PARIS -Servier, the pharmaceutical company at the heart of a massive medical scandal in France, suffered several fresh blows to its credibility this week. Yesterday, a newspaper revealed that the company is under fire from Europe's guard dog medicine for the way she studied the side effects of her medication after reaching the market. court testimony Meanwhile, leaked by two company scientists suggests that ancient Servier deleted unfavorable information from the files with which it requested regulatory approval for mediator, its drug against diabetes, in the 1970s .
the name of the Mediator, Servier brand of a drug called benfluorex-was banned in November 09 after 33 years on the french market. Although marketed as a drug against diabetes, doctors widely prescribed for people who wanted to lose weight as well. was shown mediator to cause serious heart valve problems, however, and it is now estimated to have caused up to 2,000 deaths. A French court investigating the case, and the French government announced that it will tighten regulatory oversight of drug response.
Yesterday, the French newspaper Libération reported that the European Medicines Agency (EMA) in London has set his sights on Servier as well first for problems around ranelate strontium, a drug against osteoporosis, marketed by Servier in France under the name Protelos. 30,000 French women is estimated that in France took the drug during the last 4 years.
Maraninchi Dominique, director of the French regulatory agency AFSSAPS, confirmed the EMA concerns in a telephone interview with Science Insider. In November 07, Pharmacovigilance Working Party of the EMA issued a warning that Protelos could cause serious and potentially fatal skin rash known as adverse drug with eosinophilia and systemic symptoms, and Servier ordered to correct "flaws" in his system to keep track of these adverse events, Maraninchi said.
EMA asked Afssaps carry out an inspection in December 09 to ensure Servier had followed. This inspection revealed other "critical and major findings," this time with Servier manufacturing process, and raised concerns about all drug company, said Maraninchi. Consequently, Servier was ordered to submit information about all of its drugs to the EMA, whether authorized for marketing by EMA itself or by national agencies.
EMA eventually concluded that the benefit-risk balance remains positive for Servier drug, but it instructed the company to provide additional product information for some of them, a spokesman said EMA. AFSSAPS conducted a second inspection in July this year and will present its findings at the end of this month.
Tuesday, reports in newspapers Le Figaro and Libération also expressed doubts about the integrity of Servier when regulatory application for mediator in 1973. the documents referred to the testimony of retired neurosurgeon Jean Charpentier, now 81, who prepared the regulatory file at court. Charpentier, who began working for Servier in 1968, told the judges that clinical trials have shown mediator to be a powerful appetite suppressant, but it has been minimized in its report for approved mediator as antidiabetic drug. (Diabetes was "infinitely more profitable choice" that weight loss for pharmaceutical companies, said Charpentier.)
The report did not mention that Mediator is an amphetamine derivative, Charpentier said in his testimony. "The word was amphetamine to avoid," he said.
Duhault Jacques, 78, a pharmacist who led the diabetes and obesity of the company's laboratory in the 1960s, told the judges he regretted that Servier did not shoot mediator as a precautionary measure in 1999 Libération reported. His studies have described the drug as a "powerful appetite suppressant." in January 1969, said the drug, then known under its code name S992, "causes the almost complete anorexia from day one."
Servier has denied all allegations. in press statements, the company condemned the violation of judicial secrecy on mediators testimony, reiterated that he had "deceived neither health authorities nor the patients," and denied that Carpenter studies had been falsified.
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