Nurse urges stricter anti-depressants regulation


As concerns are expressed over prescription guidelines, a petition is calling for a new regulatory body to be established. Susan Calnan reports.

A Cork-based emergency nurse is calling on the Government to strengthen the regulatory framework for prescription drugs in Ireland.

Nuria O'Mahony, who works as a nurse in Cork University Hospital's accident and emergency department, has drawn up a petition in response to what she says is her increasing dissatisfaction with the way in which prescription drugs, in particular anti-depressant SSRIs (selective serotonin reuptake inhibitors), are monitored here.

In December 2003, O'Mahony's husband died from suicide, following a bout of mild depression. After her husband was prescribed the SSRI, Seroxat, O'Mahony claims that his symptoms became progressively worse, culminating in his suicide 13 days later.

"I am not saying that Seroxat caused my husband's suicide, but I do think that it had a significant role to play in the deterioration of his condition, which eventually ended in his death," says O'Mahony.

"Which is why I am calling for access to full and impartial information about the potential risks and adverse effects of prescription medication."

In her petition, O'Mahony specifically calls for the setting up of a new regulatory body, separate from the Irish Medicines Board (IMB), completely independent of funding received from the pharmaceutical industry, and financed entirely by the State, with public representation on its board.

She also calls for the publication of full clinical trial data, in addition to establishment of a reporting system that takes proper account of adverse reactions to drugs, reported by consumers.

"The experience of consumers should be central to a modern system for the licensing and regulation of prescription drugs," O'Mahony insists.

"Reports of adverse reactions by consumers should be given at least equal weight by the regulator, as the clinical trial data supplied by pharmaceutical companies."

Since she set up the petition, O'Mahony has garnered the support of a number of practitioners in the medical and psychiatric profession.

Dr Pat Bracken, a consultant psychiatrist at Bantry General Hospital and clinical director of West Cork Mental Health Services, has expressed his support for the petition and says he agrees with O'Mahony's call for greater independent monitoring of prescription drugs.

"One has to be careful, of course, when discussing the side-effects of SSRIs: a lot of people are taking and seem to be benefiting from such medication," says Bracken.

"Nevertheless, there is a growing body of literature, published in a number of prominent medical and psychiatric journals, which suggests that the evidence for the efficacy of SSRIs is not entirely robust."

Bracken adds that in addition to closer monitoring of the benefits and side-effects of prescription drugs, there needs to be greater transparency in relation to how drugs are monitored and regulated, adding that the links between the pharmaceutical industry and regulatory bodies should be examined more closely.

"There are a growing number of misgivings arising among those within the medical profession in relation to the pharmaceutical industry, and the way in which the industry conducts business is coming under greater scrutiny," he says.

"As medical practitioners, I feel we need to become more aware of how corporate interests can sometimes dominate agendas within medicine, in a way that isn't necessarily always in the best interest of patients," adds Bracken.

In response to measures outlined in Nuria O'Mahony's petition, the IMB said it would be inappropriate for it to comment on specific cases relating to a particular individual. A spokesperson for the board highlighted, however, that the IMB is an independent regulatory State body, and that all of its policies and decisions are based on sound scientific advice and counsel.

The IMB added that it already operates a national system of adverse drug reaction (ADR) reporting, where consumers are urged to report the side-effects of medicinal products to their healthcare professional, who in turn should report these to the IMB.

A spokesperson said the board had directly participated in a number of reviews of the SSRI, Seroxat, through its membership of the European Agency for the Evaluation of Medicinal Products (EMEA), and a full European review by EMEA's scientific committee was completed in April 2004. This review, it said, found that the benefits of Seroxat outweighed the risks associated with the use of the product.