Prescrire’s review articles 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, the editorial staff searches the websites of drug regulatory agencies (a), 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 Drug Bulletins (ISDB), and any independent institutions that have evaluated the drug in question.

Assessing drug company transparency
We also question the companies that market each drug we analyse in France, to ensure that we take into account all the documents used to justify approval for marketing or to modify an existing marketing authorisation, including unpublished data. Such unpublished data (for example, clinical expert reports, trial summary tables, etc.) may be held by the drug regulatory agency that examined the marketing authorisation application and by the company that obtained marketing authorisation.

As with the other Prescrire Awards, a systematic and totally independent process is used to grant the Information Awards.
> Click here to download the rules (pdf 254 Ko, in French).

Rewarding accountable companies
Some drug companies respond to our requests for information in a timely manner, providing us with detailed, relevant documentation, including unpublished data.

These companies are mentioned on the Honours List. Fewer generic manufacturers are featured in the list ever since Prescrire decided not to examine all new generics (b)(1).

The companies rated as Outstanding provided us with exhaustive and detailed information very quickly, sometimes without being asked.

What have the unhelpful companies got to hide?
Other drug companies either fail to respond to our requests for information or provide only limited data. They tend to delay their reply for as long as possible, i.e. only after publication of the opinion of the French Transparency committee (that assesses the medical benefits of new drugs and advises on drug reimbursement), of the price in the Journal Officiel or after the launch of their advertising campaign. They may also omit the most relevant data, claiming to be too busy, that the administrative services are too slow or that the clinical data in question are confidential.

Others withhold information as a kind of retaliation because they did not like one of our earlier product reviews. Very few pharmaceutical companies persistently withhold information. For patients’ sake, we hope that refusal of transparency and lack of respect for the independence of the editorial staff of Prescrire and for its subscribers are not their reasons for withholding information.

“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 them to be more open.

Considering the transparency of the drug company when choosing a drug
A drug company’s commitment to transparency is the fifth factor to be taken into account when choosing a drug, after its efficacy, adverse effects, convenience and price. When two treatments are indistinguishable on the basis of these first four factors, then it is in patients’ and healthcare professionals’ best interests to select the product manufactured by a company that puts all its cards on the table and does not hide information about its products, including their limitations.

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.

Notes:
a- Drug regulatory agencies release certain clinical and administrative data to health professionals and patients by publishing their public assessment reports, post-marketing follow-up data, detailed reasons for the changes made to marketing authorisations, and through rapid online publication of summaries of product characteristics (SPCs). The European Medicines Agency (EMEA) still has some way to go in this area and the French Health Products Safety Agency (Afssaps) even more so.
b-We continue to contact generic manufacturers to ask for administrative information, particularly about patents and marketing of generic drugs.

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

© Prescrire April 2009

Source: Prescrire Int 2009; 18 (100): 83.