Re:Distinct Meanings or Not: Bioequivalent vs. Bioidentical??

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Hi, . Please see responses below...

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

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<mailto:brianevans_99@...?Subject=%20Re%3ADistinct%20Meanings%20or%20Not%3\

A%20Bioequivalent%20vs%2E%20Bioidentical%3F%3F>

> brianevans_99 <brianevans_99>

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> Fri Dec 5, 2008 6:07 pm (PST)

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> ,

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> About Dr. Navar and the question of " bioidentical " hormones...

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> I find most of your posts quite sensible, when I have any basis for an

> opinion, and I'm not sure we really have any disagreement on these

> questions...

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> I was questioning Dr. Navar's knowledge, and thus her professional

> credentials ultimately, if she could say, as she did, that hormones

> made by compounding pharmacists are approved by the FDA. The basic

> drugs they make compounded versions of are altered in some way/not

> identical to the mass-produced version.

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I must confess to knowing very little about compounding pharmacists. My

understanding [which may be in error] is that a compounding pharmacist

uses standard ingredients prepared _exactly_ as ordered by the doctor.

So there should be no significant variation. Here's a blurb about

compounding pharmacies:

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<http://www.iacprx.org/site/PageServer?pagename=What_is_compounding>

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> And they are, in the FDA's own statement on the subject, NOT approved

> by the FDA. One reason, at least, is the FDA's sheer inability to to

> oversee how they are prepared. Every compounding operation is a unique

> event, subject to human error (more, presumably, than a machine-based

> factory, which can be inspected and adjusted, and is

> subject--theoretically, at least, to quality control procedures).

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The reason they are not approved by the FDA is that each one, by design,

can be different. Approval by the FDA of a specific dose ordered by a

doctor could cost _many_ millions of dollars; and that for a single

prescription. You're depending upon the doctor to prescribe the correct

ingredients and upon the pharmacist to mix them as ordered. Many people

think compounded prescriptions are better because they can be modified

from the standard preparation if the doctor deems it advisable.

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> You were saying that " bioidentical " hormones are the very same in

> every practical way to what the body makes.

No; I'm saying that bioidentical hormones are EXACTLY the same molecule

as that produced by your body. There is no way at any level to tell

them apart. It's like trying to differentiate between two electrons:

You can't do it. So to call one fake and the other " real " is absurd.

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> That may or may not be so, but certainly that's what those who hype

> this concept claim to believe.

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That's what science says; and it's based upon the best science we can

do. The support for the concept isn't " what we claim to believe " ; it's

what the evidence shows.

But at the same time, you make a good point IMHO. BHRT is in fact

hyped by a number of basically quack practitioners who claim it is far

superior to conventional treatment [and some who are not quacks]. The

quack BHRT practitioners are likely to tell you that you should buy

their bioidentical product instead of Synthroid [or some other

bioidentical product] when in fact they are the same molecule. Usually

these products will by hyped as " natural " as opposed to " synthetic " or

similar. I have as little respect for the hype as you do.

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> I had found that " bioequivalent " --which I assumed, perhaps wrongly, to

> be equivalent to " bioidentical " (using the normal meanings of the

> words, they would be) is given the meaning I used by Wiki...

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No; your understanding of bioequivalence is flawed. It is applied to

the concept that pharmaceutical preparations that are bioequivalent must

obtain the same results in the patient. They do not have to be

bioidentical, which is a totally different thing; although it could be a

fact that they are bioidentical. Bioequivalence is applied to two

medicines while bioidentical applies to molecules. Bioidentical are

identical molecules. Bioequivalent gets equivalent results.

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> ( " Bioequivalence " ---Redirected from Bioequivalent)

> " Bioequivalence is a term in pharmacokinetics...to assess the expected

> in vivo biological equivalence of two proprietary preparations of a

> drug. If two products are said to be bioequivalent it means that they

> would be expected to be, for all intents and purposes, the same... "

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> So, either we have two distinct concepts, which stipulate distinct

> com- parisons for a proprietary preparation---one to the human-made

> version, the other to another synthesized form--or else we have two

> differing Wiki definitions for two terms that are verboidentical (or

> verboequivalent)...

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The confusion of bioequivalence and bioidentical is probably common, but

a close reading of Wikipedia will make it clear to you. Note the phrase

" in vivo biological equivalence " .

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> Hope you'll be joining the other moderators,

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I'm not actually a moderator; I'm an assistant to the moderator. I

don't expect to have much to do other than to perhaps issue a few spam

warnings.

Regards,

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