Pharma giant Sanofi charged with manslaughter in birth defects case

French laboratory Sanofi is indicted for “involuntary homicides” over the devastating effects of the anti-epileptic drug valproate (Depakine). (FIle/AFP)
Short Url
Updated 03 August 2020

Pharma giant Sanofi charged with manslaughter in birth defects case

  • Studies say a Sanofi drug has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant
  • On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder

PARIS: French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug, the company said Monday, in a long-running case that has also seen it charged with fraud.
The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant.
On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder.
But research found that when pregnant women took the drug, their children had an elevated risk — between 10 to 40 percent — of congenital malformations, autism and learning difficulties.
Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families, but insists it had warned health authorities of the drug’s risks already in the 1980s.
On Monday, the company confirmed a report in Le Monde newspaper that prosecutors have now also charged it with manslaughter.
But in a statement sent to AFP it insisted it had “fulfilled its obligation” of providing information on the drug and its side-effects, and said it “contests the validity of these proceedings.”
Sanofi said it has filed a legal challenge to the indictment.
Under the French legal system, charges do not automatically result in a trial as prosecutors can decide not to proceed based on a lack of evidence.
Last month, a French court ordered the state to pay thousands of euros in damages over the scandal, saying officials should have ensured the drug was not taken by pregnant women.
The court found that health officials knew about the risk of birth defects from Depakine already in 1983, and of learning disabilities and autism from 2004.
Another 500 complaints have been lodged with France’s national compensation agency for medical accidents, which has already proposed a 6.5-million-euro ($7.6-million) package for Depakine victims.
Sanofi, a France-based multinational, is working on a candidate vaccine against the novel coronavirus with Britain’s GSK, for which it will receive up to $2.1 billion from the US government.


Arthritis drug trialled as potential treatment for COVID-19

Updated 28 September 2020

Arthritis drug trialled as potential treatment for COVID-19

  • Dr. Andy Martin: We are conducting this study to see whether otilimab could potentially ease the effect of COVID- 19 on the lungs
  • Dr. Tim Felton: The primary end point of this study is that participants are alive and free of lung failure after 28 days — so this research is potentially life-saving

LONDON: The experimental arthritis drug, otilimab, is being trialled as a potential treatment for COVID-19.

The first patient, administered with the drug, is currently being cared for at Manchester Royal Infirmary (MRI), part of Manchester University NHS Foundation Trust (MFT).

The OSCAR study (Otilimab in Severe COVID-19 Related Disease) is sponsored and funded by the pharmaceutical company GlaxoSmithKline.

The study at the MRI is being led by Dr. Andy Martin, an Intensive Care and Anaesthesia Consultant.

Dr. Martin said: “The patients eligible to take part in this study are those experiencing very severe lung difficulties due to COVID-19 infection and are receiving oxygen or ventilator support.

“We are conducting this study to see whether otilimab — which is under investigation as a potential treatment for rheumatoid arthritis — could also potentially ease the effect of coronavirus on the lungs, dampening the impact of the virus on the immune system.

Christopher Corsico, Senior Vice President Development, GSK said: “We are continuing to work hard to find solutions to address the pandemic, including exploring potential treatment options for COVID-19 patients.

“We know that some COVID-19 patients experience an overreaction of their immune system — sometimes referred to as cytokine storm — which can lead to hospitalization or death. We believe that otilimab might be able to help counter or calm this process.

Dr. Tim Felton, Honorary Consultant, Senior Lecturer at The University of Manchester and Clinical Lead for all MFT COVID-19-related research studies, leads OSCAR at Wythenshawe Hospital, which is also part of MFT.

Dr. Felton said: “The primary end point of this study is that participants are alive and free of lung failure after 28 days — so this research is potentially life-saving.

“I’d like to thank our first OSCAR participant — as well as the thousands of others who have taken part in coronavirus studies at MFT to date — as every participant who takes part in our research is contributing to the coordinated effort to enhance understanding of this global pandemic.”