French medicine watchdog indicted for drugs causing birth defects

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In a multi-year investigation into Sanofi’s epilepsy drug Depakine, the charges now include The watchdog of medicine in France, National Agency for Medicines and Health Products Safety (ANSM). The ANSM was indicted for “negligence and manslaughter” in the Depakine case.

The drug, sodium valproate, has been on the market since 1967 to treat epilepsy, migraines and bipolar disorders and is prescribed in more than 100 countries. Apparently Sanofi learned of the risk of malformation in babies in utero in the 1980s when their mothers were taking it, and then in 2003 realized that the drug could impact neurodevelopment as well, with an increased risk of autism. or learning problems. When the EMA reassessed the drug in 2014, it made strong recommendations that it should not be prescribed to women of childbearing age. But for the thousands of families already affected, it was far too late.

BioSpace spoke with Marine Martin, a mother-turned-whistleblower who had taken Depakine since the age of 6 for her epilepsy. Martin’s daughter, Salomé, suffers from neurological problems such as dysgraphia, dyspraxia and mild autism. Her son Nathan suffers from hypospadias, neurological problems, difficulties with praxis, autism, speech disorders and hyperlaxity. They both had the telltale face of valproate, a swelling caused by the side effects of valproic acid (Depakine).

Driven by an instinct that these difficulties were not random events, Martin began his own research. The fact that her son had both deformities and neurological issues had its side effects on the pesticides when she came across a Paris hospital website that said Depakine was the second most dangerous drug in take during pregnancy. This led Martin to sound the alarm, alerting others, contacting the media and public authorities. Understanding the need to unite affected families, instead of attacking the pharmaceutical giant individually, Martin founded the Association for the Assistance of Parents of Children with Anticonvulsant Syndrome, APESAC.

Martin continued to negotiate a Compensation fund of 6.5 million euros with the National Compensation Office for Victims of Medical Accidents. Sanofi does not participate in the fund. Studies conducted by the government based on Martin’s efforts have yielded heartbreaking statistics. It is estimated that 4,000 infants have been born with deformities due to in utero exposure to the drug. Between 2007 and 2014, of the 14,000 pregnant women taking Depakine, only 8,700 ended up giving birth alive. It is estimated that nearly 30,400 children have been born with mental and behavioral disorders since the drug was marketed in France in 1967.

The investigation into Sanofi began in 2016. At that time, Pascal Michon, head of the global medical franchise of products established at Sanofi, told Reuters that if the court found them responsible, they would assume that responsibility “as we always have”. Sanofi has since denied any wrongdoing, saying it alerted authorities to the risk in 1980, when it was first discovered.

The courts then targeted the ANSM, with an indictment Wednesday for the effects of the drug.

“The ANSM takes the full measure of the suffering of the victims and has been working for several years to limit exposure to valproate in women of childbearing age,” the agency said in a statement, adding that it “will respond to any questioning of Justice in order to make its full contribution to the manifestation of the truth.

With these charges officially filed, Martin said, “I am happy because I have been fighting for this cause for years. I know we will be successful. Some people call me Erin Brockovich. It makes me laugh, but it’s true that the fight is tough. These court decisions to indict Sanofi and the ANSM are small vices against a large Sanofi pharma.

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