Drug firms under fire over secrecy on 1,096 trials
Although the Irish Medicines Board (IMB) authorises all trials, it does not provide any public information on drugs being tested, the number of patients involved in trials, the drug firms concerned or the results of such studies.
IMB figures, released to the Irish Examiner, reveal 1,096 trials have been given the go-ahead since the board began licensing drug trials in 1998. That’s an average of 156 annually.
The board declined to give any further information, citing commercial sensitivity as the reason.
However, in light of recent revelations involving drug giants Merck and Pfizer, the Irish Patients Association (IPA) condemned the secrecy surrounding the licensing and outcome of Irish trials.
Merck pulled one of its pain relief drugs, Vioxx, from the market in September after participants in a cancer study showed an increased risk of heart attack. Two similar Pfizer drugs, Celebrex and Bextra, were found last month to increase the risk of heart attack and stroke more than threefold, depending on the dose.
IPA chairman Stephen McMahon said it was unacceptable for the IMB not to release further information to the public. “There should be a roadmap of whom all the trials are targeted at and where they are at present in their journey and the best body to do that in Ireland is the IMB.”
The Irish Pharmaceutical Healthcare Association (IPHA), which represents Ireland’s drug firms, said companies were poised to announce new EU-wide measures involving the release of more public information on trials.
Both industry and patient representatives are concerned at the Government’s failure to act quickly to implement standards required on foot of an EU directive.
In the meantime, Health Minister Mary Harney has accredited just three ethics committees, leaving the rest in limbo. Brian Moulten, chief executive of the Irish Clinical Oncology Research Group, which initiates up to 20 cancer trials annually, said the regulatory changes had left the whole industry in a confused state of flux.
A spokesperson for the Department of Health said no timeframe was available but indicated the new supervisory body would be incorporated into the new Health Service Executive.
