Originally published by our sister publication Pharmacy Practice News
By Gina Shaw
The recently released MAHA Report: Make Our Children Healthy Again Assessment, published May 22 by the Department of Health and Human Services, has been criticized for containing references to multiple fictitious studies and conclusions that misrepresent the studies that it does cite.
White House press secretary Karoline Leavitt blamed formatting errors that were corrected, but the corrections introduced new errors.
“This report—Make Our Children Healthy Again: Assessment—is a call to action,” the introduction stated. “It presents the stark reality of American children’s declining health, backed by compelling data and long-term trends. Today’s children are tomorrow’s workforce, caregivers, and leaders—we can no longer afford to ignore this crisis.”
However, children are much more likely to live to be productive adults today. In 1915, the first year that data on infant mortality were available, about 100 infants died per 1,000 live births. By 2022, the mortality rate was 5.61 deaths per 1,000 live births, according to the CDC.
When he issued the report, Health and Human Services Secretary Robert F. Kennedy, Jr. said it would be important to follow the evidence about children’s health. “We will end the childhood chronic disease crisis by attacking its root causes head-on, not just managing its symptoms.
“We will follow the truth wherever it leads, uphold rigorous science, and drive bold policies that put the health, development, and future of every child first,” Mr. Kennedy said in a statement.
However, experts said the report mischaracterizes or omits important aspects of scientific evidence on significant medical issues affecting children, including medications for neuropsychiatric conditions such as attention-deficit hyperactivity disorder (ADHD) and depression, childhood vaccinations, tonsillectomy for obstructive sleep apnea, and the use of tympanostomy in the treatment of ear infections.
“My chief concern is that many of the claims the report makes are overstated and misleading, and when you review many of the studies that they cite, the original language by the authors is much more tempered and nuanced than the way it is characterized in the report,” said Megan Maroney, PharmD, BCPP, a clinical associate professor of pharmacy at the Ernest Mario School of Pharmacy of Rutgers University and a clinical pharmacy specialist in psychiatry at Monmouth Medical Center, in Long Branch, N.J. “It reads like the people who wrote these statements have very little scientific knowledge.”
Medications for ADHD and Depression
As an example, Dr. Maroney noted, the report suggests that ADHD medications for children are ineffective, citing a follow-up of the National Institute of Mental Health’s MTA (Multimodal Treatment of Attention Deficit Hyperactivity Disorder) study that found that after three years, earlier advantages found for children 10 to 13 years of age taking these medications in areas of symptoms, social skills, reading scores, impairment and diagnostic status were no longer apparent (J Am Acad Child Adolesc Psychiatry 2007;46[8]:989-1002).
“However, as that study pointed out, there are many reasons why this might be, including possibly due to the age-related decline in ADHD symptoms. It’s also very difficult to do years-long studies looking at outcomes like these in a controlled way,” Dr. Maroney said. “And this conclusion is really very misleading, because ADHD medications are in fact some of the most effective medications we have in the psychiatry world. When you look at the actual response rates compared with placebo, it’s very clear that they are helpful for ADHD symptoms.”
Indeed, the MTA study found a significant advantage of treatment with these medications for ADHD at 14 and 24 months, and a 2018 systematic review and meta-analysis of 133 double-blind randomized controlled trials (81 in children) found that both methylphenidate and amphetamine were significantly better than placebo in treating ADHD, with methylphenidate slightly preferred due to a better balance of efficacy and tolerability (Lancet Psychiatry 2018;5[9]:727-738).
The report also raises alarms about increasing rates of antidepressant prescriptions for children and adolescents. “That’s true, because the rate of depression and anxiety diagnosis has increased. Even prior to the pandemic, we were experiencing a mental health crisis in kids, and that’s only gotten worse. So it’s appropriate that we are increasing the rate of prescribing to deal with this issue,” Dr. Maroney said. “And it states across the board that newer antidepressants are minimally effective in youth, which again mischaracterizes the evidence. There are some antidepressants that do have a good evidence base for effectiveness in this age group, while others don’t have as much evidence or have negative studies. In general, the report hyperfocuses on and twists the negatives about treatment for ADHD, anxiety and depression in children, and is not telling the whole story.”
“We need to enhance what we can do behaviorally, non-pharmacologically, while still recognizing that these medications will be necessary in a number of situations,” agreed Mary Petrea Cober, PharmD, another pediatric pharmacist and professor.
Childhood Vaccines
The report’s section on vaccines, “Growth of the Childhood Vaccine Schedule,” suggests that children are receiving too many vaccines too soon, stating: “Since 1986, for the average child, by one year of age, the number of recommended vaccines on the CDC childhood schedule has increased from 3 injections to 29 injections (including in utero exposures from vaccines administered to the mother).”
That’s not the right way to assess the vaccine schedule, said Paul Offit, MD, the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia. “The right way to look at it is the number of immunological challenges in the vaccines a child receives. If you add up all the immunological components in today’s childhood vaccine schedule, it’s about 170, which is less than just one vaccine children used to routinely receive: the smallpox vaccine. That’s the largest of the mammalian viruses, and it has about 200 structural and non-structural proteins.
“From an immunology standpoint, the notion that you're in any way overwhelming the immune system with vaccines is just fanciful,” Dr. Offit noted. “You have about 100 trillion bacteria living on the surface of your body, 10 times more than you have cells in your body, to which you make an immune response. You’re constantly making an immune response to the food you eat, the water you drink, the dust you inhale. Your bone marrow puts out a billion new immune cells every day.”
Dr. Offit pointed to some of the vaccines that were added in the 1980s, including the pneumococcal vaccine, the Hemophilus influenza B (or Hib) vaccine and vaccines for meningococcal disease. “What has that meant? It’s meant that we see much less meningitis than we used to. As a resident in the late 1970s, I would do two or three spinal taps a night in the emergency room trying to rule out bacterial meningitis. That almost never happens today. These vaccines have dramatically decreased or virtually eliminate a lot of the main causes of meningitis, pneumonia and sepsis-and thank goodness for that.”
The report also argues for more placebo-controlled trials of vaccines, stating (without citing specific evidence): “Many vaccines on the CDC’s childhood schedule involved small participant groups, had no inert placebo-controlled trials, and had limited safety monitoring, some lasting six months or less—raising concerns about the ability to detect rare or long-term adverse effects.”
“That’s just wrong,” Dr. Offit said. “Any new vaccine has been tested in placebo-controlled trials, often involving tens of thousands of people, and rigorously analyzed. Whenever you add a new vaccine to the schedule, you also have to prove through what are called concomitant-use studies that your vaccine doesn't interfere with the safety profile or immunogenicity profile of existing vaccines and vice versa. Now, a new and improved version of an existing vaccine cannot be ethically tested against placebo. No institutional review board would justify randomizing people to a placebo when an existing vaccine is available that works. The new vaccine is tested against the existing vaccine.”
Tympanostomy and Tonsillectomy
The report’s claim that the use of tympanostomy tubes for children with recurrent ear infections “did not reduce infections in trials—showing common surgeries cause harm without offering benefits,” also misinterprets the study it cites (N Engl J Med 2021;384[19]:1789-1799) and the overall state of the evidence, said Asitha Jayawardena, MD, MPH, an associate professor of otolaryngology and head and neck surgery at Children’s Minnesota in Minneapolis. “It is pretty clear that there was not an ENT involved in understanding the science involved with this report.”
First, the study did not include children who have chronic otitis media with effusion, conductive hearing loss and potential speech delay—a population in whom tympanostomy tubes already have established their efficacy, particularly in children with any developmental concerns. Instead, it included only children with recurrent acute ear infections, with the primary outcome being subsequent ear infections in the two years following tube placement. Although the study found that there was no overall reduction in ear infections—the primary outcome—it did find that tube placement was beneficial for several prespecified secondary outcomes, including severity of symptoms, diaper rash, days off work for parents and a significant reduction in antibiotic use.
“The study establishes that tympanostomy fundamentally changes these children's experience with recurrent acute media,” Dr. Jayawardena said. “Families know immediately when there is an ear infection, so they are able to use antibiotic ear drops to treat it, avoiding all the systemic side effects of oral antibiotics, which is something that the MAHA report rightly notes is important.”
The report also claimed that “[adenotonsillectomy] for children with sleep apnea, an historically common procedure, conferred no benefit in trials, suggesting the many, and often severe, harms of this surgery are unnecessary,” citing as evidence a single 2020 study published in Pediatrics (2020;145[2]). “That study focused on cognition after early tonsillectomy for mild obstructive sleep apnea,” Dr. Jayawardena explained. “It found that kids don’t get any smarter after they get their tonsils out, but that’s not really the question. The question is not does cognition improve after tonsillectomy, but does tonsillectomy help improve kids’ sleep apnea,” he said. “And studies have found that the answer to that is unequivocally yes, if they meet the criteria for the surgery.” The Childhood Adenotonsillectomy Trial, a randomized trial of adenotonsillectomy for childhood sleep apnea (N Engl J Med 2013;368[25]:2366-2376), found that tonsillectomy significantly reduced the severity of obstructive sleep apnea symptoms in children compared with watchful waiting, along with improvements in behavioral and quality-of-life measures.
“As a surgeon-scientist, I feel that this is a real missed opportunity, when you have a report that cites studies that are not even measuring the appropriate primary outcome. The misunderstanding of the evidence is mind-boggling,” Dr. Jayawardena said.
The American Academy of Pediatrics issued a statement noting that while it aligns with the MAHA report on some areas, including the danger of certain chemical exposures, the need to avoid ultra-processed foods, the youth mental health crisis and the need to focus on disease prevention, it expressed “stark disagreement” in many other areas, including the management of conditions such as ADHD and the claims about childhood immunizations.
“Pediatricians understand the unique needs of children, including the systemic and environmental factors that influence their health,” said AAP President Susan J. Kressly, MD, FAAP, in the statement. “If we are all going to work together to make our children healthier, we must start with the science, support well-designed research that leads us to root causes, and implement evidence-based strategies.”
Dr. Maroney reported that she recently served on advisory boards for Boehringer Ingelheim and Bristol Myers Squibb.
