I am a practicing pain management physician. Several of my patients have been placed on bioidentical hormones by a local gynecologists. The patients seem to be doing well. My understanding is that there is little to no cancer risk with bioidentical hormones versus synthetic hormones. There is only one gynecologist out of 7 in my community who prescribes these medications. The others are not interested. Is there some reason that more gynecologists do not prescribe these? I am just curious because it seems that they would be more beneficial then premarin, provera, etc which is what we used when I was in medical school.
Bioidentical Hormones
- Thread starter mille125
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Because it's marketing and no science.
Exactly, there is no science behind bioidentical hormones. They generally are compounded in a pharmacy with not FDA oversight in-terms of quantity of active ingredients. Also, there is no reason to believe they don't have the same potential side effects. If they affect receptors to the point where symptoms improve then why wouldn't they have the same side effects as pharmaceutical grade HRT? The patients are doing well because HRT works, the question is how much of the risk are you willing to accept. To advertise bioidentical hormones as risk free is disingenuous in my opinion.
Its all marketing. ACOG has a short (1.5 page) committee opinion on the matter. I attached it if you are interested.
Its all marketing. ACOG has a short (1.5 page) committee opinion on the matter. I attached it if you are interested.
Interesting article
I definitely agree with the saliva testing statement. There is no reason to gauge a drug's effect based on salivary testing when blood testing is available. Some of the other points are speculative.
1) It is amazing how some of us get on a soapbox about FDA approval. Dopamine is not FDA approved for administration in children. Gabapentin is not FDA approved for neuropathic pain. As physicians we likely use drugs off label more than we do on label. Therefore in my opinion the FDA approval comments are moot.
2) Concerning evidence, there is very strong evidence the progestin (not progesterone) in bad. Provera has been shown to cause breast cancer in the WHI trial. I dont think that anyone will dispute this. Why then does the FDA leave Provera on the market but bans estriol. I guess its science right? There is no evidence that progesterone causes cancer. Prometrium is available but is not orally absorbed well.
3) Why such a paucity of studies? The answer is Big pharma. There is no need to perform these studies because big pharma cannot patent these products and thus cannot make any money.
We need to use our brains sometimes and not continue to be slaves of big pharma (this is my point). We need to protect our patients by being unbiased sources of evidence. Too often, whether we know it or not, we are just a mouthpiece for big pharma. I still have colleagues who say without a shadow of a doubt that "they are not swayed by Big Pharma". If you really believe that then I have some land for your in Florida.
I definitely agree with the saliva testing statement. There is no reason to gauge a drug's effect based on salivary testing when blood testing is available. Some of the other points are speculative.
1) It is amazing how some of us get on a soapbox about FDA approval. Dopamine is not FDA approved for administration in children. Gabapentin is not FDA approved for neuropathic pain. As physicians we likely use drugs off label more than we do on label. Therefore in my opinion the FDA approval comments are moot.
2) Concerning evidence, there is very strong evidence the progestin (not progesterone) in bad. Provera has been shown to cause breast cancer in the WHI trial. I dont think that anyone will dispute this. Why then does the FDA leave Provera on the market but bans estriol. I guess its science right? There is no evidence that progesterone causes cancer. Prometrium is available but is not orally absorbed well.
3) Why such a paucity of studies? The answer is Big pharma. There is no need to perform these studies because big pharma cannot patent these products and thus cannot make any money.
We need to use our brains sometimes and not continue to be slaves of big pharma (this is my point). We need to protect our patients by being unbiased sources of evidence. Too often, whether we know it or not, we are just a mouthpiece for big pharma. I still have colleagues who say without a shadow of a doubt that "they are not swayed by Big Pharma". If you really believe that then I have some land for your in Florida.
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Because they arent the same. Provera is medroxyprogesterone which is molecularly and biologically different from progesterone. Premarin contains a horse estrogen (not identical). As far as risk, show me something that says that these compounds are harmful. How would your risk be greater by prescribing these versus premarin/provera (assuming that you are monitoring blood levels).
As far as articles check out JAMA Oct 6, 2004:1581 (premarin increases thrombosis and heart attacks while estriol does not)
Also JAMA Dec 6, 1995: 274(21),1676. (natural (micronized) progesterone when added to estrogen had a greater reduction of cholesterol and increase of HDL than estogen + provera)
No evidence right?
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Of course every specialty has off label uses of drugs. FDA approval of a drug is a whole different issue and as someone who leans libertarian I have a lot of issues with the FDA. I'm referring to quality control that allows us to know what is actually inside the medications we are buying. When you buy pharmaceutical grade medications you can be pretty confident that they have the quantity of active ingredient it says on the label. Compounding pharmacies have been analyzed for active ingredients and found to be inconsistent. (That being said, I give my wife a weekly injection of a medication from a compounding pharmacy - 17-OHP.)
There are many problems with the WHI trial but I don't think many gynecologists will dispute that progestins increase the risk of breast cancer. Its why we don't give it to women who have had a hysterectomy and we start HRT. I actually like to use a Mirena for endometrial protection in women getting HRT (not an FDA approved use).
As far as I know the FDA hasn't banned estriol.
I am still in my training and can't site every article that has been written about HRT.
For patients with insurance, premarin is not prescribed as frequently as it used to be. For the uninsured its a good option. Most of the transdermal estrogens that gynecologists are prescribing contains estradiol (the same stuff in birth control pills), the same hormone your ovaries make and the one that is biologically active. Estriol is an incredibly weak estrogen.
I never claimed that bioidentical hormones are more dangerous. Why do you assume that plant derived estrogens are bioidentical anyway? My understanding (correct me if I am wrong) is that bioidentical hormones end up being more expensive and we don't really know what is in them in terms of quantity and probably quality as well.
Also, when prescribing HRT we are treating symptoms so you don't typically need to monitor blood levels. We treat with the lowest effective dose for the shortest amount of time. Of course every patient is different and if you are not getting the response you expect checking levels can be warranted.
Do a little reading on this topic and you will be astonished that something like this could happen in the USA. I will give you a brief synopsis but I encourage you to read about it. It verifies what I have been saying about big pharma, in this case wyeth. Here is a sketch:
1) WHI study condemns premarin (made by Wyeth). Many women and physicians decide not to use drug. Company profits take a nose dive.
2) Wyeth decides to use its buddies at the FDA to ban estriol which competes with their synthetic products. FDA actually agrees to ban the usage of estriol even though they admit that there is not one report on any adverse effect. This is the first time that this has been done in history. They also pressure suppliers to the point the estriol becomes almost impossible to find anywhere in US. Of note the FDA does nothing to premarin which was actually the target of the WHI study.
3) Compounding pharmacies and physicians continue to prescribe and make estriol. FDA files petition to make dispense of estriol ILLEGAL. This is unprecedented. It is sitting in the Supreme Court and will likely be struck down. Still this shows you what Big Pharma can do.
Dont take my word for it. I encourage everyone reading this to look this up. You will be astonished...
