Recent Article Comparing Conventional and Bioidentical Hormones

I often get requests from doctors and patients for links to recent studies about bioidentical hormone replacement therapy.

This recent article in the latest issue of the International Journal of Pharmaceutical Compounding is a nice summary of the research to date on this topic.  The study summarizes and compares randomized, controlled trials in human females (published between 1995 and 2010) looking at conventional and bioidentical hormone replacement therapy and their impact on cardiovascular and breast cancer risks.

The authors conclude that conventional hormone replacement therapy (the use of conjugated estrogens and medroxyprogesterone) is detrimental to cardiovascular and breast health, while the use of bioidentical estrogen improves some markers of cardiovascular health but may induce breast epithelial proliferation if administered without progesterone.  For a link to the ten page article, click here.

It’s important to keep key questions in mind when reading an article such as this one about hormone replacement therapy, such as: What hormones are being studied? and, What disease end points are being looked at?

For a full list of questions to ask when reading articles and studies about this topic, see Koshland Pharm’s website that gives an overview of bioidentical hormones.  Also remember that when making decisions about your own health, it is always important to talk with a knowledgeable practitioner about the research and its implications for your treatment approach.  Thanks for reading,

Peter

Overview of Bioidentical Hormone Replacement Therapy

I am happy to announce Koshland Pharm’s updated webpage devoted to bioidentical hormone replacement therapy.  The goal of this webpage is to summarize many of the discussions  and posts from this blog into a concise format.  It addresses the commonly asked questions:

• What is bioidentical hormone replacement therapy?
• When is bioidentical hormone replacement therapy used?
• How does a person know if she or he could benefit from bioidentical hormone replacement therapy?
• What are the hormones that are most often used in bioidentical hormone replacement therapy?
• How is bioidentical hormone replacement therapy administered?
• What makes bioidentical hormone replacement therapy controversial?
• What is Koshland Pharm’s approach to bioidentical hormone replacement?

Koshland Pharm’s webpage also provides useful, downloadable checklists that can help anyone take charge of their own health.  These include our comprehensive list of hormone imbalance symptoms and our checklist for healthy living.  Check them out!

Take care,

Peter

Hormones and Fear Back in the News

Mainstream reporting of hormone replacement therapy has been mostly quiet for the last couple of years until this last week when a new analysis of the Woman’s Health Initiative came out with more concerning news about the safety of the hormone replacement drug Prempro.  For more information about the Woman’s Health Initiative, see my earlier blog post: Brief History of Women’s Hormone Replacement.

The recent report in the October 20, 2010 issue of the Journal of the American Medical Association (JAMA – click here for link) discusses follow-up findings eight years after the halt of the 2002 clinical trial.  The study reported the following findings:

• increased risk of breast cancer in patients taking Prempro (385 vs. 295 on placebo)
• women with breast cancer who had taken Prempro had cancers in more advanced stages
• more women died who had taken Prempro (25 vs. 12 on placebo) 

These findings are not surprising to those of us familiar with the research looking at the safety of certain hormone replacement therapies like Prempro. 

What is surprising is that the mainstream media and medical establishment have jumped to the same broad-based conclusions about these results that they did when the initial results of the Women’s Health Initiative were published in 2002 (see this NY Times article for an example). 

After years of trying to help people understand the difference between synthetic/equine-derived hormones like Prempro and human hormones like estradiol and progesterone, I am disheartened that the discourse still lumps all hormones into the same category and declares that “hormones are dangerous” and that “women should only use hormones for the shortest period of time possible.”   This recent report undeniably deliniates  the risks of taking Prempro, but cannot possibly speak to other types of hormone replacement therapy since it did not study those hormones. 

The unfortunate concequence of this broad-brush type analysis is that it will undoubtedly scare many women away from safe, effective hormone therapies that may truly benefit them and help them to have a better quality of life during their peri-menopausal years and beyond.  For a practitioner like myself who has concluded that there are safe, effective hormone replacement options for women, occurrences like this just remind me that there is still more work to do.  To fully understand this topic we need to be much more sophisticated in our understanding of hormones and how they work in the human body.  Taking a pill and following-up in six months is not going to achieve the results we want and maybe that, ultimately, is part of the problem.  Ultimately, each woman is going to need a treatment that is tailored to her unique physiology. 

Live well.

Thyroid Madness? Apparently so.

Those of us in the pharmacy world have certainly noticed the sporadic availability of Armour Thyroid and Nature-throid, but to those who rely on this form of thyroid supplementation (derived from desiccated porcine thyroid gland), the shortage is nothing less than a threat to their very well-being.

Hypothyroidism is a very common endocrine problem, affecting approximately 11 million people worldwide, and twice as many women as men. Symptoms of hypothyroidism include low energy, fatigue, cold in the extremities and constipation. For a comprehensive symptom checklist for hormone imbalance go to www.koshlandpharm.com/documents/Comprehensive-Symptom-List.pdf As a compounding pharmacist, the thyroid issue has been the number one concern expressed by my patients. I am glad to report that at my pharmacy we have been able to make high-quality desiccated porcine thyroid capsules with great success (patient feedback has been very positive). The thyroid powder has to be mixed with an inactive ingredient in order to properly fill the capsule and ensure that each capsule has the proper amount of active ingredient. We are able to use different inactive ingredients in addition to the standard microcrystalline cellulose (Avicel). These include acidophilus powder, and ginger root powder which have their own therapeutic benefits.

There are a couple of good discussion boards and blogs about the thyroid, namely www.thyroid.about.com and www.stopthethyroidmadness.com. Both of these sites do a good job of expressing the importance of proper thyroid testing and supplementation and hope to answer some of the questions about the current controversy surrounding Armour Thyroid and Nature-throid. Although I don’t have any answers to explain the thyroid shortage, it may be partly due to the FDA’s recent tightening of its definition of Thyroid USP, the active ingredient in these products.

As an experienced compounding pharmacist, I figure it is time to put my own two cents out there on this subject. The standard of care for hypothyroidism taught by the medical schools (and pharmacy schools) is to start a patient with levothyroxine or T4 (aka Synthroid, Levoxyl, etc.). For many patients, this is an effective treatment, but it assumes that the patient efficiently converts the levothyroxine to liothyroinine (T3), the active form of the hormone. Levothyroxine also provides no additional constituents to support the healthy functioning of the thyroid gland itself. For patients who do not respond well to levothyroxine, desiccated porcine thyroid is a viable option, and many patients do significantly better on this supplement rather than levothyroxine. One explanation as to why some patients respond better is that it contains T3 and T4 roughly in physiological doses. It also has many of other byproducts of the thyroid gland that may support healthy thyroid functioning, like T1, T2, iodine, calcitonin, and other glandular fragments. This kind of treatment harkens back to the earlier part of the 20th Century when glandulars were often used to treat many ailments, often with great success. The rise of the pharmaceutical industry in the 1950s and the marketing of single pharmacologic agents greatly diminished the use of many glandular treatments.

For patients worried about obtaining the desiccated porcine thyroid, the good news is that compounding pharmacies have been able to fill in the gap left by the manufacturers of Armour Thyroid and Nature-throid. It is important to choose a compounding pharmacy that is using a high quality form of the Thyorid USP. The FDA states that for Thyroid powder to be considered USP grade (or pharmaceutical grade), it must have between 90 and 110% of the allowed amount amount of T3 and T4. This is a very wide potency range and could potentially account for therapeutic differences between two thyroid products that are labeled as the same strength. For information about selecting a high-quality, professional compounding pharmacy see my blog post, How to evaluate a compounding pharmacy.

I also want to mention another compounded thyroid product that may be useful for some patients and has been largely been left out of the current thyroid discussion. This is a compounded capsule that has the thyroid hormones T3 and T4 in a sustained-release form. This product is similar to the off-the-shelf products like Synthroid (T4) and Cytomel (T3) with 2 distinct advantages. The first is that the T3 and T4 can be combined into a single dose and customized to a strength that perfectly suites a patient’s needs. The second advantage is that by making these capsules sustained-release, the hormones are absorbed more steadily minimizing the potential of having any low thyroid symptoms hours after taking the tablets. Since the thyroid gland produces both T3 and T4 in a steady release, this product more closely mimics natural thyroid production.

The thyroid controversy is undoubtedly going to continue for the foreseeable future. Patients educating themselves about this issue are in a good position to advocate for their health and demand relief from hypothyroid symptoms, especially if their current medications are not meeting their needs. At Koshland Pharm: Custom Compounding Pharmacy, we want to be a resource for patients and providers, as well, helping facilitate optimal health and well-being of our patients. Don’t hesitate to call us at the pharmacy if you have any questions (415-344-0600).

Live well.

Compounding Pharmacies Rule!

I wonder why Ascend Therapeutics, the maker of a prescription estrogen gel,  has been trying to scare doctors away from compounding pharmacies with misleading information.  It couldn’t be because compounding pharmacies produce a superior, customized product that is in direct competition with thier mass produced one, could it?   I ran across this interview with a compounding pharmacist in San Diego who nicely sets the record straight… go to http://www.menopausetheblog.com/2009/08/18/are-compounded-hormone-products-safe-a-pharmacist-responds/.

Live well!

Rebuttal to Newsweek

I have been remiss in writing my blog postings, but I have a good excuse.  My second daughter was born last Saturday, and I’m finally coming out of the fog.

This posting is just to provide a link to what I believe to be an excellent rebuttal to Newsweek’s nasty and misleading article about Oprah and bioidentical hormones.  Check it out at http://www.opednews.com/articles/ Newsweek-and-Oprah-A-Come-by-Jeffrey-Dach-090615-697.html.

The pharmaceutical industry may have found ways for Newsweek, and various medical organizations to propagate their self-serving talking points, but I believe the truth has a way of resonating beyond the falsehoods if we keep speaking the truth. 

What we really need is an honest debate based on the scientific evidence.  If Newsweek was willing to do that, we would have seen a much different article.

Live well!

Responding to Newsweek: Holy Moly

Well, those out there who follow the bioidentical hormone debate on the web and in the media cannot have missed the cover story article in this week’s Newsweek slamming Oprah for touting the benefits of bioidentical hormones with its most visible poster child, Suzanne Sommers.

Wow, I don’t even know where to begin.  It’s amazing the amount of vitriol and personal condemnation that can come out of the mainstream press and its blogging followers when it put its sights on someone.  In my opinion, it’s important to keep the debate about bioidentical hormones focused on the scientific evidence with the intention of improving the quality of women’s lives who are suffering from symptoms of hormone imbalance.  It seems there is no room for that level of discourse in the frame that Newsweek has put this issue.  In fact, the article seems so determined to snidely dismiss Ms. Sommers and Oprah, that it missed the even bigger story right under this tempest in a teapot, namely there are still thousands of women out there suffering and the medical establishment is unresponsive at best and obstructionist at worst.

I really appreciate the insight of Dr. Erika Schwartz (a doctor who recently gave a lecture at Harvard about bioidentical hormones) in her press release:

“I asked the chairman of the department of ob-gyn, Isaac Schiff, MD and the rest of the physicians in the audience, ‘How come Suzanne Somers and Oprah are the ones to teach the public about bioidentical hormones? What has the medical profession done with the information of the Women’s Health Initiative study? Nine years later and women are still suffering and the medical establishment has not stepped up to the plate to help women find safe solutions to menopausal symptoms. Why are bioidentical hormones still controversial?’ They had no answers.

“Oprah did. She did what no conventional media or conventional medicine has done. She has stepped up to the plate. She has given the public the missing information. Instead of indoctrinating us with the party line, Oprah has opened the door to other options. And the public has spoken. Oprah is their leader, not the American Medical Association.”

Amen to that, sister.  The bottom line is that bioidentical hormones work, and the scientific evidence for their use over conventional hormone replacement therapy is quite compelling.

Ultimately this issue will die down, and Newsweek as well as other media outlets will set their sights on the next vililan-du-jour.  In the meantime let’s keep our sights on a higher level of discourse with the goal of allowing everyone to live a good, long life, well-lived (shout out to Elephant Pharmacy).

Thank you and live well!

Answering the Critics Again: Salon.com

It seems like the mainstream media is starting to sound like a broken record when it comes to bioidentical hormone replacement (BHTR).  It’s amazing that various, supposedly independent media outlets come up with the exact same points when it comes to BHRT, often using the exact same language.  Hmmm, go figure.

The latest article comes from Salon.com (http://www.salon.com/env/vital_signs/2009/05/15/oprah_winfrey_health/).  This article, written by a Dr. Rahul Parikh, critizes the Oprah show on BHRT that featured Suzanne Summers.  He cites many of the criticims we’ve seen before with some added personal attacks for spice.  Let me refute some of the claims he makes in his article:

Dr. Parikh states that there are “no good medical studies to back up those claims [that BHRT is safer and more effective than conventional hormone replacement].  This is absolutely false.  There are lots of studies looking at the safety and efficacy of bioidentical hormones and there are many good studies that compare bioidentical hormones with non-bioidentical hormones (especially progesterone vs. medroxyprogesterone).  Furthermore, many of the bioidentical hormones are available as FDA approved off the shelf products.

Next, Dr. Parikh states that, “the word ‘bioidentical’ has no medical meaning.”  Again, I scratch my head on this one.  “Bioidentical” means that the hormones given are chemically and biologically identical to human hormones.  That seems pretty meaningful to me.

Next, Dr Parikh states that, “bioidentical hormones… come from non-FDA regulated compound [sic] pharmacies, where drugs are not  subject to the same quality standards as those made by pharmaceutical companies.”  When did FDA approval become the arbiter of quality products in the marketplace?  Compounding pharmacies still must adhere to the standards of the United States Pharmacopeia (USP), the same standards the FDA uses to regulate the drug companies.  There are many compounding pharmacies out there that make products that exceed these standards and have excellent quality assurance procedures in place.  For help in selecting an appropriate compounding pharmacy, please see my blog post,  How to Evaluate a Compounding Pharmacy.

If all this sounds familiar, you’re right.  I’ve answered these same criticisms in many earlier postings that I have listed in the category, “Answering the Critics.” 

Where do these criticisms come from?  Well, the originate from the drug companies, whose products directly compete with bioidentical hormone replacement.  Then they are disseminated to the medical establishment as “expert opinions” through organizations, like the American College of Obstetricians and Gynecologists (ACOG), that accept funding from those same drug companies.  It’s actually an ingenious system of influencing our medical system to maximize profits of the drug companies, but when it starts preventing women from obtaining potentially life-improving treatments, a dark side emerges.”

For  many women, it seems sometimes that the biggest obstacle to obtaining bioidentical  hormones (or at least learning balanced information about them) are medical doctors (like Dr. Parikh) who often seem intent on sticking to these highly biased talking points, instead of using their knowledge of physiology and anatomy to truly address the needs of their patients.  This is where women must demand that their doctors take their inquiries about BHRT seriously or risk losing a patient.  That, in my opinion, is the only way things will change.

If you have any comments or questions, please post them.

Thank you and live well!

Newsweek Lets the “Experts” Chime-in on Oprah’s Bioidentical Show

Well, I guess it’s not surprising that with Oprah’s show presenting the potential benefits of bioidentical hormones to a large audience, the mainstream media had to come back and reassert their opposition to this therapy with the same misleading data they have been giving women for decades. 

This time it was Newsweek posting an online article entitled “Uh O.” (http://www.newsweek.com/id/183842/page/1).  With that title, it’s pretty obvious which side of the debate its authors are coming down on.  And their arguments are pretty much the same boiler plate misinformation we’ve heard from the FDA and ACOG many times before.  Although I disagree with much of what is written in the article, I just wanted to comment on a few pieces that deserve a brisk rebuttal.

First the authors state that,

“the bulk of scientific research on the subject suggests that prolonged use of these [bioidentical] hormones is associated with an increased risk of serious health conditions including cancer and heart disease.” 

This is a very misleading statement.  The data that demonstrates an increased risk of serious health conditions shows that the synthetic and equine derived hormones are the ones that have this problem.  No study has ever demonstrated these same long-term adverse effects with bioidentical hormones.

Second, the article quotes a Dr. Nanette Santoro who states, “there is no medical reason to use progesterone after a hysterectomy.”  She goes on to say that supplementation with estrogen and progesterone could further increase the risk of a breast cancer occurrence. 

Both of these points are simply not true.  First of all, giving progesterone supplemention only to women who have never had a hysterectomy is one of the greatest errors in all of women’s medicine.  In my previous post, The Power of Progesterone, I discuss all of the beneficial aspects of progesterone on the entire body.  Progesterone helps regulate sleep, mood, bone health, cardiovascular health, and ultimately balances the activity of circulating estrogens.  Every study I have ever read shows that balancing estrogens with the proper dose of progesterone has no adverse effects on breast cancer rates and may even have beneficial effects.  Maybe Dr. Santoro is thinking of the synthetic medroxyprogesterone, which certainly could increase breast cancer risk, but not knowing the difference between progesterone and medroxyprogesterone clearly challenges the implication of her as an expert in her field.

Finally, the article states,

“Somers and Winfrey both say they take bio-identical hormones.  But they brushed over the fact that ‘bioidentical’ is simply a marketing term not a scientific one.  It is used to sell plant-based drugs approved by the FDA as well as unregulated drugs prepared in compounding pharmacies.  Like all supplemental hormones, both types are synthetics, even though the name implies they are more natural.”

How is “bioidentical” a marketing term and not a scientific one?  The term simply means that the hormones given are biologically, chemically, and structurally identical to human hormones.  That seems pretty scientific to me.  And how does the name imply a more natural therapy, unless natural means that we are giving human hormones?  Premerin (conjugated equine estrogens) used to say on their bottle, “derived from natural sources” even though those sources were horses.  I doubt the Newsweek authors were writing articles decrying the misleading marketing of a mass-produced pharmaceutical.

I’m disappointed but not surprised to see Newsweek publishing an article highlighting the pharmaceutical industry’s talking points.  I guess it just means that there is more work to be done to educate women about better alternatives.

Please post any comments or questions you might have.

Thank you and live well!

Answering the Critics Who Say: “Compounded Medications are Not FDA Approved”

The assertion that compounded medications should not be used because they are not FDA approved is misleading.  The FDA has never regulated the practice of pharmacy; that job is left up to the individual states.  The FDA regulates the manufacturing and marketing of mass produced pharmaceuticals that are sold on the open marketplace.

Compounded medications do not fall under this category.  They are only made in response to an individual prescription for a single patient.  The guidelines for the proper preparation of a compounded medication is set forth by the United States Pharmacopia (USP).  In some cases the USP and the FDA have similar requirements – i.e. both the FDA and the USP require that a drug strength be with in 10% of the labeled strength.  For me, I think 10% is way too high.  I strive to be within 2% of the labeled strength on all my compounded medications.

Now, it is true that the FDA will periodically inspect a drug manufacturer to make sure that they are following the required procedures, which is something the states tend not to do with compounding pharmacies.  Therefore, it is important to make sure you are using a pharmacy that is using the best equipment, has sound procedures, and tests their products on a regular basis.  See my earlier post How to Evaluate a Compounding Pharmacy for more detailed information on selecting the right pharmacy for you.  I would ask to see a pharmacy’s certificates of analysis showing that they are constantly within the 10% (or better yet 2%) allowable range for purity.  One nice thing about working with a pharmacist that you trust is that you can actually talk to them about their procedures and look at their certificates of analysis.  This is nearly impossible with a drug manufacturer.

One other aspect of the FDA’s approval process for mass produced drugs is that new drugs must prove their safety and efficacy.  Compounded medications do not have to do this, but they do need to back-up their use with scientific data.  Furthermore, most compounded medications are available in a similar FDA approved form.  Take for example bioidentical hormones.  There are FDA approved topical and oral forms of progesterone, estradiol, and testosterone.  The safety and efficacy data used for the approval of these mass-produced products can generally be extrapolated to apply to compounded medications as a customized, “off-label” use.

The FDA does have some impact on the practice of compounding pharmacy.  They control the supply stream for bulk chemicals used in compounding.  If they decide that a particular chemical is dangerous or threatens the public health, the have the power to take it off the market, making it unavailable to be made into a compounded formulation.

Finally, realizing that there are legitimate concerns about the quality of compounded medications, the Pharmacy Compounding Accreditation Board (PCAB)was created to set up strict requirements for the processes and quality assurance of making compounds.  PCAB is new, so many excellent compounding pharmacies are still in the process of being accredited, but in the next couple of years, accreditation by this board will be an important consideration when choosing a compounding pharmacy.

The bottom line is that compounding pharmacies have an important role in creating customized medications that could not be found otherwise.  I have seen many examples of the powerful effect compounding medications can have on the quality of people’s lives.  Just make sure that the pharmacy you use is committed to making the highest quality product possible.

Thank you and live well!