Off Label Use of HGH to Treat Tendon and Ligament Injuries Remains Illegal Posted on 03:33 January 17th, 2009 by Millard Baker
Dr. Richard Rydze is a vocal advocate of the use of recombinant human growth hormone (rHGH) for the treatment of tendon and ligament injuries. Dr. Rydze found HGH to be highly effective for this purpose based on the clinical results from his human growth hormone research project involving over 200 patients over the course of 5 years. Unfortunately, Dr. Rydze, as a 22-year member of the Pittsburgh Steelers medical staff and an internal medicine specialist at the University of Pittsburgh Medical Center (UPMC) was not in the best position to conduct such controversial HGH research in his private practice.
The societal stigma associated with performance-enhancing drugs and the legal restrictions on legitimate medical research by anti-steroid crusaders and the anti-doping movement quickly resulted in Dr. Rydze resignation from both the Pittsburgh Steelers organization and the UPMC after it was publicly disclosed that Rydze had purchased $150,000 worth of HGH and anabolic steroids from Signature Pharmacy with his credit card (”Former Steelers doctor embraced HGH,” January 15).
“I know it has caused me a lot of grief, simply because I believe in it and I know what it does,” Rydze said. “And to deny people the effect to heal better — that is the art of medicine, to make people heal. And using something off-label, which we use for many, many drugs … I don’t see how someone can single out one thing and say you can’t use it for off-label use. And you show me there is one side effect, and I’d be a believer. But I have never seen a side effect. And I just think it is just ignorance of people who don’t know. They just hear about it, and they assume it is bad.”
The use of human growth hormone was approved by the Federal Drug Administration (FDA) for a limited number of conditions**; the use of HGH for tendon and ligament injuries was not one of the FDA-approved indications. Any use of HGH for this purpose was considered “off-label.” An “off-label prescription” for a drug refers to its use by medical professionals to treat additional medical conditions and/or indications that were not originally approved by the FDA.
It is legal for physicians to use all FDA-approved pharmaceutical drugs for off-label purposes EXCEPT for HGH. The off-label use of human growth hormone (HGH) to accelerate healing in the treatment of tendon and ligament injuries remains illegal.
“The short answer is HGH is the only drug that cannot be lawfully distributed or prescribed for off-label uses,” said bioethicist Maxwell J. Mehlman, director of the Law-Medicine Center at Case Western Reserve University. [...]
In an e-mail to ESPN.com, another FDA spokeswoman, Susan Cruzan, wrote, “Human growth hormone is the only drug for which Congress has expressly prohibited the off-label distribution or possession with intent to distribute, making such distribution a crime under 21 USC 333.” [...]
“The off-label use is illegal,” said Travis Tygart, chief executive of the U.S. Anti-Doping Agency. “It doesn’t happen. Using [HGH] for tendon repair, he has admitted to a crime.” [...]
After consulting with legal counsel, FDA spokesman Chris Kelly issued a statement to ESPN.com, saying, “FDA has not approved any New Drug Application for a drug containing HGH for use in treating ligament/tendon injuries. If an FDA-approved drug containing HGH is being used for this purpose, it would fall within the prohibition described at 21 U.S.C. 333[e].”
Such legal prohibitions are not in the best interest of medicine or the patients seeking proper medical treatment. The therapeutic potential and medical application of pharmaceutical drugs should not be affected by the arbitrary designations of prohibited and/or banned substance in professional sports competition. The moral agenda of the United States government, the World Anti-Doping Agency (WADA) and other anti-doping organizations should not result in inferior medical care for the millions of individuals who do not compete in sports. Inferior medical care and research is an unacceptable cost to pay as a consequence of ineffective attempt to eliminate performance-enhancing drugs from sports.
“There is off-label for everything,” Rydze said, defending his use of HGH. “I mean, everything. Ninety percent of medicine is off-label. … We use seizure drugs for treating migraines. We use drugs all the time [for other uses]. I think this drug gets way overtalked about, way overplayed.”
When told the FDA specifically prohibits the use of HGH for any unapproved purpose, Rydze said: “I’m not aware of that. It can’t be used off-label? For what reason?”
Dr. Richard Rydze is correct. The off-label use of FDA-approved medications is a widely accepted practice. The only reason why the off-label distribution of HGH is expressly prohibited as illegal is due to its potential use as a performance-enhancing drug.
Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31 percent (Radley, et al. 2006). New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that between 50 percent and 75 percent of all medications prescribed by pediatricians in the U.S. are for off-label applications.
Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label, and more than half of cancer patients received at least one drug for an off-label indication. Frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.
The explicit agenda of the World Anti-Doping Agency to make international laws governing certain pharmaceutical consistent with their anti-doping code represents a travesty for the practice of medicine and medical research.
** The Federal Food, Drug, and Cosmetic Act prohibits knowingly distributing or possessing with intent to distribute human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition that has been authorized by the Secretary of Health and Human Services pursuant to 21 U.S.C. § 355. 21 U.S.C. § 333(c). The Food and Drug Administration (FDA) has approved human growth hormone only for the following uses: short stature in children with growth hormone deficiency, ideopathic short stature in children, short stature in children with Turner or Prader-Willi syndrome, short stature in children with chronic renal insufficiency, adults with biochemically documented growth hormone deficiency (GHD) diagnosed either in adulthood or childhood, adults with wasting disease associated with AIDS, and adults with short bowel syndrome.
