The British Medical Journal (BMJ) is reporting that criminal charges have been laid against Servier itself, French regulatory bodies that looked the other way while Mediator continued to kill people, companies affiliated to Servier, and 14 individuals directly involved in the fraud.
The French government forced Servier to withdraw Mediator from the market back in 2009, but after 33 years of being widely available, the damage had already been done.
While clinical studies indicated that benfluorex had a potentially beneficial effect on glycemic control and insulin resistance, making it an attractive option as a diabetes medication, several other studies confirmed that it is directly linked to an increased risk of valvular heart disease.
Then, in 2011, regulatory organization Inspection Générale des Affaires Sociales (IGAS) compiled a 260-page report on the many ways in which this drug harmed people, as well as the massive cover-up involved in its staying on the market for three decades.
The journal The Lancet outlined some of their findings:
Few have emerged with their reputations untarnished by the IGAS report. Servier is accused of relentlessly marketing the drug “at odds with its medical properties” and of applying undue lobbying pressure on regulators and on the medical community to ensure the successful commercialisation of its product. AFSSAPS, the French drug regulators, are deemed “inexplicably tolerant of a drug with no real therapeutic value”. They are also painted as an “overworked” bureaucracy “entangled in cumbersome and complex legal procedures”, and “restrained by fear of litigation”. The broader medical and scientific communities also take flak for irresponsible behaviour.
Servier, of course, immediately disputed the findings, complaining that important facts were missing from the report. Lucy Vincent, Servier's general director of external affairs, insisted that “drug development is an inherently risky business, and that those involved have the difficult task of constantly trying to balance a complex set of risks and benefits in patients who may lose out by not taking a drug.” (Related: U.S. prosecutors clamp down on Big Pharma companies colluding to hike “generic” drug prices.)
The facts do not back her claims, however. Servier developed benfluorex back in the 1960s as a derivative of amphetamine, which was known to suppress appetite. They also developed two other such derivatives, and called them fenfluramine and dexfenfluramine. All three drugs were very similar, but Servier insisted on getting benfluorex classified as a different class of drug. While fenfluramine and dexfenfluramine were marketed as anorexigens for obesity, benfluorex was marketed primarily as a diabetes medication.
When fenfluramine was withdrawn from markets around the world two decades later, after being linked to increased risk of pulmonary heart disease, Servier conveniently failed to disclose the fact that benfluorex was essentially the same thing. This meant that benfluorex continued to be marketed for decades more, resulting in the avoidable deaths of over 2,000 people.
Servier cannot hide behind errors in the reports, or the weighing up of risk versus gain. What really lies behind this absolute lack of regard for human life is money: The company reported annual sales of over $24,000,000 in the years before the drug was banned.
Though the government is now prosecuting the culprits, that will likely be of little comfort to those who lost their loved ones to corporate greed.
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