Nexavar saved Tony Clark’s life, and he wants to make sure it helps save other victims of kidney cancer too.
That’s why the Erin Mills resident was in Ottawa Monday, to watch his oncologist, Dr. Jennifer Knox, tell a dozen members of the Commons Health Committee that Canada is making a tragic mistake in not approving two new drugs, Nexavar and Sutent, that have shown remarkable results in clinical studies.
Given a year to live in June 2004, Clark and his wife Sharon went on a desperate search for help, and they found it in Nexavar, a drug that was just then being tested in clinical research programs at the Cleveland Clinic. It stabilized Clark’s kidney cancer, which is usually so highly developed by the time it is discovered in patients that little can be done.
Clark, co-founder of the Kidney Foundation of Canada, said today that Dr. Knox made a compelling pitch to MPs, telling them that our country, once on the leading edge of many medical breakthroughs, is in danger of being left behind.
The two drugs have already been approved for public funding in 13 countries including U.S., France, England and Italy and most Canadian private drug plans now cover it.
But a federal body called the Common Drug Review (CDR) has recommended that, despite approval from Health Canada, the drugs not be funded through provincial health care plans.
The main reason Nexavar is not accepted is that, believe it or not, it has done too well in its clinical studies.
Clark explains that when the drug was given to patients in its major trial it produced, “extremely compelling, positive results. The results were so good that Bayer felt, for ethical reasons, they had to cut the trial short. They felt that the people who were on the placebo had to be given the drug. As a result, the trial was not long enough.”
Talk about your Catch 22 — multiplied multifold.
Because Nexavar was so good at saving patient’s lives it had to be given, in all good conscience, to the patients in the study who were not receiving it. As a result, the definitive scientific proof that CDR requires to approve the drug can’t be produced. Nexavar is a victim of its own success.
These two drugs are just two of several so-called “orphan drugs” for rare disorders which are not being funded. Another Mississaugan, Guy Ashford-Smith was also in Ottawa last week to make a pitch on behalf of Myozyme, the drug that the support group for Pompe’s Disease which he heads, is championing. It is allowing older adults to live longer with the disease and saving lives of child victims, who rarely used to live to see their first birthday.
“I didn’t go over there (to Ottawa) for myself,” says Clark. “I’m no longer on Nexavar and I am grandfathered, so that I can get it again if I need it. But I am devastated for the other patients who are coming along behind me. There are 4,900 new kidney cancer patients per year. They are not going to be able to get any treatment.”
Dr. Knox told MPs that Nexavar, “represents a tremendous breakthrough after decades of research in the treatment for kidney cancer.”
It will only a breakthrough for average Canadians, however, when they can get access to it.