Possible conflicts of interest due to doctors' relationships with pharmaceutical companies, problems with the licensing agency for new medicines, and the prescribing of drugs "for want of an alternative" are just some of the issues raised in a major Oireachtas report published last week. It makes for uncomfortable reading, writes John Downes
It was a letter from a member of the public, Nuria O'Mahony, which in part prompted last week's report from an Oireachtas health subcommittee on adverse drug reactions (ADRs) in pharmaceuticals.
Convinced that her husband had taken his own life because of side effects from antidepressants, she wanted answers.
But while committee members initially set out to examine the specific issue of ADRs, one of the most striking features of the final report was the sheer breadth of topics with which it dealt.
At its launch in Leinster House last week, Deputy Paudge Connolly, chairman of the subcommittee of the Oireachtas Health Committee and Independent candidate for Cavan-Monaghan, appeared to acknowledge as much, stressing that the issues raised represented only the "tip of the iceberg", having also previously said that members were "only scratching the surface".
Another Fine Gael spokesman on health, Dr Liam Twomey, went even further. He told those present that the committee had soon found it necessary to extend their remit due to the range of issues which emerged.
"We've opened ourselves, to some degree, to a can of worms," he said. "I hope it's one that is never closed."
Even the most brief perusal of the final report reveals why.
Overall, the report is careful to recognise the "valuable role" which pharmaceuticals have played in the development of modern medicine - and the fact that some 24,000 people are employed in the industry here, an increase of more than 100 per cent in the past 10 years.
But it is also unequivocal in its criticisms of this same industry, labelling its influence and the persuasiveness of its promotion of its products as "unhealthy".
There is little doubt that some of its recommendations make for uncomfortable reading regarding the relationship between medical practitioners and pharmaceutical companies.
For example, the report recommends that consideration should be given by the Medical Council to compiling a register of any "significant benefits" which medical practitioners receive from pharmaceutical companies - including an overnight stay or long-distance travel, or where professionals writing articles or presenting lectures receive commercial support. This would address the risk of potential conflicts of interest, it states.
It also suggests that the high incidence of prescribing errors indicates that some professionals are not receiving sufficient continuing medical education, with such training sometimes provided from drug company - rather than State - funds.
Elsewhere, the report focuses much of its ire on the role of the Irish Medicines Board (IMB), highlighting concerns about how it receives funding through fees for services to drug companies.
This is something which puts the companies in the position of "clients of the IMB", the report states, before adding that this is hardly an ideal situation for an agency concerned with public safety.
Similarly, it notes suggestions 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".
As a result, it says there could be merit in dividing the IMB into two agencies - one to deal with licensing and a second with post marketing surveillance.
The second pharmacovigilance agency could also fund independent "Phase 4" studies, where necessary, to assess the impact of new drugs on the target population - rather than studies being funded by drug companies as is often the case at the moment.
Interestingly, this second agency could then find itself in a position of "checking up" on the implications of decisions taken by its sister licensing agency, thereby creating what some have described as a "healthy tension" which appears to be missing at present.
However, others maintain that given the complex nature of the licensing process, we should continue to allow the same individuals engaged in this process - and who have detailed knowledge of these drugs - to follow up on how they perform when applied to the marketplace.
Another issue highlighted in the report is the suggestion that psychiatric drugs may tend to be prescribed "for want of an alternative".
"It is in the absence of a full range of counselling and psychotherapy services that many medicines, intended for moderate to severe psychiatric disorders, are prescribed for minor symptoms," it warns.
It also highlights concerns about the clinical trial process: "A variety of techniques can be used by companies to show their drug in a favourable light," it states. "Trials should approximate more closely to conditions in routine clinical settings and should include comparator drugs and non-drug approaches."
Similarly, the subcommittee expresses concerns about drugs companies' sponsorship of health messages aimed at specific clinical conditions, and advocates the provision of "yellow cards" in clinics, pharmacies and health centres, as well as online reporting, to allow members of the public to report ADRs.
The reaction to the report from the medical profession, pharmaceutical companies and the IMB has been mixed. The president of the Medical Council, Dr John Hillery, told The Irish Times he welcomed the report's particular emphasis on the need for increased State support for continuing medical education.
Asked what he thought about the suggestions regarding the compilation of a register of significant benefits for practitioners, he said that this, and the overall report, would be considered in the context of a current review of the Medical Council's ethical guidelines.
This review is due to be completed during the term of the next council, as the current one is expected to finish its work over the coming months.
But he acknowledges that such guidelines are just that - guidelines - before stressing that if there is a serious suggestion someone is doing something unethical in any area, then they would be answerable to the council's fitness to practice committee
On the broader issues raised in the report, he says the relationship between pharmaceutical companies and practitioners is "a constant issue for debate within the profession".
"The first thing I find reassuring is that everywhere I go, doctors are aware of this as an issue . . . people are aware of it and are questioning how to deal with it," he says. "Secondly, the regulatory body has set out certain guidance and is continually reviewing that."
For its part, the IMB, in a statement, issued a strong defence of its method of funding. The current model "is typical of medicine regulatory agencies throughout the world", it says, adding it receives additional funding from the Department of Health and Children for specific activities.
"The IMB wishes to emphasise that its decisions are taken following consultation with independent experts, always in the interests of patients and are never influenced by commercial considerations," it said.
"Ireland is in the top seven countries in the world for the reporting of suspected adverse reactions to medicinal products."
Brian Murphy of the Irish Pharmaceutical Healthcare Association (IPHA) says the report makes some "very positive statements" about the role of pharmaceuticals in medical care.
He also points out the existence of strict codes of practice and regulation, applying to both the marketing of products and links between practitioners and the industry.
OECD statistics have shown that the percentage of the population using medication is not a significant issue in Ireland, he says. But Ireland also has a relatively low life expectancy, something which he suggests is linked with this fact.
In this context he labels as "unfair" the report's concerns about the industry's promotion of drugs and drug use, stressing that any individual with a concern can contact the IPHA and this would be fully investigated.
"I thought the chair of the committee and its members were quite careful not to demonise the industry," he says. "It is not about a pill for every ill . . . promotion is about raising awareness of a condition, which allows practitioners to catch this at an early stage. And it may be that you need exercise, a change of diet or medication."
With its inclusion of a statutory requirement for doctors to maintain their professional competence on an ongoing basis, as well as other developments such as the streamlining of the system for complaints and inquiries, the imminent Medical Practitioners' Act offers hope that at least some of the issues the report identified will be addressed in the near future.
But for the thousands of Irish people who have taken, or continue to take, pharmaceuticals on a regular or irregular basis, another key element in advancing the report's recommendations will clearly be the significance attached to it by bodies such as the Medical Council.
Arguably more crucial, however, will be the extent to which the next Government - whatever its political hue - assesses the report's recommendations and implements them.
This includes providing the necessary funding for further in-depth research into individual issues it raises. Indeed, further research on many of the report's findings was recommended by the authors.
There is always the possibility that the report will be left lie and the recommendations not acted.
However, those who worked on the report argue that the issues it raises are too important to be ignored.