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To prevent repeats of the Mediator° (benfluorex) disaster:
attitudes need to change

Healthcare professionals and patients, as well as drug experts and health authorities, must learn to balance medicines’ harms against their benefits.

In recent months, France has been questioning its policy on drugs and the behaviour of those responsible. Blame has been laid at the door of the pharmaceutical companies and the regulatory agencies after the Mediator° affair revealed damaging attitudes on both sides.

Healthcare professionals and patients have emerged relatively untarnished, even though Mediator° was prescribed by doctors, often off label as a slimming drug, and dispensed by pharmacists, sometimes on the insistence of patients.

Profound and lasting changes are required to the firms’ and regulatory agencies’ practices. But in order for all the lessons of the Mediator° affair to be learned, healthcare professionals and patients must be more wary about medications. It is better for healthcare professionals to tell patients that no satisfactory drug treatment has yet been found to meet their need, for example to lose weight. Healthcare professionals must refrain from prescribing or recommending drugs to satisfy their wish to assist the patient at any price rather than on the basis of scientific evidence. They must fight against a certain fatalism with regard to drugs’ adverse effects.

It would be better too if in many areas patients did not rely too heavily on drugs. They need to be wary of media pundits, word-of-mouth opinions and online forums. And they should remain critical and choose reliable sources of information.

Too often those who have expertise or authority have a paternalistic attitude, concealing the truth from the public and patients. Confusion of roles and too close a relationship between representatives of the firms and the health authorities are to be avoided at all costs.

©Prescrire 1 December 2011

"Lessons from the Mediator° scandal" Prescrire Int 2011; 20 (121): 284. (pdf, free)

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