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- 02 January 2020

What does "Off-Label" mean?

Dr. Stefano Pallanti uses his notions of advanced clinical research to offer his patients the most innovative and effective therapies ever, around 20 years ahead of hospitals and clinics that rely on outdated guidelines for treatment choice.

Off-Label Use of Medical Treatments

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.

The gap between Innovation and Approval

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.

FDA approval and Risk-Benefit assessment

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 case of Neuromodulation Therapies

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.

False Myth about "Off-Label" prescribing ― Psychiatric Times, October 2019

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