by Anna Maria Barry-Jester

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It was 2022 when pediatrician Tom Herr realized just how many babies on the Rosebud reservation in South Dakota were already infected with syphilis when they took their first breaths. He was seeing more and more patients who’d spent their first weeks in a tangle of tubes that pumped antibiotics into their tiny bodies. Some had died in the womb.

With growing alarm, Herr and other health officials spread the word, appealing to bosses at the federal Indian Health Service and tribal health authorities, writing op-eds and talking to reporters. But as the months ticked by, the crisis mounted.

By 2023, an astonishing 3% of all Native American babies born in South Dakota were infected.

Now, according to tribal leaders, the syphilis rate among American Indians and Alaska Natives in the Great Plains surpasses any recorded rate in the United States since 1941, when it was discovered that penicillin could treat the infection.

On a map of rising syphilis cases nationwide, some reservations stand out like a red alert.

Desperate for help, in late February of this year tribal leaders from four Great Plains states took the extreme step of asking U.S. Department of Health and Human Services Secretary Xavier Becerra to declare a public health emergency. The Great Plains Tribal Leaders’ Health Board asked the secretary to deploy commissioned officers from the U.S. Public Health Service to help diagnose and treat people for syphilis, and to provide emergency funding for the tribes to improve their response capabilities.

More than 10 weeks later, Becerra has not responded.

“We need to free up resources so we can take extraordinary measures to respond to these extraordinary circumstances,” said Meghan Curry O’Connell, chief public health officer for the tribal health board.

Syphilis, which is transmitted primarily through sexual intercourse, is easily treatable. But the disease is life-threatening when left unchecked. Babies infected in the womb can be born in excruciating pain, with deformed bones, brain damage or other serious complications. They can even die.

The emergency declaration may be the only way to get money in time to prevent more babies from getting sick or dying. The typical funding processes — which go through the federal budget or the Centers for Disease Control and Prevention — can lead to a delay of a year or more before money trickles down to communities.

In response to questions from ProPublica about why Becerra hasn’t replied to the emergency request, an HHS spokesperson wrote that “HHS has received the request and will respond directly” to the Great Plains tribes, but did not provide a time frame for doing so.

ProPublica also sent questions about the outbreak to Dr. Natalie Holt, chief medical officer for the Indian Health Service’s Great Plains office. In response, IHS provided written answers from both Holt and HHS.

The rise of syphilis cases among Native American communities, particularly in some Great Plains states, is “especially concerning,” Holt said. She said that Great Plains IHS is working with the South Dakota Department of Health and tribal partners to “maximize syphilis case identification, contract tracing and treatment efforts.”

HHS wrote that it was “taking action to slow the spread with a focus on those most significantly impacted,” noting that it had held a workshop for tribes and created a national task force to “leverage federal resources.” It also pointed to guidelines IHS had released in October 2023 about how to respond to the outbreak.

Syphilis has been on the rise nationwide for a decade, and the country has repeatedly run low on penicillin, the medicine used to cure it. But amid a shortage of health care providers and money the disease was spreading faster on reservations.

Because syphilis is treatable and can be so devastating to a baby, even one case of an infected infant is a sign that a health system is failing.

Alarms about health care in the area have been ringing for years, in large part due to neglect from various arms of the federal government, including chronic underfunding from Congress for the health care system for Native Americans.

Now, the silence from HHS is threatening to perpetuate what health workers say is a preventable outbreak that endangers the lives of children.

“The more you delay, the harder it is to contain. More people infected, more infant deaths,” O’Connell said.

The U.S. government is obligated to provide health care to many tribes, including several in the Great Plains, under a variety of treaties. It does so largely through the Indian Health Service, a series of clinics and hospitals on reservations and in cities primarily in the western United States.

Unlike other major health programs like Medicare, IHS funding is determined by a congressional vote each year. It has always fallen far short of the $50 billion tribes say is needed. The IHS spends a little over one-third of what the Veterans Health Administration spends per patient and half of what the government spends on health care for federal prisoners, according to the most recent data available.

When infectious diseases inevitably arrive, as they do in every community, the Indian Health Service is often ill equipped to respond, according to current and former employees. Those existing shortfalls have made the syphilis outbreak even more challenging.

Holt, the chief medical officer at IHS Great Plains, wrote, “Public health initiatives are chronically underfunded.” Responding to infectious diseases requires “substantial ‘boots-on-the-ground,’” she said, noting that the U.S. is experiencing a national health care staff shortage, including a dearth of nurses, providers and other support personnel.

At the end of 2020, HHS released a national strategic plan to tackle sexually transmitted infections, including syphilis. The report noted concerning rates of syphilis in Native American babies across the country, which by then were already three times higher than in the population as a whole. Officials set a goal to bring the rate down by more than 15% by 2025.

Instead, over the next two years, the rate of syphilis among Indigenous people in the Great Plains soared by 1,865%. Around 80% of the cases in South Dakota in recent years have been among Native people, who represent less than 10% of the state population.

At Rosebud, Herr started spending his weekends at work, poring over patient charts. He made a list, tracking those who had tested positive but gone untreated. He shared the list with colleagues and tried to figure out how to get people their penicillin.

“We just did this with COVID,” he thought. “We know what to do.”

Herr set up an alert in the electronic medical record system to flag patients who needed treatment. On the walls of reservation hospitals and clinics, staff hung colorful posters featuring pregnant bellies, encouraging people to get tested.

The more you delay, the harder it is to contain. More people infected, more infant deaths.

—Meghan Curry O’Connell, chief public health officer for the tribal health board

Nurses held a few testing events in the community, diagnosing several people. The tribal health board held testing events in Rapid City.

Other Native American reservations were struggling as well. Jessica Leston, then a director for the Northwest Portland Area Indian Health Board, was tracking infectious disease data throughout the West when she noticed a cluster of new syphilis cases at a reservation in Montana. In a community of under 10,000 people, a dozen patients had been diagnosed in one week. She alerted colleagues at Indian Health Service headquarters, and they learned that three of the cases were stillborn babies.

The Montana outbreak was detailed in the Indian Health Service’s budget justification to Congress last year. In 2023, the president’s budget proposal called for $9.3 billion for IHS, a modest increase from the previous year, with additional increases over the next decade. Congress approved $6.9 billion for the system that serves 2.6 million people.

“People always say we care about babies,” Leston said. “Now we aren’t even caring about babies.”

Last year, the tribal health board called in the CDC through a program that deploys the agency’s experts for one to three weeks during outbreaks. CDC staff concluded, as Vox reported last year, that there isn’t enough prenatal care in the area and that patients lack transportation to the few available clinics. CDC disease investigators provided care to 14 people during their visit, noting that all but one would have gone untreated without their help.

The CDC recommended that tribes test and treat people outside of clinics, transport patients to appointments and hire additional workers to find the sexual partners of those who’ve tested positive so that they can be treated as well. The officials also suggested the tribes consider the use of rapid tests, which can return results in time for a patient to be treated before they leave the clinic.

All of those suggestions are nearly impossible to implement, tribal health officials told ProPublica.

Prenatal care used to be more readily available at the Indian Health Service facilities across the Pine Ridge, Rosebud and Cheyenne River reservations, which span nearly 5 million acres, an area approximately the size of New Jersey.

Over the last two years, many staff left and weren’t replaced. Across the three reservations, only Pine Ridge had an obstetrician for much of the last year, according to several people with direct knowledge of the situation. Holt said that the IHS is working to hire more providers and that there is now an additional part-time obstetrician at Pine Ridge and another working two days a week at Cheyenne River.

People with any kind of pregnancy risk factor — including a patient over 34 and another with high blood pressure — have said they were told to drive up to three hours to Rapid City.

Tribal health officials lack the staff or money for mobile clinics and more testing events to find new cases.

They also struggle to track existing cases because three states and the Indian Health Service have refused to share contact information for patients who test positive. South Dakota recently began sharing this crucial information with the tribal health board, but the Indian Health Service and Iowa, North Dakota and Nebraska still do not. Health departments in Iowa, North Dakota and Nebraska did not respond to questions about data sharing.

As for the rapid tests, the Indian Health Service nationally recommends their use. But current and former staff in South Dakota said that area managers have denied their requests for these tests. Instead, providers said, they must use a test that has to be sent out to a lab and wait three to seven days for results. By that time, it can be hard to locate patients for treatment.

Holt said that the IHS “supports data sharing in the interest of improving population health” and that tribes must follow an established policy to request and receive the data. Regarding rapid tests, she wrote that the Great Plains IHS prefers to do the lab-based testing because “we feel this approach improves speedy access to treatment.”

The CDC also urged the tribes to research how punitive policies stop people from seeking medical care. In South Dakota and on several reservations, a pregnant person with illegal substances in their system can be charged with a felony. And providers are required to contact child protective services if they know a person has used drugs during pregnancy. Doctors described patients being screened for drug use at hospitals, with or without their consent, and then taken to jail. People in the area know this risk and sometimes avoid medical visits as a result, women and providers said.

The South Dakota tribes and state officials have shown no indication they are considering changing these policies.

Immediately after the CDC visit last summer, the tribes put in a formal request to the agency for more help. A few CDC staffers returned to the area in April to help find and treat patients who have tested positive. It’s an important step, O’Connell said. But given how far syphilis has reached into the community, a few days of help at few reservations is not enough to stop babies from dying.

The tribes also worry about the damage that’s already been done. In addition to asking for help preventing new infections, leaders asked for a longer-term plan to make sure that children born with syphilis get the care they need in years to come.

Herr remains haunted by one patient file from Rosebud. It belongs to a young woman who came to the hospital in labor and delivered a stillborn baby. A week later, when the patient was long gone, test results came back showing she had syphilis.

Hospital staff tried a few times to follow up to no avail. The woman returned to the hospital months later, this time in the midst of a miscarriage. Based on her medical records, Herr believes she lost both pregnancies due to untreated syphilis.

When Herr retired from IHS in January of this year, the woman still hadn’t been treated.

We plan to continue reporting on Native American health care and are looking for experts and sources. Help us make sure our journalism is responsible and focused on the right issues. We’d especially like to hear from tribal members about their experiences, along with employees of the Indian Health Service, and tribal leaders and elders. If this is you, please fill out the form below or reach out to reporter Anna Barry-Jester at anna.barryjester@propublica.org.

This post was originally published on Articles and Investigations – ProPublica.

by Aliyya Swaby

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week.

After a federal appeals court ruled this week that transgender people are legally entitled to the same access to medically necessary health care as everyone else, the immediate reaction of the states of North Carolina and West Virginia was to vow to appeal the decision to the U.S. Supreme Court.

The immediate reaction of Hann Henson, an employee of a North Carolina school district who’d spent years struggling to access gender-affirming care, was to break into tears. Last year, ProPublica wrote about his tumultuous journey seeking medical support in his gender transition while living in a state with a long history of discrimination against transgender people.

“Having something that you know is going to help you feel better, is going to help you feel whole, and having it constantly dangled above your head is just dehumanizing,” he said.

The 4th U.S. Circuit Court of Appeals, based in Virginia, ruled that the two states violated federal law by banning coverage of certain treatments for transgender people but allowing it for others. These cases were the first of their kind to reach a federal appeals court and the decision could influence states and courts in other parts of the country.

For years, transgender people have argued in court that the North Carolina state employee health plan and West Virginia Medicaid program discriminated against them by refusing to cover certain treatments when they are prescribed for transgender people. The court’s majority agreed with this argument, in line with previous district court rulings, highlighting that West Virginia’s Medicaid program “covers mastectomies to treat cancer, but not to treat gender dysphoria.”

Henson found out about the lawsuit in 2022 soon after he started his job as a communications specialist for a North Carolina school district. He realized he was sprinting against a clock, with the state under a court order to cover gender-affirming care while the legal fight was underway. He scheduled what he hoped would be his last major surgery for November 2023, two months after the appeals court heard oral arguments on the case.

But as he got closer to the date, he realized he had to delay the surgery due to a stomach ulcer. He said the looming court decision was all he could think about for months. He even considered trying to go ahead with the procedure despite his poor health. He finally got the surgery in late March.

Dale Folwell, the state treasurer and a named defendant, used the lawsuit in his campaign for governor. (He lost the Republican primary in March.) He maintained in interviews and court documents that the state health plan should have the authority to determine which employee benefits are covered. He reiterated those comments in a statement this week: “Untethered to the reality of the Plan’s fiscal situation, the majority opinion opens the way for any dissatisfied individual to override the Plan’s reasoned and responsible decisions and drive the Plan towards collapse.”

Hann Henson and his wife, Aly Young, in Asheville, North Carolina, last summer (Annie Flanagan, special to ProPublica)

Henson will need a follow-up surgery in five months, a common part of the process. He said he now feels a sense of relief knowing the appeals court decision ensures that he likely won’t lose access to his care at a critical time. But he worries about other transgender people seeking services and imagines them refreshing a court website compulsively just like he did.

For now, the ruling protects access to gender-affirming care for transgender people on both states’ health plans. The decision would apply to any federal court cases brought in other states in the 4th Circuit: South Carolina, Virginia and Maryland. The 11th Circuit is currently considering two similar cases out of Georgia and Florida.

All the active judges on the court heard oral arguments in the case in September. In their ruling Monday, eight of the 14, almost all of whom were appointed by Democratic presidents, ruled in favor of the transgender plaintiffs. “In addition to discriminating on the basis of gender identity, the exclusions discriminate on the basis of sex,” wrote Judge Roger Gregory, who was initially appointed by President Bill Clinton and confirmed under the George W. Bush administration.

The states argued that gender-affirming care cost too much and was medically ineffective, so they were justified in not covering it. The court’s majority opinion dismissed both arguments as lacking support. Evidence shows covering the care would likely cost states very little, and major medical associations support broad access to gender-affirming care, citing evidence that prohibiting it can harm transgender people’s mental and physical health.

The judges who signed the three dissenting opinions were all appointed by Republican presidents. “In the majority’s haste to champion plaintiffs’ cause, today’s result oversteps the bounds of the law,” Judge Julius Richardson, a President Donald Trump appointee, wrote in the principal dissent. “The majority asserts that the challenged exclusions use medical diagnosis as a proxy for transgender persons, despite the complete lack of evidence for this claim.”

North Carolina and West Virginia are planning to appeal the decision to the U.S. Supreme Court, according to press releases from each state. “We are confident in the merits of our case: that this is a flawed decision and states have wide discretion to determine what procedures their programs can cover based on cost and other concerns,” West Virginia Attorney General Patrick Morrisey said in a statement.

It remains to be seen how and whether other states and insurance companies with restrictive policies for covering gender-affirming care will act in response to the opinion.

“It should serve as a cautionary tale not just to states that implement state health plans and Medicaid programs but also to private insurers,” said Omar Gonzalez-Pagan with Lambda Legal, which represented the transgender plaintiffs in North Carolina and West Virginia. “I would hope that this serves as a determining factor in the adoption of any bad policies as an inspiration to get rid of policies that currently exist.”

This post was originally published on Articles and Investigations – ProPublica.

by Anna Clark

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The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim.

“This is a significant step forward,” said Peter Lurie, president and executive director of the Center for Science in the Public Interest and a former FDA associate commissioner. These tests have “always been one of the remaining gaping holes in the FDA regulatory structure. And it’s great to see that the agency has taken concrete steps to close it.”

The new rule cites coverage of the issues with lab-developed tests by multiple media outlets and researchers, including ProPublica articles: one that revealed problems with prenatal genetic screenings, popularly known as NIPTs or NIPS and the other on faulty lab-testing for COVID-19 overseen by one company.

The move comes after decades of debate and stalled legislation on LDTs, which also include certain cancer screenings as well as some tests for rare diseases. Because these tests are designed, manufactured and used in a single lab, they escape most federal oversight over marketing and accuracy.

A large coalition of labs, associations and academic medical centers have long pushed back on the prospect of increased FDA involvement in these tests. It would be too onerous, they’ve argued, and it jeopardizes patient access to health services.

One of nearly 7,000 comments submitted in response to the draft rule came from the Association for Molecular Pathology, representing a wide-ranging group of professionals associated with laboratory testing. The FDA’s proposed changes “would result in laboratory professionals being treated as product manufacturers instead of board-certified healthcare providers,” the association’s president wrote, and it would “unequivocally hinder and harm patient care.”

The agency’s hands-off approach dates back to an era when these tests were a relatively small, low-risk sector of the health care system. Now, they are a much bigger player and include high-stakes tests made by commercial companies. While the Centers for Medicare and Medicaid Services reviews lab operations, it doesn’t check whether the tests themselves are clinically valid. The tests aren’t registered with the federal government, so nobody knows how many exist. In 2021, Pew Charitable Trusts estimated that 12,000 labs are likely to deploy them, many of which process thousands a day.

The ProPublica story on prenatal genetic screenings referenced by the FDA revealed how the agency didn’t check the tests before they reached patients or evaluate marketing claims made by the companies that sell them. Companies aren’t required to publicly report when a test gets it wrong, the investigation found, and no federal agency can recall faulty screenings. The story detailed how false positives, false negatives and indeterminate results can have painful consequences for expecting parents. (We also published a guide to the prenatal tests to help families with their questions.)

Our coronavirus investigation showed how a Chicago-based company with state and local contracts in Nevada sold testing services that were unreliable from the start. As it became clear that the lab was telling infected people that they had tested negative for the virus, company officials nonetheless expanded the reach of the lab’s testing. The company declined to comment for ProPublica’s previous stories on these problems.

The rule will go into effect over a four-year period. Within two years, test-makers will be expected to meet registration and listing requirements, among others, which is “a critical part of this rule,” according to Cara Tenenbaum, a former FDA policy adviser whose consultancy has advocated for more active oversight.

“At least knowing what is out there will be huge,” she said in an email.

High-risk tests will need to meet new FDA review requirements before reaching the marketplace starting in November 2027. Moderate-risk and low-risk tests will need to do the same starting in May 2028. It’s unclear how prenatal screening tests would be categorized.

The agency generally will not enforce some or all requirements for certain LDTs, including tests that were first marketed before the rule was issued and have not since been modified or have been modified in certain limited ways.

The agency will also generally not enforce some or all requirements for tests used within the Veterans Health Administration or the Department of Defense, as well as certain tests that meet other narrow conditions.

Nonetheless, the rule marks a massive shift in the FDA’s approach to a sector that touches millions. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” FDA commissioner Robert Califf said in an agency news release.

The final rule, he added, aims to “help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”

The FDA tried to rein in the lab tests a decade ago, issuing a draft guidance in 2014. That prompted a two-year backlash from opponents. The agency ultimately dropped it.

Some critics have argued that regulation of LDTs should happen through legislation rather than rulemaking. But many also largely opposed a bipartisan bill in 2022 that came the closest to passing before ultimately being dropped at the end of the year. Later efforts to move a similar bill forward have not gained traction in Congress.

Laurie Menser, chief executive of the Association for Molecular Pathology, said in an emailed statement that the association is “very disappointed” in the new rule.

“It’s unfortunate the agency continues to overstep its authority and bypass the country’s legislative process,” Menser said. “AMP is currently reviewing the different aspects of the rule and assessing the many implications for our members and patient care.”

Lurie, who was closely involved with the FDA effort to address the tests a decade ago, said the rule has been a long time coming. “People had identified this problem a very long time ago, and wanted to take action, but found themselves stymied by opposition,” he said.

“I think that it shows real courage on the part of the agency, as well as commitment to the public health, to take this step,” he added.

This post was originally published on Articles and Investigations – ProPublica.

by Audrey Dutton

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week.

After decades of detaining psychiatric patients in maximum security prison cells, Idaho is finally on the verge of building a secure mental health facility that would house those with serious mental illness more humanely.

Idaho Gov. Brad Little on Monday signed into law a bill, passed with bipartisan support, to allocate $25 million to construct a facility. It would have 26 beds, with 16 dedicated to patients who display violent behaviors and whose mental illness is so severe that they are put into involuntary treatment by court order.

The action follows a ProPublica article in December that found that Idaho lawmakers and state officials were told at least 14 times since 1954 that the state needed a secure mental health unit, separate from a prison, and at least eight times since 1974 that locking away patients without a conviction could violate their civil rights and invite a lawsuit. The patients haven’t been convicted or, in many cases, even charged with a crime.

Idaho Department of Correction Director Josh Tewalt reiterated the need for a new facility in February, when he presented the agency’s budget to the Joint Finance-Appropriations Committee. Tewalt had just toured the prison’s psychiatric unit with the governor and lieutenant governor, and they saw four patients that day “that were civil commits, that had never been convicted of a crime, that are being housed at the Idaho Maximum Security Institution,” he told the committee.

Idaho’s prison staff are expected to provide mental health care in a place “that was designed specifically to incapacitate,” Tewalt said.

“It’s a practice that has a significant amount of risk for us as a state,” he said. “Not having a secure environment that is not a prison is — is problematic. And other states have dealt with the consequences of that through judicial intervention. So, I think this is a problem that isn’t going to go away. It’s one that continues to worsen.”

The Idaho Department of Correction doesn’t yet know the timeline for construction of the facility, which is expected to go on state-owned land south of Boise.

C Block holds the acute behavioral health unit of the Idaho Maximum Security Institution. The prison block is divided into three sections, one of which has nine cells for men considered “dangerously mentally ill.” They include patients who haven’t been charged or convicted of a crime. (Sarah A. Miller for ProPublica)

Mental health advocate Marilyn Sword was among the first to warn Idaho legislators in the 1970s that it was unwise, and maybe illegal, to put a corrections agency in charge of noncriminal patient care. That was sold as a temporary arrangement while the state created a secure unit.

“Who knew ‘temporary’ would be 50 years!” Sword told ProPublica in a text message last week. “I will be watching what happens with location and construction and, of course, an appropriation to [the Idaho Department of Health and Welfare] next year to staff the unit.”

Little attempted in 2023 to get funding for a new facility, but the Legislature’s budget committee declined to vote on it.

A month after ProPublica’s article, Little brought back his proposal.

The budget committee voted almost unanimously last month to approve the new facility.

Members of Idaho’s Republican-controlled House and Senate approved the funding package last week.

Rep. Wendy Horman, a Republican from East Idaho who co-chairs the budget committee, told ProPublica that, when she saw the article in December, she immediately called the Legislature’s budget division manager and spoke with Tewalt.

Horman said the catalyst for her decision to support the project was simple: This time, she had more information.

“I do think that brought attention to the problem,” Horman said of ProPublica’s reporting.

Tewalt said the article “absolutely” played a role in legislators’ decisions about funding the facility.

The reporting seemed to create among policymakers “almost a sense of urgency to understand this issue better, to figure out how they could try to be helpful in solving,” he said. “And, you know, fortunately, it came at a time where it’s not because we’re being ordered by the courts to do something.”

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This post was originally published on Articles and Investigations – ProPublica.

by Heather Vogell, ProPublica, photography by June Watsamon Tri-yasakda, special to ProPublica

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LOPBURI, Thailand — When Gustun Aunlamai arrived at school at age 4, he was so overweight that his teacher worried he’d have trouble breathing during naptime. His arms and legs were thick. His mouth peeked out from two ballooning cheeks. He moved slowly.

Throughout his toddler years, Gustun had regularly asked his parents to refill his bottle with his favorite “milk” — a type of formula made especially for kids his age. And they were happy to oblige. Sumet Aunlamai and Jintana Suksiri, who lived in a rural province north of Bangkok, had carefully chosen the brand.

Like other Thai parents, they’d been bombarded by formula advertising on television, online and in grocery stores, where a rainbow of boxes and canisters of powdered toddler milk featured teddy bears in graduation caps and giveaways like toys or diapers. It cost far more than cow’s milk but promised to make Gustun stronger and smarter.

What Jintana didn’t know, as Gustun chugged the formula and his weight neared 70 pounds, was that her son’s choice drink had sparked an international feud.

First image: Gustun Aunlamai and his mother, Jintana Suksiri, at home. Second image: Gustun as a toddler.

In 2017, Thai health experts tried to stop aggressive advertising for all formula — including that made for toddlers. Officials feared company promotions could mislead parents and even persuade mothers to forgo breastfeeding, depriving their children of the vital health benefits that come with it. At the time, Thailand’s breastfeeding rate was already among the lowest in the world.

But the $47 billion formula industry fought back, enlisting the help of a rich and powerful ally: the United States government.

Over 15 months, U.S. trade officials worked closely with formula makers to wage a diplomatic and political pressure campaign to weaken Thailand’s proposed ban on formula marketing, a ProPublica investigation found.

U.S. officials delivered a letter to Bangkok asking pointed questions, including whether the legislation was “more trade restrictive than necessary.” They also lodged criticisms in a bilateral trade meeting with Thai authorities and on the floor of the World Trade Organization, where such complaints can lead to costly legal battles.

Thai officials argued the new regulation would protect mothers and babies. In the end, though, the Thai government backed down. It banned advertising for infant formula but allowed companies to market formula for toddlers like Gustun — one of the industry’s most profitable and dubious products. The final law also slashed penalties for violators.

“Our law is really weak and enforcement is really weak,” said Dr. Siriwat Tiptaradol, who championed the proposed ban as a former adviser to Thailand’s health minister, in an interview in Bangkok. “I was upset and disappointed.”

Dr. Siriwat Tiptaradol, a former adviser to Thailand’s health minister, in Nonthaburi, Thailand

The U.S. endeavor in Thailand was part of a decadeslong, global effort to protect the United States’ significant formula production and export business. ProPublica reviewed thousands of pages of emails and memos by U.S. officials, letters to foreign ministries, correspondence from industry groups and academic research. We also interviewed health experts and government leaders in nearly two dozen countries, including former U.S. officials.

Together, the reporting shows the U.S. government repeatedly used its muscle to advance the interests of multinational baby formula companies, such as Mead Johnson and Abbott, while thwarting the efforts of Thailand and other developing countries to safeguard the health of their youngest children.

Just last March, at a meeting in Dusseldorf, Germany, U.S. officials opposed a reference to formula advertising bans in a new international food standard for toddler milk. The move came after industry lobbying.

At the center of many efforts was the Office of the United States Trade Representative, which advises the president on trade policy. Emails show its staff in regular contact with formula makers and their industry groups through meetings, calls and position papers — which the industry used to hammer its objections to regulations around the world. “Mead Johnson and other infant formula producers have been very vocal, expressing concerns to the Thai and U.S. governments about what they feel is the imminent passage of this measure,” U.S. officials wrote in 2016 as Thailand considered its formula marketing ban.

Documents Show Internal Clash Before U.S. Officials Pushed to Weaken Toddler Formula Rules

Explore the interactive story here.

Officials with the USTR and other trade-focused agencies, including those within the U.S. Department of Agriculture, then echoed those positions in communications with other countries or in international forums like the WTO, the documents showed.

“The U.S. is highly influential,” said Dr. Robert Boyle, a doctor at Imperial College London who has researched international formula use.

In many places, the lobbying appeared to succeed. Hong Kong, for example, watered down some of its formula regulations after objections from U.S. trade officials, who said in a draft letter that the rules “could result in significant commercial loss for U.S. companies.” And a proposal in Indonesia stalled after questions from the U.S. at the WTO.

Notably, such advocacy has not only hindered local attempts to stop formula marketing that critics say is misleading or even predatory, but it has also undermined the work of U.S. foreign aid and health officials, who have long supported breastfeeding across the globe. They call it “one of the highest returns on investment of any development activity” because of its well-documented benefits for babies’ health and cognitive growth.

“I think it is shocking,” said Jane Badham, an independent nutrition consultant and expert in child feeding who works internationally. “One doesn’t realize how much this kind of interference is happening.”

The meddling broke into public view in 2018, when officials from the Trump administration were accused of threatening to withhold military aid from Ecuador if the country didn’t drop its proposed resolution in support of breastfeeding at the World Health Organization; the U.S. ambassador later denied making threats. But ProPublica’s investigation found that the scope of the interference far exceeded that incident and continues today under the Biden administration. In fact, Ecuador and Thailand were just two stops on a worldwide crusade against regulation that has spanned Republican and Democratic presidential administrations and touched more than a dozen countries, including South Africa, Guatemala and Kenya, as well as Southeast Asian nations such as the Philippines, Malaysia and Vietnam.

The U.S. Has Waged a Global Campaign Against Formula Regulation

U.S. agencies have intervened in at least 17 jurisdictions over the last several decades on behalf of the formula industry, often to oppose measures that would restrict formula marketing or require additional safety precautions.

Source: ProPublica review of academic research, World Trade Organization records, letters and other U.S. government documents, WikiLeaks cables and news accounts. (Lucas Waldron/ProPublica)

Neither Abbott nor Mead Johnson responded to requests for interviews or to detailed questions from ProPublica. The latter’s parent company, Reckitt, also did not respond to our request for comment.

USTR officials declined to be interviewed for this story. In response to written questions, an agency spokesperson said in a statement that under President Joe Biden, the trade agency has emphasized respecting the role of foreign governments in deciding the appropriate regulatory approach, including with respect to infant formula. USTR has been committed “to making sure our trade policy works for people — not blindly advancing the will of corporations,” the statement said.

That has meant moving the office “away from the formerly standard view that too often deemed legitimate regulatory initiatives as trade barriers,” the spokesperson said, adding that the move has “enervated” corporate players who have been used to “getting their way at USTR for decades.”

The spokesperson, however, declined to provide examples of the new approach in relation to formula. She also declined to respond to questions about government documents that show the trade office under Biden working with other federal agencies to pursue the same playbook on formula as prior administrations.

In 2021, for example, officials complained to Filipino trade authorities about stricter formula marketing rules they considered “overkill,” and expressed fears about regulatory “spillover” elsewhere in Southeast Asia. In Kenya, they sought to strike a provision in a proposed formula advertising ban after an industry group sent USTR a paper seeking its deletion.

Public health officials are increasingly raising concerns about toddler milk, especially as companies deploy advertising for products using bold — and, critics say, often unsupported — health claims.

In October, the American Academy of Pediatrics published a new report warning about the marketing for toddler formula. “Products that are advertised as ‘follow-up formulas,’ ‘weaning formulas’ or ‘toddler milks and formulas’ are misleadingly promoted as a necessary part of a healthy child’s diet,” said Dr. George Fuchs III, a lead author of the study. The drinks are worse than infant formula for babies under 1 year, he said, and “offer no benefit over much less expensive cow’s milk in most children older than age 12 months.”

A TV advertisement for toddler milk in Thailand

Unlike infant formula, toddler milks are not regulated by the Food and Drug Administration. Nutrition experts have warned about hefty doses of sweeteners and sodium in some brands.

The Infant Nutrition Council of America, a formula industry group, defended toddler drinks, saying they “can contribute to nutritional intake and potentially fill nutrition gaps for children 12 months and older.”

Toddler milk made up just 11% of all formula sales in the United States in 2023, but it was much more popular abroad, according to Euromonitor, which tracks sales data. Worldwide, it made up 37% of sales. In Thailand, it accounted for more than half.

The country is now struggling to address the consequences of the law’s weakening, researchers and officials say. More than 1 in 10 Thai children under 5 years old face what researchers call a “double burden of malnutrition” that leaves some struggling with obesity and others lagging behind growth targets. Increased breastfeeding could help address both problems.

“You go to school and see a lot of kids are overweight,” said Dr. Somsak Lolekha, president of the Royal College of Pediatricians of Thailand and the Pediatric Society of Thailand. “We have a big problem in Thailand.”

Targeting “the Sippy Cups of the World”

Formula is one of only two products with international recommendations to prohibit its marketing. The other is tobacco.

The warning dates to 1981, when the nations that make up the governing body of the WHO passed the International Code of Marketing of Breast-Milk Substitutes. It aimed to stop all promotion of drinks meant to replace breast milk.

The move followed reports in the 1970s that thousands of infants in impoverished countries were falling ill and dying after drinking formula.

A 1974 report by a British group called War on Want about the dangers of baby formula in developing countries featured advertisements for Dumex and Nestlé. (War on Want)

Not only were mothers using costly formula to replace breast milk, which would have given their babies better immunity, but the water parents mixed milk powder with was sometimes contaminated, leading to life-threatening bacterial infections and diarrhea. Overdiluted formula was causing severe malnutrition, too. Activists called for a boycott of the world’s biggest formula maker, Nestlé, which had heavily promoted its products in developing countries.

During the height of the controversy, an average 212,000 babies in low- and middle-income countries died preventable deaths linked to formula use annually, an academic paper circulated by the National Bureau of Economic Research estimated last year. (Nestlé disputed the research and said it was the first formula company to incorporate the WHO recommendations into its marketing policy in 1982.)

The United States cast the sole “no” vote against the international code, with the Reagan administration citing First Amendment protections on advertising. The Washington Post quoted a senior federal official who resigned over the decision, saying it would be “seen in the world as a victory for corporate interests.”

To be sure, formula was crucial for babies who didn’t have access to breast milk. But for those who did, public health experts feared aggressive advertising and free samples would derail a critical cycle. Once babies start drinking formula regularly, research shows, their mothers’ breast milk supply can drop.

“The evidence is strong,” a WHO and UNICEF report explains. “Formula milk marketing, not the product itself, disrupts informed decision-making and undermines breastfeeding and child health.”

In the years since the international code was adopted, at least 144 countries have sought to enshrine its voluntary restrictions into laws that bar formula marketing in stores, hospitals and elsewhere. Despite poor enforcement in many places, the laws have had measurable benefits. Studies have shown that countries that adopted marketing bans saw their breastfeeding rates rise, and more breastfeeding is in turn linked to fewer infant deaths. It also reduces mothers’ risk of certain cancers.

Baby formula manufacturers responded to slower growth in infant formula sales by creating products for older babies and toddlers — age groups that fell outside most regulations.

Brands of infant and children’s formula milk on display at a Bangkok supermarket in September

“We have a proven global demand-creation model,” Greg Shewchuk, Mead Johnson’s head of global marketing, told investors in 2013. “Capture baby very early on, often before it’s born, hold onto them through feeding and their feeding challenges and extend them as long as possible.”

Mead, which was based in the United States until a British company bought it in 2017, termed the strategy A-R-E: Acquisition, Retention, Extension.

Slides from a presentation by Mead Johnson Nutrition executives at a 2013 conference in Europe show the company’s business model to promote children’s formula products. (U.S. Securities and Exchange Commission)

To make toddler products more attractive to parents, who usually just gave their kids cheaper cow’s milk beginning at age 1, formula makers began adding nutritional supplements like DHA, an omega-3 fatty acid found in fish and algae with purported benefits for brain and eye health.

The claims, however, are unproven. Studies have found no definitive link between babies’ brain and eye development and DHA supplementation, a 2017 meta-analysis of 15 studies found, according to Cochrane, a nonprofit that supports systematic reviews of health research. In fact, breastfed babies perform better on intelligence tests.

Infant Formula Looks Nearly Identical to Toddler Milk on a Grocery Store’s Shelves in Bangkok

Thailand’s Milk Code restricts the advertisement of infant formula, but marketing of toddler milk is generally allowed.

Still, formula companies used additives like DHA “as a hook to expand their market share,” said Peter Buzy, CFO and treasurer of Martek Biosciences Corp., which produced DHA, at an analysts’ meeting in 2004. “Really targeting, you know, the sippy cups of the world.”

A spokesperson for the Infant Nutrition Council of America defended the health and nutrition claims, saying they “are based on science and medical research and meet all legal, regulatory and nutritional science requirements.”

The marketing worked. Toddler milk has overtaken infant formula in worldwide sales, according to Euromonitor. Global toddler milk sales have grown by 25% since 2013, to almost $20 billion. A little less than two gallons of toddler milk can cost $30 or more, compared with around $3.94 a gallon for regular milk in the U.S.

For formula manufacturers, the popularity of the product had another benefit: It helped them circumvent local rules against marketing infant formula. By using similar logos, colors or fonts across product lines, legal advertisements for toddler milk effectively promoted baby formula too, even in places where it was subject to a marketing ban. Nutrition experts and advocates called the tactic “cross-promotion.”

During the past decade, sales of regular infant formula grew about 10% worldwide, to $15 billion.

A Focus on Developing Nations

In 2014, Jintana gave birth to the couple’s first child, whom they nicknamed “Captain” after a soccer player.

The family lived in military housing in Lopburi, a rural province two hours north of Bangkok whose capital city is world famous for its flourishing monkey population. With Sumet serving in the Army, Jintana took time off from her job in customer relations to care for the newborn.

She breastfed Captain until it was time to return to work three months later. The couple shopped for formula. Health claims formula makers listed on packages were “very important,” Sumet said through a translator. They settled on a product called Dumex that promised to strengthen Captain’s brain, immunity and eyes. It was made by the French giant, Danone, which boasts that the brand “has happily raised generations of Thais.”

From left, Phacharawit “Gustun” Aunlamai, now 6; Jintana Suksiri; Phacharacamol “Captain” Aunlamai, 9; and Sumet Aunlamai at their home in Lopburi, Thailand, in September

Millions of women like Jintana had been entering the workforce in developing regions such as Southeast Asia. The big six transnational companies that make most of the world’s baby formula saw this as a boon.

For Mead Johnson, the maker of Enfamil, the benefits of developing economies were twofold. “Firstly, in most countries, breastfeeding is incompatible with women participating fully in the workforce,” CEO Kasper Jakobsen said in a 2013 earnings call. “And, secondly, as women participate in the workforce, that creates a rapid increase in the number of dual-income families that can afford more expensive, premium nutrition products.”

By then, Thailand was Mead’s fifth-biggest market worldwide. And Southeast Asia was well on its way to becoming more important to the formula industry than the U.S. and European markets combined.

As business boomed, advocates lambasted the industry for its practices. Mead employees, for example, allegedly bribed health care workers at government hospitals in China so they would recommend the company’s formula to new mothers — charges the company ultimately resolved with a $12 million settlement in 2015; the company did not admit or deny regulators’ findings in the agreement. Danone faced similar allegations from Chinese media related to the brand Captain and Gustun drank, Dumex. Danone said at the time that it accepted responsibility for the lapses and suspended the program involved, according to the BBC.

The industry maintained close relationships with the medical establishment in Thailand, too. One pediatrician and advocate for breastfeeding, Dr. Sutheera Uerpairojkit, told ProPublica that two decades ago, she saw formula companies offer doctors and medical staff trips abroad in exchange for giving patients free samples and collecting their data. Some took the trips. Sutheera did not participate.

Dr. Sutheera Uerpairojkit, a pediatrician at MedPark Hospital in Bangkok

Thailand adopted the international code in 1984 — but only as a voluntary measure. Over the years, Siriwat and others pushed for tougher formula marketing restrictions without success. In one meeting, he and colleagues at the Thai health ministry pressed formula companies to comply with the voluntary rules, which they’d routinely broken. The businesses resisted. “One company said, ‘If I do not violate, I cannot compete with other companies,’” Siriwat recalled in September.

“That makes me very angry,” he said, remembering how he stormed out of the room.

By 2014, with Thailand’s breastfeeding rate at only 12%, according to one survey, Siriwat persuaded the health minister to seek legislation to formally ban marketing infant and toddler formula. He wanted the new law to include enforcement and penalties for violators.

The WHO, a United Nations agency promoting health, wanted more countries to pursue such measures. Its staff in 2016 released new recommendations on ending the promotion of formula products for toddlers, as well as infants. In theory, that guidance could help countries like Thailand fend off trade complaints about new marketing bans. And an endorsement by the WHO’s member nations would underscore the recommendations’ importance.

But public health wasn’t the only concern as nations prepared to vote.

U.S. Intervention on a Global Stage

The WHO effort alarmed formula makers, which worried that it would kick off a new round of laws against formula marketing. “That’s what’s at stake by a new measure that’s being proposed by the WHO, without any scientific evidence,” Audrae Erickson, a Mead Johnson lobbyist, told a trade association crowd.

Industry groups scrambled to arrange meetings with high-level officials in Washington. “Clearly, the potential economic and international trade implications from this proposed draft guidance are quite significant,” the pro-industry Infant Nutrition Council of America said in a letter to an FDA official in 2016.

That year, companies and trade groups connected to commercial milk formula, including Abbott Laboratories and Nestlé, spent almost $7 million lobbying U.S. officials about WHO matters, after a decade in which their lobbying disclosures had not mentioned the organization at all, a study found.

The industry’s outreach spanned Washington. The Infant Nutrition Council of America, for instance, lobbied the Senate, House and USTR — as well as the commerce, state, agriculture and health departments, lobbying records show. The efforts attracted the attention of leaders in both parties, including House Speaker Paul Ryan, who called President Barack Obama about the issue, according to records obtained by ProPublica.

Inside the administration, USTR took up the formula industry’s cause. “USTR does not support issuance of the guidance or resolution” on toddler milk, wrote Jennifer Stradtman, a USTR official, in an email to other federal officials. Furthermore, she wrote, her office “will not be able to accept” any resolution that encouraged WHO member countries to convert any of the guidance into law.

It wasn’t the first time the USTR sided with industry despite public health concerns: In 2013, a group of Democratic senators scolded U.S. Trade Representative Michael Froman for a proposal to help tobacco companies use trade law to “subvert” tobacco control measures — a stance the lawmakers called “deplorable and a serious threat to global public health.”

In the debate over toddler milk, officials from Froman’s office repeatedly questioned science, prompting a fight with public health officials, internal documents show.

In one exchange, then-USTR lawyer Sally Laing objected to a sentence from the guidance that said research suggests food preferences are established early in life.

“Unsupported,” Laing wrote.

Health officials pushed back on that, as well as other USTR edits. “MUST NOT DELETE,” the Centers for Disease Control and Prevention protested in all caps, arguing that key language in the resolution was, in fact, backed by scientific evidence. But such concerns appeared to get lost in the debate, as those sentences were ultimately struck from the text.

Documents Show Internal Clash Before U.S. Officials Pushed to Weaken Toddler Formula Rules

Explore the interactive story here.

Meanwhile, as WHO member nations gathered to vote in Geneva, formula lobbyists had U.S. officials “on speed dial” and urged them to weaken the WHO resolution, said Jimmy Kolker, who led the negotiations for the U.S. as an assistant secretary in the Health and Human Services Department.

And the industry’s agents appeared to have inside knowledge. A baby-formula industry association lobbyist cornered Kolker. “From her approach, it was obvious to me that she had been forwarded an internal, very-limited-distribution USG email,” he wrote in an email to other U.S. government officials. “This is unacceptable and makes our job as negotiators significantly more difficult.”

In the end, the United States delegation persuaded WHO nations not to “endorse” their staffs’ own recommendations. Instead, the body voted only that it “welcomes with appreciation” the guidance — language that undercut its utility. The resolution, lacking the weight of an official endorsement, left many nations puzzled over whether it would help neutralize trade complaints.

“That has caused a lot of confusion,” said Laurence Grummer-Strawn, a WHO official who focuses on child feeding and former nutrition chief for the CDC. “What does that really mean?”

Stradtman and Laing could not be reached for comment. Froman did not respond to requests for comment, and a USTR spokesperson declined to comment on the office’s actions during the WHO debate. In a general statement, the spokesperson said that “with regard to infant formula, USTR, in conjunction with others in the interagency, work to uphold and advocate for policy and regulatory decisions that are based on science.”

The practical impact of the resolution’s weakened wording became clear within months, when the U.S. and other dairy producers like Australia and Canada accused Thailand of attempting to obstruct trade with its marketing ban. Thai officials argued their country had a “strong need for a regulation,” saying the “sales promotion” of milk formula for babies and toddlers contributed to the nation’s low rate of breastfeeding. But when it referenced the WHO’s guidance and resolution to support its position at the WTO, the U.S. countered that those measures did not amount to “an international standard.”

When the Thai National Legislative Assembly finally passed its formula marketing measure in April 2017, the provisions that the U.S. and its allies — plus some Thai doctors and industry lobbyists — had complained about most loudly were either watered down or gone entirely. Lawmakers had reduced the maximum criminal penalty for violations from three years in prison to one year in prison and the maximum fine from about $8,730 to $2,910, a USDA document shows.

Advocates for the Thai Milk Code, including Siriwat, who is clapping, visited the Thai parliament before the law passed. The purple sign says, “Protect Thai kids from being victims of powder milk,” and the white sign says, “I was fed by breastmilk until I was 3 years old.” (Courtesy of Dr. Siriwat Tiptaradol)

The law banned the marketing of infant formula and outlawed cross-promotion, but it still allowed advertising on products for 1- to 3-year-olds.

At a June 2017 meeting of the WTO, the U.S. called the changes “a welcome modification.”

“Addicted to the Bottle”

The next year, Sumet and Jintana celebrated the birth of their second child, Gustun. As she had with her firstborn, Jintana breastfed Gustun until he was 3 months old, then started him on formula so she could go back to work.

The couple diligently followed the “stages” prescribed by Dumex, which came in a cheery red package: Stage 1 formula when Gustun was an infant, Stage 2 when he was an older baby and Stage 3 when he became a toddler. He craved formula, and his parents, believing it was healthy, always gave him more. By the time he was 3, he reached his peak weight of about 66 pounds — the same as an average 9-year-old. He was drinking six or seven bottles a day, each holding about 12 ounces of toddler milk.

Gustun’s picture, from when he was heavier, on display at his school in Lopburi, Thailand

Jintana wasn’t worried at first as Gustun grew pudgy. His brother, Captain, had been big, too — almost 60 pounds — at the same age. But when Gustun started school in person after the pandemic, his teachers were concerned. They had seen others arrive, as one put it, “addicted to the bottle.” The weight slowed Gustun down during movement time, his teacher Tida Rakrukrob said through a translator. “He would move slowly and was less active compared to other children,” she said.

When another teacher posted a video on TikTok showing herself comforting and talking with Gustun one day, it went viral — receiving 732,000 likes and many comments about how cute he was. But his teacher’s concern with his difficulty moving led his parents to bring him to see a doctor, who tested him for a hormone imbalance and checked him for diabetes. The tests came back negative. The parents reduced the fried food, dessert and snacks Gustun ate.

The biggest change the family made, though, was eliminating toddler formula from his diet. His school gave him cow’s milk instead, as it did for other children.

Gustun’s extra weight began to disappear.

Looking back, Jintana said she thinks he gained so much “because of the toddler milk.”

Today at age 6, Gustun is no longer on a restricted diet — he can eat fried food and dessert — and weighs 35 pounds, about half of what he weighed at the peak of his Dumex consumption. He is more outgoing at school, Jintana said, and plays soccer with his older brother every day. Captain lost a similar amount of weight after switching to cow’s milk at school and is now 9 and slim, weighing around 51 pounds.

Gustun and Captain play soccer at home in Lopburi, Thailand.

One Monday in September, the brothers — both in soccer jerseys — kicked a ball back and forth in the driveway of the family’s brightly painted red house. Gustun, who has a lightning bolt shaved into his hairline, chased the ball and tried to get it away from his brother, who darted about quickly, tapping it from foot to foot.

“Now, his movement is perfect,” his mother said.

Danone, the company that makes Dumex, said in a statement that while breast milk offers children the best nutritional start, “50 years of scientific research into nutritional needs in early life underpins our products, and we do not make claims that have not been backed up by scientific research.” The company said that research has shown that toddler milk can provide nutrition and help improve the diet of children age 1 and older, reducing the risk of iron and vitamin D deficiency.

“We encourage parents to follow the guidelines on pack when using our products, which are carefully calibrated so that babies and infants receive the right amount of nutrients they need each day from our products,” the company said.

“The Tactic is ‘I Will Violate Your Law’”

A formula display with a promotional toy keyboard at a grocery store in Bangkok

Thailand’s marketing restrictions have done little to curb practices like cross-promotion, said Nisachol Cetthakrikul, who has worked in the Thai health ministry and studied the law.

Indeed, at two supermarkets in Bangkok, shiny walls of powdered formula boxes seven shelves high greeted shoppers on a warm day in September. There were few differences between packages for products intended for babies and those intended for toddlers.

Formula makers and stores offered steep discounts for toddler milk, calling one a “Mommy Fair Shock Deal.” An offer on one shelf told parents if they spent about $87 on Hi-Q1 toddler formula, made by Danone, they could receive a free yellow and blue swing set worth about $27. Other offers included a clay “pizza dough cooking fun set,” a toy keyboard and microphone, and even a pushable “speedcar trolley” that a toddler could sit in.

A 2022 study led by Nisachol found 227 instances of formula marketing that violated the law.

The government has levied fines for violations, but Thailand’s health ministry doesn’t name offenders. “The tactic is ‘I will violate your law,’” Siriwat said, “‘and prepare the budget for the fine.’”

Thai health authorities have tried to fight back by raising parents’ awareness of the benefits of breastfeeding. The health ministry, for example, erected billboards saying “breast milk is medicine” and called doctors to a meeting to urge them to promote breastfeeding among their patients. But these campaigns are no match for the formula companies’ massive spending on marketing, Siriwat said.

A billboard promoting breastfeeding in Bangkok, Thailand (Heather Vogell/ProPublica)

While Thailand’s exclusive breastfeeding rate for babies six months or younger rebounded to about 29% in 2022, UNICEF found, it is still far short of the WHO’s target of at least 50% by 2025. The country’s rates of obesity and stunting for children 5 and under are higher today than they were in 2016, the year before the watered-down formula law passed.

Dr. Somsak Lolekha, president of the Thai pediatric society, said formula isn’t the only reason for children’s weight problems. But it plays a big role, he said, because it’s so easy to drink — a point that tracks with studies showing that babies who breastfeed longer are less likely to become obese and develop diabetes than those who drink formula.

Dr. Somsak Lolekha, president of the Pediatric Society of Thailand, in Bangkok

Last summer, Thailand joined more than 100 nations at the WHO’s headquarters in Geneva to explore ways to fight unethical formula marketing. Attendees sat at long tables in a sleek, modern auditorium. Like other nations’ representatives, Dr. Titiporn Tuangratananon, an official with Thailand’s health ministry, declared her intentions on brightly colored paper posted at the front of the room: “Fully control” the marketing of formula to young children, and “Increase + expand enforcement.”

In an interview, Titiporn said health officials are trying to update the country’s marketing rules — including making some forms of toddler formula advertising, such as giveaways, discounts and free samples, illegal.

But that could ultimately prove difficult in a country that is now the seventh-largest market in the world for formula.

In fact, according to Titiporn, the government has already been deluged by public comments critical of its regulatory efforts. She suspected the pro-marketing remarks, some of which had been repeatedly copied and pasted, came from representatives of the formula industry.

“We know that it’s not real,” Titiporn said. “It’s not the real mothers.”

Chalida Ekvitthayavechnukul contributed reporting.

This post was originally published on Articles and Investigations – ProPublica.

by Megan Rose

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Returning to his home state of Utah, where more babies are born with cleft lip and palate than is typical, Dr. Devan Griner made plans to open his own practice, joining the small cohort of plastic surgeons nationwide who treat the condition.

As he recruited doctors to fill out a team in 2017, Griner had lunch with an orthodontist who’d long worked in the state. He quizzed Griner on his credentials and then turned to bone grafting, a common procedure for cleft patients, who are often missing a piece of their upper jaw. Sitting back, the doctor looked hard at Griner and lobbed a test question: At what age would Griner do bone grafts on patients?

It was a surprising question. There is broad consensus nationwide to time bone grafts to when a patient is getting certain adult teeth, and so Griner, a bit taken aback, replied that of course he does it then. That’s when Griner said the orthodontist relaxed, leaned in over their Neapolitan pizza and declared, “We have a bone grafting problem here in Utah.”

Almost immediately Griner encountered it for himself. Patients began turning up who’d had treatment that departed from the standard of care in ways Griner found alarming. In many cases, he felt they’d had, or been advised to undergo, grueling, and possibly unnecessary, facial surgeries earlier than his profession advised. And they were all treated at Primary Children’s Hospital in Salt Lake City.

As more former Primary Children’s patients sought out Griner’s team, the doctors started to question among themselves, and then with other cleft doctors in the state, whether they needed to do something. It’s a rare and risky move to call out a fellow doctor’s work, much less a team at a well-known hospital. Most children born with a cleft in the five-state region around Utah are treated at Primary Children’s, some traveling the farthest distance for care in the nation. It’s the largest pediatric hospital in the area, and for many, it had been the only choice.

A crucial question emerged: Did the hospital’s patients, and their anxious parents, know that the care they were getting at Primary Children’s was different from what cleft surgeons at top hospitals around the country provided?

The question hit at the heart of a common tension in medicine between the sort of innovation that drives life-enhancing advances and the accepted standard of care, which is informed by peer-reviewed medical studies, broad agreement among specialists and insurance company policies. What information are patients, especially children, owed? And how should regulators respond when doctors want to try something new — especially when doctors, and their choices, may be geographically or otherwise isolated from their peers?

Dr. Devan Griner, a plastic surgeon, at the Cleft and Craniofacial Institute of Utah in Provo (Hannah Yoon for ProPublica)

In the case of cleft lip and palate, the future of children’s faces are on the line. The success of some cleft procedures isn’t fully known until a child has finished growing. Although there can be signs along the way, not until cleft patients are almost adults will doctors be able to fully assess if a certain treatment done at 2 years old was ultimately beneficial or harmful.

Griner’s team and other doctors who’d worked in Utah eventually felt they had to take collective action. A group of nine doctors decided to file a formal complaint with the state, saying “this is about protecting children.” Among their allegations: Some doctors on the hospital’s cleft team were performing bone grafts on patients who were too young — around age 2 — and using an off-label, controversial bone growth product that many doctors shun. They were performing intensive jaw surgeries — which require children to wear a large metal device screwed into their heads for months — so early that they risked some children needing to repeat the operation. And the team was performing surgeries some patients didn’t need.

“They just over, overoperate,” said Lisa Morris, one of the cleft doctors on the state complaint.

Cleft specialists at seven large pediatric institutions around the country, including Seattle Children’s Hospital and Nationwide Children’s Hospital, told ProPublica that the way doctors performed several procedures sharply departed from their speciality’s most common practices.

Utah’s Division of Professional Licensing is investigating the practices of several doctors on Primary’s cleft team, which is staffed by University of Utah doctors. The state agency originally closed the complaint with little investigation, but after an appeal to the head of Utah’s commerce department, which oversees licensing, the division reopened it in April.

Dr. Dana Johns, director of Primary Children’s cleft team, said the fact that her team’s practices don’t align with those of her colleagues in the field “doesn’t mean that different is wrong.” She said that intervening earlier helps protect children with visible facial differences from a gamut of bullying in their formative teen years.

In interviews, both Primary Children’s and the University of Utah told ProPublica they stand by their protocol and fully inform their patients during appointments about how and why their care differs. What the team does is “clinically defensible and potentially advantageous,” Kathy Wilets, a University of Utah Health spokesperson, wrote in a statement.

But ProPublica’s questions, the hospital said, prompted the hiring of two independent cleft surgeons to formally review the protocol. Bioethicists have also reviewed the hospital’s informed consent procedures, leading administrators to make changes to its cleft consent policies and consider hospitalwide changes.

Dr. Jay Agarwal, the hospital’s chief of plastic surgery, said the cleft team believes the standard methods of treating cleft lip and palate aren’t good enough and is trying to advance care by fixing children’s mouths at younger ages and in ways that could eliminate the need for surgery when they’re older.

“We always have to try to do better,” he said.

But parents of some of Primary Children’s patients say their children were unwitting participants in what the hospital calls innovation and what some other cleft experts deemed a potentially risky deviation from evidence-based treatment. Experts said bone grafts done at such an early age could stunt facial growth, resulting in the upper lip looking pushed back and impairing basic tasks such as talking and chewing.

The final results of the early bone grafting won’t be known for years. Patients treated under the new bone-grafting protocol Primary Children’s started around 2017 won’t start seeing full outcomes until around 2029.

Emily Rogers still feels the burden of remorse six years after her son’s bone graft when he was 21 months old. She, like members of several families ProPublica spoke with, said the former head of the program didn’t tell her that bone grafting at that age was unusual, that the hospital was just starting to try it or that doctors weren’t sure how her son’s face would grow after the procedure.

“It’s sickening to find out later you put your kids in their hands and they lied to you, basically,” she said. “That’s what it feels like: It was a lie.”

Gavin Rogers, 7 sits with his mom, Emily Rogers, at their home in Farmington, Utah. (Hannah Yoon for ProPublica) The Standard of Care

From the time a cleft is spotted on a sonogram during pregnancy, parents begin prepping for a series of surgeries to help their child with a noticeable facial difference. Each step of care throughout childhood builds upon the last, slowly marching the face toward the form it failed to take in the womb. A doctor’s misstep can veer the mouth off course or mean more surgery.

People unfamiliar with clefts, besides perhaps what they’ve seen on Operation Smile fundraising commercials, tend to think of the treatment as a one-and-done surgery to repair a small slit in the lip. And while that can be the case, for a lot of babies born with the condition, it’s much more involved. Often, a wide split starts at the nostril, goes down the lip, runs through the upper jaw and continues back through the roof of the mouth toward the throat. Sometimes there are splits on both sides of the mouth.

Cleft lip and palate together affect about 1 in 1,600 babies in the U.S.; around 2,500 are born with both each year. It is unclear why Utah has a higher rate. In general, the cause of a cleft is not well understood. According to the Centers for Disease Control and Prevention, there is some evidence that genetics can play a role, and some environmental factors, such as smoking during pregnancy or taking certain medications, can increase the chances of a cleft forming, which happens in the first trimester.

With cleft lip and palate, often a split starts at the nostril, goes down the lip and through the upper jaw, and continues back through the roof of the mouth toward the throat. Sometimes the split is on both sides of the mouth. (Illustration by Matt Twombly, special to ProPublica)

A cleft can affect a child’s teeth, position of the midface and nose, and ability to hear, breathe, swallow and speak. Many cleft patients need care from a range of specialists from their earliest days until adulthood. Successful cleft treatment repairs those issues, leaving patients’ faces with little evidence of their cleft issues by the time they are grown.

Like most well-known conditions, there is a treatment plan for cleft lip and palate that a majority of doctors follow, known generally as the standard of care. ProPublica spoke with more than a dozen cleft specialists nationwide, and all acknowledged the variability, subjectivity and debate in cleft care. Several pointed out there aren’t large randomized trials that have definitively provided answers, and care continues to evolve. Still, they all laid out the same general timeline of cleft treatment and the reasons for it.

Doctors usually repair the lip and nose around 3 to 6 months, close the palate around 9 to 18 months and then wait to do a bone graft until children are about 5 to 11 years old, though there is debate about when in that age range is best. Jaw surgery, if needed, typically waits until the child is done growing. Most patients will need rhinoplasty and years of orthodontia as well and, in some cases, additional surgeries to help with things like speech.

Richard Kirschner, chief of plastic and reconstructive surgery at Nationwide Children’s in Ohio and the editor of a widely used cleft textbook, said this timeline is based on evidence collected over decades in the care of thousands of patients.

To the doctors at Primary Children’s, the skepticism they’re facing is the plight of pioneers.

“I think it’s easy to keep doing things the same way in the way they’ve always been done,” said Agarwal, who noted that he doesn’t think there is a standard of care in cleft. “And, you know, that’s the answer for a lot of groups that they feel like they don’t want to try new things. And that’s OK. I mean, nothing’s wrong with that.”

Dr. Dana Johns in an exam room at Primary Children’s Hospital (Kim Raff for ProPublica)

Faizi Siddiqi, who helped start the university’s cleft team in 2003, stopped practicing last year and died from cancer in January at age 58. ProPublica was unable to reach him for comment before his death. Duane Yamashiro, an orthodontist who was the medical director of the cleft program for almost 20 years, declined through a spokesperson to comment. So did the most senior plastic surgeon currently on the team, Barbu Gociman. All three are named on the state complaint. Johns and the rest of cleft team doctors are not named on the complaint, and the hospital and the University of Utah declined to comment on it.

“We stand firmly behind our surgical approaches and believe they deliver the best outcomes for our patients, although, through an extensive review of our program we realize there are opportunities to improve the way we communicate with our patients and their families,” Wilets said in a written statement. “The safety and care of our patients is the most important thing to us.”

“We apologize for any distress to any patient family who feels we didn’t meet their expectations and did not feel comfortable addressing their concerns directly with us,” Wilets wrote.

The hospital has around 700 to 800 cleft patients at any given time, and Wilets said its cleft outcomes are in line with or better than other centers’.

In responding to concerns that patients’ families told ProPublica about, Jess Gomez, a hospital spokesperson, wrote, “We have no record of prior complaints from the families you’ve identified regarding their care, and we are saddened to learn of the concerns you’re sharing with us.” He added that the patients were cared for by Siddiqi, so the hospital is unable to respond to specifics about treatment discussions.

Innovating in surgery is a gray area. Unlike drug development, which has strict rules, surgeons are allowed wide leeway to try new things. “It’s a little bit of the Wild West,” said Dr. Jonathan Marron, director of clinical ethics at Harvard, and there isn’t agreement on what the right balance is between supporting innovation and protecting patients.

Doctors have an ethical obligation to make sure their patients are aware of how their protocol differs and what the rationale is for not doing the standard. “Informed consent, in my mind, is an important aspect of this,” he said.

As more and more doctors stick to a standard, the less acceptable a deviation from that standard practice is, Marron said. But figuring out where that line is can be difficult.

Innovating in surgery is not an area that’s robustly regulated. Last year, Utah lawmakers made it easier for doctors to practice outside the standard by loosening the rules that had restricted it, though the law still requires that patients are informed in writing and consent. The hospital and University of Utah didn’t respond to questions about whether patients are informed in writing about any deviations from the standard of care. Since ProPublica began reporting, the hospital has updated its written informed consent form regarding families’ options, Wilets said, and it now “more explicitly” tells patients that there is no standard protocol for cleft patients and different institutions have different protocols.

In other parts of the world, cleft lip and palate care has undergone changes based on government oversight. For example, in the United Kingdom there used to be many cleft centers with wide variations in success. Then the government audited outcomes, looking at factors such as how well patients were able to speak and how well their jaws aligned. Some centers achieved much better results with fewer surgeries. The government consolidated care among fewer centers to improve results and consistency. There isn’t any similar oversight in the United States.

“I think the important thing to understand here is that there’s not a whole lot of regulation in terms of who is looking after clinical outcomes,” Kirschner said. “And so it’s really [left] up to parents to do their research.”

An Outside Doctor

When Griner questioned the parents of the former Primary Children’s patients, he said, none of them understood that the treatment their child had received wasn’t the norm. The parents cycled through shock, anger and grief in his office so often that eventually he could tell by their faces what they’d say next, he said. The remorse stage was the hardest to hear, with parents blaming themselves for not asking more questions.

The parents, dogged by inchoate worries, had come to him seeking a second opinion once Griner and his partners opened their practice, he and some patients said.

Griner, who remembers going door to door to fundraise for Primary Children’s as a child, said he’d always believed that the hospital’s general excellence included the cleft team. He had wanted to work there. But Griner says that after he chose a fellowship position in Texas instead of with the University of Utah, relations soured.

Later, after seeing the unit’s handiwork firsthand in his practice, he took his concerns to the hospital’s administration. During 2018 and 2019, he said, he had three conversations with different levels of leadership, including the hospital’s then-CEO, about the poor cleft outcomes he and others were seeing. Each time, he said, his concerns weren’t taken seriously.

A spokesperson for Primary Children’s said the former CEO and another administrator couldn’t recall any such conversations, and the third, a director of surgical services at the time, said he recalled only casual conversations between colleagues. “If a concern were adequately raised by Dr. Griner, the concern would have been investigated and necessary action would have been taken,” Gomez said in an email.

As Griner’s new cleft team settled in, their worries mounted. Once a month, the cleft team would meet with patients to collectively discuss next steps. After a former Primary Children’s patient would leave one of those meetings for the first time, the doctors said they would look at each other, shaking their heads: “Can you believe that?”

Griner checks the teeth of Robbie McFerson, 4, while his mom, Sarah McFerson, holds him at the Cleft and Craniofacial Institute of Utah in Provo. (Hannah Yoon for ProPublica)

Primary Children’s undertakes two surgeries to repair the palate instead of one, something most doctors in the United States have stopped doing. The hospital is unusual in that it uses a prosthetic device to cover the palate hole, which requires more time under anesthesia when swapped out for a new one. The hospital also often surgically expands the palate of young patients when a retainer-like device would typically be used instead.

To Griner and his team, the timing of two major procedures — bone grafting and jaw surgeries — were worrying enough on their own, but along with other ways Primary Children’s is an outlier, they were concerned that patients were getting aberrant care at many stages.

Finally, in 2022, a group of doctors — many of whom compete with Primary Children’s — raised the issues with the state. Ten doctors’ names appear on the complaint, though one told ProPublica that although he agreed with many of the concerns, he wasn’t aware he’d been included on it.

(One of the plastic surgeons who signed the complaint, Rodney Schmelzer, has a complicated history with Primary Children’s. He lost his privileges there in 2017 and has two ongoing lawsuits against the hospital, one of which also names Yamashiro and Siddiqi. The hospital and the doctors have denied the allegations.)

Utah’s Department of Commerce, which oversees the Division of Professional Licensing, said it could not confirm nor deny an investigation.

The complaint alleges that Primary Children’s doctors “routinely exploit Cleft Patients and their families by … subjecting [them] to excessive numbers of surgeries outside the standard of care” without being honest about the risks, benefits or alternatives, which the doctors say violates medical ethics and Utah law.

Major Jaw Surgeries

Paige Holland started looking for a second opinion when Primary Children’s said her 7-year-old son would next need major jaw surgery to correct the underbite that commonly afflicts cleft patients.

The operation, called a LeFort distraction, sounded medieval to Holland: Doctors would cut part of his upper jaw from his skull and screw a rigid metal device, called a halo, to the outside of his head. Wires would attach his upper jaw to the device, and every day for weeks Holland would turn screws to tighten the wires and slowly pull her son’s jaw bone forward and allow more bone to grow. He’d wear the halo for months.

The LeFort Halo Procedure Initial jaw alignment: Cleft patients often have severe underbites. This can affect how the face looks and can also impact basic functions, such as chewing. Surgical procedure: Doctors make cuts along the upper jaw so it can be repositioned. LeFort device attachment: Doctors screw a rigid metal device, called a halo, to the outside of the head and attach it to the upper jaw. After the surgery, patients tighten the wires daily to pull the jaw forward over the course of a few weeks. New bone grows, lengthening the jaw. The child wears the halo for several months to allow the bone to heal. (Illustrations by Matt Twombly, special to ProPublica)

Jaw surgeries aren’t unusual for cleft patients, but the age Primary Children’s often does them makes the hospital an outlier. Holland’s son would have been as young as 9 at the time of the surgery, according to his Primary Children’s medical records reviewed by ProPublica.

The American Cleft Palate Craniofacial Association guidelines state that “whenever possible, [jaw] surgery should be delayed until physical maturation is essentially completed.’’ Cleft doctors at six leading hospitals said they don’t perform jaw surgeries until children stop growing. For girls, that’s about 14 to 16 years old; for boys, it’s closer to 18.

Until recently, Primary Children’s website told families to expect possible jaw surgery between 9 and 10 years old. But it has since changed the age range to between 9 and 15-plus. Some other cleft centers also perform early jaw surgeries, and Kirschner told ProPublica he thinks that surgeries performed before maturity fall within the standard of care, though he personally waits for patients to be grown.

Primary Children’s data from 2020 showed that the average age of LeFort halo surgery there was 11.4 years old, according to a paper published by the hospital’s cleft team that analyzed nearly 60 cleft patients who had halos over a three-year period. The age of the patients ranged from 8 to 16 years old.

Cleft doctors ProPublica spoke with said they perform jaw surgery before maturity in only a tiny proportion of cases, usually only if medically necessary. Dr. Roberto Flores, head of the program at NYU, estimated the number at no more than 5%.

At Seattle Children’s Hospital, even in those extraordinary cases, the surgery would not happen until 12 to 14 years old, when most of the adult teeth are finished coming in, according to the hospital’s former chief of craniofacial surgery, Richard Hopper.

“I’ve been with the cleft team for 20 years, and I can pretty conclusively say we haven’t done a Lefort … on a patient younger than 12 years old, 11 at the earliest,” Hopper said last year before he took a job with Texas Children’s Hospital.

“The earlier you do a jaw surgery, the more likely you’re going to have to repeat it later,” a cleft team surgeon at a top-rated pediatric hospital said. “Basically you’re committing kids to having an extra operation.”

The best practice, many doctors said, is to do one definitive jaw surgery close to adulthood.

“It’s a brutal enough operation. You wouldn’t want to have to do it twice,” a leader in the field said. Both doctors asked not to be identified out of concern it would jeopardize relationships within the small community of doctors who provide cleft care.

Primary’s Johns said such critiques ignore the psychosocial issues children with cleft deal with. Bullying should be given more weight in treatment plans, she said, and repairing a child’s differences before high school has merit. Most of her surgeries wait till at least age 12, she said, and when she does them on younger patients, it’s for either psychosocial or other pronounced medical problems.

Dr. Trace Lund checks Robbie’s palate and teeth. Children with cleft lip and palate often have extra or missing teeth, or teeth that emerge in the wrong spot. (Hannah Yoon for ProPublica)

Moreover, patients who wait until maturity can sometimes require extensive operations involving both the upper and lower jaws, Johns said. Patients who’ve had the surgery young might require a second jaw surgery, she said, but it would involve only the upper jaw. The trade-off, she said, is worth it.

Rohit Khosla, surgical director of the cleft team at Stanford Medicine Children’s Health who trained Johns during her fellowship, reviewed all of the hospital’s protocols at her request. In general, Khosla told ProPublica that he thought the hospital’s methods were controversial but not problematic. He found several problems with the cleft team’s study designs and conclusions, but overall its “protocols are conscientiously thought out with [a] goal to provide a high level of care,” he said in a summary of his report. The hospital would not share his full written review and asked Khosla to stop speaking with ProPublica once it was completed. Primary Children’s also set up a double-blinded review — neither the hospital nor reviewer knew whom the other was — to further assess its protocols, but the hospital said it would not make the report public when it was completed.

In looking at the hospital’s latest LeFort data, Khosla wrote that in the “last few years” the average age has increased to 14, “which I find more acceptable.”

On a Facebook page for Utah parents of children with cleft, numerous posts over the years speak to the hospital’s push to perform LeForts young. Some talk about how their children endured the surgery before 10 years old — “not going to lie the Halo is tough!” one mother wrote — and needed to repeat a jaw surgery as a teenager.

Holland said she thought there had to be another way to fix her son’s underbite and asked about braces. After Primary Children’s said there wasn’t, she said, she sought a second opinion with Griner, who sent him to an orthodontist instead. Holland’s son was one of at least seven former Primary Children’s patients whom Griner said he diverted from having surgery before maturity. None of them, in Griner’s opinion, had any medical necessity for the operation before maturity or reported bullying or other psychosocial issues. Schmelzer, who also signed the complaint against Primary Children’s, said his medical records showed similar numbers.

Griner recalled one startling case last summer in which Primary Children’s had lined up surgery for a 9-year-old child whose jaw was nearly normal. An independent plastic surgeon who specializes in cleft at a large academic institution reviewed the patient’s CT scan for ProPublica and confirmed Griner’s assessment that there was no need for surgery.

Holland’s son, now 13, has only a minor underbite after orthodontics and likely won’t need jaw surgery at all.

“He’s totally fine,” Holland said. “He was saved from a major surgery.”

Experimenting With Bone Grafts

About seven years ago, spurred by what Johns said was a “hypothesis we had,” Primary Children’s cleft team began experimenting with how surgeons bone grafted the upper jaw.

Without putting in place the protections of a formal research study, Johns and her colleagues decided the invasive surgeries could be done successfully when children were years younger — age 2 — than was standard practice in their field.

The “gold standard” for a bone graft is to use a piece of the child’s own hip. At 2, a patient doesn’t have enough bone to harvest. So over a period of about two years, Primary Children’s tested in its toddler-age patients different combinations of materials that would create a lasting bone graft.

Among the materials was a controversial product called bone morphogenic protein, or BMP, which stimulates bone growth. The BMP is put into the jaw where the child is missing bone and, in theory, spurs the body to naturally make bone, gradually filling the gap.

Some cleft doctors have hailed BMP as a less invasive way to treat patients since it first came to market in 2002 — but Primary Children’s believed it could be used in children years younger than their peers at other centers.

The parents of several patients told ProPublica they were never informed that their child was undergoing an untested procedure. In some cases the bone graft failed, necessitating a repeat of the painful operation.

In 2017, Gavin Rogers, 21 months old with the wispy blond hair of a baby, had bone graft and hard palate repair. Afterwards, “he was screaming all the time. He wasn’t sleeping, wasn’t eating. I had to squirt milk into his mouth,” his mom, Emily Rogers, recalled.

Gavin at 21 months, after his bone graft at Primary Children’s Hospital in 2017. His parents said they weren’t told that a bone graft at that age was unusual. (Courtesy of Emily Rogers)

Primary’s decision to use BMP in toddlers was a risky bet. In 2015, the U.S. Food and Drug Administration issued a safety warning about using BMP in children. The warning said that BMP hadn’t been approved for children “because their bones may still be growing and using this product may cause serious injuries.” The FDA action followed revelations of injuries, including alleged deaths, related to the use of BMP in spine patients. BMP’s maker was subjected to a congressional investigation and paid hundreds of millions to settle civil suits.

The FDA recommended against routine use in children and told doctors to be sure to inform parents about the risks.

Doctors are allowed to use products like BMP for so-called off-label purposes and commonly do, often to the benefit of their patients. In 2017, Dr. Jeff Hammoudeh, a plastic surgeon at Children’s Hospital Los Angeles, published one of the largest studies of BMP in cleft patients and found that over nine years of use its safety and success was comparable to using bone from the child’s hip. But the average age of his patients was 11 and his youngest patient was 6. He said he wouldn’t use BMP in patients any younger than that because of concerns, shared by other experts, about the long-term growth of a child’s face and questions about the safe amount to use in a child of that size.

Johns, of Primary Children’s, said that Hammoudeh’s study was one of the reasons her team felt confident in using BMP.

Hammoudeh said doctors need to be up-front about what they are doing and build in clear guardrails. When he experimented with performing lip repairs in newborns, he did so through a supervised research study. Parents, he said, were given the choice to have the traditional protocol, just as they were for bone grafting with BMP.

Some doctors may eschew the word “experiment” when trying out a new protocol, he said, but that’s what it is — even if they deem it “innovation.”

“You can soften the terminology any which way, but if you don’t know what the results will be, you don’t know what the results will be,” he said.

Johns told ProPublica she doesn’t offer parents the choice to have a bone graft at the traditional age because she’s confident that her way is better. Giving them the option, she said, “means that we’re telling them, ‘OK, we’re going to allow you to have subpar results.’”

Johns said that since as early as 2018, the parents of patients have been told that the new protocol is superior to traditional care, a claim she said is supported by observational results from the team’s first patients.

The Rogerses and other parents who spoke with ProPublica said Siddiqi, the lead plastic surgeon at the time, led them to believe that grafting at toddler age was the standard of care.

“One hundred percent,” said one mom, whose daughter was not yet 18 months at the time of the procedure and had to repeat the surgery later. She said the conversation with a reporter “was the first I’m hearing this isn’t typical.”

After his surgery, Gavin happened to see a new doctor outside the hospital. Rogers said she stopped breathing when she learned that around the country, many doctors time bone grafts to when certain adult teeth come in. Gavin still didn’t have all his baby teeth.

And the bone graft didn’t work. Gavin faces a second bone graft surgery this summer at 8 years old — in the age range when most other doctors would have done it the first time.

Gavin lies on his bed at his home in Farmington, Utah. He’ll need a second bone graft surgery this summer. (Hannah Yoon for ProPublica)

Four years after Primary Children’s started the protocol, the hospital did its first formal study — a review of 14 patients’ medical records. From around 2017 to mid-2019 — when Johns was telling patients the protocol was a success — the cleft team used different surgical techniques and a combination of bone products, including the BMP, that proved unreliable, and some patients needed additional grafts, according to the study and a university spokesperson.

A hospital spokesperson said its bone grafting procedures have advanced since patients such as Gavin had the operation. Khosla, the Stanford doctor who reviewed the protocol, reported in his summary that newer hospital data demonstrates good early results.

Johns and Agarwal said their new protocol was a slow evolution and didn’t need to be overseen by independent reviewers. Performing a bone graft sooner, they said, would solve a common problem in cleft patients in which the arch of their mouth is narrow and collapses inward as they grow. Moving to age 2 was a minor progression, Johns said, noting that the mouths of a 5-year-old, the youngest age most doctors would do a bone graft, and a 2-year-old are similar.

“There was nothing that felt outlandish about it,” Johns said.

Johns concedes they don’t know yet how their patients’ faces will grow over time. So far, she said the outcomes are trending in the right direction, “but we recognize that we’ve got eight more years to continue to see if it holds up.”

She’s clear about this uncertainty with her patients, she said, as well as how Primary’s protocols diverge from the standard. She said if parents are uncomfortable, she encourages them to seek a second opinion. (One mother said Johns’ colleague told her that he would no longer treat her son after she sought a second opinion.)

Primary Children’s Hospital in Salt Lake City (Kim Raff for ProPublica)

Jessica Bernstein, whose 6-year-old son is a cleft patient at Primary Children’s and whom the hospital connected with ProPublica, said she had the utmost confidence in the care received and felt Johns and the other doctors carefully thought out decisions. She said they told her that the hospital’s timeline for care was based on the latest, best research. Although she said she wasn’t informed that aspects of the hospital’s protocol differ from the standard or that BMP was off-label for children, she felt her son was being treated in the right place.

Other cleft doctors said previous attempts to fix the upper jaw line between birth and 2 years old — known as “primary bone grafting” — were abandoned because of poor outcomes.

Dr. Ron Hathaway recalls when he was at the University of Indiana and participated in a study that compared outcomes at five cleft centers. One fared significantly worse. The upper jaws of many of its patients didn’t grow as expected, leaving them with underbites. Hathaway was stunned to learn it was his program.

Indiana, it turned out, was the only one that grafted before age 2. The others waited until patients were school age. Hathaway had been involved in such grafting at Indiana since 1992, and now he faced the humbling data that his patients were three times more likely than the study’s best center to need invasive jaw surgery because of it.

“I had to go home and have a serious conversation with my surgeons,” he said.

Indiana eliminated primary bone grafting, and when the study was repeated 10 years later, Hathaway said, outcomes had drastically improved. While this type of research can’t definitively prove causation, he said, “a thinking person would say primary bone grafting causes [poorer growth] of the upper jaw.”

The original study was published in 2011, joining a body of research over decades that showed such grafting was “significantly detrimental,” Kirschner, of Nationwide, said.

Nevertheless, in 2016 the cleft team at Primary Children’s began questioning whether operating earlier would be better, said Agarwal, the chief of plastics. He and Johns said what they do is different — in terms of a slightly older age and specifics of the procedure — from the primary bone grafting of the past. Khosla, of Stanford, wrote in his review summary that the protocol challenges conventional wisdom, but “their rationale and the theoretic benefits are sensible.”

For Cindy Anderson, whose daughter’s bone graft echoed Gavin’s in both timing and failure, it wasn’t just that her daughter had to repeat a surgery. Had they been informed of the innovative nature, Anderson said they might have agreed because of their faith in the doctors. But not to be given a chance to consent made them feel duped.

She said they’re left wondering about Primary Children’s: “What the heck are they doing?”

Mariam Elba contributed research.

This post was originally published on Articles and Investigations – ProPublica.