The Information Awards focus on the quality of the information provided to Prescrire by the pharmaceutical companies whose products we examined in the New Products section of our French edition during the previous year (in 2011: issues 327 to 338).
Prescrire’s reviews dealing with new drugs and indications are based on a thorough literature search for documents relating to the drug’s pre-approval assessment, especially clinical trial reports.
In addition to textbooks and bibliographic databases, Prescrire editors search the websites of drug regulatory agencies, health economics institutions, health technology assessment agencies and other institutions specialising in the relevant therapeutic field. Prescrire regularly asks drug regulatory agencies to provide specific information and unpublished documents. We also search other independent journals belonging to the International Society of Drug Bulletins (ISDB), and any independent institutions that have evaluated the drug in question.
Assessing drug company transparency
We also request relevant information from the companies that market each drug we analyse in France, to ensure that we take into account all data, including unpublished data, used to justify marketing approval or to modify an existing marketing authorisation. These unpublished data such as expert reviews and Periodic Safety Update Reports or PSURs are held both by the regulatory agency that examined the application and by the company that obtained marketing authorisation for its product.
As is the case with the other Prescrire Awards, a systematic and totally independent process is used to grant the Information Awards.
> Rules governing the Prescrire Awards (pdf, in French)
Rewarding accountable companies
Some drug companies respond to our requests for information in a timely manner and provide us with thorough and relevant data, including unpublished data. These companies are mentioned on the Honours List. The companies rated as “Outstanding” provided us with exhaustive and detailed information without delay, sometimes without being asked.
What do unhelpful companies have to hide?
Other drug companies either fail to respond to our requests for information or provide only limited data. Some of them tend to delay their response as long as possible, i.e. only after publication of the opinion of the French Transparency Committee (that assesses the comparative effectiveness of new drugs and provides advice on drug reimbursement), or of the price in the Journal Officiel, or after the launch of their advertising campaign. They may also omit the most relevant data, claiming they are too busy, that the administrative services are too slow, that the clinical data are confidential, or that their headquarters raise objections. Other companies withhold information as a form of retaliation because they did not like one of our earlier product reviews.
“Red cards” for withholding information are a way of highlighting persistent shortcomings in the provision of information by certain drug companies and a way of encouraging more openness.
2011, following France’s Mediator° scandal: a visible effort by some companies
The Mediator° (benfluorex) scandal alerted the French public that withholding information about drug adverse effects was unacceptable. Some companies, including some that were awarded “Red Cards” in the past, expressed their desire for change and even proposed to meet with the Prescrire team in order to better understand the nature of the information we expect to receive in response to our requests.
These meetings provided an opportunity to explain the Prescrire literature search methodology, which aims to take into account all evaluation data, and to highlight that transparency is important for pharmaceutical companies. A drug company’s transparency is one of several criteria to be considered when choosing a drug, after efficacy, adverse effects, convenience and price.
In 2011, we noticed encouraging signs of more openness from some companies, which could ultimately benefit Prescrire’s subscribers and their patients, but it is too early to measure their real impact.
Watch this space in 2012.
About Prescrire's information ratings
Whenever we examine a new drug or indication, the review is accompanied by one of four pictograms rating the transparency of the company concerned for their response to our request for information about their product (for details search for “ratings system” online at english.prescrire.org). See : > Prescrire's Information Ratings
©Prescrire February 2012
"The 2011 Prescrire Awards" Prescrire Int 2012; 21 (125): 78-82. (pdf, free)
