Bioidentical Hormone Therapy: An Interview with Peter Koshland, Pharm. D.

Peter Koshland, Pharm.D, is a graduate of the UCSF School

Peter Koshland, Pharm.D

of Pharmacy, where he is currently an Adjunct Professor of Clinical Pharmacy and a member of the Alumni Association’s Board of Directors. He is committed to the health and well-being of his patients through close collaboration with practitioners in the application of evidence-based medicine. In 2009, Peter opened Koshland Pharm: Custom Compounding Pharmacy, which became the first compounding pharmacy in San Francisco to be accredited by the Pharmacy Compounding Accreditation Board (PCAB). Koshland Pharm makes customized medications and specializes in bioidentical hormone replacement therapy, veterinary medications, and pain management. Learn more at www.koshlandpharm.com.

Can you briefly describe what bioidentical hormonal therapy (BHRT) is?

Bioidenticals are groups of plant-sourced compounded hormones that are modified in the lab to take on the exact chemical structure of our bodies’ hormones. The three main principles of BHRT are:

• We use hormones identical to human hormones. When we put them in the body, the body recognizes them as it would a hormone it made itself.
• We give people amounts that are in the range of what they would normally produce
• We want to balance all the hormones in your body with each other.

We would never want to automatically apply the same procedure to different patients. There are some for whom a tiny dose is more than enough, and others who need more. BHRT is individualized medicine.

Compounding is a great tool for hormone therapy because it is customized for the individual. When you get a compounded prescription, it’s made by that individual pharmacy specific to your body's needs.

To get the best outcomes, it is important for a compounding pharmacy to operate using a triad structure of communication between the physician, patient, and pharmacist. We are available to patients, and there’s an open line of communication between the compounding pharmacy and the prescribing physician. You don’t always put someone on the therapy and have perfect results immediately, in fact that almost never happens. Communication is a big part of it. With bioidenticals, you have a direct relationship with the person who’s formulating the therapy.

How often do you have patients coming to you for help with menopause symptoms? Can you describe any successes or failures that you’ve seen with patients coping with menopause symptoms?

Dozens and dozens of patients a day come to us for help with menopause symptoms. We often get feedback like, “It saved my life. It gave me my life back. It’s a miracle. I wish I’d known about this ten years ago.” We also hear when things don't go right, and that's an opportunity to discuss with the patient things we might be able to do to address their concerns.

Most patients are looking to hormone replacement to address immediate symptoms that they are experiencing, such as brain fog, hot flashes, and an overall decline in quality of life. But there are reasons to do it beyond just symptom management. If they’re worried about bone loss in the future, they may want to discuss this therapy with their physician. Estrogen replacement is very effective in preventing bone loss after menopause. Hormone replacement can be part of a strategy for healthy aging, as well as managing menopause.

Many women are skeptical about the safety of using any kind of hormonal therapy. How safe are bioidentical hormones?

There are certain things we are afraid of based on the Women’s Health Initiative reporting on hormone replacement therapy. The fear really grew out of proportion from the real risks involved. There may even be protective effects with estrogen, same with progesterone. If you look at the clinical trials for estriol vaginal cream in treating vaginal dryness, for example, we know it’s safe and effective. One part of the Women's Health Initiative used estrogen only for patients who had had hysterectomies and showed a lower incidence of breast cancer and cardiovascular disease. Women who had hormone replacement intervention earlier in menopause actually did even better than women with no intervention in outcomes like cardiovascular disease.

To read an article by a New York Times journalist who summarizes current research related to bioidentical hormones and relates the research to her own experience with menopause, you can read “The Estrogen Dilemma” by Cynthia Gorney. It is always important to discuss the research and its implications for your own particular treatment with your doctor.

There is some controversy about BHRT because of its variability and individual nature prevents it from being studied and regulated. The FDA is in the process of developing testing protocol for safety of bioidenticals. What do you think? Will this improve the field?

You’ve raised two important aspects to BHRT: the individualized nature of BHRT and the variability in BHRT hormone products, and how those two issues impact the ability to study and regulate BHRT.

On studying BHRT:

Although the individualized nature of BHRT does make it difficult to study on a large scale, components of BHRT treatment have actually already been studied. Two large clinical trials are currently underway in the U.S. They are the KEEPS study and the ELITE study, which are large-scale, double-blind, placebo-controlled trials – the gold standard when it comes to clinical trials. They are looking at the effects of estrogen therapy on the rate of atherosclerosis, or the hardening of the arteries. The results of these studies, which can be followed at www.clinicaltrials.gov, are very important to the BHRT field. When reading about trials that have looked at BHRT, it is important to keep key questions in mind, such as “what kind of hormone is being studied, and what disease or symptomatic end point is being looked at?”

On the variability of BHRT hormone products:

Because compounding pharmacies are regulated by individual state boards of pharmacy and not the FDA, it is true that the hormone products a woman gets from one pharmacy might not be of the same quality those from another pharmacy. I do think that the testing of BHRT hormones made at compounding pharmacies is key to ensuring their quality. A compounding pharmacy with the best quality procedures will have a systematic process of “skip lot testing”, where they send a percentage of their prescriptions out to be tested on a monthly basis to ensure that their compounded medications are within 10% of their labeled strength.

Given all of this information, what should patients look for in a pharmacy?

To address the overall issue of variability in the medications made at compounding pharmacies, a non-profit organization was founded in 2006 by leaders in the field of compounding pharmacies, including the National Association of State Boards of Pharmacy. This non-profit organization is called the Pharmacy Compounding Accreditation Board (PCAB) and has the mission of ensuring a high standard when it comes to pharmacy compounding. PCAB accredits compounding pharmacies only when they have met the highest standards of safety and quality in the profession, by implementing procedures such as skip lot testing. When looking for a compounding pharmacy, finding one with a PCAB accreditation will help give you a basic level of comfort that they’re doing things at a high standard. Also make sure that you can establish a good relationship with the pharmacy so they can be responsive to your needs as you refine your therapy.

Is there any dietary action one can take, either supplementation or elimination, that can improve the efficacy of this treatment? How about as a measure to prevent this treatment from becoming necessary?

Oftentimes menopause symptoms are a way to get people in the door about other types of lifestyle intervention – stress reduction, healthy diet, and thyroid health, for example.

Healthy diet is a huge piece of the overall picture. If a person has unhealthy eating habits, stress, or chronic disease, BHRT can only go so far. These issues are best addressed in collaboration with a knowledgeable practitioner. For an overall checklist for healthy living, check out www.koshlandpharm.com/bhrt.

Would you say that it’s fair to categorize BHRT as natural?

It depends on how you define natural. I categorize it as natural. We’re restoring balance. We’re not imposing a drug to supersede the activities of the body. We’re nudging it back into balance, and sometimes that’s all it takes. Sometimes, for whatever reason, we need to rebalance the endocrine system. During menopause, the ovaries stop producing hormones the way they used to. If someone is having terrible symptoms and they’re suffering, there’s no reason not to utilize it.

Aside from menopause, what are some common conditions that you use BHRT to treat?

We treat all hormone imbalance symptoms. For example, migraine headaches. One person had intractable migraine for two years, had been on every imaginable pharmaceutical. We put her on progesterone and her migraine went away the next day, she couldn’t believe it.

What about cost? Are bioidenticals covered by insurance?

It depends on the plan. Sometimes it’s completely covered, other plans don’t cover it at all. For estrogen therapy, we try to keep the price around what people would pay for copays, around $25 per month. Testosterone replacement for men tends to be more expensive because it requires higher doses. We hope for cost never to be a barrier to treatment.

Is there anything else you think women should know about bioidenticals?

It's important to find a pharmacy and a physician that you can really work with. The best outcomes happen when the patient is working with a pharmacist and doctor to address their overall health, including diet, lifestyle and hormones. There are safe and effective treatments available. Know that you don’t need to suffer through menopause. ¹

¹ Koshland, Peter, interviewed by Olivia M. Cerf, July 17, 2012.