Amos H Presler's research while affiliated with Brown University and other places
We agree with the recommendations of Furberg et al1 and their observations of the weaknesses in the drug safety process of the FDA. While meetings of FDA advisory panels are public, most other discussions and negotiations that figure prominently into FDA decisions involve only FDA employees and drug industry representatives, with the FDA outmanned and out-financed by industry. A single FDA officer generally has major responsibility for the approval of a drug in a process that involves negotiation with a host of industry physicians, scientists, lawyers, and marketing experts over a number of years. This psychologically, scientifically, and financially imbalanced relationship and the absence of other parties forces the FDA to ration its demands and puts the agency at risk of being captured by the economic interests it regulates.2 We recommend additional measures to prevent regulatory capture and to improve the independent analysis of postmarketing adverse events.
In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues
... Not only good governance, but effective mechanisms to counteract conflict of interests among political and government actors, and prevent regulatory capture are also needed. 54,55 The WHO Framework of Engagement with non-State Actors 56 can be applied to country contexts when engaging with private entities in the prevention and control of NCDs. Strengthening the capacities of government lawyers to defend lawsuits by industries and take litigating against law violations is also critical. ...
... Withdrawal of rofecoxib (within 5 years of approval), muraglitazar (after getting approval letter) and torcetrapib (taken off trials towards the end of approval process) are some recent examples.  These drugs were withdrawn because of safety issues which emerged late in the drug development process or after the drug had obtained approval. The uncertainties regarding efficacy and safety assume more significance in case of new biopharmaceuticals as the first generation is going off patent and similar biologics are not identical to the reference biopharmaceutical. ...