The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee decided yesterday to recommend restrictions on the use of anti anemia drugs to treat patients with certain types of cancer.

The drugs in question, which include Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit, are called erythropoiesis-stimulating agents, or ESAs, and are used to boost red blood cells in patients who typically become anemic from kidney disease or chemotherapy.

The panel voted 13 to 1 in favour of keeping the drugs for use by many cancer patients, reported the New York Times.

But it voted to recommend the drugs not be used to treat patients with breast cancer or head and neck cancer (the vote was 9 to 5 in favour of restriction). Head and neck cancers include those that affect the throat, sinuses and lymph nodes.

And in a third vote, the committee recommended the drugs not be used in cases where the intention is to cure the patient’s cancer (11 to 2, with 1 abstention). This generally refers to patients having chemotherapy following surgery for an early stage cancer, and where doctors believe there is a chance the cancer has been removed.

The FDA usually follows recommendations of its advisory committees, but it does not have to. Agency representatives told the press they will be considering these recommendations immediately, but gave no particular dates for a decision, reported the Associated Press.

John Jenkins, FDA director for new drugs said it was clear from the discussion that the panel was concerned about the safety risks of ESAs, but were not certain about the scope of the risks. “We don’t have perfect data about that point,” said Jenkins.

The evidence considered by the panel came from 8 studies on ESAs that taken as a whole set, suggest that the drugs hasten death and tumour growth when used to achieve hemoglobin levels higher than those recommended on the drug label (so called off label use).

Amgen and J&J said the studies did not show a consistent pattern of the results cited by the FDA, and pointed out that the studies were looking at higher than recommended hemoglobin targets.

The drug companies said they are still testing the drugs for levels within those recommended by the label but the results won’t be through for at least five years.

The committee also discussed the sales tactics used by the drug companies, where large discounts are given for bulk purchase, and there is a chance doctors can profit if the reimbursement they get from insurers and patients exceeds what they paid for the drugs, said the New York Times. Some panel members said this led to over use of the drugs, the drug companies said it did not.

However, there are those, like Robert L Erwin, president of the Marti Nelson Cancer Foundation, who believe the current practice “has led to distrust”, reported the Times.

The panel’s recommendations do not affect the use of ESAs in kidney patients, since this was not on the agenda.

Sources: Associated Press, New York Times.

Written by: Catharine Paddock, PhD