igf-1 and trt

[stat1951]

I e-mailed JAMA and asked if possibly this article had not been reviewed by the editorial staff as extensively as it should have been, I pointed out that at kleast hundreds of doctors and clinics currently offer HgH very openly for antiaging purposes and queried as to whether there maybe wasn't an error on what the FDA and/or Secretary of Health was allowing...

This is the reply that I received:

JAMA stands behind the articles it publishes. JAMA is editorially independent from AMA.

Sincerely,

Margaret A. Winker, MD
Deputy Editor, JAMA
Director, Division of Scientific Online Resources
phone 312-464-2486
fax 312-464-5824
margaret.winker@jama-archives.org

So obviously JAMA is standing behind the article 100% and accepts it as having been well-researched and accurate.

Actually will cover next levels of communications in the following post as their replies were a little bit longer!

Larry

[stat1951]

OK, here's what I received back from the FDA:

Dear Larry,

Thank you for your message to the Division of Drug Information in the Center
for Drug Evaluation and Research (CDER).

Use of human growth hormone is governed by 21 U.S.C. 333(e)(1), which
provides: "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. . . 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". Please note that this provision explicitly
prohibits "off-label" use of approved human growth hormone drug products.
There are no recombinant human growth hormone (somatotropin) products that are approved by the FDA for anti-aging treatment. The citation is located at:

http://frwebgate.access.gpo.gov/cgi-...Cite:+21USC333.

You can locate the approved uses for human growth hormones in the approved labeling of the specific drug products at:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

You may find the following information helpful:

FDA Letter to Dr. Perls Regarding Distribution of GH for Anti-Aging:
http://www.bumc.bu.edu/www/BUSM/Cen/images/oct_2004.pdf

HGH-Related Alerts From the National Institute on Aging (NIH) and the
Federal Trade Commission:
http://www.ftc.gov/bcp/conline/pubs/alerts/hghalrt.pdf
http://www.ftc.gov/opa/2005/10/pacherbal.htm

FDA Warning Letters:
http://www.fda.gov/foi/warning_letters/g4543d.htm
http://www.fda.gov/foi/warning_letters/g3461d.htm

Thank you again for your message. We hope that the above information will
help answer your question.

Sincerely,
Codruginfo

And here is what I received - in a rather abrupt format - from the DOJ (tthese are the main ssegments, as many sections got into discussing laws involving steroids from back several decades ago, etc., etc.):

In 1990, Congress enacted more stringent controls with higher criminal penalties for offenses involving the illegal distribution of anabolic steroids and human growth hormone. This new legislation, which was enacted as part of the Anabolic Steroids Control Act, Pub.L. No. 101-647, title XIX, §§ 1901-05, resulted in a reconfiguration of the statutory scheme regulating the distribution of both anabolic steroids and human growth hormone. The 1990 Act reclassified anabolic steroids as Schedule III controlled substances, effective February 27, 1991.[FN5] See 21 U.S.C. § 812(c) (1992). The 1990 Act also amended 21 U.S.C. § 333(e)(1) to explicitly criminalize as a five-year felony the distribution and possession, with intent to distribute, of human growth hormone "for any use . . . other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Human Services . . . and pursuant to the order of a physician . . . ."[FN6] Pub.L. No. 101-647, title XIX, § 1904 (codified at 21 U.S.C. § 333(e)(1) (1992)). The 1990 Act also provided that criminal forfeiture would be available as an additional penalty for convictions involving illegal distribution of human growth hormone under the newly amended 21 U.S.C. § 333(e)(1). See Pub.L. No. 101-647, title XIX, § 1904 (codified as 21 U.S.C. § 333(e)(3) (1992))....

Prosecuting distribution of human growth hormone is different from virtually any other drug prosecution under the FDCA. Among other things, proof of interstate distribution of the drug is unnecessary. Additionally, the mens rea requirement for a felony is "knowing distribution" or "knowing possession with intent to distribute," not "intent to defraud or mislead."

Thus, prosecuting non-physicians for distributing human growth hormone is akin to prosecuting a narcotics case under the Controlled Substances Act. As a result, establishing liability in such cases is simpler than for other FDCA offenses. This is particularly true because the only two authorized manufacturers of human growth hormone (Genentech and Eli Lilly) have both established stringent restrictions over the distribution of their products to ensure that only physicians can gain access to the drugs. Under the current restrictions, only hospital pharmacies can order the drug; local pharmacies cannot. Thus, most non-physician cases involving the distribution of human growth hormone will involve one of three scenarios: (1) diverted human growth hormone, obtained either through theft or via a drug-dealing physician; (2) smuggled human growth hormone; or (3) counterfeit human growth hormone.

Prosecuting a physician brings other considerations into play. Because section 333(f)(1) allows physicians to distribute human growth hormone in connection with either (1) "treatment of a disease" or (2) "other recognized medical condition" which has been authorized by the Secretary of Human Services...

Moreover, application of U.S.S.G. § 2F1.1(b)(4) (2-level enhancement because the offense involved conscious or reckless risk of serious bodily injury) should be sought as matter of course. This is because human growth hormone is a potentially dangerous drug, which when used by adults can lead to diseases having significant mortality rates. Its misuse in adults poses a wide array of serious side effects, including significant cardiovascular disease, irreversible enlargement of the heart, and development of polyps and malignancies of the colon...

Just wanted to make sure this info got passed along before the e-mails got filed and promptly lost!

Larry

[cpeil2]

So the basic question remains: "What constitutes adult onset human growth hormone deficiency?"

[Sunkist]

I have a relationship with an MD/PhD ethicist. One of his main considerations is organ donor allotments.. for obvious reasons, and they go over who gets what.

To the point: One of the things his group is currently looking at is person's right to recieve non mood/conscious altering substances for his own use, and conversely, the right to limit this for supposed prevention of 'self harm'... for in concert with this idea... this is the only applicable concept for a substance that when used or ingested will/could not HARM another. ( We all know that this has other constructs such as licensure, and who makes money from what, but ethically this should be the only consideration.)

I see a trend coming from the ethical body who tend to be somewhat liberal here in looking at a change in the status quo: in direct consideration of the stance of big pharma and the FDA. Had not transplants come along, the ethical consideration of a person's individual right to purchase/ decide/ donate would never be considered as an adjunct. I paper on this is coming out in the next 12 months are so, I am given to believe. It is still the ant and the elephant, but who knows. DHEA may unite some strange allies.

I do believe again the restriction of substances that might make one less likely to get sick, or need meds is a prime consideration of the FDA's alignment with pharmaceutical companies. I can't for the life of me see another possible reason with the evidence that is out there on some of this stuff.

[cpeil2]

I also think that the law's current position toward hGH use is an artifact from before the recombinant product was available. In the mid-20th century, very limited amounts of HGH were available, extracted from cadaver pituitary glands. The stuff was so expensive and in such short supply that any use of it other than for growth disorders in children was considered frivoluous. It was a zero-sum game: any use of it by an adult deprived someone else who had what was then seen as a more legitimate need.


The arrival of recombinant products has changed all that. The stuff is plentiful and relatively inexpensive. But attitudes in the medical profession and among lawmakers have not kept up with the increase in the availability.

[hackskii]

I used to buy HGH and it is legal with a scrip similar to HCG.

IGF-1 is higher in women then men and this is due to estrogen (from what I have read).

HGH does raise IGF-1 too.

HGH gets released by the pituitary gland during REM sleep.
With the presence of insulin GH does not get released from the pituitary gland, so those high carb meals before bed are a no no.

I have tried HGH and I actually like it alot.
Not much bang for the buck but for long term life extension use it is 1iu a day for many months.
The benefits are mainly seen over long periods of time like, softer skin, increased fat loss, muscle gain, better concintration, etc.

But for me it was the super deep sleep and the wild dreams, not nightmares but some of the most vivid dreams I have ever had.
I did have a sense of well being on it though.
Oh and the best part........Lost 4" on my waist and only about 3 lbs of bodyweight.
Seems it has a localised fat loss and is sub-Q right into the fattest part of the stomach.

Night time apps are the best time as GH is released at this time.

It is expensive and the stomach will come back if you eat the same as were on

I really like it but it is expensive and happens to be faked alot.

I got mine delivered right to my door, it is not illegal, they cut you a scrip and there are many places that will run your blood and perscribe it to you.

The older you are the better it works too.

[pmgamer18]

hackskii post does not show up unless you post back.

[cpeil2]

Originally Posted by hackskii

I used to buy HGH and it is legal with a scrip similar to HCG.

IGF-1 is higher in women then men and this is due to estrogen (from what I have read).

HGH does raise IGF-1 too.

HGH gets released by the pituitary gland during REM sleep.
With the presence of insulin GH does not get released from the pituitary gland, so those high carb meals before bed are a no no.

I have tried HGH and I actually like it alot.
Not much bang for the buck but for long term life extension use it is 1iu a day for many months.
The benefits are mainly seen over long periods of time like, softer skin, increased fat loss, muscle gain, better concintration, etc.

But for me it was the super deep sleep and the wild dreams, not nightmares but some of the most vivid dreams I have ever had.
I did have a sense of well being on it though.
Oh and the best part........Lost 4" on my waist and only about 3 lbs of bodyweight.
Seems it has a localised fat loss and is sub-Q right into the fattest part of the stomach.

Night time apps are the best time as GH is released at this time.

It is expensive and the stomach will come back if you eat the same as were on

I really like it but it is expensive and happens to be faked alot.

I got mine delivered right to my door, it is not illegal, they cut you a scrip and there are many places that will run your blood and perscribe it to you.

The older you are the better it works too.

Of course hGH is legal, but only for the uses the FDA has approved it for. It is against US federal law to use it for anything other that its approved indications. Thus, unlike most other medications, it is illegal for a doc to prescribe it for off-label use.

[hackskii]

Possibly but I did buy it from Mexico to ship strait to my door with zero problems.

Also places like Florida Rejuvination center can get you into their life extension program too and you can get it that way legal too.

Or places in Palm Springs do this too.

I am saying it can be purchased and I have bought it myself a number of times but it is expensive.

[cpeil2]

Originally Posted by hackskii

Possibly but I did buy it from Mexico to ship strait to my door with zero problems.

Also places like Florida Rejuvination center can get you into their life extension program too and you can get it that way legal too.

Or places in Palm Springs do this too.

I am saying it can be purchased and I have bought it myself a number of times but it is expensive.

It's pretty easy to get a script for it. But this entire thread is devoted to the question of whether or not those scripts, even from legitimate, well-meaning age management docs, are legal or not. They may not be.

[stat1951]

Originally Posted by cpeil2

It's pretty easy to get a script for it. But this entire thread is devoted to the question of whether or not those scripts, even from legitimate, well-meaning age management docs, are legal or not. They may not be.

Thanks!!!

You finally hit the nail on the head!

Yes, hundreds - maybe thousands - of antiaging doctors are prescribing it - and for off-label uses - and therefore in violation of the law. There supposedly has been enforcements (in the last few months) of at least one case supposedly in Hawaii and one in Florida.

And then the article in JAMA???

Coincidence?

Sure.....

That's the way the Feds work. Send some "messages" out first, to give the docs a chance to get away from that practice... so when serious enforements start, no one can say, "Well, jeez, I didn't know". And Congress specifically mandated that the DEA enforce this violation - and not the FDA. And this violation is a significant felony. So improperly prescribing HgH - whether you agree with it or not and whether you like it or not - can technically be considered in the same realm (legally) as selling steroids... in fact, I believe that the legal language in the US Code is in the same section as that which covers steroids.

And as to: "adult onset human growth hormone deficiency", the FDA does specifically interpret what consitutes a legal use of HgH in that area....

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....

If you note, what it says is that HgH is approved by the FDA specifically for not "adult onset human growth hormone deficiency" in general, but then with this big gray area as to what then defines that, the FDA says:

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

That is a specific medical disorder and is determined by specific chemical and imaging tests.

And I am sure that the doctors dealing in HgH for these types of off-label uses will vigorously fight these enforcements... that would only make sense as anyone would do so facing a felony conviction that they disagree with. But understanding what the law says versus what one would like it to say is the first step needed in preparation to confront such an issue.

Personally, I'd love to see A4M and some of the many other medical and health organizations use their clout to work at getting the law changed - rather than simply establishing self-defense funds to provide legal aid to any doctors facing enforcement (not that the latter element isn't also important).

Larry

[HeadDoc]

as the head docs in A4M use hgh themselves, I would think they are motivated to take this course.

[love_en]

Does anyone know when that doctor in Hawaii got prosecuted for prescribing HGH? The timing of that action may have a lot to do with why doctors here will not treat my hypogonadism. If a doctor gets hung for non-scheduled HGH, I can just imagine what happens to a doctor who prescribes testosterone. On paper, I believe the crusade against HGH has a lot to do with how it is used for athletic enhancement. However, I am with the conspiracy theorists in saying that it is not in the best interest of mainstream medicine to keep people healthy with replacement doses of hormones. Thinking futher, this might be the reason why you need to test almost zero on a cortisol test before you will be treated for adrenal insufficiency. There is more money to be made if you are sick with anxiety/depression, arthritis, allergies, IBS and fatigue.

[cpeil2]

Originally Posted by love_en

If a doctor gets hung for non-scheduled HGH, I can just imagine what happens to a doctor who prescribes testosterone.

HGH isn't scheduled at the federal level, but I believe one or two states have scheduled it. Even if it isn't scheduled at the federal level, 21 USC § 333(e) prohibits the distribution or possession with intent to distribute hGH for any use in humans other than for uses approved by the HHS Secretary and pursuant to a valid prescription. If convicted, the party can be imprisoned for up to ten years, depending on circumstances.

[Sunkist]

That is exactly why docs like Swale, et al., need to be protected by us. I get my blood draws and vitals regularly, and they go into my DO's records. I cannot self Rx by law, and obviously that is not my field as well.

I also will go to court and sue as necessary if anything ever happens... it is my personal right to receive something that is not harmful to others... unless the others are health care entites that don't receive my money for their medications.

My last thought.. why has not the huge insurance industry entered into the frey? They would save a lot of money from not paying for illness if they supported anti-aging and TRT physicians.