The IOM report on drug safety is a pompous and inaccurate reshash developed by people who know nothing about drug development and it shows….It ignores the past 4 years of science and the efforts to integrate it and the panel was stacked with managed care and anti-industry types who believe that one size fits all drugs are all that people need and that companies are capable of producing… Ultimately, it is the report that is the real danger to the public health.
To suggest, as the report does, that when a drug is at the FDA, it’s safety profile is uncertain, is to suggest that it can ever be certain or that by piling on mountains of data post market you can ferret out rare safety events or that even if you can you can thereafter determine which people should get the drugs relative to benefits based on the data. The report and the committeee never provide examples of “how-to”. Rather, it is a knee-jerk reaction to headlines that themselves are based on fear, not science. The identification of ALLHAT as an example is the sort of throwaway and play to the crowd comment that has nothing to do with drug safety evaluation in the first place and secondly reflects a bias towards the findings of ALLHAT which themselves are subject to considerable controversy. What’s more the recommendation that Congress require such large science projects as the model for Phase 4 studies is ominous and troubling. And it contradicts the reports own findings that Bayesian type analysis and observation studies can be used with more sophisticated databases. But then again, the IOM report is more interested in sticking it to drug companies than in getting them to share data and develop measures to make drug safety a continuous part of the drug evaluation and development process.
Restrictions on access to medicines the committee recommends would make getting new drugs onerous and place new burdens on doctors and patients alike. Banning any member with any financial invovlement with companies solves the saftey problem exactly how? And, PS, it drives away the best talent.