The U.S. Food and Drug Administration’s (FDA) recent announcement for a significant update on estrogen-related medications for menopause exemplifies this. These opioid alternatives will soon no longer carry sweeping black-box warnings. Wellness Trust FDA Commissioner Marty Makary announced a surprising thing. Bubbles of opposition are forming as experts question whether this decision is backed by enough good science and whether it follows the FDA’s typical regulatory procedures.
On a press call earlier this month, new school dean of health policy and -drumroll please- public health, Dr. He cast his decision as a needed provocation to what he termed the “paternalism of medicine.” He focused on the positive impact of increasing access to hormone therapy, arguing that it “has preserved marriages” and is “life-changing—even life-saving.” This announcement was met with widespread criticism. It based its decision on a July panel that lacked oncologists and did not allow for public comment before the meeting.
This represents a big departure for the FDA in its enforcement strategy. For the first time, the agency is using a roundtable panel to steer its regulatory course. Despite the presence of researchers very experienced in menopause and physicians with extremely large social media followings, specialists in oncology were omitted. Critics have long contended that this politically-driven approach takes the scientific rigor out of the decision-making process at the FDA.
Lauren Streicher, a clinical professor of obstetrics and gynecology who attended the press conference, expressed her concerns about the process. She said she appreciated how the panel provided space for people to provide their own, personal opinions and concerns versus just relaying scientific information. As Streicher candidly reflected, “It dawned on me pretty quickly that this wasn’t going to be a scientific panel. This method is not empirical in nature. These are in fact two very separate problems that got conflated in all the discussions.
Yet Makary boldly asserted, with no evidence whatsoever, that this expanded access to hormone therapy will dramatically improve women’s health outcomes nationwide. Surprisingly, this announcement has generated a firestorm of criticism. He stated, “There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy.” So instead of the modest advance that it is, Makary boldly declares this a “medical breakthrough.” It strives to radically improve women’s liveability.
Makary’s claims are not universally accepted by experts. Pauline Maki, an NIH panel member, highlighted the risk of harm associated with hormone therapy. She stated, “Women are trying desperately to get the truth, and they’re having a really difficult time,” emphasizing the need for accurate information. Maki noted that while there may be risks involved, “the harm is maybe real, but certainly it’s not showing benefit.”
Streicher was critical of the former black-box warnings for being not only misleading but harmful. She stated, “The label was designed to frighten women and to silence doctors,” and expressed her belief that the warnings were “not only scientifically wrong but offensive.” She pressed that there’s no reason hormone therapy should have ever been stigmatized in this way. She sung the FDA’s praises, stating with certainty that “Those products are indeed completely safe.”
In light of these developments, Streicher emphasized her cautious approach regarding hormone therapy: “Do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.” This sentiment reflects a broader concern among healthcare professionals about ensuring that individualized patient care remains paramount in discussions surrounding menopause management.
The issue surrounding hormone affirmation therapy has been a contentious topic for decades. Studies have yielded inconsistent findings on its effectiveness and safety. FDA that hormone replacement therapy (HRT) reduces all-cause mortality and fracture risk if initiated within 10 years of menopause HHS Press Secretary. As some experts caution, we should not be throwing around blanket recommendations for its use.
“Randomized studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures.” – HHS spokesperson
This persistent controversy sheds light on the multifaceted nature of menopause management and the need for evidence-based practices in medical decision-making. As healthcare providers navigate these changes, they face the challenge of balancing patient needs with evolving guidelines from regulatory bodies.