Interesting read on compounded "Bioidentical HRT".

[T Man]

My wife came across this article offering a negative view of compounded hormone preparations. I agree with the fact that you really don't know what you are getting in terms of quality control and ingredients. I guess you really have to know and trust who you are dealing with. Just thought I would pass it along.

http://www.pharmwatch.org/strategy/bioidentical.shtml

[cpeil2]

Originally Posted by T Man

My wife came across this article offering a negative view of compounded hormone preparations. I agree with the fact that you really don't know what you are getting in terms of quality control and ingredients. I guess you really have to know and trust who you are dealing with. Just thought I would pass it along.

http://www.pharmwatch.org/strategy/bioidentical.shtml

He identifies an important issue - widespread use of misleading advertising by Internet concerns. Unfortunately, in painting practioners practicing HRT with such a broad brush, he discourages consumers from informing themselves.

[SWALE]

Here are a few of the nonsensical statements made in this article:

“Compounded "bioidentical hormones" are plant-derived hormones that pharmacists prepare and label as drugs”

MANY of our medications are derived from plant-based preparations, and ALL--whether from a compounder or a major drug manufacturer--are "drugs". What a nonsensical statement to make. And the author claims to be quaified to speak on these topics, and is looking out for us?

“the relevant chemicals (steroids) in plants are not identical to those in humans”

The hormones in the mass-produced preparations are NOT "identical to those in humans". The BIOIDENTICAL (which is why they are called that!) ones from compounders ARE. The very problem with the medications studied, for instance, in the WHI, is they are estrogens produced by HORSES, and SYNTHETIC progesterones, known as progestins. Different molecules with SIMILAR (but not exact) effects. It's the "not exact" effects which lead to the increased risk of morbidity. Bioidentical hormones produce--as they must, since they are exactly like those already found in the body--exactly the same effects in the body as endogenously produced ones. More on the WHI later…but see my follow-up replies in this very thread for another example of how completely ignorant this "report" is.

The author obviously does not even know what the phrase "bioidentical" means.

“raw materials from the plants must be converted to human hormones synthetically”

Again, this is the process by which many of our medications--including those by the major drug manufacturers--are mass produced as well.

“Many promoters of bioidentical hormone products advocate saliva testing to determine who might benefit from them. In fact, some nonstandard labs encourage consumers to order tests based on whether they have various symptoms.”

While I do not use them, saliva testing is an emerging science. But what does this have to do with the intent of the article, other than to try to reinforce its smear of Compounding Pharmacies? They are two entirely unrelated topics--except to be included in the same biased, small-minded smear of compounders.

And aren't "various symptoms" what lead all physicians to draw all initial labs, doctor?

“The risk involved in prescribing a hormonal product depends on its chemical composition and biochemical properties, not on how it was made."

FINALLY, a cogent point! And one which is detrimental to the arguments made in this article.

“many offbeat physicians are prescribing compounded "bioidentical" products as though they are safer than standard prescription drug products."

“offbeat physicians”??? In his day, Dr. Joseph Lister was nearly driven from medicine for the “offbeat” notion that Surgeons should wash their hands and change their blood and feces-soaked gowns between surgeries. Merely washing hands between deliveries reduced infant mortality by over 90%--in one day! Those at the forefront have often been deemed “offbeat” (and worse), only to be proven right later on.

And if the author actually learned a bit of what he is writing, he would know that bioidentical estrogen and natural progesterone are indeed MUCH safer than toxic doses of horse estrogen and progestins.

The "offbeat" (what an unprofessional comment to make in the first place) physicians who prescribe bioidentical hormones that I know are some of the most intelligent and talented on this earth. Their intellect and superior reasoning and clinical skils are what led them to appreciate the benefit of replacing homrones only with those which are exactly like those found in the body naturally. Doesn't that make sense?

“There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies.”

It is a fact that synthetic progesterones, known as “progestins” are vaso-constrictors. So, is it any wonder they cause an increase in cardiovascular events? Natural progesterone is a vasodilator—so the effect is the opposite. I’m not sure where that body did their research, other than listening to Drug Reps.

“Most compounded products have not undergone rigorous clinical testing for either safety or efficacy. There are also concerns regarding their purity, potency, and quality."

Completely untrue. Compounding pharmacies must operate under very strict criteria. And the components they introduce must be USP Grade pharmaceuticals. Just more untrue and unfair smear.

“The FDA requires manufacturers of FDA-approved products that contain estrogen and progestins to include a black box warning that reflects the findings of the Women's Health Initiative. However, compounded products (including "bioidentical" hormones) are not approved by the FDA and have been exempt from having to provide patient package inserts that contain warnings and contraindications for estrogens and progestins.”

Amongst other issues in this paragraph, compounders do not use “progestins”—they use natural progesterone. And the Black Box warning applies to the use of estrogens derived from horses and synthetic progesterones--which bioidentical hormones are NOT. Therefore the Black Box warning correctly does not apply. Did th eauthor apply even a whit of critical thinking before publishing this nonsense?

“Given the lack of well-designed and well-conducted clinical trials of these compounded hormones, all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA and may also have additional risks unique to the compounding process.”

The evidence is overwhelming to those of use who are open-minded, unbiased, logical and have not sold out to the pharmaceutical giants. On top of that, this is just more unfair smear of good, ethical compounding pharmacies.

To sum it up, it is obviously the author's belief that hormones derived from other animal sources, as well as those who are similar to (but not exactly) are superior than those which are identical to those God naturally put into our own bodies. Is this REALLY an arguement anyone wants to make?

“Steer clear of anyone who prescribes "bioidentical" hormones or recommends saliva testing as the basis for evaluating hormone status.”

I would advise to “steer clear” of anyone who is so completely ignorant of medicine and pharmacology as to make such a ridiculous statement.

Does anyone know who actually funds this website?

[SWALE]

A simple point to be made: the testosterone powder mixed into a compounded product is exactly the same as that which goes into Androgel or Testim.

[T Man]

Excellent read Dr. John. I was hoping that we would get some expert opinion and knowledge regarding the article. Thanks.