A Santa Monica physician who touted a controversial menopause remedy on the Oprah Winfrey Network and acquired testimonials for her work from such celeb sufferers as mannequin Cindy Crawford and actress-author Suzanne Somers has been disciplined by California’s medical board for gross negligence.
In a settlement authorized late final month, the Medical Board of California put Dr. Prudence Hall on probation for 4 years, faulting her for being “unaware” of potential dangers posed by the plant-based hormones — together with most cancers — and failing to observe her sufferers correctly.
Hall used quite a few hormones to deal with two ladies, in response to the board, lacking an aggressive uterine most cancers in a single affected person and treating the opposite primarily based on an “incorrect diagnosis in a manner such that [Hall] stood to gain financially.”
“My jaw was on the floor. This is just egregious,” stated Dr. Jen Gunter, a San Francisco Bay Area OB-GYN who reviewed the medical board’s report. “You hear about all these self-described functional medicine doctors providing these treatments. Never in my wildest dreams did I think it would be in this ballpark.”
A press release issued by Hall’s publicist Monday didn’t handle the specifics of the board’s findings however usually defended the physician’s outcomes and dedication to sufferers.
“Dr. Hall continues to devote her career and life to helping patients achieve optimal health and wellness,” the assertion stated.
“She utilizes advances in modern medicine plus proven natural therapies. Safely incorporating results of the latest medical research has allowed her to achieve exceptional results for her patients.”
The assertion added that Hall “joins respected physicians worldwide who are also using” this kind of hormone remedy.
The hormone therapies prescribed by Hall are supposedly personalized to particular person sufferers’ wants and are usually not authorized by the Food and Drug Administration. They are referred to as “bioidentical” as a result of their molecular construction is the same because the pure hormones present in a girl’s physique, together with estrogen and progesterone.
Hall has claimed to have handled more than 40,000 sufferers with them over 30 years. Under the phrases of her settlement with the board, she is now not allowed to advertise herself as a specialist in hormone remedy, an OB-GYN or an endocrinologist, and she or he should submit her medical observe to oversight by an outdoor doctor who will report back to the board. She is allowed to proceed treating ladies for menopause administration and different well being points.
Her case stands as a doable warning to many different physicians and suppliers who’ve embraced such unproven hormone remedies. Popularized by testimonials from celeb ladies, these made-to-order hormones are utilized by as much as 2.5 million ladies within the United States, in response to one study.
Representatives for Crawford and Somers stated they selected to not remark right now.
Hall has been hailed by supporters as a “pioneer” in this kind of customized bioidentical hormone remedy, showing on nationwide tv and infomercials and selling such remedies as a digital fountain of youth.
“It’s not about age; it’s about how healthy your hormones are,” Hall instructed Sarah Ferguson, the Duchess of York, in a conversation on the Oprah Winfrey Network in 2011. “It’s new to think we don’t have to grow old and grow ill.”
In her appearances, Hall provides an interesting message to ladies getting into their 50s and 60s who’re on the lookout for “natural” aid from scorching flashes, night time sweats, lack of libido, getting old pores and skin or different issues.
The hormone remedies she supplies are “like water to a plant,” Hall told Somers on an episode of Somers’ tv program, “The Suzanne Show.” “How could water be bad for a plant? … Hormones do not cause cancer.”
Dr. David Gorski, a surgical oncologist, professor of surgical procedure at Wayne State University School of Medicine and a longtime critic of unproven various medication, rejected Hall’s analogy. “I’m not a gardener by any stretch of the imagination,” he stated, “but even I know that too much water can kill a plant.”
Many different clinicians and researchers say there’s no evidence to again up the claims by Hall and different docs that these personalized remedies are simpler or safer or that they act any in a different way within the physique than FDA-approved hormone substitute therapies.
Some bioidentical hormones, not like those primarily utilized by Hall, are FDA-approved. They are manufactured in pharmaceutical crops utilizing commonplace formulation and have been proven to alleviate menopausal symptoms — although they haven’t been examined in giant, long-term trials — in response to a report in Harvard Women’s Health Watch.
The personalized therapies utilized by Hall and different docs are blended in compounding pharmacies and customarily are not tested for security and efficacy, in response to Harvard Women’s Health Watch and other reports.
Compounded bioidenticals are massive enterprise. In 2013, U.S. gross sales of those merchandise had been estimated in one study at $845 million, in contrast with a $three.7 billion marketplace for conventional, FDA-approved hormone substitute drugs.
“There’s a definite concern that for some women they may be dangerous,” stated Dr. Janet Pregler, director of the Iris Cantor-UCLA Women’s Health Center. “Often these [hormones] are presented as risk-free, when we as physicians know that nothing you put in your body is risk-free.”
Subscribe to KHN’s free Morning Briefing.
Women flocked to bioidentical hormone therapy after the Women’s Health Initiative, a large federally funded examine on a broadly used hormone substitute remedy for menopausal ladies, was halted prematurely in 2002 over issues about an elevated threat of breast most cancers, coronary heart illness and stroke.
Hall, in response to medical board investigators, put a affected person with a household historical past of uterine most cancers on a routine of bioidentical hormones after the girl complained of “zero libido” and menstrual migraines. She additionally prescribed iodine and two adrenal hormone dietary supplements. The affected person began to bleed — a possible warning signal of uterine most cancers — however Hall prescribed her extra hormones, in response to the medical board.
Ultimately, the affected person developed a cancerous mass in her uterus — however board investigators alleged that Hall didn’t detect it, after performing ultrasounds on the affected person that she was not licensed to research. She charged the affected person $7,000 over three years for the therapy, in response to the board.
In the 2 instances for which she was disciplined — which occurred between 2011 and 2015 — the medical board discovered that Hall handled ladies who weren’t but in menopause however whom she incorrectly identified as being in perimenopause. Those are the years instantly earlier than menopause that may create uncomfortable signs reminiscent of scorching flashes and low libido. Their lab exams confirmed hormone values inside regular limits, the board stated.
The second affected person had quite a few different circumstances together with diabetes and a historical past of psychiatric issues, in response to the board. The board stated Hall identified the affected person with hypothyroidism when no medical proof supported such a prognosis — and that later aberrations that surfaced in lab testing had truly been brought on by the doctor’s therapy.
Hall offered herself to sufferers as a specialist in “hormone balance,” or endocrinology,” however doesn’t have any post-medical college coaching by an accredited fellowship in both medical or reproductive endocrinology, in response to the board.
It’s not the primary time California’s medical board has disciplined a health care provider for prescribing such bioidentical hormones. In 2009, the board put Dr. Michael Platt of Rancho Mirage on 5 years’ probation after charging him with negligence and incompetence for his remedies of a number of sufferers. The physician, creator of “The Miracle of Bio-identical Hormones,” later was compelled to give up his license.
Experts say such docs reap the benefits of sufferers’ vulnerability as they age.
“We all fear getting older and loss of sexuality, and the way society makes women feel, women are more vulnerable to it, for sure,” stated Gunter, the Bay Area OB-GYN. “I don’t blame the patients for going to the doctor and putting trust in them. I blame the doctors for saying this can somehow help them.”
Sheila Cosgrove Baylis of People journal contributed to this report.
Barbara Feder Ostrov: email@example.com”>firstname.lastname@example.org, @barbfederostrov