FDA warning about "bioidentical hormones"

[Lani]

http://ap.google.com/article/ALeqM5j...dcKHwD8U2JMUO1

[TSund]

On the other hand, there is also a lack of appropriate studies for the POSITIVE benefits of natural hormones, esp. progesterone. Sorry to be a cynic, but there is heavy corporation influence on the FDA. Studies on natural hormones got left in the dust when $$$$ started flashing for synthetic drugs. (always more profitable because you cannot patent natural formulas) My take is estrogen in any form should be limited save on a case basis. However, there seems to be evidence that points to natural progesterone having many positive effects including in some cases fighting the estrogen imbalance that can lead to cancers. Synthetic progesterones were deemed dangerous to pregnant women and fetus. However, the body literally swims in natural progesterone during pregnancies (and interesting to note that women who have had children have a lower instance of bc)

Any takes on John Lee's books?

[AlaskaAngel]

This may not be the best link about this issue, but it is one:

http://www.hormoneprofile.com/Librar...rmonealert.htm

This issue originated some time ago. Women who made the personal decision to use compounded forms of progesterone for various health problems were obtaining it through pharmacists, a number of whom felt that indeed there may be at least as much genuine logic for keeping the availability for women to make that choice rather than being limited to synthetic drugs provided by pharmaceutical companies. These pharmacists went to bat for women to have that kind of choice.

While it is important to protect consumers, the question arises as to what non-synthetic, or natural (sometimes referred to as bioidentical) substances may be next to be prohibited in favor of synthetic products made for profit by pharmaceutical companies, if it is so easy to limit access in this situation?

If research to document whether or not there is actually benefit to these substances is not done (and since they are not patentable they are not profitable), are we being prevented from finding better answers for helping us to stay healthy, or at the least, less toxic (and perhaps more affordable) answers?

AlaskaAngel

[AlaskaAngel]

This link explains the issue more clearly in terms of estriol:

http://news.morningstar.com/newsnet/...00871_univ.xml

[hutchibk]

Just to play a little devil's advocate here... I am not in such a hurry to cast such a cynical light over the FDA regarding this. In reading the article, the FDA is doing nothing more than telling the internet sites to stop marketing them as safe (which has not been proven) and to stop making unproven claims to sell them. They are not prohibiting anyone from selling them (unless, perhaps, they have the illegal ingredient in them). They are still available to anyone who seeks them out. Should one wish to seek them out, my opinion is that it would be wise to seek out a naturopathic doctor who is knowledgeable and reputable to prescribe and/or compound, administer, and monitor you, and one who knows how his product is manufactured and where it comes from. My opinion is that the FDA needs to create an arm of the administration to specifically oversee and monitor the supplements, vitamins and herbs that are sold by everyone from very reputable companies/doctors to multitudes of snake oil salesmen. Where and how and with what ingredients are these things being produced? Are they really what they say they are? Take last year's pet food fiasco for example. Ingredients sold to the pet food companies were not really what the Chinese companies said they were, they were either entirely the toxic plastic chemical melamine, or were cut/laced with melamine to extend the supply of the supposed ingredient in order to make more money from it. So, you see, there are greedy agendas on both ends of the spectrum. Most supplement or herb companies do not want you to know their manufacturing standards and processes, which nobody checks on thanks to very powerful supplement industry lobbyists, of which there are hundreds. It is a multi-million dollar, largely un-scrutinized industry. Personally, I would never buy a drug or supplement over the internet, not since a friend's young wife died two years ago from liver toxicity caused by 3 weeks of using chinese herbs she ordered on the internet to treat arthritis in her knee, and it was determined that not all ingredients were natural herbs. Just one girl's opinion.

[AlaskaAngel]

Yes, and thanks for doing a good job of explaining the FDA's position. That is why I posted the second link, because it did a better job of explaining the issue. We do need to be concerned about safety. But if there is no one to fund studies for natural products to determine whether or not some of the non-synthetic choices are as good, better, or worse we also end up primarily with extensively advertised combination synthetic hormonal products. Has that been proven to be better, as good, or worse?

A.A.

[hutchibk]

I would contend that there is money out there - and the multi-million dollar supplement/vitamin/'natural' herbs industry knows how to get access to it - to fund studies. But it would shed unwanted light on many of their practices, which I am certain is of huge concern to them. I use natural remedies, but with the consultation of a professional whom I trust. He has followed, scrutinized and been involved in much research... much info is out there and people are researching the safety on small scale, but unless the industry is scrutinized and regulated by the FDA or similar type of administration, I suspect it will remain largely self-aggrandizing and "tread at your own risk" territory.

[TSund]

Hi Brenda,

I agree with you on safety issues; however as was proven by the synthetic hormone debacle, "safety" has many dimensions. Pharmaceutical companies KNEW that bio-identical would be safer and better, but there was nothing to be gained financially by that fact.

[hutchibk]

Honestly, I don't have a dog in the fight about HRT or BHRT, I don't know for sure what anyone KNOWS about whether they are safe or safer, and granted, 'natural' always carries the assumption of being safer... but also know that as of late last year, the American Medical Assoc, The Endocrine Society, and The American Assoc of Clinical Endocrinologists all adopted policy asking the Food and Drug Administration to conduct surveys of compounded bioidenticals for purity and accuracy. They also called for mandatory adverse event reporting by the hormones' makers, including pharmacies, and a registry of these occurrences.

I am just filling in the other bits of info that I find important when doing my research and which sometimes don't seem to be as readily considered when discussing such things.

[AlaskaAngel]

No dogs here.


The thing is, what is the upshot of all this in terms of general women's health care? Some trusted individuals who do extensive research are able to recognize the truth about natural substances, but otherwise the result of standard of care criteria based on clinical trials is that for the vast majority of women the mainstream docs do not. How do we go about getting the research done?

[TSund]

Breast Cancer Drop
Tied To Less Hormone Use

ROB STEIN / Washington Post 19apr2007


<TABLE cellSpacing=0 cellPadding=20 width=225 align=right border=0><TBODY><TR><TD width="100%">Mindfully.org note:

Those who protest most loudly against the idea that Hormone Replacement Therapy (HRT) may cause breast cancer will most likely be those financially invested in HRT.

When we fool around with levels of hormones in our bodies we are only asking for problems. Doctors prescribing HRT can easily be likened to fooling around with your body because they do not know enough to be doing so.

And while it is understandable that some women prefer the risks involved with HRT in order to be able to regulate their bodies better, they must keep those risks in mind. From all that we've read about HRT, it definitely comes with a high level of risk.

Another way to upset the balance of hormones in ones body is by exposure to plastics, pesticides and other synthetic chemicals and products.

More about hormones . . .
<HR>Drop in Cases
A drop in breast cancer rates may be linked to reduced usage of hormone replacement therapy.

Breast cancer diagnoses per 100,000 women, by quarter

Prescriptions for hormone replacement therapy, in millions

Source: New England Journal of Medicine, The Washington Post
</TD></TR></TBODY></TABLE>
New federal statistics provide powerful evidence that the sharp drop in hormone use by menopausal women that began in 2002 caused a dramatic decline in breast cancer cases, according to an analysis being published today.
The statistics show that the number of breast cancer cases being diagnosed began falling abruptly after concerns emerged about the safety of hormone treatment and that the decrease persisted into the following year, strengthening the case that the trends are related, researchers said.
"At first I didn't believe it — it was so astounding," said Donald A. Berry of the University of Texas, who led the analysis published in the New England Journal of Medicine. "But it really looks like it's a story that holds together."
The researchers estimated from the findings that about 16,000 fewer cases of breast cancer are being diagnosed each year because of the decrease in hormone use, a stunning reversal of a decades-long increase in cases.
"This is colossal," said Rowan Chlebowski of Harbor-UCLA Medical Center, who helped conduct the analysis. "It translates into thousands of fewer breast cancers that have been diagnosed in women in the United States and could be in the future."
The findings also help explain one of the biggest mysteries about breast cancer — why the number of cases rose steadily for decades. Increasing hormone use probably played a key role, along with better detection by mammography and other factors, several experts said.
"I think this solves at least part of the mystery," Berry said.
Others said the findings underscore the danger of drug therapies becoming widely used before they have been thoroughly tested.
"An awful lot of breast cancer was caused by doctors' prescriptions," said Larry Norton of Memorial Sloan-Kettering Cancer Center in New York. "That's a very serious and sobering thought."
Norton and others said the findings should encourage more women to stop hormone use altogether or to continue at the lowest dose and for the shortest time necessary.
The findings come as another study involving nearly 1 million British women found that hormones also increase the risk of ovarian cancer.
"These data add to the message that we really should be discouraging women from initiating menopausal hormones," said Marcia L. Stefanick of Stanford University. "We need to stop underplaying those risks. They are very real."
Some researchers, however, questioned the findings, saying the drop in breast cancer occurred too soon to have been caused by the decline in hormone use.
"Even if there was a cause and effect, you wouldn't expect it to show up for five or 10 years," said Hugh Taylor of Yale University. "It just doesn't fit with what we know about the basic biology of breast cancer."
Wyeth Pharmaceuticals, which makes the most widely prescribed hormones, also questioned the link, saying hormone use continued to fall while the breast cancer rate remained stable after the initial drop. The researchers, they said, had failed to rule out other causes, such as a decline in mammogram use.
"We do respectfully disagree with the conclusion here," said Joseph Camardo, Wyeth's senior vice president of global medical affairs.
Millions of women took hormones for years to alleviate hot flashes and other symptoms of menopause. Some also viewed hormones as a virtual fountain of youth — boosting energy, preventing wrinkles and providing health benefits, including reducing the risk of heart disease.
In 2002, however, the large federal Women's Health Initiative study stunned doctors and patients when it showed that the hormones not only failed to protect women's hearts, they appeared to increase the risk of heart attacks and strokes, as well as breast cancer and other health problems. The news prompted millions of women to abandon the drugs.
Researchers first reported last year that the breast cancer rate had dropped in 2003 after rising steadily since the 1980s, and that the drop appeared to coincide with the news about hormones. Experts have been waiting for the latest federal data, from 2004, to see if the trend persisted.
The new analysis showed that the breast cancer rate began falling almost immediately after the Women's Health Initiative findings were released in July 2002, dropping 6.7 percent between 2002 and 2003. The 2004 data showed that the rate remained at the lower level, having fallen 8.6 percent between 2001 and 2004.
The researchers said that indicates the drop was primarily caused by the decrease in hormone use and not other factors, such as fewer women having mammograms, greater use of hormone-blocking drugs such as tamoxifen or an unknown change in the environment, and that it will be long-lasting.
"The fact that the incidence rate did not go back up suggests that the effects will be long-lived," said Peter Ravdin of the University of Texas, who helped conduct the analysis.
The link is strengthened by the fact that the decline occurred primarily in women ages 50 to 69, the age group most likely to use hormones, and predominantly in a form of breast cancer sensitive to estrogen. New cases of this type fell 14.7 percent, the researchers said.
The researchers and others emphasized that further research will be needed to determine whether the reduction in diagnoses will translate into fewer deaths.
Researchers suspect hormone use may spur the growth of tumors that may never become life-threatening. Without hormone use, the tumors may remain small enough to never be detected by mammograms. They may even shrink.
"Think of a cancer that you are feeding with hormones and now you stop the fuel. What's going to happen to it?" Berry said. "Most likely it stops growing and stays under the radar, or maybe even regresses. It could even disappear."

source: 19apr2007

[hutchibk]

Hi Terri, good article. - I hope you aren't reading my posts wrong, and mistaking them as a defense of synthetic HRT. I have never taken them and never would even consider it. My menopause was chemo induced and I never even knew that women used such a thing until my gyn and doc warned me to run far and fast from anyone who might be touting them. I have never considered natural BHRT for myself either, as I was ER+ and my doc also steered me clear of those from early on. By not having a dog in the race, I mean that I have never considered going either route for help during my menopause...

My posts here are mostly due to my skeptical eye - and my preference for 'due diligence' when considering the facts of both sides of a discussion that has a lot of emotion attached to it, e.g. potentially overlooked aspects about safety/purity issues within the vitamin and natural supplements industry, especially from internet providers. I think these are the types of issues that the different medical associations are asking the FDA to address as BHRT is currently being so aggressively marketed and pushed without the benefit of hard and fast scientific study. I know that if a friend (a non-b/c friend) ever showed interest in BHRT, I would be sure to help her identify the most knowledgeable and reputable local naturopathic doctor to compound it for her, prescribe it, and monitor and follow her every moment to get it exactly right.

I did recommend to a male friend last year that he look into BHRT, and even told him of some doctors in our area who he should interview before diving in. I don't know if he ever followed through, though.

[TSund]

I'm bringing up this thread again and hoping for more input over time. This is still a subject that I find intriguing and so little info. Who else has read Dr. John Lee's books? (i.e. "What your Doctor may not tell you about breast cancer" ) Would love your opinions. Is there a chance he's right on much of what he claims or is he over the top with his push of NATURAL progesterone? I believe he did not see what we do with the necessity of chemo in certain instances, esp HER2, but I am still wondering about how natural progesterone could fit into this picture.

Is there anyone here that's taken it and believes it has possibly done harm? Pre diagnosis or after diagnosis?

Anyone used it with GOOD results? (either for the estrogen fluctuation symptoms, i.e. hot flashes or even to prevent bc or prevent reoccurance.

Not encouraging or pushing people to use w/o very careful thought, but I am interested in as much feedback as possible.

I welcome any input!

glad that Brenda is keeping me honest (grin) about my slights of the FDA and I take no offense whatsoever. (would welcome thoughts on Lee's comments on that subject also)

THanks,

Terri

[AlaskaAngel]

Hi Terry.

Given how surprised doctors were when the combination synthetic progesterone/estrogen turned out not to be a good idea, when it comes to hormones (synthetic or otherwise) they have not yet done their homework on endocrinology as it relates to much of anything other than thyroid disease or diabetes.

Until there are endocrinologists who have studied the endocrine system in relation to more than the thyroid or the pancreas sitting on each one of our tumor boards, those who prescribe cancer treatment are not taking the endocrine influence on cancers and cancer's influence on the endocrine system seriously.

Just prior to doing treatment, I asked my well-known oncologist whether it would be okay for me to use "bioidentical" progesterone throughout treatment. (It is possible that his answer was based specifically on my diagnosis and not the many others here, and I am HER2+++, ER+ and PR+.) He said using it would be fine, and that it can help some to sleep better. I asked him if using DHEA would be okay and he said no (the theory being that DHEA can break down into androgens and then estrogens). I have no idea whether he knew what he was talking about. Until the results of the testosterone trial I was in a few years later came out, it was widely believed that use of even low-dose testosterone might cause increased levels of estrogen, which the trial results indicated was not the case.

AlaskaAngel

[TSund]

Hi Lois!

I am impressed by your onc that he said OK. 99% will go to the conservative side on this issue. From what I have read he's right on. Anything that will go to the androgens I'd stay away from.

Were you already using progesterone when dx'd? Did you continue or start taking it when he said OK? Are you still on it?

Interesting, as your dx was the same as RUth's. And "common" (but not necessarily correct in my view) wisdom says no natural progesterone if PR +. But Lee claims that's a good, not a bad, in one Q &A tho I found little referring to the markers in his book in general.

TRS

[jhandley]

I have been on natural progesterone for 7 years as per Dr John Lee's book. I got myself tested for hormones after dx and was low in progesterone and high in testosterone; both of which are linked to increase in BC risk.
I suffered from many of the symptoms of low progesterone (fibrocystic disease of the breast, fibroids, endometriosis) and when I asked BC survivors how many of them had one of these, more than 80% said yes.

It helped with the hot flushes but I mostly use it for cancer protective effects because Dr Lee's reasoning and studies makes a lot of sense to me.

Cheers
Jackie

[AlaskaAngel]

Terry,

The other thing that might influence whether or not one should use progesterone would be if one has had a hysterectomy. I had one several years prior to bc diagnosis, and my onc might have also taken that into account when he said it was fine for me to use progesterone (although I doubt that even registered with him).

I used progesterone cream off and on during treatment (it was hard to be consistent about much of ANYTHING that was optional and required discipline during treatment). One problem is that it is hard to know just what schedule to use for applying it -- i.e., 7 days off and the rest of the month on, or what, once one has had a hysterectomy?

I also couldn't find any really good information on the use of it when taking tamoxifen (yea or nay) and since I was on tamoxifen for almost 2 years after chemo I dropped off the progesterone.

After that I used it again some. But then when I was considering participating in the testosterone trial I dropped off it entirely far ahead of time so as not to interfere in any way with the results from that trial. So I was off progesterone for several months for that trial.

I haven't used it regularly since then. I wish we had more help from endocrinologists with all of this. I became more interested in the use of melatonin and have used that on a fairly steady basis. But I don't know how or if that has good or bad effects when using progesterone.

I'm also unsure if using progesterone without doing it on a regular schedule might not be a good thing.

AlaskaAngel

[Madge]

Terri-

I have read Dr. Lee's book and thought it made toal sense. I took it to my endocrinologist (referred to by my oncologist due to low blood sugar issues during treatment) to get his take on it---and he pretty much said he was not well versed in female hormones and did not know of anyone in town who was. I thought this is what endocrinologists dealt with was hormones, but then agiain what do I know?
I am still intrigued by his theories on breast cancer prevention/risk of recurrance and particularly found the progesterone info worth looking into furthur.
I am convinced I was terribly estrogen dominant for many months prior to my bc diagnosis--which is what took we to my ob/gyn. in the first place who discovered the cancer--
now that you bring this up I'm going to "re-read" the book. Let me know if ya'll pursue it furthur. If I remember correctly, he listed sources/companies he considered reputable for bio-identical hormones.
Love to hear your thoughts further--

Madge

[AlaskaAngel]

Nice to meet you, Madge!

I too went to consult an endocrinologist about these things. I was.... very definite, shall we say? about wanting to know why oncologists do not prepare women for the sexuality issues that are a direct result of chemotherapy for a lot of us, and why no endocrinologists are involved in our treatment plans and discussions so that we would be able to have genuine INFORMED CONSENT.

She too said endocrinologists are "not generally trained in that area". It appears the endocrinology training programs in colleges don't seem to think it is relevant?!

AlaskaAngel

[TSund]

Jackie, can you remind me of your initial dx and where you're at now? And also when you started the progesterone in relationship to your dx.

Lois, don't know if you saw my questions up above...

Yes...I totally believe that the estrogen dominance is a predicating factor for bc. Maybe more than just that but there's a lot of research that needs to be done. I think fibrocystic higher bc risk has already been proven; what about the other factors?
THANK-YOU!!!! I'm thrilled to be getting some feedback and having some discussion on this issue.
I am still wondering if there's anyone on here who did take natural progesterone and develped bc anyways. ANd what dosage and type if so.

I take dr's prescribed compounded cream. down to 2 ml a day at 5% concentration.

But remember, I am not the bc patient, so I cannot attest either way.

I am itching to address this with Ruth, but she is also on tamoxifen and of course I have no idea how these interplay. If it were me, I think I'd go to the natural progesterone perhaps even w/o the tamoxifen, but I cannot make that rec for someone else, even Ruth. She trusts and likes our onc. (and I do too for the most part!)
interestingly enough I when I went on natural progesterone 8 years ago due to early menopause I also experienced much of what Lee says happens; the temporary "spike" in symptoms before things got much better, my periods returning to a regular cycle (for years!), the pms problems going away, the tenderness and lumpiness going mostly away, the "pr overload" resulting in estrogen+ symptoms when a change of doc resulted in too high a concentration being used, and more.

So do I read right that there are those of you on it now that were dx'd PR+ and PR-?