viernes, 8 de febrero de 2013

Corporate Crime in the Pharmaceutical Industry / 30 años después...



Nearly 30 years ago, Braithwaite’s Corporate Crime in the Pharmaceutical Industry showed that unethical and corrupt behaviour was endemic in the sector. Sadly, there is growing evidence that little has changed. Recent research suggests that violation of the law continues to be widespread. Most new medicines offer little or no therapeutic advantage over existing products, so promotion plays a huge role in achieving market share. In a crowded and competitive marketplace the temptation for companies to resort to misleading claims is great. According to Gøtzsche (doi:10.1136/bmj.e8462),1 as of July 2012, nine of the 10 largest drug companies were bound by corporate integrity agreements under civil and criminal settlements or judgments in the United States. The corporate activity that has led to recent government investigations has involved unethical and unlawful practices that are well beyond mere administrative offences.

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There are some signs that change is afoot in the US, with additional funding granted for FDA fraud detection and prosecution alongside other signals from Congress that the agency should increase its enforcement activity.11 A similar shift in the UK is less likely given successive governments’ determination to “reduce burdens on business.” Whether government authorities in the EU are willing to take enforcement action against large drug companies will become clearer on resolution of the European Medicines Agency’s investigation of Roche for safety reporting violations.12 and a French manslaughter investigation of Servier Laboratories’ former president in relation to the antidiabetes drug, benfluorex (Mediator).13
Individual instances of corporate malfeasance are indicative of wider systemic problems. Whether companies continue to “get away with it” depends, in part, on whether regulators can develop credible systems of detection, enforcement, and punishment. (Ver)

Ver también: 
Big pharma often commits corporate crime, and this must be stopped
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