« on: 05-13-13 at 06:41 pm »
Gerd: Finally got a chance to get back to this. Sorry. Academically interesting 4 me. Are we making more out of the “distinction” than needed? But, from experience (sigh), I know how much the late night infomercial people love to tout patented / patent pending.
Concerning UR last post, IMO “prevention” is not always “treatment”. For example, a vaccine can prevent a disease (e.g. smallpox, measles, polio), which I take to mean prevention of development of clinical manifestation of signs and symptoms, maybe lab findings too. But as far as I am aware, vaccines are not used to “treat” a disease once signs & symptoms have manifested themselves. It goes back to the underlying mechanism of action. (N.B. of course up/downregulation can be anticipated, my comment was directed to my personal view of ‘best practice’ when claiming a method of treatment ab initio). So, at least in some circumstances, prevention and treatment are IMO clearly distinct from each other. And if they are not distinct, either one presages - anticipates or renders obvious - the other. I was wrong when I typed that which cures always prevents.
Concerning ED, if I recall the underlying mechanism of sidenafil is blocking (or unblocking?) a particular signaling enzyme that “closes the spigot” to vascular tissue in the penis. Production of this enzyme is reduced (or something that inhibits same reduced) during sleep, giving rise to nocturnal erections, nature’s way of checking the plumbing if you will. The molecular mechanism is reasonably well established.
So what is ED anyways? Looking at the couples in the xxxxx(R) or Cialis(R) ads, and absent some confounding factors, it is just part of the natural aging process. It is not something you “prevent”, you “ameliorate” the (natural) lack of ability to achieve or maintain erection by quashing that enzyme that gets overproduced (or whose natural antagonist get under produced). In fact, every time a male takes xxxxx(R) to “treat” ED, they are just “preventing” clinical manifestation of the sign / symptom. The Argaiv folks could, in principle, file an NDA for the second indication. But FDA will put them to their proofs re endpoint.
A different but “related” hypo comes to mind: HSV2. Once one has the virus, they have it forever. Valacyclovir was developed as an improvement to acyclovir and famcyclovir for treating HSV2 outbreaks (i.e. treating signs and symptoms). But I understand valacyclovir is also approved for so-called “suppression therapy” (don’t know if indication patented) But valacyclovir does not prevent infection w/ HSV, no prophylaxis like a vaccine, it only suppresses signs and symptoms or recurrence thereof. Any "prophyaxis" is agianst manifestation of signs and symptoms, not against the viral infection pre se.
So IMO there is no one size fits all situations“rule”. It all depends on the individual facts. And the only way to “know” that I will develop the disease / disorder is if it has a proven genetic component. Even then it is only a “disposition” to develop same.