Campaigner renews bid to get acne drug banned

Health Minister Leo Varadkar has been called on to intervene with the Irish and EU regulatory authorities with a view to getting a controversial acne drug withdrawn from the market.

Campaigner Jason O’Sullivan has repeated claims his health and his life were ruined by the side effects of RoAccutane.

His case has already been rejected by the Oireachtas Public Petitions’ Committee and the EU Petitions’ Committee.

However, he has now joined forces with campaigning families in the UK where the Government’s medicines watchdog is reviewing the drug to examine the risk of psychiatric reaction, amid claims linking the drug to depression.

Mr O’Sullivan, 39, from Muckross, Killarney, had the issue raised in the Dáil and at European Parliament level.

But he has been unsuccessful with his request to the Information Commissioner for access to records held by the Irish Health Products Regulatory Authority. He is also seeking access to the files of the European Medicines Agency, which he wants to openly evaluate the drug.

Switzerland-based Roche, the world’s biggest maker of cancer drugs, took RoAccutane off the US market in 2009 after juries awarded over $33m (€24.5m) in damages to users who blamed the drug for bowel disease.

“Thousands of Irish people are suffering the ill-effects of this drug, but it continues to be prescribed here for acne.”

Mr O’Sullivan, who has not been able to work since 1998, said it was “unthinkable that a chemotherapy drug should be used for a benign condition like acne”. In approaching the health minister, Mr O’Sullivan said he wanted answers to his questions in the interest of public safety.

He has established links with a group of families in Britain who also believe the drug caused their loved ones to commit suicide. They have demonstrated outside a Roche plant.

The UK Medicines and Healthcare Products Regulatory Authority is reviewing the drug and an expert group is to consider all data on the risk of adverse psychiatric reactions to it. The country’s National Health Service has said the drug could cause suicidal thoughts in rare cases and also lists psychosis, or psychotic-like behaviour as possible side effects.

Roche, meanwhile, stated there is no study that links RoAccutane with depression or suicidal thoughts and “no definitive cause and effect relationship” had been established between the treatment and suicide.

The company said the drug was an effective medicine for severe acne, with the majority of patients cured after one treatment cycle.

The Department of Health, meanwhile, said the drug had been authorised in Ireland only for severe forms of acne which are resistant to other standard therapies, with the benefits of the treatment considered to outweigh the risks when the product is used in accordance with approved product information.

However, Mr O’Sullivan wants Mr Varadkar to take a fresh look at the use of the drug here.