english.prescrire.org > Positions > Regulatory issues > Patients' interests first

Theme: Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.

Themes

Patients' interests first

In authorising rimonabant (Acomplia°) in 2006 despite its negative risk-benefit balance, the European authorities once again chose to put pharmaceutical company interests ahead of protecting patients. It took them two years to come to their senses. Instead putting patients’ interests first, from the beginning.

When rimonabant (Acomplia°) was authorised in the European Union in 2006, we already knew enough about it to decide not to use it.

Behind all the promotional hype lay a negative risk-benefit balance in smoking cessation. The effect on body weight was obviously limited to the temporary loss of a few kilos. Any effect on the clinical complications of diabetes was purely hypothetical. Clinical evaluation already included troubling data concerning adverse effects, especially psychological disorders. For this reason, it was not allowed on the US market.

Of course, one could always hope that something positive would emerge from the clinical trials that were planned or underway. Just as one could legitimately worry about the magnitude of the psychological problems caused by the widespread use of this psychotropic substance.

When in doubt, the European authorities decided to give in to the drug company. By granting marketing authorisation, the authorities allowed the company to collect the proceeds from sales of the drug, even if it meant putting thousands of patients at risk, patients who innocently put their faith in regulation and in the (cosy) medico-pharmaceutical establishment.

In other words, once again, the authorities chose to put the drug company’s interests ahead of protecting patients. It took them two years to come to their senses. Instead of putting patients’ interests first, from the beginning.

Regulatory agencies continue to make bad choices, as in the case of cilostazol or trabectedin.

Patients and healthcare professionals have their work cut out to ensure that things change.

Source: "Bénéfice du doute" Rev Prescrire 2008; 28 (302): 885.