Models for financing the regulation of pharmaceutical promotion

Pharmaceutical companies spend vast sums promoting their products. In Italy in 1998 the figure was US $1.1 billion [1] and in the United States (US) companies spent US $57.5 billion in 2004 [2]. Promotion to doctors has been extensively studied and all forms – receiving information that originates with drug companies, using samples, taking gifts – is almost never associated with better prescribing [3-5]. The poor quality of medical journal advertising is a global issue [6]. Direct-to-consumer advertising (DTCA) is costly and drives up spending on medications; the 50 drugs that were the subject of DTCA accounted for almost as much of the increase in US spending on pharmaceuticals as the 10,000 that were not advertised directly to the public [7]. DTCA has never been reliably shown to improve compliance, lead to more appropriate early diagnosis of under-treated conditions, or prevent hospitalizations and serious disease consequences [8]. There is also indirect evidence that DTCA leads to negative health outcomes. Requests by “standardized” patients for a prescription for paroxetine (Paxil, a selective serotonin reuptake inhibitor antidepressant) for symptoms of adjustment disorder lead to a prescription in 55% of the cases despite the fact that medications are not indicated for the diagnosis [9]. Exposing patients to medications that will not benefit them means that no side effects are justified.By law, companies are only allowed to promote drugs for uses for which the national regulatory authority has approved their use. Illegal off-label promotion has both negative health and economic consequences. Eli Lilly illegally promoted olanzapine (Zyprexa) for the treatment of dementia [10,11]. Nursing homes residents with dementia who are exposed to antipsychotic drugs such as olanzapine have a two times greater risk of an adverse event compared to those not taking these medications [12]. Illegal promotion of gabapentin (Neurontin) for off-label uses that had no scientific b