Research raises concern about anaemia drugs

New concerns about the use of anaemia drugs in high doses are to be discussed at the next monthly meeting of the Irish Society of Medical Oncology.

Its president, Dr John McCaffrey, said new research discussed at a meeting of a US Food And Drug Administration (FDA) advisory panel last week was causing concern.

"We are concerned about the reports of higher vascular disease when you use higher doses of these medications so we are actually reviewing the usage," he said.

"Previously, if the patient didn't get the desired effect we would usually increase the dose to avoid giving a transfusion.

"We don't like to transfuse unless we have to. But now, there is a suggestion that that could be the group of people with an increased risk of stroke," he said.

"It isn't proven but it is enough of a concern for us to say transfusion may now be a better way for those patients."

The drugs involved are a man-made version of the protein erythropoietin and are widely used to boost production of haemoglobin in red blood cells to help fight fatigue in cancer and kidney patients.

Dr McCaffrey said the majority of patients had a very good quality of life on these drugs.

Last week, an FDA advisory panel examined new studies which showed the drugs could raise the risk of heart attacks or strokes in high doses. This followed an FDA recommendation in March that doctors should use the lowest possible dose of these medicines.

As a result, the FDA panel has suggested further restrictions to the prescribing information on these medicines.

Dr McCaffrey has also ruled out the possibility of doctors in Ireland being paid for the prescription of anaemia medicines, as happens in the US. This practice raised concern that doctors were being given an incentive to prescribe.

The extent of this legal practice came to light last week and involves two manufacturers of anemia drugs - Amgen and Johnson & Johnson. US media reports suggested the payments could be worth hundreds of millions of dollars.

Dr Brian Moulton, chief executive of the All Ireland Co-operative Oncology Research Group, said the difference between Ireland and the US was that 80 per cent of US oncologists were in private practice.

"This financial arrangement with respect to prescribing was set up through that situation. That situation does not exist in Ireland so I don't see any possibility for a financial kick-back to an Irish clinician."

In a statement to The Irish Times, Amgen Ireland said it had never offered inducements to doctors in Ireland in relation to the prescription of its anaemia products Aransesp or Epogen.

"Amgen complies fully with the laws and industry standards in each country it operates in.

"In Ireland, it is prohibited under the IPHA [ Irish Pharmaceutical Healthcare Association] Code of Practice to provide inducements to physicians to prescribe medicines," it said.

A spokeswoman for Johnson & Johnson said doctors and prescribers in Ireland had never been given rebates or discounts.

"We offer rebates or discounts for Eprex, consistent with Government regulations, only to medical institutions in Ireland."

Eprex is an anaemia drug produced and marketed by Johnson & Johnson.

The IPHA monitors the marketing of drugs through its voluntary codes of practice.

Brian Murphy, IPHA spokesman, said pharmaceutical companies were banned from using inducements and said no complaints regarding this activity had been brought to the IPHA's attention.

Any doctor accepting inducements would be in breach of the Medical Council's ethical guidelines. A drug firm found to have broken the IPHA codes could face legal action, he added.

"Companies have trading relationships with hospitals but any rebate, for example, would be to the hospital so I don't see how the doctor individually would benefit," Mr Murphy said.

Anaemia medicines are among the highest selling in the world.

Last year, 476 per cent, or over $6.6 billion, of Amgen's sales were from these products.

Johnson & Johnson had sales of $3.18 billion worth of anaemia products last year.