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Regulatory drug approval: protecting patients or serving impatient shareholders?

Gyawali and colleagues showed that a third of anticancer drugs approved by the US Food and Drug Administration on the basis of surrogate measures under accelerated processes remained authorised despite negative results after marketing authorisation.1 Regulatory agencies face a serious challenge, having only two speeds: too slow or too fast. However, the accumulating evidence indicates that they are going too fast for approval and too slow for withdrawal, and that science, the basis of their existence, hardly matters at all. Withdrawal for lack of efficacy took 10 years for drotrecogin-alfa and four for bevacizumab in metastatic breast cancer. The European Medicines Agency approved strontium ranelate and seems to have been ignoring evidence of net harm for a decade.2 To make matters worse, withdrawals, when they do take place, are more frequently for financial reasons than harm or lack of efficacy.3 Regulators seem also to forget that clinical trials may have been falsified, and that companies submitting preliminary studies often have a history of scientific malpractice. According to the independent drug bulletin Prescrire International, there are a hundred “drugs to avoid” on the market—either assessedasmoreharmful thanbeneficial or becausedrugswith abetter harms-benefits balance are available.4 Obviously, reforms are welcome.5 Improvement is unlikely, however, if there is no accountability, either by regulators as a whole or by individual officials within these organisations who make decisions or ignore evidence. Regulators’ behaviour, both action and inaction, seriously harms patients and is contagious: while regulators seem to treat scientific thinking as an afterthought, it is hardly surprising that too many academic thought leaders treat science with such contempt.