For years, the federal government has steered clear of regulating junk food, fast food, and ultra-processed food.

Now attitudes are changing. Some members of President-elect Donald Trump’s inner circle are gearing up to battle “Big Food,” or the companies that make most of the food and beverages consumed in the United States. Nominees for top health agencies are taking aim at ultra-processed foods that account for an estimated 70% of the nation’s food supply. Based on recent statements, a variety of potential politically charged policy options to regulate ultra-processed food may land on the Trump team menu, including warning labels, changes to agribusiness subsidies, and limits on which products consumers can buy with government food aid.

The push to reform the American diet is being driven largely by conservatives who have taken up the cause that has long been a darling of the left. Trump supporters such as Robert F. Kennedy Jr., whose controversial nomination to lead the Department of Health and Human Services still faces Senate confirmation, are embracing a concept that champions natural foods and alternative medicine. It’s a movement they’ve dubbed “MAHA,” or Make America Healthy Again. Their interest has created momentum because their goals have fairly broad bipartisan support even amid a bitterly divided Congress in which lawmakers from both sides of the aisle focused on the issue last year.

It’s likely to be a pitched battle because the food industry wields immense political influence and has successfully thwarted previous efforts to regulate its products or marketing. The category of “food processing and sales companies,” which includes Tyson Foods and Nestle SA, tallied $26.7 million in spending on lobbying in 2024, according to OpenSecrets. That’s up from almost $10 million in 1998.

“They have been absolutely instrumental and highly, highly successful at delaying any regulatory effectiveness in America,” said Laura Schmidt, a health policy professor at the University of California-San Francisco. “It really does feel like there needs to be a moment of reckoning here where people start asking the question, ‘Why do we have to live like this?’”

“Ultra-processed food” is a widely used term that means different things to different people and is used to describe items ranging from sodas to many frozen meals. These products often contain added fats, starches, and sugars, among other things. Researchers say consumption of ultra-processed foods is linked — in varying levels of intensity — to chronic conditions like diabetes, cancer, mental health problems, and early death.

Nutrition and health leaders are optimistic that a reckoning is already underway. Kennedy has pledged to remove processed foods from school lunches, restrict certain food additives such as dyes in cereal, and shift federal agricultural subsidies away from commodity crops widely used in ultra-processed foods.

The intensifying focus in Washington has triggered a new level of interest on the legal front as lawyers explore cases to take on major foodmakers for selling products they say result in chronic disease.

Bryce Martinez, now 18, filed a lawsuit in December against almost a dozen foodmakers such as Kraft Heinz, The Coca-Cola Co., and Nestle USA. He developed diabetes and non-alcoholic fatty liver disease by age 16, and is seeking to hold them accountable for his illnesses. According to the suit, filed in the Philadelphia Court of Common Pleas, the companies knew or should have known ultra-processed foods were harmful and addictive.

The lawsuit noted that Martinez grew up eating heavily advertised, brand-name foods that are staples of the American diet — sugary soft drinks, Cheerios and Lucky Charms, Skittles and Snickers, frozen and packaged dinners, just to name a few.

Nestle, Coca-Cola, and Kraft Heinz didn’t return emails seeking comment for this article. The Consumer Brands Association, a trade association for makers of consumer packaged goods, disputed the allegations.

“Attempting to classify foods as unhealthy simply because they are processed, or demonizing food by ignoring its full nutrient content, misleads consumers and exacerbates health disparities,” said Sarah Gallo, senior vice president of product policy, in a statement.

Other law firms are on the hunt for children or adults who believe they were harmed by consuming ultra-processed foods, increasing the likelihood of lawsuits.

One Indiana personal injury firm says on its website that “we are actively investigating ultra processed food (UPF) cases.” Trial attorneys in Texas also are looking into possible legal action against the federal regulators they say have failed to police ultra-processed foods.

“If you or your child have suffered health problems that your doctor has linked directly to the consumption of ultra-processed foods, we want to hear your story,” they say on their website.

Meanwhile, the FDA on Jan. 14 announced it is proposing to require a front-of-package label to appear on most packaged foods to make information about a food’s saturated fat, sodium, and added sugar content easily visible to consumers.

And on Capitol Hill, Sens. Bernie Sanders (I-Vt.), Ron Johnson (R-Wis.), and Cory Booker (D-N.J.) are sounding the alarm over ultra-processed food. Sanders introduced legislation in 2024 that could lead to a federal ban on junk food advertising to children, a national education campaign, and labels on ultra-processed foods that say the products aren’t recommended for children. Booker cosigned the legislation along with Sens. Peter Welch (D-Vt.) and John Hickenlooper (D-Colo.).

The Senate Committee on Health, Education, Labor and Pensions held a December hearing examining links between ultra-processed food and chronic disease during which FDA Commissioner Robert Califf called for more funding for research.

Food companies have tapped into “the same neural circuits that are involved in opioid addiction,” Califf said at the hearing.

Sanders, who presided over the hearing, said there’s “growing evidence” that “these foods are deliberately designed to be addictive,” and he asserted that ultra-processed foods have driven epidemics of diabetes and obesity, and hundreds of billions of dollars in medical expenses.

Research on food and addiction “has accumulated to the point where it’s reached a critical mass,” said Kelly Brownell, an emeritus professor at Stanford who is one of the editors of a scholarly handbook on the subject.

Attacks from three sides — lawyers, Congress, and the incoming Trump administration, all seemingly interested in taking up the fight — could lead to enough pressure to challenge Big Food and possibly spur better health outcomes in the U.S., which has the lowest life expectancy among high-income countries.

“Maybe getting rid of highly processed foods in some things could actually flip the switch pretty quickly in changing the percentage of the American public that are obese,” said Robert Redfield, a virologist who led the Centers for Disease Control and Prevention during the previous Trump administration, in remarks at a December event hosted by the Heritage Foundation, a conservative think tank.

Claims that Big Food knowingly manufactured and sold addictive and harmful products resemble the claims leveled against Big Tobacco before the landmark $206 billion settlement was reached in 1998.

“These companies allegedly use the tobacco industry’s playbook to target children, especially Black and Hispanic children, with integrated marketing tie-ins with cartoons, toys, and games, along with social media advertising,” Rene Rocha, one of the lawyers at Morgan & Morgan representing Martinez, told KFF Health News.

The 148-page Martinez lawsuit against foodmakers draws from documents made public in litigation against tobacco companies that owned some of the biggest brands in the food industry.

Similar allegations were made against opioid manufacturers, distributors, and retailers before they agreed to pay tens of billions of dollars in a 2021 settlement with states.

The FDA ultimately put restrictions on the labeling and marketing of tobacco, and the opioid epidemic led to legislation that increased access to lifesaving medications to treat addiction.

But the Trump administration’s zeal in taking on Big Food may face unique challenges.

The ability of the FDA to impose regulation is hampered in part by funding. While the agency’s drug division collects industry user fees, its division of food relies on a more limited budget determined by Congress.

Change can take time because the agency moves at what some critics call a glacial pace. Last year, the FDA revoked a regulation allowing brominated vegetable oil in food products. The agency determined in 1970 that the additive was not generally recognized as safe.

Efforts to curtail the marketing of ultra-processed food could spur lawsuits alleging that any restrictions violate commercial speech protected by the First Amendment. And Kennedy — if he is confirmed as HHS secretary — may struggle to get support from a Republican-led Congress that champions less federal regulation and a president-elect who during his previous term served fast food in the White House.

“The question is, will RFK be able to make a difference?” said David L. Katz, a doctor who founded True Health Initiative, a nonprofit group that combats public health misinformation. “No prior administration has done much in this space, and RFK is linked to a particularly anti-regulatory administration.”

Meanwhile, the U.S. population is recognized as among the most obese in the world and has the highest rate of people with multiple chronic conditions among high-income countries.

“There is a big grassroots effort out there because of how sick we are,” said Jerold Mande, who served as deputy undersecretary for food safety at the Department of Agriculture from 2009 to 2011. “A big part of it is people shouldn’t be this sick this young in their lives. You’re lucky if you get to 18 without a chronic disease. It’s remarkable.”

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Durante años, el gobierno federal ha evitado regular la comida chatarra, la comida rápida y los alimentos ultraprocesados.

Ahora, las actitudes están cambiando. Algunos miembros del círculo íntimo del presidente Donald Trump se están preparando para luchar contra las “grandes empresas alimentarias”, es decir, las compañías que producen la mayor parte de los alimentos y bebidas que se consumen en el paía.

Los candidatos a las principales agencias de salud están apuntando a los alimentos ultraprocesados, que representan aproximadamente el 70% del suministro de alimentos de Estados Unidos.

Según declaraciones recientes, una variedad de posibles opciones de normas con carga política para regular los alimentos ultraprocesados ​​pueden llegar al menú del equipo de Trump, incluidas las etiquetas de advertencia, los cambios en los subsidios a la agroindustria y los límites a los productos que los consumidores pueden comprar con la ayuda alimentaria del gobierno.

El impulso para reformar la dieta estadounidense está siendo impulsado en gran medida por los conservadores que han asumido la causa que durante mucho tiempo ha sido la favorita de la izquierda.

Los partidarios de Trump, como Robert F. Kennedy Jr., cuya controversial nominación para dirigir el Departamento de Salud y Servicios Humanos aún enfrenta la confirmación del Senado, están adoptando un concepto que defiende los alimentos naturales y la medicina alternativa.

Es un movimiento que han denominado “MAHA”, o Make America Healthy Again (Hagamos a América saludable de nuevo). Su interés ha cobrado impulso porque sus objetivos tienen un apoyo bipartidista bastante amplio, incluso en medio de un Congreso amargamente dividido en el que los legisladores de ambos partidos se centraron en el tema el año pasado.

Es probable que sea una batalla campal porque la industria alimentaria ejerce una inmensa influencia política y ha frustrado con éxito los esfuerzos anteriores por regular sus productos o su comercialización. La categoría de “empresas de procesamiento y venta de alimentos”, que incluye a Tyson Foods y Nestlé SA, registró un gasto de $26,7 millones en actividades de lobby en 2024, según OpenSecrets. En 1998 fueron $10 millones.

“Han sido absolutamente instrumentales y muy, muy exitosos en retrasar cualquier efectividad en la regulación en Estados Unidos”, dijo Laura Schmidt, profesora de política de salud en la Universidad de California-San Francisco. “Realmente parece que debe haber un momento de ajuste de cuentas aquí donde la gente comience a preguntarse, ‘¿Por qué tenemos que vivir así?’”

“Alimentos ultraprocesados” es un término ampliamente utilizado que significa cosas diferentes para distintas personas y se utiliza para describir artículos que van desde refrescos hasta muchas comidas congeladas. Estos productos a menudo contienen grasas, almidones y azúcares agregados, entre otras cosas. Los investigadores dicen que el consumo de alimentos ultraprocesados ​​está vinculado, en diferentes niveles de intensidad, a enfermedades crónicas como diabetes, cáncer, problemas de salud mental y muerte prematura.

Los líderes en nutrición y salud son optimistas de que ya se está llevando a cabo un ajuste de cuentas. Kennedy se ha comprometido a eliminar los alimentos procesados ​​de los almuerzos escolares, restringir ciertos aditivos alimentarios como los colorantes en los cereales y redireccionar los subsidios agrícolas federales de los cultivos básicos ampliamente utilizados en los alimentos ultraprocesados.

La intensificación de la atención en Washington ha desencadenado un nuevo nivel de interés en el frente legal, ya que los abogados exploran casos para enfrentarse a los principales fabricantes de alimentos por vender productos que, según ellos, provocan enfermedades crónicas.

Bryce Martínez, que ahora tiene 18 años, presentó una demanda en diciembre contra casi una docena de fabricantes de alimentos como Kraft Heinz, The Coca-Cola Co. y Nestlé USA. Desarrolló diabetes y enfermedad del hígado graso no alcohólico a los 16 años, y está tratando de hacerlos responsables de sus enfermedades.

Según la demanda, presentada en el Tribunal de Causas Comunes de Philadelphia, las empresas sabían o deberían haber sabido que los alimentos ultraprocesados ​​eran dañinos y adictivos. La demanda señalaba que Martínez creció comiendo alimentos de marca muy publicitados que son básicos en la dieta estadounidense: refrescos azucarados, Cheerios y Lucky Charms, Skittles y Snickers, comidas congeladas y envasadas, por nombrar solo algunos.

Nestlé, Coca-Cola y Kraft Heinz no respondieron a los correos electrónicos en los que se solicitaban comentarios para este artículo. La Consumer Brands Association, una asociación comercial para fabricantes de bienes de consumo envasados, cuestionó las acusaciones.

“Intentar clasificar los alimentos como poco saludables simplemente porque están procesados, o demonizar los alimentos ignorando su contenido nutricional completo, engaña a los consumidores y exacerba las disparidades en materia de salud”, dijo Sarah Gallo, vicepresidenta sénior de política de productos, en una declaración.

Otros bufetes de abogados están a la caza de niños o adultos que creen que fueron perjudicados por consumir alimentos ultraprocesados, lo que aumenta la probabilidad de demandas.

Un grupo de abogados de Indiana especializado en lesiones personales dice en su sitio web: “estamos investigando activamente casos de alimentos ultraprocesados ​​(UPF)”. Y abogados litigantes de Texas también están estudiando la posibilidad de emprender acciones legales contra los reguladores federales que, según ellos, no han controlado los alimentos ultraprocesados.

“Si usted o su hijo han sufrido problemas de salud que su médico ha vinculado directamente con el consumo de alimentos ultraprocesados, Queremos escuchar su historia”, dicen en su sitio web.

Mientras tanto, el 14 de enero la Administración de Drogas y Alimentos (FDA)  anunció que propone exigir que aparezca una etiqueta en la parte de adelante del paquete en la mayoría de los alimentos envasados ​​para que la información sobre el contenido de grasas saturadas, sodio y azúcar agregado de un alimento sea fácilmente visible para los consumidores.

Y en el Capitolio, los senadores Bernie Sanders (independiente de Vermont), Ron Johnson (Republicano de Wisconsin) y Cory Booker (demócrata de New Jersey) están haciendo sonar la alarma sobre los alimentos ultraprocesados.

En 2024, Sanders introdujo una legislación que podría conducir a una prohibición federal de la publicidad de comida chatarra dirigida a niños, una campaña nacional de educación y etiquetas en alimentos ultraprocesados ​​que digan que los productos no están recomendados para pequeños. Booker firmó la legislación junto con los senadores Peter Welch (demócrata de Vermont) y John Hickenlooper (demócrata de Colorado).

En diciembre, el Comité de Salud, Educación, Trabajo y Pensiones del Senado tuvo una audiencia para examinar los vínculos entre los alimentos ultraprocesados ​​y las enfermedades crónicas, durante la cual el comisionado de la FDA, Robert Califf, pidió más fondos para la investigación.

Las empresas alimentarias han aprovechado “los mismos circuitos neuronales que intervienen en la adicción a los opioides”, dijo Califf en la audiencia.

Sanders, que presidió la audiencia, dijo que hay “evidencia creciente” de que “estos alimentos están diseñados deliberadamente para ser adictivos”, y afirmó que los alimentos ultraprocesados ​​han impulsado epidemias de diabetes y obesidad, y cientos de miles de millones de dólares en gastos médicos.

La investigación sobre los alimentos y la adicción “se ha acumulado hasta el punto de haber alcanzado una masa crítica”, dijo Kelly Brownell, profesora emérita de Stanford y una de las editoras de un manual académico sobre el tema.

Los ataques de tres bandos —abogados, el Congreso y la administración Trump, todos aparentemente interesados ​​en presentar batalla— podrían generar suficiente presión para desafiar a las grandes empresas alimentarias y posiblemente impulsar mejores resultados de salud en Estados Unidos, que tiene la más baja expectativa de vida entre los países de altos ingresos.

“Tal vez deshacerse de los alimentos altamente procesados ​​en algunas cosas podría realmente cambiar rápidamente el porcentaje de la población estadounidense que es obesa”, dijo el virólogo Robert Redfield, que dirigió los Centros para el Control y Prevención de Enfermedades (CDC) durante la administración Trump anterior, en comentarios en un evento en diciembre organizado por The Heritage Foundation, un grupo de expertos conservador.

Las acusaciones de que las grandes empresas alimentarias fabricaron y vendieron a sabiendas productos adictivos y nocivos se parecen a las acusaciones formuladas contra las grandes tabacaleras antes de que se alcanzara el histórico acuerdo de $206.000 millones, en 1998.

“Supuestamente, estas empresas utilizan el manual de estrategias de la industria tabacalera para dirigirse a los niños, especialmente a los niños negros e hispanos, con vínculos de marketing integrados con dibujos animados, juguetes y juegos, junto con publicidad en las redes sociales”, dijo a KFF Health News René Rocha, uno de los abogados de Morgan & Morgan que representa a Martínez.

La demanda de Martínez contra los fabricantes de alimentos, de 148 páginas, se basa en documentos que se hicieron públicos en un litigio contra las empresas tabacaleras que eran dueñas de algunas de las marcas más importantes de la industria alimentaria.

Se hicieron acusaciones similares contra los fabricantes, distribuidores y minoristas de opioides antes de que aceptaran pagar decenas de miles de millones de dólares en un acuerdo de 2021 con los estados.

La FDA finalmente impuso restricciones al etiquetado y la comercialización del tabaco, y la epidemia de opioides condujo a una legislación que aumentó el acceso a medicamentos que salvan vidas para tratar la adicción.

Pero el celo de la administración Trump al enfrentarse a las grandes empresas alimentarias puede enfrentar desafíos únicos.

La capacidad de la FDA para imponer regulaciones se ve obstaculizada en parte por la financiación. Mientras que la división de medicamentos de la agencia recauda tasas de usuario de la industria, su división de alimentos depende de un presupuesto más limitado determinado por el Congreso.

El cambio puede llevar tiempo porque la agencia avanza, según algunos críticos, a ritmo de tortuga. El año pasado, la FDA revocó una regulación que permitía el aceite vegetal bromado en productos alimenticios. La agencia determinó en 1970 que el aditivo no era generalmente reconocido como seguro.

Los esfuerzos para limitar la comercialización de alimentos ultraprocesados ​​podrían impulsar demandas que aleguen que cualquier restricción viola la libertad de expresión comercial protegida por la Primera Enmienda. Y Kennedy —si es confirmado como secretario del Departamento de Salud y Servicios Sociales (HHS)—  puede tener dificultades para obtener el apoyo de un Congreso liderado por  republicanos, que defiende una menor regulación federal, y de un presidente que durante su mandato anterior sirvió comida rápida en la Casa Blanca.

“La pregunta es: ¿podrá RFK marcar una diferencia?”, dijo David L. Katz, médico fundador de True Health Initiative, un grupo sin fines de lucro que combate la desinformación sobre salud pública. “Ninguna administración anterior ha hecho mucho en este ámbito, y RFK está vinculado a una administración particularmente antirregulatoria”.

Mientras tanto, la población estadounidense es reconocida como una de las más obesas del mundo y tiene la tasa más alta de personas con múltiples enfermedades crónicas entre los países de altos ingresos.

“Hay un gran esfuerzo de base debido a lo enfermos que estamos”, dijo Jerold Mande, quien se desempeñó como subsecretario adjunto para la seguridad alimentaria en el Departamento de ASgricultura entre 2009 y 2011.

“En gran parte, esto se debe a que la gente no debería estar tan enferma tan temprano en la vida. Tienes suerte si llegas a los 18 años sin una enfermedad crónica. Es extraordinario”, observó.

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He promised to overhaul the Social Security Administration’s often heavy-handed efforts to claw back money that millions of recipients — including people who are living in poverty, are elderly, or have disabilities — were allegedly overpaid, as described by a KFF Health News and Cox Media Group investigation last year.

“Innocent people can be badly hurt,” O’Malley said at the time.

Nearly eight months since he appeared before Congress and announced a series of policy changes, and with days left before he leaves the job, O’Malley’s effort to fix the system has made inroads but remains a work in progress.

For instance, one change, moving away from withholding 100% of people’s monthly Social Security benefits to recover alleged overpayments, has been a major improvement, say advocates for beneficiaries.

“It is a tremendous change,” said Kate Lang of Justice in Aging, who called it “life-changing for many people.”

The number of people from whom the Social Security Administration was withholding full monthly benefits to recoup money declined sharply — from about 46,000 in January to about 7,000 in September, the agency said.

Asked to clarify whether those numbers and others provided for this article covered all programs administered by the agency, the SSA press office did not respond.

Another potentially significant change — relieving beneficiaries of having to prove that an overpayment was not their fault — has not been implemented. The agency said it is working on that.

Meanwhile, the agency seems to be looking to Congress to take the lead on a change some observers see as crucial: limiting how far back the government can reach to recover an alleged overpayment.

Barbara Hubbell of Watkins Glen, New York, called the absence of a statute of limitations “despicable.” Hubbell said her mother was held liable for $43,000 because of an SSA error going back 19 years.

“In what universe is that even legal?” Hubbell said. Paying down the overpayment balance left her mother “essentially penniless,” she added.

In response to questions for this article, Social Security spokesperson Mark Hinkle said legislation is “the best and fastest way” to set a time limit.

Establishing a statute of limitations was not among the policy changes O’Malley announced in his March congressional testimony. In an interview at the time, he said he expected an announcement on it “within the next couple few months.” It could probably be done by regulation, without an act of Congress, he said.

Speaking generally, Hinkle said the agency has “made substantial progress on overpayments,” reducing the hardship they cause, and “continues to work diligently” to update policies.

The agency is underfunded, he added, is at a near 50-year low in staffing, and could do better with more employees. The SSA did not respond to requests for an interview with O’Malley.

O’Malley announced the policy changes after KFF Health News and Cox Media Group jointly published and broadcast investigative reporting on the damage overpayments and clawbacks have done to millions of beneficiaries.

When O’Malley, a former Democratic governor of Maryland, presented his plans to three congressional committees in March, lawmakers greeted him with rare bipartisan praise. But the past several months have shown how hard it can be to turn around a federal bureaucracy that is massive, complex, deeply dysfunctional, and, as it says, understaffed.

Now O’Malley’s time is almost up. After this article was published Monday, and with two months left in his term, news outlets reported that he was leaving to run for chair of the Democratic National Committee.

Social Security spokesperson Nicole Tiggemann said O’Malley sent President Joe Biden a letter of resignation effective Nov. 29.

Lang of Justice in Aging, among the advocacy groups that have been meeting with O’Malley and other Social Security officials, said she appreciates how much the commissioner has achieved in a short time. But she added that O’Malley has “not been interested in hearing about our feelings that things have fallen short.”

One long-standing policy O’Malley set out to change involves the burden of proof. When the Social Security Administration alleges someone has been overpaid and demands the money back, the burden is on the beneficiary to prove they were not at fault.

(WSB-TV, Atlanta)

Cecilia Malone, 24, a beneficiary in Lithonia, Georgia, said she and her parents spent hundreds of hours trying to get errors corrected. “Why is the burden on us to ‘prove’ we weren’t overpaid?” Malone said.

It can be exceedingly difficult for beneficiaries to appeal a decision. The alleged overpayments, which can reach tens of thousands of dollars or more, often span years. And people struggling just to survive may have extra difficulty producing financial records from long ago.

What’s more, in letters demanding repayment, the government does not typically spell out its case against the beneficiary — making it hard to mount a defense.

Testifying before House and Senate committees in March, O’Malley promised to shift the burden of proof.

“That should be on the agency,” he said.

The agency expects to finalize “guidance” on the subject “in the coming months,” Hinkle said.

The agency points to reduced wait times and other improvements in a phone system known to leave beneficiaries on hold. “In September, we answered calls to our national 800 number in an average of 11 minutes — a tremendous improvement from 42 minutes one year ago,” Hinkle said.

Still, in response to a nonrepresentative survey by KFF Health News and Cox Media Group focused on overpayments, about half of respondents who said they contacted the agency by phone since April rated that experience as “poor,” and few rated it “good” or “excellent.”

The survey was sent to about 600 people who had contacted KFF Health News to share their overpayment stories since September 2023. Almost 200 people answered the survey in September and October of this year.

Most of those who said they contacted the agency by mail since April rated their experience as “poor.”

(WHIO-TV, Dayton)

Jennifer Campbell, 60, a beneficiary in Nelsonville, Ohio, said in late October that she was still waiting for someone at the agency to follow up as described during a phone call in May.

“VERY POOR customer service!!!!!” Campbell wrote.

“Nearly impossible to get a hold of someone,” wrote Kathryn Duff of Colorado Springs, Colorado, who has been helping a disabled family member.

Letters from SSA have left Duff mystified. One was postmarked July 9, 2024, but dated more than two years earlier. Another, dated Aug. 18, 2024, said her family member was overpaid $31,635.80 in benefits from the Supplemental Security Income program, which provides money to people with little or no income or other resources who are disabled, blind, or at least 65. But Duff said her relative never received SSI benefits.

What’s more, for the dates in question, payments listed in the letter to back up the agency’s math didn’t come close to $31,635.80; they totaled about a quarter of that amount.

Regarding the 100% clawbacks, O’Malley in March said it’s “unconscionable that someone would find themselves facing homelessness or unable to pay bills, because Social Security withheld their entire payment for recovery of an overpayment.”

He said that, starting March 25, if a beneficiary doesn’t respond to a new overpayment notice, the agency would default to withholding 10%. The agency warned of “a short transition period.”

That change wasn’t automated until June 25, Hinkle said.

The number of people newly placed in full withholding plummeted from 6,771 in February to 51 in September, according to data the agency provided.

SSA said it would notify recipients they could request reduced withholding if it was already clawing back more than 10% of their monthly checks.

Nonetheless, dozens of beneficiaries or their family members told KFF Health News and Cox Media Group they hadn’t heard they could request reduced withholding. Among those who did ask, roughly half said their requests were approved.

According to the SSA, there has been almost a 20% decline in the number of people facing clawbacks of more than 10% but less than 100% of their monthly checks — from 141,316 as of March 8 to 114,950 as of Oct. 25, agency spokesperson Tiggemann said.

Meanwhile, the number of people from whom the agency was withholding exactly 10% soared more than fortyfold — from just over 5,000 to well over 200,000. And the number of beneficiaries having any partial benefits withheld to recover an overpayment increased from almost 600,000 to almost 785,000, according to data Tiggemann provided.

Lorraine Anne Davis, 72, of Houston, said she hasn’t received her monthly Social Security payment since June due to an alleged overpayment. Her Medicare premium was being deducted from her monthly benefit, so she’s been left to pay that out-of-pocket.

Davis said she’s going to need a kidney transplant and had been trying to save money for when she’d be unable to work.

A letter from the SSA dated April 8, 2024, two weeks after the new 10% withholding policy was slated to take effect, said it had overpaid her $13,538 and demanded she pay it back within 30 days.

Apparently, the SSA hadn’t accounted for a pension Davis receives from overseas; Davis said she disclosed it when she filed for benefits.

In a letter to her dated June 29, the agency said that, under its new policy, it would change the withholding to only 10% if she asked.

Davis said she asked by phone repeatedly, and to no avail.

“Nobody seems to know what’s going on” and “no one seems to be able to help you,” Davis said. “You’re just held captive.”

In October, the agency said she’d receive a payment — in March 2025.

Marley Presiado, a research assistant on the Public Opinion and Survey Research team at KFF, contributed to this report.

Do you have an experience with Social Security overpayments you’d like to share? Click here to contact our reporting team.

[Update: This article was last revised at 4:45 p.m. ET on Nov. 18, 2024, to reflect that Social Security Administration Commissioner Martin O’Malley has turned in his resignation. Also, the word “partial” was added to this sentence: “And the number of beneficiaries having any partial benefits withheld to recover an overpayment increased from almost 600,000 to almost 785,000, according to data Tiggemann provided.”]

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Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy.

People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI.

The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

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When the Consumer Product Safety Commission announced that poorly designed baby loungers could suffocate babies, it warned consumers to immediately stop using them.

But when it comes to medical devices, the Food and Drug Administration and manufacturers routinely allow doctors and hospitals to continue using equipment that, as the government sees it, could injure or kill the patients it’s supposed to help. KFF Health News recently highlighted the issue of non-recall recalls in an examination of MitraClip, a cardiac implant.

In 2016, medical device giant Abbott issued a recall for the device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an FDA notice said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves.

In a notice, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

The company told KFF Health News that the device has been proved safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

Medical device recalls can include “removals,” in which the device is pulled from where it is used or sold, and “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California at San Francisco and former editor in chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo multiple recalls while still on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

In some cases, a medical device that is the subject of a recall can remain on the market safely with a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices can provide unwarranted reassurance and leave the public at risk, Dhruva said.

“Depending on the risks and benefits of the device versus the alternatives, it may be better to actually remove the recalled device from clinical use and the market,” Redberg said.

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“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.

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In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,'” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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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In the emails, David Morens, a career federal scientist now on administrative leave, described deleting messages and using a personal email account to evade disclosure of correspondence under the Freedom of Information Act.

“i learned from our foia lady here how to make emails disappear after i am foia’d but before the search starts, so i think we are all safe,” Morens wrote in a Feb. 24, 2021, email. “Plus i deleted most of those earlier emails after sending them to gmail.”

The pressure is on as Fauci himself prepares to appear June 3 before a House subcommittee exploring the origins of covid-19. The NIH, a $49 billion agency that is the foremost source of funding in the world for biomedical research, finds itself under unusual bipartisan scrutiny. The subcommittee has demanded more outside oversight of NIH and its 50,000 grants and raised the idea of term limits for officials like Fauci, who led the National Institute of Allergy and Infectious Diseases, an NIH component, from 1984 to 2022.

Lawmakers are likely to put Fauci on the spot about Morens’ emails at a time when Republicans are questioning NIH’s credibility and integrity. Even Democrats have cautioned the agency’s leaders.

“When people don’t trust scientists, they don’t trust the science,” Rep. Deborah Ross (D-N.C.) told Morens.

The subcommittee has yet to turn up evidence implicating the NIH or U.S. scientists in the pandemic’s beginnings in Wuhan, China. Nor has its work shed light on the origin of the virus.

But in a May 28 letter to NIH Director Monica Bertagnolli, the subcommittee’s chairman, Rep. Brad Wenstrup (R-Ohio), said the evidence “suggests a conspiracy at the highest levels of NIH and NIAID to avoid public transparency regarding the COVID-19 pandemic.”

Rep. Jill Tokuda, a subcommittee Democrat from Hawaii, said the evidence shows no such conspiracy. She predicted the bipartisan criticism of Morens, 76, will give way to “a clash of intentions” at the hearing as Republicans try to pin covid on Fauci.

“For them, I think this is their moment to, again, bring a lot of these baseless, false allegations to the front,” Tokuda said.

On May 29, Wenstrup asked Fauci to turn over personal e-mails ahead of his testimony.

Here are things to know as the subcommittee gears up for Fauci’s appearance.

What Is the Subcommittee Looking For?

The Select Subcommittee on the Coronavirus Pandemic is supposed to be investigating how the pandemic started and the federal government’s response. That includes such hot-button issues as vaccination policies and school closures.

A central question is whether the covid virus leaped from animals to humans at a market in Wuhan, China, or spread from a leak at the nearby Wuhan Institute of Virology. The Wuhan lab received funding from an NIH grant recipient called EcoHealth Alliance.

The congressional probe is in some ways an extension of the nation’s political, cultural, and scientific battles arising from the pandemic.

The Republican-led subcommittee has been examining NIH’s performance and that of Fauci, who advised both former President Donald Trump and President Joe Biden, becoming the face of many of the government’s most polarizing pandemic policies.

The panel called for the government to cut off EcoHealth’s funding, a process the Department of Health and Human Services recently initiated.

EcoHealth’s president, Peter Daszak, was Morens’ friend and the recipient of many of the emails under scrutiny. A wildlife biologist credited with helping to develop the first covid antiviral drug, remdesivir, Daszak said he and his organization did nothing wrong.

“We were so accurate in our predictions that a bat coronavirus would emerge from China and cause a pandemic, that when it did, we’re dragged in front of the crowd with their pitchforks and blamed for it,” Daszak said in an interview.

What’s at Stake for NIH?

The Republican-led subcommittee is challenging NIH’s credibility. The agency performs and funds a wide variety of medical and scientific research, work that is often the foundation of new medicines and other treatments, and has long enjoyed bipartisan support from Congress. The agency is home to the “Cancer Moonshot,” a Biden priority.

As head of NIAID and a presidential adviser, Fauci helped guide the public during the pandemic on measures to avoid infection, such as mask-wearing and maintaining physical distance.

But at a May 22 hearing, Wenstrup said Fauci’s NIAID “was, unfortunately, less pristine than so many, including the media, would have had us all believe.”

In his letter to Bertagnolli, Wenstrup said there was evidence that a former chief of staff of Fauci’s might have used intentional misspellings — such as a variant of “EcoHealth” — to prevent emails from being captured in keyword searches by FOIA officials.

Wenstrup’s office did not respond to questions or an interview request.

An aide to the top Democrat on the subcommittee, Rep. Raul Ruiz of California, said he was unavailable for an interview.

Why Were Morens’ Emails Alarming?

The emails show a pattern of trying to shield communications from public disclosure.

“We are all smart enough to know to never have smoking guns, and if we did we wouldn’t put them in emails, and if we found them we’d delete them,” Morens wrote on June 16, 2020.

“The best way to avoid FOIA hassles is to delete all emails when you learn a subject is getting sensitive,” he wrote on June 28, 2021.

Some of Morens’ emails included sexual or sexist remarks, including one from December 2020: “Beverage is always good, and best delivered by a blonde nymphomaniac.” In another email, discussing how former Centers for Disease Control and Prevention Director Rochelle Walensky got her job, he remarked, “Well, she does wear a skirt.”

Morens apologized at the May 22 hearing and called some of what he wrote “misogynistic.”

“Some of the emails I’ve seen that you all have provided look pretty incriminating,” he testified.

Asked if he ever sent information related to covid to Fauci’s personal email, he said he didn’t remember but might have.

Morens said some of his comments were “snarky jokes” intended to cheer up his friend Daszak, the EcoHealth president, who was receiving death threats over media coverage of his organization’s relationship with the Wuhan lab.

Morens testified that he didn’t knowingly delete official records.

Ross, the North Carolina representative, said the emails “inflict serious damage on public trust for the entire scientific enterprise.” She said the dangers can be seen in eroding public confidence in vaccines, contributing to recent outbreaks of measles.

Rep. Debbie Dingell (D-Mich.) said Morens showed disdain for the Freedom of Information Act. The subcommittee’s investigation has been an unfounded effort to pin the blame for the pandemic on NIH and NIAID, and Morens’ emails have helped blur the issues, she said.

Do the Emails Reveal the Origins of Covid?

No, as Democrats have emphasized.

In a way, Morens’ correspondence undercuts allegations that people at the top of NIAID covered up a lab leak in Wuhan.

None of Morens’ emails describe any effort to suppress evidence of a lab leak and, in an email sent from a private account, he ridiculed the idea, calling it “false to the point of being crazy.” But the subcommittee’s senior Democrat, Ruiz, criticized Morens for dismissing the lab leak theory.

“Unless and until we see specific evidence on the origins” of the virus that causes covid, “the scientific process requires that we examine all possible hypotheses with objectivity,” Ruiz said.

KFF Health News senior correspondent Arthur Allen contributed to this report.

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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Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF.

“I think we could be entering a somewhat novel era of pricing,” Khan told reporters.

Khan is regarded as one of the most aggressive antitrust regulators in recent U.S. history, and she has paid particular attention to the harm that technological advances can pose to consumers. Antitrust regulators at the FTC and the Justice Department set a record for merger challenges in the fiscal year that ended Sept. 30, 2022, according to Bloomberg News.

Last year, the FTC successfully blocked biotech company Illumina’s over $7 billion acquisition of cancer-screening company Grail. The FTC, Justice Department, and Health and Human Services Department launched a website on April 18, healthycompetition.gov, to make it easier for people to report suspected anticompetitive behavior in the health care industry.

The American Hospital Association, the industry’s largest trade group, has often criticized the Biden administration’s approach to antitrust enforcement. In comments in September on proposed guidance the FTC and Justice Department published for companies, the AHA said that “the guidelines reflect a fundamental hostility to mergers.”

Price fixing removes competition from the market and generally makes goods and services more expensive. The agency has argued in court filings that price fixing “is still illegal even if you are achieving it through an algorithm,” Khan said. “There’s no kind of algorithmic exemption to the antitrust laws.”

By simply using the same algorithms to set prices, companies can effectively charge the same “even if they’re not, you know, getting in a back room and kind of shaking hands and setting a price,” Khan said, using the example of residential property managers.

Khan said the commission is also scrutinizing the use of artificial intelligence and algorithms to set prices for individual consumers “based on all of this particular behavioral data about you: the websites you visited, you know, who you had lunch with, where you live.”

And as health care companies change the way they structure their businesses to maximize profits, the FTC is changing the way it analyzes behavior that could hurt consumers, Khan said.

Hiring people who can “help us look under the hood” of some inscrutable algorithms was a priority, Khan said. She said it’s already paid off in the form of legal actions “that are only possible because we had technologists on the team helping us figure out what are these algorithms doing.”

Traditionally, the FTC has policed health care by challenging local or regional hospital mergers that have the potential to reduce competition and raise prices. But consolidation in health care has evolved, Khan said.

Mergers of systems that don’t overlap geographically are increasing, she said. In addition, hospitals now often buy doctor practices, while pharmacy benefit managers start their own insurance companies or mail-order pharmacies — or vice versa — pursuing “vertical integration” that can hurt consumers, she said.

The FTC is hearing increasing complaints “about how these firms are using their monopoly power” and “exercising it in ways that’s resulting in higher prices for patients, less service, as well as worse conditions for health care workers,” Khan said.

Policing Noncompetes

Khan said she was surprised at how many health care workers responded to the commission’s recent proposal to ban “noncompete” clauses — agreements that can prevent employees from moving to new jobs. The FTC issued its final rule banning the practice on Tuesday. She said the ban was aimed at low-wage industries like fast food but that many of the comments in favor of the FTC’s plan came from health professions.

Health workers say noncompete agreements are “both personally devastating and also impeded patient care,” Khan said.

In some cases, doctors wrote that their patients “got really upset because they wanted to stick with me, but my hospital was saying I couldn’t,” Khan said. Some doctors ended up commuting long distances to prevent the rest of their families from having to move after they changed jobs, she said.

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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One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

The government database, called “Open Payments,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.

But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members’ objectivity.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. “They should or must disclose this due to bias.”

The Open Payments database records several kinds of payments from drug and device makers. One category, called “associated research funding,” supports research in which a physician is named a principal investigator in the database. Another category, called “general payments,” includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.

At the public meeting to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members.

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place,” she said. “This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest.”

Abbott “has no influence over who is selected to participate in FDA advisory committees,” a spokesperson for the company, Brent Tippen, said in a statement.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn’t have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.

One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: “People from the outside looking in would probably say yes.”

He noted that Abbott’s money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: “There’s probably a better way to provide transparency.”

The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer’s covid-19 vaccine had been a Pfizer consultant.

Appearance Issues

FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as “anything that would give an ‘appearance’ of a conflict.”

The FDA has discretion to decide whether someone with an “appearance issue” can serve on a panel, according to a guidance document posted on the agency’s website. Relationships more than a year in the past generally don’t give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member’s impartiality, the document says.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, an FDA explainer says.

If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.

The FDA’s approach to disclosure contrasts with rules for conferences at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures going back 24 months.

Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.

‘Unbridled Enthusiasm’

The FDA has designated TriClip a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease” compared with current treatments, an agency official, Megan Naber, told the advisory committee.

Naber said that for breakthrough devices, the “totality of data must still provide a reasonable assurance of safety and effectiveness” but the FDA “may be willing to accept greater uncertainty” about the balance of risks and benefits.

In a briefing paper for the advisory committee, FDA staff pointed out findings from a clinical trial that didn’t reflect well on TriClip. For example, patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn’t respond to a request for comment on those findings.

The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.

Hauptman said during the meeting that the question of safety was “very, very clear” but added: “I just felt the need to pull back a little bit on unbridled enthusiasm.” Who will benefit from the device, he said, “needs better definition.”

Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott totaling about $197,000 in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.

Hauptman said in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”

Some committee members voted in favor of the device despite concerns.

Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general payments totaling about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.

“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” he said in the meeting.

In an email, he said of his Abbott payments: “All was disclosed and reviewed by the FDA.” He said that he “can be impartial” and that he “openly expressed … concerns about the treatment.”

Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general payments totaling about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions and added that doctors have “a lot to learn” once it’s on the market. For instance: By using the device to treat patients now, “do we set people up for catastrophes later?”

In an email, Krucoff said he completed a “very thorough conflict of interest screening by FDA for this panel,” which focused not only on Abbott but also on “any work done/payments received from any other manufacturer with devices in this space.”

John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he “would have liked to have seen more rigorous data to support efficacy.”

In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott’s success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.

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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