Hair Loss - Let's carefully specify the meaning of a "local" effect!

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Let's carefully specify the meaning of a "local" effect! (Topicals)

posted by RonLev, 28.05.2008, 12:11

» » Bryan,
» »
» » I appreciate your spirited and scientifically rigorous rebuttals. I
» » would only add as a coda to this discussion that many drugs in this
» field
» » (and I am including ALL hormonal modulators in this discussion, not
» just
» » antiandrogens for treatment of hair disorders) are developed with an
» » acknowledgement of some risk as a part of their side effect profile. As
» I
» » mentioned in response to Benji's unfortunate experience with
» finasteride
» » and dutasteride, even well-established, fully FDA-approved drugs will
» not
» » pass muster by your standard. That is not to say that your standard
» is
» » wrong, it is just that the state of the art currently puts us in a
» position
» » where antiandrogenic control cannot be absolutely locally restricted.
» If
» » you want truly effective control of DHT in the here-and-now, this is
» the
» » risk that patients and their doctors must weigh, and for most the
» benefits
» » outweigh the risks.
»
» I must take issue with your claim that "even well-established, fully
» FDA-approved drugs will not pass muster" by my standard. I'm astonished
» that you would try to take some of the heat off (topical) flutamide by
» implying that all other antiandrogens are going to have similar risks with
» systemic absorption. But such is not the case! :-P I'm sure you're aware
» that topical spironolactone has been thoroughly tested in both animals and
» humans, and been found to have no detectable systemic absorption (one study
» applied a spiro cream to literally HALF the entire body surface area of
» some human test subjects, with no ill effects). Topical spiro may not be
» all that powerful an antiandrogen, but one feature it _does_ have that
» topical flutamide apparently doesn't is that all-important "local"
» antiandrogenic effect.
»
» And what about topical RU58841?? That substance has been thoroughly
» tested in animals (and at least privately in humans), and probably has the
» greatest ratio of local-to-sytemic antiandrogenic effect of any substance
» ever discovered. It has NO known risk of a systemic antiandrogenic effect
» when applied topically, yet has a very potent "local" effect which has been
» described as "castration-like" in some of the animal studies.
»
» So I think you're being rather disingenuous by trying to make us believe
» that all other antiandrogens are going to have the same issues and problems
» as flutamide, when used topically. But that is clearly NOT the case. When
» anybody makes an objective comparison of the animal studies with flutamide
» and the animal studies with (say) RU58841, a huge gulf is seen to exist
» between the two which stretches out like the Grand Canyon. And yet you're
» trying to convince us that your new flutamide product is going to be about
» as good as one can get with the current state of the art. I don't believe
» that, and I doubt that very many other people believe it, either. The
» difference between flutamide and RU58841 (at the very least in the animal
» studies, and that carries a LOT of weight with me) is like the difference
» between day and night.
»
» Bryan,
In studies directly comparing spironolactone and flutamide,flutamide has been shown to be a more potent antiandrogen (Moghetti, P: J. Clin. Endocrinol. Metab. 85(1) 2000). But more importantly from a practical perspective, spironolactone has an objectionable odor especially when combined with minoxdil and requires a viscid base to remain stable in solution. This imposes a dilemma on patients: they must either tolerate the odor or messyness (most do not) or separate the spironolatone application from the minoxidil application--a ritual that quickly becomes too bothersome for the patient, who eventually looks for another type of treatment.

RU58841 is a wonderful drug that will never see the light of day because of the disinterest of Roussel Uclaf (now a part of Aventis) to pursue the expense of an FDA approval. (Compounders don't need an FDA approval for hair loss, but we are legally bound to use components that are FDA approved for some legitimate indication.)

Bryan, of course we looked at alternatives that you consider worthy, and there is a reason why we rejected them.

RonLev


RonLev is located in [NA] and he is available to meet: NO

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