Spain is getting closer to launching its first trial with medicinal cannabis, which between 200,000 and 500,000 patients could be using by the end of the year to alleviate their pain or the effects of their treatments. But it remains to be seen how many will actually be using it, how they will take it, and where they will purchase it.
Pending the vote on the opinion and the dissenting votes submitted by the majority of parties, one of the main changes introduced in the final text was the expansion of its indications, initially limited to spasticity in people with multiple sclerosis, seizures in some forms of epilepsy, and chronic non-cancer pain, including neuropathic pain.
Finally, after intense negotiations between parliamentary groups, it was extended to include endometriosis, cancer pain, and nausea and vomiting caused by chemotherapy.
"We could have been a little more generous in interpreting the evidence and included anorexia in cancer patients and sleep disorders," comments Manuel Guzmán, professor of Biochemistry and Molecular Biology at the Complutense University of Madrid. Never as a first option.
Adding up all the indications, and drawing on the experience of countries such as the United States, Canada, Israel, and the Netherlands, Guzmán suggests a figure of 0.5% of the population as potential beneficiaries, which reduces to more than 200,000. However, he warns: this is a "very rough" estimate that, until the program is launched, cannot be refined.
For now, he sees it as a second- or third-line alternative therapy; in the future, he predicts that CBD—the non-psychoactive compound—will be one of the first antiepileptic options for pediatric epilepsy, and THC will be "close" to becoming one for sleep disorders, but "much more research is needed."
Thus, the most relevant groups to whom medical cannabis will be targeted are people with chronic non-cancer pain and those with cancer. But never as a first option.
The Spanish Pain Society (SED) believes it is "very logical" to incorporate it as an adjuvant medication for patients undergoing cancer, says Jesús de Santiago, the coordinator of its Cannabinoid Working Group.
"Not everyone with a tumor will be given a cannabinoid," so it's not an easy group to calculate. According to the Spanish Society of Medical Oncology (SEOM), the presence of pain varies and depends on the type and extent of the disease, as well as individual tolerance. It estimates that pain may be the main symptom in 40% patients undergoing treatment and 75% patients with advanced cancer.
The SED's position is that cannabinoids should be used as a third-line treatment for refractory pain, especially neuropathic pain; for other types of pain, they should be considered as an individual therapeutic trial if all other established treatments have failed and in the context of a multidisciplinary evaluation. In other words, individual treatment should be considered on a case-by-case basis.
Among patients with chronic pain, 8% is neuropathic, and within this subgroup, between 30% and 50% is refractory, which means that the potential beneficiaries of this new treatment would be around 400,000, this doctor estimates.
The rest, he insists, should be studied within the context of an individualized trial. This is what should happen to alleviate the visceral pain of endometriosis, which, according to the Guidelines for the Care of Women with Endometriosis in the National Health System, affects more than 2 million women.
Fibromyalgia, a type of nociplastic pain—considered orphan pain because its exact location is unknown—usually manifests as generalized pain associated with fatigue, sleep disturbances, and gastrointestinal disorders, and affects approximately 900,000 Spaniards.
But the president of the Medicinal Cannabis Observatory, Carola Pérez, isn't so sure "until I see it in black and white," since the subcommittee's report doesn't explicitly mention this disease as it does with endometriosis.
Avoid increased consumption
One of the biggest fears holding back this step was the fear of increased consumption; that's why he urges governments to implement training and awareness programs. "Dispensing programs that have been accompanied by other educational programs have had better results than completely commercial and free-market programs. People must understand that a medication, just because it's a medication, doesn't necessarily mean it's good for someone who isn't sick. I don't get chemotherapy if I don't have cancer, nor do I take an antibiotic if I don't have an infection. It's easy to understand," he summarizes.
Everything mentioned above still needs to be regulated, and Congress has given the Spanish Agency for Medicines and Medical Devices (AEMPS) six months to do so. Guzmán isn't skeptical and expresses his hope that "by Christmas, the first patient will be able to access their medication in a pharmacy." From then on, the real process will begin.
Carola Pérez is somewhat more skeptical "given the current state of healthcare": she appreciates this "giant step" that has taken her seven years of struggle, but she needs to see the recommendations, which she find "somewhat lacking," translated into reality, she says with a broken voice.
For the patients she represents, it's "a very important first step, also on an emotional level," because they've spent "years on the black market, being prejudged, stigmatized, without support or legal or health security."
"And now, finally, it's acknowledged that we're not criminals," he applauds.
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