What the report says...
On drug company sponsorship/relationship with medical practitioners:
It expresses concern at drug companies' sponsorship of health messages aimed at specific clinical conditions. While noting the companies do not promote individual products, it says the underlying effect "may be to promote favourable attitudes of the public towards drug therapies".
It recommends that the Department of Health, in consultation with the Health Promotion Unit (HPU), the IMB and the industry, should endeavour to ensure that these messages encompass information on non- drug therapies.
It argues that potential conflicts of interest created among doctors due to promotion by pharmaceutical companies needs to be addressed. It recommends that the Medical Council review the situation.
It notes that a similar House of Commons report recommended the compilation of a register of "significant" benefits received from pharmaceutical companies by medical practitioners.
The report says this "is worth consideration in Ireland".
On overprescribing of drugs:
It notes the point made by several witnesses and subcommittee members themselves that psychiatric drugs may tend to be prescribed "for want of an alternative".
"The patient presenting with symptoms expects some tangible form of treatment and the practitioner feels under pressure to respond so as, at the minimum, to send the patient away in a more confident frame of mind."
It claims a constant theme is the excessive use of medication prescribed by healthcare professionals and, in particular, the excessive use of psychiatric drug therapies.
It states that some of the responsibility for this lies in the promotional activities of the drug companies and needs to be balanced by a programme of public education on drug use.
It recommends an increase in the number of psychologists and counsellors available in the community health services.
On the Irish Medicines Board:
The report notes that the method of funding switched to fees for services to drug companies when the IMB was established.
Although this has some positive benefits, it also tends to put the drug companies "in the position of clients of the IMB with the inference that the IMB has a corresponding obligation to meet its 'clients" needs".
As a result, the report says there would be merit in the Department of Health collecting the fees from the drug companies and consolidating the receipts into an annual grant to the board.
It highlights submissions to the subcommittee that an agency which licenses drugs is likely to "be compromised to some degree if the drugs which it has licensed subsequently turn out to be problematic".
"The failure of the drug might then be seen to reflect badly on the agency's original decision and lead to some reluctance on the part of the agency to come to grips realistically with the problems," it states.
On clinical trials:
The report says a "major and inevitable weakness of the clinical trials system is that clinical samples are much smaller than the target populations who will ultimately receive the licensed product".
It notes that "Phase 4" studies, which follow the drug as it is dispensed through the target population, are the main means of identifying problems (and efficacy) in the post marketing phase.
It recommends that clinical trials should approximate more closely to conditions in routine clinical settings and should include comparator drugs and non-drug approaches.
On increasing awareness:
The report recommends increasing the volume of publicity targeted at prescribers and pharmacists and the commencement of a campaign to inform the public of the need to report ADRs.
At the same time yellow cards should be widely available (eg in clinics, pharmacies and health centres), while it should be possible also to report ADRs online to the pharmacovigilance agency or the IMB.
John Downes