French Government Denies Cover-Up of Birth Defects Study Related to Sanofi Epilepsy Drug
August 11, 2016
By Mark Terry, BioSpace.com Breaking News Staff
A French weekly satirical newspaper, Le Canard Enchaine, is claiming that France’s health ministry is covering up a study showing that a Sanofi drug for epilepsy, Depakine, causes fetal malformations. The French agency denies that it was covering it up, or delaying the publication of the study. Sanofi, for its part, indicated it wasn’t aware of the study’s data and could not comment.
Sanofi did, however, say that the company was aware of the risk of fetal malformations as far back as the 1980s, and that those risks were well documented in the drug’s accompanying literature. Also, around 2003, Sanofi found that the drug, which contains sodium valproate (Valproic acid), had an impact on fetal neurological development and could lead to autism or learning problems. That information was provided to the health authorities, who updated the documentation in 2006. In France, drug documentation requires approval by health authorities.
The study in question on Depakine, was performed by France’s national drug agency, ANSM, and health insurance agency, CNAMTS. The study was initiated about a year ago.
Between 2007 and 2014, 10,000 pregnant French women took the drug, even though the risks were known. Le Canard Enchaine accused the French health ministry of delaying the study’s publication, which the French government agency has denied. The first part of the study is being presented on August 24 to the APESAC, a French organization that helps parents of children with fetal anti-convulsant syndrome. The full study and a response plan is expected in September.
Earlier this week, Marine Martin, president of APESAC, called this a “health scandal” and that the French government was responsible, in a television interview with Europe 1. “This figure doesn’t surprise me at all. The number of potential victims is huge. I’ve been saying it for years: the health agency has been covering for the laboratory by continuing to grant authorization of this product on the market. So there is complicity between different successive governments. So the responsibility of the state and the laboratory is huge in this health scandal.”
In February, the French social affairs inspection agency, IGAS, accused the French health authorities and Sanofi of being slow to respond to the risks associated with the drug. IGAS estimates that from 2006 to 2014, between 425 and 450 babies were born with congenital birth defects or were stillborn as the result of exposure to Depakine.
Depakine has been on the market since 1967. It is used to treat epileptic seizures and bipolar disorder. The malformations identified are typically cleft palate and spina bifida. About 40 percent of children whose mothers took the drug during pregnancy developed neuro-developmental problems like autism. Approximately 11 percent have physical malformations like spina bifida, or heart and kidney issues.
The drug’s equivalent in the UK is called Epilim, and an article in The Telegraph News reports that a British victims’ group indicated that the drug was “very likely” prescribed to a similar number of UK women in the period of 2007 to 2014. In the case of Epilim in the UK, related warning labels were only initiated in July, although the UK government estimates that 175 infants are born annually with birth defects connected to the drug. It has been for sale in the UK since 1973.
The French government has estimated that potentially 7,000 children have been hurt by the drug since it was released.
Valproic acid is marketed in the U.S. and Canada as Epival by Abbott Laboratories .