ABSTRACT

Scientists at drug agencies are not only up against a powerful industry, they are also often up against their own superiors and their advisory committees who may have less than ideal motives for their decisions. There are pervasive financial conflicts of interest in drug regulation, and regulators may go back and forth between the industry and drug agencies, the ‘revolving door’ phenomenon. The scandal involved the minister of health who arranged for drug companies to pay bribes in order to get their drugs approved and sold at ‘suitable’ prices. The multitude of regulatory decisions provides many opportunities for buying off regulators. In some Asian countries, drug registration can be secured for small amounts of money. Lobbying is strong in Brussels, which until 2010 had resulted in extreme secrecy in European drug regulation. One of the most harmful practices in drug regulation is to approve drugs based on their effects on surrogate outcomes.