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

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

Exactly How Multifactorial Is Childhood Obesity?

The full title of this study is “Unraveling Childhood Obesity: A Grounded Theory Approach” to Psychological, Social, Parental, and Biological Factors.” Its four authors are from three different universities and they look at seven major categories of interest: social factors; biological and genetic factors; psychological factors; family condition-related factors; feeding and health-related practices; parenting style factors; and consequences of obesity.

These are further broken down into a couple of dozen subcategories. In other words, there is very thorough coverage of everything that is known, or suspected, to affect the bodies of young humans. Why? Because…

Despite the extensive studies that have been conducted to explore the specific issue, the impact of several factors that influence, generate, worsen, and make chronic the phenomenon needs further exploration.

This work was done in order to come up with a “grounded theory” that includes them all. According to the study authors,

Grounded theory, as a qualitative research methodology, shows great potential for solving the complexities inherent in multifactorial issues. The aim […] is to construct a theoretical framework or a cohesive explanatory mechanism that explains the phenomena being studied. The application of grounded theory methodology includes analyzing and interpreting data that are mostly qualitative like observations, interviews, texts, and documents.

Needless to say, the numerous factors “interact in complex ways, highlighting the multifactorial nature of childhood obesity.” The authors begin by discussing BMI (body mass index) and other measurement tools, and note that “the absence of a universally agreed-upon definition” of childhood obesity makes every aspect of the search for knowledge more challenging. But it is more necessary than ever, because…

[…] obesity represents a significant component of the worldwide challenge of chronic illness and disability, carrying substantial social and psychological consequences that impact individuals of all ages and socioeconomic backgrounds.

In the realm of causation classification, which area holds the most sub-categories? Perhaps surprisingly to some interested parties, “social factors” includes an abundance of categories, five to be exact. One of them has to do with specific time periods, which in turn will surely be divided into even more sub-categories.

Three possibilities spring to mind. First, there is the historical era. When Americans plodded westward with covered wagons pulled by horses, very few cases of childhood obesity existed. Another place where time makes a difference is in the child’s lifespan. As one example, there appears to be a stage of infancy when trying to shovel solid food into a baby can cause lifelong damage to the digestive system.

Likewise, there is a specific time period during which a problem can be solved. Younger people are more likely to be able to lose weight through one means or another, while adults are more likely to stay fat. That is simply how things are and, as always, further research is needed on every front.

The “biological and genetic factors” category has four sub-categories, and so does “family condition-related factors.” Perhaps it is unfair, that what parents say, do, practice, preach, model, ignore, punish, reward, discuss, clam up about, encourage, discourage, and pay for (or don’t), makes so much difference. Family influence (and lack of it) is responsible for an awful lot, and there is no point in pretending.

One way or another, childhood obesity ends up being everybody’s problem. On the importance of starting early, agreement is universal. The need is felt to construct a theoretical framework that includes all the recognized factors and all the connections between them.

Your responses and feedback are welcome!

Source: “Unraveling Childhood Obesity: A Grounded Theory Approach,” ResearchGate.net, August 2024
Image by Roy Patrick Tan/Attribution-ShareAlike 2.0 Generic