Call to end secrecy on new drug approval
Wednesday March 31st, 2010
Researchers are calling for an end to the "secrecy" surrounding approval of new drugs.
On the website of the British Medical Journal, Dr Silvio Garattini and Dr Vittorio Bertele of the Institute for Pharmaceutical Research, Milan, Italy, say there is a new opportunity for transparency.
They write: "Questions about the benefits of the flu drug oseltamivir (Tamiflu) in otherwise healthy people have fuelled debate about the secrecy surrounding the documentation submitted for marketing authorisation of new medicines."
A recent Cochrane review cast doubt on the effectiveness and safety of oseltamivir and on the system by which drugs are evaluated, regulated and promoted. It showed several "important inconsistencies" and a potential conflict of interest due to funding from the drug's manufacturer, Roche.
The Italian experts point out that the European health directorate, DG Sanco, is taking control of the agency in charge of drug regulation. Its priority should be to end the secrecy surrounding approval decisions, they believe.
"Greater transparency would open drug dossiers to evaluation by the scientific community and help independent interested parties define the benefit-risk profile of new medicines before they are allowed on to the market," they explain.
The authors would like access to further information on new drugs, including any opposition to a drug's approval.
Secrecy exists to avoid giving competitors an advantage, they write. But research is also paid for by academic institutions supported by public money, and the drug market is supported by national health services.
"The public is thus not only a beneficiary of new discoveries but also an essential partner. It therefore has the right of access to all relevant information."
Godlee, F. and Clarke, m. Why don't we have all the evidence on oseltamivir? The British Medical Journal, 2009;339:b5351.
Tags: Europe | Flu & Viruses | Pharmaceuticals
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