Response To Media Reports on Bioidentical Hormones Causing Uterine Cancer.
Recently an article was reported in the Herald Sun by journalist Sue Dunlevy who claimed the rise in uterine cancer was due in part to compounded bioidentical hormones. The report was full of many inaccuracies obviously intended to incite emotion and alarm which seems to be the formula many journalists use to sell their story with reckless abandonment of the truth.
The report indicated that “compounding chemists are using women as human guinea pigs are to party to blame” for the rise in uterine cancer. This statement infers that there is no research on the safety of compounded bioidentical hormones and compounding chemists are acting irresponsibly. Often it is erroneously claimed by so called experts there is no research on the safety of bioidentical hormones. This may be the case if you burry your head in the sand but if you actually look you will see there is in fact lots of studies on its safety.
Of particular note in 2005 the Fournier E3N- European Prospective Investigation into Cancer and Nutrition (EPIC) cohort study published a 6 year trial in the International Journal of Cancer followed 54,548 postmenopausal women. Compared to women who had never used HRT, taking Bio-Identical Estriol alone produced a 30%reduced risk of breast cancer; using Bio-Identical Estradiol plus natural progesterone lead to a 10% decreased risk of breast cancer; while using estradiol alone had a 10% increased risk of breast cancer and worst of all, taking estradiol plus synthetic progestins caused a 40% increased risk of breast cancer.
(Source:Fournier et al, “Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort,” Int J Cancer 2005 Apr 10;114(3):448-54.)
In January 2008, with eight years of follow-up, data was released from E3N showing that women using synthetic HRT had a 60% higher risk of cancer, while women using Bio-Identical Hormones still had the same risk as women using no HRT of any kind.
(Source:Fournier et al, “Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study,” Breast Cancer Res Treat 2008 Jan;107(1):103-11.)
There is too much research to cover in this article so the author would refer you to an excellent review by Dr Holtorf which was published in peer reviewed Postgraduate Medicine (Vol 121, 2009) titled “The Bioidentical Hormone Debate: Are Bioidentical Hormones safer or more efficacious than commonly used synthetic versions in hormone replacement therapy”. The conclusion of this review was that “the medical literature supports the claim that bioidentical hormones have some distinctly different, often opposite, physiological effects to those of their synthetic counterparts. With respect to the risk for breast cancer, heart disease, heart attack and stroke, substantial scientific and medical evidence demonstrates that bioidentical hormones are safer and more efficacious form of HRT than commonly used synthetic versions”.
Now specifically related to risks of uterine cancer while on HRT the accepted cause is unopposed estrogen. It is commonly accepted if there is an inadequate amount of progesterone to counterbalance the effects of estrogen then uterine cancer can potentially develop and so some experts have questioned the ability of bioidentical progesterone to adequately protect women from uterine cancer when taking estrogen replacement. A review published in Climacteric 2016 (Vol 19, 4, 316-328) reviewed about 40 studies which delt with the impact of micronized bioidentical progesterone on the endometrium. Many studies measured endometrial thickness in addition to determining the incidence of endometrial cancer. For both oral and vaginally applied progesterone used in conjunction with an estrogen there was no change in endometrial thickness and NO increased risk of endometrial cancer. For progesterone creams five studies were identified and only one of these measured endometrial thickness which did show an increase with progesterone cream however this study was using a high 1mg dose of estradiol therefore the progesterone dose would have been inadequate. None of the 5 studies found any increased risk of endometrial cancer using progesterone cream in combination with estrogen.
Therefore the accusation that bioidentical hormones are in part responsible for the rise in uterine cancer does not correspond with the real research. The report in the Medical Journal of Australia (MJA) co written by Prof. Neville Hacker referred to in Sue’s article reported the case of three women whom developed endometrial cancer after taking compounded bioidentical HRT troches, one of which had previously been on traditional HRT for 8 years previous to the compounded HRT which some how seems irrelevant? Very little detail was provided about the other two patients stating the doses used were unknown. This critical detail was omitted which could uncover the reason why these two women developed endometrial cancer but more about this in a moment. The other point of interest is the primary author of this MJA article was John Eden who also happens to consult for Wyeth (Big Pharma) who is the largest supplier of pharmaceutical HRT in the world. Conflict of interest maybe?
Sue also goes on stating that a search of adverse events data base revealed 6 cases of adverse events were reported for progesterone over the years. With all due respect for those six women – only 6! I bet Big Pharma would pay off a number of politicians for such a safety track record. Do a similar search for pharmaceutical HRT and see how many cases there are. Approximately 50% of women who start on pharmaceutical HRT stop due to unbearable side effects. So for Sue to exaggerate that 6 cases is somehow a grave danger is irresponsible and lacks perspective.
Sue’s report also indicated that it is unclear if “sterility test checks are ever carried out” on compounded medicines. Bioidentical hormones are usually delivered by treansdermal or oral administration which does not require the product to be sterile as it is delivered to an unsterile area. Only injectable medicines are required to be sterile. Pharmaceutical companies are not required to ensure their tablets or capsules are sterile so why impose this inappropriate restriction on compounding pharmacies? Obviously Sue does not understand when sterility is appropriate.
The report then goes on to say “the corner chemist can make anything without testing”. The intention of this statement is to demean and reduce the value of compounding pharmacies and create the picture of the corner store producing medications. Many compounders such as ourselves have invested heavily in GMP grade facilities with multiple laboratories which could hardly be described as your “corner chemist”. We adhere to many regulations such as the Guidelines by the Pharmacy Board of Australia and USP (US Pharmacopoeia standards) to name only a couple. Not to mention the great value our many customers find in our service so our true value cannot be reduced by critics.
I am not suggesting that Bioidentical Hormones cannot cause uterine cancer if used incorrectly. Any form of hormone replacement can cause cancer if it is not dosed correctly and the appropriate balance of hormones is not achieved. It is all about balance when it comes to hormones! To offer protection ideally the ratio between progesterone to estradiol should be around 100-200:1. If this balance is not achieved then insufficient protection is achieved and risks increase. Therefore as I have been advocating for the last 20 years it is very important to monitor your hormone levels while on bioidentical hormones and adjust the doses accordingly to ensure the appropriate balance is achieved, not only between estrogen and progesterone but also between the three main estrogens. In addition because progesterone has a short half life and thus eliminated rapidly ideally it should be administered as a slow release capsule or transdermally (which acts like a slow release mechanism) to prolong its effects and thus maintain ongoing protection throughout the day. If troches are used they should be dosed multiple times a day to maintain sufficient progesterone levels.
The uterine cancer cases reported in MJA discussed above were using troches and may well have been due to an excessive dose of estrogen, inadequate dose of progesterone to counter the effects of the estrogen or only dosed once a day which does not provide ongoing protection throughout the day. This is why these details are so important and why the author cannot understand why these details were omitted from the MJA report. It is not right to blame the treatment – bioidentical hormones – if they are prescribed incorrectly or not being appropriately monitored. The author has compounded bioidentical hormones, mainly as creams, for 1000’s of women over the last 20 years and has not had a single reported case of uterine cancer in all that time. Please do not listen to the argument I have heard countless times over the years by so called experts who claim that creams do not absorb – this incorrect assumption is based on blood test results which the research shows is inaccurate due to red blood cell binding – details beyond the scope of this article. When either saliva or urine tests are used to monitor hormone levels applied by creams their levels are shown to increase within 2 hours of applying the cream – fact!
At least Sue had the decency to suggest other possible causes for the rise in uterine cancer such as obesity although it was only a very brief mention and she did not go into blaming the obesity on the food industry and our poor personal food choices and addiction to sugar and the underlying cause of this. Since her article other cut and paste so called journalists have copied her original article but decided that obesity was not worthy of a mention so decided to leave that part out and solely lay the blame on bioidentical hormones. This is why I do not read the news as it no longer contains any truth but someones own personal agenda to sell their story and get their 5 minutes of fame by inciting emotions and outrage on baseless claims. I urge the readers of this article to start discerning what your fed by the media as the majority at best is distorted biased semi-truths and more often down right lies.
See Sue that is how it is done – do your research and present the truth – not that hard even for a non journalist.