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 possession of 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 ill-conceived mandate.

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 medication.

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 trade names:
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 heard.

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 doctor-prescribed HRT.

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 the 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 Androgel
(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 subjects.

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

Free Web Counter
Free Hit Counter