[NEWS] Growth Hormone Illegal for Off-Label Anti-Aging Use

[Millard]

Because of 1988 and 1990 amendments to the Food, Drug and Cosmetic Act, off-label distribution or provision of human growth hormone to treat aging or age-associated illnesses is illegal in the United States, according to a report in the Journal of the American Medical Association.

The findings, which were peer-reviewed by independent experts and by the journal's legal counsel, appear in the Oct. 26 issue.

A team of three noted health researchers revealed a largely unknown and unenforced law that thousands of entrepreneurs and physicians are breaking. The authors are Dr. Thomas Perls, director of the New England Centenarian Study at Boston Medical Center and associate professor of medicine at Boston University School of Medicine; Dr. Neal Reisman, clinical professor of plastic surgery at Baylor College of Medicine and associate chief of plastic surgery at St. Luke's Episcopal Hospital, who is also an attorney; and S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago School of Public Health.

Human growth hormone, or HGH, is a substance released by the pituitary gland that spurs growth and development in children and adolescents. As a drug, it can be prescribed legally only for three rare conditions: HGH deficiency-related syndromes that cause short stature in children, adult HGH deficiency due to rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV/AIDS. According to the U.S. Food and Drug Administration, any and all other uses of the drug, including the off-label use as an alleged treatment for aging and its related conditions, are illegal.

But many Web sites and anti-aging clinics market HGH with claims that the hormone stops and reverses aging and provides many other benefits, including improved nail and hair growth, better sleep, improved skin tone, better digestion, increased strength, weight loss, better eyesight and enhanced sexual function.

"Prescribing and administering HGH has become a routine intervention in an industry that is variably called anti-aging, regenerative, longevity or age management medicine," said Perls. "Hundreds of thousands of patients who have received HGH in recent years as a purported treatment for aging are unaware that they are receiving the drug illegally.

"Although there is no evidence that HGH administration stops or reverses aging, many people spend a great deal of money on these products," Perls said. "On the contrary, responsibly conducted and peer-reviewed science indicates that HGH could in fact accelerate aging and shorten lifespan. It is associated with very high rates of serious adverse effects, and long-term use could increase one's risk of cancer."

According to Olshansky, "off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone. 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 anti-aging intervention is a major public health concern not just because it is illegal, but also because its provision for anti-aging is not supported by science and it is potentially harmful."

http://www.newswise.com/p/articles/view/515455/

 

[Millard]

Provision or Distribution of Growth Hormone for "Antiaging"- Clinical and Legal Issues

Thomas T. Perls MD, MPH; Neal R. Reisman MD, JD, FACS; S. Jay Olshansky PhD; Journal of the American Medical Association, Vol 294 (16); IN PRESS- Embargoed by JAMA until 4pm, EDT, October 25, 2005
(This paper is unrelated to the research conducted in the New England Centenarian Study) Supporting Resources


The Section of the Federal Food Drug and Cosmetic Act Stipulating Restrictions and Penalties Regarding the Distribution and Provision of HGH:

(Please go to section (e) "Prohibited distribution of human growth hormone". Also note that in 1993, this section was redesignated as (f) and (f), pertaining to devices was redesignated as (g).)

Title 21: Food and Drugs, Chapter 9--Federal Food, Drug, and Cosmetic Act, Subchapter III: Prohibited Acts and Penalties, Sec. 333. Penalties.

U.S. Department of Justice Human Growth Hormone/Steroids Statutory Overview:
Title 4 (Civil) Resource Manual. United States Attorneys' Manual. Human Growth Hormone/Steroids Statutory Overview. 1998

FDA Letter to Dr. Perls Regarding Distribution of GH for Anti-Aging:
October 2004

FDA Warning Letters:
http://www.fda.gov/foi/warning_letters/g4543d.htm
Costello G. FDA warning letter addressed to Alan Blair and Affordable HGH.com., June 30, 2002

HGH-Related Alerts From the National Institute on Aging (NIH) and the Federal Trade Commission:
Pills, Patches, and Shots: Can Hormones Prevent Aging? National Institute on Aging Age Page. January, 2005.
"HGH" Pills and Sprays: Human Growth Hype? FTC Consumer Alert. June 8, 2005.
FTC Stops False Claims about Fountain of Youth Oral Sprays: Sprays Do Not Contain, or Cause the Body to Produce, Human Growth Hormone as Claimed. October 18, 2005.

 

[JoeyNess]

awesome!!!!!!!!!

 

[HeadDoc]

If HGH is being prescribed without medical indication, such as adult onset growth hormone deficiency, it may well be inappropriate. There are journal acticle published thru AMA that have supported the use of hgh in adults. Rudman's classic study was published in NEJ of Med. This is one of the most conservative journals in the AMA arsenal.

 

[ciobl]

both institutions, Illinois at Chicago by employing this clown and Boston by allowing him to conduct a 'study' lose credibility.

Anti-Aging Doctors Sue Professors

Heard the one about the professor who jokingly gave the two osteopathic physicians a bottle of snake oil? Well, they didn’t think it was funny.In fact, the co-founders of the Chicago-based American Academy of Anti-Aging Medicine (A4M) decided to sue S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago, and Thomas Perls, associate professor of geriatrics at Boston University, for $240 million. According to the defamation complaint filed in an Illinois court, Olshansky and Perls conspired to undermine A4M’s scientific credibility and in turn to harm the business prospects of Ronald Klatz and Robert Goldman, the two founders. The result, according to the complaint, was several professional disappointments, including the loss of a $20 million contract for Medical Development Management, an Illinois corporation in which Klatz and Goldman are the principal shareholders.

The University of Illinois at Chicago is backing its professor in the case, and footing the legal bill. “The university has become involved because it is an issue of academic freedom,” said Bill Burton, a spokesman. “Professor Olshansky is doing his job … to search for the truth and speak it. That is the purpose of a research university. The university is defending its purpose.”

http://insidehighered.com/news/2005/06/21/suit

 

[Millard]

In fact, the co-founders of the Chicago-based American Academy of Anti-Aging Medicine (A4M) decided to sue S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago, and Thomas Perls, associate professor of geriatrics at Boston University, for $240 million. According to the defamation complaint filed in an Illinois court, Olshansky and Perls conspired to undermine A4Ms scientific credibility and in turn to harm the business prospects of Ronald Klatz and Robert Goldman, the two founders. The result, according to the complaint, was several professional disappointments, including the loss of a $20 million contract for Medical Development Management, an Illinois corporation in which Klatz and Goldman are the principal shareholders.

Wow. I don't know which is more disturbing attempts to undermine and limit the medical applications of growth hormone OR the frivolous lawsuits.

I'd love to see the court documents. Obviously, there is a bigger story underneath all this.

 

[Millard]

If HGH is being prescribed without medical indication, such as adult onset growth hormone deficiency, it may well be inappropriate. There are journal acticle published thru AMA that have supported the use of hgh in adults. Rudman's classic study was published in NEJ of Med. This is one of the most conservative journals in the AMA arsenal.

What struck me is that they simply dismissed "adult onset gh deficiency" as a legitimate medical indication.

They outlined only three legitimate (allegedly FDA sanctioned) reasons for prescribing GH including this one which is their interpretation of "adult onset" indication:

• adult HGH deficiency due to rare pituitary tumors and their treatment

(italics added by admin)

 

[HeadDoc]

medical indication for that disorder is usually IGF-1 and Igfbp-3 levels. Having a tumor is a new one to me. I'm just going to have to wait and see. Most docs are willing to consider it on the basis on low IGF-1 levels alone. If the negative opinion becomes law, this would be a hugh shock to the anitaging industry: clients and doctors. I met a lot of docs at an A4M training on HRT that are using hgh themselves. Lets not forget the utility of the "ideopathic" diagnosis.

 

[ciobl]

They outlined only three legitimate (allegedly FDA sanctioned) reasons for prescribing GH including this one which is their interpretation of "adult onset" indication:

* adult HGH deficiency due to rare pituitary tumors and their treatment

it did strike me as well administrator. as you know, the word 'rare' is widely used and let me clarify, I am not a linguistic professor, is widely used in the medical field, as for example, when just a handful of people have acquired a disease or are showing symptoms of an almost unknown disease that has not been vastly studied or has not been subjected to the rigorous demands of clinical trials and experiments.
And even then, I might say, it is not 'rare' as we all know, but rather a subtle infrequent, not as dispersed, not widely recognized but to say it is 'rare' or 'uncommon' or 'scarce' ?
it is evident, emphasis on the word 'rare' was made and it did struck me as well.
if we ask anybody about a disease, they might not elaborate on the conditions, causes, symptoms, procedures to follow up, medications to take, etc. but to say it is a 'rare' condition ?

as i went back to the article, I found myself emerged on the apparent confusion that the authors, not FDA representatives were disseminating.

so the same control authoritative maneuvers hidden under a merely academic research were used by the university of chicago in what I see as an attempt to defamation of facts and concrete ideas.

The authors wanted to discredit and at some extent demoralize any credentials these entrepeneurs have deposited among the anti-aging patients

while i disagree with a lot of actions from fda, their response letter was magnificent and clarified any misunderstanding that was created in the first place by these doctors.
The alleged suit i see it as counterproductive with future revenue losses and possibly sanctions or investigation of these products by the court.

 

[SWALE]

Here's a link to A4M's official response to the JAMA article:

http://www.worldhealth.net/p/anti-aging-hgh-20051111.html

 

[HeadDoc]

thanks for posting that.

 

[Millard]

PRESS RELEASE
December 21, 2005

LAS VEGAS, Dec. 21 /PRNewswire/ -- Rick Collins, Esq., of the New York law firm of Collins, McDonald & Gann, P.C. (http://www.cmgesq.com/), recently presented a lecture entitled "Legal Update 2005: Prescribing Growth Hormone for Adult Growth Hormone Deficiency" at the 13th Annual International Congress on Anti-Aging Medicine. The presentation clarified a commentary in the October 26, 2005 Journal of the American Medical Association entitled, "Provision or Distribution of Growth Hormone for 'Antiaging': Clinical and Legal Issues."

"The commentary suggests that the replacement of human growth hormone in deficient, aging adults is illegal because of a little-known federal law," said Mr. Collins, a legal authority on anabolic steroids and performance- enhancing hormones. "But the suggestion overlooks the historical context and intent of that law."

Mr. Collins points out that the statute, part of the Anti-Drug Abuse Act of 1988, was originally written for anabolic steroids. Passed when sports doping had reached national consciousness, it was intended to combat steroid trafficking to athletes. Heightened alarm over drugs in sports, including Canadian sprinter Ben Johnson's steroid positive at the 1988 Seoul Olympics, resulted in the scheduling of anabolic steroids as controlled substances in 1990. Congress chose not to take such a drastic approach to growth hormone after testimony that growth hormone lacks the adverse psychological and physical effects of steroids. Instead, Congress took the lesser approach of inserting growth hormone into the statute that formerly applied to steroids.

"Prescribing growth hormone for non-medical reasons, including performance enhancement or 'anti-aging' in the absence of medical need, is illegal," says Mr. Collins. "But nothing in the statute restricts physicians from treating diseases or other recognized medical conditions for which the use of growth hormone has been authorized by the FDA. Any implication that the statute was intended to prohibit hormone replacement in mature, clinically deficient adults is incorrect."

Collins, McDonald & Gann, P.C., represents individuals and corporations on civil and criminal matters. Contact: info@cmgesq.com
Contact: Richard D. Collins, 516-294-0300, info@cmgesq.com
Website: http://www.cmgesq.com/

 

[HeadDoc]

thanks for following this. Here's a reference to Dr. Ron Rothenberg's letter back to JAMA on the topic.

http://ehealthspan.com/download/ResponseToJAMA_GH_Article.doc