During a recent panel discussion hosted by the Food and Drug Administration (FDA), obstetrician Dr. JoAnn Pinkerton voiced her strong objections to the current warning labels on hormone replacement therapy (HRT). Her direct appeal was clear: "Please stop harming women." Dr. Pinkerton contends that the FDA's black box warning labels on hormone replacement therapies deter women from utilizing medications that can significantly alleviate the symptoms of menopause.
Dr. Pinkerton was among a group of 12 medical professionals, predominantly experts in obstetrics and women's health, who urged the FDA to consider the removal of these warning labels specifically for low-dose estrogen treatments. These medications are commonly prescribed to help manage symptoms associated with menopause or perimenopause. Unlike traditional systemic hormone therapy, which is absorbed throughout the body, low-dose estrogen is delivered locally through methods such as creams or rings.
The black box warning is the most severe safety label that the FDA can apply to prescription drugs. According to Dr. Pinkerton and her colleagues, the warning for low-dose estrogen treatment is unnecessary and not backed by scientific evidence. The medication is often used to combat symptoms like frequent urinary tract infections, vaginal dryness, and pain during sexual intercourse. Dr. Pinkerton emphasizes that the current boxed warning overstates the risks associated with low-dose estrogen treatments.
The perspective on the safety of hormone therapy for menopause has evolved significantly over recent decades. In 2002, the Women's Health Initiative, a major study on women's health, was partly halted due to concerns linking hormone therapy with increased risks of cancer and stroke, particularly breast cancer. However, ongoing research has since shown that the perceived cancer risks may have been exaggerated, leading to a reevaluation of when and how hormone therapy should be prescribed.
Many proponents of women's health have long advocated for a change in the narrative surrounding hormone therapy. Recent studies indicate that the cancer risks associated with certain hormone treatments are relatively low and that the benefits for menopausal women are substantial. Dr. Marty Makary, the current FDA commissioner and a surgeon—not an obstetrician—expressed his concern during the panel, stating that over 50 million women have been denied the potential health benefits of hormone replacement therapy due to outdated medical dogma.
Numerous obstetricians and gynecologists have voiced their support for removing the black box warning on low-dose vaginal estrogen treatments, citing a lower risk of cancer. Dr. Monica Christmas, an OB-GYN and associate medical director for The Menopause Society, humorously noted the slow pace of government processes in addressing this issue. While she advocates for the removal of warnings for low-dose estrogen, she expressed caution regarding systemic estrogen treatments, which carry different cancer risk profiles.
Dr. Christmas remarked, "For the vast majority of people, the risk is low, even for systemic hormone therapy, but it's not zero." She acknowledged that the black box warning could facilitate important discussions between doctors and patients about the risks and benefits of such medications. The panel's focus primarily revolved around low-dose estrogen, although Makary hinted at the potential for removing warnings for systemic therapies as well, citing studies suggesting benefits such as reduced risk of osteoporosis.
The FDA panel's approach has raised questions regarding its adherence to traditional scientific evaluation processes. Adriane Fugh-Berman, a pharmacology professor at Georgetown University, criticized the panel's structure, arguing it lacked the rigorous evaluation typically seen in FDA decision-making. She advocated for a more comprehensive public input period and the inclusion of a diverse range of experts, including epidemiologists and oncologists, in the discussions.
Despite the unconventional nature of the panel, some obstetricians found value in the heightened attention to the topic. Dr. Rachel Rubin, a urologist specializing in sexual medicine and a panel member, expressed her optimism. She acknowledged that while the FDA's process was less rigorous than usual, the discussion on hormone therapy and menopause was long overdue. "The fact that the head of the FDA wants to be talking about this topic is extraordinary," she stated.
While the panel has generated excitement within the medical community about the potential for change in hormone therapy policies, Dr. Monica Christmas cautioned against allowing enthusiasm to overshadow the essential risk-benefit analyses that patients and physicians must conduct when considering hormone treatments. "Hormone therapy has become synonymous with menopause," she pointed out, emphasizing the importance of thorough evaluations before initiating treatment.
