Luca De Fiore and Tom Jefferson: Pills from the world

European regulatory agencies frequently inform doctors and pharmacists about their activities, paying particular attention to pharmacovigilance. The Italian Medicines Agency (AIFA) started a new information feed on 3 April 2012: “Pills from the world.” Every morning a news item is posted online, but analysis of some of the posted items is thought provoking.

AIFA declares that the news items are abstracted from research papers “published in selected scientific journals”—a very onerous task, given the number of studies published daily. AIFA does not clarify the criteria for the selection of the sources, and the choice seems generally random.

On 10 November 2014, a news item that focused on two antihypertensive agents was published. It was abstracted from a journal published by the Baishideng Publishing Group, a “predatory publisher” as reported by the list published annually by the documentalist Jeffrey Beall.

AIFA also states that “the goal [of “Pills from the world”] is to provide . . . a complete and independent information feed.” Strangely, on 19 November 2014 a news item was devoted to a study about the safety and tolerability of oseltamivir in infants and children. The item did not report that the authors of the study are employees of Roche, Genentech, and Quintiles. William Blumentals (one of the authors) is among the most frequently cited authors in the investigation about the “Tamiflu saga.”

The overwhelming supply of studies should enable a careful selection of the sources of information on “Pills from the world.” “Less is more” also applies in this area if we consider that, of the 60 000 articles published each year in the 140 most cited journals, only 5% survive an evaluation of the quality of the research methods used by the authors.

When informing doctors and pharmacists about the use of medicines, public institutions such as AIFA should wisely select the primary literature, keeping in mind that the most valuable papers are concentrated in a few journals. In all cases, sources should be critically evaluated.

A closer monitoring of the activities of the national health institutions by the scientific and academic community is needed. This is the aim of the new project “Politiche del Farmaco” (Drug Policies), which was started by the Italian members associated with the International Society of Drug Bulletins.

Luca De Fiore is the chairman of the Associazione Alessandro Liberati, Network Italiano Cochrane, the Italian network linked to the Cochrane Collaboration.

Competing interests: None.

Tom Jefferson, reviewer, Cochrane Acute Respiratory Infections Group, 00187, Rome, Italy.

Competing interests: TJ was a co-recipient of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children—

In addition: TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to oseltamivir phosphate; Tamiflu [Roche] and in a labour case on influenza vaccines in healthcare workers in Canada. In 1997-99 TJ acted as consultant for Roche, in 2001-2 for GSK, and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral which did not get approval from the FDA). TJ was a consultant for IMS Health in 2013, and in 2014 was retained as a scientific adviser to a legal team acting on the drug Tamiflu (oseltamivir, Roche).