Regulator reconsidering vision-loss drug ruling

A government regulator is meeting Wednesday to hear an appeal of itsdecision to reject a drug that has proven effective in treating the leading cause ofvision lossamong Canadians.

The controversy over Lucentis is about money, not medicine, with supporters praising the drug's success in treating wet age-related macular degeneration (AMD) which can cause vision loss even thoughthe drugcan cost $1,600 a month.

Critics saidthere is a cheaper, similar drugthat does the same thing, and claimed the company is being greedy. Thecancer drug Avastin, however,has not been tested for treating AMD.

Health Canada approved Lucentis last year, but the Common Drug Review (CDR) which analyses the clinical and cost-effectiveness of drugs for provincial drug plans, except Quebec's rejected it.

Now the company with the marketing rights, Novartis Pharmaceuticals Canada, is appealing that decision.

It's backed by the Canadian National Institute for the Blind (CNIB), which has been soliciting public support and asking people to write to the CDR and governments.

Without CDR approval, the drug will not be available through provincial drug plans, and it's beyond the means of many of the 100,000Canadians facing AMD.

"All Canadians, regardless of income, deserve the chance to maintain their eyesight," Jim Sanders, president and CEO of CNIB, said in a recent release.

It's 'the drug I've been praying for'

Comedian Mary Walsh, who has AMD in one eye and has been told it will affect the other, wrote to federal Health Minister Tony Clement in support of Lucentis.

It's "the drug I've been praying for. It may mean that I don't lose vision in my second eye this drug brings me hope," said her letter, which was posted on the CNIB website.

On the other side of the issue, medical ethicist Arthur Schaffer from the University of Manitoba said the price is too high.

"Companies have a right to a reasonable profit, but they don't have a right to a spectacular fortune siphoned out of medicare and pharmacare."

Avastin and Lucentisare chemically similar, and made by the same manufacturer, Genentech. (Novartis got the Canadian marketing rights for Lucentis from Genentech.)

Some doctors are using Avastin to treat AMD because it is so much cheaper.

"We have a feeling as a group of retina specialists that it works well, but we don't know for sure," said opthalmologist Dr. Alan Cruess.

The U.S. andBritish governments are paying for a head-to-head trial of Avastin and Lucentis, but that will take three years.

AMDis an age-related, degenerative disease of the macula, a small area at the centre of the retina. The growth of blood vessels into the retina can preventsufferers from seeing fine details, and can leadto blindness.