Prescrire’s review articles dealing with new drugs and indications are based on a thorough literature search for all documents relating to the drug’s pre-approval assessment, especially clinical trial reports.

In addition to textbooks and standard bibliographic databases, we search the websites of drug regulatory agencies, health economics institutions, health technology assessment agencies, and other institutions specialising in the relevant therapeutic field. We also search other independent journals belonging to the International Society of Drugs Bulletins (ISDB) and any independent institutions that have evaluated the drug in question.

Assessing drug company transparency
We also question the companies that market drugs in France, to ensure that we take into account all documents, including unpublished data, used to justify approval for marketing. The regulatory agency that approved the product, and/or the applicant, may also possess important unpublished data, including unpublished clinical trial reports.

Some regulatory agencies release most of these data into the public domain, through publication of their assessment reports. The French regulatory agency AFSSAPS, and EMEA, the European agency, are very slowly opening up their work to public scrutiny, especially with respect to postmarket follow-up data.

As with the other Prescrire Awards, a systematic and totally independent process is used to grant Information Awards. The rules are available on our website, at www.prescrire.org

Rewarding accountable companies
Some drug companies respond to our requests for information in a timely manner, providing us with the documents, including unpublished data, submitted in support of their application for marketing approval. These companies are mentioned on the Honours List.

There are fewer generic manufacturers than in previous years, owing to our decision not to examine all new generics (1). However, we continue to contact these companies for information on the planned release dates of their generic drugs.

The companies rated as Outstanding provided us with exhaustive and detailed documentation without delay.

Encouraging companies to be more open
Other drug companies either fail to respond to our repeated requests for information, or grudgingly provide limited data that are already in the public domain. They tend to reply at the very last moment, so that their advertising campaigns can proceed unhindered before the relevant issue of the Journal goes to press. They may also omit the most relevant data, coming up with excuses like “the regulatory department is too busy”, “the administrative services are too slow” or “the clinical data in question are confidential”. Others withhold information as a form of retaliation because they didn’t like the conclusions of one of our earlier product reviews.

Few drug companies persistently withhold information. For patients’ sake, we hope that refusal of transparency or lack of respect for independence, in the interests of biased product promotion, do not constitute reasons for withholding information.

Company commitment to transparency and treatment choices
A drug company’s commitment to transparency is the ‘fifth dimension’ to be taken into account when choosing a drug, after efficacy, safety, convenience and price. When two drugs are otherwise indistinguishable, then it is in patients’ and healthcare professionals’ best interests to select the product manufactured by a company that puts its cards on the table, and that does not try to hide information, including the limitations of their products.

Prescrire's rating system Each article examining a new drug is accompanied by a symbol (one of four) and brief summary rating the transparency of the manufacturer for their response to our requests for information concerning their product.

References:
1- Prescrire Editorial Staff “Les copies du mois. Mieux faire face à l’avalanche de copies“ Rev Prescrire 2007; 27 (280): 106.

© Prescrire April 2008

Source: Prescrire Int 2008; 17 (94): 77.