Posted: Friday 2 September 2005
Mind, the mental health charity, has voiced mixed opinions on the Government's response to the Health Committee Report on the Influence of the Pharmaceutical Industry, published yesterday.
While the Government has accepted many of the recommendations made by the Committee in part or in full, there remain serious concerns over the commitment needed from government to effect change. Mind is also extremely disappointed that several Health Committee recommendations to improve the transparency of the industry and above all, patient safety, have been rejected.
Mind commends the stated commitment towards increased openness at the MHRA, the UK drugs watchdog. New emphasis on inclusion of the consumer voice in regulation, through involvement of patients and lay people in the advisory process, is also welcomed. Yet this rhetoric must be turned into reality, with adequate resources, support and training being provided. The review of SSRIs showed the MHRA was slow to act on information direct from consumers as well as from clinical trials. Hesitation from the regulator to listen to the consumer may have endangered or even cost lives.
Mind is disappointed that the Health Committee's recommendations on the publication of clinical trials have not been adopted fully. Both Mind and the Health Committee wanted to see independent publication of full clinical trial data. The Government will be obliged under new European legislation to commit to the publication of summary data, but any scientist working outside the confines of the MHRA will not have access to the full trial data on any particular drug. The Licensing Authority still retains the right to decide what information will be put into the public domain. Transparency, it seems, still only goes so far.
Mind is also concerned that patient groups and charities will not be legally required to declare any commercial links with pharmaceutical companies that they have. The proposed voluntary system of self-regulation may not be robust enough; the public should be fully informed about the fundraising standards of charities they support, just as they should have the right to see all the information available about a particular drug.
Richard Brook, Chief Executive of Mind, said:
"While we welcome the Government's apparent commitment to improving the accountability of the pharmaceutical industry in the UK, many issues have yet to be resolved. We remain concerned at the pharmaceutical industry's close relationships with Government and the MHRA, and feel the criticism levelled at the Government by ministers on the Health Committee should have been a catalyst for major reform. As recent experiences with Seroxat and Vioxx have shown, profit is too often put before the patient - with potentially lethal consequences."