Which Meds are Safe When You’re Pregnant? Science Wants to Find Out
A pregnant woman is uncertain which medicine is safe to take.
Sarah Mancoll was 22 years old when she noticed a bald spot on the back of her head. A dermatologist confirmed that it was alopecia aerata, an autoimmune disorder that causes hair loss.
Of 213 new drugs approved from 2003 to 2012, only five percent included any data from pregnant women.
She successfully treated the condition with corticosteroid shots for nearly 10 years. Then Mancoll and her husband began thinking about starting a family. Would the shots be safe for her while pregnant? For the fetus? What about breastfeeding?
Mancoll consulted her primary care physician, her dermatologist, even a pediatrician. Without clinical data, no one could give her a definitive answer, so she stopped treatment to be "on the safe side." By the time her son was born, she'd lost at least half her hair. She returned to her Washington, D.C., public policy job two months later entirely bald—and without either eyebrows or eyelashes.
After having two more children in quick succession, Mancoll recently resumed the shots but didn't forget her experience. Today, she is an advocate for including more pregnant and lactating women in clinical studies so they can have more information about therapies than she did.
"I live a very privileged life, and I'll do just fine with or without hair, but it's not just about me," Mancoll said. "It's about a huge population of women who are being disenfranchised…They're invisible."
About 4 million women give birth each year in the United States, and many face medical conditions, from hypertension and diabetes to psychiatric disorders. A 2011 study showed that most women reported taking at least one medication while pregnant between 1976 and 2008. But for decades, pregnant and lactating women have been largely excluded from clinical drug studies that rigorously test medications for safety and effectiveness.
An estimated 98 percent of government-approved drug treatments between 2000 and 2010 had insufficient data to determine risk to the fetus, and close to 75 percent had no human pregnancy data at all. All told, of 213 new pharmaceuticals approved from 2003 to 2012, only five percent included any data from pregnant women.
But recent developments suggest that could be changing. Amid widespread concerns about increased maternal mortality rates, women's health advocates, physicians, and researchers are sensing and encouraging a cultural shift toward protecting women through responsible research instead of from research.
"The question is not whether to do research with pregnant women, but how," Anne Drapkin Lyerly, professor and associate director of the Center for Bioethics at the University of North Carolina at Chapel Hill, wrote last year in an op-ed. "These advances are essential. It is well past time—and it is morally imperative—for research to benefit pregnant women."
"In excluding pregnant women from drug trials to protect them from experimentation, we subject them to uncontrolled experimentation."
To that end, the American College of Obstetricians and Gynecologists' Committee on Ethics acknowledged that research trials need to be better designed so they don't "inappropriately constrain the reproductive choices of study participants or unnecessarily exclude pregnant women." A federal task force also called for significantly expanded research and the removal of regulatory barriers that make it difficult for pregnant and lactating women to participate in research.
Several months ago, a government change to a regulation known as the Common Rule took effect, removing pregnant women as a "vulnerable population" in need of special protections -- a designation that had made it more difficult to enroll them in clinical drug studies. And just last week, the U.S. Food and Drug Administration (FDA) issued new draft guidances for industry on when and how to include pregnant and lactating women in clinical trials.
Inclusion is better than the absence of data on their treatment, said Catherine Spong, former chair of the federal task force.
"It's a paradox," said Spong, professor of obstetrics and gynecology and chief of maternal fetal medicine at University of Texas Southwestern Medical Center. "There is a desire to protect women and fetuses from harm, which is translated to a reluctance to include them in research. By excluding them, the evidence for their care is limited."
Jacqueline Wolf, a professor of the history of medicine at Ohio University, agreed.
"In excluding pregnant women from drug trials to protect them from experimentation, we subject them to uncontrolled experimentation," she said. "We give them the medication without doing any research, and that's dangerous."
Women, of course, don't stop getting sick or having chronic medical conditions just because they are pregnant or breastfeeding, and conditions during pregnancy can affect a baby's health later in life. Evidence-based data is important for other reasons, too.
Pregnancy can dramatically change a woman's physiology, affecting how drugs act on her body and how her body acts or reacts to drugs. For instance, pregnant bodies can more quickly clear out medications such as glyburide, used during diabetes in pregnancy to stabilize high blood-sugar levels, which can be toxic to the fetus and harmful to women. That means a regular dose of the drug may not be enough to control blood sugar and prevent poor outcomes.
Pregnant patients also may be reluctant to take needed drugs for underlying conditions (and doctors may be hesitant to prescribe them), which in turn can cause more harm to the woman and fetus than had they been treated. For example, women who have severe asthma attacks while pregnant are at a higher risk of having low-birthweight babies, and pregnant women with uncontrolled diabetes in early pregnancy have more than four times the risk of birth defects.
Current clinical trials involving pregnant women are assessing treatments for obstructive sleep apnea, postpartum hemorrhage, lupus, and diabetes.
For Kate O'Brien, taking medication during her pregnancy was a matter of life and death. A freelance video producer who lives in New Jersey, O'Brien was diagnosed with tuberculosis in 2015 after she became pregnant with her second child, a boy. Even as she signed hospital consent forms, she had no idea if the treatment would harm him.
"It's a really awful experience," said O'Brien, who now is active with We are TB, an advocacy and support network. "All they had to tell me about the medication was just that women have been taking it for a really long time all over the world. That was the best they could do."
More and more doctors, researchers and women's health organizations and advocates are calling that unacceptable.
By indicating that filling current knowledge gaps is "a critical public health need," the FDA is signaling its support for advancing research with pregnant women, said Lyerly, also co-founder of the Second Wave Initiative, which promotes fair representation of the health interests of pregnant women in biomedical research and policies. "It's a very important shift."
Research with pregnant women can be done ethically, Lyerly said, whether by systematically collecting data from those already taking medications or enrolling pregnant women in studies of drugs or vaccines in development.
Current clinical trials involving pregnant women are assessing treatments for obstructive sleep apnea, postpartum hemorrhage, lupus, and diabetes. Notable trials in development target malaria and HIV prevention in pregnancy.
"It clearly is doable to do this research, and test trials are important to provide evidence for treatment," Spong said. "If we don't have that evidence, we aren't making the best educated decisions for women."
Chicken that is grown entirely in a laboratory, without harming a single bird, could be sold in supermarkets in the coming months. But critics say the doubts about lab-grown meat have not been appropriately explored.
Last November, when the U.S. Food and Drug Administration disclosed that chicken from a California firm called UPSIDE Foods did not raise safety concerns, it drily upended how humans have obtained animal protein for thousands of generations.
“The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their food is safe and lawful,” the agency said in a statement at the time.
Assuming UPSIDE obtains clearances from the U.S. Department of Agriculture, its chicken – grown entirely in a laboratory without harming a single bird – could be sold in supermarkets in the coming months.
“Ultimately, we want our products to be available everywhere meat is sold, including retail and food service channels,” a company spokesperson said. The upscale French restaurant Atelier Crenn in San Francisco will have UPSIDE chicken on its menu once it is approved, she added.
Known as lab-grown or cultured meat, a product such as UPSIDE’s is created using stem cells and other tissue obtained from a chicken, cow or other livestock. Those cells are then multiplied in a nutrient-dense environment, usually in conjunction with a “scaffold” of plant-based materials or gelatin to give them a familiar form, such as a chicken breast or a ribeye steak. A Dutch company called Mosa Meat claims it can produce 80,000 hamburgers derived from a cluster of tissue the size of a sesame seed.
Critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
That’s a far cry from when it took months of work to create the first lab-grown hamburger a decade ago. That minuscule patty – which did not contain any fat and was literally plucked from a Petri dish to go into a frying pan – cost about $325,000 to produce.
Just a decade later, an Israeli company called Future Meat said it can produce lab-grown meat for about $1.70 per pound. It plans to open a production facility in the U.S. sometime in 2023 and distribute its products under the brand name “Believer.”
Costs for production have sunk so low that researchers at Carnegie Mellon University in Pittsburgh expect sometime in early 2024 to produce lab-grown Wagyu steak to showcase the viability of growing high-end cuts of beef cheaply. The Carnegie Mellon team is producing its Wagyu using a consumer 3-D printer bought secondhand on eBay and modified to print the highly marbled flesh using a method developed by the university. The device costs $200 – about the same as a pound of Wagyu in the U.S. The initiative’s modest five-figure budget was successfully crowdfunded last year.
“The big cost is going to be the cells (which are being extracted by a cow somewhere in Pennsylvania), but otherwise printing doesn’t add much to the process,” said Rosalyn Abbott, a Carnegie Mellon assistant professor of bioengineering who is co-leader on the project. “But it adds value, unlike doing this with ground meat.”
Lab-Grown Meat’s Promise
Proponents of lab-grown meat say it will cut down on traditional agriculture, which has been a leading contributor to deforestation, water shortages and contaminated waterways from animal waste, as well as climate change.
An Oxford University study from 2011 concludes lab-grown meat could have greenhouse emissions 96 percent lower compared to traditionally raised livestock. Moreover, proponents of lab-grown meat claim that the suffering of animals would decline dramatically, as they would no longer need to be warehoused and slaughtered. A recently opened 26-story high-rise in China dedicated to the raising and slaughtering of pigs illustrates the current plight of livestock in stark terms.
Scientists may even learn how to tweak lab-grown meat to make it more nutritious. Natural red meat is high in saturated fat and, if it’s eaten too often, can lead to chronic diseases. In lab versions, the saturated fat could be swapped for healthier, omega-3 fatty acids.
But critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
A Slippery Slope?
Some academics who have studied the moral and ethical issues surrounding lab-grown meat believe it will have a tough path ahead gaining acceptance by consumers. Should it actually succeed in gaining acceptance, many ethical questions must be answered.
“People might be interested” in lab-grown meat, perhaps as a curiosity, said Carlos Alvaro, an associate professor of philosophy at the New York City College of Technology, part of the City University of New York. But the allure of traditionally sourced meat has been baked – or perhaps grilled – into people’s minds for so long that they may not want to make the switch. Plant-based meat provides a recent example of the uphill battle involved in changing old food habits, with Beyond Meat’s stock prices dipping nearly 80 percent in 2022.
"There are many studies showing that people don’t really care about the environment (to that extent)," Alvaro said. "So I don’t know how you would convince people to do this because of the environment.”
“From my research, I understand that the taste (of lab-grown meat) is not quite there,” Alvaro said, noting that the amino acids, sugars and other nutrients required to grow cultivated meat do not mimic what livestock are fed. He also observed that the multiplication of cells as part of the process “really mimic cancer cells” in the way they grow, another off-putting thought for would-be consumers of the product.
Alvaro is also convinced the public will not buy into any argument that lab-grown meat is more environmentally friendly.
“If people care about the environment, they either try and consume considerably less meat and other animal products, or they go vegan or vegetarian,” he said. “But there are many studies showing that people don’t really care about the environment (to that extent). So I don’t know how you would convince people to do this because of the environment.”
Ben Bramble, a professor at Australian National University who previously held posts at Princeton and Trinity College in Ireland, takes a slightly different tack. He noted that “if lab-grown meat becomes cheaper, healthier, or tastier than regular meat, there will be a large market for it. If it becomes all of these things, it will dominate the market.”
However, Bramble has misgivings about that occurring. He believes a smooth transition from traditionally sourced meat to a lab-grown version would allow humans to elide over the decades of animal cruelty perpetrated by large-scale agriculture, without fully reckoning with and learning from this injustice.
“My fear is that if we all switch over to lab-grown meat because it has become cheaper, healthier, or tastier than regular meat, we might never come to realize what we have done, and the terrible things we are capable of,” he said. “This would be a catastrophe.”
Bramble’s writings about cultured meat also raise some serious moral conundrums. If, for example, animal meat may be cultivated without killing animals, why not create products from human protein?
Actually, that’s already happened.
It occurred in 2019, when Orkan Telhan, a professor of fine arts at the University of Pennsylvania, collaborated with two scientists to create an art exhibit at the Philadelphia Museum of Art on the future of foodstuffs.
Although the exhibit included bioengineered bread and genetically modified salmon, it was an installation called “Ouroboros Steak” that drew the most attention. That was comprised of pieces of human flesh grown in a lab from cultivated cells and expired blood products obtained from online sources.
The exhibit was presented as four tiny morsels of red meat – shaped in patterns suggesting an ouroboros, a dragon eating its own tail. They were placed in tiny individual saucers atop a larger plate and placemat with a calico pattern, suggesting an item to order in a diner. The artwork drew international headlines – as well as condemnation for Telhan’s vision.
Telhan’s artwork is intended to critique the overarching assumption that lab-grown meat will eventually replace more traditional production methods, as well as the lack of transparency surrounding many processed foodstuffs. “They think that this problem (from industrial-scale agriculture) is going be solved by this new technology,” Telhan said. “I am critical (of) that perspective.”
Unlike Bramble, Telhan is not against lab-grown meat, so long as its producers are transparent about the sourcing of materials and its cultivation. But he believes that large-scale agricultural meat production – which dates back centuries – is not going to be replaced so quickly.
“We see this again and again with different industries, like algae-based fuels. A lot of companies were excited about this, and promoted it,” Telhan said. “And years later, we know these fuels work. But to be able to displace the oil industry means building the infrastructure to scale takes billions of dollars, and nobody has the patience or money to do it.”
Alvaro concurred on this point, which he believes is already weakened because a large swath of consumers aren’t concerned about environmental degradation.
“They’re going to have to sell this big, but in order to convince people to do so, they have to convince them to eat this product instead of regular meat,” Alvaro said.
Hidden Tweaks?
Moreover, if lab-based meat does obtain a significant market share, Telhan suggested companies may do things to the product – such as to genetically modify it to become more profitable – and never notify consumers. That is a particular concern in the U.S., where regulations regarding such modifications are vastly more relaxed than in the European Union.
“I think that they have really good objectives, and they aspire to good objectives,” Telhan said. “But the system itself doesn't really allow for that much transparency.”
No matter what the future holds, sometime next year Carnegie Mellon is expected to hold a press conference announcing it has produced a cut of the world’s most expensive beef with the help of a modified piece of consumer electronics. It will likely take place at around the same time UPSIDE chicken will be available for purchase in supermarkets and restaurants, pending the USDA’s approvals.
Abbott, the Carnegie Mellon professor, suggested the future event will be both informative and celebratory.
“I think Carnegie Mellon would have someone potentially cook it for us,” she said. “Like have a really good chef in New York City do it.”
In this week's Friday Five, breathing this way may cut down on anxiety, a fasting regimen that could make you sick, this type of job makes men more virile, 3D printed hearts could save your life, and the role of metformin in preventing dementia.
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
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Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
- Breathing this way cuts down on anxiety*
- Could your fasting regimen make you sick?
- This type of job makes men more virile
- 3D printed hearts could save your life
- Yet another potential benefit of metformin
* This video with Dr. Andrew Huberman of Stanford shows exactly how to do the breathing practice.