Faced with ongoing deregulation, with companies overstepping their roles, and with decision makers and heath authorities who still fail to make patients’ interests their top priority, it is up to healthcare professionals to assure quality of care and maintain patient trust.

Training and education
Quality healthcare requires continuing education for healthcare professionals and reliable information for patients. This implies:

• basic education for all healthcare professionals in the principles of critical appraisal (Rev Prescrire n°320), so that they are in a position to analyse clinical assessment data on individual drugs, instead of relying solely on others’ judgement (Rev Prescrire n°321); it is particularly important to be able to distinguish surrogate endpoints from robust outcomes that take adverse effects into account (Rev Prescrire n°320);
• searching SPCs for important “buried” information such as clinical trial data and adverse effects (Rev Prescrire n°319);
• being able to recognise a drug’s pharmacological class, notably by using international nonproprietary names (INNs), in order to avoid exposing patients to known adverse effects (Prescrire Int n°108);
• reminding patients not to believe everything they read or hear in the media. Reports of research results in the lay media can be misleading: many researchers have a tendency to exaggerate the significance of their findings, both for financial reasons and for personal status (Rev  Prescrire n°320);
• acknowledging one’s errors, as part of a constructive attitude towards improving professional practice (Prescrire Int n°109).

Mobilise!
The positive impact that healthcare professionals and patients can have on healthcare quality was illustrated by several events in 2010:

• a French physician succeeded in bringing the severe adverse effects of benfluorex (ex-Mediator°) to the public’s attention (Rev Prescrire n°325 and www.english. prescrire.org), and a national health insurer (Cnamts) commissioned a study of its adverse effects (issue 316 p. 114), both of which led to benfluorex being withdrawn from the French market;
• patient groups successfully lobbied for market reinstatement of 100-mg capsules of efavirenz that are adapted to the treatment of certain HIV-infected young children (Rev Prescrire n°320).

Resist "medicalisation of life"
Disease-mongering continued unabated in 2010, especially in the field of mental health (Rev Prescrire n°321and www.english. prescrire.org). Thus, in draft version V of the Diagnostic and Statistical Manual (DSM), to be published in 2012, certain diagnostic criteria are bizarre and diagnostic thresholds for some illnesses have been lowered (Rev  Prescrire n°323). In 2010, the indications for sertraline were extended to cover various anxiety disorders (panic disorder, social anxiety disorder, post-traumatic stress disorder) (Rev Prescrire n°316).

Companies are trying to get their products authorised for use in earlier stages of the disease concerned. For example, glatiramer is now authorised for suspected recent-onset multiple sclerosis (Prescrire Int n°108). This medicalisation serves companies’ interests by expanding the market for their drugs, at the expense of patient safety and well-being.

©Prescrire April 2011

"New drugs and indications in 2010: inadequate assessment; patients at risk" Prescrire Int 2011: 20 (115): 105-110. (Pdf, free)