Ethics, Public Opinion, and Lived Experience

A certain school of thought holds that actual legitimate science exists only in a lab with a lot of fancy equipment, and that “anecdotal evidence” is trash, unworthy of even a glance. But there are times when anecdotal is the only type of evidence on offer. This is because of the ethics, or rather the lack of ethics, that would be involved in knowingly testing unproven drugs on pregnant women.

As an example of the type of problem that can arise, polycystic ovary syndrome (PCOS) makes a woman particularly vulnerable to unexpected pregnancy when inner conditions change, like when taking weight-loss drugs — which indirectly attests to the usefulness of social media. A troubling connection between drugs, pregnancy or lack thereof, and PCOS, is just the kind of detail that can be usefully shared in an online forum.

Social media to the rescue

Utilizing available platforms, women have taken it upon themselves to communicate with each other, sharing good news and bad news, fears, regrets, and fluctuating emotions. For instance, after two C-sections, someone had been assured that she was now infertile, except she wasn’t.

After being on Ozempic for four months, this woman turned up pregnant — not a circumstance to be taken lightly. Even a healthy unplanned child can seriously affect a family’s well-being, let alone an unexpected baby with a birth defect — the possibility of which has not yet been ruled out.

For the foreseeable future, the majority of available data might continue to be of the anecdotal variety. If there is one thing the World Wide Web excels at, that function is providing a way for all sorts of like-minded people to connect with each other. Women seem eager to share their stories and opinions with others who have been through the experience of GLP-1 plus pregnancy, or who might be likely to accidentally or purposely embark on it.

For instance, in March of this year, a Healthline article reported that TikTok was abuzz with reports of surprise pregnancies associated with Ozempic, to the point where such conceptions are called “Ozempic babies” regardless of which pharmaceutical product or brand is in use.

There are reports from women who tried for years to start a family, then lost (even just a relatively small amount of) weight due to a GLP-1 preparation, and had what some call miracle babies. As for what problems might come along with such a “miracle,” that story will take many years to unfold.

Of course, part of this trend must be attributed to weight loss alone, because it was happening even before these particular GLP-1 drugs hit the market. Texas endocrinologist Dr. Neha Lalani notes that weight loss alone can lead to improvement in the patient’s metabolic health to the point where ovarian function might be spontaneously restored:

[I]ncreased fertility and surprise pregnancy has been well-reported in previously infertile patients, even with modest weight loss (approximately 5%) with lifestyle modification as well as other weight loss medications.

For The Washington Post, journalist Amy Klein looked into the anecdotal reports which have appeared on TikTok, Reddit, and in a Facebook group called “I got pregnant on Ozempic” that boasts over 500 members. A typical history is offered by a woman who had been taking semaglutide for diabetes and incidentally lost around 80 pounds. She initially thought her nausea was drug-induced, but it was morning sickness.

Another, because of polycystic ovary syndrome, had been unable to conceive for 10 years. In her words, “My little Mounjaro baby is almost 6 months old.” PCOS is often found concurrent with obesity, and the profession has already learned that losing as little as 5% of body weight can improve the odds of successful conception.

PCOS, with its insulin resistance, weight gain and infertility, is a risk factor that can portend the development of type 2 diabetes, so GLP-1 receptor agonists are often prescribed. For Pharmacy Times, doctoral candidate Alejandra C. Nogueira explained in more depth:

[A] recent metanalysis highlighted that even significant weight loss did not improve clinical pregnancy or live birth rates. Therefore, increased unplanned pregnancies with concurrent semaglutide use in women who are not receiving fertility treatments could be indirectly tied to the drug’s ability to promote weight loss rather than a direct effect on fertility.

It has been understandably feared that the GLP-1 drugs might harm fetuses. A recent study of 168 women who, unsuspecting of pregnancy, took such drugs in their first trimester, found pregnancy outcomes no worse than those of women with diabetes or obesity. Nevertheless, many authorities point out that a developing fetus needs sufficient nutrition, so anything that impairs an expectant mother’s appetite is probably not a good idea.

Ozempic and Wegovy, prescribed for type 2 diabetes and obesity respectively, are both made by Novo Nordisk. Whenever a member of the press asks, company representatives specify that any drug trials have specifically excluded women who were either pregnant or trying to be, so “not enough human data is available to establish whether semaglutide is associated with major birth defects, miscarriage, or adverse outcomes for either the mother or the baby.”

The company does not recommend its products to be used during breastfeeding, either. In lab rats, semaglutide shows up in the mama rats’ milk, and the implications of this regarding humans are not known. And now that these drugs are accepted for teens and even children, there is no way of knowing what effect this will have on their future ability to bear healthy babies.

Importantly, the consensus seems to be that if there is any possibility of pregnancy when a woman is using these medications, contraception not connected with the gastrointestinal tract should definitely be chosen. Plenty of alternatives exist, including good old-fashioned condoms.

Your responses and feedback are welcome!

Source: “’Ozempic Babies’: How Weight Loss Drugs Can Interfere with Birth Control and Boost Fertility,” Healthline.com, 03/26/24
Source: “An Ozempic baby boom? Some GLP-1 users report unexpected pregnancies,” WashingtonPost.com, 04/05/24
Source: “So-Called “Ozempic Babies” Raise Questions About Unintended Effects of GLP-1 Agonists,” PharmacyTimes.com, 10/03/24
Image by Pat Hartman

GLP-1 Drugs and Babies, Part 2

Any factor with the potential to affect a baby throughout its entire lifetime is not a thing to be taken lightly. A number of authorities have something to say about the subject of GLP-1 drugs in conjunction with pregnancy.

Many media articles mention Ozempic, a drug which, because of its early and widespread popularity, seems to stand in for and take the fall for the whole group of similar meds. But that one preparation does not represent the entire range of risk. Another brand’s packaging, for instance, warns of increased risk to the fetus, of cleft lip and cleft palate.

The Food and Drug Administration states that no one should take GLP-1 drugs if they are trying to become pregnant. For those who are planning on motherhood and are on a GLP-1, the FDA recommends stopping the medication at least two months before trying to conceive.

Jamie Winn, Pharm.D., told journalist Cathy Cassata,

While no studies have been conducted on pregnant people taking GLP-1 drugs, studies in animals such as rats, rabbits, and monkeys showed that these animals experienced high rates of miscarriages when they were given an injectable GLP-1 medication. The babies the animals gave birth to were smaller in size than usual and with more birth defects.

Just to complicate matters, pregestational diabetes has long been known to “increase the risk for potential pregnancy, including birth defects, miscarriage, fetal growth restriction, premature labor, and preeclampsia.” Some professionals believe that so far, weight-loss drugs offer no greater risk than insulin, which pregnant women with diabetes have needed to take.

Still, clinical endocrinologist Dr. Sethu Reddy has said that no GLP-1 receptor agonist is “indicated for improving fertility” and that “risk can not be ruled out.” On the other hand, GLP-1 receptor agonists seem to perform no worse than insulin, and patient acceptability and adherence are great advantages.

But this only applies to the small percentage of potential mothers who must receive extra protection because of their diabetes. Dr. Sonia Hernández-Díaz is quoted as saying,

[T]he safety of these agents in pregnancy is largely unknown, as pregnant women are typically excluded from clinical trials; hence, treatment guidelines do not recommend these agents in pregnancy.

Around the same time, a Swedish study provided reassurance about the prenatal exposure experienced by fetuses when the mothers are treated for obesity with semaglutide. Only a month later, it was announced that a study of 50,000 pregnancies in six countries, followed up for the first year after birth, provided “reassuring” answers regarding the GLP-1 drugs. Still, even though they apparently post no greater risk than insulin, one year of follow-up cannot tell the whole story.

A researcher who wants to know everything about the effects these drugs have on mothers and their babies cannot simply round up a group of suitable female subjects and keep them on the premises, while hourly monitoring every body function. Nor can they even pay women who have used or are using the substances to turn themselves and their fetuses into lab specimens.

(To be continued…)

Your responses and feedback are welcome!

Source: “Ozempic’s Effects on Pregnancy and Fertility: Experts Answer 4 Common Questions,” Healthline.com, 08/14/24
Source: “Are Weight Loss Drugs Like Ozempic Safe While Trying to Get Pregnant?,” Healthline.com, 04/25/23
Source: “Are GLP-1 receptor agonist drugs safe to use in pregnancy?,” MedicalNewsToday.com, 12/16/23
Source: “Prenatal exposure to GLP-1 receptor agonists and other second-line antidiabetics may not pose greater risk to infants than insulin,” Harvard.edu, 12/11/23
Source: “First Large Study of GLP-1 Receptor Agonists During Pregnancy,” JAMANetwork.com, 01/02/24
Image by Vladimir Pustovit/Attribution 2.0 Generic

As Obesity Booms, Doctors Seek Additional Treatment Options

A recent article on Medscape highlights the work and the opinions of Dr. Gitanjali Srivastava, a professor of medicine, pediatrics, and surgery, and the medical director of Obesity Medicine at Vanderbilt University, who had been practicing pediatric medicine for nearly a decade before completing an obesity medicine fellowship at Massachusetts General Hospital in 2013. Reflecting on that time, she recalls that there were no established guidelines or curricula for the specialty.

At that point, obesity was already a widespread issue, but there was still significant stigma both in the medical field and among the general public. After completing her fellowship, Dr. Srivastava spent months traveling and meeting with hospital executives across the country, explaining the importance and value of obesity medicine, covering details about its budget, business model, space needs, and revenue potential.

Specialized obesity treatment gains traction

Today, the field of obesity medicine is growing rapidly. More patients are seeking obesity treatment, and healthcare systems are actively recruiting specialists and building metabolic health centers. Since 2020, the number of doctors certified by the American Board of Obesity Medicine (ABOM) has nearly doubled, and fellowships have more than doubled as well. This year, over 2,100 doctors from various specialties will take the board exam, marking obesity medicine’s increasing integration with other medical fields.

The growing demand for obesity treatment has coincided with the U.S. Food and Drug Administration’s approval of GLP-1 injections, which have shown remarkable weight loss effects. Dr. Marcio Griebeler, head of the obesity medicine fellowship at Cleveland Clinic, explains that the recognition of obesity as a chronic disease, rather than a lifestyle issue, has been long overdue. Obesity treatment has shifted away from advice about diet and exercise to a more scientific understanding of the disease.

Dr. Kimberly Gudzune, chief medical officer for the ABOM Foundation, and others highlight that the brain functions differently in people with obesity, making it more challenging for them to lose weight through willpower alone. New treatments like GLP-1 have shown that obesity can be managed with medication, much like conditions such as high blood pressure or diabetes, but the disease often returns if treatment stops.

More obesity management and treatment training is needed

As more patients seek obesity care, doctors from various specialties are being asked about obesity treatment options, yet many feel unprepared due to a lack of education in this area. Medical training has historically neglected obesity and metabolic health, according to Dr. Nina Paddu, an obesity medicine specialist, who notes that her own training barely addressed these topics.

Dr. Srivastava explains that while the medical community has long sought to establish guidelines for obesity treatment, only recently has enough evidence emerged to create standards. Over the past five years, understanding of obesity’s underlying causes has advanced, with research highlighting the brain’s role and its connections to other diseases. This progress is transforming the way multiple specialties, including endocrinology and surgery, approach obesity.

In response to the growing need, more doctors are pursuing additional training in obesity management. The ABOM offers two certification pathways: completing 60 hours of continuing medical education (CME) credits or undertaking a 12-month fellowship. Dr. Srivastava points out that while the fellowship is more intensive, many physicians are choosing to immerse themselves in it to further their careers. Some return to their previous specialties, but many take on roles specifically focused on obesity medicine.

Despite the field’s growth, there are still not enough obesity specialists to meet the rising demand. With only a small percentage of U.S. physicians certified by the ABOM, many patients may not have access to comprehensive care. Dr. Gudzune emphasizes that while the field is expanding, it remains small relative to the number of patients in need.

Liraglutide is safe for kids as young as six, study finds

Speaking of weight loss medications, a new study shows that liraglutide, a drug already approved for treating obesity in adults and teens, is safe and effective for children as young as six when combined with diet and exercise. The results of the study were published in The New England Journal of Medicine. The drug was found to reduce body mass and slow weight gain in kids aged 6 to 11. Based on these results, the manufacturer, Novo Nordisk, has asked U.S. regulators to expand its use for this younger age group. If approved, it would be the first drug authorized for treating the most common form of obesity affecting over 20% of U.S. children in this age range.

The study involved 82 children, with those receiving liraglutide showing a 5.8% reduction in body mass index (BMI) after over a year of treatment, compared to a BMI increase of 1.6% in the placebo group. Nearly half of the children taking the drug saw significant health improvements. However, side effects, particularly gastrointestinal issues like nausea and vomiting, were common. While experts welcome the potential benefits of the drug, they urge caution in its widespread use due to the risks and lack of long-term data.

The study highlights liraglutide’s potential to treat the underlying causes of obesity in young children, potentially preventing serious health issues like diabetes and heart disease later in life. The trial will continue, with further results expected in 2027.

Your responses and feedback are welcome!

Source: “Doctors Seek Additional Obesity Training in Wake of Obesity Patient Boom,” Medscape.com, 10/1/24
Source: “Weight-loss drug Saxenda effective for kids as young as 6, study shows,” MSN.com, 9/29/24
Source: “Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial,” NEJM.org, 9/10/24
Image by Accuray on Unsplash

Childhood Obesity Awareness Month — Odds and Ends

Dengue fever is one of the reasons to avoid mosquitoes if at all possible. Millions of people catch it every year, and while four out of five don’t even show symptoms, others get it really bad — as in, total body pain, and bleeding from places that do not normally bleed. While many cases may be almost negligible, the disease can also usher in a miserable death. The same person might have a barely noticeable case one time, and the next time a fatal one.

To make matters worse, dengue has traveled to geographical areas where it did not use to exist, like the southern United States. And according to other recent news, both obesity and diabetes are risk factors that increase the likelihood of a person’s case of dengue being severe.

Researchers in Sri Lanka looked at 4,782 cases among young people aged 10 to 18. The Conclusions follow:

Obesity appears to be associated with an increased risk of hospitalization in dengue, which should be further investigated in longitudinal prospective studies. With the increase in obesity in many countries, it would be important to create awareness regarding obesity and risk of severe disease and hospitalization in dengue.

Another source pins down the hospitalization risk for obese children as being twice as high as for the others. The same report notes that “there has been limited focus on the impact of obesity on many infectious diseases.” Furthermore, the odds are worse for girls than for boys. (This caveat also applies to influenza, COVID-19, and “many other infections.”) Dengue has been identified as a Neglected Tropical Disease, so maybe having this connection pointed out will lead to more strenuous efforts toward prevention.

They just can’t seem to get it right

A study published in Nutrients reveals that “60% of all baby foods don’t meet standards established by the World Health Organization.” The research team tested 651 products sold by 10 different major retail chains and found that infant and toddler foods on supermarket shelves contain too much bad stuff and not enough good stuff:

In fact, researchers discovered that only about 30% of these products complied with the WHO’s protein recommendations and only 56% complied with sugar guidelines.

During the first year, a child does just fine with breast milk or iron-fortified formula. In the words of neonatal dietician Chelsea Britton, “Food before one is just for fun,” which is an excellent reason to ignore the commercial offerings and start acclimating a child to real food.

Recommended are “natural purees like yogurt, hummus, smashed beans, and smashed avocado.” Aim for protein, iron and calcium, and don’t add any salt or sugar. Let a child become accustomed to what real, genuine food is supposed to taste like, and don’t assume that your own jaded palate and overworked taste buds can be the judge of that.

In a separate but equally appalling offense, no brands meet the promotional standards set by the WHO, meaning that their advertising is misleading and the information they provide for the buyer is incorrect. It is forbidden to advertise a product as organic, non-GMO, BPA-free, or without artificial flavors or colors, if this claim is not factually true.

Forbidden, but apparently not enforceable. Another example would be calling something a fruit snack, whose main ingredient is flour. Lead researcher Daisy Coyle found that the average infant/toddler food label includes several prohibited claims. Only four products were found whose packaging featured no prohibited claims.

And don’t even look at the front label. Turn the jar around, take out your magnifier, and check the ingredients list and nutrition label, for the real story. Baby food from a grocery shelf should have a very short list of ingredients — the main vegetable, fruit or meat, and enough water to make it spoonable. The cereals, like oatmeal and rice, ought to contain added minerals and vitamins.

Your responses and feedback are welcome!

Source: “Dengue fever,” MayoClinic.org, undated
Source: “Is the rise in childhood obesity rates leading to an increase in hospitalizations due to dengue?,” AC.uk, 2024
Source: “Childhood obesity tied to double the risk of dengue hospitalization,” UMN.edu, 06/28/24
Source: “Most Baby & Toddler Foods Don’t Meet Nutrition Standards, Study Finds,” Parents.com, 08/28/24
Image by markus119/Attribution 2.0 Generic