US Preventive Services Tasks Force Recommends Interventions (Not Drugs) for Children and Teens with High BMI

The Washington Post reported in June 2024 that the US Preventive Services Task Force (PSTF) issued guidelines to address the growing problem of obesity among children and teenagers. The U.S. Preventive Services Task Force is “an independent, volunteer panel of national experts in disease prevention and evidence-based medicine.”

The guidelines urge physicians to refer children with weight issues to programs that can help children eat well, exercise safely, and understand how to read food labels. The guidelines don’t recommend obesity drugs which are regulated by the Food and Drug Administration (FDA).

The PSTF guidelines apply to children 6 years of age and older who have a body mass index (BMI) in the 95th percentile. BMI uses a person’s height and weight. The PSTF guidelines are different than the 2017 guidelines that promoted screening alone. The new guidelines also promote interventions/programs.

While some doctors and obesity experts support the new guidelines, other doctors say the guidelines should also include medical interventions such as the use of a “semaglutide drug” which is becoming an increasingly popular weight-loss medication class. For example, the Food and Drug Administration approved the “use of the drug Wegovy in children 12 and older in 2022.”

According to Susma Vaidya, an associate medical director at the IDEAL Clinic, the weight-loss program at Children’s National Hospital in D.C., “Having the option of medication in the appropriate clinical scenario is very important.” “I am a big believer in medication, and I think that we have been advocating for lifestyle change for a long time and haven’t made a whole lot of progress.”

The extent of the child obesity problem

The US Centers for Disease Control and Prevention (CDC), according to the Washington Post article, reports that 14.7 million children between 2 to 19 are obese. The CDC estimates that the cost of healthcare for these children is more than $1 billion in health yearly.

The pros and cons of medications for obese children

The pro argument

One mother who favors medication as part of obesity medical care and whose son began a weight-loss drug in 2023 said that the inspiration for having her son begin using a weight-loss drug was because he wrote a suicide not saying that he felt helpless about losing weight. The mother said that her son lost 120 pounds (from 340 down to 220). She said her son is now more outgoing and at a healthier weight. The mother says she pays $68 every 90 days. The rest is covered by insurance. Without insurance, the cost of the medication would be much higher.

According to the National Library of Medicine, a 2023 trial of semaglutide on teens between 13 and 17 and a BMI at or above the 965h percentile resulted in 44% of the teens having a BMI reduction – a loss “so significant they were reclassified as being normal weight or overweight, rather than obese.”

The con argument

The argument against obesity medications includes concerns about side effects that include nausea, diarrhea, and vomiting which could have long-term effects.

Doctors counter that argument by arguing that obesity can cause a lifetime of physical and mental problems including an increased risk of developing Type 2 diabetes, heart problems, and high blood pressure. Obesity in children can also cause anxiety, depression, and other emotional difficulties.

“It’s a case-by-case decision based on the child, but we’re not talking about the teen who wants to lose a few pounds for the summer,” said Mona Sharifi, a pediatrician and researcher at Yale School of Medicine and a fellow of the American Academy of Pediatrics. “We’re talking about the child who is severely affected, and they need to be presented with all their options.”

What do the Preventive Services Task Force guidelines propose?

The guidelines provide for 26 or more hours of counseling and “supervised physical activity for up to one year.”

The task force, according to John M. Ruiz, a U.S. Preventive Services Task Force member, said that the Task Force didn’t include weight loss medications because there hasn’t been enough research into their effectiveness for adolescents. He said that the guidance could be amended if and when favorable studies are reported.

While the Task Force hasn’t recommended weight loss drugs, the American Academy of Pediatrics did, in 2023, recommend that weight-loss medications for eligible patients be reviewed with families.

One of the difficulties with the use of medications for childhood obesity is the cost. Insurers and government programs will need to cover the cost for many children and their parents. The Medicare Modernization Act of 2003 restricts coverage of weight-loss medications such as Wegovy, which can cost more than $1,000 a month without insurance.

AHIP, an insurance trade group, said that the trade group supports providing “high-quality evidence-based care” for people who are obese. AHIP did not say whether the trade group was less likely to approve weight-loss medications because the Task Force did not recommend the medications.

The counterargument to failing to fund obesity medications now is that the patients will need more costly drugs and surgeries later.

FDA and weight loss drugs

FDA approval of Wegovy (semaglutide) for adults

On June 4, 2021, FDA approved Wegovy (semaglutide) injection for chronic weight management in

“Adults” with “obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity.”

The approval of Wegovy is the first approved chronic weight management drug since 2014. The drug is approved for “chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.”

According to the FDA, nearly 70% of American adults are obese or overweight. Obesity increases the risk of death, heart disease, stroke, and diabetes. Obesity/overweight is linked to some types of cancer. A loss of 5-10% of body weight reduces the risk of heart disease.

FDA states that Wegovy:

“Should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis.”

Wegovy was approved after four 68-week trials. The largest of these trials enrolled adults with diabetes.

“The average age at the start of the trial was 46 years and 74% of patients were female. The average body weight was 231 pounds (105 kg) and the average BMI was 38 kg/m2. The people who used Wegovy lost an average of 12.4% of their initial body weight compared to the people in the trial who used a placebo”.

Some of the side effects of Wegovy include “nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension,” and other side effects. Wegovy’s prescribing information includes many different types of warnings.

“The FDA granted the approval to Novo Nordisk. Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for type 2 diabetes in 2017.”

Other FDA-approved weight loss drugs

We recently wrote about FDA-approved weight loss drugs for adults.

“Weight loss drugs need to be pre-approved by the FDA because the drugs provide a therapeutic benefit – the loss of weight helps improve a patient’s health starting with improving their heart and diabetes outlook.”

As recently as November 8. 2023, the FDA approved the weight-loss drug Zepbound (tirzepatide). We discussed the rigorous scientific approval process the FDA took before approving Zepbound.

In addition to obtaining FDA approval, other compliance issues health drug manufacturers and medical providers who prescribe or fill these medications should review with our experienced healthcare lawyers include the following:

• Can the manufacturer show that the drugs are safe and effective?
• The possible side effects
• Appropriate manufacturing practices.
• Consumer protection so that the manufacturers and physicians don’t mislead the public about the advantages and disadvantages of weight-loss drugs. False claims may be investigated by the Federal Trade Commission.
• Ethical standards such as a “proper medical assessment or the exploitation of vulnerable individuals seeking quick weight loss solutions.”
• FDA oversight and monitoring.

Other approved weight loss drugs for adults include the following medications. Each drug has different prescription requirements, levels of effectiveness, and risk factors:

• Xenical (Orlistat)
• Alli (Orlistat)
• Contrave (Bupropion-Naltrexone)
• Saxenda (Liraglutide)
• Qsymia (Phentermine-Topiramate)
• Imcivree (Setmelanotide)
• Zepbound (tirzepatide)

The US Preventive Services Task Force recently approved guidelines that recommended that children and teens with a high BMI receive treatment interventions. The US PSTF did not include chronic weight loss medications. Some doctors support the use of a semaglutide drug for childhood and teenage obesity/overweight conditions for children and teenagers. Other doctors argue that medications for children and teenagers must undergo rigorous testing – such as the testing the FDA has done for some adult-approved weight loss drugs.

Doctors, medical practices, and manufacturers who prescribe or manufacture weight loss medications should contact Cohen Healthcare Law Group, PC to review their legal and healthcare compliance requirements. Our experienced healthcare lawyers advise physicians about compliance laws and regulations issues.