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Wed 16 Aug 2006 04:00 AM

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AMD drug approval sparks controversy

A drug hailed by opthamologists as the first treatment to effectively treat the wet form of age-related macular degeneration (AMD), is at the center of an international clash between doctors and the pharmaceutical industry.

A drug hailed by opthamologists as the first treatment to effectively treat the wet form of age-related macular degeneration (AMD), is at the center of an international clash between doctors and the pharmaceutical industry.

Lucentis, produced by Genetech, has won FDA approval to treat wet AMD, but is pitted against widespread off-label use of the cheaper colon cancer drug, Avastin.

Wet AMD is caused by the abnormal growth of blood vessels behind the eye. Those vessels can leak blood and other fluid, causing scar tissue that can destroy the center of the retina over time.

Lucentis inhibits a protein believed to contribute to the formation of such blood vessels. In two major studies of patients suffering from the disease, 95% of those treated with Lucentis showed no decline in vision over one year and 34 to 40% improved their sight.

Avastin, also produced by Genetech, is the parent molecule of Lucentis but has not been specifically designed for wet AMD treatment. However, doctors worldwide have been repackaging it into tiny injectable doses, since Professor Philip Rosenfeld, a US ophthalmologist, pioneered its use in the treatment of neovascular AMD and macular oedema.

Avastin costs less than US $15 per dose, compared to an estimated US $1,950 per dose for Lucentis. Doctors fear federal approval will see Avastin use restricted, forcing patients who cannot afford Lucentis to go without treatment.

Roche Australia, who owns the non-US rights to Avastin, reportedly has already announced it will stop supplying Avastin to pharmacies that repackage it for AMD use.

“People will go blind, there’s no doubt about it,” said Dr Wilson Heriot, chairman of the Australian Macular Degeneration Foundation. “That sounds emotive, but it is absolutely real.

“Roche is doing something that hasn’t been done before – they are refusing to supply pharmacies with a drug, and they only reason they are doing that is to force people to use a more expensive drug.

“There is no science that shows Lucentis is better.”

Professor Rosenfeld also accused the pharma industry of putting profits before patients.

“This shows both how good they (the drug companies) are and on the flip side, how greedy they are,” he said.

While anecdotal evidence for Avastin use is good, regulators require randomised controlled trials before they grant a license. These trials can generally only afford to be carried out by drug companies, and Genetech has reportedly said it has no plans to investigate Avastin’s effectiveness in wet AMD, when Lucentis is already in place and proving its value.

For UK doctors, Genetech’s reluctance to apply for a license for this use of Avastin means NICE, the NHS funding body, cannot consider it for approval. Instead, doctors must battle for primary care funding, while they wait for NICE to pass approval on Lucentis or another expensive drug called Macugen.

“From the patient’s point of view, if they have an eye condition that deteriorates very quickly, there’s no question of waiting,” said Professor David Wong, chairman of the scientific committee of the Royal College of Ophthalmologists. “We’re talking about days or weeks rather than months.

“The question is, should we do nothing and say there is no randomised controlled trial to prove Avastin is of value?”

Genetech says its main objections over the use of Avastin focus on the drug’s potentially adverse effects when used intravitreally for wet AMD. At the 2005 annual meeting of the American Academy of Ophthalmologists, Genentech identified several areas of concern. These included problems in keeping Avastin sterile when splitting it into the small quantities required for retinal treatment; the lack of pre-clinical trial toxicity data for Avastin in retinal therapy; and the length of time Avastin takes to exit the system (100 times longer than Lucentis).

However, Dr Rosenfeld has argued that the issue of sterility is not a problem. His lab takes every precaution to have the drug safely divided into the desired dosages for injection, he said, and they have had no safety issues so far. The other concerns, he added, are theoretical, not having presented themselves as problems in actual practice.

There are an estimated 50 million AMD sufferers worldwide, with five million new cases diagnosed each year.

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