english.prescrire.org > Positions > Regulatory issues > Sending the wrong signals

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.  

Sending the wrong signals

In early 2009, 60 mg capsules of orlistat, containing half the prescription dose were approved without a prescription. Once again, the authorities are sending a signal to drug manufacturers that they can continue to develop and market drugs offering little if any concrete therapeutic benefit.

In the late 1990s the EU Commission authorised through the centralised procedure the marketing of orlistat 120 mg capsules, available only by medical prescription. A decade later, in early 2009, 60 mg capsules, containing half the prescription dose were approved without a prescription, making orlistat the first prescription-only drug to change status and become authorised for self-medication in the European Union.

However, with or without a prescription, orlistat provides only temporary and limited weight loss and has no proven impact on the complications of obesity. In addition, its adverse effects are frequent, sometimes embarrassing, and occasionally serious.

Management of overweight and obese patients is based first and foremost on nondrug measures, focusing on the complications associated with obesity, dietary measures, appropriate physical activity, and perseverance.

The role of orlistat is marginal. People who buy orlistat may simply be wasting their money. But the easy availability of this drug sends the wrong signal to adolescents that they can, and therefore must, conform to the skinny body image promoted in the media.

And once again, the authorities are sending a signal to drug manufacturers that they can continue to develop and market drugs offering little if any concrete therapeutic benefit while continuing to neglect the real needs of many patients. It is not by writing drug companies blank cheques in the form of market authorisations for “self-medication” products that the authorities will remedy the situation.

©Prescrire 2009

Prescrire Int 2009; 18 (101): 96.
More information:
"orlistat half the dose
without a prescription"
Prescrire Int 2009;
18 (101): 101