From the Guidelines
Growth hormone therapy should only be prescribed for approved indications, such as growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, chronic kidney disease, and HIV-associated wasting, with careful consideration of contraindications, to minimize the risk of misuse and associated medico-legal concerns. The primary misuses of growth hormone therapy include off-label prescribing for anti-aging purposes, athletic performance enhancement, and cosmetic height increases in children without growth hormone deficiency. These inappropriate uses expose patients to serious health risks, including increased cancer risk, cardiovascular complications, joint pain, carpal tunnel syndrome, edema, and glucose intolerance, as highlighted in the clinical practice recommendations for growth hormone treatment in children with chronic kidney disease 1.
Medico-Legal Concerns
From a medico-legal perspective, physicians prescribing growth hormone for non-FDA approved indications may face malpractice claims, license sanctions, and even criminal charges under laws like the Anti-Doping Sports Act. Healthcare providers must obtain proper informed consent, document medical necessity, follow established treatment guidelines, and maintain thorough records of patient monitoring. The high cost of growth hormone (ranging from $10,000-60,000 annually) creates additional legal concerns regarding insurance fraud when prescribed inappropriately.
Contraindications and Monitoring
Physicians should be aware of the contraindications for growth hormone therapy, including active malignancy, diabetic retinopathy, and severe respiratory compromise, as outlined in the recommendations for GH treatment and monitoring 1. Regular monitoring of patients on growth hormone therapy is crucial, including assessments of stature, height velocity, pubertal development, skeletal maturation, renal function, thyroid hormone levels, serum glucose, calcium, phosphate, bicarbonate, and parathyroid hormone levels.
Benefits and Risks
The benefits of growth hormone therapy in specific patient subgroups, such as prepubertal patients with chronic kidney disease, have been demonstrated in clinical trials, with significant increases in height velocity and final height 1. However, the risks associated with growth hormone therapy, including slipped capital femoral epiphysis and intracranial hypertension, must be carefully weighed against the potential benefits. Healthcare providers should prioritize the safety and well-being of their patients, adhering to established treatment guidelines and monitoring protocols to minimize the risks associated with growth hormone therapy.
From the Research
Misuses of Growth Hormone Therapy
- Off-label use of GH therapy as an anti-aging treatment or sports enhancement is clearly at odds with current guidelines and should not be prescribed under any circumstances 2
- Use of GH therapy for conditions not approved by the US Food and Drug Administration, such as non-GH-deficient short stature, without proper evaluation and diagnosis, can be considered a misuse 3, 4
Possible Medico-Legal Aspects
- Prescribing GH therapy without proper diagnosis and evaluation can lead to medico-legal issues, such as liability for adverse effects or inadequate treatment 2, 5
- Failure to inform patients of the potential risks and benefits of GH therapy, as well as alternative treatment options, can also lead to medico-legal issues 2, 5
- The use of GH therapy in adults with growth hormone deficiency requires careful consideration of the individual patient's needs and medical history, and should be based on evidence-based guidelines to minimize the risk of medico-legal issues 2, 5