The import of medicinal cannabis-based products, which had been escalating since 2015, exploded during the Covid-19 pandemic, according to unpublished data from Anvisa (National Health Surveillance Agency).
The number of import authorizations for these products rose from 8,522 in 2019, jumped to 19,120 in 2020 and reached 33,793 until the last 11th of November.
The growth of the market has also been accompanied by an increase in demand for the elderly. In four years, the participation of people over 65 years of age in CBD import requests (Cannabidiol, a therapeutic substance derived from Cannabis, without psychoactive effect) has almost quadrupled
In 2015, the public accounted for 6.8% of the total authorizations from Anvisa. In 2019, this share jumped to 23.6%.
Children under the age of ten, who previously represented 50% of these permits, now account for 21%. The remainder is distributed among other age groups.
The data are from BRCANN, an association of cannabinoid industries based on data from Anvisa, obtained through the Access to Information Law.
Since December 2019, seven products have already been approved by Anvisa for sale in pharmacies and drugstores under medical prescription, but the sector estimates that a large part of patients still seek imported products.
According to Tarso Araújo, who directs BRCANN, more doctors are seeking training for cannabis prescription. The courses are mostly offered by the cannabinoid industries.
“There is still a lot of prejudice, misinformation and even social intimidation around the prescription of Cannabis. But Anvisa’s decisions ended up legitimizing the demand for Cannabis as a health product and providing more legal certainty for a doctor to prescribe.”
This is despite a 2014 CFM (Federal Council of Medicine) resolution that only allows neurologists and psychiatrists to prescribe medical cannabis to children with epilepsies refractory to conventional treatment.
According to the industry report, these specialties account for only a third of prescriptions. The remainder is divided between general practitioners, geriatricians, orthopedists, in addition to a portion that omitted the specialty in the authorization requests.
Sought by Folha, the CFM did not respond to questions about the fact that doctors are prescribing Cannabis outside the council’s seal and whether there are plans to expand the indications of the products for other diseases.
According to prescribing physicians, during the pandemic there was an increase in cases of anxiety, depression and chronic pain, and the demand for medicinal cannabis for these purposes grew a lot among the adult public.
Psychiatrist Mauro Aranha, former president of Cremesp (Regional Council of Medicine of the State of São Paulo), says that clinical experience with cannabidiol has been shown to be positive for some anxiety and depressive symptoms, for which conventional treatments do not work. to your satisfaction.
“There are no more refined scientific works [duplo cego e randomizados] that attest to this benefit, but since it is a drug that does not have significant risks, why not give it a try? we have authorization [de importação] from Anvisa for that”, he says. The authorized formulation for this purpose is cannabidiol with up to 0.2% of THC (Tetrahydrocannabidiol, a substance with psychoactive effect) .
General practitioner José Roberto Lazzarini says that cannabidiol, due to its neuroprotective and anti-inflammatory action, has worked very well in the triad of chronic pain, anxiety and sleep problems, in addition to cases of Alzheimer’s and Parkinson’s diseases. There is no strong evidence for these indications.
“Older people suffer from these symptoms. In Alzheimer’s and Parkinson’s, cannabis does not change the evolution of the disease, but it greatly improves their quality of life and well-being. They start to sleep better, it reduces agitation, anxiety.”
Journalist AdÃlia Belotti, 67, was one of those who joined the use of cannabidiol to alleviate the pain she felt due to arthrosis in both knees. “Even so, I’ve always had an active life, I’ve always enjoyed walking. But in the first months of the pandemic I stopped everything, I didn’t leave the house. In my bedroom, my knees gave out, I couldn’t walk anymore. I went into an infinite loop of pain , steroids and fear,” she says.
Fear because, due to a previous problem in the femur, an aseptic necrosis, she was advised not to use steroids. Last October, she started using cannabidiol at the suggestion of her general practitioner.
“In April, on my birthday, I thought I would no longer walk [como atividade fÃsica]. Last week I walked ten kilometers. I cried with joy. Of course, at my age and the degree of arthrosis I have, there is no pain at all. But now I can live with her, I no longer feel incapable. I’m also sleeping much better”
According to Tarso Araújo, the state of evidence for cannabis varies greatly according to the indication and over time. “The surveys are in full swing. Phase 3 surveys are coming out every year [mais robustas], review studies. There are different degrees of scientific evidence, doctors can work with any degree.”
Araújo says that a lot of doctors prescribe cannabis for diseases that still don’t have a strong level of evidence, but that clinical experience is favorable.
Geriatrician Maisa Kairalla, from Unifesp (Federal University of São Paulo), says that there has been great pressure from patients and cannabis companies for prescription. “For use in the elderly, we lack evidence. People are using off label, often associating cannabis with allopathic medication for dementia, for example.”
According to her, this association can bring risks of falls to the elderly, for example. “Depending on concentration, it could be psychotropic. I’m not against it, as long as I have evidence.”
JUDICIALIZATION GROWS IN SP
At the same time as the medical cannabis market grows, legalization in the SUS for these products is also on the rise. In states like Paraná and Rio Grande do Sul, they already appear among the most demanded.
In São Paulo, a survey by the State Department of Health shows that until mid-November there were 154 lawsuits ordering the São Paulo government to offer these products. In 2019, there were 122 demands and, last year, 158. Per year, the average public expenditure was R$ 4 million.
Most of these actions ask for treatments for epilepsy, childhood autism, pervasive developmental disorders, cerebral palsy, Parkinson’s disease, Alzheimer’s, multiple sclerosis, severe depression, rheumatoid arthritis, migraine, among others.
According to the secretariat, in addition to the lack of proof of safety and efficacy or specifications in the package insert for use for many of these products, the expenses impact the public health budget, favoring individual rights over public policies established in the SUS.
“They oblige the State to supply products without registration with Anvisa, delimitation of a safety dose, evidence of efficacy, therapeutic indication or clinical control of use.”
In 2019, the STF (Supreme Federal Court) ruled that lawsuits referring to products not registered with Anvisa should be filed exclusively against the Union. However, since then, 355 lawsuits have been distributed to the State of São Paulo, generating expenses of R$ 456, 9,000 in three years.
According to Judge Ana Carolina Morozowski, of the 3rd Federal Court of Curitiba (PR), the judicialization of cannabis should increase even more due to recent court decisions that understood that, if there is authorization from Anvisa for the import of cannabidiol, both the SUS and the health care providers have to pay for it.
Morozowsk stresses that evidence for the use of cannabis is very weak for most clinical indications. “Maybe one day it will still be proven that it has benefits for many pathologies, which is really wonderful, but, for today, the only strong scientific evidence is for refractory epilepsy. I’m zero conservative, but there is an ideological bias behind it. Cannabis for a lot of things that don’t have evidence, it’s like defending chloroquine.”
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