«I estimate that there could be thousands of people affected by Depakine in Spain»

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The director of the Pediatric Environmental Health Unit at the Virgen de la Arrixaca University Clinic, in Murcia, managed, among others, to put Sanofi on the bench for the effects of Depakine in pregnancy. Few people can say that, and even fewer, in the absence of a final ruling, reach a decision against a pharmaceutical company.

When did your unit start investigating the relationship between drugs and disorders?

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We treated the first patient in 2013. He was born with a malformation. People affected by valproate have the right to a careful environmental clinical history that what it does is look for risk factors associated with the disease they present. For example, if you find one associated with a drug, you should be suspicious. In the future, this environmental clinical history will have to be incorporated into health systems because today it is only done in the Murcia unit and in one being created in Olot. A critical judgment must be made about the causes. When it comes to intrauterine exposures, if they say the cause is unknown or multifactorial, they are shelving families and knowledge. It is necessary to educate and train health professionals to eliminate environmental and chemical risks. Depakine patients are not like that because they did not go to the doctor precisely. We must improve the chemical safety of pregnancy.

How many affected could there be in Spain?

I estimate there will be thousands.

How many families have already gone through your consultation with questions and how many got the question right?

Around 30-35 and valproate may have been relevant in more than 20; that is, by more than two thirds.

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After the decision, do more families ask to be treated at your unit?

Yes, and this concern will grow. Many of these women, unlike thalidomide, are here (alive). Why is this happening to your child? It's the first thing I ask and I let them talk. We doctors should ask more questions. It is very important to listen to them. They spent years tormenting themselves with the idea of whether it was because of something they caught.

Do they come from all over the country?

Yes. And this is due to the lack of Environmental Health units. In the Health and Environment Strategy we have already asked Teresa Ribera to create these units against valproate, chemicals, pollution... We need them. In Europe, he talks about green jobs, and in the health system I say that new professional profiles must be incorporated to respond to these problems.

I tell you this because the Association of Victims of Valproic Acid Syndrome tells me that some neurologists continue to say that this Depakine and autism thing is nonsense…

It is not for lack of evidence, since the 80s there have been scientific studies that warn about this. Pride is very bold. You have to be a little more humble. It may not be known and referred if they help the patient. In the future there will be a unit of this type in each autonomy for Depakine, chemical safety, cancer, malformations, reproductive problems...

How would you evaluate Sanofi's role during these years?

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Well, having so much evidence… but I would focus on the national pharmacovigilance system. It's frankly improveable. This sentence should give a boost to pharmacovigilance and specific chemical safety during pregnancy because it is the future of the country. And by that I mean the drug agency. More than the social alarmism of families, I am concerned about the institutional calm that I hope and trust will end up creating units in all autonomies.

What should parents do to get their children diagnosed?

I am very happy to welcome you. They have the right to know the cause.

But being transferred to Murcia depends on your doctor's wishes. What can they do?

They have to assert their rights and demand in patient care until they are successful.

By the way, which diseases can be prevented?

Many. Chronic diseases are related to the health of ecosystems. You have to get to the cause before the person gets sick with one goal: eliminate the inducing risks. It has been shown that putting fewer chemicals, stopping smoking, even in people who have had cancer, improves their health indicators and even survival.

With Covid, the role of Nature in health was discussed, but…

Covid is a powerful warning from Nature, but we will certainly need a SARCoV-3. There are already changes, but inertia is inertia. Even today, health managers in autonomies say that health systems must be humanized, when what should be done is to naturalize Health Systems. This is the challenge that the health system will face. We found that 15% in childhood cancers is attributable to environmental factors, as well as 35% in neurodegenerative diseases and even 40% in asthma. And these are conservative data. Therefore, for every euro allocated to Environmental Medicine, the return will be enormous.

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