igf-1 and trt

[SWALE]

It is not illegal for physicians to prescribe GH to treat adult onset Growth Hormone deficiency. The paper quoted by stat is total nonsense. No basis in reality whatsoeve,r, and an embarrassment to JAMA. How it got by its editors is beyond me.

The A4M has assembled a team of lawyers (headed by Rick Collins, I should suspect) to represent any physician who is being persecuted for appropriately prescribing GH.

The position of many in the conventional medical community reminds me of when Dr. Joseph Lister was driven from medicine to daring to suggest surgeons should wash their hands and change their blood and feces-soaked gowns between surgeries.

Merely washing hands between deliveries reduced the mortality of childbirth by more than 90% INSTANTLY.

[stat1951]

Originally Posted by SWALE

It is not illegal for physicians to prescribe GH to treat adult onset Growth Hormone deficiency. The paper quoted by stat is total nonsense. No basis in reality whatsoeve,r, and an embarrassment to JAMA. How it got by its editors is beyond me.

The A4M has assembled a team of lawyers (headed by Rick Collins, I should suspect) to represent any physician who is being persecuted for appropriately prescribing GH.

The position of many in the conventional medical community reminds me of when Dr. Joseph Lister was driven from medicine to daring to suggest surgeons should wash their hands and change their blood and feces-soaked gowns between surgeries.

Merely washing hands between deliveries reduced the mortality of childbirth by more than 90% INSTANTLY.

Have to admit that I'm quite confused now.

I agree that the position of the article is nonsense in that it has no reasonable medical basis... but are you saying that the law itself doesn't exist? I called Federal representatives of two different agencies in the local area and both verified the existence of this law and the core summary of the language.

Even more confusing, if this law doesn't exist and isn't being enforced - or enforcement contemplated - then why has "A4M has assembled a team of lawyers to represent any physician who is being persecuted for appropriately prescribing GH"?

Can 4AM obtain the actual statutory language and get it posted it so that one can determine just exactly what the law says?

Larry

[cpeil2]

Originally Posted by stat1951

Have to admit that I'm quite confused now.

I agree that the position of the article is nonsense in that it has no reasonable medical basis... but are you saying that the law itself doesn't exist? I called Federal representatives of two different agencies in the local area and both verified the existence of this law and the core summary of the language.

Even more confusing, if this law doesn't exist and isn't being enforced - or enforcement contemplated - then why has "A4M has assembled a team of lawyers to represent any physician who is being persecuted for appropriately prescribing GH"?

Can 4AM obtain the actual statutory language and get it posted it so that one can determine just exactly what the law says?

Larry

You're confused because you allowed yourself to be hoodwinked by the article. You can find the text of the statute on any website that has a searchable copy of the US Code, www.findlaw.com, for example. As I pointed out in a previous post, the statute itself says nothing about what a proper use of growth hormone is. It leaves that to the HEW Secretary (in other words, FDA). Thus, it can be said that the statute incorporates by reference FDA documents concerning the proper indications for human growth hormone. It has been approved for Adult Onset Growth Hormone Deficiency. Go to the source documents (the NDA's on the FDA website)--ignore the article. THe NDA's themselves describe the disorder broadly. They do not define it narrowly as the JAMA article does.

[stat1951]

Originally Posted by cpeil2

You're confused because you allowed yourself to be hoodwinked by the article. You can find the text of the statute on any website that has a searchable copy of the US Code, www.findlaw.com, for example. As I pointed out in a previous post, the statute itself says nothing about what a proper use of growth hormone is. It leaves that to the HEW Secretary (in other words, FDA). Thus, it can be said that the statute incorporates by reference FDA documents concerning the proper indications for human growth hormone. It has been approved for Adult Onset Growth Hormone Deficiency. Go to the source documents (the NDA's on the FDA website)--ignore the article. THe NDA's themselves describe the disorder broadly. They do not define it narrowly as the JAMA article does.

Hey, thanks for clearing that up!

I will definitely follow-up with that examination of the NDAs for HGH usage at the FDA website.

While not an issue directly effecting me (at least at this point), I have a definite paranoia about these types of things. I have dealt with the Feds on various issues (professionally and at the personal level) in the past and fully grasp that they at times have certain "agendas" (either organizational or political) that come in to play where the Feds will specify their own narrow "interpretations" to address those (usually hidden) agendas.

With the assault on first prohormones and now DHEA (and concerns about Codex with its aggressive limitations of supplements in general), I tend to think that it's a legitimate paranoia... but hope that I'm wrong and this whole thing was just a "test run" to see what kind of a flap would be raised and that this issue dies a nice and quiet death with no enforcements being attempted... cause it doesn't do you any good to fight the system and win if you and your business end up financially bankrupted in the end and you end up a "basketcase"!

Again, thanks much for that clarification - it was greatly appreciated.

Larry

[cpeil2]

Originally Posted by stat1951

Hey, thanks for clearing that up!

I will definitely follow-up with that examination of the NDAs for HGH usage at the FDA website.

While not an issue directly effecting me (at least at this point), I have a definite paranoia about these types of things. I have dealt with the Feds on various issues (professionally and at the personal level) in the past and fully grasp that they at times have certain "agendas" (either organizational or political) that come in to play where the Feds will specify their own narrow "interpretations" to address those (usually hidden) agendas.

With the assault on first prohormones and now DHEA (and concerns about Codex with its aggressive limitations of supplements in general), I tend to think that it's a legitimate paranoia... but hope that I'm wrong and this whole thing was just a "test run" to see what kind of a flap would be raised and that this issue dies a nice and quiet death with no enforcements being attempted... cause it doesn't do you any good to fight the system and win if you and your business end up financially bankrupted in the end and you end up a "basketcase"!

Again, thanks much for that clarification - it was greatly appreciated.

Larry

Actually, Larry, in the enthusiasm of the moment, I overreached in my previous statement. I have not looked at the NDA's. What I looked at was the package inserts. Every word of the package insert has to be approved by FDA. FDA wouldn't approve a package insert that was incompatible with the NDA. If anything, the package insert would be more restrictive than the NDA.

[stat1951]

Originally Posted by cpeil2

Actually, Larry, in the enthusiasm of the moment, I overreached in my previous statement. I have not looked at the NDA's. What I looked at was the package inserts. Every word of the package insert has to be approved by FDA. FDA wouldn't approve a package insert that was incompatible with the NDA. If anything, the package insert would be more restrictive than the NDA.

All right, I am having trouble navigating the FDA site to locate HGH specific NDAs, so I have simply e-mailed them for information on those NDAs in general and their interpretation of same as relates to that October 2005 issue of JAMA.

Still looking though....

Larry

[stat1951]

Okay, this gets more and more confusing.

Please see the following link:

http://www.fda.gov/foi/warning_letters/g3437d.htm

This is a formal warning letter from the FDA to a site in Florida promoting the use of a particuular antiaging protocol using a specific HGH drug. In this case, Saizen. They have this to say specifically as relates to Saizen:

Saizen is a "drug" as defined by 21 U.S.C. 321(g). Saizen has a new drug application (N019-764) approved by FDA. Saizen is approved for one indication only, namely for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

What is even more troublesome, is that the FDA goes on further to state this:

Finally, distribution of your HGH product violates 21 U.S.C. 333(f). Saizen is being promoted and distributed on your web site for an unapproved use. There are no recombinant HGH products that are approved by the Food and Drug Administration (FDA) for anti-aging treatment. 21 U.S.C. 333(e) states that ". . .whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under 21 U.S.C. 355 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, United States Code, or both."

That sure sounds a lot like the language used in the JAMA article from last October. In fact, it sounds exactly like that language. And of particular note is this section, re-stated for emphasis:

There are no recombinant HGH products that are approved by the Food and Drug Administration (FDA) for anti-aging treatment.

I noted that this letter was dated from June of 2002, so it is fairly recent.

Still looking.

A lot of info at the FDA site, just a matter of coaxing it out. Plus they should reply to the e-mail and hopefully that will shed some distinct light on the subject also.

Larry

[stat1951]

cpeil2,

One last quick addition (besides which my eyes are losing it from going through pages of search documents on the FDA web site).

Here's another "Warning Letter", this one issued to an antiaging clinic up in the New England area somewhere. Here's the link:

http://www.fda.gov/foi/warning_letters/g3461d.htm

Note extremely similar language, with specifically this language also in this second letter:

Distribution of your hGH product violates 21 U.S.C. 333(f). Your hGH product is being promoted and distributed for an unapproved use. There are no recombinant hGH products that are approved by the Food and Drug Administration (FDA) for anti-aging treatment. 21 U.S.C. 333(f) states that "...whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under 21 U.S.C. 355 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, United States Code, or both."

Well, that's it for now. Will wait until (if?) I hear something back from the FDA itself with some type of clarification on this.

Larry

[cpeil2]

Originally Posted by stat1951

Okay, this gets more and more confusing.

Please see the following link:

http://www.fda.gov/foi/warning_letters/g3437d.htm

This is a formal warning letter from the FDA to a site in Florida promoting the use of a particuular antiaging protocol using a specific HGH drug. In this case, Saizen. They have this to say specifically as relates to Saizen:



What is even more troublesome, is that the FDA goes on further to state this:



That sure sounds a lot like the language used in the JAMA article from last October. In fact, it sounds exactly like that language. And of particular note is this section, re-stated for emphasis:



I noted that this letter was dated from June of 2002, so it is fairly recent.

Still looking.

A lot of info at the FDA site, just a matter of coaxing it out. Plus they should reply to the e-mail and hopefully that will shed some distinct light on the subject also.

Larry

HGH was only approved for treatment of Adult onset growth hormone deficiency recently 2004, I think. That letter predates this.

And yes, they do consistently maintain that growth hormone is not approved for any anti-aging use . . . . . meaning that they do not consider its use for diagnosed adult onset growth hormone deficiency to be an anti-aging use.


If you google "adult onset growth hormone defciency," you can find sources that define the disorder as narrowly as the JAMA article did. Significantly (because, as I said, the FDA must approve every single word of a package insert) neither of the package inserts for Saizen (Serono) or Nutropin (Genentech) define the disorder so narrowly. I haven't looked at the package insert for Humatrope, but I would imagine it would read about the same as the other two (if Lilly submitted an NDA for adult onset growth hormone deficiency).

[cpeil2]

Originally Posted by cpeil2

HGH was only approved for treatment of Adult onset growth hormone deficiency recently 2004, I think. That letter predates this.

And yes, they do consistently maintain that growth hormone is not approved for any anti-aging use . . . . . meaning that they do not consider its use for diagnosed adult onset growth hormone deficiency to be an anti-aging use.


If you google "adult onset growth hormone defciency," you can find sources that define the disorder as narrowly as the JAMA article did. Significantly (because, as I said, the FDA must approve every single word of a package insert) neither of the package inserts for Saizen (Serono) or Nutropin (Genentech) define the disorder so narrowly. I haven't looked at the package insert for Humatrope, but I would imagine it would read about the same as the other two (if Lilly submitted an NDA for adult onset growth hormone deficiency).

Last night, I did a little more digging. Genentech's product, Nutropin, has been approved for adult onset growth hormone deficiency since 1996.

I also looked at the package insert for Eli Lilly's product, Humatrope. The language is identical to that for Saizen.

Nutropin's insert is different from the other two in that it provides specific diagnostic critera - "Biochemical diagnosis of adult GH deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak GH < 5 µg/L) . . ."

[stat1951]

Originally Posted by cpeil2

HGH was only approved for treatment of Adult onset growth hormone deficiency recently 2004, I think. That letter predates this.

And yes, they do consistently maintain that growth hormone is not approved for any anti-aging use . . . . . meaning that they do not consider its use for diagnosed adult onset growth hormone deficiency to be an anti-aging use.


If you google "adult onset growth hormone defciency," you can find sources that define the disorder as narrowly as the JAMA article did. Significantly (because, as I said, the FDA must approve every single word of a package insert) neither of the package inserts for Saizen (Serono) or Nutropin (Genentech) define the disorder so narrowly. I haven't looked at the package insert for Humatrope, but I would imagine it would read about the same as the other two (if Lilly submitted an NDA for adult onset growth hormone deficiency).

cpeil2,

RE: HGH was only approved for treatment of Adult onset growth hormone deficiency recently 2004, I think. That letter predates this.

That would be very good then.

In fact, that would be excellent.

The question that would follow that up then, would be what specifically defines "adult onset growth hormone deficiency"? That phrase actuallyseems to be - according to multiple drug companies - as "Adult Growth Hormone Deficiency" or AGHD and that AGHD is what was specifically approved, but that appears to be just a matter of different names for the same thing as they seem to be used interchangeably.

http://www.prnewswire.com/cgi-bin/st...2812461&EDATE=

Would being mildly hypogonadal (low testosterone ranges but still within reference ranges) and moderately low IGF-1 / GH levels but still within reference ranges) qualify one to fit the definition of "adult onset growth hormone deficiency"? Or if one was even strongly hypogonadal but now had very good levels due to being on TRT but still had moderately low GH / IGF-1 levels, would that constitute as being "adult onset growth hormone deficiency" (since that would fit the profile of most posters who are wondering about the need for hGh)?

According to Serono, makers of Saizen, (as from the above link):

There are also studies indicating that patients with AGHD have an
increased risk of mortality from cardiovascular disease, possibly
attributable to their growth hormone (GH) deficiency. GH deficiency in adults can result from a pituitary or peri-pituitary tumor or as a direct result of the surgery/radiation used to manage these conditions. Less commonly, GH deficiency in adults arises from a deficiency acquired in childhood.

From the always helpful people at the Cushing's support people (as Cushing's often - but not always - develops situations with severely below normal ranges of GH / IGF-1):

The laboratory diagnosis of Growth Hormone Deficiency can be made by biochemical markers or provocative testing. Serum IGF-1 level is a useful indicator of the adequacy of Growth Hormone... The insulin tolerance test is the study of choice for provacative testing. A growth hormone release of less than ng/ml is response to insulin induced hypoglycemia is considered indicative of GHD. Alternative tests that use glucagon, propranolol, or levadopa may be used but have a lesser established diagnostic value... IGF-1 levels may also be reduced by poor nutrition, hepatic disease, poorly controlled diabetes, and hypothyroidism...

BTW, have you read the full article from JAMA? I read segments from the article as were posted early on by MedScape. I wonder if the authors themselvesd did discuss the use of hGh for AGHD and are simply referencing hGh use in purely "antiaging" situations?

Larry

P.S. AActually it appears - if I'm reading the info from the FDA correctly - that the FDA approved hGh for the use in AGHD quite a bit earlier, something like the mid 90s??? In which cae those letters would NOT "pre-date" the FDA decision. The FDA did expand the approval of hGh use in 2004 in five "new" areas...

As of 2004, hGh has been approved by the U.S. Food and Drug Administration for treatment of five other types of short stature:

Turner syndrome
Chronic renal failure
Prader-Willi syndrome
Intrauterine growth retardation
Idiopathic short stature (ISS)

No mention was made of AGHD - and most pharmaceutical companies seem to indicate an approval for AGHD much earlier (???). And FDA seems to indicate an approval for use in AGHD situations as early (possibly) as 1996 (???).

I gotta track down the full article - as I'm wondering if this academic discussion hasn't been arguing "apples versus oranges" all along....

[cpeil2]

Originally Posted by stat1951

cpeil2,

RE: HGH was only approved for treatment of Adult onset growth hormone deficiency recently 2004, I think. That letter predates this.

That would be very good then.

In fact, that would be excellent.

The question that would follow that up then, would be what specifically defines "adult onset growth hormone deficiency"? That phrase actuallyseems to be - according to multiple drug companies - as "Adult Growth Hormone Deficiency" or AGHD and that AGHD is what was specifically approved, but that appears to be just a matter of different names for the same thing as they seem to be used interchangeably.

http://www.prnewswire.com/cgi-bin/st...2812461&EDATE=

Would being mildly hypogonadal (low testosterone ranges but still within reference ranges) and moderately low IGF-1 / GH levels but still within reference ranges) qualify one to fit the definition of "adult onset growth hormone deficiency"? Or if one was even strongly hypogonadal but now had very good levels due to being on TRT but still had moderately low GH / IGF-1 levels, would that constitute as being "adult onset growth hormone deficiency" (since that would fit the profile of most posters who are wondering about the need for hGh)?

According to Serono, makers of Saizen, (as from the above link):


From the always helpful people at the Cushing's support people (as Cushing's often - but not always - develops situations with severely below normal ranges of GH / IGF-1):



BTW, have you read the full article from JAMA? I read segments from the article as were posted early on by MedScape. I wonder if the authors themselvesd did discuss the use of hGh for AGHD and are simply referencing hGh use in purely "antiaging" situations?

Larry

P.S. AActually it appears - if I'm reading the info from the FDA correctly - that the FDA approved hGh for the use in AGHD quite a bit earlier, something like the mid 90s??? In which cae those letters would NOT "pre-date" the FDA decision. The FDA did expand the approval of hGh use in 2004 in five "new" areas...



No mention was made of AGHD - and most pharmaceutical companies seem to indicate an approval for AGHD much earlier (???). And FDA seems to indicate an approval for use in AGHD situations as early (possibly) as 1996 (???).

I gotta track down the full article - as I'm wondering if this academic discussion hasn't been arguing "apples versus oranges" all along....

There are no ready answers to your questions, and that is why you could say that the law in this area is unsettled. The A4m's position is based on a narrow interpretation of the statute and a broad understanding of what constitute's an adult growth hormone deficiency. The JAMA authors' position is based on a broad interpretation of the law and a narrow view of adult growth hormone deficiency. Because the law has rarely, if ever, been enforced, there is no body of jurisprudence to guide anyone's thinking and behavior. It's new ground. We all know that executive agencies like the DOJ typically interpret statutes in a manner that gives them the broadest possible discretion. Many times, their interpretation of a statute turns out to have been improper. But it all has to be settled in the courts. The a4m recognizes this and that's why they have their legal team ready and waiting.

[Sunkist]

"Note that this article was from the October, 2005, issue of JAMA. I believe that the Feds specifically emphasized the placement of this article (as well as the recent enforcement action) to "get the word out" prior to more extensive enforcement activity. That would fully parallel their actions in prohibiting prohormones, currently working on legislation to prohibit OTC sales of DHEA, etc.

Larry"

This is scary stuff I agree. I hope the elderly contingent with their clout will help with the DHEA. Votes are all that get the attention of the pols to slow done the FDA, Pharma conglom from stopping anything that might keep us healthy. It is my belief that they decided to go after TRT one bit at a time: andro, DHEA, making Test a CIII... they want to make it so hard to do that no one will do it, and all steroids are sin.

If we are all heathy, how will they sell all their overpriced drugs? It is fine to stuff a million SSRI's down the gullets of a stranded population, but it is wrong to replace a normal substance in our own bodies? I think not.

[stat1951]

Originally Posted by Sunkist

" This is scary stuff I agree. I hope the elderly contingent with their clout will help with the DHEA. Votes are all that get the attention of the pols to slow done the FDA, Pharma conglom from stopping anything that might keep us healthy. It is my belief that they decided to go after TRT one bit at a time: andro, DHEA, making Test a CIII... they want to make it so hard to do that no one will do it, and all steroids are sin.

If we are all heathy, how will they sell all their overpriced drugs? It is fine to stuff a million SSRI's down the gullets of a stranded population, but it is wrong to replace a normal substance in our own bodies? I think not.

Excellent comment - and the main point that I've been trying to make. I believe that there's two elements at play here. One is the element that confuses hormones like DHEA and Testosterone with artificial androgens such as anabolic steroids (one being natural hormones of the body and the other not). That element then gets influenced by the other element who has financial reasons for removing those natural bioidentical (basically) hormones from easy access by the consumer who legitimately needs those therapies.

As we are watching that happen currently (recent banning of prohormones, current legislation to remove DHEA as an OTC supplement, this "coincidental" printing of this controversial article in JAMA, warning letters - verified - being sent out by the FDA, claims made concerning enforcement actions having been already conducted, etc., etc.), I have no doubt that you are right as to what is "apparently" going on. And I agree with you that it's not right... but our unspoken personal opinions are not likely to mean very much.

As this relates to the IGF-1 / hGh position, my concern is that a step up of enforcement will strongly convince many antiaging doctors to step back from prescribing hGh simply to avoid the Federal hassle. Many don't belong necessarily to A4M so won't have access to that legal team (besides which, I wonder, is A4M going to pick up the total cost of that legal defense or will the clinic / individual doctor be responsible to all or some protion of those extensive legal costs???).

And here's how the process works (been there, done that):

1. The individual gets indicted for the offense. Generally the Feds will use undercover agents to make multiple visits so they can get numerous "counts" of violation. That way they can indicted for ten or twenty (or whatever) counts of felony violations in their indictment.

2. Now at this point, things don't go "on hold" while there's some kind of academic / legal debate going on between the defense team and the authorities about the fine points and interpretations of the law. That might be how it works with FDA regulations (don't know, haven't been there). But with criminal law violations, the individual then gets formally charged with those multiple-count indictments - and goes to trial.

3. There's then a trial. At a minimum, several months go by befoer the trial. If you get convicted, then your defense team - if they believe you have a valid appeal point (or the money for them is there either way) - then you file an appeal. If you win, then the prosecution (DOJ) files an appeal. The appeal process takes at least several months. If the appeal goes beyond the first levels then the process is going to take at least a couple of years more. In both cases there's a considerable extra level of legal expense.

4. Generally during this whole process the Feds get a specific court order to either (A) shut down your practice, or at least to (B) halt the practice being disputed via the indictments.

5. On top of that, even if not completely shut down, you then lose a lot of new customers (patients) and even have quite few of established customers (patients) drift away because of the stigma involved of being an "indicted felon". So the business - if allowed even to stay open - ends up losing a lot of business. And... guess what happens with insurance rates?

6. And if you win, there ends up being no one you can sue. You cant sue the DEA as they were enforcing a law on the books with legally executed search warrants and arrest warrants based on grand jury indictments. You can't sue the grand jury. You can't sue the DOJ prosecutors (they have qualified immunity). And you can't sue the Federal courts (as judges have full immunity).

So you can end up "winning"... but losing everything in the meantime. Most of their business. Their health. Their mental health (the anguishes involved are unbelievable to anyone who hasn't been through the process). Sometimes their marriages and othe family relationships. So in pursuing their agendas, the Feds openly understand that even when they "lose", you don't necessarily "win" and a certain point is still being made.

And of course if you lose then you're facing Federal prison time and some unbelieveably steep monetary fines.

So of course the idea of A4M having a legal team in place to defend their members is a great idea. Excellent. But even more effective of a strategy would be to ALSO initiate an extremely strong lobbying effort to either get the law repealed or to get it amended. Even better yet would be to openly ally with groups that are springing up to address concerns with either the banning of DHEA and / or the concerns of CODEX being adopted and supplements in generally becoming highly restricted... after all, there IS strength in numbers.

But then that's just my opinion.... I think that they key here will be to see which way the Feds move with this issue. Was the appearance of this article in JAMA simply conincidental? Or was it a "planted article" that is a part of that "step-by-step" approach to get the message out and "make their point"? Unfortunately, only time will tell.

Larry

P.S. If anyone is interested, I contacted a long-time acquaintance of mine who is a professional legal researcher for a law firm and received an e-mail response that the criminal statute being referred to here is "21 U.S.C. 333(e)". He seemed to be quite interested in this topic and I believe is going to be doing some specific research on it (not that I didn't kind of help him along in coming to that point of interest with a little "encouragement").