people deserve it and some people don’t. It’s been a philosophical, ideological, you know, something that Democrats feel very strongly about.

Cohrs: Oh, I just want to jump in on the covid money as well — much smaller deal, fewer impacts on patients — but it has been kind of interesting and over the last couple of weeks that the Biden administration has rolled out some new programs that cost quite a bit of money, as there’s this horizon, this call for Congress to claw back unspent covid funds. I mean, they’re spending $5 billion now on developing vaccines and therapeutics, $1 billion on vaccine access, when they said they didn’t have any money. So it’s just kind of interesting that, you know, when these funds are committed to a program legally, then Congress can’t claw them back. So I’m curious to see what else we’ll see as these negotiations solidify.

Carey: All right. We’ll keep our eye on it. And I want to just check in briefly on the Senate side. I know we’ve discussed these issues on the podcast before. The Senate Health, Education, Labor and Pensions Committee has been working on legislation focused on drug prices and pharmacy benefit managers. This morning we have a framework introduced from the Senate Finance Committee. It’s with Sen. Wyden, the chair from Oregon, who’s a Democrat, and Sen. Mike Crapo, Republican from Idaho, that also seeks to address PBMs in the prescription drug supply chain. We also have the moving, or maybe not moving, but introduce legislation, anything new there on insulin prices with Sen. Warnock and Sen. Kennedy to cap the out-of-pocket price at $35. Any movements there in the Senate, any insight you could offer?

Cohrs: On the Senate Finance [Committee] side, that is a very significant development, that they’ve decided to get in on the fun this week of putting together a package, just because their committees do have jurisdiction over so much federal spending. And Sen. Wyden has been involved in this issue. He’s put out — I found a package of bills from 2019, and, you know, he’s been on this issue a long time. So I think his team has proven they can craft big-picture, very impactful policy with the Inflation Reduction Act. So I think that’s certainly something to watch with that much federal spending on the line. And on insulin, you know, Sen. Schumer this week has committed to have some sort of insulin pricing provision in whatever package might come together — it’s still pretty amorphous — but it’s unclear what that’s going to look like. There is another proposal from Sen. Collins and Sen. Shaheen, two much more senior members of the caucus, and that mechanism works differently. For patients, it would look pretty similar. But on the back end, for insurers, for drugmakers, both of those programs would work differently. So they haven’t sorted that out yet. HELP hasn’t even picked a date for their hearing and formally announced it yet. So we are in early stages, but there’s certainly a lot swirling around.

Carey: Absolutely. And we’ll keep our eye on all of that as well. So I’d like to also chat a little bit about some ACA developments that happened this week. President Biden recently announced that hundreds of thousands of immigrants brought to the United States illegally as children will be able to apply for Medicaid and the Affordable Care Act’s health insurance exchanges. This allows participants in the Obama-era Deferred Action for Childhood Arrivals program, also known as DACA, to access government-funded health insurance programs. You can expect pushback from conservative leaders of states that have been reluctant to expand Medicaid, possibly also pushback from Republican members of the Hill on this provision. And then, in other ACA news, the administration has finalized new rules that are aimed at making it easier for consumers to sign up for ACA plans, in particular those who are losing their coverage through Medicaid or the Children’s Health Insurance Program. The Centers for Medicare & Medicaid Services, also known as CMS, will also give state marketplaces the option to hold a special enrollment period for people who lose their Medicaid or CHIP coverage. What could this possibly mean for enrollment in the program, right, to making it easier for DACA participants to enroll in the ACA or people losing their coverage through CHIP or Medicaid? I think it’s about 16 million people now in the program. Does this build more support for it? Are Republicans going to engage against it? Do they think that’s simply a losing battle because they’ve never agreed on an alternative?

Raman: I mean, right now, we’ve had historic levels of people in Medicaid and CHIP just because states have been unable to unenroll them from coverage during the public health emergency for covid. And now that states are starting to recheck their rolls and see who’s still eligible, who’s not eligible, we’ve been expecting just, you know, a big drop in different people that would be either getting uninsured or maybe moving to a different type of plan with a private or the exchanges. And I think it’s been something that, you know, states and the federal government have been working on for the entire time of just, you know, different ways to make sure that that drop-off in the number of uninsured folks doesn’t skyrocket as states are going through this process. And so I think the timing is important in that, you know, you’re trying to counteract the drop. And HHS [the U.S. Department of Health and Human Services] has been touting, you know, the high levels of uptake in the ACA and just like the low uninsured rate and this has been something they’ve just kind of been pushing, you know, month after month. This has been something that has been like a big achievement for them. And so now really like push comes to shove to say that, you know, it doesn’t drop off dramatically if you want to continue touting some of these achievements and making sure that people don’t drop off just because the emergency is ending and that guaranteed coverage isn’t there.

Kenen: So there are multiple issues in the question that are exposed, the DACA, which —

Carey: Of course it can’t be just one question I have to ask four at once.

Kenen: The DACA, which is also known as the Dreamers, Biden is trying to cover them. Democrats have been trying to give them legal status and got nowhere. In fact, they’re probably further away from that than they were five or six years ago. But to get them health coverage is something the Democrats — it’s like the least they can do to this population. But I can’t imagine there’s not going to be a political and/or a legal fight from the states who are going to have to pay for their share of it, right? I mean, Medicaid is a state-federal joint expenditure, and the states that don’t want to cover these people will well resist or sue. Or, I mean, everything ends up in court; I would imagine this will, too, or baked into the debt ceiling — you know, one more thing to fight about with the debt ceiling. So that’s one issue. I mean, the other issue is this unwinding of this huge Medicaid population. Most of these people are going to be eligible for some kind of coverage. Some of them are still going to be eligible for Medicaid. Some of them are going to be eligible for very good deals for sort of low-income working people on the ACA. And some have jobs that they can get insured through — theirs or a partner or a family member. But really, the only ones who are ineligible for anything would be those in the remaining Medicaid gap states. But that’s like theoretically, if we did everything right, the only people that would be ineligible are the Medicaid gap population, which is now down to about 10 states, assuming North Carolina, you know, finalizes their approval or, you know, enacts their expansion. But like, that’s the perfect world, and we don’t live in a perfect world. I mean, some of these people are going to get lost in the shuffle. And in fact, maybe several million; their estimates are like maybe 6 million, you know, no one knows. But, you know, our health care system is complicated. You know, getting a letter in the mail saying, you know, “Sayonara, Medicaid,” is not all of them will know how to negotiate new coverage even when they’re eligible, and we’re going to have to do a really good job of helping them. And that has to be from the federal government, from the state governments, from the health system itself, from advocates, from Congress. You know, everyone’s going to have to pitch in to get these people what they’re eligible for. And I don’t see that as an overnight success story. I think that there are people who should be covered and can be covered who won’t be covered. Eventually we’ll probably catch up and most of them enrolled. But I think that some of them have periods of uninsurance.

Carey: It’s absolutely a major undertaking. I know we’ll all be watching closely. OK, that’s the news for this week. Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week and think you should read it too. As always, don’t worry if you miss it. We’ll post the links on our podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device.

Kenen: I actually want to read the first sentence of this piece. This is a guest essay in The New York Times by Amy Silverstein. She’s a heart transplant recipient. She’s, I guess, about 60 now, and she’s about to die, not because her heart, her transplanted heart is failing — she writes about how she kept that in pristine condition — but because she’s got cancer. And it’s called “My Transplanted Heart and I Will Die Soon,” and it begins, “Today, I will explain to my healthy transplanted heart why, in what may be a matter of days or weeks at best, she — well, we — will die.” And in addition to being just a heart-tugger, I did not know a lot of what she explores about transplant medicine, that we think of transplants as medical miracles — and they are; you know, she had like an extra 35 years of life — but they’re also, transplant medicine itself hasn’t really, according to what she writes, transplant medicine itself — the drugs, the care they get, these heavy-duty drugs haven’t improved in 40 years. While she has a healthy heart, she has metastatic lung cancer because of these drugs. The medical care around transplant can be quite dangerous. And I knew nothing about that, and I’ve covered health for a long time. So it’s a tragic story and it’s also a scientific failure or a medical system or a medical research failure story that I hope a lot of people who have the power to change it read.

Carey: Sandhya, what’s your extra credit?

Raman: So my extra credit is from ABC News. It’s called “Puerto Rico’s Water Supply Is Being Depleted, Contaminated by Manufacturing Industry on the Island, Experts Say.” It’s a triple byline from Jessie DiMartino, Lilia Geho, and Julia Jacobo. And I thought their story was really interesting because it looks at the effects of the manufacturing industry on the water supply in Puerto Rico. The manufacturing there is, in Puerto Rico, is really high because there used to be a tax incentive that’s now lapsed to create a huge boom in manufacturing in the ’60s and ’70s. And kind of looking at the impacts of that, and over time and to the environment, and pharma manufacturing in particular, is 65% of what has been the industrial groundwater withdrawals. So in areas that rely heavily on groundwater on an island, this is felt especially hard. And so they go through a lot of the implications of some of that and how the manufacturing affects it, especially in an island with a finite water supply.

Carey: Rachel.

Cohrs: Mine is, the headline is, “‘I Hate You, Kathie Lee Gifford!’ Ozempic Users Report Bizarre Dreams,” in The Wall Street Journal and by Peter Loftus. Our newsroom has been covering the weight loss drug explosion this year, and I think this story was just so colorful and just a great example of reporting on the side effects that emerge when so many people are interested or want to take a drug. And I think there is certainly a public service to people understanding what they’re getting into and just hearing from all sorts of people, because certainly there are agencies who are supposed to be doing that. But I think there’s also just a lot of buzz that’s fascinating. The writing was just so rich and bizarre. And yeah, it was a great read and a great illustration on it, too.

Carey: Well, speaking of weight loss and getting fat out of our bodies, my story is from The New York Times, called “A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement,” by Anna Kodé, and I hope I’m pronouncing your name correctly. You might have heard or seen all these ads about the treatment called CoolSculpting. It uses a device on a targeted part of the body to freeze fat cells. Patients typically undergo multiple treatments in the same area, and in successful cases, the cells die and the body absorbs them. “But for some people,” Anna writes, “the procedure results in severe disfigurement. The fat can grow, harden and lodge in the body, sometimes even taking on the shape of the device’s applicator.” The manufacturer says this is a rare side effect, but a Times investigation that drew on internal documents, lawsuits, medical studies, and interviews indicates the risk to patients may be considerably higher. So that’s our show. As always, if you enjoyed the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. And as always, you can email us with your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me @maryagnescarey. Rachel?

Cohrs: @rachelcohrs.

Carey: Joanne?

Kenen: @JoanneKenen.

Carey: Sandhya.

Raman: @SandhyaWrites.

Carey: We’ll be back in your feed next week. Until then, be healthy.

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