ANSM warns of the dangers of CBD purchased on the Internet

Edito. This week, ANSM issued an alert concerning the use of products containing cannabidiol (CBD) purchased «outside the legal circuit», notably to treat epileptic children. The health agency is aware of a «worrying» increase in the purchase of CBD products over the Internet, and points out that the quality and safety of these products are in no way guaranteed. Whose fault is it?

The legal circuit

In this instance, ANSM points out that, since the beginning of December 2018, Temporary Use Authorizations (ATU) have been available «on a temporary and nominative basis» for Epidiolex, a drug used in cases of severe epilepsy such as Lennox-Gastaut and Dravet syndromes. However, patients wishing to have access to them must go through an extensive administrative procedure and obtain their doctor's prior approval. In addition, the ATU procedure is highly regulated and above all, is exceptional and lasts only one year. The patient must have exhausted all other treatment options, and use Epidiolex as a last resort. In short, this is what the famous «legal circuit» looks like.

On the Internet, patients can purchase CBD oil in just three clicks. Epidiolex is no more and no less than a CBD oil with a precise and constant dosage, and a safe sanitary control circuit.

The ANSM recommends against buying products on the Internet for medical use, as this is done in disregard of quality control and professional medical supervision. The ANSM also recognizes the value of CBD in the treatment of epilepsy, but warns of the potential dangers of toxic interactions with other anti-epileptic drugs. Epidiolex is therefore not to be taken, according to ANSM grant criteria, or as adjuvant therapy with other antiepileptics.

What is ANSM waiting for?

While this trend is growing, a number of questions remain, particularly concerning the conditions of access to medical cannabis in France. While ANSM for example, is blocking the availability of Sativex, is she in the best position to complain about patients seeking immediate solutions to their problems?

Why maintain an exceptional and prohibitive procedure that deprives many people of adequate medical follow-up? Why, more generally, let patients in need resort to the illegal circuit to buy cannabis? And if CBD does indeed help some people, ill or otherwise, why not set up official regulations with the relevant authorities to distinguish wellness products accessible to all via the Internet and in stores from medical products available by prescription?

If the hunt for CBD stores may have had an effect, it is probably to encourage their customers to buy on the Internet, without necessarily having the necessary advice on how to use the products, some of whose origins may be obscure. Market regulation would also enable those who have already decided to dispense with medical supervision to have access to a healthy and safe product. Research could also benefit, with national studies on CBD's medical potential, appropriate dosages and drug interactions.

Medical cannabis is already legal in 21 countries of the European Union, Switzerland, Norway, Israel and Turkey, and in most American states. Even in France, its therapeutic value is recognized for neuropathic pain (Marinol), multiple sclerosis (Sativex) and epilepsy (Epidiolex). And yet, access is still difficult or impossible for some. According to NORML, As of December 2017, only 74 ATU nominatives have been issued for Marinol® since 2001.

As for Sativex, it is legal but has to be imported, at prohibitive prices for some patients as it is not marketed in France. Finally, patients who undertake to treat themselves are treated like criminals. This situation poses a real ethical issues concerning access to healthcare.

It's not all doom and gloom either: France has nevertheless taken steps towards’opening up access to medical cannabis in plant form and its derivatives. Although reasoning on the relevance of medical cannabis of the ANSM has not yet concretely opened up access to medical cannabis, it's a first step. A modernizing ATU procedures designed to simplify them has also been in force since September 2018.