Why are some TRT treatments not FDA approved?

[LowTestosterone38]

No matter what message board I go to or what TRT book I read, many guys speak of adding an anti-estrogen drug like clomid or an aromatase inhibitor like arimidex to their testosterone. Many guys also talk about combining testosterone with HCG, especially for secondary hypogonadism.

At the same time, it sounds like a lot of guys have trouble...at least initially...in talking their doctors into prescribing them these off label treatments. By off label, I mean non FDA approved for TRT. A lot of guys post about "their doctors not being up on this stuff" and I have to ask why that is.

I believe a lot of the problems with TRT is due to the ad hoc approach many TRT patients and many of TRT prescribing doctors take to the whole process. By ad hoc, I mean informal, not definitively proven and definitely non FDA approved for the purposes they are taking these substances.

My experience is not many guys have trouble getting formally diagnosed with low T...as many do have low T. The drug companies have decided to make TRT big business and there are many patented testosterone drugs available now to replace testosterone. Go to a lot of doctor's offices and you will see brochures for Androgel, Testim, etc. These testosterone drugs ARE FDA approved for both primary and secondary hypogonadism. Androgel, Testim, Striant, the patches as well as testosterone injections...are all FDA approved to treat hypogonadism.

But the rest of this stuff is not FDA approved for TRT, and I believe thats where the problem is.

Clomid and arimidex are FDA approved to treat breast cancer in females. Nowhere in the PDR or any mainstream medical literature are these drugs FDA approved to counter estrogen buildup from TRT administration in men or to counter excess aromatase from TRT. Its all sort of like hearsay almost.

"I read on the Internet you should take clomid or arimidex along with Testim or Androgel, it counters the estrogen buildup." Or, "some bodybuilder guy in the gym told me I should take arimidex with my Androgel." Or "some expert guru testosterone doctor from California that nobody ever heard of says you need to take clomid with your testosterone cypionate injections."

Who says so? These "experts?" No wonder a lot of doctors never heard of these treatments. Why isnt this stuff formally FDA approved as adjunctive treatments for TRT in men?

Same thing goes for HCG. HCG is FDA approved as some sort of fertility drug. Its use in TRT is purely off label and non FDA approved. No wonder most doctors...not even a lot of doctors who do TRT...ever heard of HCG for TRT...or are willing to prescribe it. Or know how to do it.

My point is, if its not formally FDA approved for a specific medical condition, you cant expect your doctor to know about it or be comfortable prescribing it. Non FDA approval for a drug also means its use for anything other than its original intended use is "off label," which increases a doctor's liability.

Can you blame doctors for diagnosing you with hypogonadism, giving you some testosterone replacement drug and then basically cutting you lose? The way the system is presently set up, thats all they really can (safely) legally get away with.

If arimidex, clomid, HCG and other drugs are really useful adjuncts for hypogonadal men taking testosterone, then those drugs need to be made formally FDA approved for those purposes. Only after that occurs, will mainstream doctors become aware of their use and be willing to freely prescribe them as adjunctive drugs for TRT.

Ive seen the same exact thing in psychopharmacology for about a decade now.

Patient: "Oh doc, I read about this drug called "wonderful" on the Internet, its not FDA approved for depression, they brought it out for epilepsy, but I read it has helped some with depression like mine."

psychiatrist: "uh...yeah, I think I read something about that in the American Journal of psychiatry. But its not something I do in my own practice. Its just research stuff. Maybe if you were at a University teaching hospital they might be willing to try that with you. Sorry."

Three years later it gets FDA approved for a new purpose of depression:

Patient: "Doc, I read about this new drug that just got FDA approved for depression called "wonderful. Can I try some?"

Psychiatrist: "Sure, here is a prescription and also some samples to get you started. The hot drug rep was here yesterday, told me all about it. Gave me a boatload of samples and literature. Let me describe the most common side effects before you go. I hope it works for you."

I have seen this with so many drugs over the years.

Fred

[HeadDoc]

there are research studies that validate HCG and arimidex for HRT purposes. Go over the Dr. Ron Rothenberg's site and pick a lecture and see the citations.

CHI - Preventive Medicine, Anti Aging, Human Growth Hormone

[jinxie1]

hcG for treatment of secondary:

http://www.endo-society.org/quickcon...line053006.pdf

The insert that came with my hCG said that it is also for treating men with secondary. In light of that statement, I would think that the FDA must have blessed this representation, and that it is approved for this purpose.

All of this said, I agree with the sentiment expressed in your post, Fred. It can be very exasperating.

Treating the patient and his/her symptoms needs to become the rule, rather than the exception. And the FDA needs to evolve -- and stop selling out to Big Pharma -- with this mission in mind.

[LowTestosterone38]

Originally Posted by jinxie1

hcG for treatment of secondary:

http://www.endo-society.org/quickcon...line053006.pdf

The insert that came with my hCG said that it is also for treating men with secondary. In light of that statement, I would think that the FDA must have blessed this representation, and that it is approved for this purpose.

All of this said, I agree with the sentiment expressed in your post, Fred. It can be very exasperating.

Treating the patient and his/her symptoms needs to become the rule, rather than the exception. And the FDA needs to evolve -- and stop selling out to Big Pharma -- with this mission in mind.

Hmmmmm I did not know that. If its in the official monograph that comes with the drug, that means its FDA approved for a use. I thought HCG was only approved for fertility type purposes...a very specific type drug almost bordering on being like an "orphan drug."

If its FDA approved for secondary, Id be more comfortable and willing to use it.

The other stuff though....the anti-estrogen/anti-aromatase drugs...man, taking a woman's breast cancer drug just doesnt seem safe to me. Id like to see those drugs get some formal study and FDA approval.

Fred

[LowTestosterone38]

Originally Posted by jinxie1

hcG for treatment of secondary:

http://www.endo-society.org/quickcon...line053006.pdf

The insert that came with my hCG said that it is also for treating men with secondary. In light of that statement, I would think that the FDA must have blessed this representation, and that it is approved for this purpose.

All of this said, I agree with the sentiment expressed in your post, Fred. It can be very exasperating.

Treating the patient and his/her symptoms needs to become the rule, rather than the exception. And the FDA needs to evolve -- and stop selling out to Big Pharma -- with this mission in mind.

Anybody got an online copy of an official HCG monograph? It should describe its official FDA approved uses on the monograph. Id like to see that.

I once asked a pharmacist about HCG (he knew I was on Androgel at the time) and he looked at me like I was whacked. He told me "HCG is for fertility, not for TRT." I had the understanding it was an off label use of the drug...maybe I am wrong.

Fred

[HeadDoc]

Originally Posted by LowTestosterone38

Anybody got an online copy of an official HCG monograph? It should describe its official FDA approved uses on the monograph. Id like to see that.

I once asked a pharmacist about HCG (he knew I was on Androgel at the time) and he looked at me like I was whacked. He told me "HCG is for fertility, not for TRT." I had the understanding it was an off label use of the drug...maybe I am wrong.

Fred

Ferring Pharmaceuticals - Fertility Products

[cpeil2]

Originally Posted by LowTestosterone38

The other stuff though....the anti-estrogen/anti-aromatase drugs...man, taking a woman's breast cancer drug just doesnt seem safe to me. Id like to see those drugs get some formal study and FDA approval.

Fred

If the AI or SERM were something like a chemotherapy agent intended to kill tumor cells by poisoning them, yes, it would be foolish to take such a drug unless you had breast cancer.


But SERMs and AIs act on estradiol, depriving certain tumor cell lines of the estradiol they need to thrive. To me, it's a big difference.

That's not to say that anbody should take SERMs or AIs casually. Some guys, and their docs, have the mistaken notion that an anti-E should be routinely taken.

Actually, an anti-E should only be taken after laboratory confirmation that the guy's E2 needs to be managed

The best and most experienced TRT docs use anti-E's with a lot of caution.


Its a good thing to maintain some skepticism. There are a lot of docs out there looking to increase their revenue stream by offering TRT after taking a weekend seminar sponsored by a compounding pharmacy.

[LowTestosterone38]

Originally Posted by HeadDoc

Ferring Pharmaceuticals - Fertility Products

# "Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males."


OK, well thats better. But still, how do you know if your secondary hypogonadism is due to a pituitary deficiency or a hypothalamus deficiency? I had an MRI Pituitary study recently that came back normal.

Fred

[RPHMark]

The HCG is not approved (to my knowledge) for adjunctive use with Testosterone, but is approved as monotherapy for secondary hypogonadism. That being said, much of medicine/pharmacology is based on using the pharmacology of a drug and comparing it with known disorders to determine if there may be some off-label uses that make sense. There are numerous drugs used off-label on a daily basis; so common in fact, many drs don't even know they are using the drug off-label. Remember, in order for a pharmaceutical company to go throgh the trouble and major expense of getting approval for a new indication there has to be signifigant financial return possible. Why bother if the drs will prescribe it off-label anyway?

[HeadDoc]

if you take the HCG and the testis do not respond to this LH analogue, then you would be primary. If before the HCG trial, the LH is high, and the Testosterone is low, there is possibility of primary hypogonadism. If before the HCG trial, LH and FSH are low and testosterone is low, there is a possiblility of secondary.

[LowTestosterone38]

Originally Posted by cpeil2

If the AI or SERM were something like a chemotherapy agent intended to kill tumor cells by poisoning them, yes, it would be foolish to take such a drug unless you had breast cancer.


But SERMs and AIs act on estradiol, depriving certain tumor cell lines of the estradiol they need to thrive. To me, it's a big difference.

That's not to say that anbody should take SERMs or AIs casually. Some guys, and their docs, have the mistaken notion that an anti-E should be routinely taken.

Actually, an anti-E should only be taken after laboratory confirmation that the guy's E2 needs to be managed

The best and most experienced TRT docs use anti-E's with a lot of caution.


Its a good thing to maintain some skepticism. There are a lot of docs out there looking to increase their revenue stream by offering TRT after taking a weekend seminar sponsored by a compounding pharmacy.

This is an intelligent and reasoned sounding post.

The part about docs wanting to increase their revenue got my attention. Did you know that drug companies rate doctors on how many prescriptions they prescribe for a certain drug? I found this out via an Internal medicine doctor of mine. He was telling me about one of his GlaxoSmithKline Paxil drug reps...they keep track of doctors and encourage them to prescribe the patented drugs. Its kind of hush hush, drug companies dont like to talk about it or admit it, but it goes on.

See if a drug company does that for drugs that have lost their patents...it doesnt happen. It only happens with the newer "best" drugs that still have that good old patent on them.

I bet in ten or however more years it takes Androgel and Testim to lose their patents, the same companies will tweak something on those drugs, give it a shiney new name and market it as the newest, best TRT drug, "better than the old TRT drugs."

Its happened with antidepressants a lot. They did that with Celexa...it lost its patent and the company tweaked a molecule, gave it a new name (Lexapro) and resubmitted it to the FDA as a new drug. Then marketed it like hell.

The company that makes Effexor did the same thing with that drug, it lost its patent, they tweaked it a bit, gave it a new name and resubmitted it as a new antidepressant.

The company that makes a popular antipsychotic called Risperdal, tweaked that drug a little, gave it a new name, resubmitted it to the FDA as a different drug and marketed it as "the improved Risperdal."

Its a bunch of bullshit...

I bet the TRT companies do the same with Testim and Androgel when they lose their patents.

I wonder how many guys taking TRT are really victims of doctors who have been brainwashed by drug companies and are under pressure to prescribe.


Fred

[LowTestosterone38]

Originally Posted by RPHMark

The HCG is not approved (to my knowledge) for adjunctive use with Testosterone, but is approved as monotherapy for secondary hypogonadism. That being said, much of medicine/pharmacology is based on using the pharmacology of a drug and comparing it with known disorders to determine if there may be some off-label uses that make sense. There are numerous drugs used off-label on a daily basis; so common in fact, many drs don't even know they are using the drug off-label. Remember, in order for a pharmaceutical company to go throgh the trouble and major expense of getting approval for a new indication there has to be signifigant financial return possible. Why bother if the drs will prescribe it off-label anyway?

I understand what you are saying, believe me. Im not against off label drug prescribing, I realize it goes on a lot and many times it is needed. I also understand the cost and bureaucratic hassles companies have to go thru to get a drug FDA approved for a specific purpose. But that being said, this is TRT...you are messing with MAJOR HORMONES. This is one of the master hormones, probably the other ones being thyroid and insulin.

I like to see major adjunctive drugs for TRT formally studied and formally FDA approved. Thats just my preference. If drugs like clomid, arimidex, etc. are useful adjunct drugs to testosterone, I think that should be heavily studied and if it is found bona fide useful (and safe), then submit it to the FDA for additional purposes than female breast cancer.

Thats just my opinion. This way, Im not perceived by many doctors as some "fringe patient" who is treating myself and kinda of whacky. Because honestly, a lot of these TRT docs, you ask them for clomid or arimidex and they are going to look at you strange. I had to ask my doc to order E2 tests for me...he did it but said "well, we can do that, but thats not standard testing."

Im just saying if you formalize it via FDA approval, you get less lip from these doctors and things go down smoother.

Fred

[JanSz]

Originally Posted by LowTestosterone38

I understand what you are saying, believe me. Im not against off label drug prescribing, I realize it goes on a lot and many times it is needed. I also understand the cost and bureaucratic hassles companies have to go thru to get a drug FDA approved for a specific purpose. But that being said, this is TRT...you are messing with MAJOR HORMONES. This is one of the master hormones, probably the other ones being thyroid and insulin.

I like to see major adjunctive drugs for TRT formally studied and formally FDA approved. Thats just my preference. If drugs like clomid, arimidex, etc. are useful adjunct drugs to testosterone, I think that should be heavily studied and if it is found bona fide useful (and safe), then submit it to the FDA for additional purposes than female breast cancer.

Thats just my opinion. This way, Im not perceived by many doctors as some "fringe patient" who is treating myself and kinda of whacky. Because honestly, a lot of these TRT docs, you ask them for clomid or arimidex and they are going to look at you strange. I had to ask my doc to order E2 tests for me...he did it but said "well, we can do that, but thats not standard testing."

Im just saying if you formalize it via FDA approval, you get less lip from these doctors and things go down smoother.

Fred

Progress is being held hostage.

Stop admissions to Hall of Fame..

Start New Hall of Fame.
Open to anybody on anything, as long as he/she breaks a record.

[cpeil2]

Originally Posted by LowTestosterone38

This is an intelligent and reasoned sounding post.

The part about docs wanting to increase their revenue got my attention. Did you know that drug companies rate doctors on how many prescriptions they prescribe for a certain drug? I found this out via an Internal medicine doctor of mine. He was telling me about one of his GlaxoSmithKline Paxil drug reps...they keep track of doctors and encourage them to prescribe the patented drugs. Its kind of hush hush, drug companies dont like to talk about it or admit it, but it goes on.

See if a drug company does that for drugs that have lost their patents...it doesnt happen. It only happens with the newer "best" drugs that still have that good old patent on them.

I bet in ten or however more years it takes Androgel and Testim to lose their patents, the same companies will tweak something on those drugs, give it a shiney new name and market it as the newest, best TRT drug, "better than the old TRT drugs."

Its happened with antidepressants a lot. They did that with Celexa...it lost its patent and the company tweaked a molecule, gave it a new name (Lexapro) and resubmitted it to the FDA as a new drug. Then marketed it like hell.

The company that makes Effexor did the same thing with that drug, it lost its patent, they tweaked it a bit, gave it a new name and resubmitted it as a new antidepressant.

The company that makes a popular antipsychotic called Risperdal, tweaked that drug a little, gave it a new name, resubmitted it to the FDA as a different drug and marketed it as "the improved Risperdal."

Its a bunch of bullshit...

I bet the TRT companies do the same with Testim and Androgel when they lose their patents.

I wonder how many guys taking TRT are really victims of doctors who have been brainwashed by drug companies and are under pressure to prescribe.


Fred

True . . . capitalism and good medicine don't always mix well.

[keith1958]

All I know is that I am so glad I do not follow everything the FDA has to say.