Regulating the drugs industry transparently

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Making regulation responsive to commercial interests: streamlining drug industry watchdogs

New prescription drugs are developed and tested for quality, safety, and efficacy by the pharmaceutical industry, and little or no drug testing is conducted by governments in modern industrialised countries. Governments have regulatory authorities which have a legal duty to protect public health by ensuring that new drugs are not licensed unless they are of adequate quality, safety, and efficacy (box 1). The thousands of birth deformities and deaths caused by thalidomide focused public and professional concerns on how the commercial interests of pharmaceutical companies may diverge from, or conflict with, the interests of patients and public health. The reasoning behind the creation of new government regulatory authorities in the post-thalidomide era was therefore that they should be “entirely independent” of the commercial interests of the pharmaceutical industry and should act on behalf of the public interest by checking the adequacy of the test data produced by the industry.1–3 I explain how these government regulatory authorities in the European Union, which were initially established to provide independent scrutiny of pharmaceutical firms in the interests of public health, have become increasingly responsive to the commercial interests of the industry (box 2

Rethinking transparency and accountability in medicines regulation in the United Kingdom

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A Model for Donation Verification

In this paper, we introduce a model for donation verification. A randomized algorithm is developed to check if the money claimed being received by the collector is $(1-\epsilon)$-approximation to the total amount money contributed by the donors. We also derive some negative results that show it is impossible to verify the donations under some circumstances

The Comparison of Creatinine and Cystatin C Value in Preeclampsia Severity and Neonatal Outcome

Objectives: to compare the levels of creatinine and cystatin C with the severity of preeclampsia, and assess neonatal outcomes.Materials and Methods: Creatinine, cystatin C, and neonatal outcomes were assesed in 17 normotensive samples, 17 samples of mild preeclampsia and 17 samples of severe preeclampsia. Analysis of data with statistical tests of ANOVA and t test differences between 2 proportions.Results: The mean levels of creatinine in the normotensive group, mild preeclampsia, severe preeclampsia are 0.56 mg/dL, 0.67 mg/ dL, and 0.75 mg/dL, p=0.138; While on cystatin C are 0.82 mg/L, 1.03 mg/L and 1.32 mg/L, p=0.000. The adverse neonatal out-come wasn't found in the normotensive group. In mild pre-eclampsia obtained 1 preterm birth and 1 intrauterine fetal death (IUFD), whereas in severe preeclampsia obtained 3 babies born preterm, 1 IUFD, and 1 intrauterine growth restriction (IUGR).Conclusion: levels of cystatin C was increased significantly in line with increased severity of preeclampsia, whereas creatinine was not increased significantly. Cystatin C is better than crea-tinine as a marker of renal dysfunction in preeclampsia patients. There was an increase in adverse neonatal outcomes in the group of preeclampsia