Re:Compounding & Bioequivalence

[Guest guest]

Hi, ,

Straight from Wikipedia: " The term " bioidentical " denotes hormones that

are chemically synthesized so as to be identical to the endogenous

hormones of the human body. " That means the molecules are identical.

My quest was in response to repeated assertions here that T4 [as in

Synthroid] is " poison " or " fakey " . Not true; it's identical at the

molecular level with that produced by the human thyroid gland.

I don't disagree with much of what you say. But my search was limited

to an attempt to verify what I felt sure I had read before; which is

basically the same as the Wikipedia quote. Were I interested in the

quality of care provided by Dr. Navar I would be asking many of the same

things you did. I simply did not need the level of certainty that I

would need if I were being treated by Dr. Navar, as the level of

expertise to satisfy [actually, confirm] my interest was actually quite

low. So I did not have any interest in gaining the level of confidence

in the competence of Dr. Navar that you expressed. Had I not already

been virtually certain of the facts prior to my search I would of course

had a much greater interest in her competence.

What I really should have done is looked at Wikipedia or some other such

source rather than take the path I did; and left Dr. Navar out of it

completely.

I don't know much about compounded prescriptions. My understanding is

that they may only legally be prepared by a properly licensed

pharmacist, and that they should contain EXACTLY the type and quantity

of chemicals prescribed by the doctor. I suspect that anything else

constitutes malpractice; but you probably know a lot more about it than

I do.

I am sure that IN PRACTICE a considerable quantity of the hype about

bioidentical hormone treatment is exactly that: hype. And it may at

some point prove to be the same as the hype about organic food: In many

cases the expensive, " organic " produce shows the same chemical residue

as the standard commercial product; all that was changed was the label

and the price tag.

..

..

> Posted by: " brian cooper " brianevans_99@...

>

<mailto:brianevans_99@...?Subject=%20Re%3ACompounding%20%26%20Bioequivalen\

ce>

> brianevans_99 <brianevans_99>

>

>

> Mon Dec 1, 2008 6:29 pm (PST)

>

> ,

>

> I'm sorry you seemed to have missed my point(s) about Dr. Navar.

> Before I consulted almost any practitioner, I would normally want to

> have some idea of where or how they got the basic training that gives

> them the medical authority imputed to them (her, in this case). No, it

> doesn't have to be a prestigious allopathic institution, like Harvard

> or s Hopkins, though very competent iconoclasts have come out of

> each. And some effective techniques and practitioners fall under the

> rubric of non- traditional medicine.

>

> Not to say you're necessarily in good hands with an MD--especially

> when it comes to endocrinology. But plenty of people are taking

> advantage of the shortage of endos (etc), and widespread,

> understandable dissatisfaction with mainstream endos and other

> specialists, to put some questionable credentials on the end of their

> names. Many of them are from mail-order,or today--internet-

> -universities, or hole-in-the-wall places that are unaccredited, and

> are more interested in making a buck than in giving any real useful

> and scientifically proven training (if they're even capable of that).

> Our healthcare system is so unregulated that, so far as I know, if

> you're practicing alternative medicine, there are no real standards or

> enforce- ment in terms of nature or quality of " professional "

> training. The best example I have at the moment is Jon/ Gray, who

> wrote the " Mars and Venus " blockbusters. His degree came from a now

> discredited " Pacific-something

> University, " which his publisher didn't look into or care about. Hey,

> it helped sell books, because buyers assumed he had solid advanced

> training behind his theories or interpretations.

>

> So, Dr. Navar starts out with me as a question mark. But when she says,

> that prescriptions COMPOUNDED by compounding pharmacists are approved

> by the FDA, that simply isn't true. Sure, the FDA has approved the

> original manufacturer's formulation and dosage, as developed and

> manufactured by (usually) a Big Pharma company. And their

> manufacturing facilities are (theoretically, and sometimes, actually)

> inspected by the FDA--remember Fall of 2007(?), when the FDA found

> that a plant in England that made flu vaccine wasn't turning out safe

> or effective products; they put a ban on importing or using them?

>

> A compounding pharmacist does the mixing and measuring himself in

> small batches and may add things that aren't in the approved version.

> And the FDA isn't looking over their shoulders, before, during or

> after. This is another weak point in our system, though I imagine

> there are arguably situations where there is good medical reasons to

> have something com- pounded.

>

> Here's what the FDA itself--with all its own faults!!!--says about com-

> pounding---

>

> http://www.fda.gov/fdac/features/2000/400_compound.html

> <http://www.fda.gov/fdac/features/2000/400_compound.html>

>

> The point all this was leading to is that if " Dr. " Navar knows so

> little as to think drugs compounded with a lot of discretion by a

> compounding pharmacist are " approved by the FDA, " her lack of some

> basic information about the system throws doubt on her broader

> knowledge and competence.

>

> Finally, on the " bioequivalent/bioidentical " question, , I

> believe you were using the term in the sense of, say, comparing

> synthetic T4 or T3 to what the body produces naturally.

>

> My understanding--and right now, it is limited to the Wiki entry,

> which I normally go beyond, but have no time to now--is that when

> you're using the term/concept, bioidentical/bioequivalent, you're

> talking about how one (usually new) drug compares in its effects on

> the body with a competing drug that is already on the market. I'm not

> sure the issue of whether you can really make something that is

> exactly like a substance produced by the body has been established. It

> may vary with the drug or substance, but who wants their product to be

> compared--probably unfavorably--with the real thing?

>

>

>

> But doesn't it come down to whether it can be proven possible to make

> exact clones of what Nature makes...whether the body can tell the

> difference between synthetic and " bioequivalent " and whether the

> manufac-turer has the knowledge, equipment and integrity to make them

> that way, even if it costs more and cuts into his profit.

>

> Have there been any studies by impartial and qualified groups (if

> there is such a thing) that PROVE " bioidentical " hormones are what

> they are claimed to be? Or is it marketing hype--a sexy concept that

> appeals to people who are understandably cynical about the flawed

> stuff that too often comes out of the drug industry?

>

> Let's look at levothyroxine, leaving out the natural thryoid drugs

> like Armour (if only because their broad range of hormones--T3, T4,

> T1,T3/etc?)

> make it impossible to compare to just one synthetic hormone, like T-4).

>

> > __________________________________________________________

> > 4a. Dr. Navar either ignorant or dishonest

> > Posted by: " " res075oh@... <mailto:res075oh%40verizon.net>

> > jamesl33511

> > Date: Sun Nov 30, 2008 3:19 pm ((PST))

> >

> > I don't know anything about Dr. Navar except what I saw

> > on the post

> > quoted. I was searching for a confirmation of statements

> > I've heard

> > before that T4 and T3 are in fact bioidentical. I found the

> > info on Dr.

> > Navar's site. As she seems to specialize in treatments

> > involving

> > bioidentical hormones and such I felt she should be

> > familiar with the

> > subject.

> >

> > You seem to have gotten a completely different slant on her

> > article than

> > I did. I did not find any ignorant or dishonest statements

> > in the

> > portions I scanned. If you're interested in where she

> > got her medical

> > degree and did her post op then I'd suggest you ask

> > her.

> >

> > My _only_ purpose was to find confirmation that T4 and T3

> > are all

> > bioidentical. That's what I accomplished. This was a

> > response to the

> > posts we keep seeing here within which T4 is called

> > " poison " of " fakey " .

> > In fact they are IDENTICAL to the T4 made by a healthy

> > human thyroid gland.

> >

> >