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In the UK, 20,000 babies born with deformities due to incorrect information about a medicine

LETTER FROM LONDON

The scandals of the NHS, the British health system, follow one another but are not alike. After the publication in early April of a horrific report of the preventable deaths of 201 babies in maternity wards in the Midlands, the Sunday Times revealed on April 17that an epilepsy drug sodium valproate was still given to women during pregnancy without adequate warning, although the risk of it causing serious malformations in the fetus has been reported for fifty years.

Up to 20,000 babies have been born with autism syndrome, learning disabilities or physical deformities after their mothers took sodium valproate during pregnancy, since the drug was approved in the UK, in 1973.

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In France, in the Depakine affair, between 16,000 and 30,000 children were also born disabled. But the Ministry of Health created a compensation fund in 2016 and the manufacturer Sanofi was found liable in January, following the first class action in the field of health in France (the laboratory has appealed). Not so in the United Kingdom, where the families of victims still face the silence of the Johnson government.

In the early 1970s, the British medical profession still remembers the thalidomide scandal, a sedative administered in the 1950s and 1960s to pregnant women suffering from nausea, but causing serious malformations of the upper and lower limbs of the foetuses. About 2,000 victims are listed at the time. In 1968, following a long media campaign by the Sunday Timesa compensation fund is created – it is then topped up by the drug distributor in the country.

“Paternalism”

It was in the wake of this scandal that the British Committee for the Safety of Medicines (CSM) was created. It examines on several occasions, between 1972 and 1973, the safety of sodium valproate, after the manufacturer Sanofi alerted to potential teratogenic effects – dangerous for the embryo – during clinical trials on animals. But the members of the CSM believe that the risk is low and choose not to warn the public.

Quoted by Sunday TimesDr. Rebecca Bromley, specialist in neuropsychology at the University of Manchester, delivers a disturbing analysis: the decision of the committee was “probably influenced by the paternalism of the time”. He didn’t seem to consider the need, “for women to have a say, being fully informed about their treatment”.

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