Anytime I debate the roll of performance enhancing drugs in healthy adult men, especially as we age, a cogent argument will usually try to question my disdain for what I perceive to be the negative effect of media-driven misinformation, politics, and alarmist with agendas. So what if network and cable news get it wrong? Why should I care if Geraldo “smells steroids?” I should just keep laughing at Don Hooton when his foundation makes ludicrous claims such as Tom Hanks is performing on Broadway “high on steroids” because he took a cortisone shot in his hand. It doesn’t change anything, right? Steroids and growth hormone are illegal.
Well, yes….. and no, and hence this is a complicated issue. For the sake of this discussion I’m going to use GH as the example. Steroids would follow a similar yet much more complicated path to your medicine cabinet, however GH represents only a slightly less lurid substance. Remember that it took quite a while for GH to catch up with steroids’ nefarious ranking among the agenda waving alarmists, however, steroids fall under Schedule 3 of the DEA’s list of controlled substances and are treated as a prescription narcotic. Growth hormone is classified as a prescription medication with specific guidelines for use contained in title 21 of the US Code (USC). But that doesn’t mean you’ll get a slap on the wrist if you get caught breaking the law controlling it:
Section 303(e)(1) of the Food, Drug & Cosmetic Act (FDCA), Title 21 USC 333(e) (1), “prohibits knowingly distributing, or possessing with the intent to distribute, HGH 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 (HHS) under section 505 of the FDCA (21 U.S.C. 355) and pursuant to the order of a physician. The Secretary of HHS has not authorized, for example, any HGH use for anti-aging, bodybuilding, or athletic enhancement. Thus, distributing, or possessing with the intent to distribute, HGH for these uses or any other unapproved use violates section 303(e)(1) of the FDCA. A violation of section 303(e)(1) carries up to 5 years imprisonment and fines and, if the offense involves an individual under the age of 18 years of age, up to 10 years imprisonment and fines.”
The reason we have such absurd penalties for a naturally occurring hormone is a direct result from pressure exerted by the media, politicians, community groups, and alarmists with agendas who have cast a shadow over an entire industry, erroneously in the name of saving our children. Because of such penalties, GH is under prescribed and difficult for doctors to implement in therapies that have substantial clinical data to back them. Here’s a true example that has nothing to do with performance enhancement or anti-aging just to show you how pervasive and how destructive these stupid laws panned out:
A physician had a patient in the hospital who had been on dialysis for several months. After two weeks on GH therapy, he began to make urine again. He was understandably very excited. Even after he was discharged from the hospital, the amount of fluid removed by dialysis continued to be reduced as his kidney function improved. Naturally, he wanted to continue this GH kidney restoration. The attending physician wrote prescriptions for GH along with letters of explanation for why he required it. The insurance company would not pay for it because it was not ‘FDA approved’ for kidney problems, even though it would have saved them tens of thousands of dollars by eliminating the need for dialysis.
To make matters worse, no pharmacy would agree to fill the prescription even though the patient agreed to pay for it himself. The pharmacies were afraid of being scrutinized by the Feds. The patient has essentially been sentenced by the government to a life on dialysis, thanks to raving morons who think kids are going to jump over a beer keg and mainline GH with dirty needles.
On the other side of the coin, because GH works, people intent on using it will despite the penalties and retarded advisories from the Taylor Hooton Foundation. In fact, quite a few doctors and clinics are moving a bunch of GH. From 2005 to 2011, inflation-adjusted sales of GH were up 69 percent, according to an Associated Press (AP) analysis of pharmaceutical company data collected by the research firm IMS Health. It’s interesting to note that during the same time frame, sales of the average prescription drug rose just 12 percent.
This increase has been in the wake of years of raids, sports scandals and media attention, yet major drug makers sold a whopping $1.4 billion worth of GH in the U.S. last year. That’s more than industry-wide annual gross sales for penicillin or prescription allergy medicine.
In total eight companies – up from two in 2005 – have been granted permission to market GH by the FDA, although many nutritional companies produce so-called GH releasers or outright scam products claiming to be GH.
Pituitary Growth Hormone by Anabolic Research is a scam
The No. 1 producer of GH is Roche subsidiary Genentech, that had nearly $400 million in GH sales in the U.S. last year, up an inflation-adjusted 66 percent from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively. Pfizer now gets more revenue from its GH brand, Genotropin, than from Zoloft, its well-known anti-depressant drug.
Endocrinologists estimate there are fewer than 45,000 U.S. patients who might legitimately take GH for its approved use. They would be expected to use roughly 180,000 prescriptions or refills each year, considering typical patients are prescribed GH three months at a time. However, according to IMS Health data, U.S. pharmacies last year supplied almost twice that much GH — 340,000 orders.
And those figures don’t include GH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.
Regardless, experts agree that the data shows too many sales and too many prescriptions for the number of people known to be under FDA approved treatment. At least half of last year’s sales likely went to patients not legally allowed to get the drug. And, of course, this does not include illegal black market sales, and illegally compounded GH products.
Children who develop a pituitary deficiency of growth hormone at a young age will never grow normally and are destined to become dwarfs in adulthood if untreated. Human growth hormone therapy was initially developed to treat those children so they could grow to become normal adults. Initially, supplies were very limited, expensive and sometimes contaminated because it was harvested from cadavers, and there was not enough growth hormone available to treat all the children who needed it. With the development of recombinant DNA technology, human growth hormone has become more available and in a very pure, safe, form.
The easy availability of growth hormone now provides a new dimension in health care and preventive medicine, at least it would seem. However, regardless of any stated or published benefit GH has to offer the aging or athletically challenged, the FDA and the health care industry would rather expose you to almost anything else but growth hormone. Why?
After you’re done growing, GH must continue to be present in the body (at somewhat lower levels) throughout life to maintain physical and mental health and well-being. Tissue repair, healing, cell replacement, organ integrity, bone strength, brain function, enzyme production, integrity of hair, nails, skin and vital organs all require the ongoing availability of adequate GH. After age 20, GH production falls progressively and consistently at an average rate of about 14% per decade. By age 60, it is not uncommon to measure a GH loss of 75% or more. Physical decline with age correlates directly with decreased secretion of GH by the pituitary gland.
It would stand to reason then that taking GH as we age could stave off the effects of aging. Not totally nor completely, but the benefits from GH replacement reported in the scientific literature and published in numerous peer reviewed journals over the years do include increased muscle mass, improved physical strength, reduced fatigue, decreased fat (especially abdominal fat), increased bone strength, and revitalization of liver, kidney, spleen, and brain functions. Skin regains a more youthful appearance with fewer wrinkles and sexual functioning improves. Cholesterol decreases and cartilage in joints becomes stronger. Osteoporosis, Parkinson’s disease and Alzheimer’s disease are improved. Healing is speeded. And, a markedly better quality of life has also resulted for AIDS patients receiving growth hormone.
So, why can’t we use it?
According to the United States Food and Drug Administration (FDA), FDA-approved GH (GH that had an acceptable level of negative side effects and did not overly endanger the public) can be legally prescribed for a limited number of conditions including:- hormonal deficiency that causes short stature in children
- long-term treatment of growth failure due to lack of exogenous GH secretion
- long-term treatment of short stature associated with Turner syndrome
- adult short bowel syndrome
- adult deficiency due to rare pituitary tumors or their treatment
- muscle-wasting disease associated with HIV/AIDS
On the surface, “FDA approval” is an “approval”, which is not a law, and not even a “disapproval” of any other use for the same medication. If you tell your teen-age kid they can go out tonight, that approval doesn’t mean they can’t stay home and play video games instead.
To wit, the foreword of the Physician’s Desk Reference, in accordance with the laws of the states governing the practice of medicine, states:
“The FDA has also recognized that it does not limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may choose to prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. The FDA also observes that accepted medical practice includes drug use that is not reflected in approved drug labeling.”The FDA also recognizes that it does not have authority over health care professionals or the practice of medicine. However, in the case of GH, They do! The following section of the Federal Food Drug and Cosmetic Act provides the restrictions and penalties regarding the distribution of GH:
Title 21: Food and Drugs, Chapter 9–Federal Food, Drug, and Cosmetic Act, Subchapter III: Prohibited Acts and Penalties, Sec. 333. Penalties.
Section (e) lists:
(e) Prohibited distribution of human growth hormone
(1) Except as provided in paragraph (2), 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 section 355 of this title 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, or both.
(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].
(4) As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.
The FDA specifically approves the use of GH to treat GH adult deficiency of hypothalamic origin. The following is taken from the FDA approved package insert from Eli Lily’s Humatrope:
“Adult Patients:
Humatrope is indicated for the replacement of endogenous GH in adults with GH deficiency who meet any of the following two criteria:
“Adult-Onset (AO): Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.”
Not surprisingly, aesthetics and anti-aging benefits are not considered “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 section 355 of this title ….” In other words, while GH levels do decrease over time, if the levels are typical for someone in his 50’s, a prescription of GH to a 55 year old might be a problem.
Is that confusing, or what? If the GH deficiency is the result of a disease then the doctor can prescribe it, but if the deficiency is typical then, the way I read the law, it’s making nefarious drug dealers out of doctors. If the doctor does little more than write a prescription and it is filled by a pharmacy, is the doctor at legal risk? In other words, is the writing of a prescription considered the “distribution” of GH?
Unfortunately, the FDA contends that a licensed physician writing a prescription for GH for an unauthorized use, but not actually physically providing the GH to a patient, would be a violation of 21 USC § 333(e).
The agency interprets “distribution” as used in 21 USC § 333(e) to include the writing of a prescription. In addition, all federal criminal statutes, including 21 USC § 333(e), are covered by 18 USC § 2:
“(a) Whoever commits an offense against the United States or aids, abets, counsels, commands, induces or procures its commission, is punishable as a principal.
(b) Whoever willfully causes an act to be done which if directly performed by him or another would be an offense against the United States, is punishable as a principal. ”
So, what we have is a confounded set of laws dictated by people with little or no medical or scientific training, who have never laid eyes on a patient, who invariably have some vested financial interest – as with insurance companies or with a political agenda – are deciding the treatment for sick people and making criminals out of the doctors who treat them. And guess what? The insurance industry is not liable for any medical problems resulting from their denial. The doctor will probably be sued instead.
So, the next time I rage about idiots like Don Hooton and the other hysteria mongers who are using steroids and GH as fodder for their soap box folly, I’m saying so because of the damage they do. These morons are not saving a single kid from anything. All they have done and continue to do is vilify legitimate drugs with legitimate uses and ultimately cause them to be denied to people who can genuinely derive benefit from them. Like I always say, you want to save the children? Then get rid of alcohol and cigarettes….
