- Twenty-five (50%) of the 50 new brand name products introduced to the market in France that we examined in 2008 were designed to treat cancer, HIV infection or rare diseases. None represented a major therapeutic advance. Line extensions making treatment more convenient included methadone capsules and a liquid form of metformin.
- Marketing authorisation does not provide sufficient guarantees of safety and effectiveness. In 2008 we rated 23 new products as “Not acceptable” and advised our readers to avoid them.
- Drug regulatory agencies were reluctant to take the necessary measures, such as refusal to grant marketing authorisation, to protect patients from exposure to drugs with negative risk-benefit balances.
- Serious incidents involving contamination of certain batches of nelfinavir and heparin are reminders that the pharmaceutical industry needs to maintain the highest quality standards.
- Drug prices remain high and bear little relation to therapeutic benefits.
- It is now clear that direct drug advertising to the public and healthcare professionals has negative public health consequences. However, it has not yet been banned.
- In summary, deregulation continued in 2008. Only by maintaining pressure on the authorities and regulatory agencies can patients and healthcare professionals resist these negative trends.
Source: Prescrire Int 2009; 18 (100): 84-88.
©Prescrire 2009