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.

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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.

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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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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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[UPDATED on April 18]

The new drug looked so promising — except for that one warning sign.

At the American College of Rheumatology’s annual meeting in 2008, Duke University’s Dr. John Sundy proudly announced that pegloticase, a drug he’d helped develop, was astoundingly effective at treating severe gout, which affects perhaps 50,000 Americans. In about half of those who had taken it, the drug melted away the crystalline uric acid deposits that encrusted their joints to cause years of pain, immobility, or disfigurement.

But Sundy also disclosed an unsettling detail: In one clinical trial, patients who got the drug were more likely to develop heart problems than those who didn’t. The day after Sundy’s talk, the stock price of Savient Pharmaceuticals, which developed the drug with Duke scientists, plunged 75%.

That danger signal would disappear in later studies, and the FDA approved pegloticase, under the trade name Krystexxa, two years later. But the small biotech company never recovered. In 2013, Savient was sold at auction to Crealta, a private equity venture created for the purpose, for $120 million.

Two years later, a young company now called Horizon Therapeutics bought Crealta and its drug portfolio for $510 million.

Even at that price, it proved a good deal. Krystexxa brought in $716 million in 2022 and was expected to earn $1 billion annually in coming years.

Although Horizon says it now has 20 drugs under development, in its 15 years of existence it has yet to license a product it invented. Yet the company has managed to assemble a war chest of lucrative drugs, in the process writing a playbook for how to build a modern pharmaceutical colossus.

As the White House and both parties in Congress grapple with reining in prescription drug prices, Horizon’s approach reveals just how difficult this may be.

Horizon’s strategy has paid off handsomely. Krystexxa was just one of the many shiny objects that attracted Amgen, a pharmaceutical giant. Amgen announced in December that it intends to buy Horizon for $27.8 billion, in the biggest pharmaceutical industry deal announced in 2022.

Horizon’s CEO, Tim Walbert, who will reportedly get around $135 million when the deal closes, has mastered a particular kind of industry expertise: taking drugs invented and tested by other people, wrapping them expertly in hard-nosed marketing and warm-hued patient relations, raising their prices, and enjoying astounding revenues.

He’s done this with unusual finesse — courting patients with concierge-like attention and engaging specialist clinicians with lunches, conferences, and research projects, all while touting his own experience as a patient with a rare inflammatory disease. Walbert’s company has been particularly adept at ensuring that insurers, rather than patients, bear the costly burdens of his drugs.

A federal prosecutor in 2015 began examining allegations that Horizon’s patient assistance program had worked with specialty pharmacies to evade insurers’ efforts to shun Horizon’s expensive drugs. A separate probe opened in 2019 over alleged kickbacks to pharmacy benefit managers, companies that negotiate to get Horizon’s drugs covered by insurers. Those investigations appear to be no longer active, Horizon spokesperson Catherine Riedel said. The company this year disclosed a third probe, concerning methods the company allegedly used to get prior authorization of its drugs. Justice officials did not respond to requests for comment on the investigations.

An Injection of Marketing

To help sell its drugs, Horizon blankets specialist physicians with marketing and peer-to-peer appeals. Its payments to physicians for things like consulting, speeches, and meals totaled $8.7 million in 2021, compared with the $10 million it paid them for research, federal records show. By contrast, Seagen, a biotech company of roughly the same size, paid doctors a total of $116 million, with nearly $112 million of that pegged for research. Riedel said Horizon’s marketing and educational approaches were “necessarily unique” because of the challenges of treating rare and neglected diseases.

Walbert launched Horizon in 2008 in the Chicago area by combining and refashioning generic drugs into single pills. Duexis, Horizon’s first drug, is a mixture of generic Motrin and Pepcid. Its Vimovo combines generic Aleve and Nexium. In a 2017 article, a ProPublica reporter described being prescribed Vimovo for a shoulder injury. It cost him nothing, but his insurer was billed $3,252 for pills that together cost about $40 for a month’s supply in generic form. Horizon sold more than $57 million worth of Vimovo that year.

In 2014 and 2015, respectively, Horizon picked up two relatively new drugs that had no generic versions: the immunosuppressant Actimmune and Ravicti, which treats a rare genetic disorder. Soon Horizon was charging more than $50,000 a month for each, placing Actimmmune fourth and Ravicti second on GoodRx’s 2020 list of the most expensive U.S. drugs.

Horizon’s net sales soared from $20 million in 2012 to $981 million in 2016; Walbert’s pay package followed suit, topping an astronomical $93.4 million in 2015 in salary and stock. Stock analysts questioned the long-term soundness of a strategy of simply selling old drugs for mind-boggling prices, but Walbert was using the cash to refashion the company as a rare-diseases franchise.

His approach would make Walbert a darling of pharmaceutical investors and his board, which lavished him with over $20 million in compensation each of the past three years. While most biotechs and startups borrow heavily from venture capital to do science and have no idea how to develop and market a drug, Walbert got cash coming in quickly. “He did it backwards,” said Annabel Samimy, an analyst at Stifel Financial Corp. “Horizon built commercial platforms before they got into drug development.”

Generating “robust sales of what sounded like not very interesting drugs” allowed Walbert “to start a company on not very much,” said Oppenheimer analyst Leland Gershell. All the while, Horizon funded and cultivated the patient advocacy groups that can help lobby for a drug to be approved by the FDA and placed on insurers’ formularies, the lists of drugs health plans cover for patients.

Speaking From Experience

As Walbert and his spokespeople often point out, Walbert and his youngest son suffer from a rare disease, and Walbert also has an autoimmune disease. Walbert won’t name the diseases, but has said he’s taken the anti-inflammatory injectable Humira since 2003 — the year he led that drug’s commercial launch as a vice president at Abbott Laboratories. Humira has become the bestselling drug in history, with about $200 billion in all-time global sales.

In 2014, Walbert moved Horizon’s headquarters to Ireland, which nearly halved its tax rate. A year later it gained control of Krystexxa, and in 2017 it bought, for $145 million, a failing company that produced Tepezza, a drug for thyroid eye disease, which causes unsightly eye bulging and pain.

Tepezza quickly became a blockbuster, with $3.6 billion in total sales in 2021 and 2022. The company conducted additional clinical research on both Tepezza and Krystexxa, but it also spent heavily promoting these and other drugs to specialists who could prescribe them.

All the while it steadily raised prices. Savient put Krystexxa on the market in 2011 at $2,300 per injection. Horizon charges roughly 10 times as much. Six months of Tepezza treatment can run more than $400,000.

Horizon’s publicity emphasized the company’s sensitivity to patients, and its constant contact with disease advocates.

“Our scientists are attuned to the unmet needs of patients, their diagnostic and therapeutic journey,” Bill Rees, Horizon’s vice president for translational sciences, told KFF Health News. “It’s the marrying of the basic clinical science with a focus on the needs of the patient that differentiates us.”

To make sure patients keep using its drugs, clinicians say, Horizon staffers negotiate with insurance carriers, and the company offers drug discounts to lower-income patients while swaddling them with attention from its medical staff.

“Horizon has a nurse talk to each and every patient before every appointment,” said Dr. Brigid Freyne, who treats around half a dozen patients each year with Krystexxa at her Murrieta, California, rheumatology clinic. “The patients who come in here are highly motivated to get their IV. They get the message that it’s very important and they are fortunate to get the medicine.”

None of the manufacturers of her other infusion drugs shower patients with this kind of attention, she said.

While at Abbott, Walbert pioneered direct-to-consumer advertising for specialty drugs like Humira, a trend that aggravated insurers, who anticipated, correctly, that they would soon be shelling out billions for expensive drugs.

Horizon’s marketing plan for Krystexxa includes direct-to-consumer ads aimed at driving patients to specialists. The drug is designed for recalcitrant gout patients, who often have large lumps on their fingers, feet, and kidneys. Many, though not all, are heavy drinkers of beer or soda sweetened with high-fructose corn syrup, which can increase the buildup of uric acid, the cause of gout, said Dr. Robert McLean of Yale University.

While Krystexxa can help patients with advanced gout, the American College of Rheumatology views it as a drug of last resort, with plenty of cheaper, early intervention alternatives available.

“I prescribe it maybe once a year,” McLean said. “From a cost-effectiveness standpoint, it warrants questioning.”

Horizon recently started a publicity campaign addressed to all gout sufferers, urging them to see a rheumatologist or a nephrologist — the specialists it has targeted with Krystexxa educational materials — before the disease does too much harm.

“Horizon would like you to say, ‘Everyone with serious gout should be started on Krystexxa,’” said Dr. James O’Dell, a rheumatologist at the University of Nebraska Medical Center. The Horizon pitchmen he deals with are “nice guys, but we don’t believe that’s the best way.”

The company defends its marketing practices. “We learn what matters most to patient communities and act. This approach has been validated by independent third-party research,” said Riedel.

The Federal Trade Commission said in January it was seeking more information on the Amgen-Horizon merger. Sen. Elizabeth Warren (D-Mass.), citing high prices for Horizon and Amgen drugs, urged the agency to nix the deal.

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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Julie Rovner
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Julie Rovner is chief Washington correspondent and host of KHN’s 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.

With Medicare and Social Security apparently off the table for federal budget cuts, the focus has turned to Medicaid, the federal-state health program for those with low incomes. President Joe Biden has made it clear he wants to protect the program, along with the Affordable Care Act, but Republicans will likely propose cuts to both when they present a proposed budget in the next several weeks.

Meanwhile, confusion over abortion restrictions continues, particularly at the FDA. One lawsuit in Texas calls for a federal judge to temporarily halt distribution of the abortion pill mifepristone. A separate suit, though, asks a different federal judge to temporarily make the drug easier to get, by removing some of the FDA’s safety restrictions.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of STAT News, and Lauren Weber of The Washington Post.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Lauren Weber
The Washington Post

@LaurenWeberHP

Read Lauren's stories

Among the takeaways from this week’s episode:

• States are working to review Medicaid eligibility for millions of people as pandemic-era coverage rules lapse at the end of March, amid fears that many Americans kicked off Medicaid who are eligible for free or near-free coverage under the ACA won’t know their options and will go uninsured.
• Biden promised this week to stop Republicans from “gutting” Medicaid and the ACA. But not all Republicans are on board with cuts to Medicaid. Between the party’s narrow majority in the House and the fact that Medicaid pays for nursing homes for many seniors, cutting the program is a politically dicey move.
• A national group that pushed the use of ivermectin to treat covid-19 is now hyping the drug as a treatment for flu and RSV — despite a lack of clinical evidence to support their claims that it is effective against any of those illnesses. Nonetheless, there is a movement of people, many of them doctors, who believe ivermectin works.
• In reproductive health news, a federal judge recently ruled that a Texas law cannot be used to prosecute groups that help women travel out of state to obtain abortions. And the abortion issue has highlighted the role of attorneys general around the country — politicizing a formerly nonpartisan state post. –And Eli Lilly announced plans to cut the price of some insulin products and cap out-of-pocket costs, though their reasons may not be completely altruistic: An expert pointed out that a change to Medicaid rebates next year means drugmakers soon will have to pay the government every time a patient fills a prescription for insulin, meaning Eli Lilly’s plan could save the company money.

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

Julie Rovner: The New York Times’ “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins.

Alice Miranda Ollstein: The New York Times’ “Alone and Exploited, Migrant Children Work Brutal Jobs Across the U.S.,” by Hannah Dreier.

Rachel Cohrs: STAT News’ “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why,” by Sanjay Kishore and Suhas Gondi.

Lauren Weber: KHN and CBS News’ “This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” by Brett Kelman and Anna Werner.

Also mentioned in this week’s podcast:

• Politico’s “Why One State’s Plan to Unwind a Covid-Era Medicaid Rule Is Raising Red Flags,” by Megan Messerly.
• The Washington Post’s “Doctors Who Touted Ivermectin as Covid Fix Now Pushing It for Flu, RSV,” by Lauren Weber.
• NPR’s “To Safeguard Healthy Twins in Utero, She Had to ‘Escape’ Texas for Abortion Procedure,” by Selena Simmons-Duffin.
• The Daily Beast’s “Tennessee Abortion Ban a ‘Nightmare’ for Woman With Doomed Pregnancy,” by Michael Daly.

click to open the transcript

Transcript: March Medicaid Madness

KHN’s ‘What the Health?’Episode Title: Medicaid March MadnessEpisode Number: 287Published: March 2, 2023

Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, March 2, at 10 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 Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: And we officially welcome to the podcast panel this week Lauren Weber, ex of KHN and now at The Washington Post covering a cool new beat on health and science disinformation. Lauren, welcome back to the podcast.

Lauren Weber: Thanks for having me.

Rovner: So we’re going to get right to this week’s news. We’ve talked a lot about the political fight swirling around Medicare the past couple of weeks. So this week, I want to talk more about Medicaid. Our regular listeners will know, or should know, that states are beginning to re-determine eligibility for people who got on Medicaid during the covid pandemic and were allowed to stay on until now. In fact, Arkansas is vowing to re-determine eligibility for half a million people over the next six months. Alice, the last time Arkansas tried to do something bureaucratically complicated with Medicaid, it didn’t turn out so well, did it?

Ollstein: No. It was so much of a cautionary tale that no other state until now has gone down that path, although now at least a couple are attempting to. So Arkansas was the only state to actually move forward under the Trump administration with implementing Medicaid work requirements. And we covered it at the time, and just thousands and thousands of people lost coverage who should have qualified. They were working. They just couldn’t navigate the reporting system. Part of the problem was that you had to report your working hours online and a lot of people who are poor don’t have access to the internet. And, you know, the system was buggy and clunky and it was just a huge mess. But that is not stopping the state from trying again on several fronts. One, they want to do Medicaid work requirements again. The governor, Sarah Huckabee Sanders, has said that they plan to do that and also they plan to do their redeterminations for the end of the public health emergency in half the time the federal government would like states to take to do it. The federal government has incentives for states to go slow and take a full year to make sure people know how to prove whether or not they qualify for Medicaid and to learn what other insurance coverage options might be available to them. For instance, you know, Obamacare plans that are free or almost free.

Rovner: Yeah. Presumably most of the people who are no longer eligible for Medicaid but are still low-income will be eligible for Obamacare with hefty subsidies.

Ollstein: That’s right. So the fear is that history will repeat itself. A lot of people who should be covered will be dropped from coverage and won’t even know it because the state didn’t take the time to contact people and seek them out.

Rovner: This is something that we will certainly follow as it plays out over the next year. More broadly, though, there have been whispers — well, more than whispers, whines — over the past couple of weeks that President [Joe] Biden’s challenge to Republicans not to cut Social Security and Medicare, and Republicans’ apparent acceptance of that challenge, specifically leaves out Medicaid. Now, I never thought that was true, at least for the Democrats. But earlier this week, President Biden extended his promises to Medicaid and the Affordable Care Act. How much of a threat is there really to Medicaid in the coming budget battles? Rachel, you wrote about that today.

Cohrs: There is a lot of anxiety swirling around this on the Hill. I know there’s a former Trump White House official who’s circulated some documents that are making people a little bit nervous about Republicans’ position. But it is useful to look at existing documents out there. It is not reflective necessarily of the consensus Republican position. And it’s a very diverse party right now in the House. They have an incredibly narrow majority and Kevin McCarthy is really going to have to walk a tightrope here. And I think it is important to remember that when Medicaid has come up on steep ballot initiatives in red states, so many times it has passed overwhelmingly. So I think there is an argument to be made that Medicaid enjoys more political support among the GOP voting populace than maybe it does among members of Congress. So I think I am viewing it with caution. You know, obviously, it’s something that we’re going to have to be tracking and watching as these negotiations develop. But Democrats still hold the Senate and they still hold the presidency. So Republicans have more leverage than they did last Congress, but they’re still … Democrats still have a lot of sway here.

Rovner: Although I’ll just point out, as I think I pointed out before, that in 2017, when the Republicans tried to repeal the Affordable Care Act, one of the things they discovered is that Medicaid is actually kind of popular. I think … much to their surprise, they discovered that Medicaid is also kind of popular, maybe not as much as Medicare, but more than I think they thought. So I guess the budget wars really get started next week: We get President Biden’s budget, right?

Ollstein: And House Republicans are allegedly working on something. We don’t know when it will come or how much detail it will have, but it will be some sort of counter to Biden’s budget. But, you know, the real work will come later, in hashing it out in negotiations. And, really, a small number of people will be involved in that. And so just like Rachel said, you know, you’re going to see a lot of proposals thrown out over the next several months. Not all of them should necessarily be taken seriously or taken as determinative. Just one last interesting thing: This has been a really interesting education time, both for lawmakers and the public on just who is covered under these programs. I mean, the idea is that Medicare is so untouchable, is this third rail, because it is primarily seniors, and seniors vote. And seniors are more politically important to conservatives and Republicans. But people forget a lot of seniors are also on Medicaid. They get their nursing home coverage through there. And so I’ve heard a lot of Democratic lawmakers really hammering that argument lately and saying, look, you know, the stereotype for Medicaid is that it’s just poor adults, but …

Rovner: Yeah, moms and kids. That was how it started out.

Ollstein: Exactly.

Rovner: It was poor moms and kids.

Ollstein: Exactly. But it’s a lot more than that now. And it is more politically dicey to go after it than maybe people think.

Rovner: Yeah, I think Nancy Pelosi … in 2017 when, you know, if the threat with Medicare is throwing Granny off the cliff in her wheelchair, the threat of Medicaid is throwing Granny out of her nursing home, both of which have their political perils. All right. Well, we’ll definitely see this one play out for a while. I want to move to the public health beat. Lauren, you had a really cool story on the front page of The Washington Post this week about how the promise of ivermectin to treat infectious diseases in humans. And for those who forget, ivermectin is an anti-wormer drug that I give to my horse and both of my dogs. But the idea of using it for various infectious diseases just won’t die. What is the latest ivermectin craze?

Weber: Yes, and to be clear, there is an ivermectin that is a pill that can be given to humans, which is what these folks are talking about. But there’s this group called the Front Line COVID-19 Critical Care Alliance that really pushed ivermectin in the height of covid. As we all know on this podcast, scientific study after scientific study after clinical trial has disproved that there is any efficacy for that. But this group has continued to push it. And I discovered, looking at their website back this winter, that they’re now pushing it for the flu and RSV. And as I asked the CDC [Centers for Disease Control and Prevention] and medical experts, there’s no clinical data to support pushing that for the flu or RSV. And, you know, as one scientist said to me, they had data that … had antiviral properties in a test tube. But as one scientist said to me, well, if you put Coca-Cola in a test tube, it would show it had antiviral properties as well. So there’s a lot of pushback to these folks. But, that said, they told me that they have had their protocols downloaded over a million times. You know, they’re … absolutely have some prominence and have, you know, converted a share of the American population to the belief that this is a useful medical treatment for them. And one of the doctors that has left their group over their support of ivermectin said to me, “Look, I’m not surprised that they’re continuing to push this for something else. This is what they do now. They push this for other things.” And so it’s quite interesting to see this continue to play out as we continue into covid, to see them kind of expand, as these folks said to me, into other diseases.

Rovner: I know I mean, usually when we see these kinds of things, it’s because the people who are pushing them are also selling them and making money off of them. And I know that’s the case in some of this, but a lot of these are just doctors who are writing prescriptions for ivermectin. Right? I mean, this is an actual belief that they have.

Weber: Yeah, some of them do make money off of telehealth appointments. They can charge up to a couple hundred dollars for telehealth appointments. And one of the couple of co-founders had a lucrative Substack and book deal that talks about ivermectin and do get paid by this alliance. One of them made almost a quarter of a million dollars in salary from the alliance. But yeah, I mean, the average doctor that’s prescribing ivermectin, I mean — there were over 400,000 ivermectin prescriptions in, I think, it was August of 2021. So that’s a lot of prescriptions.

Rovner: They’re not all making money off of it.

Weber: They’re not all making money. And I mean, what’s wild to me is Merck has come out and said, which, in a very rare statement for a pharmaceutical company, you know, don’t prescribe our drug for this. And when I asked them about RSV and the flu, they said, yeah, our statement would still stand on that. So it’s a movement, to some extent. And the folks I talked to about it, they really believe …

Rovner: And I will say, for a while in 2021, you couldn’t get horse wormer, which is a very nasty-tasting paste, even the horses don’t really like it. Because it was hard to get ivermectin at all. So we’ll see where this goes next. Here’s one of those “in case you missed It” stories. The Tulsa World this week has an interview with former Republican Sen. James Inhofe, who said, in his blunt Inhofe way, that he retired last year not only because he’s 88, but because he’s still suffering the effects of long covid. And he’s not the only one — quote, “five or six others have [long covid], but I’m the only one who admits it,” he told the paper, referring to other members of the Senate, presumably other Republican members of the Senate. Now, mind you, the very conservative Inhofe voted against just about every covid funding bill. And my impression from not going to the Hill regularly in 2021 and 2022 is that while covid seemed to be floating around in the air, lots of people were getting it, very few people seemed to be getting very sick. But now we’re thinking that’s not really the case, right?

Ollstein: When I saw this, I immediately went back to a story I wrote about a year ago on Tim Kaine’s long covid diagnosis and his attempts to convince his colleagues to put more research funding or treatment funding, more basic covid prevention funding … you know, fewer people will get long covid if fewer people get covid in the first place. And there was just zero appetite on the Republican side for that. And that’s why a lot of it didn’t end up passing. Inhofe was one of the Republicans I talked to, and I said, you know, do you think you should do more about long covid? What do you think about this? And this is what he told me: “I have other priorities. We’re handling all we can right now.” And then he added that long covid is not that well defined. And he argued there’s no way to determine how many people are affected. Well.

Rovner: OK.

Ollstein: So that … in “Quotes That Aged Poorly Hall of Fame.”

Rovner: You know, obviously Tim Kaine came forward and talked about it. But now I’m wondering if there are people who are slowing down or looking like they’re not well, maybe they have long covid and don’t want to say.

Ollstein: Well, I mean, something that Tim Kaine’s case shows is that there’s no one thing it can look like and somebody can look completely healthy and normal on the outside and be suffering symptoms. And Tim Kaine has also said that members of Congress have quietly disclosed to him and thanked him for speaking up, but said they weren’t willing to do it themselves. And he, Tim Kaine, told me that he felt more comfortable speaking up because the kind of symptoms he had were less stigmatized. They weren’t anything in terms of impeding his mental capacity and function. And there’s just a lot of stigma and fear of people coming forward and admitting they’re having a problem.

Rovner: I find it kind of ironic that last week we talked about how, you know, members of Congress and politicians with mental health, you know, normally stigmatizing problems are more willing to talk about it. And yet here are people with long covid not willing to talk about it. So maybe we’ll see a little bit more after this or maybe not. I want to talk a little bit about artificial intelligence and health care. I’ve been wanting to talk about this for a while, but this week seems to be everyone is talking about AI. There have been a spate of stories about how different types of artificial intelligence are aiding in medical care, but also some cautionary tales, particularly about chat engines. They get all their information from the internet, good or bad. Now, we already have robots that do intricate surgeries and lots and lots of treatment algorithms. On the other hand, the little bit of AI that I already have that’s medical-oriented, my Fitbit, that sometimes accurately tracks my exercise and sometimes doesn’t, and the chat bot from my favorite chain drugstore that honestly cannot keep my medication straight. None of that makes me terribly optimistic about launching into health AI. Is this, like most tech, going to roll out a little before it’s ready and then we’ll work the bugs out? Or maybe are we going to be a little bit more careful with some of this stuff?

Cohrs: I think we’ve already seen some examples of things rolling out before they’re exactly ready. And I just thought of my colleague Casey Ross’ reporting on Epic’s algorithm that was supposed to help …

Rovner: Epic, the electronic medical records company.

Cohrs: Yes, yes. They had this algorithm that was supposed to help doctors treat sepsis patients, and it didn’t work. The problem with using AI in health care is that there are life-and-death consequences for some of these things. If you’re misdiagnosing someone, if you’re giving them medicine they don’t need, there are, like, those big consequences. But there are also the smaller ones too. And my colleague Brittany Trang wrote about how with doctor’s notes or transcripts of conversations between a physician and a patient sometimes AI has difficulty differentiating between an “mm-hm” or an “uh-huh” and telling whether that’s a yes or a no. And so I think that there’s just all of these really fascinating issues that we’re going to have to work through. And I think there is enormous potential, certainly, and I think there’s getting more experimentation. But like you said, I think in health care it’s just a very different beast when you’re rolling things out and making sure that they work.

Weber: Yeah, I wanted to add, I mean, one of the things that I found really interesting is that doctors’ offices are using some of it to reduce some of the administrative burden. As we all know, prior authorizations suck up a lot of time for doctors’ offices. And it seems like this has actually been really helpful for them. That said, I mean, that comes with the caveat of — my colleagues and I and much reporting has shown that — sometimes these things just make up references for studies. They just make it up. That level of “Is this just a made-up study that supports what I’m saying?” I think is really jarring. This isn’t quite like using Google. It cannot be trusted to the level … and I think people do have caution with it and they will have to continue to have caution with it. But I think we’re really only at the forefront of figuring out how this all plays out.

Rovner: I was talking before we started taping about how I got a text from my favorite chain drugstore saying that I was out of refills and that they would call my doctor, which is fine. And then they said, “Text ‘Yes’ if you would like us to call” … some other doctor. I’m like, “Who the heck is this other doctor?” And then I realize he’s the doctor I saw at urgent care last September when I burned myself. I’m like, “Why on earth would you even have him in your system?” So, you know, that’s the sort of thing … it’s like, we’re going to be really helpful and do something really stupid. I worry that Congress, in trying to regulate tech, and failing so far — I mean, we’ve seen how much they do and don’t know about, you know, Facebook and Instagram and the hand-wringing over TikTok because it’s owned by the Chinese — I can’t imagine any kind of serious, thoughtful regulation on this. We’re going to have to basically rely on the medical industry to decide how to roll this out, right? Or might somebody step in?

Ollstein: I mean, there could be agency, you know, rulemaking, potentially. But, yes, it’s the classic conundrum of technology evolving way faster than government can act to regulate it. I mean, we see that on so many fronts. I mean, look how long has gone without any kind of update. And, you know, the kinds of ways health information is shared are completely different from when that law was written, so …

Rovner: Indeed.

Weber: And as Rachel said, I mean, this is life-or-death consequences in some places. So the slowness with which the government regulates things could really have a problem here, because this is not something that is just little …

Rovner: Of the things that keep me awake at night, this is one of the things that keeps me awake at night. All right. Well, one of these weeks, we will not have a ton of reproductive health news. But this week isn’t it. As of this taping, we still have not gotten a decision in that Texas case challenging the FDA approval of the abortion pill, mifepristone, back in the year 2000. But there’s plenty of other abortion news happening in the Lone Star State. First, a federal judge in Texas who was not handpicked by the anti-abortion groups ruled that Texas officials cannot enforce the state’s abortion ban against groups who help women get abortion out of state, including abortion funds that help women get the money to go out of state to get an abortion. The judge also questioned whether the state’s pre-Roe ban is even in effect or has actually been repealed, although there are overlapping bans in the state that … so that wouldn’t make abortion legal. But still, this is a win for the abortion rights side, right, Alice?

Ollstein: Yeah, I think the right knows that there are two main ways that people are still getting abortions who live in ban states. They’re traveling out of state or they are ordering pills in the mail. And so they are moving to try to cut off both of those avenues. And, you know, running into some difficulty in doing so, both in the courts and just practically in terms of enforcing. This is part of that bigger battle to try to cut off, you know, people’s remaining avenues to access the procedure.

Rovner: Well, speaking exactly of that, Texas being Texas, this week, we saw a bill introduced in the state legislature that would ban the websites that include information about how to get abortion pills and would punish internet providers that fail to block those sites. It would also overturn the court ruling we just talked about by allowing criminal prosecution of anyone who helps someone get an abortion. Even a year ago, I would have said this is an obvious legislative overreach, but this is Texas. So now maybe not so much.

Ollstein: I mean, I think lots of states are just throwing things at the wall to see what sticks and to see what gets through the courts. You had states test the waters on banning certain kinds of out-of-state travel, and that hasn’t gone anywhere yet. But even things that don’t end up passing and being implemented can have a chilling effect. You have a lot of confusion right now. You have a lot of people not sure what’s legal, what’s not. And if you create this atmosphere of fear where people might be afraid to go out of state, might be afraid to ask for funding to go out of state, afraid to Google around and see what their options are that serves the intended impacts of these proposals, in terms of preventing people from exploring their options and seeing what they can do to terminate a pregnancy.

Rovner: Yeah. Well, meanwhile, a dozen states that are not named Texas are suing the FDA, trying to get it to roll back some of the prescribing requirements around the abortion pill. The states are arguing that not only are the risk-mitigation rules unnecessary, given the proven safety of mifepristone, but that some of the certification requirements could invade the privacy of patients and prescribers and subject them to harassment or worse. They’re asking the judge to halt enforcement of the restrictions while the case is being litigated. That could run right into [U.S. District] Judge [Matthew] Kacsmaryk’s possible injunction in Texas banning mifepristone nationwide. Then what happens? If you’ve got one judge saying, “OK, you can’t sell this nationwide,” and another judge saying … “Of course you can sell it, and you can’t use these safety restrictions that the FDA has put around it.” Then the FDA has two conflicting decisions in front of it.

Weber: Yeah, and I find the battles of the AGs and the abortion wars are really fascinating because, I mean, this is a lawsuit brought by states, which is attorneys general, Democratic attorneys general. And you’re seeing that play out. I mean, you see that in Texas, too, with [Ken] Paxton. You see it in Michigan with [Dana] Nessel. I mean, I would argue one of the things that attorney generals have been the most prominent on in the last several decades of American history and have actually had immediate effects on due to the fall of Roe v. Wade. So we’ll see what happens. But it is fascinating to see in real time this proxy battle, so to speak, between the two sides play out across the states and across the country.

Rovner: No, it’s funny. State AGs did do the tobacco settlement.

Weber: Yes.

Rovner: I mean, that would not have happened. But what was interesting about that is that it was very bipartisan.

Weber: Well, they were on the same side.

Rovner: And this is not.

Weber: Yeah, I mean, yeah, they were on the same side. This is a different deal. And I think to some extent, and I did some reporting on this last year, it speaks to the politicization of that office and what that office has become and how it’s become, frankly, a huge launching pad for people’s political careers. And the rhetoric there often is really notched up to the highest levels on both sides. So, you know, as we continue to see that play out, I think a lot of these folks will end up being folks you see on the national stage for quite some time.

Ollstein: I’ve been really interested in the states where the attorney general has clashed with other parts of their own state government. And so in North Carolina, for example, right now you have the current Democratic attorney general who is planning to run for governor. And he said, I’m not going to defend our state restrictions on abortion pills in court because I agree with the people challenging them. And then you have the Republican state legislatures saying, well, if he’s not going to defend these laws, we will. So that kind of clash has happened in Kentucky and other states where the attorney general is not always on the same side with other state officials.

Rovner: If that’s not confusing enough, we have a story out of Mississippi this week, one of the few states where voters technically have the ability to put a question on the ballot, except that process has been blocked for the moment by a technicality. Now, Republican legislators are proposing to restart the ballot initiative process. They would fix the technicality, but not for abortion questions. Reading from the AP story here, quote, “If the proposed new initiative process is adopted, state legislators would be the only people in Mississippi with the power to change abortion laws.” Really? I mean, it’s hard to conceive that they could say you can have a ballot question, but not on this.

Ollstein: This is, again, part of a national trend. There are several Republican-controlled states that are moving right now to attempt to limit the ability of people to put a measure on the ballot. And this, you know, comes as a direct result of last year. Six states had abortion-related referendums on their ballot. And in all six, the pro-abortion rights side won. Each one was a little different. We don’t need to get into it, but that’s the important thing. And so people voted pretty overwhelmingly, even in really red states like Kentucky and Montana. And so other states that fear that could happen there are now moving to make that process harder in different ways. You have Mississippi trying to do, like, a carve-out where nothing on abortion can make it through. Other states are just trying to raise, like, the signature threshold or the vote threshold people need to get these passed. There are a lot of different ways they’re going about it.

Rovner: I covered the Mississippi “personhood” amendment back in 2011. It was the first statewide vote on, you know, granting personhood to fetuses. And everybody assumed it was going to win, and it didn’t, even in Mississippi. So I think there’s reason for the legislators who are trying to re-stand up this ballot initiative process to worry about what might come up and how the voters might vote on it. Well, because I continue to hear people say that women trying to have babies are not being affected by state abortion bans and restrictions, this week we have not one but two stories of pregnant women who were very much impacted by abortion bans. One from NPR is the story of a Texas woman pregnant with twins — except one twin had genetic defects not only incompatible with life, but that threatened the life of both the other twin and the pregnant woman. She not only had to leave the state for a procedure to preserve her own life and that of the surviving twin, but doctors in Texas couldn’t even tell her explicitly what was going on for fear of being brought up on charges of violating the state’s ban. I think, Alice, you were the one talking about how, you know, women are afraid to Google. Doctors are afraid to say anything.

Ollstein: Yeah, absolutely. I mean, it’s a really chilling and litigious environment right now. And I think, as more and more of these stories start to come forward, I think that is spurring the debates you’re seeing in a lot of states right now about adding or clarifying or expanding the kind of exceptions that exist on these bans. So you have very heated debates going on right now in Utah and Tennessee and in several states around, you know, should we add more exceptions because there are some Republican lawmakers who are looking at these really tragic stories that are trickling out and saying, “This isn’t what we intended when we voted for this ban. Let’s go back and revisit.” Whether exceptions even work when they are on the books is another question that we can discuss. I mean, we have seen them not be effective in other states and people not able to navigate them.

Rovner: We’ve seen a lot of these stories about women whose water broke early and at what point is it threatening her life? How close to death does she have to be before doctors can step in? I mean, we’ve seen four or five of these. It’s not like they’re one-offs. The other story this week is from the Daily Beast. It’s about a 28-year-old Tennessee woman whose fetus had anomalies with its heart, brain, and kidneys. That woman also had to leave the state at her own expense to protect her own health. Is there a point where anti-abortion forces might realize they are actually deterring women who want babies from getting pregnant for fear of complications that they won’t be able to get treated?

Ollstein: Most of the pushback I’ve seen from anti-abortion groups, they claim that the state laws are fine and that doctors are misinterpreting them. And there is a semantic tug of war going on right now where anti-abortion groups are trying to argue that intervening in a medical emergency shouldn’t even count as an abortion. Doctors argue, no, it is an abortion. It’s the same procedure medically, and thus we are afraid to do it under the current law. And the anti-abortion groups are saying, “Oh, no, you’re saying that in bad faith; that doesn’t count as an abortion. An abortion is when it’s intended to kill the fetus.” So you’re having this challenging tug of war, and it’s not really clear what states are going to do. There’s a lot of state bills on this making their way through legislatures right now.

Rovner: And doctors and patients are caught in the middle. Well, finally this week, Eli Lilly announced it would lower, in some cases dramatically, the list prices for some of its insulin products. You may remember that, last year, Democrats in Congress passed a $35-per-month cap for Medicare beneficiaries but couldn’t get those last few votes to apply the cap to the rest of the population. Lilly is getting very good press. Its stock price went up, even though it’s not really capping all the out-of-pocket costs for insulin for everybody. But I’m guessing they’re not doing this out of the goodness of their drugmaking heart, right, Rachel?

Cohrs: Probably not. Even though there’s a quote from their CEO that implied that that was the case. I think there was one drug pricing expert at West Health Policy Center, Sean Dickson, who is very sharp on these issues, knows the programs well. And he pointed out that there’s a new policy going into effect in Medicaid next year, and it’s really, really wonky and complicated. But I’ll do my best to try to explain that, generally, in the Medicare program, rebates are capped, or they have been historically, at the price of the drug. So you can’t charge a drugmaker a rebate that’s higher than the cost. But …

Rovner: That would make sense.

Cohrs: Right. But that math can get kind of wonky when there are really high drug price increases and then that math gets really messed up. But Congress, I want to say it was in 2021, tweaked this policy to discourage those big price increases. And they said, you know what? We’re going to raise the rebate cap in Medicaid, which means that, drugmakers, if you are taking really big price increases, you may have to pay us every time someone on Medicaid fills those prescriptions. And I think people thought about insulin right away as a drug that has these really high rebates already and could be a candidate disproportionately impacted by this policy. So I thought that was an interesting point that Sean made about the timing of this. That change is supposed to go into effect early next year. So this could, in theory, save Lilly a lot of money in the Medicaid program because we don’t know exactly what their net prices were before.

Rovner: But this is very convenient.

Cohrs: It’s convenient. And there’s a chance that they’re not really losing any money right now, depending on how their contracts work with insurers. So I think, yeah, there is definitely a possibility for some ulterior motives here.

Rovner: And plus, the thing that I learned this week that I hadn’t known before is that there are starting to be some generic competition. The three big insulin makers, which are Lilly, Sanofi, and Novo Nordisk, may actually not become the, almost, the only insulin maker. So it’s probably in Lilly’s interest to step forward now. And, you know, they’re reducing the prices on their most popular insulins, but not necessarily their most expensive insulin. So I think there’s still money to be made in this segment. But they sure did get, you know, I watched all the stories come across. It’s, like, it’s all, oh, look at this great thing that Lilly has done and that everything’s going to be cheap. And it’s, like, not quite. But …

Cohrs: But it is different. It’s a big step. And I think …

Rovner: It is. It is.

Cohrs: Somebody has to go first in breaking this cycle. And I think it will be interesting to see how that plays out for them and whether the other two companies do follow suit. Sen. Bernie Sanders asked them to and said, you know, why don’t you just all do the same thing and lower prices on more products? So, yeah, we’ll see how it plays out.

Weber: Day to day, I mean, that’s a huge difference for people. I mean, that is a lot of money. That is a big deal. So, I mean, you know, no matter what the motivation, at the end of the day, I think the American public will be much happier with having to pay a lot less for insulin.

Rovner: Yeah, I’m just saying that not everybody who takes insulin is going to pay a lot less for insulin.

Weber: Right. Which is very fair, very fair.

Rovner: But many more people than before, which is, I think, why it got lauded by everybody. Although I will … I wrote in my notes, please, someone mention Josh Hawley taking credit and calling for legislation. Sen. Hawley from Missouri, who voted against extending the $35 cap, as all Republicans did, to the rest of the population, put out a tweet yesterday that was, like, this is a great thing and now we should have, you know, legislation to follow up. And I’m like: OK.

Cohrs: You’ll have to check on that. I actually think Hawley may have voted for it.

Rovner: Oh, a-ha. All right.

Cohrs: There were a few Republicans.

Rovner: Thank you.

Cohrs: It’s not enough, though.

Rovner: Yeah, I remember that they couldn’t get those last few votes. Yes, I think [Sen. Joe] Manchin voted against. He was the one, the last Democrat they couldn’t get right. That’s why they ended up dropping …

Cohrs: Uh, it had to be a 60-vote threshold, so …

Rovner: Oh, that’s right.

Cohrs: Yeah.

Rovner: All right. Good. Thank you. Good point, Rachel. All right. Well, that is the news for this week. Now it is 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 khn.org and in our show notes on your phone or other mobile device. Alice, why don’t you go first this week?

Ollstein: Yeah. So I did the incredible New York Times investigation by Hannah Dreier on child labor. This is about undocumented, unaccompanied migrant children who are coming to the U.S. And the reason I’m bringing it up on our podcast is there is a health angle. So HHS [the Department of Health and Human Services], their Office of Refugee Resettlement has jurisdiction over these kids’ welfare and making sure they are safe. And that is not happening right now. The system is so overwhelmed that they have been cutting corners in how they vet the sponsors that they release the kids to. Of course, we remember that there were tons of problems with these kids being detained and kept for way too long and that being a huge threat to their physical and mental health. But this is sort of the pendulum has swung too far in the opposite direction, and they’re being released to people who in some cases straight up trafficking them and in other cases just forcing them to work and drop out of school, even if it’s not a trafficking situation. And so this reporting has already had an impact. The HHS has announced all these new initiatives to try to stop this. So we’ll see if they are effective. But really moving, incredible reporting.

Rovner: Yeah, it was an incredible story. Lauren.

Weber: I’m going to shout out my former KHN colleague Brett Kelman. I loved his piece on, I guess you can’t call it a medical device because it wasn’t approved by the FDA, which is the point of the story. But this device that was supposed to fix your jaw so you didn’t have to have expensive jaw surgery. Well, what it ended up doing is it messed up all these people’s teeth and totally destroyed their mouths and left them with a bunch more medical and dental bills. And, you know, what I find interesting about the story, what I find interesting about the trend in general is the problem is, they never applied for anything with the FDA. So people were using this device, but they didn’t check, they didn’t know. And I think that speaks to the American public’s perception that devices and medical devices and things like this are safe to use. But a lot of times the FDA regulations are outdated or are not on top of this or the agency is so understaffed and not investigating that things like this slipped through the cracks. And then you have people — and it’s 10,000 patients, I believe, that have used this tool — that did not do what it is supposed to do and, in fact, injured them along the way. And I think that the FDA piece of that is really interesting. It’s something I’ve run into before looking at air cleaners and how they fit the gaps of that. And I think it’s something we’re going to continue to see as we examine how these agencies are really stacking up to the evolution of technology today.

Rovner: Yeah, capitalism is going to push everything. Rachel.

Cohrs: So my extra credit this week is actually an opinion piece, in Stat, and the headline is “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why.” It was written by Sanjay Kishore and Suhas Gondi. I think the part that really stood out to me is they analyzed the backgrounds and makeups of hospital boards, especially nonprofit hospitals. I think they analyzed like 20 large facilities. And the statistic that really surprised me was that, I think, 44% of those board members came from the financial sector representing investment funds, real estate, and other entities. Less than 15% were health care workers, 13% were physicians, and less than 1% were nurses. And, you know, I’ve spent a lot of time and we’ve spent a lot of time thinking about just how nonprofit hospitals are operating as businesses. And I think a lot of other publications have done great work as well making that point. But I think this is just a stark statistic that shows these boards that are supposed to be holding these organizations accountable are thinking about the bottom line, because that’s what the financial services sector is all about, and that there’s so much disproportionately less clinical representation. So obviously hospitals need admin sides to run, and they are businesses, and a lot of them don’t have very large margins. But the statistics just really surprised me as to the balance there.

Rovner: Yeah, I felt like this is one, you know, we’ve all been sort of enmeshed in this, you know, what are we going to do about the nonprofit hospitals that are not actually acting as charitable institutions? But I think the boards had been something that I had not seen anybody else look at until now. So it’s a really interesting piece. All right. Well, my story this week is the other big investigation from The New York Times. It’s called “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins. And it’s about those same risk-mitigation rules from the FDA that are at the heart of those abortion drug lawsuits we talked about a few minutes ago. Except in this case, the drug company in question, Jazz Pharmaceuticals, somehow patented its risk-mitigation strategy as the distribution center — it’s actually called the REMS [Risk Evaluation and Mitigation Strategies] — which is managed to fend off generic competition for the company’s narcolepsy drug. It had also had a response already. It has produced a bipartisan bill in the Senate to close the loophole — but [I’ll] never underestimate the creativity of drugmakers when it comes to protecting their profit. It’s quite a story. OK. That’s our show for this week. 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 — all one word — at kff.org. Or you can tweet me. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Rachel.

Cohrs: @rachelcohrs

Rovner: Lauren.

Weber: @LaurenWeberHP

Rovner: We will be back in your feed next week. In the meantime, be healthy.

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KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Las aflicciones del barrio se remontan a principios de los años 70, cuando la industria desapareció y el tráfico de drogas se afianzó. Con cada nueva oleada de drogas, la situación se agrava. Ahora está peor que nunca. Ahora, con la llegada de la xilacina, un tranquilizante de uso veterinario, nuevas complicaciones están sobrecargando un sistema ya desbordado.

“Hay que poner manos a la obra”, dijo Dave Malloy, un veterano trabajador social de Philadelphia que trabaja en Kensington y otros lugares de la ciudad.

Los traficantes utilizan xilacina, un sedante barato no autorizado, para cortar el fentanilo, un opioide sintético 50 veces más potente que la heroína. El nombre callejero de la xilacina es “tranq”, y el fentanilo cortado con xilacina se llama “tranq dope”.

La xilacina lleva una década diseminándose por el país, según la Agencia Antidroga (DEA). Su aparición ha seguido la ruta del fentanilo: empezando en los mercados de heroína en polvo blanco del noreste y desplazándose después hacia el sur y el oeste.

Además, ha demostrado ser fácil de fabricar, vender y transportar en grandes cantidades para los narcotraficantes extranjeros, que acaban introduciéndola en Estados Unidos, donde circula a menudo en paquetes de correo exprés.

La xilacina se detectó por primera vez en Philadelphia en 2006. En 2021 se encontró en el 90% de las muestras de opioides callejeros. En ese año, el 44% de todas las muertes por sobredosis no intencionales relacionadas con el fentanilo incluyeron xilacina, según estadísticas de la ciudad. Dado que los procedimientos de análisis durante las autopsias varían mucho de un estado a otro, no hay datos exhaustivos sobre las muertes por sobredosis con xilacina a nivel nacional, según la DEA.

Aquí en Kensington, los resultados están a la vista. Usuarios demacrados caminan por las calles con heridas necróticas en piernas, brazos y manos, que a veces llegan al hueso.

La vasoconstricción que provoca la xilacina y las condiciones antihigiénicas dificultan la cicatrización de cualquier herida, y mucho más de las úlceras graves provocadas por la xilacina, explicó Silvana Mazzella, directora ejecutiva de Prevention Point Philadelphia, un grupo que ofrece servicios conocidos como “reducción del daño”.  

Stephanie Klipp, enfermera que se dedica al cuidado de heridas y a la reducción de daños en Kensington, dijo que ha visto a personas “viviendo literalmente con lo que les queda de sus extremidades, con lo que obviamente debería ser amputado”.

El papel que desempeña la xilacina en las sobredosis mortales pone de relieve uno de sus atributos más complicados. Al ser un depresor del sistema nervioso central, la naloxona no funciona cuando se trata de un sedante.

Aunque la naloxona puede revertir el opioide de una sobredosis de “tranq dope”, alguien debe iniciar la respiración artificial hasta que lleguen los servicios de emergencia o la persona consiga llegar a un hospital, cosa que a menudo no ocurre. “Tenemos que mantener a las personas con vida el tiempo suficiente para tratarlas, y eso aquí es diferente cada día”, explicó Klipp.

Si un paciente llega al hospital, el siguiente paso es tratar el síndrome de abstinencia agudo de “tranq dope”, que es algo delicado. Apenas existen estudios sobre cómo actúa la xilacina en humanos.

Melanie Beddis vivió con su adicción dentro y fuera de las calles de Kensington durante unos cinco años. Recuerda el ciclo de desintoxicación de la heroína. Fue horrible, pero después de unos tres días de dolores, escalofríos y vómitos, podía “retener la comida y posiblemente dormir”. Con la “tranq dope” fue peor. Cuando intentó dejar esa mezcla en la cárcel, no pudo comer ni dormir durante unas tres semanas.

Las personas que se desintoxican de la “tranq dope” necesitan más medicamentos, explicó Beddis, ahora en recuperación, quien ahora es directora de programas de Savage Sisters Recovery, que ofrece alojamiento, asistencia y reducción de daños en Kensington.

“Necesitamos una receta que sea eficaz”, señaló Jeanmarie Perrone, médica y directora fundadora del Centro de Medicina de Adicciones de Penn Medicine.

Perrone dijo que primero trata la abstinencia de opioides, y luego, si un paciente sigue experimentando malestar, a menudo utiliza clonidina, un medicamento para la presión arterial que también funciona para la ansiedad. Otros médicos han probado distintos fármacos, como la gabapentina, un medicamento anticonvulsivo, o la metadona.

“Es necesario que haya más diálogo sobre lo que funciona y lo que no, y que se ajuste en tiempo real”, afirmó Malloy.

Philadelphia ha anunciado recientemente que va a poner en marcha un servicio móvil de atención de heridas como parte de su plan de gastos de los fondos del acuerdo sobre opioides, con la esperanza de que esto ayude al problema de la xilacina.

Lo mejor que pueden hacer los especialistas en las calles es limpiar y vendar las úlceras, proporcionar suministros, aconsejar a la gente que no se inyecte en las heridas y recomendar tratamiento en centros médicos, explicó Klipp, que no cree que un hospital pueda ofrecer a sus pacientes un tratamiento adecuado contra el dolor. Muchas personas no pueden quebrar el ciclo de la adicción y no hacen seguimiento.

Mientras que la heroína solía dar un margen de 6-8 horas antes de necesitar otra dosis, la “tranq dope” solo da 3-4 horas, estimó Malloy. “Es la principal causa de que la gente no reciba la atención médica adecuada”, añadió. “No pueden estar el tiempo suficiente en urgencias”.

Además, aunque las úlceras resultantes suelen ser muy dolorosas, los médicos son reacios a dar a los usuarios analgésicos fuertes. “Muchos médicos ven eso como que buscan medicación en lugar de lo que está pasando la gente”, dijo Beddis.

Por su parte, Jerry Daley, director ejecutivo de la sección local de un programa de subvenciones gestionado por la Oficina de Política Nacional de Control de Drogas (ONDCP), dijo que los funcionarios de salud y las fuerzas del orden deben comenzar a tomar medidas enérgicas contra la cadena de suministro de xilacina y transmitir el mensaje de que las empresas deshonestas que la fabrican están “literalmente beneficiándose de la vida y las extremidades de las personas”.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The neighborhood’s afflictions date to the early 1970s, when industry left and the drug trade took hold. With each new wave of drugs, the situation grows grimmer. Now, with the arrival of xylazine, a veterinary tranquilizer, new complications are burdening an already overtaxed system.

“It’s all hands on deck,” said Dave Malloy, a longtime Philadelphia social worker who does mobile outreach in Kensington and around the city.

Dealers are using xylazine, which is uncontrolled by the federal government and cheap, to cut fentanyl, a synthetic opioid up to 50 times stronger than heroin. The street name for xylazine is “tranq,” and fentanyl cut with xylazine is “tranq dope.” Mixed with the narcotic, xylazine amplifies and extends the high of fentanyl or heroin.

But it also has dire health effects: It leaves users with unhealing necrotic ulcers, because xylazine restricts blood flow through skin tissue. Also, since xylazine is a sedative rather than a narcotic, overdoses of tranq dope do not respond as well to the usual antidote — naloxone — which reverses the effects of only the latter.

Xylazine has been spreading across the country for at least a decade, according to the Drug Enforcement Administration, starting in the Northeast and then moving south and west. Plus, it has proven to be easy for offshore bad actors to manufacture, sell, and ship in large quantities, eventually getting it into the U.S., where it often circulates by express delivery.

First detected in Philadelphia in 2006, xylazine was found in 90% of street opioid samples in the city by 2021. That year, 44% of all unintentional fentanyl-related overdose deaths involved xylazine, city statistics show. Since testing procedures during postmortems vary widely from state to state, no comprehensive data for xylazine-positive overdose deaths nationally exists, according to the DEA.

Here in Kensington, the results are on display. Emaciated users walk the streets with necrotic wounds on their legs, arms, and hands, sometimes reaching the bone.

Efforts to treat these ulcers are complicated by the narrowing of blood vessels that xylazine causes as well as dehydration and the unhygienic living conditions that many users experience while living homeless, said Silvana Mazzella, associate executive officer of the public health nonprofit Prevention Point Philadelphia, a group that provides services known as harm reduction.

Stephanie Klipp, a nurse who does wound care and is active in harm reduction efforts in Kensington, said she has seen people “literally living with what’s left of their limbs — with what obviously should be amputated.”

Fatal overdoses are rising because of xylazine’s resistance to naloxone. When breathing is suppressed by a sedative, the treatment is CPR and transfer to a hospital to be put on a ventilator. “We have to keep people alive long enough to treat them, and that looks different every day here,” Klipp said.

If a patient reaches the hospital, the focus becomes managing acute withdrawal from tranq dope, which is dicey. Little to no research exists on how xylazine acts in humans.

Melanie Beddis lived with her addiction on and off the streets in Kensington for about five years. She remembers the cycle of detoxing from heroin cold turkey. It was awful, but usually, after about three days of aches, chills, and vomiting, she could “hold down food and possibly sleep.” Tranq dope upped that ante, said Beddis, now director of programs for Savage Sisters Recovery, which offers housing, outreach, and harm reduction in Kensington.

She recalled that when she tried to kick this mix in jail, she couldn’t eat or sleep for about three weeks.

There is no clear formula for what works to aid detoxing from opiates mixed with xylazine.

“We do need a recipe that’s effective,” said Dr. Jeanmarie Perrone, founding director of the Penn Medicine Center for Addiction Medicine and Policy.

Perrone said she treats opioid withdrawal first, and then, if a patient is still uncomfortable, she often uses clonidine, a blood pressure medication that also lessens anxiety. Other doctors have tried gabapentin, an anticonvulsant medication sometimes used for anxiety.

Methadone, a medication for opioid use disorder, which blunts the effects of opioids and can be used for pain management, seems to help people in tranq dope withdrawal, too.

In the hospital, after stabilizing a patient, caring for xylazine wounds may take priority. This can range from cleaning, or debridement, to antibiotic treatment — sometimes intravenously for periods as long as weeks — to amputation.

Philadelphia recently announced it is launching mobile wound care as part of its spending plan for opioid settlement funds, hopeful that this will help the xylazine problem.

The best wound care that specialists on the street can do is clean and bandage ulcers, provide supplies, advise people not to inject into wounds, and recommend treatment in medical settings, said Klipp. But many people are lost in the cycle of addiction and don’t follow through.

While heroin has a six- to eight-hour window before the user needs another hit, tranq dope wanes in just three or four, Malloy estimated. “It’s the main driver why people don’t get the proper medical care,” he said. “They can’t sit long enough in the ER.”

Also, while the resulting ulcers are typically severely painful, doctors are reluctant to give users strong pain meds. “A lot of docs see that as med-seeking rather than what people are going through,” Beddis said.

In the meantime, Jerry Daley, executive director of the local chapter of a grant program run by the Office of National Drug Control Policy, said health officials and law enforcement need to start cracking down on the xylazine supply chain and driving home the message that rogue companies that make xylazine are “literally profiting off of people’s life and limb.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Julie Rovner is chief Washington correspondent and host of KHN’s 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.

Health care was a recurring theme throughout President Joe Biden’s 2023 State of the Union address on Capitol Hill this week. He took a victory lap on recent accomplishments like capping prescription drug costs for seniors on Medicare. He urged Congress to do more, including making permanent the boosted insurance premium subsidies added to the Affordable Care Act during the pandemic. And he sparred with Republicans in the audience — who jeered and called him a liar — over GOP proposals that would cut Medicare and Social Security.

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.

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Sarah Karlin-Smith
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Alice Miranda Ollstein
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Read Alice's stories

Among the takeaways from this week’s episode:

• President Joe Biden’s State of the Union address emphasized recent victories against high health care costs, like Medicare coverage caps on insulin and out-of-pocket caps on prescription drug spending. Biden’s lively, informal exchange with lawmakers over potential cuts to Medicare and Social Security seemed to steal the show, though the political fight over cutting costs in those entitlement programs is rooted in a key question: What constitutes a “cut”?
• Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. And last year’s Senate fights demonstrate that sometimes the opposition comes from within the Democratic Party.
• While some abortion advocates praised Biden for vowing to veto a federal abortion ban, others felt he did not talk enough about the looming challenges to abortion access in the courts. A decision is expected soon in a Texas court case challenging the future use of mifepristone. The Trump-appointed judge’s decision could ban the drug nationwide, meaning it would be barred even in states where abortion continues to be legal.
• The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. In other FDA news, the agency recently changed policy to allow gay men to donate blood; announced new food safety leadership in response to the baby formula crisis; and kicked back to Congress a question of how to regulate CBD, or cannabidiol, products.
• In drug pricing, the top-selling pharmaceutical, Humira, will soon reach the end of its patent, which will offer a telling look at how competition influences the price of biosimilars — and the problems that remain for lawmakers to resolve.

Also this week, Rovner interviews Kate Baicker of the University of Chicago about a new paper providing a possible middle ground in the effort to establish universal health insurance coverage in the U.S.

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

Julie Rovner: The New York Times’ “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters,” by Stephen I. Vladeck

Alice Miranda Ollstein: Politico’s “Mpox Is Simmering South of the Border, Threatening a Resurgence,” by Carmen Paun

Sarah Karlin-Smith: KHN’s “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen

Rachel Cohrs: ProPublica’s “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” by David Armstrong, Patrick Rucker, and Maya Miller

Also mentioned in this week’s podcast:

• The Associated Press’ “20 Attorneys General Warn Walgreens, CVS Over Abortion Pills,” by Jim Salter
• NPR’s “A Trump-Appointed Texas Judge Could Force a Major Abortion Pill off the Market,” by Sarah McCammon
• Politico’s “Federal Judge Says Constitutional Right to Abortion May Still Exist, Despite Dobbs,” by Kyle Cheney and Josh Gerstein
• The Becker Friedman Institute’s “Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor?” by Katherine Baicker, Amitabh Chandra, and Mark Shepard

click to open the transcript

Transcript: A Health-Heavy State of the Union

KHN’s ‘What the Health?’Episode Title: A Health-Heavy State of the UnionEpisode Number: 284Published: Feb. 9, 2023

Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Feb. 9, at 10 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 Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: And Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: Later in this episode, we’ll play my interview with Kate Baicker of the University of Chicago. She’s one of the authors of a new paper outlining a new proposal for the U.S. to achieve universal health insurance coverage, something every other developing nation already has, but we have not yet been able to achieve. But first, this week’s health news. We’re going to start, of course, with the State of the Union, which was livelier than usual, with way more back and forth than I’ve ever seen at one of these, and also more health-heavy than usual. I’m going to start with entitlements, notably the president threatening Republican proposals to hold the debt ceiling hostage for cuts in Social Security and Medicare. I’m still trying to decide whether this was intended or not, but Biden nevertheless ended up getting Republicans to vow not to demand cuts in Social Security and Medicare in exchange for raising the debt ceiling later this year. Here is the tape.

President Joe Biden: So, folks, as we all apparently agree, Social Security and Medicare is off the books now, right? And they’re not going to strike … [prolonged applause] All right. We got unanimity!

Rovner: So was this very clever or very lucky or both?

Ollstein: Well, it’s a little not quite what it seems. Republicans have been swearing up and down more recently that they never intended to cut Medicare and Social Security. But when they say “We want to reform it, we want to shore it up,” they’re talking about things that could limit benefits for beneficiaries. So it’s a semantics game, in part. I also want to point out that neither Republicans nor Biden have yet said that they consider Medicaid in that same untouchable category. So that really jumped out at me in the speech as well.

Rovner: Yeah, I mean, if you don’t touch Social Security or Medicare — and the Republicans are trying to say that because this has been used as a weapon for so many years — then basically that leaves Medicaid. And as we discovered in 2017, when they were trying to repeal the Affordable Care Act, Medicaid is actually pretty popular, too, because it takes care of a lot of people’s grandparents in nursing homes. I’m wondering when somebody is going to bring that up. Obviously, over the years, many, quote-unquote, “cuts” have been made to both Social Security and Medicare, mainly to slow the growth of the programs so that we can continue to afford them. Many more, quote-unquote, “cuts” will have to be made going forward. Every time you reduce payment to a drugmaker or a hospital or any other health care provider, that’s a cut, but it helps beneficiaries. So, you know, you say “cuts,” [and] beneficiaries say “they’re going to cut our benefits.” Not necessarily. They may just be making the program more affordable, including for the beneficiaries. I mean, this is just the continuous back and forth of each side, weaponizing Medicare in particular, right?

Ollstein: Well, and until we see actual proposals on paper, like you’re indicating, it is a semantics game — what some people consider a cut might not be what other people consider a cut. And there’s going to be all sorts of rhetorical games over the next several months along these lines. So, I’m waiting till we see an actual black-and-white proposal that we can all pick at and analyze together.

Rovner: Well, as we have seen, there’s danger in putting things on paper, as Rick Scott discovered this week. For those who don’t remember, it was his rather infamous proposal — was it last summer, I think? It was before the election — suggesting that all federal programs be sunsetted every five years and then have to be reauthorized, which would include Social Security and Medicare and Medicaid. And that’s not playing well at this point, as I think was predicted at the time, including by us. So moving on, I was also impressed at how the speechwriters managed to combine the, quote, “victory lap” stuff, record Affordable Care [Act] enrollment, Medicare drug price changes, limits on insulin, and surprise bills with the agenda ahead: expanding insulin price caps to the non-Medicare population, Medicaid expansion in the states that haven’t done it, making the Affordable Care Act subsidies expansions permanent. But none of these things — popular, though they may be — are likely to happen in this Congress, are they? … These are the things that fell out of the bill that passed last year.

Cohrs: Right. A lot of those cost money, which is going to cause even more problems this Congress than it did in the last one. And I thought it was pretty informative that the chair of the Energy and Commerce Committee in the House threw cold water on the insulin price-cap idea because it did gain some Republican support in the Senate when it came up for a vote. That was complicated. We won’t go into it. But yeah, it wasn’t a straight up-and-down vote on that policy, really. So I think there was some hope that maybe Republicans could get on board with it. But I think, because it applies to private market insurers, [it was called] a socialist policy, like, they just don’t want government in private plans, even though it’s a wildly popular policy. So, yeah, I think that doesn’t seem like a good signal for that policy in particular and for Medicaid expansion and a lot of these things. Democrats couldn’t even do it when they all agreed or had power in both the House and the Senate. So it’s definitely not a good indication for a lot of these things.

Ollstein: Let’s not forget that [Sen. Joe] Manchin [D-W.Va.] was the one who put the kibosh on the federal Medicaid expansion. He thought it wasn’t fair to states like his that expanded a long time ago and have been paying in a little bit. He thought it wasn’t right that states that were holdouts get a free ride. And the other Democrats argued back that it’s not fair for the residents in those states to be left out in the cold uninsured either. So this will continue. But like Rachel said, not going anywhere soon.

Rovner: So the things that in theory could happen, and these didn’t mostly come up in the speech or didn’t come up very much. But earlier in the day, Biden officials were floating a quote-unquote, “unity agenda” that included a long list of potentially bipartisan health issues, starting with the “cancer moonshot,” mental health and opioid treatment, strengthening the mental health parity rules. Some of these things actually could happen, right?

Cohrs: Yeah, I think especially on the mental health package, I think there was some unfinished business from last Congress, from the Senate Finance Committee. I think that all of these are issues that have been talked about this Congress already. And the leaders have signaled that they might be interested in. But I think there is some daylight here, and we’re still in very much the agenda-setting, throwing ideas out there that are a very vague part of this Congress. And I think actually getting things down on paper and going through hearings and that kind of thing will signal which areas there might actually be some agreement on. But again, spending is going to be a big challenge and there’s just not going to be time to get to everything.

Rovner: I think one of my frustrations is that normally the State of the Union comes right before the president’s budget comes out, usually within a week or two. And this year, the president’s budget isn’t coming out until March 9. So we have this, you know, talk about agenda-setting. We’re going to have a lot of time for people to just yap at each other without any specifics. But speaking of things that didn’t and aren’t likely to happen, the president didn’t talk very much about abortion. And what he did say — like threatening to veto any abortion ban Congress might pass, which won’t happen either with Democrats in charge of the Senate — that disappointed abortion rights supporters. They’re not happy, right, Alice?

Ollstein: Some were not. To be fair, some praised the speech, praised the president for saying the word “abortion.” This was a big thing over much of his career, including the beginning of his presidency. He would talk around it and not actually say the word “abortion,” which the groups felt contributed to stigma around it. And so the big mainstream groups, Planned Parenthood, NARAL, put out statements praising the speech, praising him for saying he would veto a ban, although, again, like you said, that’s a hypothetical. It’s not going to happen. But some other groups were critical that, one, he didn’t talk about some of the very looming direct threats to abortion access in the courts that we’re probably going to get to later.

Rovner: In a minute.

Ollstein: Just in a minute! But they were frustrated that he didn’t lay out more specifics that his administration will actually do to respond to the current loss of access in a lot of the country. They felt that we’re in a crisis moment and he spent less of the speech on abortion than he did on resort fees. That was a sore point for some advocates who I talked to.

Rovner: There was a lot of emphasis on junk fees. And I get why: These are the things that drive people crazy, and, particularly, in times of high inflation. But yes, abortion came very late in the speech — almost after a lot of people had tuned out and stopped paying attention, which I think also made some people unhappy. Well, speaking of abortion, here we are waiting for another make-or-break court decision out of Texas. Alice, this time it’s the future of the “abortion pill,” not just in Texas, but around the nation that’s at stake. How did we get here? And could we really see the abortion pill banned nationwide?

Ollstein: We really could. People have really been sleeping on this case, including some elected officials who were slow to realize the impact it could have. And mainly what people don’t understand is a bunch of states already ban all methods of abortion, including the pill, and then some additional states besides that have restrictions just on the pill. So this will mainly hit blue states and states where abortion access still exists. And so it could really have a huge impact because those states are now serving more than just their own populations. And in a lot of places, losing access to medication abortion means losing access to all abortion because there aren’t clinical services available. And so my colleague and I did some reporting on how the Biden administration is preparing or not for this ruling. They rebuffed calls from activists to declare a public health emergency for abortion. They said they don’t think that would help. While they do plan to appeal the ruling should the FDA lose, the upheaval that could happen in the meantime can’t really be overstated. And not to mention that an appeal would go to the 5th Circuit, which is very conservative, and then to the Supreme Court, which just overturned Roe v. Wade. And so while most experts we’ve talked to don’t think the legal arguments are that sound, you just can’t really …

Rovner: And remind us, this is the lawsuit that’s challenging the 22-year-old approval of the drug in the first place.

Ollstein: Exactly. And so health care legal experts also say that besides the absolute upheaval in the abortion space that this could cause, this would just completely destroy any certainty around drug approvals for the FDA. If anybody could come back decades later and challenge the approval of a drug, how can drugmakers feel comfortable developing and submitting things for approval and making their plans around that? It’s very chaotic.

Rovner: Sarah, is the FDA worried about this case? Has it not been on their radar either?

Karlin-Smith: I mean, they’re involved in the defense.

Rovner: They’re being sued.

Karlin-Smith: Right. I think it is a concern if this is used, right? If the folks who want this drug pulled would win, does it become precedent-setting in a way that you can get other products pulled? Perhaps. Again, the sentiments would not be there for a lot of other products in the way to use it. But it is a bit concerning when you think about judges having this power to overrule the scientific decisions we’ve left to civil servants, not politicians or judges, because they have expertise in science and medicine and clinical trial design and all these things we just would not expect judges to be able to rule on.

Rovner: Well, speaking of more politics, this week — actually, last week — a group of 20 state attorneys general from states with abortion restrictions wrote to CVS and Walgreens, which had already announced that they would apply to become providers of the abortion pill, warning them not to rely on the Justice Department’s interpretation of a 19th-century law that banned the use of the U.S. mail to send abortifacients. The letter doesn’t outright threaten the companies. It merely says that, quote, “We offer you these thoughts on the current legal landscape.” Has anybody sued over this yet? And what do we expect to happen here? I mean, are CVS and Walgreens going to back off their plans to become providers?

Ollstein: Well, the anti-abortion elected officials and advocacy groups are hoping that’s the case. But I think this could play out in so many ways. I mean, one, we have this national ruling that could come down, but we also have a few state rulings that could flip things the other way and force states that have put restrictions on the abortion pill to lift those restrictions and allow it. So now we have cases pending in North Carolina and West Virginia. One of them is by the manufacturer of the abortion pill, saying that states don’t have the right to put the FDA’s hat on their own heads and make those decisions. And the other is by an abortion provider, a doctor who says that these state restrictions hurt her ability to practice and hurt her patients. And so it’s just wild that we can swing anywhere from a national ban to forcing states with bans to lift those bans. I mean, it’s just all up in the air right now. I wanted to quickly point out two other things. A lot of activist groups say they are not counting on the Biden administration to adequately respond to this crisis. And so they’re doing a couple things. One, they’re encouraging people to do something known as “advance provision,” which is order abortion pills before they’re pregnant, before you need them, and just have them on hand just in case. And so they’re advising people do that in advance of the ruling. Interestingly, the FDA does not support that practice, but activist groups are encouraging it anyways. And then the other thing is the abortion pill regimen is actually two pills. And the big FDA lawsuit only goes after the first one. And so people are saying, you know, you can terminate a pregnancy just by taking a few of the second pill, even though that has a higher rate of not working and needing a follow-up procedure. And so …

Rovner: Although it’s still like, 95%, right?

Ollstein: It’s still very effective, but not quite as effective as using the two pills together.

Rovner: And I think it used to be when people would go to Mexico, that’s what they would get. They would get misoprostol, not mifepristone, which is what we think of as “the abortion pill” — and also methotrexate, which we talked about in the context of people with diseases for which methotrexate is indicated not being able to get it because it can cause abortions. But that’s another option there, right? And … it would be hard for FDA to pull those drugs because those drugs do have a lot of uses for other diseases.

Karlin-Smith: Or FDA could, I guess, be forced to take off the formal indication for use for abortion, but the drug would be out there and then could be subject to off-label prescribing, which then could potentially, I guess, impact insurance coverage if you’re using it for abortion. Pivot to if you had to go back to this one-drug regimen while, yes, it would still exist and be possible, I think a lot of providers are worried about the added burden that would create on folks that help people obtain abortion. And this system is just not set up to have enough workers to deal with that more complicated regimen. And it seems like it could end up leading to more need for surgical abortions, depending on how well it works and so forth. So I think logistically it creates a lot more challenges.

Rovner: Yeah, it’s a mess. Well, meanwhile, last issue here, we have a curious story out of a lawsuit in federal district court here in Washington, D.C., in which a judge proffered the notion that while the Supreme Court may have found no right to abortion in the 14th Amendment, that doesn’t mean there isn’t a federal right under the 13th Amendment. That’s the one barring slavery, specifically the restriction on the pregnant person’s personal liberty. As the judge correctly pointed out, the majority in last year’s Dobbs [v. Jackson Women’s Health Organization] ruling may well believe there’s no right to abortion anywhere in the Constitution. But that’s not the question that they litigated. Is this potentially an avenue that abortion rights advocates are going to explore?

Ollstein: I am not hearing a lot of hope being placed on this. If it goes anywhere, it would go back to the same Supreme Court that just ruled last year. And so abortion rights advocates are not optimistic about this strategy, but I think it’s a good indication of really both sides right now just trying to get as creative as possible and explore every legal avenue in the U.S. Constitution, in state constitutions, things where it never says the word abortion, but you could interpret it a certain way. I think that’s what we’re seeing right now. And so it’s really interesting to see where it goes.

Rovner: We are literally at the point where everybody is throwing whatever they can against the wall and seeing what sticks. All right. Well, let us turn to the federal research establishment. Late last month, a panel of advisers recommended a set of policies to strengthen oversight of so-called gain-of-function research that could inadvertently cause new pandemics. This was also one of the subjects of the first House hearing that called leading federal public health officials up on the carpet. What do we learn from the hearing? And has the federal government actually been funding gain-of-function research, or do we even know for sure?

Cohrs: So there has been a moratorium on this sort of research. And the interim director of the NIH [National Institutes of Health] quibbled over the term “gain-of-function research.” And he said we’re talking about a very select part of all of the research that could technically fall under that umbrella term. But he did say that there is a moratorium on funding that right now; there’s not current funding because they are reviewing their practices. And an advisory board did pass proposals and he laid out the process forward for that. So once those are finalized, he’ll write a memo to [Department of Health and Human Services] HHS Secretary Xavier Becerra, then it will get to the White House. So there is this bureaucratic progression that these new guidelines are going to go under, and it’s been pretty transparent and public so far. But we’ll see how things ultimately turn out. But I think they are very sensitive to this politically and they are trying to create guidelines that offer some lessons learned from some of the criticism they’ve gotten recently.

Rovner: And I think, I mean, this has become one of the major lines of argument about Republicans trying to figure out where covid came from. Perhaps it came from U.S.-funded gain-of-function research in China, which we don’t know, I don’t think. But there’s been a lot of “Yes, you did”-“No, you didn’t” going on. I mean, Sarah, does this go back to the, you know, politicians playing scientists?

Karlin-Smith: A little bit. And I think at the hearing, a lot of the Republicans who are pressuring NIH in particular on this are not super interested in listening to the subtleties and nuance of the argument. They just really want to make the point and bring up in people’s minds the possibility of, you know, covid being a lab leak, which I think … which hasn’t 100% been ruled out, but it’s kind of on the 98%, probably 99% ruled out by a lot of scientists. And so it was very hard for NIH and those lawmakers to have a reasonable discussion about the nuances and where this research might possibly benefit us in future pandemic prep. What type of precautions do need to be put in place? And I think NIH was trying to strive to communicate that actually a lot of what was recommended in this oversight report is things they’ve been working on and have put in place. But the hearing was designed by Republicans more to land those political punches and sound bites and not really delve into “Are there policy improvements that could be made here?”

Rovner: Well, speaking of civil servants trying to do their science policy jobs, the FDA’s been busy the last couple of weeks, including lifting a ban on men who have sex with other men donating blood. That’s a ban that’s been in effect in one way or another since the 1980s, when AIDS was first discovered. And in the wake of baby formula shortages, there’s now going to be a new deputy commissioner for food. And finally, the agency is asking Congress for new authority to regulate CBD [cannabidiol] products, particularly as more states legalize marijuana in all forms for recreational use. Sarah, this is an awful lot of stuff at once. Big policy changes where they try to hide some of them, or did they just all show up at once because that’s when they got finished?

Karlin-Smith: The food changes were sort of driven by events not quite within their control, and the blood policy, the CBD stuff were things in the works for some number of years now. So FDA is busy, and these are different divisions operating under it. I think the CBD stuff is drawing a lot of frustration because FDA had been working on considering how to regulate this aspect of hemp for a while now. And instead of coming up with a policy and taking action, they’ve rewound the circle; we’re back to square one and putting it on Congress’ issues. So that’s like one area where there’s a lot of frustration versus, I think, people are generally happier that the blood donation process was finally gone through and changed.

Rovner: Yes, the wheels of the federal regulatory process move slowly, as we know. All right. Finally this week, drug prices. Humira — which is a biological that treats rheumatoid arthritis and many other serious ailments, and for which you have undoubtedly seen TV commercials if you have ever turned on your television, because it’s the top-selling pharmaceutical in the world — is reaching the end of its patent life. That will soon provide the first real test of where the Affordable Care Act’s pathway to allow biosimilar competitors — effectively biologics version of generic drugs — whether that will actually bring down prices. Because there’s a chance here that there’s going to be a bunch of competitors to Humira and the price isn’t going to come down, right?

Karlin-Smith: Yeah, I mean, that’s a major concern for a number of reasons that get us back to the broader U.S. drug pricing debate and — including the role of pharmacy benefit managers in figuring out how people get coverage of their drugs. So Humira is one of the first biologics to lose patent protection, where patients actually fill the prescriptions themselves and give themselves the medicine, which is a very different payment system than if you’re getting a biologic medicine at a doctor’s office or a hospital. And so the way that most of the insurers are covering the drug for this year, they’re actually going to charge patients the same out-of-pocket cost in most instances, as if you’ve got the brand drug or the biosimilar. And because, unlike traditional generic medicines, a lot of these, at least initially, they’re not what is called auto-substitutable. So if your doctor writes you Humira, the pharmacist doesn’t automatically give you that generic. So you’d actually have to request a new prescription from your doctor, and they’d have to write it. And if you’re not going to pay less, why are you motivated to do that?

Rovner: When you’re not even positive how much whether the drug works the same way, whether the biosimilar works the same way.

Karlin-Smith: Right. And they think people are a little bit more hesitant. They don’t understand how biosimilars work compared to generic drugs, where it took — again, when the generic drug industry first started, it took people a while to get comfortable. So there are those issues. So, basically, what has happened is AbbVie has given insurance plans and payers’ discounts on their brand drug to keep it in a good place on their formularies. So there will be savings to the broader health system, for sure. The problem is if that doesn’t get passed on to the patients, and AbbVie can continue their market monopoly, my worry is, down the line, what happens to this biosimilar industry overall? Humira is not the only top-selling, big-selling biologic medicine where we want to bring down the cost. So if these biosimilar competitors don’t eventually gain market share and make money off of doing this, why are they going to go back and develop a biosimilar and try and lower the cost of the next big drug? And that’s what people are watching. I think there’s cautious optimism that, as more biosimilars for Humira launch, there will be some pressure for insurance companies to cut deals and lower prices and not just rely on making money off high rebates. But we don’t really know how it’s going to play out. And AbbVie was pretty creative over the years. In some ways that helped patients and others questionable — how much of … like, you know, there’s high concentration of the drug, low concentration. There is citrate-free, non-citrate-free. And that means that not all the competitors are going to be exactly the same in a way that creates as much competition as it seems at first. So yeah, it’s going to be messy.

Rovner: This is the famous evergreening that we saw with drugs. I mean, where they would change something small and get a whole new patent life.

Karlin-Smith: Right. So usually with generic research, you need three direct competitors to help bring the price down a lot. But in the case of Humira, while there’s going to be, probably at least six competitors this summer, maybe more, they’re not all direct competitors for the same version of Humira. So it sort of bifurcates the space a bit more and makes it harder to, you know, figure out the economics of all of that.

Rovner: Well, if you thought that drug pricing was confusing, now we’re adding a whole new level to it. So, I’m sure we will be talking about this more as we go forward. OK. That’s the news for this week. Now, we will play my interview with Kate Baicker of the University of Chicago. Then we will come back and do our extra credits.

I am excited to welcome to the podcast Katherine Baicker, currently the dean of the University of Chicago Harris School of Public Policy and soon to be provost of the university. Congratulations.

Katherine Baicker: Thank you so much.

Rovner: So, Kate is a health economist who is well known to health policy students for a lot of things, but most notably as the co-lead author of the Oregon Medicaid health experiment, which was able to follow a randomized population of people who got Medicaid coverage and a population that didn’t to help determine the actual impact of having Medicaid health insurance. Today, she’s here as lead author of a paper with a new way to possibly provide health coverage to all Americans. Kate, thank you so much for joining us.

Baicker: It’s a pleasure.

Rovner: So your new paper is called “Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Safety Net.” And in that single sentence, you’ve pretty much summed up the entire health insurance debate for, like, the last half-century. For those who don’t know, why is it that the U.S. doesn’t have universal insurance when literally all of our economic competitors do?

Baicker: Well, like so many things about our health care system, it goes back to the history of how it evolved, as well as some things that are different about the U.S. from other countries. If you look at how big the U.S. is geographically, how diverse our country is, how heterogeneous the health needs are. A lot of the solutions you see in other countries might not work so well in the U.S.

Rovner: So … and we’ve basically just not ever gotten over the hump here.

Baicker: Well, I also think we haven’t been asking the right questions necessarily. There is a real debate about whether health care is a “right” or not. And, of course, your listeners can’t see my “air quotes,” but I put that in air quotes because I think that’s the wrong question. Health care is not just one thing. Health care is a continuum of things. And if we just boil it down to should people have access to care or not, that doesn’t let us engage with the hard question of how much care we want to provide to everyone and how we’re going to pay for it.

Rovner: So I know a lot of people assume that the Affordable Care Act would — I’ll use my air quotes — “fix” the U.S. health insurance problem. And it has gone a long way to cover a lot of previously uninsured people. But who are the rest of the uninsured and why don’t they have coverage? It’s not necessarily who you think, right?

Baicker: That’s right. And, you know, the ACA, or Obamacare, actually made a lot of headway in covering big swaths of the uninsured population. There was a lot of discussion about health insurance exchanges, but actually more people were covered by Medicaid expansions than by health insurance exchanges. But both of those, as well as letting young people up to age 26 get on their parents’ policies. All of this chipped away at the ranks of the uninsured, but it left, for example, undocumented immigrants uninsured and also the vast majority of the uninsured people in the U.S. are already eligible for either a public program or heavily subsidized private insurance. And we have a problem of takeup and availability, not just affordability.

Rovner: So let’s get to your proposal. It’s not really that different from things that either we’ve tried in some parts of our health insurance ecosystem or what other countries do. What would it actually look like if we were to do it?

Baicker: Well, if you go back to what I think is the right question of how much health care do we want to make sure that everyone has access to and how are we going to get them enrolled in those programs? I think one key feature is having that coverage be as low-hassle as possible, automatic if possible, because we know that nonfinancial barriers to insurance are responsible for a lot of the uninsured population we still see today.

Rovner: We’ve seen that with pension plans, right? That automatically enrolling people get more people to actually put money away?

Baicker: That’s right. That’s one of the takeaways from behavioral economics is that defaults matter. Meaning what the baseline is and letting you opt in and out makes a big difference because people tend to stick with where they are. There’s a lot of inertia in saving for retirement, in enrolling in health insurance, in lots of different things. And being sophisticated in how we design the mechanics of those programs is important, as well as making sure that they’re financially affordable to people. So one step is making sure that whatever is available to people is as easy as possible for them to take advantage of. But the other is having a much harder discussion about what we want that basic package to be. And when you say “I want everybody to have all of the care that might possibly be available, no matter what price and no matter how much it impacts their health,” that’s more than 100% of GDP. We just can’t do that and still have any money for anything like food and housing and education and roads and all of the things that we also care about. So if we had that tough discussion as a nation, as a body politic, to say, here is the care that we think is really high-value that we think is a right for everyone and that we want to make sure is available to everyone, then people could be automatically enrolled in that default package and have the option to get more care that is more expensive and maybe a little less effective, but still worth it to them that they purchase on their own. And that opens up a whole host of other questions and ethical dilemmas that I’m sure you’re going to want to ask about.

Rovner: But it also — as a lot of people are concerned, that something like “Medicare for All” would eliminate the incentive to innovate new kinds of care. I mean, obviously, there’s this race to figure out, you know, a drug to treat Alzheimer’s and that if the federal government were to basically set prices for everything, that there would be no more innovation incentive. You actually address that here, right?

Baicker: Yes. And I’m so glad you raised that concern, because there are many challenges to having a monolithic one-size-fits-all Medicare for All type plan. One of them is, you know, affordability for the system and accessibility. But another is the dulled incentive for innovation and the dulled drive towards having new medicines and new treatments available. Medicare is very slow to innovate. It took 40-plus years for Medicare to include prescription drugs at all. And that was because when Medicare was formed in the Sixties, prescription medicine wasn’t a very important part of health care. It wasn’t a very expensive part of health care, there just weren’t that many drugs to treat people. Well, now those medicines are crucial to health and well-being. And Medicare finally added a prescription drug benefit in 2005. But that was a long lag, and that’s just one example. So I think having some fundamental access to care that we know is of high value for everyone could be coupled with having the option to purchase more generous insurance that covers more things. And that private insurance layered on top would really provide the financial incentives for continued innovation. It acknowledges the reality that in a world of scarce resources, higher-income people are going to have more health care than lower-income people. And that is an ugly reality and one that we ought to grapple with ethically, and as a matter of public policy priorities. I would argue we’re already rationing care. It is not possible for public programs to pay for all care for all people, no matter what the price, no matter what the health benefit, and being intentional about defining what it is we’re going to cover with public dollars and then letting people buy more care with private dollars is a way perhaps to make a financially sustainable system that also promotes innovation.

Rovner: And this isn’t really new. I mean, lots of other countries do this. I was in Switzerland a decade ago, and I remember that they … their extra-benefit package includes things like single rooms in hospitals and homeopathic medicine and things that I’m not sure we would end up putting into our top-up plans, but it’s something that’s important to them.

Baicker: Yes. And when people point to our European counterparts and say, look, they all have single-payer. In fact, a lot of them have a hybrid system like the one that we’re describing. And it’s important to differentiate: We’re talking about a basic plan that’s available for everyone. That doesn’t mean that it only covers cheap things. It should only cover high-value things. But some cheap things are incredibly ineffective and low-value, and some expensive things are really important for health and very high-value. So it’s about the value of the dollar spent in terms of producing health, not whether it’s expensive or cheap. And so when you think about having a top-up plan, it shouldn’t be about billing cost sharing that, you know, lower-income people are exposed to in the basic plan. It should be about adding services that are of less health importance but still valuable to the people purchasing them.

Rovner: Obviously, the biggest issue here is going to be who’s going to make that determination? I’m old enough to remember fights over the ACA, death panels, and the independent Medicare advisory board that never happened. In fact, there were a lot of these, you know, we’re going to appoint experts. And it never happened because none of the experts ever wanted to be on these panels. How do you overcome that hurdle of actually grappling with the decision of what should be covered?

Baicker: Yes, the devil is always in the details for these things, and you put your finger on a really important one where we haven’t provided a robust answer, and our analysis is meant to highlight the importance of making these hard decisions and the value of this framework. But we don’t have a magic bullet for this. I would argue that having Congress make this decision every year is a recipe for lobbying and decision-making that doesn’t actually line up with value. There’s an opportunity perhaps to have a panel of experts who, as you note, is just a hop, skip and a jump from being called a “death panel.” But I think we can rely on some clinical guidelines as guardrails on this. And we do have some examples of experimentation in this direction in the U.S. In fact, more than experimentation — if you look at Medicare Advantage, this used to be a small part of the Medicare program. These are private plans for Medicare beneficiaries that are now, I think, pretty soon going to be the majority of plans that people have. And it’s a mechanism for people to choose among plans that have some things that have to be covered, but can then add additional benefits for enrollees, and it can be a little more tailored to what people value in their plans. So I don’t think that’s the answer either. But it’s a proof of concept that we can do something like this in the U.S.

Rovner: So in some ways this would bridge the gap between Republican marketplace ideas and Democratic Medicare for All ideas. But it feels like, since the fight over the Affordable Care Act, Republicans have moved more to the right on health care and Democrats have moved more to the left on health care. You are no stranger to partisan politics nor the ways of Washington, D.C. How could everybody be brought back to what I daresay looks like a political compromise?

Baicker: Well, I’m an economist, as you noted, and that’s notoriously bad at understanding actual human beings. I don’t have any idea for the path forward through the political thicket that we’re in. In some ways, it is a little disheartening to see how difficult it is to do some basic commonsense things. In any complicated system like the U.S. health care system, there are always small technical fixes that need to be made that are just commonsense, that ought not to be political. And it’s hard to do those.

Rovner: We’re lacking in common sense right now in Washington.

Baicker: Yeah. So I can’t say that I’m hugely optimistic about a big change happening right away. On the other hand, I think covid really highlighted to people across the political spectrum how important it is to have continuity of coverage, how disparate our current system is in terms of access to care, how problematic it is to have your main avenue of health insurance be through your employer when a pandemic is coupled with a recession. So I think the challenges and the vast inequities of our health care system were laid bare during covid. So it is perhaps salient enough that people might be willing to consider alternative structures. But I can’t say I’m holding my breath.

Rovner: Well, Kate Baicker, thank you very much for, if anything, a great thought experiment. It’s really wonderful to look your way through … it’s like, oh, we could get there, maybe in another half a century.

Baicker: I hope sooner than that.

Rovner: I do, too. Thank you so much.

Baicker: My pleasure.

Rovner: OK, we’re back. And 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 khn.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first this week?

Cohrs: My extra credit is headlined “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” in ProPublica by David Armstrong, Patrick Rucker, and Maya Miller. And I thought this story was just such a good illustration of the jargon that we use in D.C., of, like, utilization management and prior authorization. And sometimes these terms just feel so impersonal. But I feel like this story did such a good job walking through one patient’s struggle to find something that worked and then just the arbitrary choices that insurers were making, looking at their bottom line to try to prevent him from getting a very expensive treatment that actually did increase his quality of life significantly. So I would definitely recommend, as we’re thinking about insurers’ role in this whole health care cost debate as well.

Rovner: Yeah, it does bring home how the patient is always in the middle of this. Alice.

Ollstein: I chose a piece by my colleague Carmen Paun called “Mpox Is Simmering South of the Border, Threatening a Resurgence,” and it’s about how the U.S. was extremely successful in vaccinating high-risk people against mpox, which for folks who still remember the artist formerly known as monkeypox, the name was changed to reduce stigma and be more accurate. The U.S. vaccination campaign and messaging campaign to the most high-risk populations was really successful and did the trick. But as we learned from covid and every other infectious disease, if you don’t take care of other parts of the world, it could eventually come back. We’re not an island, and even islands aren’t safe. But, you know, this is about a bunch of countries, including Mexico, that really have made no mass vaccination effort at all. You know, some civil society groups are trying on their own, but they just don’t have official government backing. And that’s really dangerous. And it meant that cases are surging in parts of Latin America and parts of Africa. And as we saw from covid, that leads to the development of new variants and things traveling back to the U.S. and other places around the world. So, certainly, something to pay attention to.

Rovner: Public health is important. World public health is important. Sarah.

Karlin-Smith: I looked at a piece called “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen for Kaiser Health News. It’s a deep dive into CVS and Optum moving out of, to some degree, business places where they provide home infusion services of perinatal nutrition to people that essentially cannot eat or drink in most cases. And they basically decided that it’s not a great business opportunity for them in many cases. But these are people that really depend on these services to live and survive, and they’re very complex medicines and essential nutrition to get and deliver. And at the same time, I think what really fascinated me about this story is it talks about this dynamic of while companies are getting out of the space where you’re providing this service to people that need these IV treatments to survive and live, there also has been development of these medical spas, as they’re called, where people that actually do not need IV hydration or IV nutrition are essentially being given it for nonmedical purposes. And there’s a lot of money being made there. And it just shows you how some of the profit incentives in our system don’t necessarily align with treating the people that actually need the health care first.

Rovner: Yeah, it’s like the people with diabetes not being able to get their drugs because people in Hollywood want to lose 10 pounds fast. But this obviously is, you know, another life-or-death issue. Well, I chose an op-ed this week in The New York Times by the University of Texas law professor Steven I. Vladeck called “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters.” And it answered a lot of questions for me. First, how is it that so many suits end up in front of the same judges who the plaintiffs know are likely to rule in their favor, and all in Texas? So it turns out that Texas has distributed its federal judges in a way that in nine districts there is only one judge. And in 10 more, there are only two judges. Obviously, there’s no random draw in those districts where there’s only one judge. That’s what you’re going to get. So we keep seeing some of the same Texas judges, first Judge Reed O’Connor in Fort Worth, and now Matthew Kacsmaryk, a former advocate for a conservative think tank and the only federal judge in Amarillo. Judge O’Connor had the big ACA case, now has a big preventive care case. Judge Kacsmaryk has the abortion pill case that we’ve been talking about. It’s a really interesting piece about how that could really twist justice. But it also includes several ways to fix it. We’ll have to see if any of them actually get taken up.

OK. That is our show for this week. As always, if you enjoyed 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 — all one word — @kff.org. Or you can tweet me as long as Twitter is still up. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Rachel

Cohrs: @rachelcohrs

Rovner: Sarah.

Karlin-Smith: @SarahKarlin

Rovner: We will be back in your feed next week. Until then, be healthy.

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To bring a new drug to market, the FDA requires pharmaceutical firms to perform extensive studies to demonstrate safety and efficacy, which are often expensive and time-consuming to conduct to the agency’s specifications. Getting a drug to market a few months sooner and for less expense than usual can translate into millions in profit for the manufacturer.

That is why a private equity-backed startup like Headlands Research saw an opportunity in creating a network of clinical sites and wringing greater efficiency out of businesses, to perform this critical scientific work faster. And why Moderna, Pfizer, Biogen, and other drug industry bigwigs have been willing to hire it — even though it’s a relatively new player in the field, formed in 2018 by investment giant KKR.

In July 2020, Headlands announced it won coveted contracts to run clinical trials of covid-19 vaccines, which would include shots for AstraZeneca, Johnson & Johnson, Moderna, and Pfizer.

In marketing its services, Headlands described its mission to “profoundly impact” clinical trials — including boosting participation among racial and ethnic minorities who have long been underrepresented in such research.

“We are excited,” CEO Mark Blumling said in a statement, to bring “COVID-19 studies to the ethnically diverse populations represented at our sites.” Blumling, a drug industry veteran with venture capital and private equity experience, told KHN that KKR backed him to start the company, which has grown by buying established trial sites and opening new ones.

Finding and enrolling patients is often the limiting and most costly part of trials, said Dr. Marcella Alsan, a public policy professor at Harvard Kennedy School and an expert on diverse representation in clinical trials, which have a median cost of $19 million for new drugs, according to Johns Hopkins University researchers.

Before covid hit, Headlands acquired research centers in McAllen, Texas; Houston; metro Atlanta; and Lake Charles, Louisiana, saying those locations would help it boost recruitment of diverse patients — an urgent priority during the pandemic in studying vaccines to ward off a disease disproportionately killing Black, Hispanic, and Native Americans.

Headlands’ sites also ran, among other things, clinical studies on treatments to combat Type 2 diabetes, postpartum depression, asthma, liver disease, migraines, and endometriosis, according to a review of website archives and the federal website ClinicalTrials.gov. But within two years, some of Headlands’ alluring promises would fall flat.

In September, Headlands shuttered locations in Houston — one of the nation’s largest metro areas and home to major medical centers and research universities — and Lake Charles, a move Blumling attributed to problems finding “experienced, highly qualified staff” to carry out the complex and highly specialized work of clinical research. The McAllen site is not taking on new research as Headlands shifts operations to another South Texas location it launched with Pfizer.

What impact did those sites have? Blumling declined to provide specifics on whether enrollment targets for covid vaccine trials, including by race and ethnicity, were met for those locations, citing confidentiality. He noted that for any given trial, data is aggregated across all sites and the drug company sponsoring it is the only entity that has seen the data for each site once the trial is completed.

A fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. But Headlands’ trajectory shows the potential risks of trying to combine independent sites and squeeze efficiency out of studies that will affect the health of millions.

Yashaswini Singh, a health economist at Johns Hopkins who has studied private equity acquisitions of physician practices, said consolidation has potential downsides. Singh and her colleagues published research in September analyzing acquisitions in dermatology, gastroenterology, and ophthalmology that found physician practices — a business with parallels to clinical trial companies — charged higher prices after acquisition.

“We’ve seen reduced market competition in a variety of settings to be associated with increases in prices, reduction in access and choice for patients, and so on,” Singh said. “So it’s a delicate balance.”

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, called private equity involvement in trials “concerning.”

“We need to make sure that patients” know enough to provide “adequate, informed consent,” he said, and ensure “protections about the privacy of the data.”

“We don’t want those kinds of things to be lost in the shuffle in the goals of making money,” he said.

Blumling said trial sites Headlands acquired are not charging higher prices than before. He said privacy “is one of our highest concerns. Headlands holds itself to the highest standard.”

Good or bad, clinical trials have become a big, profitable business in the private equity sphere, data shows.

Eleven of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies, a KHN analysis found. Those companies have been involved in studies ranging from covid vaccines to treatments for ovarian cancer, Parkinson’s disease, and Alzheimer’s.

Contracted firms also analyze patient data and prepare materials to secure approval from regulatory agencies, in hopes of getting more drugs to market faster. And a big draw for investors: Clinical research companies make money whether or not a drug succeeds, making it less risky than investing in a drug company.

The number of clinical trials has exploded to more than 434,000 registered studies this year as of late November, more than triple the number a decade ago.

Still, most trial sites are physician practices that don’t consistently perform studies, according to a presentation by Boston-based investment firm Provident Healthcare Partners.

“Independent sites are being purchased by private equity, and they’re moving into larger site groups of 30, 40, and then their game plan is to roll that up into a business and then sell it again,” said Linda Moore Schipani, CEO of Clinical Research Associates, a Nashville-based company that worked on covid vaccine trials for AstraZeneca, Novavax, and Pfizer. “That’s kind of the endgame.”

Headlands is a prime example. It announced in November 2019 that it would acquire six centers in the U.S. and Canada, including three sites in Texas and Louisiana owned by Centex Studies that would help improve participation among Hispanics and African Americans.

It has made other acquisitions since then and opened new sites in areas with “extremely limited trial options,” something Blumling says distinguishes his company.

“I’m not an evangelist for private equity,” Blumling said. “The ability of KKR to be willing to invest in something that is a three- to five-year return versus a one- to two-year return is something that you won’t see out there.”

A research center in Brownsville, Texas — a stone’s throw from the U.S.-Mexico border and where 95% of the population is Hispanic or Latino — is one of several where it is partnering with Pfizer to boost patient diversity.

To recruit patients, Headlands “is really going beyond what a lot of sites do, which is social media,” Blumling said in an interview. “It’s going within churches, community fairs, really getting out into as much as possible the broader community.”

Headlands closed the Houston and Lake Charles sites because of staffing issues, Blumling said, and finished or moved their studies elsewhere. Blumling said the decision to close those locations “did not have anything to do with the speed of trials.”

Similarly, he said, Headlands is moving the McAllen site’s operations to Brownsville “because it had a larger population of trained personnel.”

“We want to continue to grow sites and do great work,” Blumling said. “If we can’t find the people in order to do that at the quality that we demand, which is at the highest level, then it doesn’t make sense to keep those sites.”

‘The Writing to Me Was on the Wall’

In 2006, Devora Torrence co-founded Centex Studies, which she described as “my little mom and pop business” in a 2021 podcast about female entrepreneurs in science. She said a flurry of interest from private equity came at the end of 2018. The appeal was evident: Drug companies were relying on bigger clinical trial networks.

“The thing is speed, getting it to market. With a bigger network, you get that speed,” Torrence said on the podcast. “The writing to me was on the wall that either I get some outside investment and scale up myself, or kind of listen to these guys and see if maybe now would be the right time to exit.”

Joining Headlands had its benefits during the pandemic because she could “lean on” its other sites with experience running vaccine trials. “Had we not gotten those … we may not still be here,” Torrence said.

Torrence, whose LinkedIn profile said she left the company in 2021, didn’t respond to messages from KHN.

Lyndon Fullen, a health care consultant and former Centex employee, said private equity provides funding that allows companies to add study sites.

“I completely support it,” he said. “If it’s about reaching that large patient population, it’s of course better to have larger groups with that funding.”

Opportunity in Long Covid

Contract research organization Parexel saw opportunity in the covid pandemic — millions of people were developing long covid after infection and there were few, if any, meaningful treatment options.

The company, which employs more than 19,000 people, was acquired in 2021 by EQT Private Equity and Goldman Sachs’ private equity arm for $8.5 billion, billions more than the $4.5 billion that private equity firm Pamplona Capital Management paid when it took Parexel private in 2017.

A growing body of research shows the debilitating effects of long covid, including a recent study of tens of thousands of patients in Scotland where nearly half had not fully recovered months later. But treatments addressing its root causes could be years away. “It’s a huge number of people,” said Dr. Nathalie Sohier, who leads Parexel’s infectious diseases and vaccines franchise. “There’s a lot of need.”

Long covid represents the promise and peril of the work to develop new drugs: Millions of patients create a potentially lucrative market for drug companies, and yet researchers and industry experts say they are reluctant to jump in. In part, that’s because “it’s not a well-defined disease, and that really makes it highly risky for companies to invest in research,” said Cecil Nick, a vice president for Parexel.

“How are we going to be able to tell the FDA that our drug works? We can’t count the number of people who died; we can’t count the number of people in the hospital,” said Dr. Steven Deeks, a University of California-San Francisco professor who is running an observational study on long covid patients.

As of August, among more than 4,400 covid studies, only 304 focused on long covid. A third of those were related to drug development, Sohier said.

Sohier said “there are few” companies in its long covid program. That hasn’t stopped Parexel from pitching itself as the ideal partner to shepherd new products, including by doing regulatory work and using remote technology to retain patients in trials. Parexel has worked on nearly 300 covid-related studies in more than 50 countries, spokesperson Danaka Williams said.

Michael Fenne, research and campaign coordinator with the Private Equity Stakeholder Project, which studies private equity investments, said Parexel and other contract research organizations are beefing up their data capacity. The aim? To have better information on patients.

“It kind of ties into access and control of patients,” Fenne said. “Technology makes accessing patients, and then also having more reliable information on them, easier.”

KHN senior correspondent Fred Schulte and Megan Kalata contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This story can be republished for free (details).