Tag: FDA

Judge Signals He Could Rule to Halt Sales of Common Abortion Pill

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During a four-hour hearing last week that could eliminate nationwide access to a common and widely used abortion pill, federal Judge Matthew Kacsmaryk, of the Northern District of Texas, signaled his conservative Christian beliefs early and often.

Speaking from the bench in a courtroom in Amarillo, Texas, Kacsmaryk repeatedly used language that mimicked the vocabulary of anti-abortion activists. It also reflected the wording of the lawyers seeking to overturn the FDA’s two-decade-old approval of mifepristone, one of the drugs in the two-pill regimen approved for early pregnancy termination.

Each time a lawyer from the Department of Justice, representing the FDA, referred to “medication abortion,” Kacsmaryk returned to the language of conservative Christian activists, using monikers like “chemical abortion” and “mail-in abortion,” phrases at odds with conventional medical terminology.

The stakes in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, are high: Abortion rights advocates fear that Kacsmaryk, an appointee of then-President Donald Trump and a former lawyer at the First Liberty Institute, a conservative Christian legal group, could rule within days to force manufacturers to pull mifepristone from the market nationwide. If that happens, clinics and obstetricians and gynecologists across the country will be able to prescribe only misoprostol, the second drug in the two-pill regimen, for miscarriages and early abortion care. Misoprostol is still extremely safe but less effective and comes with more side effects.

The ruling would be unprecedented in the history of approved drugs and could affect the health care of millions of women, even those in states where abortion is still legal.

“One conservative judge is impacting the rights of women in California and New York,” said Greer Donley, an associate professor of law at the University of Pittsburgh Law School and expert on reproductive health law. “The endgame is to stop as many abortions as possible by any means necessary.”

When the conservative majority on the Supreme Court eliminated the federal right to abortion, Justice Brett Kavanaugh, a Catholic, wrote that the court was not outlawing abortion throughout the United States. “On the contrary,” Kavanaugh wrote, “the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process.”

But in the nine months since the announcement of the decision in Dobbs v. Jackson Women’s Health Organization, Christian legal groups have made their strategy clear: eliminate abortion nationwide by filing lawsuits in federal courts that make scientific claims, unsupported by mainstream medical organizations, to raise doubts about the safety of abortion pills and contraception.

These legal decisions, which conservatives might once have decried as “judicial activism,” are partially necessary because abortion rights continually poll positively, with voters even in solidly conservative states like Kansas and Kentucky refusing to enact bans.

“After Dobbs, there have been more and more efforts to move things away from the popular majority and into the hands of judges like Kacsmaryk,” said Mary Ziegler, a law professor and abortion historian at the University of California-Davis School of Law. “Because voters are not sold on fetal rights and because the only way to a national ban on abortion is likely to come from the conservative courts,” she said.

Ziegler added of anti-abortion campaigners, “They don’t want solutions that work only in Tennessee and Texas.”

The strategy of casting doubt on established and accepted science is not new in conservative circles, nor is it limited to abortion.

For decades, conservative Christian legal groups have introduced scientific uncertainty where there had been none: Claims that abortion causes breast cancer or infertility are unsupported by medical and scientific research but nevertheless made their way into state laws, requiring physicians in certain states to tell patients about risks from abortion that do not exist.

And in a recent opinion that ended birth control access for teens without parental consent in Texas, the same judge as in the mifepristone case — Kacsmaryk — exaggerated the health risks of prescription birth control in his decision, asserting that states have an interest in protecting the health of girls.

“Several popular methods of birth control carry serious side effects,” Kacsmaryk wrote, later quoting from Planned Parenthood educational material that read, “Complications are rare, but they can be serious. In very rare cases, they can lead to death.”

That case, Deanda v. Becerra, was filed by a Christian father who cited religious objections to a federal family planning program. And in the mifepristone case, fundamentalist Christian groups have argued that the drug is unsafe, despite ample research and decades of use testifying to the contrary.

Alliance Defending Freedom, which describes itself as the world’s largest legal organization committed to protecting “God’s design for marriage and family,” is pushing to outlaw abortion pills. Erik Baptist, an attorney for the group, said in a statement following the March 15 hearing that the “the FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground.”

He added, “It’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”

Conservative legal groups like ADF have been savvy about exploiting small wins in the courts and building on them, such as the 2007 decision Gonzales v. Carhart, which upheld a federal ban on a rarely used method of abortion.

The decision had minimal practical impact, as the procedure in question was rarely performed, but it established an important legal principle: When scientific uncertainty arises in legal disputes — is a medical procedure, device, or medication safe or not? — legislatures get to decide.

“The court said when there is scientific uncertainty the tiebreaker goes to the legislature,” said Ziegler.

But there is little question that mifepristone is safe: More than 5.6 million women have successfully used medication abortion since 2000, according to the FDA. In 2008, the Government Accountability Office investigated the FDA’s approval of mifepristone and concluded the process was consistent with FDA regulations.

In the courtroom, Baptist acknowledged that no court had ever ordered the FDA to remove a drug from the market over the agency’s objections, and legal observers say there remains a huge question whether the court can order the secretary of the Department of Health and Human Services, who oversees the FDA, to do so.

But Laurie Sobel, an associate director for women’s health policy at KFF, who listened to the hearing in a Dallas courtroom, said anti-abortion attorneys argued that the mailing of abortion medications strips states of their ability to protect women and children. (The hearing, which Kacsmaryk did not, initially, publicly announce, was not streamed to the public, and the court has yet to release a transcript.)

But Jessica Ellsworth, an attorney representing Danco Laboratories, a manufacturer of mifepristone, told the court that abortion remained legal in all states because it was allowed for preventing a patient’s death or serious bodily injury. Using mifepristone is the safest method of abortion, she argued, noting the judge’s decision in the case could ban it in every state.

“If Kavanaugh said, ‘We’re going to send it back to the states to be decided by their elected representatives,’ this is the exact opposite,” said Donley.

Kacsmaryk appeared ready to grant a preliminary injunction in favor of anti-abortion groups, asking ADF’s Baptist what kind of remedy he was seeking.

Baptist responded, “The court has an interest in preventing dangerous drugs from entering the marketplace.” He added, “Any relief you grant must be complete. The harm of chemical drugs knows no bound.”

FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm

In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.

Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the AGGA, now trains dentists to use another device it has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.

The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.

Tenenbaum said that after KHN and CBS News published their report, she was contacted by “very concerned” FDA officials who said they have begun “looking into” the AGGA but have yet to determine how much legal authority the agency has to regulate it.

“The FDA is looking at what authorities they may have around this device — what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”

A photo of Cara Tenenbaum being interviewed by CBS.
Cara Tenenbaum is a former senior policy adviser in the FDA’s device center. Tenenbaum says the FDA has begun looking into the Anterior Growth Guidance Appliance, or AGGA, after KHN and CBS investigated the device.(CBS News)

KHN and CBS News have reviewed online messages verifying that an FDA official has communicated with Tenenbaum about the AGGA. The FDA declined to comment on the AGGA or confirm whether it was evaluating the device.

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 others — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices.

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the device was never submitted to the FDA, which he believes doesn’t have jurisdiction over it. Tenenbaum has said the lack of registration is “incredibly problematic” because that is one method by which the FDA collects reports of a device’s negative effects.

She encouraged anyone who has witnessed complications from the AGGA to assist the FDA by submitting a report through its MedWatch portal.

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”

Victor Krauthamer, a former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency’s authority, ensuring any future action has a solid legal foundation.

Krauthamer said he expects the FDA to take regulatory action against the AGGA, including sending a warning letter to the manufacturer and potentially taking custody of the devices.

“At this point, I would be surprised if there wasn’t some sort of compliance action, such as a seizure,” Krauthamer said, adding later, “I think that’s probably where the FDA is — trying to make a case that will hold in court and won’t be thrown out.”

Jeffrey Oberlies, an attorney for AGGA manufacturer Johns Dental Laboratories, said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on the AGGA or the FDA’s interest in the device.

Galella said in his deposition he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use the appliance. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments like sleep apnea and temporomandibular joint disorder, or TMJ.

“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

Dentists across the country have drawn from Galella’s teachings on their websites, often saying the AGGA can “grow,” “remodel,” or “expand” an adult’s jaw without surgery. At least 11 of those dentists’ websites appear to have removed any mention of the AGGA since the KHN-CBS News investigation was published March 1.

“I think that’s good to hear,” said Boja Kragulj, a former professional clarinetist who has alleged in a lawsuit that the AGGA did catastrophic harm to her teeth. “I think when you take away this information from patients that are searching for the appliance and seeing these claims, that’s generally a good thing.”

A photo of Boja Kragulj outside, similing and showing her teeth.
Boja Kragulj in December 2018, after she had been wearing an AGGA for about a year, she says.(Al Maniscalco)

Kragulj is one of at least 20 AGGA patients who have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not — and cannot — work. The plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Some allege in lawsuits they will lose teeth because of the device and added in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.

“I can take my finger now and I can literally wiggle my front teeth,” said Melanie Pappalardi, 28, who said she wore an AGGA for a year and filed a lawsuit in Indiana. “I can’t bite into absolutely anything.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, has said in a written statement that the AGGA “is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Attorneys for Galella and his company, the Facial Beauty Institute, have denied liability in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount but continues to fight allegations in the other cases. The Las Vegas Institute, which previously held AGGA classes for dentists and promoted the device on Facebook, denied liability in court and has a pending motion to end claims in one lawsuit in which it is named as a defendant.

In a sworn deposition filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson said that in 2020 he began to question the claims about what the AGGA could accomplish, then severed all ties with Galella.

However, that same year the Las Vegas Institute pivoted to the Anterior Remodeling Appliance, or ARA, according to Facebook posts by Dickerson. Dickerson has said in multiple Facebook posts over the past three years that the AGGA and ARA are very similar, including in a June 2021 post that described ARA as “almost exactly the same appliance.” He also said that most dentists associated with the Las Vegas Institute have switched to the ARA, which is made by a different dental laboratory than AGGA’s manufacturer.

“Different lab. Same thing,” Dickerson said in another Facebook post.

The Las Vegas Institute did not respond to requests for comment on the ARA. Institute attorney William Schuller has previously declined to discuss the ARA.

Dental specialists who have warned about the AGGA said they are also alarmed by the ARA.

A screenshot of a website with an ARA dental deviced circle and an arrow pointing to it.
The LVI Anterior Remodeling Appliance, or ARA, is seen on the website of its manufacturer, Five Star Orthodontic, as shown on Internet Archive’s Wayback Machine. Five Star Orthodontic no longer features the device on its website and declined to comment on the product.(KHN illustration; Five Star Orthodontic)

Dr. Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, each of whom have said they’ve examined multiple patients harmed by the AGGA, said after looking at a photo of the ARA from the manufacturer’s website, it appears to be very similar to the AGGA.

“It is very similar to the AGGA,” Mandelaris said in an email. “Almost identical.”

March Medicaid Madness

The Host

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

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

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

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Also mentioned in this week’s podcast:

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One Texas Judge Will Decide Fate of Abortion Pill Used by Millions of American Women

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AMARILLO, Texas — Federal judges in Texas have delivered time and again for abortion opponents.

They upheld a state law that allows for $10,000 bounties to be placed on anyone who helps a woman get an abortion; ruled that someone opposed to abortion based on religious beliefs can block a federal program from providing birth control to teens; and determined that emergency room doctors must equally weigh the life of a pregnant woman and her embryo or fetus.

Now abortion rights advocates — galvanized by the reversal of Roe v. Wade — are girding for another decision from a Texas courtroom that could force the FDA to remove a widely used abortion pill from pharmacies and physicians’ offices nationwide.

The wide-ranging lawsuit, brought by a conservative Christian legal group, argues that the FDA’s approval process more than two decades ago was flawed when it authorized the use of mifepristone, which stops the development of a pregnancy and is part of a two-drug regimen used in medication abortions.

“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, senior counsel with the Alliance Defending Freedom, part of a conservative coalition that brought the suit in federal district court in Amarillo, Texas. “And we’re asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it’s required to do.”

A decision in the case was expected as soon as Friday. If successful, the lawsuit would force federal officials to rescind mifepristone’s approval, and manufacturers would be unable to ship the drug anywhere in the United States, including to states like California, Massachusetts, Illinois, and New York where abortion remains legal.

Abortion rights supporters and medical groups have pushed back on the lawsuit’s claims. Twelve leading medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, say medication abortion is effective and safe.

Indeed, decades of research show the risk of major complications from taking abortion pills is less than 0.4% — safer than such commonly used drugs as Tylenol or Viagra.

“We’ve got 23 years of data domestically that shows how safe medication abortion is, and it’s been used internationally for decades,” said Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a medical organization with clinics in several states. “It’s much safer than somebody being forced to carry a pregnancy against their will.”

About 5 million women in the United States, federal data shows — and millions more across the world — have safely used abortion pills. They can be taken up to 10 weeks into a pregnancy and are also used by OB-GYNs to manage early miscarriages. All told, more than half of all abortions in the U.S. are a result of medication rather than a medical procedure, according Guttmacher Institute research.

Medication abortion involves taking two pills: mifepristone, which blocks the pregnancy hormone, progesterone; and misoprostol, which induces a miscarriage. Both drugs have long and safe track records: Misoprostol was approved in 1988 to treat gastric ulcers, with mifepristone earning approval in 2000 to end early pregnancy.

By filing its lawsuit in Amarillo, the Alliance Defending Freedom was almost guaranteed to draw U.S. District Judge Matthew Kacsmaryk, a President Donald Trump appointee who worked as deputy general counsel at First Liberty Institute, a conservative nonprofit advocating for religious liberty, before being confirmed to the federal judiciary in 2019.

Civil rights groups universally opposed Kacsmaryk’s nomination to the Northern District of Texas. U.S. Sen. Susan Collins, a Republican from Maine, said during the confirmation process that Kacsmaryk showed “alarming bias against LGBTQ Americans and disregard for Supreme Court precedents.”

“He’s made statements in opposition to reproductive rights, linking up reproduction to the feminist movement and making anti-feminist statements,” said Elizabeth Sepper, a law professor at the University of Texas-Austin, adding that the Supreme Court’s decision last summer in Dobbs v. Jackson Women’s Health Organization, which overturned Roe, allowed the suit against the FDA to proceed. “Prior to Dobbs, the right to abortion would have stood in the way of this lawsuit. But now the conservative legal movement feels empowered.”

The lawsuit is the latest effort by opponents of abortion rights to stymie the use of abortion pills, which many people seeking abortion prefer because it allows them to control their own health care and affords privacy for a process that involves cramping and bleeding, similar to a miscarriage.

“When you have medication abortion, part of the process happens at home. And a lot of people like that,” said Hagstrom Miller, of Whole Woman’s Health. “People can be at home with their loved ones and can sort of schedule the passing of the pregnancy around their work schedule or their child care schedule.”

Harle, however, said that the FDA used a provision to approve the drug that should be used only for medications that treat illness, and that pregnancy is not an illness, but a condition.

“They didn’t meet the standards of federal law,” she said.

Mifepristone’s approval was investigated in 2008 — during the Republican administration of George W. Bush — by the Government Accountability Office, a congressional watchdog, which found that the process was consistent with FDA regulations.

“It’s hard to think of a drug that’s been under more scrutiny than mifepristone,” said I. Glenn Cohen, a Harvard Law School professor and one of 19 FDA scholars who filed an amicus brief opposing the lawsuit. “We don’t think there’s a problem here statutorily or medically. It’d be very dangerous to allow a single judge sitting in Amarillo to essentially order a drug that’s used by many women in America off the market.”

But Harle said that no amount of scientific data would be enough to convince her that mifepristone should be on the market.

“I think chemical abortion does great harms to women and their unborn children,” she said. “And that’s what this lawsuit is really about.”

Abortion care providers like Hagstrom Miller are bracing for the ruling. “I think people know that what happens in Texas doesn’t stay in Texas,” she said. “Some of the most progressive states in the country will face restrictions if this lawsuit is successful.”

If that’s the case, her clinics and OB-GYNs across the country will be forced to use only misoprostol for miscarriage and early abortion care, something that will reduce the efficacy of the method: While taking the two pills together is 99.6% effective in terminating early pregnancy, misoprostol alone — although still extremely safe — is about 80% effective.

Hagstrom Miller also notes that side effects from misoprostol can be more intense, including nausea, diarrhea, and severe cramping and bleeding.

“And that matters, right?” she said. “People should have access to the highest level of medical care.”

A Health-Heavy State of the Union

The Host

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

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

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

Among the takeaways from this week’s episode:

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

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

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

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

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

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

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

Also mentioned in this week’s podcast:

To hear all our podcasts, click here.

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Part I: The State of the Abortion Debate 50 Years After ‘Roe’

The Host

The abortion debate has changed dramatically in the seven months since the Supreme Court overturned Roe v. Wade and its nationwide right to abortion. Nearly half the states have banned or restricted the procedure, even though the public, at the ballot box, continues to show support for abortion rights.

In this special two-part podcast, taped the week of the 50th anniversary of the Roe decision, an expert panel delves into the fight, the sometimes-unintended side effects, and what each side plans for 2023.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN.

Among the takeaways from this week’s episode:

  • Exemptions to state abortion bans came into question shortly after the Supreme Court’s decision to overturn Roe, with national debate surrounding the case of a 10-year-old in Ohio who was forced to travel out of state to have an abortion — although, as a rape victim, she should have been able to obtain an abortion in her home state.
  • The restrictions in many states have caused problems for women experiencing miscarriages, as medical providers fear repercussions of providing care — whether affecting their medical licenses or malpractice insurance coverage, or even drawing criminal charges. So far, there have been no reports of doctors being charged.
  • A Christian father in Texas won a lawsuit against the federal government that bars the state’s Title X family-planning clinics from dispensing birth control to minors without parental consent. That change poses a particular problem for rural areas, where there may not be another place to obtain contraception, and other states could follow suit. The Title X program has long required clinics to serve minors without informing their parents.
  • Top abortion opponents are leaning on misinformation to advance their causes, including to inaccurately claim that birth control is dangerous.
  • Medication abortion is the next target for abortion opponents. In recent months, the FDA has substantially loosened restrictions on the “abortion pill,” though only in the states where abortion remains available. Some opponents are getting creative by citing environmental laws to argue, without evidence, that the abortion pill could contaminate the water supply.
  • Restrictions are also creating problems for the maternal care workforce, with implications possibly rippling for decades to come. Some of the states with the worst maternal health outcomes also have abortion bans, leading providers to rethink how, and where, they train and practice.
  • Looking ahead, a tug of war is occurring on state and local levels among abortion opponents about what to do next. Some lawmakers who voted for state bans are expressing interest in at least a partial rollback, while other opponents are pushing back to demand no changes to the bans. With Congress divided, decisions about federal government spending could draw the most attention for those looking for national policy changes.

Also this week, Rovner interviews Elizabeth Nash, who tracks state reproductive health policies for the Guttmacher Institute, a reproductive rights research group.

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on SpotifyApple PodcastsStitcherPocket Casts, or wherever you listen to podcasts.

GOP House Opens With Abortion Agenda

The Host

Having spent its entire first week choosing a speaker, the Republican-led U.S. House finally got down to legislative business, including passing two bills backed by anti-abortion groups. Neither is likely to become law, because they won’t pass the Senate nor be signed by President Joe Biden. But the move highlights how abortion is sure to remain a high-visibility issue in the nation’s capital.

Meanwhile, as open enrollment for the Affordable Care Act nears its Jan. 15 close, a record number of people have signed up, taking advantage of renewed subsidies and other help with medical costs.

This week’s panelists are Julie Rovner of KHN, Margot Sanger-Katz of The New York Times, Alice Miranda Ollstein of Politico, and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s episode:

  • The House now has a speaker after 15 rounds of full-chamber roll call votes. That paved the way for members to be sworn in, committee assignments to be made, and new committee chairs to be named. Cathy McMorris Rodgers (R-Wash.) and Jason Smith (R-Mo.) will be taking the helm of major health committees.
  • McMorris Rodgers will lead the House Energy and Commerce Committee; Smith will be the chairman of Ways and Means. Unlike McMorris Rodgers, Smith has little background in health issues and has mostly focused on tax issues in his public talking points. But Medicare is likely to be on the agenda, which will require the input of the chairs of both committees.
  • One thing is certain: The new GOP-controlled House will do a lot of investigations. Republicans have already reconstituted a committee to investigate covid-19, although, unlike the Democrats’ panel, this one is likely to spend time trying to find the origin of the virus and track where federal dollars may have been misspent.
  • The House this week began considering a series of abortion-related bills — “statement” or “messaging” bills — that are unlikely to see the light of day in the Senate. However, some in the caucus question the wisdom of holding votes on issues like these that could make their more moderate members more vulnerable. So far, bills have had mostly unanimous support from the GOP. Divisions are more likely to emerge on topics like a national abortion ban. Meanwhile, the Title X program, which pays for things like contraception and testing for sexually transmitted infections, is becoming a hot topic at the state level and in some lawsuits. A case in Texas would restrict contraception availability for minors through this program.
  • It’s increasingly clear that abortion pills are going to become an even bigger part of the abortion debate. On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.
  • Anti-abortion groups are planning protests in early February at large pharmacies such as CVS and Walgreens to try to get them to walk back plans to distribute abortion pills in states where they are legal.
  • A growing number of states are pressuring the Department of Health and Human Services to allow them to import cheaper prescription drugs from Canada — or, more accurately, importing Canada’s price controls. While this has long been a bipartisan issue, it has also long been controversial. Officials at the FDA remain concerned about breaking the closed supply chain between drugs being manufactured and delivered to approved U.S. buyers. The policy is popular, however, because it promises lower prices on at least some drugs.
  • Also in the news from the FDA: The agency granted accelerated approval for Leqembi for the treatment of Alzheimer’s disease. Leqembi is another expensive drug that appears to work, but also carries big risks. However, it is generally viewed as an improvement over the even more controversial Alzheimer’s drug Aduhelm. Still to be determined is whether Medicare — which provides insurance to most people with Alzheimer’s — will cover the drug.
  • As the Affordable Care Act enrolls a record number of Americans, it is notable that repealing the law has not been mentioned as a priority for the new GOP majority in the House. Rather, the top health issue is likely to be how to reduce the price of Medicare and other health “entitlement” programs.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read, too:

Julie Rovner: The Washington Post’s “Social Security Denies Disability Benefits Based on List With Jobs From 1977,” by Lisa Rein

Margot Sanger-Katz: Roll Call’s “Providers Say Medicare Advantage Hinders New Methadone Benefit,” by Jessie Hellmann

Alice Miranda Ollstein: The New York Times’ “Grant Wahl Was a Loving Husband. I Will Always Protect His Legacy.” By Céline Gounder

Sarah Karlin-Smith: KHN’s “Hospitals’ Use of Volunteer Staff Runs Risk of Skirting Labor Laws, Experts Say,” by Lauren Sausser

Also mentioned in this week’s podcast:

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KHN’s ‘What the Health?’: Congress Races the Clock

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The lame-duck Congress is making slow progress on its long to-do-before-the-end-of-the-year list. Democrats agreed to lift the covid-19 vaccine mandate for the military as part of the big defense authorization bill, but efforts to ease federal restrictions on marijuana didn’t succeed.

Meanwhile, the fight against high drug prices has spread to employers, which are trying a variety of strategies to spend less on prescription drugs while still giving workers access to needed medications.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Anna Edney of Bloomberg News, and Sandhya Raman of CQ Roll Call.

Among the takeaways from this week’s episode:

  • The race to the holiday break is on, with no agreement so far on spending as current government funding is set to expire on Dec. 16. Although another continuing resolution is expected, it would likely leave out measures such as addressing mental health, so lawmakers would need to start over next year. The annual defense authorization bill is also in the works and would end the military’s covid vaccine mandate.
  • In the wake of the infant formula shortage, an FDA advisory group report this week said the agency’s work on food regulation needs a major overhaul, especially when it comes to enforcement power and leadership.
  • In drug pricing news, Americans can expect to see the costs of covid testing, vaccines, and treatments rise as federal subsidies run out and leave the pandemic response subject to the same cost and access disparities common to the nation’s health care system. Meanwhile, entrepreneur Mark Cuban’s discount prescription drugs company is teaming up with EmsanaRx, a nonprofit pharmacy benefit manager — thereby cutting out for-profit PBMs in another attempt to cut costs for patients.
  • Health care providers are pushing Congress to stop a long-planned cut in Medicare payments, while a new report from KFF shows the three largest for-profit hospital chains are seeing operating margins that exceed pre-pandemic levels. The Centers for Medicare & Medicaid Services also issued new rules this week on “prior authorization” that providers say could temper the bureaucratic hassle of dealing with Medicare. And private equity firms are getting into the game of running clinical trials, while in insurance, UnitedHealth Group is buying up providers.
  • On reproductive health, an Alabama woman is suing the county government that jailed her on the suspicion she had exposed her fetus to drugs. Her issue? She was not pregnant. The case raises questions about how changes to abortion access are playing out across the country.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: The AP Stylebook’s “Abortion Topical Guide,” by The Associated Press

Anna Edney: The Washington Post’s “Drugs Killed 8 Friends, One by One, in a Tragedy Seen Across the U.S.,” by Lenny Bernstein and Jordan-Marie Smith

Joanne Kenen: Columbia Journalism Review’s “Anonymous Woman,” by Becca Andrews

Sandhya Raman: CQ Roll Call’s “At International Conference, Dobbs Dominates Debate,” by Sandhya Raman

Also mentioned in this week’s podcast:

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

Pese al consejo de Katie Couric, médicos dicen que las ecografías de seno pueden no ser necesarias

Cuando Katie Couric compartió la noticia de su diagnóstico de cáncer de mama, la ex presentadora del programa Today de NBC dijo que veía este nuevo reto de salud como un momento para animar a la gente a hacerse pruebas de detección de cáncer. 

“Por favor, háganse su mamografía anual”, escribió en su página web el mes pasado. “Pero igual de importante, averigüen si necesitan pruebas adicionales”.

En el ensayo, Couric, de 65 años, explicaba que, como tiene senos densos, se hace una prueba de ultrasonido además de la mamografía todos los años para detectar el cáncer de seno. La ecografía mamaria, también llamada sonograma, utiliza ondas sonoras para tomar imágenes del tejido mamario.

A veces puede identificar tumores malignos que son difíciles de detectar en una mamografía en mujeres con pechos densos, que significa tener una alta proporción de tejido fibroso y glándulas, y menos tejido graso.

Couric, que se sometió a una colonoscopía en vivo en televisión después de que su primer esposo muriera de cáncer de colon, y que perdió a una hermana por cáncer de páncreas, lleva mucho tiempo abogando por mejores opciones de detección.

Expertos en cáncer de seno aplaudieron a Couric por llamar la atención sobre la densidad mamaria como factor de riesgo de cáncer. Pero no coinciden con su defensa de las pruebas complementarias.

“No tenemos pruebas de que la revisión auxiliar reduzca la mortalidad por cáncer de mama o mejore la calidad de vida”, dijo la doctora Carol Mangione, profesora de medicina y salud pública de UCLA que preside el Grupo de Trabajo de Servicios Preventivos de Estados Unidos, un grupo de expertos médicos que hace recomendaciones sobre servicios preventivos tras sopesar beneficios y daños.

Couric no respondió al pedido de comentarios.

Además de la mamografía anual, algunas mujeres con mamas densas se hacen una ecografía o una resonancia magnética para tratar de identificar las células cancerosas que no se detectan en la mamografía. En la mamografía, el tejido fibroso denso aparece de color blanco y hace más difícil ver un cáncer, que también se ve blanco. El tejido mamario graso, que aparece oscuro en la mamografía, no oculta los cánceres de mama.

Dado que la tomosíntesis digital de las mamas, o mamografía en 3D, está cada vez más extendida, un número creciente de mujeres se hace esta prueba de chequeo en lugar de la mamografía estándar en 2D.

La mamografía 3D reduce el número de falsos positivos y parece identificar más cánceres en algunas mujeres con mamas densas, aunque se desconoce el impacto en la mortalidad. 

El grupo de trabajo da una calificación de “I” a la ecografía para las mujeres con mamas densas cuyos resultados de la mamografía no indican ningún problema. Esto significa que la evidencia actual es insuficiente para evaluar si los beneficios superan los daños del examen adicional.

Uno de los principales efectos nocivos que preocupa a los investigadores son los falsos positivos.

Las imágenes complementarias en mujeres que no tienen un riesgo elevado de padecer cáncer de mama pueden identificar posibles puntos problemáticos, lo que puede dar lugar a pruebas de seguimiento, como biopsias, que son invasivas y suelen aumentar el temor de las pacientes al cáncer. Pero la investigación ha descubierto que muy a menudo estos resultados resultan ser falsas alarmas.

Si 1,000 mujeres con senos densos se someten a una ecografía tras una mamografía negativa, la ecografía identificará entre dos y tres cánceres, según los estudios. Pero las imágenes adicionales también identificarán hasta 117 problemas potenciales que llevan a visitas y pruebas de seguimiento, pero que finalmente se determinan como falsos positivos.

“Por un lado, queremos hacer todo lo posible para mejorar la detección”, dijo la doctora Sharon Mass, ginecóloga y obstetra en Morristown, New Jersey, y ex presidenta de la sección de New Jersey del Colegio Americano de Obstetras y Ginecólogos. “Pero, por otro lado, hay muchos costos y angustia emocional” asociados a los resultados falsos positivos.

El grupo profesional no recomienda la revisión suplementaria para las mujeres con senos densos que no tienen ningún factor de riesgo adicional de cáncer.

Muchos otros grupos profesionales tienen una posición similar.

“Recomendamos tener una conversación con un proveedor de atención médica, y que las pacientes entiendan si sus senos son densos”, dijo Mass. “Pero no recomendamos que todo el mundo se haga la prueba”.

En particular, para aproximadamente el 8% de las mujeres que tienen senos extremadamente densos, vale la pena tener una conversación con un médico sobre la detección adicional, dijo Mass.

Del mismo modo, para las mujeres con senos densos que tienen factores de riesgo adicionales para el cáncer de mama, como antecedentes familiares de la enfermedad o un historial personal de biopsias de mama para comprobar los cánceres sospechosos, la ecografía puede tener sentido, dijo.

Las mamas densas son relativamente comunes. En Estados Unidos, se calcula que el 43% de las mujeres mayores de 40 años tiene mamas consideradas densas o extremadamente densas. Además de dificultar la interpretación de las mamografías, las mujeres con mamas densas tienen hasta el doble de probabilidades de desarrollar cáncer de mama que las mujeres con senos de densidad media, según las investigaciones.

Estudios han demostrado que las mamografías reducen la mortalidad por cáncer de seno. Sin embargo, aunque parece intuitivo que un mayor número de pruebas mejore las probabilidades de vencer al cáncer, las investigaciones no han demostrado que las mujeres tengan menos probabilidades de morir de cáncer de mama si se hacen una ecografía o una resonancia magnética suplementaria tras un resultado negativo de la mamografía.

Treinta y ocho estados y el Distrito de Columbia tienen leyes que exigen que se notifique a las pacientes sobre la densidad mamaria después de una mamografía, aunque no todas ordenan que se informe a las mujeres sobre su propia situación. Algunos estados exigen que las aseguradoras cubran las pruebas complementarias.

En 2019, la Administración de Alimentos y Medicamentos (FDA) propuso que la información sobre la densidad mamaria se incorporara a las cartas que reciben las pacientes después de una mamografía. Esa regla aún no se ha concretado, pero la agencia indicó a los legisladores que espera emitirla a más tardar a principios de 2023.

Las pruebas de imagen complementarias pueden ser caras si el plan de salud no las cubre. Una ecografía puede costar $250, mientras que un MRI puede salir $1,084 si se paga del propio bolsillo, según la Brem Foundation to Defeat Breast Cancer.

La diputada Rosa DeLauro (demócrata de Connecticut) tuiteó que está trabajando en un proyecto de ley con Couric que cubriría los MRI  y las ecografías para las mujeres con mamas densas.

Algunos médicos recomiendan otras medidas que pueden ser más eficaces que las pruebas adicionales para las mujeres con senos densos que quieren reducir su riesgo de cáncer de mama.

“Si realmente quieres ayudarte a tí misma, pierde peso”, dijo la doctora Karla Kerlikowske, profesora de medicina y epidemiología/bioestadística de la Universidad de California-San Francisco, que ha desarrollado calculadoras para ayudar a las personas a evaluar su riesgo de cáncer de mama. “Modera su consumo de alcohol y evita la sustitución hormonal a largo plazo. Son cosas que puedes controlar”.

La leche de fórmula puede ser adecuada para los bebés, pero expertos advierten que los niños pequeños no la necesitan

Las fórmulas para niños pequeños son un negocio floreciente en Estados Unidos: las ventas de estas bebidas se han duplicado con creces en los últimos años, ya que las empresas han convencido a los padres de que sus hijos necesitan ese refuerzo. Muchos expertos, sin embargo, advierten que estos productos, diseñados para niños de 1 a 3 años, no cubren las necesidades nutricionales más allá de lo que ofrece la dieta típica de un niño pequeño, están sujetos a menos regulaciones que los preparados para lactantes y son caros.

Además, algunos padres alimentan a los bebés con las versiones para niños pequeños, a pesar de que no cumplen con las normas federales para las fórmulas para lactantes y pueden no proporcionar a los bebés los nutrientes adecuados para mantener su crecimiento.

Los pediatras y funcionarios federales de salud señalan que cuando la mayoría de los niños cumple un año, pueden comenzar a beber leche de vaca o un sustituto de la leche a base de plantas sin azúcar. En una declaración de “consenso” de 2019, la Academia Americana de Pediatría y otras organizaciones de salud y nutrición recomendaron no usar fórmulas para niños pequeños, al indicar que “no ofrecen ningún valor nutricional único más allá de lo que se podría obtener con alimentos saludables; además, pueden aportar azúcares añadidos a la dieta.” Las fórmulas para niños pequeños suelen contener edulcorantes y grasas que añaden calorías.

Algunas de las mismas empresas que producen fórmulas para lactantes -como Enfamil, Gerber y Similac- también fabrican fórmulas para niños pequeños, al igual que algunas marcas más pequeñas y de boutique que anuncian que tienen cualidades orgánicas u otras cualidades especiales. Las fórmulas para niños pequeños están disponibles en casi todos los lugares en los que se venden fórmulas para bebés y se promocionan como productos que aportan nutrientes adicionales para ayudar al desarrollo del cerebro, el sistema inmunitario y los ojos de los niños, entre otros beneficios. Son diferentes de las fórmulas médicas prescritas para niños con necesidades específicas.

Un estudio realizado en 2020 reveló que las ventas de fórmulas para niños pequeños en Estados Unidos aumentaron a 92 millones de dólares en 2015, frente a los 39 millones de 2006.

Los padres suelen confundirse con el marketing de las fórmulas, según un estudio dirigido por Jennifer Harris, investigadora de marketing y salud pública de la Universidad de Connecticut. La investigadora descubrió que el 60% de los cuidadores creía falsamente que las fórmulas para niños pequeños tienen nutrientes que no pueden obtener de otros alimentos.

El doctor Anthony Porto, gastroenterólogo pediátrico y profesor de pediatría de la Universidad de Yale, afirmó que le preocupa que estos productos puedan aportar a los niños pequeños más nutrientes y calorías de los que necesitan. A diferencia de lo que se diseña para los bebés, la fórmula para niños pequeños no tiene normas nutricionales: los expertos afirman que es imposible estandarizar un suplemento para la dieta de los niños pequeños porque no hay dos niños iguales.

En los grupos de discusión, dijo Harris, los padres dicen que alimentan a sus hijos con leche de fórmula para llenar las lagunas nutricionales cuando un niño no está comiendo lo suficiente, una preocupación común entre los padres.

“Los bebés suelen ser comedores voraces”, dijo el doctor Stephen Daniels, presidente de pediatría del Hospital Infantil de Colorado. Pero alrededor del primer año de edad, el crecimiento de los niños se estanca, dijo, y “de repente ya no tienen el hambre de antes”. Eso puede preocupar a los padres, añadió, pero “es un fenómeno completamente normal”.

Si los padres tienen dudas sobre la dieta de sus hijos, dijo Daniels, deben consultar a un pediatra o a un médico de familia.

Blanche Lincoln, presidenta del Infant Nutrition Council of America, que representa a los fabricantes de Enfamil, Gerber, Similac y las marcas blancas, dijo en un correo electrónico que las fórmulas para niños pequeños pueden ser útiles porque pueden llenar “las brechas nutricionales durante este período de transición a los alimentos de mesa”. Lincoln, una exsenadora de Arkansas, dijo que las bebidas “ayudan a contribuir a las necesidades nutricionales específicas de los niños pequeños, proporcionando energía y nutrientes importantes, así como vitaminas y minerales esenciales durante este importante período de crecimiento y desarrollo”.

Pero la leche de fórmula para niños pequeños no solo la ingieren ellos, sino también los bebés.

En un estudio reciente, Porto y sus colegas descubrieron que el 5% de los padres de los lactantes declaró haber dado a sus bebés bebidas promocionadas para el grupo de mayor edad. Y la investigación de Harris indicó que el 22% de los padres de bebés mayores de 6 meses había alimentado a sus bebés con leche de fórmula para niños pequeños en el mes anterior. Ambos estudios se realizaron antes de la reciente escasez de fórmula, lo que puede haber agravado el problema.

“Las fórmulas para lactantes y las fórmulas para niños pequeños suelen estar una al lado de la otra en el supermercado”, explica Harris. “Se parecen, pero las fórmulas para niños pequeños son más baratas que las fórmulas para bebés. Así que la gente las confunde y coge la que no es. O piensan: ‘Oh, esta es más barata. Voy a comprar esta”.

Según un correo electrónico de la portavoz de la FDA, Lindsay Haake, las bebidas para niños pequeños no se ajustan a la definición de fórmula infantil, por lo que no están sujetas a los mismos requisitos. Eso significa que no tienen que someterse a los ensayos clínicos y a las pruebas de seguridad de patógenos que hacen las versiones para bebés. “A diferencia de los preparados para lactantes, los preparados para niños pequeños no son necesarios para satisfacer las necesidades nutricionales de los consumidores a los que van destinados”, dijo Haake.

En una declaración a KHN, el Infant Nutrition Council of America dijo: “Las bebidas para niños pequeños tienen un uso y una composición nutricional distintos a los de la fórmula infantil; ambos no son intercambiables. El etiquetado de las bebidas nutricionales para niños pequeños identifica explícitamente el producto como una bebida para niños pequeños destinada a niños de 12 meses o más en la parte delantera de la etiqueta del envase”.

Sin embargo, varias marcas caras de fórmulas para niños pequeños hechas por empresas más pequeñas -que a menudo se anuncian como elaborados con leche de cabra, leche entera A2 (que carece de una proteína láctea común) o ingredientes veganos que no son de soja-, sí cumplen los requisitos nutricionales para los bebés, y algunos lo anuncian.

Harris argumentó que esto también confunde a los padres y no debería permitirse. El hecho de que una fórmula para niños pequeños tenga los ingredientes nutricionales exigidos por la FDA para las fórmulas infantiles no significa que haya cumplido con las demás pruebas exigidas a las fórmulas infantiles, dijo.

Los reguladores federales no han obligado a ninguna de las empresas a retirar esos productos. En un correo electrónico, la portavoz de la FDA, Marianna Naum, dijo: “La FDA no comenta sobre posibles acciones para hacer cumplir (la ley)”.

Una empresa, Nature ‘s One, cuyas fórmulas para niños pequeños se llaman “Baby’s Only”, recibió cartas de advertencia hace una década de la FDA sobre el hecho de que las promocionara para bebés. Ese caso se cerró en 2016. El sitio web de la compañía dice que la fórmula Baby’s Only “cumple con los requisitos de nutrientes para bebés” y que “Baby’s Only Organic® puede servirse hasta los 3 años de edad“. Sus detractores dicen que ese lenguaje implica que la fórmula está bien para los bebés menores de 1 año. El sitio web de la compañía y su cuenta de Instagram tienen testimonios de padres que indican que alimentan a sus bebés con la fórmula, así como fotos de bebés bebiéndola.

Jay Highman, director general y presidente de Nature’s One, dijo que Baby’s Only está claramente etiquetada como una fórmula para niños pequeños y que en la parte posterior de la lata se indica que “Baby’s Only está destinada a un niño pequeño de 1 año de edad o más o cuando lo indique un profesional de la salud.” También dijo que desde el lanzamiento de la empresa en 1999, sus fórmulas han cumplido todas las normas nutricionales, de fabricación y de seguridad exigidas a las fórmulas infantiles, aunque no tengan que hacerlo. “Nos comportamos como si fuéramos una fórmula para bebés, pero la vendíamos como una fórmula para niños pequeños”, dijo Highman.

Dijo que los ensayos clínicos exigidos por la FDA son una gran barrera para sacar al mercado una nueva fórmula infantil y que muchos otros países no exigen un ensayo clínico. Baby’s Only ha completado recientemente un ensayo clínico, dijo, y la empresa espera poder venderlo pronto como fórmula infantil.

Sin embargo, los pediatras y los expertos en nutrición siguen advirtiendo a los padres sobre el uso de las bebidas para niños pequeños. “No hay duda de que las fórmulas para lactantes son muy importantes durante el primer año de vida”, afirma Daniels. Pero no recomienda la versión para niños pequeños “porque no es tan útil, porque es confusa, porque es cara”.