Is big business becoming more important than patient care when it comes to licensing drugs, asks Sylvia ThompsonRising drug costs: for whose benefit?
Are public health concerns becoming a lower priority in decisions regarding what new drugs are placed on the market as countries such as Ireland are increasingly economically dependent on international pharmaceutical industries? Are business interests superceding improved patient care in choices about which drugs are licenced in the West? These were recurring questions at an international conference in University College Cork last week.
Academics and health practitioners explored issues such as "the cosy relationship" between doctors and pharmaceutical company representatives, the often conflicting interests of professionals working for drug regulatory authorities (e.g. holding shares in drug companies whose drugs they are responsible for licencing), the low level of reporting on adverse drug reactions and potential bias towards drug therapies when patient associations are principally funded by drug companies.
The increasing cost of drugs to national exchequers also came under scrutiny when Dr Michael Barry from the National Centre of Pharmacoeconomics explained recent trends in drug expenditure and consumption in Ireland (see panel).
However, the most poignant discussion surrounded both the short and long-term effects of anti-depressants. Andrew Herxheimer, clinical pharmacologist who works for the London-based Cochrane Collaboration and DIPEx, a database of patients' experiences of illness, presented findings from a study into suicide analysed by time of onset [of suicidal behaviour] and dose change in medication. Of 91 suicides studied, 22 reported the onset of suicidal thoughts seven days after starting medication and nine between eight and 30 days after starting medication. In the same study, suicidal behaviour and dose increase was linked for 11 patients and withdrawal from medication and suicidal behaviour was linked in 16 cases. "We need a centre where patients can report directly on adverse drug reactions so that they can be analysed and publicised," he said.
Dr Terry Lynch, general practitioner and psychotherapist based in Limerick, questioned whether the widespread prescription of antidepressants particularly SSRIs (selective serotonin reuptake inhibitors) is backed up by scientific research. "Over 300,000 people in Ireland were prescribed antidepressants in Ireland in 2002. That is one in 10 adults. A high per cent of these people are admitted to psychiatric hospitals in spite of the increased prescribing of antidepressants," said Lynch.
"The accepted view is that depression is caused by low serotonin levels and a patient information leaflet on a drug such as Seroxat states that it works by bringing up serotonin levels back to normal. Yet we don't know how to measure serotonin levels," said Lynch.
Lynch, who is the author of Beyond Prozac - healing mental distress (Marino Books) wrote to the Irish Medicines Board questioning whether such information is backed up by scientific evidence. He received a reply stating that "it was not consistent with scientific evidence and the company were asked to review their patient information leaflet accordingly".
"There is a great need for self-reflection in the medical profession. And, there needs to be innovation in lots of other areas than drug therapies," said Dr Lynch.
Charles Medevar, London-based commentator on medicines policy and drug safety, suggested that side effects of antidepressants such as "loss of libido and weight gain" are sometimes not deemed to be medically serious. "Yet, in terms of a relationship, the loss of libido is just as likely to induce depression".
Medevar added that the recent growth of "lifestyle drugs" has led to an increasing medicalisation of human disappointment. "The disease of depression has been expanded to include disappointment and human misery. The roots of good health lie in communities in the examples of health and support people give each other," he said.
Patients from the Cork Advocacy Network, a group fighting for better rights for psychiatric patients, also spoke of long-term personal costs of drug therapy. "In my experience, it is all about medication. I was diagnosed with manic depression after the birth of my first child 34 years ago and I have been in and out of mental hospitals for over 30 years. There was no occupational therapy, no psychotherapy. Drug therapies alone are dehumanising," said Helena O'Donovan.
Representatives from Patient Focus and Positive Action, the support and lobby group for women who became infected with Hepatitis C through contaminated blood products, also spoke at the conference.
Called Health, Democracy and the Globalised Pharmaceutical Industry - exploring the politics of drug regulation internationally and in Ireland, the conference was organised by Kathy Glavanis-Grantham, Department of Sociology and Orla O'Donovan, Department of Applied Social Studies, University College Cork, both of whom are members of Health Action International, a lobby group working to improve the rational use of essential medicines worldwide. HAI hosted its annual meeting in Cork city at the weekend.
See also www.haiweb.org
State expenditure on medicines in Ireland has increased fourfold from 1993 to 2003, according to Dr Michael Barry, from the National Centre for Pharmacoeconomics. Speaking at Health, Democracy and the Globalised Pharmaceutical Industry, the UCC conference, Barry said: "Last year, expenditure was approximately €943 million, a 15 per cent increase on the previous year and the seventh consecutive year with a double digit increase, a growth rate amongst the highest in Europe."
Over 90 per cent of this cost was associated with the General Medical Services (i.e. medical cards) scheme and the Drugs Payment scheme (the scheme introduced in 1999 in which no individual or family will have to pay more than €78 each month for approved prescribed medication).
Barry pointed to two factors contributing to the increased costs - the prescribing of new and more costly medicines (e.g. statins, a genre of cholesterol lowering drugs) and the growth in the number of prescription items (10 years ago, two to three drugs might be prescribed for heart disease, now four to five drugs may be prescribed).
The cost breakdown of drugs paid for under the Drugs Payment Scheme was also explored at the conference. Barry gave an example of the breakdown of fees paid to pharmacists at the end of last year as follows: ingredient cost of drug (e.g. pravastatin 40mg/day for 28 days) €54.29, standard dispensing fee €2.59 and 50 per cent mark up on ingredient cost €27.15, bringing the monthly supply cost to €84.03.
Perhaps more interesting is the potential savings that substitution of branded drugs with generic drugs would create. Again, using a statin drug as an example, Barry estimated that €880,000 could be saved if a generic drug was prescribed, on this drug alone.
In Ireland, the cost-effectiveness of drugs used is not a standard factor in prescribing, whereas in Britain, GPs are routinely given comparisons between their prescribing patterns (including the per cent of generic medications prescribed). The result is that over 50 per cent of prescriptions are for the cheaper generic drugs in Britain whereas approximately 5 per cent of prescriptions are for generic drugs in Ireland.