The DEA's mandate, the FDA's off-track agenda, and how both are hurting you.
The DEA (Drug Enforcement Administration)
has a pretty straight forward agenda. Their mandate is to curtail the illegal sale and
controlled substances in the United States. Their overreach in pursuit of narcotics
and steroids, has created a climate of fear among physicians, and resulted in a reluctance
to prescribe testosterone replacement therapy and sufficient pain relief for post
operative patients. For all their effort and resources the agency has had no impact on the
illegal drug trade and has only served to deny neccesary medication to those in need. The
blame for this travesty lies at the feet of the politicians who handed down this
The FDA (The Food and Drug Agency)
is another story altogether. Once reliable guardians of the public health, this agency is
broken. It is in worse disarray than FEMA and for the same reasons. It took me awhile to
realize that the FDA's new screwy agenda is the manifestation of this administration's
cronyism that regularly appoints incompetent crooks to positions that call for impeccable
judgement and high ethical standards.
The Intrinsa testosterone patch for menopausal HRT along with the weight
loss drug Rimonabant (acomplia) are sitting in a limbo-land of "long-term testing needed
for unknown possible health risks" (although the phase I, II & III trials found no
evidence of harmful side effects)..... while breast implants serving no medical purpose
and with a history of leaking, and Vioxx with known danger of heart attacks sailed through
the approval process. One FDA advisory panel member even had the gall to assert that known
risks were better than unknown potential risks.
Reasons for nixing intrinsa: the DEA's mandate against controlled steroidal
substance testosterone combined with the current socio-political climate in this country
of sexual repression.
Reasons for nixing rimonabant: it suppresses appetite by accessing the same part of the
brain that triggers the "munchies" in marijuana users. So although rimonabant is sort of
the anti-marijuana, this obscure association alone is enough to damn this breakthrough
In both cases the FDA and their flunky doctors went to elaborate lengths to suggest that
female sexual dysfunction neither exists nor responds to testosterone, and that weight
loss drugs do not work. When the phase III trials disproved both assertions, the FDA
retreated back into the shelter of the "possible unknown health risk" rationale.
The can of worms was .................................
This Was Supposed To Have Been Ours Now!!
Intrinsa, a fatality of the new dysfunctional FDA
This year a whole new generation of patches and gels for women from various
pharmaceutical cos was due to hit the market, led by
Procter & Gamble Co's Intrinsa Testosterone Patch.
BioSante Pharmaceuticals was proceding to final testing, and heading toward
application for FDA approval of their estrogen, progesterone and testosterone gels under
LibiGel (female testosterone gel)
Bio-E/P-Gel (estradiol + progestogen gel)
Bio-E-Gel (estradiol gel)
LibiGel-E/T (estradiol + testosterone gel)
Also an Italian drug company was developing a female dhea patch last I
The stage was set to change the face of womens health so that no other women would go
through the ordeal that I suffered. Women would finally look forward to effective
The old FDA had promised Procter & Gamble a fast track approval
for Intrinsa. The new dysfunctional FDA instead took an
action that can be expected to have a devastating impact on the line of revolutionary HRT
products next in line for approval, and gynecology will remain where it now resides .. in
the stone ages.
FDA's poor excuse... testosterone's effect on women and possible health
dangers are unstudied. (This is of course utter nonsense, as there is plenty of existing
favorable research, and low dose topical testosterone gels and pellets have been
prescribed to menopausal women for decades with great benefits to their health and no
catastrophic ill effects.)
At the FDA advisory hearings on Intrinsa, here were plenty of references to
much-hyped health risks of HRT in the
WHI study. The fact is, women in this study were prescribed estrogen or estrogen
coupled with progesterone. NO woman who took part in the WHI trial was administered
testosterone in any form. This illogic is akin to citing health risks of aspirin and
applying them to tylenol. In fact there is
evidence. that if the test subjects had been given testosterone in addition to
estrogen and progesterone, the minor cancer and heart risks (that were exaggerated out of
all preportion by the press) would been averted.
To put the frosting on the cake, several months after denying menopausal women the
life-giving health benefits of
Intrinsa, the FDA lent their approval to a number of medications in the same
class as Vioxx and there has been talk of Vioxx's manufacturer putting their drug back on
pharmacy shelves. FDA committee members had the gall to say that while these pain
relievers are known to have resulted in fatal heart attacks, perhaps a known risk is safer
than an unknown risk. (Intrinsa has completed Phase III trials with no hint of any health
risks and further promising studies are underway.)
The next insult added to injury was FDA's approval of breast implants, serving no medical
necessity, and known to leak.
Early on there were a lot of press reports questioning the efficacy of testosterone to
boost female libido and even speculating that female sexual dysfunction (FSD) was a term
coined by drug manufacturers to describe a fabricated condition. Evidence from the Phase
III trial validated the existence of FSD, and indisputably concluded that
Intrinsa reverses the condition. This put a stop to the "denial"
merchants. But it has not turned the press or the FDA from casting Intrinsa
in the light of a "recreational drug" and downplaying its health benefits.
Intrinsa's impeccable safety record throughout the clinical studies has not
halted these "doomsday prophets" from harping on unknown dangers of long-term use.
What IS known are the
benefits of testosterone to heart and bone and virtually every bodily system in both
men and women, but this evidence is conveniently ignored by the FDA.
Intrinsa has been hyped by the press as a "female viagra".
Intrinsa does indeed have a male counterpart, but it is not viagra; it is
(1% testosterone gel).
Androgel sailed through FDA's approval board 5 years ago in February 2000
after clinical trials spanning a 42 month trial that studied a mere 163 male test
Intrinsa (deemed to require "long-term testing") has undergone clinical
trials that spanned 48 months and studied 1095 female test subjects.
While it would be easy to attribute this discrepancy to gender bias, I have come to see it
instead as the 'FEMA syndrome' of the new FDA. Whereas the old FDA
based their decisions on science and was impervious to special interest, the new
corrupt FDA takes its orders from
politicians and the politically charged and over-empowered DEA.
Androgel and other products for male testosterone replacement therapy are
also on the
DEA's hit list/wish list for removal, but it is harder to remove an approval
rating already granted (particularly in a product with no record of adverse effects) than
it is to deny an approval rating for a new product. On the strength of that advantage I
will delay addressing the issue of imperiled male androgen replacement for the time being.
However, Nick O'Hara Smith in the UK maintains a very informative website on male
hypogonadism and the difficulties with getting the medical community to address the
problem. Click here
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