Tag: FDA

From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

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.

In a YouTube video posted by the Columbia University Department of Surgery several years ago, Mehmet Oz discussed the origins of MitraClip and, using a model of the heart, explained how the device is used to treat leaky mitral valves. The process involves essentially stapling the mitral valve so it works more effectively, he said. MitraClip yielded “massive improvements” in a group of people with heart failure, he said.(Screengrab of a Columbia University Department of Surgery video)

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.

An image excerpted from an FDA document of the MitraClip system.
A 2019 FDA document included an illustration of the MitraClip system and explained how it works. The system, which has undergone a series of changes since it was introduced, includes a clip that is implanted into the heart’s mitral valve and equipment used to insert the clip. The document presented data on MitraClip’s safety and effectiveness and listed dozens of potential adverse effects.(Photo illustration of 2019 FDA document)

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.

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.

An extract from an FDA document showing the MitraClip's clip.
An image from the 2019 FDA document showing a clip implanted to hold flaps of the heart’s mitral valve together. MitraClip is deployed via a catheter threaded through a major blood vessel.(Photo illustration of 2019 FDA document)

“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 photo of a sign with Abbott's logo outside of its headquarters.
Abbott Laboratories is headquartered in Abbott Park, Illinois.(Christopher Dilts/Bloomberg via Getty Images)

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 still from an animation of the MitraClip in action.
A video posted on YouTube by Abbott illustrates the workings of the heart’s mitral valve and two types of mitral regurgitation, primary and secondary. It shows how, in a MitraClip procedure, a clip is implanted through what the company describes as “a minimally invasive transcatheter procedure.” In the video, a clip is inserted into the heart and affixed to flaps of the mitral valve.(Screengrab of an Abbott video)

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.

The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.(Sarah Silbiger/Getty Images)

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.

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:

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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.

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

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”.

California y Nueva York buscan frenar la venta de píldoras para adelgazar a menores

California y Nueva York están a punto de ir un paso más allá que la Administración de Drogas y Alimentos (FDA) en la restricción de la venta de píldoras dietéticas sin receta a menores de edad, mientras pediatras y defensores de la salud pública tratan de protegerlos de las trampas para perder de peso de forma extrema que circulan por internet.

Un proyecto de ley presentado al gobernador Gavin Newsom prohibiría a los menores de 18 años en California la compra de suplementos para adelgazar sin receta, ya sea en línea o en tiendas. Otro proyecto similar aprobado por los legisladores de Nueva York está en la mesa de la gobernadora Kathy Hochul. Ninguno de los dos demócratas han indicado qué harán.

Si ambas medidas se convierten en ley, sus defensores esperan que den impulso a la  restricción de la venta de píldoras dietéticas a niños y adolescentes en más estados. Massachusetts, Nueva Jersey y Missouri han presentado proyectos de ley similares y sus defensores planean seguir presionando el próximo año.

Casi 30 millones de personas en Estados Unidos padecerán un trastorno alimentario a lo largo de su vida; el 95% de ellas tiene entre 12 y 25 años, según el Johns Hopkins All Children’s Hospital. Agrega que los trastornos alimentarios conforman el mayor riesgo de mortalidad de todos los trastornos mentales. Y ahora es más fácil que nunca que los menores consigan las pastillas que se venden en internet o en las estanterías de las farmacias.

Todos los suplementos dietéticos, incluidos los destinados a la pérdida de peso, representaron casi el 35% de los  productos de salud que se venden sin receta dentro de una industria que generó $63,000 millones en 2021, según Vision Research Reports, una empresa de investigación de mercado.

Los suplementos dietéticos, que abarcan una amplia gama de vitaminas, hierbas y minerales, están clasificados por la FDA como alimentos y no se someten a pruebas científicas y de seguridad como se hace con los medicamentos que se venden con y sin receta.

Los defensores de la salud pública quieren mantener los productos para adelgazar —con anuncios que pueden prometer “¡Baja 2 libras a la semana!” y nombres de pastillas como Slim Sense— alejados de los jóvenes, sobre todo de las chicas, ya que investigaciones han relacionado algunos productos con los trastornos alimentarios.

Un estudio publicado en el American Journal of Public Health, en el que se realizó un seguimiento a más de 10,000 mujeres de entre 14 y 36 años durante 15 años, halló que “las que usaban píldoras para adelgazar tenían una probabilidad ajustada cinco veces mayor de recibir un diagnóstico de trastorno alimentario por parte de un proveedor de atención médica en un plazo de 1 a 3 años que las que no las utilizaban”.

Se ha descubierto que muchas píldoras están contaminadas con ingredientes prohibidos y peligrosos que pueden causar cáncer, ataques cardíacos, derrames cerebrales y otros males. Por ejemplo, la FDA aconsejó al público que evitara Slim Sense de Dr. Reade porque contiene lorcaserina, que puede causar trastornos psiquiátricos y alteraciones de la atención y de la memoria. La entidad ordenó su retiro y no se pudo contactar con la empresa para que ofreciera declaraciones.

“Los fabricantes sin escrúpulos están dispuestos a correr riesgos con la salud de los consumidores, y están mezclando sus productos con ingredientes farmacéuticos ilegales, esteroides, estimulantes excesivos e incluso estimulantes experimentales”, dijo Bryn Austin, director fundador de Strategic Training Initiative for the Prevention of Eating Disorders, o STRIPED, que apoya las restricciones. “Los consumidores no tienen ni idea de que esto es lo que hay en este tipo de productos”.

STRIPED es una iniciativa de salud pública con sede en la Escuela de Salud Pública T.H. Chan de Harvard y el Hospital Infantil de Boston.

La Natural Products Association, un grupo comercial que representa a la industria, refuta que las píldoras dietéticas causen trastornos alimentarios y citan la ausencia de quejas de los consumidores a la FDA sobre efectos adversos de los productos de sus miembros. “Según los datos de la FDA, no existe ninguna relación entre ambas cosas”, dijo Kyle Turk, director de asuntos gubernamentales de la asociación.

La asociación sostiene que sus miembros adhieren a procesos de fabricación seguros, pruebas aleatorias de los productos y directrices de comercialización adecuadas. A los representantes también les preocupa que si los menores no pueden comprar suplementos sin receta, puedan comprarlos a “delincuentes” en el mercado negro y socavar la integridad de la industria. Según los proyectos de ley, los menores que compren productos para adelgazar deberán presentar una identificación junto con una receta médica.

No todos los grupos empresariales se oponen a la prohibición. La American Herbal Products Association, un grupo comercial que representa a fabricantes y minoristas de suplementos dietéticos, dejó de oponerse al proyecto de ley de California una vez que se modificó para eliminar las categorías de ingredientes que se encuentran en suplementos no dietéticos y vitaminas, según Robert Marriott, director de asuntos regulatorios de esa entidad.

Los defensores de los niños han encontrado tendencias preocupantes entre los jóvenes que imaginan su tipo de cuerpo ideal según lo que ven en las redes sociales. De acuerdo a un estudio encargado por Fairplay, una organización sin fines de lucro que trata de poner fin a las prácticas de marketing perjudiciales dirigidas a los niños, descubrió que niños de tan solo 9 años seguían tres o más cuentas de desórdenes alimentarios en Instagram, mientras que la edad media era de 19 años. Los autores lo llamaron una “burbuja a favor de los trastornos alimentarios“.

Meta, propietaria de Instagram y Facebook, dijo que el informe carece de matices, como reconocer la necesidad humana de compartir los momentos difíciles de la vida. La compañía sostiene que la censura generalizada no es la respuesta.

“Los expertos y las organizaciones de seguridad nos han dicho que es importante encontrar un equilibrio y permitir que la gente comparta sus historias personales al tiempo que se elimina cualquier contenido que fomente o promueva los trastornos alimentarios”, dijo Liza Crenshaw, una vocera de Meta, en un correo electrónico.

El doctor Jason Nagata, pediatra que atiende a niños y adultos jóvenes con trastornos alimentarios que ponen en peligro su vida, cree que el fácil acceso a las pastillas para adelgazar contribuye a las condiciones de sus pacientes en el Hospital Infantil UCSF Benioff de San Francisco. Ese fue el caso de una de sus pacientes, una niña demacrada de 11 años.

“Básicamente había entrado en un estado de inanición porque no recibía suficiente nutrición”, dijo Nagata, que aportó un testimonio de apoyo al proyecto de ley de California. “Estaba tomando estas píldoras y teniendo otro tipo de comportamientos extremos para perder peso”.

Nagata dijo que el número de pacientes con trastornos alimentarios que atiende se ha triplicado desde que comenzó la pandemia. Están desesperados por conseguir pastillas para adelgazar, algunas con resultados modestos. “Hemos tenido pacientes que han sido tan dependientes de estos productos que son hospitalizados y siguen pidiendo estos productos por Amazon”, dijo.

Los defensores de la salud pública recurrieron a las legislaturas estatales en respuesta a la limitada autoridad del gobierno federal para regular las píldoras dietéticas. En virtud de una ley federal de 1994 conocida como Ley de Educación y Salud sobre Suplementos Dietéticos, la FDA “no puede intervenir hasta que haya un problema claro de daño a los consumidores”, dijo Austin.

Al no poder hacer frente a la fuerte presión de la industria de los suplementos en el Capitolio, defensores de la salud pública han optado por centrarse en los estados. Sin embargo, existe una presión para que la FDA mejore la supervisión de lo que se incluye en las píldoras dietéticas.

El senador federal Dick Durbin, de Illinois, presentó en abril un proyecto de ley que exigiría a los fabricantes de suplementos dietéticos registrar sus productos, junto con los ingredientes, ante el organismo regulador.

Sus defensores afirman que el cambio es necesario porque se sabe que los fabricantes incluyen ingredientes peligrosos. C. Michael White, de la Facultad de Farmacia de la Universidad de Connecticut, encontró que el 35% de los productos sanitarios contaminados procedía de suplementos para la pérdida de peso, en una revisión de una base de datos sobre fraudes sanitarios.

Algunos ingredientes han sido prohibidos, como la sibutramina, un estimulante. “Era un suplemento para adelgazar muy utilizado que acabó siendo retirado del mercado estadounidense por su elevado riesgo de provocar cosas como ataques cardíacos, derrames cerebrales y arritmias”, dijo White.

Otro ingrediente era la fenolftaleína, que se utilizaba en los laxantes hasta que se identificó como presunto carcinógeno y se prohibió en 1999. “Pensar que ese producto siga en el mercado estadounidense es simplemente inconcebible”, dijo.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.