A Santa Monica doctor who touted a controversial menopause therapy on the Oprah Winfrey聽Network and聽received testimonials for her work from聽such celebrity patients as model Cindy Crawford and actress-author Suzanne Somers has been disciplined by California鈥檚 medical board for gross negligence.
In 聽approved late last month, the Medical Board of California put Dr. Prudence Hall on probation for four years, faulting her for being 鈥渦naware鈥 of potential risks posed by the plant-based hormones聽鈥 including cancer聽鈥斅燼nd failing to monitor her patients properly.
Hall used numerous hormones to treat two women, according to the board, missing an aggressive uterine cancer in one patient and treating the other based on an 鈥渋ncorrect diagnosis in a manner such that [Hall] stood to gain financially.鈥
鈥淢y jaw was on the floor. This is just egregious,鈥 said Dr. Jen Gunter, a San Francisco Bay Area OB-GYN who reviewed the medical board鈥檚 report. 鈥淵ou 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.鈥
A statement issued by Hall鈥檚 publicist Monday did not address the specifics of the board鈥檚 findings but generally defended the doctor鈥檚 results and commitment to patients.
鈥淒r. Hall continues to devote her career and life to helping patients achieve optimal health and wellness,鈥 the statement said.
鈥淪he 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.鈥
The statement added that Hall 鈥渏oins respected physicians worldwide who are also using鈥 this type of hormone therapy.
The hormone therapies聽prescribed by Hall are supposedly customized to individual patients鈥 needs and are generally not approved by the Food and Drug Administration. They are known as 鈥渂ioidentical鈥 because their molecular structure聽is 聽as the natural hormones found in a woman鈥檚 body, including estrogen and progesterone.
Hall has claimed to have聽treated patients with them over 30 years. Under the聽terms of her settlement with the board, she is no longer allowed to promote herself as a specialist in hormone therapy,聽an OB-GYN or an endocrinologist, and she must submit her medical practice to oversight by an outside physician who will report to the board. She is allowed to continue treating women for menopause management and other health issues.
Her case stands as a possible warning to many other physicians and providers who have embraced such unproven hormone treatments. Popularized by testimonials from celebrity women, these made-to-order hormones are used by up to 2.5 million women in the United States, according to one .
Representatives for 聽and Somers said they chose not to comment at this time.
Hall has been hailed by supporters as a 鈥減ioneer鈥 in this type of personalized bioidentical hormone therapy, appearing on national television and infomercials and promoting such treatments as a virtual fountain of youth.
鈥淚t鈥檚 not about age; it鈥檚 about how healthy your hormones are,鈥 Hall told Sarah Ferguson, the Duchess of York, in聽聽on the Oprah Winfrey Network in 2011.听鈥淚t鈥檚 new to think we don鈥檛 have to grow old and grow ill.鈥
In her appearances, Hall offers an appealing message to women entering their 50s and 60s who are looking for 鈥渘atural鈥 relief from hot flashes, night sweats, loss of libido, aging skin or other concerns.
The hormone treatments she provides are 鈥渓ike water to a plant,鈥 Hall聽聽on an episode of Somers鈥 television program, 鈥淭he Suzanne Show.鈥 鈥淗ow could water be bad for a plant? 鈥 Hormones do not cause cancer.鈥
Dr. David Gorski, a聽surgical oncologist, professor of surgery at Wayne State University School of Medicine and a longtime critic of unproven alternative medicine, rejected Hall鈥檚 analogy. 鈥淚鈥檓 not a gardener by any stretch of the imagination,鈥 he said, 鈥渂ut even I know that too much water can kill a plant.鈥
Many other clinicians and researchers say there鈥檚聽 to back up the claims by Hall and other doctors that these customized treatments are聽more effective or safer or聽that they act any differently in the body than聽FDA-approved hormone replacement聽therapies.
Some bioidentical hormones, unlike the ones primarily used by Hall, are聽FDA-approved. They are manufactured in pharmaceutical plants using standard formulas and聽have been shown聽to relieve 聽鈥 though they have not been tested in large, long-term trials 鈥 according to a report in Harvard Women's Health Watch.
The customized therapies used by Hall and other doctors are mixed in compounding pharmacies and generally are for safety and efficacy,聽according to Harvard Women's Health Watch and .
Compounded bioidenticals are big business. In 2013, U.S. sales of these products were estimated in at $845 million, compared with a $3.7 billion market for traditional, FDA-approved hormone replacement medications.
鈥淭here鈥檚 a definite concern that for some women they may be dangerous,鈥 said Dr. Janet Pregler, director of the Iris Cantor-UCLA Women鈥檚 Health Center. 鈥淥ften these [hormones] are presented as risk-free, when we as physicians know that nothing you put in your body is risk-free.鈥
Women flocked to bioidentical hormone treatment after the Women鈥檚 Health Initiative, a massive federally funded study on a widely used聽hormone replacement therapy for menopausal women, was halted prematurely in 2002 over concerns about an elevated risk of breast cancer, heart disease and stroke.
Hall, according to medical board investigators, put a patient with a family history of uterine cancer on a regimen of bioidentical hormones after the woman complained of "zero libido" and menstrual migraines.听She also prescribed iodine and two adrenal hormone supplements. The patient started to bleed 鈥 a potential warning sign of uterine cancer 鈥 but Hall prescribed her more hormones, according to the medical board.
Ultimately, the patient developed a cancerous mass in her uterus 鈥 but board investigators alleged that Hall failed to detect it, after performing ultrasounds on the patient that she was not certified to analyze. She charged the patient $7,000 over three years for the treatment, according to the board.
In聽the two聽cases for which she was disciplined 鈥斅爓hich occurred between 2011 and 2015 鈥 the medical board found that Hall treated women who were not yet in menopause but whom she incorrectly diagnosed as being in perimenopause. Those are the years immediately before menopause that can create uncomfortable symptoms such as hot flashes and low libido. Their lab tests showed hormone values within normal limits, the board said.
The second patient had numerous other conditions including diabetes and a history of psychiatric disorders, according to the board. The board said Hall聽diagnosed the patient with hypothyroidism when no clinical evidence聽supported such a diagnosis 鈥 and that later aberrations that surfaced in lab testing had actually been caused by the physician's treatment.
Hall聽presented herself to patients as a specialist in "hormone balance," or聽endocrinology," but does not have any post-medical school training聽by an聽accredited fellowship in either medical聽or reproductive endocrinology, according to聽the聽board.
It鈥檚 not the first time California鈥檚 medical board has disciplined a doctor for prescribing such bioidentical hormones. In 2009, the board put Dr. Michael Platt of Rancho Mirage on five years鈥 probation after charging him with negligence and incompetence for his treatments of several patients.听The doctor, author of 鈥淭he Miracle of Bio-identical Hormones," later was forced to surrender his license.
Experts say such doctors take advantage of patients' vulnerability as they age.
鈥淲e all fear getting older and loss of sexuality, and the way society makes women feel, women are more vulnerable to it, for sure,鈥 said Gunter, the Bay Area OB-GYN. 鈥淚 don鈥檛 blame the patients for going to the doctor and putting trust in them. I blame the doctors for saying this can somehow help them.鈥
Sheila Cosgrove Baylis of People magazine contributed to this report.
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