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Consumer group calls for Xenical withdrawal

Obesity treatment is linked to onset of colon cancer, claims Public Citizen

US consumer group Public Citizen has petitioned US regulators for the immediate removal from the market of Roche's obesity drug, Xenical (orlistat), claiming it can cause changes in the lining of the intestinal tract which have been linked to the onset of colon cancer.

ìThis drug, which treats obesity, causes a significant increase in the incidence of aberrant crypt foci (ACF), which are widely believed to be a precursor of colon cancer,î said the petition.

Public Citizen said the petition was based on findings from the pharmacology review of Roche's own data and a recent independent confirmation that orlistat causes ACF in the colon of rats.

ìWe take any questions regarding safety extremely seriously,î said a Roche spokesman. ìTo date, the overwhelming body of evidence indicates Xenical is safe and consumers should continue to feel confident in the product.î

Last week, GlaxoSmithKline (GSK) received an ìapprovableî letter from the US Food and Drug Administration (FDA) to market a lower dosage of the drug as an OTC product, although the UK firm is still required to meet certain conditions, which have not been made public.

GSK said it would ìwork with the FDA to address their comments and recommendationsî and was still hopeful it could launch an OTC version under the name ìAlliî in the third or fourth quarter of this year. The UK firm said it plans to sell Alli at around $12-15 for a week's treatment; analysts say the OTC version could bring in more than $1bn a year.

Public Citizen has voiced its opposition to the plans for the OTC launch.

ìThe failure to ban the prescription version of this drug, or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence,î said Dr Sidney Wolfe, Public Citizen's director of health research.

The petition, which was also signed by Theresa Pretlow and Thomas Pretlow, both pathology professors at Case Western Reserve School of Medicine, has cited two studies that showed those patients on Xenical lost about 13 pounds while those not receiving the drug lost seven pounds. It described orlistat as ìa drug that has shown minimal efficacy coupled with a still unresolved potential to cause breast and colon cancerî.

30th September 2008

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