A subcommittee of the Congress of Deputies will approve this Tuesday, predictably, a report to approve the use of therapeutic cannabis in Spain.
In the absence of details on how it will be applied, the step forward is imminent: the Ministry of Health has already promised to assume the recommendations agreed by parliamentarians.
The regulation of this substance as a medicine has the approval of the Spanish Pain Society (SED), which has very recently changed its traditional position to position itself in favor of certain cases.
Its president, María Madariaga (Madrid, 49 years old), coordinator of the pain units of the Santa Sofía University Hospital and the HM Torrelodones Hospital, asks to "open your hand" to give new alternatives to patients and continue generating knowledge in their field,
Ask.
What is the reason for this change in the position of the SED?
Why are they now in favor of medical cannabis?
Response.
It is a position that advocates a laxity in the recognition of the scientific evidence that can support the use of medicinal cannabis for certain types of chronic pain, in certain patients, with an exhaustive, rigorous follow-up, which has to do with the change of posture of the European Federation of Pain in accordance with the legislative changes in Spain and other countries.
P.
So, the change of position is not motivated by new evidence?
R.
It is what we need: to open the hand with the evidence classification system.
That is to say, you use [medical cannabis] for a pathology, with a certain group, with a treatment of X and you assess the evolution over time, the response to pain, the adverse effects, the improvement in quality of life... That requires time and money.
If you want to have quality evidence and studies that allow you to safely recommend medical cannabis for a group of patients, you need more of those studies and if we don't open our hands we won't be able to [have them].
That's the problem, it's not like the single-molecule clinical trial system [with which most drugs on the market are tested].
It is much more difficult and takes much more time.
It is the whiting that bites its tail.
Chronic pain is very difficult to treat.
Serious patients, with intense, refractory chronic pain, who require devices, rehabilitation, drugs... fall short of all that and continue to have pain.
Medical cannabis appears to work on some types of chronic pain.
Not always, but it seems to work and it is certainly a good analgesic drug that has its risks and its benefits.
We have to be in real conditions to know how long to recommend it, at what dose, in what pathology, what adverse effects we can find and how to treat them as doctors that we are.
Right now the patient is supplied outside [of the health system]: on the internet, they look for friends, neighbors.
Everything is crazy.
Q.
Would the regulation apply the reality principle?
A.
Trying to apply the scientific method to the reality of use and the pressure to find new alternatives to the treatment of chronic pain, which is so difficult to treat.
But we need to know more about cannabinoids.
They cannot tell us how the patients themselves work, that is absurd because they are combining it with other drugs.
We need data.
Q.
Will it be like doing a clinical trial in the real world?
R.
It is necessary to assess the patient's response to certain combinations of cannabinoids, THC and CBD [the two active ingredients] combined with others, and assess the response in joint pain, for example, for chronic sciatic or pain due to a lesion of the central nervous system at the spinal cord level;
and how it influences the quality of life, the quality of sleep.
We know positively that cannabinoids improve nausea, vomiting in the context of chemotherapy;
they also improve appetite in cancer patients, terminal patients or those with acquired immunodeficiency disorder.
These are potential benefits, but there are also side effects.
We know that cannabinoids don't always mix well.
The more powerful they are as pain relievers, the more adverse effects they produce.
But, of course, looking the other way,
More information
The life with pain of eight million people
P.
Other colleagues of yours point out that since they are not patentable, the pharmaceutical industry is not interested in spending money on clinical trials.
R.
I think there are companies that have a lot of interest in medical cannabis, but it is something that I cannot assess, it is not my responsibility.
Our interest is to advance in the knowledge of pain, in its treatment and in improving the quality of life of our patients.
How can we do it?
Observational studies can be started and followed up;
that costs a lot of money.
But it must be done and have non-interested financing to obtain real data of what happens in the short and long term.
Madariaga poses for EL PAÍS, on Friday, June 17. Samuel Sánchez
P.
In the new positioning of the SED, they recommend these drugs as a third line of treatment, what does this mean?
A.
[It's for] patients who are already taking everything at high doses, or who have been refractory and have severe pain, uncontrollable pain... Thank God it's a very small percentage of our patients.
Over time, perhaps others may find relief even if they are not that severe, but for that we need that indication data.
Because if it works for that kind of pain, it can work for another.
Q.
In principle, what are the two lines of treatment that patients should exhaust to access medical cannabis?
R.
The base would be analgesics and anti-inflammatories.
In second place would be the minor opioids and then the major opioids.
We are going to try to find alternatives to clinical trials
controlled and this will give us [the possibility of studying] a large number of patients with different pathologies and really assess what happens to them in the long term.
It is the same type of studies that were launched in the United States when the opioid epidemic began.
They found that older opioids did not work after three months of continuous use.
These data that are golden and have been achieved very little time ago, and it really is something that we could try to do in Spain as well [with cannabis].
P.
Due to its use in countries where it is more consolidated, it could be deduced that in Spain more than 200,000 people can benefit.
R.
Yes, there is sometimes talk of 200,000, 400,000.
They are many.
And if they work in those that are more serious, we will be able to assess the response in others.
But of course, we need safety data, we don't want patients to think this is smoking a joint;
We are talking about an oral route and, at most, an inhaled route, authorized and all controlled with a dispenser.
It is not about smoking a joint, that is very important to know.
It is another drug.
It will be necessary to assess the risk of developing other problems due to the long-term use of cannabinoids, just as we have done with opioids.
P.
There are those who think that opening the hand to medical cannabis can be the Trojan horse for the entrance of recreational use.
R.
We are clear about that.
But we still think that the regulation of medicinal cannabis cannot be bad, quite the opposite.
What we need are control mechanisms and indications for patient follow-up and very strict control.
We all have to be up to the task: our political managers and also the doctors who, by the way, need a lot of training in medical cannabis.
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