Winnipeg Free Press - PRINT EDITION

The deadly toll of drug-approval drag

  • Print

A recent survey of general practitioners by the Canadian Liver Foundation revealed 57 per cent of GPs don't know hepatitis C can be cured despite the fact more than 70 per cent of hep C patients who undergo treatment with available medicines are being cured right now.

Obviously, we must create more public awareness about hepatitis C when even medical professionals seem so unaware of what's going on. Especially when there are thousands of people who don't even know they are carrying the virus (hep C is a "silent disease" -- symptoms often don't appear until the liver is severely damaged).

A simple blood test will indicate the presence of hep C, but what is the use of that if over half of our family doctors don't know there are treatments and cures they can refer patients to? Meanwhile, 1,000 people die needlessly each year and thousands more cannot work or provide for themselves because they waited too long to get diagnosed and allowed the hep C to do its damage when it could have been treated.

There are still thousands of people in that remaining 30 per cent who cannot be cured by the present treatment of pegylated interferon, ribavirin and a protease inhibitor. For them, there is good news and there is bad news.

Many new advances in drug development in the United States have increased cure rates to greater than 90 per cent and approaching 99 per cent. The bad news is that 1,000 to 1,500 more may die in the time it may still take for a new drug developed by Gilead Industries of California to be approved for use in Canada.

The new drug is called sofosbuvir (brand name Sovaldi) and Gilead has obtained almost complete "clearance" with patients so far. Unfortunately, Health Canada requires up to 225 days to review the research and findings made by Gilead in order to issue a "notice of compliance." Then the drug must go through CDR (common drug review process), which "is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness and patient evidence for drugs." CDR also provides formulary listing recommendations to Canada's publicly funded drug plans (except Quebec)."

Following that, the Pan Canadian Pricing Alliance (PCPA) gets together to develop a national price for the drug and then, finally, all the information is turned over to the provinces, basically to repeat the entire process because health care is, after all, a provincial responsibility. Currently, Sovaldi has been assigned a notice of compliance and is through the CDR process. But it may be another 12 to 18 months before Manitobans will have access to this therapy.

The total time it takes for the drug to be researched and then made available in Canada by prescription? At least five years.

Current estimates have 1,000 people per year dying from hep C in Canada, so that's at least 5,000 needless deaths. And nobody really knows how many people are out there carrying this virus without knowing it themselves, and then when they find out, not seeking treatment because their family doctor isn't up to speed.

Why do I know all this?

Because I have hepatitis C and I am in the fourth and final stage of liver damage. Fortunately for me, I have lucked into a clinical trial.

I can't speak for other patients, but I can tell you I will endure whatever side-effects that go along with the new treatment because I don't have any other option; most likely not five years, unless somebody wants to spot me a liver (pun intended).

On behalf of the many others who I assume might feel the same way, I can only hope and respectfully request that the process to approve this drug for use in Canada be sped up.

And if you might be one of the estimated 300,000 people in Canada who are carrying the hep C virus, but you are one of those who just don't know, it's a simple, routine blood test.

Ask them to check for the hepatitis C virus.

Don Marks is a Winnipeg writer.

Republished from the Winnipeg Free Press print edition January 20, 2014 $sourceSection0

Fact Check

Fact Check

Have you found an error, or know of something we’ve missed in one of our stories?
Please use the form below and let us know.

* Required
  • Please post the headline of the story or the title of the video with the error.

  • Please post exactly what was wrong with the story.

  • Please indicate your source for the correct information.

  • Yes


  • This will only be used to contact you if we have a question about your submission, it will not be used to identify you or be published.

  • Cancel

Having problems with the form?

Contact Us Directly
  • Print

You can comment on most stories on You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

You can comment on most stories on You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

Have Your Say

New to commenting? Check out our Frequently Asked Questions.

Have Your Say

Comments are open to Winnipeg Free Press print or e-edition subscribers only. why?

Have Your Say

Comments are open to Winnipeg Free Press Subscribers only. why?

The Winnipeg Free Press does not necessarily endorse any of the views posted. By submitting your comment, you agree to our Terms and Conditions. These terms were revised effective April 16, 2010.


Make text: Larger | Smaller


Total Body Tune-Up: Farmer's Carry

View more like this

Photo Store Gallery

  • Jia Ping Lu practices tai chi in Assiniboine Park at the duck pond Thursday morning under the eye of a Canada goose  - See Bryksa 30 Day goose challenge Day 13- May 17, 2012   (JOE BRYKSA / WINNIPEG FREE PRESS)
  • JOE BRYKSA/WINNIPEG FREE PRESS Local- A large osprey lands in it's nest in a hydro pole on Hyw 59  near the Hillside Beach turnoff turn off. Osprey a large narrow winged hawk which can have a wingspan of over 54 inches are making a incredible recovery since pesticide use of the 1950's and  1960's- For the last two decades these fish hawks have been reappearing in the Lake Winnipeg area- Aug 03, 2005

View More Gallery Photos


Are you concerned about the number of homicides so far this year?

View Results

Ads by Google