Dr. Clarke's Website

Lewis K. Clarke, M.D. Ph.D.
Truth about HGH and FDA

The Truth about HGH (and the FDA)


Who Is Your Doctor?

The recent media hysteria about human growth hormone is yet another example of why government officials and reporters and any non-scientist have no business deciding what belongs in a doctor’s therapeutic regimen. I even heard talk of PRISON TERMS for people and even their doctors caught using HGH. It will become painfully obvious as I go through the science behind the medicine, that the government should be governing, not doctoring. For example, if you review my discussion of NEUROGENESIS, you will see the importance of HGH in stimulating the growth of new brain cells after a stroke. In the upcoming review of the last ten years of science you will also see the dramatic effects of HGH on healing of wounds and skin grafts in hospital burn units. I have several patients who are no longer on dialysis because of the use of HGH. You will also see that the bulk of the scientific studies on HGH and cancer actually demonstrate that HGH INHIBITS the growth of tumors and ADDS to the effects of conventional chemotherapies.


Wouldn’t it be a travesty if we were sent to prison for using a hormone, which the body itself produces, to prevent or cure cancer, cure end-stage kidney disease ending a patient’s lifelong dialysis nightmare, healing burn patients, healing wounds and fractured bones?  This mentality will grind progress in medicine to a screeching halt. WAKE UP EVERYONE!!! There’s science out there telling us what to do, and anyone unfamiliar with reviewing scientific studies and who has not examined the patient one on one should not be in a position to decide what is best for a patient under a doctor’s care. A democratic vote does not decide science or patient care.


ONE MORE TIME. Science is not a democratic process. Medicine is not a democratic process.


What Does FDA Approval Mean?

Let’s clarify another issue. I heard over and over from the media, that HGH was “only approved for …”. There is a terrible misunderstanding of what “FDA approval” means.


v     It does NOT mean that the drug, in this case a human hormone, cannot be used for other therapeutic purposes.  SAY IT AGAIN? It does NOT mean that if, in the doctor’s opinion, HGH would help get a patient off dialysis (as several studies are beginning to demonstrate) he is not allowed to use HGH for that patient and that all parties, the doctor, the patient and the pharmacist who supplies it, should go to prison.

v     “FDA approval” is an “approval”, which is NOT a law, and NOT even a  “disapproval” of any other use for the same medication. SAY IT AGAIN? If your mother says you can spend the night with Joey, that approval doesn’t mean you can’t stay home and do your homework instead.

v     FDA approval DOES mean that the drug had an acceptable level of untoward side effects and did not overly endanger the public.

v     FDA approval DOES mean that the pharmaceutical company has not spent the hundreds of millions of dollars to do all the studies required by the FDA to get all those other therapeutic uses of the drug approved individually.


The foreword of the Physician’s Desk Reference states, “The FDA has also recognized that the FD&C Act does not, however, 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.” And this is consistent with the laws of the states governing the practice of medicine.

Why Misinterpreting “FDA approval” Hurts YOU”

The insurance companies love using the “it’s not FDA approved for that” excuse for denying medicine and services. Here’s a true story for you, one of many that happen to my patients every day. Last month I had a patient in the hospital who had been on dialysis for several months. After two weeks on HGH and my anabolic and metabolic protocol, 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 HGH kidney restoration. I wrote prescriptions for HGH with letters of explanation 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.


And, if you thought it couldn’t get worse than that, no pharmacy would agree to fill the prescription even though the patient agreed to pay for it himself because the pharmacies were afraid of being scrutinized by the FEDS. My patient has essentially been sentenced by the government to a life on dialysis.


What is happening to us in America? Why do we feel such an uncontrollable urge to take science and medicine out of the doctor-patient exam room and hand it over to people in offices far away? These are people with little or no medical or scientific training, who have never laid eyes on the patient, who invariably have some vested financial interest as with insurance companies or with a political agenda? My office spends as much time on the phone arguing with high school grads hired by an insurance company to deny services and medicines to my patients as we do seeing the patient. Every time I write a prescription for a patient, my office staff spends 45 minutes on the phone getting it “precerted” by one of these mindless hirelings. And guess what! The insurance industry is NOT liable for any medical problems resulting from their denial. (The doctor will probably be sued instead.)


Wouldn’t you prefer having a family doctor make the decisions about your care? A doctor who has known your family for two generations, all your familial and childhood diseases and genetics, and actually CARES about you? 

Okay, I know that sounded like I lost my head for minute, but it’s really quite germane to the subject of HGH. Now, let’s talk about the science of HGH.


What HGH Definitely Will Do

v     Increases healing rate of skin grafts

v     Increases strength of wound healing in conditions of malnutrition

v     Increases protein anabolism in burn patients

v     Induces a positive nitrogen balance and connective tissue synthesis in diabetics and COPD

v     Improves nerve conduction in injured spinal cords

v     Differentiates adult stem cells into functional neurons in injured brain tissue

v     Increases bone density, even in diabetes

v     Increases bone fracture healing rate

v     Decreases ventilator weaning time in respiratory failure

v     Reverses congestive heart failure

v     Reduces injury and scarring after myocardial infarction

v     Increases cardiac output and stroke volume

v     Decreases peripheral vascular resistance

v     Increases renal glomerular filtration rate

v     Decreases serum creatinine in kidney failure

v     Enhances immunologic surveillance and NK cells

v     Reverses sarcopenia (muscle wasting) and weakness associated with illness and aging

v     Improves inspiratory pressure in COPD

v     Accelerates intestinal healing in ulcerative bowel disease and Crohn’s

v     Restores aged visceral organs to “youthful” size

v     Enhances lipolysis (fat burning), esp. abdominal fat

v     Improves lean body mass to fat ratio

v     Get you expelled from competitive athletics




What HGH Probably Will Not Do

v     Grow hair on bald men

v     Restore youthful hair color

v     “Grow a mini breakfast sausage into a Kielbasa”



Most Common Concerns Regarding the Use of HGH







 Let me get my references and I'll finish this section. I can only work on this late at night so give me a little more time to finish these sections as they require enormous literature reviews over many years of publications.