Dear Minister,

I am now writing to you for the fourth time in roughly two months, as you have failed to respond to any of my open letters of concern of July 5th, July 30th, and August 8th, 2012.

First, while your government promises accountability, the gap between promise and delivery increases by the day. The 2011 document, “Accountable Government: A Guide for Ministers and Ministers of State”, says Ministers are accountable to Parliament, and that they should maintain good relations and open lines of communication with parliamentarians.

While it is disappointing that you choose not to meet your own government’s guidelines and respond to a colleague, it is absolutely objectionable that you refuse to answer questions of profound significance to 55-75,000 Canadians living with multiple sclerosis (MS).

 Second, I have been asking since May 3rd, 2012 what the process was for the drug review of Gilenya, an oral MS drug approved by your government and linked to deaths internationally, which is still being prescribed to Canadians with MS. Two months later on July 3rd, your Director of Parliamentary Affairs and Northern Policy asked whether I would retract my order paper question regarding Gilenya (and another MS drug, Tysabri) in exchange for the earlier promised briefing. Astoundingly, she explained that there were not the resources to provide both a technical briefing and answers to my order paper question, as a result of your government’s “cuts”.  She promised to get back to me on July 4th; I am still waiting for any response.

It appears that you chose not to be transparent, accountable and open with Canadians regarding the drug review for Gilenya, as we learned on August 23rd via the Canadian Press, that there is now an up-dated product monograph for the drug. Since a number of Canadians have reported heart-related side-effects, and there will be Canadians who must weigh the pros and cons of taking this drug, those with MS would have welcomed the opportunity to learn how the government was reviewing the evidence.

Regarding the new Gilenya monograph, was Health Canada in consultation with the European Medicines Agency, which issued questions and answers regarding the ongoing review of Gilenya (review follows serious cardiovascular events in patients taking the medicine) on January 19th, 2012? Was Health Canada in discussion with the US Food and Drug Administration (FDA) on the matter, as the organisation unveiled a similar adjustment to Gilenya prescription guidelines on May 14th, 2012 (http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm)?

Canada’s new guidelines are long overdue given the fact that the EMA issued advice to health professionals seven months ago, and the FDA released their guidelines three months ago. Notwithstanding the concerns expressed by many regarding the drug’s safety record, the Therapeutic Products Directorate has chosen to “drag its feet” ignoring what has been obvious to many other countries, and in so doing, placed many thousands of Canadians at unnecessary risk.

The growing safety concerns for Tysabri remain unaddressed in this country which I believe is unconscionable. How many MS patients in this country need to die before we issue updated regulatory guidelines? 

Tysabri was fast-tracked by Health Canada, despite the fact that it was known to cause a fatal brain infection, progressive multifocal leukoencephalopathy (PML). As of August 1st, 2012, there have been 271 confirmed cases of PML worldwide; 59 of 271 of those with PML have died.  This is an increase of 13 cases, and five deaths since June (and the data provided in my letter of July 5th to you).

Third, I have been raising the issue of follow-up care for those who have had treatment for chronic cerebrospinal venous insufficiency (CCSVI) since the summer of 2010.  Therefore, will you include follow-up care as an agenda item at your next Federal-Provincial-Territorial Ministers of Health conference? Will follow-up care be included in the next meeting of the Scientific Expert Working Group on Multiple Sclerosis, and will you commit to taking a public stand on the subject of advocating for follow-up care?

Fourth, I must once again address the issue of transparency of information from your portfolio. I received the results of my ATIP request regarding correspondence between the Canadian Institutes of Health Research and the Multiple Sclerosis Society of Canada (MSSC). In my previous requests, the name, email address, and text of emails from the MSSC were largely given.  Why has the afore-mentioned material largely been struck in this ATIP (resulting in some 50 almost-blank pages), and why is material being included that should have been sent in my very first ATIP request (i.e. many requests ago)? That is, why is the government letting key information out in “drips and drabs”?

Finally, I note that it is one year and 59 days since you announced clinical trials for CCSVI, which have yet to begin. Time is of the essence here. Since your announcement, there will have been three new MS diagnoses daily (for a total of almost 1,300 new MS patients in Canada), the 55,000 to 75,000 Canadians with MS will have worsened, on average, by one EDSS score,  and more than 460 Canadians with MS will have died. When will the ethical review for the CCSVI clinical trials announced on April 18th, 2012 be complete, and when will the trial begin? Canadians with MS deserve an answer.

I am very much hoping for an answer this time.

Yours very truly,

Kirsty Duncan MP-Etobicoke North

http://kirstyduncan.liberal.ca/blog/kirstys-august-27th-letter-to-the-minister-of-health/