igf-1 and trt

[stat1951]

Originally Posted by Vforcer2

Larry, thanks for the posted research and info. It was interesting.

Since your IGF-1 levels are consistently high, do you look young for your age, have soft supple skin, less wrinkles, above average muscle mass, better immune system, etc?

Unfortunately I don't know what my IGF-1 levels were before this hypercortisolism / hypogonadal condition developed.

So were my levels consistently high over my lifetime? Or have they been elevated just since this condition as a part of my body's response to fight that condition?

1. Do I look young for my age? Hmmm.... I like to think that I do a little bit....

2. Soft supple skin? Definitely not.

3. Wrinkles? Hmmm... no, not really. (Light brown hair / mustache have definitely turned white/gray however!)

4. Above average muscle mass? Yes, definitely. But was into power lifting and heavy weight training up until my second round of neck / spinal surgery in 1998, and have retained quite a bit of muscle mass.

5. Immune system? Seems to be a toss up. I seem to get slightly less flus or colds than the family in general, but then when I do get a bug it seems to last longer.

Larry

[stat1951]

Originally Posted by novice

My IGF-1 is 255 and I am 27 years old. I always thought TRT raises IGF-1. Would I benefit from HGH?

255 is mid range for age 27, fairly close even to being in the "upper quarter" (which would be pretty much the optimal range). Since your age range is 117 - 329, the upper quarter of that range would be from 276 - 329, so I think your levels are actually pretty decent.

Personally I believe that TRT does improve IGF-1 levels, but as with most natural hormonal changes, it's a pretty slow steady process. Personally I would think that benefits of HGH would be minimal, but then I'm a layman so that's strictly IMHO as based on the numbers.

BTW, personally I would ignore the ranges at the higher age levels and focus on aiming for a range that would be considered optimal for the age group(s) of 26 - 35... something in the range of 275 - 350.

As relates to the HGH, there's a thread discussing some cautions as to the prescription of HGH...

Using HGH to lower SHBG

Growth Hormone Deemed Illegal for Off-Label Antiaging Use - Medscape, 10/28/05 - "1988 and 1990 amendments to the Food, Drug, and Cosmetic Act (FDCA) make off-label distribution or provision of GH to treat aging or age-related diseases illegal in the U.S."

Oct. 28, 2005 — Growth hormone (GH) is illegal for off-label antiaging use, according to an article in the Oct. 26 issue of JAMA. This article reviews the literature concerning the uses and adverse effects of GH as well as the legal ramifications of selling, using, or prescribing it.

"Prescribing and administering GH has become a routine intervention in an industry that is variably called anti-aging, regenerative, longevity or age management medicine," lead author Thomas Perls, MD, MPH, from Boston University School of Medicine in Massachusetts, said in a news release. "Hundreds of thousands of patients who have received GH in recent years as a purported treatment for aging are unaware that they are receiving the drug illegally."... The FDA has approved GH only for GH deficiency-related syndromes causing short stature in children, adult GH deficiency caused by rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV and AIDS... "Off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone," says coauthor S. Jay Olshansky, PhD, from the University of Illinois at Chicago School of Public Health. "According to laws instituted by Congress more than 10 years ago, HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them. The use of HGH as an alleged antiaging intervention is a major public health concern not just because it is illegal, but also because its provision for antiaging is not supported by science and it is potentially harmful."... Although GH, unlike anabolic steroids, is not a schedule III drug, Congress specifically authorized the Drug Enforcement Agency to investigate offenses related to HGH distribution. The penalties for distribution or provision of GH for antiaging purposes may include up to five years in prison, or 10 years if the offense involves a minor, with fines of up to $250,000 for an individual or $500,000 for an organization, or alternatively, twice the gross gain or loss from the offense, in addition to forfeiture of property used in or derived from violations of the HGH law...

Larry

[novice]

Wow that sounds serious. I thought HGH was commonly prescribed for antiaging purposes.

[HeadDoc]

Originally Posted by novice

Wow that sounds serious. I thought HGH was commonly prescribed for antiaging purposes.

based upon need HGH is prescribed for antiaging purposes by physicans trained in antiaging medicine. Not enough docs are trained in antiaging medicine.

[cpeil2]

Originally Posted by novice

Wow that sounds serious. I thought HGH was commonly prescribed for antiaging purposes.

One of the approved indications for GH is adult growth hormone deficiency secondary to hypopituitarism. Since the appearance of the JAMA article, the A4M is taking the position that GH deficiency in an adult is a reliable sign of hypopituitarism, i.e. that any adult whose IGF-1 level (and therefore their GH level) is low has a diseased pituitary gland.


I don't know anything about diagnosing pituitary problems. That may be a reasonable position. But I'm not sure the FDA and/or the DOJ will be persuaded.

[stat1951]

Originally Posted by HeadDoc

based upon need HGH is prescribed for antiaging purposes by physicans trained in antiaging medicine. Not enough docs are trained in antiaging medicine.

Yes, antiaging physicians do prescribe for that purpose, but it IS illegal... please read the above article again in detail. Notye emphasized sections below.

It is my understanding that DEA has already made arrests for prosecution by DOJ of at least one doctor (Hawaii, I believe it was) for violating this law.

The FDA has approved GH only for GH deficiency-related syndromes causing short stature in children, adult GH deficiency caused by rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV and AIDS... "Off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone," says coauthor S. Jay Olshansky, PhD, from the University of Illinois at Chicago School of Public Health. "According to laws instituted by Congress more than 10 years ago, HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them. The use of HGH as an alleged antiaging intervention is a major public health concern not just because it is illegal...

I believe people should be cautioned as to what the law actually is - whether they agree with it or not - and not just discussed as simply what "everyone else is doing"... just so they can be aware of the risks in case they happen to be caught up in the next "example" that the Feds decide to focus on. If individuals and doctors choose to ignore the legal violation and proceed forward with such treatment then at least do so knowing the risk(sO of felong convictions.

Congress specifically authorized the Drug Enforcement Agency to investigate offenses related to HGH distribution. The penalties for distribution or provision of GH for antiaging purposes may include up to five years in prison, or 10 years if the offense involves a minor, with fines of up to $250,000 for an individual or $500,000 for an organization...

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

[1cc]

Originally Posted by stat1951

Yes, antiaging physicians do prescribe for that purpose, but it IS illegal... please read the above article again in detail. Notye emphasized sections below.

It is my understanding that DEA has already made arrests for prosecution by DOJ of at least one doctor (Hawaii, I believe it was) for violating this law.



I believe people should be cautioned as to what the law actually is - whether they agree with it or not - and not just discussed as simply what "everyone else is doing"... just so they can be aware of the risks in case they happen to be caught up in the next "example" that the Feds decide to focus on. If individuals and doctors choose to ignore the legal violation and proceed forward with such treatment then at least do so knowing the risk(sO of felong convictions.



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

I can't believe how rediculous this is. I believe that doctors can prescribe almost any medication for off label conditions, so why should HGH be any different. There was a doctor from Australia who once said that ulcers were caused by the H.pylori bacteria and could be treated with anti-biotics. At the time I don't believe there was any cure for ulcers, and he was ridiculed for his belief and for prescribing anti-biotics to cure ulcers. He went so far as to drink a cocktail of H.pylori bacteria in order that he could develop an ulcer to prove his point. He did finally prove his point by developing an ulcer and then curing himself with anti-biotics. He was recently awarded the Nobel prize for his work in this area.

The benefits of HGH for anti-aging purposes are almost beyond dispute considering the number of doctors that have prescribed it and seen evidence of it's effects, not to mention the amount of doctors that have actually used HGH themselves and have experienced first hand the benefits of HGH. This leads one to an inevitable conclusion that there is a conspiracy to keep people frail and sick in order that they can continue to consume the numerous medications that the drug companies produce.

[cpeil2]

Originally Posted by stat1951

Yes, antiaging physicians do prescribe for that purpose, but it IS illegal... please read the above article again in detail. Notye emphasized sections below.

It is my understanding that DEA has already made arrests for prosecution by DOJ of at least one doctor (Hawaii, I believe it was) for violating this law.



I believe people should be cautioned as to what the law actually is - whether they agree with it or not - and not just discussed as simply what "everyone else is doing"... just so they can be aware of the risks in case they happen to be caught up in the next "example" that the Feds decide to focus on. If individuals and doctors choose to ignore the legal violation and proceed forward with such treatment then at least do so knowing the risk(sO of felong convictions.



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

Larry, I think you should be mindful of the fact that you are not quoting a primary source. The JAMA article was authored by individuals having an obvious bias against anti-aging therapies. It is important to note that they state the diagnostic criteria for Adult Growth Hormone Deficiency very narrowly, when in fact, they are vague enough to allow considerable interpretation.

They state "adult GH deficiency caused by rare pituitary tumors and their treatment . . . ."


Here is a draft package insert for Saizen from the FDA website. The language in the draft is identical to that in the package insert that you can download from Serono's web site.

It gives the diagnostic criteria for Adult Growth Hormone Deficiency as:

Adult onset:

Patients who have growth hormone deficiency . . . as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy or trauma . . .

Growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test.

I don't have a link for it, but the package insert for Genentech's product is even more vague - the condition should be "biochemically diagnosed."

Based on these documents, the A4M's position that someone having a low IGF-1 level has pituitary disease appears more reasonable. I imagine it is evidence at least of pituitary insufficiency.

[HeadDoc]

Here is the response of Dr. Ron Rothenberg to the JAMA article. Please note that many docs practicing HRT after training not only prescribe HGH, they sell it.

http://ehealthspan.com/download/Resp...GH_Article.doc

[LiquidGib]

Originally Posted by 1cc

I can't believe how rediculous this is. I believe that doctors can prescribe almost any medication for off label conditions, so why should HGH be any different. There was a doctor from Australia who once said that ulcers were caused by the H.pylori bacteria and could be treated with anti-biotics. At the time I don't believe there was any cure for ulcers, and he was ridiculed for his belief and for prescribing anti-biotics to cure ulcers. He went so far as to drink a cocktail of H.pylori bacteria in order that he could develop an ulcer to prove his point. He did finally prove his point by developing an ulcer and then curing himself with anti-biotics. He was recently awarded the Nobel prize for his work in this area.

damn, that's pretty interesting! Any more info on this? Any links, I wanna read more about this doctor

[stat1951]

Originally Posted by HeadDoc

Here is the response of Dr. Ron Rothenberg to the JAMA article. Please note that many docs practicing HRT after training not only prescribe HGH, they sell it.

http://ehealthspan.com/download/Resp...GH_Article.doc

I understand that many antiaging doctors are "up in arms" over that article, Rather than shooting the messengers, those doctors should be working hard to get the law changed. The information quoted in that article IS the law. If you don't believe it, call up your local area FDA representative or FDA representative - as I did - and they will confirm it. That part of the message in the article was NOT something made up by those authors... it IS the law.

And, yes, many antiaging doctors and TRT doctors sell HGH... that was the whole point of the article - and the enforcement action taken was against a doctor (again, I believe that it was in Hawaii, but not 100% sure) who was in fact selling the product.

Personally, I believe that HGH should be available to doctors for reasonable use (i.e., even "off label" use) as with just about any other medication. But I also believe that there's a duty to caution people as to what the law actually is. There is a definite mindset at the Federal level to begin reducing access to these types of positive health measures for older individuals. We are seeing it in the attacks already conducted on prohormones and the current attack on DHEA (with legislation proposals currently before Congress to ban DHEA from OTC sales... I posted a previous thread about that fact and with a link on how to contact your specific legislators and urge them to vote against that bill... the thread didn't seem to gather much attention).

But it is simply irresponsible to argue that the article is incorrect and that the authors are simply making this up. One disagreeing with the validity of a particular law doesn't mean that it's no longer a criminal violation.

cpeil2,

I agree completely with this point:

I think you should be mindful of the fact that you are not quoting a primary source. The JAMA article was authored by individuals having an obvious bias against anti-aging therapies. It is important to note that they state the diagnostic criteria for Adult Growth Hormone Deficiency very narrowly, when in fact, they are vague enough to allow considerable interpretation.

Unfortunately, that does not negate the language of the law - and the fact that enforcement activity will be based upon the interpretation of the DEA and DOJ.

Changing the law - with strong consumer activism as well as strong influnce actions by antiaging and HRT doctors - to me would be a far better approach rather than depending on fine-splitting of hairs on definitions between the A4M on one hand and the Department of Justice teams of lawyers on the other!

Personally, I also believe that there's a lot of truth to what 1cc has to say:

This leads one to an inevitable conclusion that there is a conspiracy to keep people frail and sick in order that they can continue to consume the numerous medications that the drug companies produce.

Just so everybody has it straight, I agree with your positions and favor the reasonable use of HGH far beyond what the statutory language indicates. I simply posted information of a cautyionary nature so that people approach these situations well aware of "potential" risks...

And I fear that at some point the same Federal mindset will take similar drastic actions against Testosterone itself (see 1cc's comments) if a stand isn't taken somewhere and somehow. Some might consider that somewhat paranoid, but I simply look at the record of what has gone on so far.

Larry

[HeadDoc]

this reflects the same political mentality that shuns stem cell research.

[1cc]

Originally Posted by HeadDoc

this reflects the same political mentality that shuns stem cell research.

Those who oppose stem cell research do it on the basis of moral ethics. The issue against HGH and other hormones has nothing to do with morals or ethics. Matter of fact there seems to be no logical reason as to why they are so against these drugs. All the evidence points to the fact that people who use them, get better and live more healthier lives and are sick less frequently. How can this be bad.

[cpeil2]

Originally Posted by stat1951

Unfortunately, that does not negate the language of the law - and the fact that enforcement activity will be based upon the interpretation of the DEA and DOJ.

Larry, first let me start by saying that I agree with you completely, that given the current climate, and the current unsettled state of the law, that patients and practitioners alike need to approach HGH therapy with their eyes open, knowing that they may be risking prosecution.

I would like to point out, though, that the law doesn't permit DOJ and/or DEA to determine what is and is not a proper use of HGH. Under the language of the statute, enforcement agencies must look to FDA for guidance as to what an improper use is. The recent Supreme Court decision regarding the Oregon assisted suicide law is an indication that the courts take a dim view of the Attorney General attempting to practice medicine.

The FDA has already spoken in this regard. By approving NDA's for HGH as a treatment for Adult Growth Hormone Deficiency, wherein the NDA's define the disorder broadly, the FDA has expressed what it considers to be proper use of HGH in treatment of adults. Additionally, the FDA has said that any use of HGH for anti-aging purposes is illegal. However (and this is only my opinion), the FDA has not defined "anti-aging" purposes with any specificity. Thus, the FDA's statement on the topic cannot be said to provide practitioners and patients with fair notice of what is and is not illegal.

Given the current state of the law, I would say that a practitioner who prescribes HGH without any laboratory evidence of pituitary insufficiency has good reason to fear prosecution. I think it is arguable that at least some laboratory evidence of pituitary or hypothalamic disease, e.g. low IFG-1, secondary hypogonadism, places the practitioner (and the patient, of course) within the law.

And yes, since I fundamentally agree with your call for caution, the above discussion is largely academic.

[stat1951]

Originally Posted by 1cc

Those who oppose stem cell research do it on the basis of moral ethics. The issue against HGH and other hormones has nothing to do with morals or ethics. Matter of fact there seems to be no logical reason as to why they are so against these drugs. All the evidence points to the fact that people who use them, get better and live more healthier lives and are sick less frequently. How can this be bad.

1cc,

Actually, it is an ethical issue, but in the other direction (see your initial comments as referencing potential conspiracy concerns). IMHO, the ruling society prefers that as we age that we spend more extensive money over a longer time period by simply being less healthy and therefore needing to consume more and more expensive pharmaceuticals. Llook at the sheer number of pharmaceutical medications aired as ads on TV today... those ads aren't aimed at doctors, but at the consumer... So the giant pharmaceutical companies and the giant food corporations are making out like bandits... (almost as well as Exxon Mobil - )...

So from that viewpoint, those agencies and organizations and individuals who are mandating the restriction and criminal enforcement of HGH off-label use ARE being unethical and immoral...

I do know that legislative representatives are concerned primarily with getting re-elected (or elected to a higher office) and that concerns over votes can and often do outweigh lobbyist influence. So joining with existing organizations who are fighting to save supplement on general and - right now - DHEA is simply a good idea. Once a couple of "battles" are won then unreasonable restrictions on reasonable use of HGH could be tackled to remove criminal enforcement penalties for it's off-label usage.

Personally I believe that this type of thing is all the more reason for individuals to become more of activitists in matters such as these - even to just a small degree. E-mailing one's representatives takes only a few minutes - and spreading the word around to interested friends and family to also do so takes only a couple of more minutes. It seems being pro-active in that regard might be a better strategy than simply sitting back and hoping that the courts will rule the right way and overturn unreasonable laws.

Larry


P.S. cpeil2: yes, it will be interesting to see the direction that DEA and the DOJ goes in addressing th8is situation. There is an element that clearly expresses the strict definition that HGH is legal ONLY for the specified disorders that were spelled out... I noted that the language actually states "HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them"...

In regards to: The recent Supreme Court decision regarding the Oregon assisted suicide law is an indication that the courts take a dim view of the Attorney General attempting to practice medicine. , I believe that the difference here is that the Attorney General is enforcing a law that has been on the books as enacted by the Federal congress roughly ten years ago... and like you said, the primary need for caution is evident as "the above discussion" is indeed largely academic (and I know that I sure as heck wouldn't want to be part of a test case!).

Fortunately, my IGF-1 levels have been very good (exceptionally so as of the last time they were checked), so I currently don't have a problem in that direction. Personally, I believe that TRT treatments themselves help maintain positive levels of IGF-1 and growth hormones - plus I also find the indicators of low-dose selegeline possibly boosting IGF-1 levels to also be intriguing.