Valerie
05-11-2003, 10:31 AM
Sent: 5/9/2003 1:39 PM
HELP US END THE WAIT FOR PEGASYS!
To mark National Hepatitis Awareness Month, the Canadian Hepatitis C Network implores you to show your support for approval of PEGASYS. During the month of May, please e-mail or fax the letter below to The Honourable Anne McLellan, McLellan.A@parl.gc.ca or (fax) 613-943-0044. We've been waiting far too long for approval of PEGASYS in this country and this needs to end now!
May, 2003
Dear Minister McLellan,
I am writing in regards to the intolerably long delay for approval of the newest drug treatment for hepatitis C, pegylated interferon (Pegasys) with ribavirin. This delay clearly indicates the lack of priority given to the treatment of hepatitis C in this country. The combination of Pegasys with ribavirin is now available in more than 70 countries worldwide. Many Canadians with hepatitis C, especially those whose disease is considered difficult-to-treat (genotype 1 and cirrhosis), are aware of the international evidence demonstrating superior results with Pegasys and ribavirin. Some have been forced to put their lives on hold and perhaps their health at risk awaiting this newest treatment.
If a drug like Pegasys was being reviewed for cancer, AIDS, heart disease or arthritis, do you think this kind of delay would be allowed to happen? I suspect not.
It is obvious that Health Canada recognizes the “breakthrough” benefits of the combination of Pegasys and ribavirin, because it has placed the application on “fast track.” However, it appears that the eagerly awaited “combo” cannot be approved until the review of Pegasys monotherapy (without ribavirin) has been completed. Unfortunately, it has been after almost three years since application for monotherapy Pegasys was filed and this application is not on fast track. There is no indication as to when the review of monotherapy will be completed and the “expedited review” of the combination therapy begun.
We know, based on the millions of dollars and hundreds of Health Canada personnel that have been diverted to dealing with SARS and West Nile Virus, that the resources for urgent review and approval can be found, if there is the political will. We do not doubt the value of these expenditures for these diseases. Similarly, hepatitis C remains a Canadian public health crisis with thousands of new cases every year. It is a serious, life-threatening disease for hundreds of thousands of Canadians today.
Pegasys with ribavirin is a treatment that has been developed and proven effective for up to 75% of those with hepatitis C. We urge you to give Canadians with hepatitis C the urgent attention that this healthcare crisis deserves. May is Hepatitis Awareness Month in Canada. It would be an incredible tribute if you could let those with hepatitis C know that Health Canada will be making Pegasys combination therapy available in the very near future.
Thank you for your consideration and support.
_______________
Signature
HELP US END THE WAIT FOR PEGASYS!
To mark National Hepatitis Awareness Month, the Canadian Hepatitis C Network implores you to show your support for approval of PEGASYS. During the month of May, please e-mail or fax the letter below to The Honourable Anne McLellan, McLellan.A@parl.gc.ca or (fax) 613-943-0044. We've been waiting far too long for approval of PEGASYS in this country and this needs to end now!
May, 2003
Dear Minister McLellan,
I am writing in regards to the intolerably long delay for approval of the newest drug treatment for hepatitis C, pegylated interferon (Pegasys) with ribavirin. This delay clearly indicates the lack of priority given to the treatment of hepatitis C in this country. The combination of Pegasys with ribavirin is now available in more than 70 countries worldwide. Many Canadians with hepatitis C, especially those whose disease is considered difficult-to-treat (genotype 1 and cirrhosis), are aware of the international evidence demonstrating superior results with Pegasys and ribavirin. Some have been forced to put their lives on hold and perhaps their health at risk awaiting this newest treatment.
If a drug like Pegasys was being reviewed for cancer, AIDS, heart disease or arthritis, do you think this kind of delay would be allowed to happen? I suspect not.
It is obvious that Health Canada recognizes the “breakthrough” benefits of the combination of Pegasys and ribavirin, because it has placed the application on “fast track.” However, it appears that the eagerly awaited “combo” cannot be approved until the review of Pegasys monotherapy (without ribavirin) has been completed. Unfortunately, it has been after almost three years since application for monotherapy Pegasys was filed and this application is not on fast track. There is no indication as to when the review of monotherapy will be completed and the “expedited review” of the combination therapy begun.
We know, based on the millions of dollars and hundreds of Health Canada personnel that have been diverted to dealing with SARS and West Nile Virus, that the resources for urgent review and approval can be found, if there is the political will. We do not doubt the value of these expenditures for these diseases. Similarly, hepatitis C remains a Canadian public health crisis with thousands of new cases every year. It is a serious, life-threatening disease for hundreds of thousands of Canadians today.
Pegasys with ribavirin is a treatment that has been developed and proven effective for up to 75% of those with hepatitis C. We urge you to give Canadians with hepatitis C the urgent attention that this healthcare crisis deserves. May is Hepatitis Awareness Month in Canada. It would be an incredible tribute if you could let those with hepatitis C know that Health Canada will be making Pegasys combination therapy available in the very near future.
Thank you for your consideration and support.
_______________
Signature