Fairly Short Answer: Maybe, but for sure, it should cause BHRT docs to learn from the case and re-examine their protocols and systems in treating, following-up and referring-out patients for diagnostics.
Bioidentical Hormone Replacement Therapy (BHRT) is a huge business now. It was invented by Jonathan Wright back in the late 1970’s, but it only took off after Suzanne Somers wrote her trilogy of books about it around twenty years ago. Since that time, Ms. Somers has become the poster girl for why women should be on BHRT. This is a G rated blog, so I’ll spare you the details of the many ways she claims that BHRT has helped her, but let’s just say that she’s an effective poster girl.
Ok, I can’t resist, here is a cartoon I found about BHRT. Not sure how it applies to this post, but I like it and it’s an good take-off of one of the all-time great movie lines (from “When Harry Met Sally”).
Now to business:
At the end of August, BHRT doctor Prudence Hall entered into a stipulated settlement with the Medical Board of California which put her on probation and included another term which might cause her continuing problems.
Here is the stipulation, attached to which is the Accusation (Cali. board term for board complaint)
Hall, based in Santa Monica, has some celebrity patients and has been interviewed as Suzanne’s BHRT doctor in a few of Suzanne’s books, so Hall is apparently, (somewhat perjoritively) considered to be the hormone doc “to the stars.” As a result, Hall’s board sanction was widely reported in the press. Here is the LA Times story about her sanction.
Hall’s press agent responded to the LA Times article. Judge for yourself how effective the response was.
A few words about the sanction, then some comments about the Accusation, and what California BHRT physicians should learn from the case.
When a medical board thinks a physician mistreated one or more patients over a period of time, it automatically charges the doctor with gross negligence and repeated acts of negligence (and sometimes incompetence, for good measure). There’s also almost always a charge for bad record keeping. That’s what the board did in this case (save for incompetence).
Hall’s case involved two patients, and there was significant harm alleged in one, namely, delay in the diagnosis of cancer.
Unless you’re very lucky or very good, (and I’m happy to report that I’ve been at least one of those), the minimum settlement terms the board will agree to is a lengthy probation period (technically, license revocation, stayed pending a probation period, usually 3-5 years), a practice monitor, and extra CME courses.
If the board has concerns that the doctor might not possess sufficient knowledge or skills to practice safely within the standard of care, it will also require that the physician submit to an extensive skills evaluation program by the UC San Diego PACE program.
The rub is that the PACE skill evaluation condition in a settlement also includes a provision that the doctor will abide by PACE’s recommendations. Sometimes PACE recommends practice limitations/exclusions during the term of probation, or even more, like skill enhancement prior to resumption of practice.
Lawyers who don’t routinely represent CAM/integrative physicians tell their physician clients that the PACE evaluation is no big deal. And it isn’t, if the physician is boarded in the area he/she practices, is CME current in the standard of care in the field, generally practices in accordance with the standard of care of the specialty, and just made some errors of judgment or missed a diagnosis which led to the sanction.
But it’s different with CAM/integrative physicians because they don’t follow the standard of care, and often don’t even know the details of standard of care because it’s not how they practice. I’ve seen CAM docs prohibited from areas of practice which they think they know based on a PACE finding of lack of competence, stemming from their inability to acknowledge or follow the standard of care. But that’s largely unknown to lawyers unfamiliar with CAM/integrative physicians, because it’s not a problem which their standard of care physician clients normally have.
Dr. Hall’s settlement contains the aforedescribed PACE term, and so her skills and knowledge about hormone replacement therapy will be evaluated, and PACE will decide whether she can continue with her Bioidentical Hormone approach to female complaints. My advice to her is take the evaluation seriously, maybe even prepare some, and take a different tone than what is evidenced in her PR response mentioned above. If she doesn’t, she may find herself limited to writing scripts for Premarin and Prempro, if that.
I won’t go through the Accusation in detail but I will point out the highlights in the two patient cases, both of which involve BHRT
1. The board thinks that BHRT is unproven and can cause uterine cancer, perhaps especially in patients having a family history of it.
My comment: The patient was diagnosed with uterine cancer after several years of BHRT given by Hall. There is no way to prove causation in an individual case like this, but in light of Hall’s alleged diagnostic failures, the board was going to come down hard on her for giving it and letting the cancer develop undetected under her (regrettably) limited watch.
2. The board didn’t agree with Hall’s determination that the patient was perimenopausal.
3. The board didn’t appreciate her diagnosing the patient with low thyroid and low D3 at the initial visit, prior to lab work.
My comment: It’s very common for CAM docs to make a preliminary diagnosis of low thyroid based on symptoms alone, and do an empiric trial of thyroid replacement. Bad luck that it happened in a patient who developed uterine cancer after several years of BHRT with inadequate follow-up and some apparent bad decisionmaking.
4. The board was unhappy that the patient received hormone therapy (estrogen, Progesterone, DHEA, Pregneolone, Testosterone) as well as D3, thyroid replacement and iodine despite normal lab values. (Gulp!)
My comment: This is of course disturbing since this kind of presentation and therapy recommendation is common in the BHRT crowd.
5. The board was critical of Hall for an office pelvic ultrasound and her interpreting it without having any post medical school training.
My comment: That’s disturbing since it’s a common practice among BHRT physicians who specialize in women’s problems.
6. The board faulted Hall for not ordered an endometrial sampling (uterine biopsy) after prolonged bleeding, and for not even requiring the patient to come in for an office visit, and was in general disturbed by Hall’s lack of appropriate follow-up of increasingly alarming symptoms consistent with uterine cancer (in part my interpretation).
My comment: This is the big deal and the reason for the heavy sanction. I think the board felt that Hall didn’t understand one of the most fundamental rules in this kind of case. If you can’t establish an alternative source of bleeding, the presumption is that it is some kind of uterine cancer. The first priority is to rule out uterine cancer which is normally and definitively done by sampling. Reliance on an in-office pelvic ultrasound, interpreted in-house by someone without advanced training is not enough.
7. The board was very critical of her use of hormones which resulted in “supratherapeutic levels.”
8. The Board was unhappy about the fact that despite all the hormone therapy, changes to the therapy, and reporting of symptoms over a three year period, there were only 3 office visits over a three year period.
My comment: that seems too few to me, given all the changes to the therapy and the increasing symptoms.
There was much less discussion of the second patient, MS. The board’s main issues were:
1. Diagnosing the patient with hypothyroidism without clinical evidence, and then prescribing thyroid which caused supratherapeutic levels without giving proper informed consent or doing a thyroid exam. According to Hall, part of the rationale for the thyroid therapy was weight loss.
2. Lack of coordination of care with other health care practitioners, including the patient’s psychiatrist, which the board didn’t like, since the patient had some suicidal tendencies, and there was no consideration of what effect the thyroid meds would have on her psychiatric drugs.
3. Like in the other case, the board didn’t agree with Hall’s determination that the patient was perimenopausal.
4. And as in the other case, the board didn’t like all the hormones without documented findings of clinical deficits.
5. The board didn’t like the fact that Hall did a “baseline” pelvic ultrasound prior to initiation of BHRT, because the patients didn’t have any symptoms. The board called that negligence.
My comment: I think the board is wrong. At worse, it’s reasonable defensive medicine, and it contradicts or is at odds with the board’s position in the other case. It seems to me that if there is a possibility that BHRT (or any hormone replacement therapy) might cause or contribute to uterine cancer, why not do a baseline ultrasound? If there’s an abnormal thickening, that might be relevant information or more likely, a contraindication.
6. The patient was under Hall’s care for about a year and received a lot of BHRT, thyroid and other medications. After going to Scripps weight management and an endocrinologist, most of Hall’s medication recommendations were terminated or dramatically cut back (thyroid), indicating that Hall’s treatment recommendations were inappropriate or no longer needed.
Finally, the Board didn’t like the fact that Hall called herself an endocrine specialist even though she wasn’t boarded in endocrinology.
So what are the lessons from this settlement?
1. At a minimum, I think every California BHRT doc should read the Accusation, at least to know what the board thinks about some of the things you folks are doing.
2. I think it’s clear that the first patient filed a complaint (and/or sued) because of a failure to diagnosis her uterine cancer over a three year, three visit period. Better follow-up and appropriate, timely diagnostic procedures might have avoided the complaint, or if not, would have lessened the need for the PACE skills reevaluation.
a. So the specific lesson to be learned is what you folks should already know: Unexplained (or abnormally longer than expected bleeding, or even questionable bleeding) requires further work-up, because the presumption is that it’s cancer, and cancer must be ruled out.
b. The definitive and gold-standard diagnostic test is a sampling. Abdominal pelvic ultrasound is not a substitute because it’s not sufficiently evidence based. (Ok you can’t get that from the Accusation, but this is my opinion)
c. Even transvaginal ultrasound done and interpreted in-house by someone without advanced training does not appear to be acceptable according to the board’s position in this case.
Admittedly the Accusation contains some alarming comments by the Board about BHRT. However, in the end, the main complainant was alleged to have received bad medical care and follow-up which resulted in a substantial delay in the diagnosis of a serious and life threatening cancer. Based on apparently inadequate follow-up and testing, I think a complaint would have been filed and warranted even if the doctor was conventional and the therapy was Premarin. So despite the Board’s general negative comments about BHRT, the reality is if you’re vigilant in your follow-up and attuned to changes, chances are you won’t be faced with this kind of problem.
The second case shows what happens when conventional practitioners look at how a BHRT doctor works. That’s alittle troubling, because many BHRT doctors might have treated the patient the same way, or maybe not. Take a look at the facts in the Accusation and you tell me. However, I don’t think the hypothyroid diagnosis and thyroid prescription would have justified a PACE skills evaluation. I think the first case was the driving force behind that.
But for what it’s worth, I sometimes get the sense that some BHRT docs have too much blind faith in BHRT and don’t sufficiently appreciate issues brought forth by their patients, because of the aforementioned faith in the treatment. And for those folks, my therapeutic recommendation is increased skepticism and more vigilance in following their patients.
Rick Jaffe, Esq.