Compounding & Bioequivalence

[Guest guest]

,

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

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@...

> 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.

>

>

> .

> .

>

> >

> > Posted by: " brian cooper "

> brianevans_99@...

> >

>

<mailto:brianevans_99@...?Subject=%20Re%3ADr%2E%20Navar%20either%20ignoran\

t%20or%20dishonest>

> > brianevans_99

> <brianevans_99>

> >

> >

> > Sun Nov 30, 2008 9:01 am (PST)

> >

> >

> > This Dr. Navar (and what is his/her doctorate in, and

> from what

> > institution, pray tell?--not that I'm saying

> practitioners from even

> > the most prestigious med schools are acceptably

> competent on many

> > issues, let alone honest and ethical) claims:

> >

> > " ....Bioidentical hormones are FDA approved...All

> hormones [!!!!]

> > available at the compounding pharmacist are FDA

> approved. They require

> > a doctor’s prescription with instructions to the

> pharmacist as to the

> > form of the medication, dosage and how it is to be

> used.

> > >

> > For a manufacturer to produce and advertise a

> medication, they must

> > first prove to the FDA that each particular dosage

> form, strength and

> > use will perform according to their advertising, be

> safe and

> > effective. This costs the manufacturer a huge amount

> of money... "

> > >

> > My internist started gave me a couple of monthly

> injections of

> > testosterone supplementation a couple of years ago. I

> opted out as

> > soon as I found my PSA was unacceptably high

> (can't believe he was out

> > to lunch on that one). But was also concerned that,

> with shots

> > (compared with daily gel applications)

> > , the dose starts out high, and then goes down over

> the course of the

> > month). More to the point here, I found that this

> medication came from

> > a local compounding pharmacist, who had prepared it

> according to his

> > or her best lights; and apparently had a contract with

> the med

> > practice, or at least sold it when they ordered...

> >

> > But my research on compounding pharmacies revealed

> that they are NOT

> > inspected--how could they be??--by the FDA (which

> doesn't even do a

> > decent job of inspecting drug factories!!) The

> compounder could be

> > careless, have a drinking or drug problem, or any

> number of other

> > things that could interfere with careful and effective

> preparation and

> > dispensing of the product. And the medical practice is

> hardly in a

> > position to judge the results. If the stuff

> doesn't work, they'd

> > likely figure the patient just wasn't

> responding...

> >

> >

>

>

>

> Messages in this topic (2)

> ________________________________________________________________________

> ________________________________________________________________________

>