Trump's Tylenol Warning: Missing Data on Drug Effects During Pregnancy

Trump's Tylenol Warning: Missing Data on Drug Effects During Pregnancy

M Hasan    1:00 AM   

The Challenges of Conducting Research with Pregnant Women

The recent controversy surrounding the Trump administration’s warnings about Tylenol and its potential link to autism has brought attention to a broader issue: the lack of comprehensive data on the safety and effectiveness of many drugs during pregnancy. This problem has only worsened since the fall of Roe v. Wade, as state abortion bans have created new barriers for including women of reproductive age in drug trials and other health studies.

Medical experts and women’s health advocates argue that these restrictions are making it harder to gather reliable data, as both scientists and participants face increased legal risks if a drug harms a fetus. Without clear information on how medications affect pregnant women, navigating conflicting messages from government agencies and medical groups becomes even more challenging.

The Impact of Abortion Bans on Medical Research

The Trump administration has emphasized its commitment to “gold-standard science” when it comes to testing the safety of pharmaceutical drugs during pregnancy. HHS spokesperson Andrew Nixon stated that the president’s warnings about Tylenol and autism stem from a dedication to sharing critical public health information once it becomes available.

However, emerging data suggests that this kind of scientific evidence is becoming increasingly difficult to obtain in many parts of the U.S. For example, PRESTO, a federally funded online database where people trying to conceive share data with researchers, saw a 27% drop in participation in states that banned abortion after the Dobbs ruling. There was no such decline in states with abortion protections.

Allison Whelan, a bioethicist at Georgia State University, explained that in the post-Dobbs era, research involving pregnant individuals is becoming more ethically and legally complex. Concerns about causing harm to a fetus could lead to potential violations of fetal personhood laws or abortion laws.

Legal and Ethical Challenges

Since the fall of Roe v. Wade, 12 states have enacted complete abortion bans, while 10 more have bans that apply before fetal viability (around 22 to 24 weeks). Some of these laws date back decades, long before women had the right to vote or ultrasounds were available. Others were passed in the lead-up to or shortly after the Dobbs decision.

Lawmakers who support these policies claim they aim to protect both fetuses and mothers, arguing that women are often coerced into terminating pregnancies. Some red-state lawmakers have amended their bans in response to unintended consequences, such as an increase in sepsis and hemorrhaging in Texas. However, most have not added exceptions for fetal anomalies, despite concerns that diagnoses can be incorrect.

This means that in 10 states where abortion is prohibited, women whose fetuses develop birth defects must either travel out of state or carry the pregnancy to term, even if the fetus is likely to die shortly after birth.

Ethical Guidelines and Research Protocols

The ethical guidelines governing most research today were developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974 — the year after Roe legalized abortion nationwide. According to the World Health Organization, any research involving pregnant women that could harm a fetus should only occur in settings where safe and legal abortion access is guaranteed.

In the current post-Dobbs landscape, however, the patchwork of abortion restrictions creates uncertainty for both researchers and participants. A 2024 report by the National Academies of Sciences, Engineering and Medicine noted that fear of liability is a major obstacle to enrolling pregnant women in medical studies.

Risks to Researchers and Participants

Clinical trials often require female participants to take regular pregnancy tests to monitor for any potential harm to a developing fetus. Some trials also require reporting adverse pregnancy outcomes like miscarriages, stillbirths, or birth defects.

After Dobbs, some scientists worry that this information — which is not protected by federal privacy laws — could be subpoenaed and used in prosecutions. Several state bans also threaten felony charges for anyone who helps a patient obtain an abortion, raising concerns that researchers could be targeted for simply learning about a trial participant’s pregnancy and discussing options with them.

The FDA issued draft guidance urging researchers to include pregnant and lactating women in studies but did not address the varying levels of abortion access across states or offer ways to protect researchers and participants from legal risks.

Legal Consequences and Fear

Many states have “chemical endangerment” laws that have been used to prosecute women for using drugs during pregnancy, including prescription medications. A New York Times investigation found thousands of cases between 2016 and 2023 where mothers were reported for taking antidepressants, ADHD medications, and even over-the-counter cold medicine.

A September report by Pregnancy Justice revealed nearly 400 charges were brought against women in 16 states for substance use during pregnancy between 2022 and 2024. In some states, like Alabama, prosecutors do not need to prove harm to the fetus to secure a conviction.

Longstanding Issues in Medical Research

Anti-abortion activists argue that excluding women of reproductive age from medical research is not a new problem. For decades, women have been left out of drug trials due to fears of causing birth defects. This has led to many drugs’ side effects on pregnant individuals being discovered only after they are on the market.

Despite policy changes in the 1990s that allowed more women to participate in clinical trials, researchers still struggle to enroll enough pregnant women. Women remain underrepresented in studies of cancer, cardiovascular disease, and blood disorders, putting them at greater risk for adverse drug reactions.

The Need for Better Data

With the current lack of data on drug safety during pregnancy, women’s health advocates warn that focusing on drugs like Tylenol may deter pregnant women from taking needed medications, worsening conditions that can harm both mothers and fetuses.

Health Secretary Robert F. Kennedy Jr. has focused on drugs used by pregnant women, leading to recommendations that may discourage necessary treatments. Clinicians fear this could result in uncontrolled fevers and other health issues that increase the risk of miscarriages and birth defects.

Conclusion

The challenges of conducting research with pregnant women are complex and multifaceted. As legal and ethical boundaries shift, the scientific community faces growing uncertainty about how to proceed safely and effectively. Without better data, the risks to both mothers and fetuses will continue to rise, leaving many without clear guidance on the safest treatment options.

The Secret I've Carried for 56 Years — Now Revealed to Save Lives

The Secret I've Carried for 56 Years — Now Revealed to Save Lives

M Hasan    8:31 AM   

A Personal Story of Abortion Before Legalization

In 1957, as I prepared to leave England for the United States, my mother offered me some final advice. Instead of the usual words of wisdom about marriage or life, she gave me a method to terminate a pregnancy. She suggested boiling half a bottle of red wine and drinking it while it was hot, then standing on a chair and jumping off several times. Her recommendation was unusual, but not uncommon at the time.

At that point in history, abortion was not only illegal but also dangerous. In the United Kingdom, many women used knitting needles to end their pregnancies, while in the United States, wire coat hangers were a common tool. My mother believed her method was safer. However, I found her advice amusing and did not take it seriously. I planned to be fitted with a diaphragm upon arriving in America, as I was confident I could avoid unplanned pregnancies.

Upon my arrival, I looked up obstetricians in the yellow pages and found a doctor nearby. To my disappointment, she refused to fit me, stating I should return after I was married. This was the same policy in Britain, where contraception was only available to married women. My wedding was just two weeks away, and I wondered what this doctor thought would happen on my honeymoon.

Our first child, Ruth, was born two years after our marriage, followed by Dan 21 months later. Caring for two young children was exhausting, but I found it exhilarating. Watching them grow was like witnessing a miracle. Then, three and a half years later, I discovered I was pregnant again.

During my morning sickness, Ruth and Dan both contracted German measles, or rubella. I knew the risks—pregnancy during the first trimester could lead to serious birth defects, including deafness, cataracts, heart problems, developmental disabilities, and even stillbirth. When I asked my obstetrician what he would do if I caught rubella, he simply shrugged and said, “Nothing.” A friend who had the same experience attempted suicide and spent the rest of her life in a vegetative state.

After our third child, Jonathan, was born, we moved to Berkeley, where I was fitted with an IUD. Ezra’s architectural practice was thriving, and he was teaching at UC Berkeley. He often traveled, leaving me to manage three children with different needs. I felt overwhelmed and inadequate as a parent.

In 1969, when Jonathan entered kindergarten, I returned to my studies at the University of California. Life finally felt more balanced. But one morning, I woke up with the familiar signs of early pregnancy. I denied the possibility at first, relying on my IUD, which I believed to be 99% effective. However, I was part of that unlucky 1%.

The thought of carrying a baby alongside the IUD terrified me. What damage could it cause? More importantly, I couldn’t handle another child. Life was just beginning to feel normal, and the idea of a fourth child filled me with dread.

I made an appointment with my obstetrician, who confirmed the pregnancy. I told him I was resigned to having another baby, but he sensed my reluctance. “Go home and talk to your husband,” he said. “If you decide you don’t want to continue, call my office and say you’re bleeding heavily. I’ll meet you at the hospital.”

I was stunned. For the first time, I felt a sense of relief. The doctor was offering me a choice, something I never thought possible. After discussing it with Ezra, we both agreed we didn’t want another child.

The next day, I called the doctor’s office and lied about heavy bleeding. Ezra drove me to the hospital, where we met the doctor. As I was wheeled into the operating room, the nurse squeezed my hand and said, “You’ll be fine.” That was the last thing I remembered.

When I awoke, I was relieved and grateful. Ezra brought me my favorite ice cream, and we shared our feelings of relief. I didn’t tell anyone about the procedure. I was afraid of the legal consequences, and I kept the secret until now.

Had my doctor not offered this option, I might have gone to Mexico or faced the dangers of illegal procedures. Many women suffered from botched abortions or lacked access to healthcare altogether. I was risk-averse and would have likely carried the pregnancy to term, leading to a life of exhaustion and resentment.

Today, at 92, I still feel anger toward legislators who force women to carry pregnancies against their will. Women are often portrayed as foolish teenagers, but many mature women with families face these difficult decisions. Right-to-life advocates focus on rare procedures while ignoring the suffering of women who undergo them.

I share my story now because I believe it can help wake people up to the dangers of restricting reproductive rights. We are returning to a time when women are denied control over their bodies. Doctors fear following the example of my obstetrician, and women with complications are left to suffer.

Stories of regret after abortion are common in antiabortion circles, but my experience was the opposite. It allowed us to have the family we wanted. I have no regrets.

I will always be grateful to my doctor, who risked his career to help me. Now, women are forced to resort to unsafe methods, just as they did before abortion became legal. We are returning to the days of coat hangers and knitting needles.

Cynthia Ehrenkrantz is a writer and storyteller. She was born in Britain and immigrated to the United States in 1957. Her memoir, “Seeking Shelter: Memoir of a Jewish Girlhood in Wartime Britain,” is available wherever books are sold. She lives in Westchester County, New York.

Woman in Menopause Prescribed Antidepressants for Additional Treatment

Woman in Menopause Prescribed Antidepressants for Additional Treatment

M Hasan    4:57 AM   

Understanding Perimenopause and the Misdiagnosis of Mental Health Conditions

Leslie Ann McDonald, a 46-year-old online fitness coach in the Philadelphia area, found herself in a cycle of exhaustion and confusion. She often skipped her weightlifting routine and would drop her daughter off at school before heading back to bed. Her body ached, she struggled to sleep, and her brain felt foggy. Despite not feeling depressed, her doctor prescribed an antidepressant. She even sought therapy, but it wasn’t until a decade later that she received the correct diagnosis: perimenopause.

McDonald’s experience is not uncommon. Many women going through menopause or perimenopause are prescribed antidepressants like Zoloft, Prozac, or Wellbutrin, even though these medications may not address the root cause of their symptoms. According to recent studies, more than a third of women experiencing menopause or perimenopause are prescribed these drugs, with usage doubling during these years. However, many health experts now argue that the majority of these women never needed antidepressants in the first place.

The Role of Hormone Therapy in Menopause Treatment

Perimenopause, the transitional phase leading up to menopause, is marked by fluctuating hormone levels, which can cause a range of symptoms including anxiety, fatigue, and brain fog. These symptoms are often misinterpreted as signs of depression, leading to the prescription of antidepressants instead of addressing the hormonal imbalance directly.

Hormone therapy, particularly estrogen, is considered the most effective treatment for managing menopause symptoms. Yet, medical schools have historically provided limited training on menopause, contributing to a lack of understanding among healthcare providers. This gap in education has led to delayed or incorrect diagnoses, leaving many women without proper care.

A recent push by doctors and researchers on a Food and Drug Administration (FDA) panel aimed to update warnings about topical estrogen treatments. Currently, these medications carry warnings about potential breast cancer risks and their use in preventing cardiovascular disease or dementia. However, proponents argue that these warnings are outdated and may be deterring women from seeking necessary treatment.

The Impact of Misinformation and Medical Training

The Women’s Health Initiative (WHI) study from 2002 linked hormone therapy to increased risks of breast cancer, heart attacks, and strokes. However, subsequent research has shown that these risks were primarily associated with older women starting hormone therapy after menopause. As a result, the use of hormone therapy dropped significantly over the years.

Despite this, the North American Menopause Society still recommends hormone therapy as the first-line treatment for menopause symptoms. Experts emphasize that hormone therapy should be considered early, especially for women experiencing severe symptoms such as brain fog, mood changes, and hot flashes.

Changing Perspectives on Menopause Care

As more Gen X and older millennial women enter menopause, they are advocating for better treatment options. They are no longer willing to endure the same challenges their mothers faced. Menopause has also become a significant area of focus in healthcare, with over 40% of U.S. women in some stage of menopause or perimenopause. For many, this period can last one-third of their lives, making it a critical health concern.

Experts like Dr. Heidi Flagg, an OB-GYN and menopause specialist, stress the importance of educating both clinicians and patients about the role of hormones in menopause. “We are doing women a disservice by not talking to them about a natural hormone that will improve their mood and sexual function,” she says.

What Women Can Do

Until more healthcare providers receive proper training, women must take an active role in their health. Experts recommend finding a provider who specializes in menopause or perimenopause, as certified by organizations like The Menopause Society. Early intervention is crucial, as many women begin experiencing perimenopause in their 30s.

Educating oneself about menopause and its symptoms is also essential. Pairing medication with lifestyle changes such as nutrition and exercise can help alleviate symptoms. Sharing experiences with other women and discussing concerns with healthcare providers can lead to more accurate diagnoses and effective treatment plans.

A Call for Better Healthcare Education

With the growing awareness of menopause as a significant health issue, there is a push for better education and policy changes. Three states have already passed menopause-related laws, and more are considering similar legislation. The Menopause Society has launched a $10 million training program to equip over 25,000 healthcare workers with the knowledge needed to treat menopause effectively.

For women like Leslie Ann McDonald, the journey to finding the right treatment was long and challenging. But her story highlights the importance of self-advocacy and the need for a shift in how menopause is understood and treated in the medical community.