Doctor To The Stars Is Disciplined Over Use Of Controversial Menopause Therapy
In a variation on our usual Insurance column, this month we present a recent news story, followed by two commentaries: one by regular Insurance columnist Dr. John Rush, and one by physician Dr. Jill Stocker.
Barbara Feder Ostrov
Sept. 12, 2018 (Los Angeles Times) — A Santa Monica doctor who touted a controversial menopause therapy on the Oprah Winfrey Network and received testimonials for her work from such celebrity patients as model Cindy Crawford and actress-author Suzanne Somers has been disciplined by California’s medical board for gross negligence.
In a settlement approved last month, the Medical Board of California put Dr. Prudence Hall on probation for four years, faulting her for being “unaware” of potential risks posed by the plant-based hormones — including cancer — and 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 “incorrect diagnosis in a manner such that [Hall] stood to gain financially.”
“My jaw was on the floor. This is just egregious,” said 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 statement issued by Hall’s publicist Monday did not address the specifics of the board’s findings but generally defended the doctor’s results and commitment to patients.
“Dr. Hall continues to devote her career and life to helping patients achieve optimal health and wellness,” the statement said. “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 statement added that Hall “joins respected physicians worldwide who are also using” this type of hormone therapy.
The hormone therapies prescribed by Hall are supposedly customized to individual patients’ needs and are generally not approved by the Food and Drug Administration. They are known as “bioidentical” because their molecular structure is the same as the natural hormones found in a woman’s body, including estrogen and progesterone.
Hall has said she has treated more than 40,000 patients with them for more than 30 years. Under the terms of her settlement with the board, she is no longer allowed to promote herself as a specialist in hormone therapy, 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 female celebrities, these made-to-order hormones are used by up to 2.5 million women in the United States, according to one study.
Representatives for Crawford and Somers declined to comment.
Hall has been hailed by supporters as a “pioneer” in this type of personalized bioidentical hormone therapy, appearing on national television and infomercials, and promoting such treatments as a virtual fountain of youth.
“It’s not about age; it’s about how healthy your hormones are,” Hall told 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 offers an appealing message to women entering their 50s and 60s who are looking for “natural” relief from hot flashes, night sweats, loss of libido, aging skin or other concerns.
The hormone treatments she provides are “like water to a plant,” Hall told Somers on an episode of Somers’ television 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 surgery at Wayne State University School of Medicine and a longtime critic of unproven alternative medicine, rejected Hall’s analogy.
“I’m not a gardener by any stretch of the imagination,” he said, “but even I know that too much water can kill a plant.”
Many other clinicians and researchers say there’s no evidence to back up the claims by Hall and other doctors that customized treatments are more effective or safer or that they act any differently in the body than FDA-approved hormone replacement therapies.
Some bioidentical hormones, unlike the ones primarily used by Hall, are FDA-approved. They are manufactured in pharmaceutical plants using standard formulas and have been shown to relieve menopausal symptoms — though they have not been tested in large, long-term trials — 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 not tested for safety and efficacy, according to Harvard Women’s Health Watch and other reports.
“There’s a definite concern that for some women they may be dangerous,” said 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.”
Women flocked to bioidentical hormone treatment after the Women’s Health Initiative, a massive federally funded study on a widely used 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. She also prescribed iodine and two adrenal hormone supplements. The patient started to bleed — a potential warning sign of uterine cancer — but Hall prescribed her more hormones, according to the medical board.
Ultimately, the patient developed a cancerous mass in her uterus — 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 the two cases for which Hall was disciplined — which occurred from 2011 to 2015 — the medical board found that she 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 diagnosed the patient with hypothyroidism when no clinical evidence supported such a diagnosis — and that later aberrations that surfaced in lab testing had actually been caused by the physician’s treatment.
Hall presented herself to patients as a specialist in “hormone balance” or “endocrinology” but does not have any post-medical school training by an accredited fellowship in either medical or reproductive endocrinology, according to the board.
It’s not the first time California’s 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’ probation after charging him with negligence and incompetence for his treatments of several patients. Platt, author of “The Miracle of Bio-identical Hormones,” later was forced to surrender his license.
Experts say such doctors take advantage of patients’ 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,” said 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.”
Barbara Feder Ostrov is a senior correspondent for Kaiser Health News, an editorially independent publication of the Kaiser Family Foundation. Sheila Cosgrove Baylis of People magazine contributed to this report.
Commentary by John J. Rush, M.D., FACEP, MBA, MHA
As many age management medicine physicians, I read with great interest the accompanying article about Dr. Prudence Hall. From purely an insurance perspective, and without commenting on the merits of the specific cases mentioned in the article, it certainly emphasizes the need for physicians to carry medical liability insurance that protects them in Board of Medicine inquiries. Specifically, physicians should look for language in their medical malpractice policy that states the insurance company will defend them in a formal licensing or professional conduct review by a state agency in an administrative regulatory proceeding.
Insurance companies have experience with the board of medicine procedures and can hire attorneys and bring in expert witnesses to refute allegations made against physicians. Without this protection, physicians can be easily overwhelmed by the financial requirements needed in a prolonged conflict with a State Board of Medicine. Many State Boards of Medicine show obvious bias toward/against various types of practices. That bias can also extend to physicians in the media or with high profiles. It is up to the insurance company to educate boards that are often made up of retired physicians who have not necessarily kept pace with the latest evidence based medical literature/practices.
Additionally, basic risk management should be top-of-mind for AMM Physicians. We need to immediately and fully investigate any abnormal lab values and/or signs/symptoms. Document your investigation thoroughly. If that investigation still leaves questions, refer patients to the appropriate specialist.
While Dr. Hall’s situation may not have ended differently, keeping these points in mind will help all AMM Physicians mitigate or obtain a far more satisfactory outcome.
John J. Rush, M.D., is Chairman & CEO, Longevity Physicians Insurance Company. Dr. Rush attained his medical degree from Northeastern Ohio Universities College of Medicine. He went on to complete an emergency medicine residency at Loma Linda University. Dr. Rush also graduated from Pfeiffer University, completing an executive MBA/MHA program. He has completed physician training & certification in Age Management Medicine, jointly sponsored by The Cenegenics Education and Research Foundation (CERF) and the Foundation for Care Management (FCM). Dr. Rush has been practicing Age Management Medicine since 2009 and founded Longevity Physicians Insurance Company specifically for the practicing age management physician. Call 860.466.5307, or go to www.LongevityPhysiciansInsurance.com for an application. Email firstname.lastname@example.org.
Longevity Physicians Insurance Company was created because traditional medical malpractice insurance companies simply don’t understand Age Management Medicine. Typical medical malpractice rates offered to AMM physicians are based upon family practice/internal medicine rates. Age Management Medicine physicians see less patients, do less procedures, and rarely attend patients in a hospital setting. So why do AMM physicians pay malpractice insurance companies for risks that don’t exist? According to a recent survey, AMM physicians are paying average malpractice insurance rates of between $10,000 and $14,000/year, depending upon the state in which they practice. In addition, LPIC has found that many carriers do not specifically cover hormone replacement therapy in the policy. LPIC premiums are about half of typical malpractice rates.
Additional commentary by Jill E. Stocker, D.O.
The recent tirade in the LA Times, with Dr. Prudence Hall’s name as the prime target, is yet another media attempt to sensationalize misinformation and terrify women. It perpetuates what so many women are told at their traditional family doctor or OB/GYN’s office when they see and feel hormonal decline….it’s “in their head”(which is far from the truth), and that we should be treating women as numbers and not living, breathing, feeling human beings.
The reality is, there are numerous studies showing the safety and efficacy of BioIdentical Hormones, with regard to not just the person’s quality of life, how they look/feel/function, but also reducing several age related diseases such as heart disease, diabetes, and yes, cancer. The media doesn’t like to print these, they prefer scare tactics to perpetuate old medicine.
While the article references Bioidentical hormones not being FDA approved, it doesn’t explain that something occurring in nature cannot be patented, therefore, there is no big pharma money to force the issue of getting Bioidentical hormones FDA approved. This does NOT, however, mean that there are no long term studies about them and their safety. There is a plethora! I often tell my patients “More is not always better”, stressing the importance of using efficacious doses and monitoring by a properly trained physician skilled in Bioidentical hormones. This is the education patients, and physicians, need.
The oath we take as physicians is to “do no harm”. By keeping safe and effective Bioidentical hormones from patients because most physicians are operating off of old information, we would be doing harm. We, as Age Management/ Hormonal Optimization physicians have a duty to educate the misinformed…doctors and patients alike, so that new medicine can come to the forefront, providing improved quality of life and reduction of age related disease, and overall improved longevity. The goal in life is to not just survive, but to thrive.
Dr. Jill Stocker is a practicing physician at The Body Well in West Hollywood, CA, and an AMMG member. Dr. Stocker was named a Top Doctor of 2018 by Los Angeles Magazine. She may be reached at email@example.com.