“Off-label" indicates the use of a drug or medical device for a protocol not officially included in the guidelines and not described on the instruction sheet.
We know that documented scientific data regarding the effectiveness of a new treatment will take about 17 years before Administrative Agencies such as the Food and Drug Administration (FDA) include them in their guidelines (Harvard Business Review).
During this long period of time, scientific research produces new advances daily: consequently, a large gap develops between approved treatments and those not yet approved but scientifically tested and proven to be effective.
Only a doctor who acquires knowledge of advanced clinical research daily can prescribe off-label treatments, whether pharmacological or via medical devices. Those who limit the use of medicine within the 17-year-old guideline and do not explain how more can be done by scientific evidence lacks updating.
The FDA, when deciding to approve a product or drug, must consider whether the benefits outweigh the risks. The FDA usually tends to approve a product that has some calculated risk if the potential benefit were significant, such as an artificial heart valve that can save someone's life.
The process for approving medical devices such as Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS) or Photo-Bio-Modulation - therapies that do not present obvious risks - typically proves very lengthy.
In addition, the FDA, to determine whether the product, drug or food additive performs as safely and effectively as it claims to be, does not conduct its own testing but instead reviews the results of independent clinical and laboratory testing. Therefore, just because a device has been approved by the FDA does not always mean that it represents the best solution currently.
The FDA approved Transcranial Magnetic Stimulation (TMS) for Resistant Depression in 2008 and for Obsessive-Compulsive Disorder in 2018. This means that TMS for other disorders, and other neuromodulation methods remain off-label, for now.
We certainly know, however, that the indications for neuromodulation therapies have been scientifically proven and established.
Our treatment plans
Treatment for Depression integrates many different skills and must be carried out by specially trained specialists. The treatments generally offered often do not work because the specific subtype of depression and other comorbid disorders are not considered.
At the Istituto di Neuroscienze, we offer person-centered treatment for depression based on individualized diagnosis and integrated with natural cures.
What is Attention Deficit/Hyperactivity Disorder (ADHD) and what are the most common symptoms? Find out on this dedicated page.
The Istituto di Neuroscienze represents a center of excellence for the diagnosis and treatment of ADHD in adults.
Biennial course on Anxiety Disorders organized by the European College of Neuropsychopharmacology
A unique opportunity to expand your knowledge and experience in the field of Anxiety Disorders.
Dr. Stefano Pallanti will lecture on Neuromodulation Therapies during the 4th module of the course.