The CCSVI Ontario Executive encourages our Canadian Members on our CCSVI Newport Beach/Costa Mesa Group to:

1.

copy the letter to Minister Aglukkaq and Dr. Beaudet and send it to them (and Mr. Harper, Mr.Rae, Dr. Layton and Dr. Butler-Jones) with a covering letter expressing your own thoughtsOR

2.

or write your own letter to the Minister and Dr. Beaudet.Remember that

surface mail to Federal MPs is free

 – 

no postage required.Addresses for Mr. Harper, Mr. Rae, Dr. Layton and Dr. Butler-JonesHon. Stephen Harper, MPOffice of the Prime Minister80 Wellington StreetOttawa, Ontario, K1A 0A2Mr. Bob Rae, MPHouse of CommonsOttawa, Ontario, K1A 0A6Dr. Jack Layton, MPHouse of CommonsOttawa, Ontario, K1A 0A6Dr. David Butler-JonesChief Public Health OfficerPublic Health Agency of Canada130 Colonnade RoadA.L. 6501HOttawa, Ontario, K1A 0K9

Hon. Leona Aglukkaq

Dr. Alain BeaudetMinister of Health President, Canadian Institutes of Health Research

460 Confederation Building 160 Elgin Street, 9th Floor,

Address Locator 4809A

Ottawa, Ontario

K1A 0A6 K1A 0W9

Dear Minister Aglukkaq and Dr. Beaudet,

The announcement on Wednesday, 29 June 2011, that the Harper Government will fund clinical trials for testing and treatment of CCSVI was welcome. It is encouraging to know that theHarper Government now acknowledges the persuasiveness of existing evidence regarding theassociation of CCSVI with multiple sclerosis and the improvement to the quality of life thatmany Canadians with MS experience after treatment for CCSVI.However, the announcement raises some serious questions. These questions are listed below andwe would appreciate receiving your response. If, as you stated at your press conference,transparency is a goal then the clarification that you can provide in your response to ourquestions will go a long way towards convincing Canadians with MS that the process you are planning to put in place can be trusted.

1.

Why is Phase I of the clinical trials devoted to determining if balloon angioplasty is safewhen recent studies (e.g., Siskin/Mandato) have already established safety and balloonangioplasty is already a recognized low risk standard of care for correcting venous andarterial problems?

2.

It is our understanding that Phase 2 of the clinical trials will be a blinded study whichmeans that half the participants will be treated and half will receive a sham treatment;both groups will be followed for a period of time. We understand that this phase isintended to answer questions about the placebo effect. What are the ethical and moralcriteria that were considered for requiring a clinical trial to include an invasive shamprocedure to be performed on Canadians with MS? Will a panel composed of medicalethics experts and experts in testing and treating CCSVI be convened to advise on theneed for a sham procedure?

3.

Bill S-204, an Act to establish a national strategy for chronic cerebrospinal venousinsufficiency (CCSVI), was tabled in the Senate by Senator Jane Cordy and calls formulti-centre clinical trials to be conducted across the country. Will the clinical trialsfunded by the Harper Government be conducted in multi-centres across the country?

4.

Bill S-204 also calls for the establishment of an advisory panel composed of expertswho have been or who are actively engaged in testing or treating CCSVI. Will theprocess you intend to put in place include these experts? If so, who are the kinds of experts you will involve in establishing the criteria for a call for research proposals, in selecting the best proposals,

in developing the standards for testing and treatment, and in developing the training and expertise required to conduct the trials in developing the tracking mechanisms for those Canadians who are or who have been treated outside Canada to ensure that data on the efficacy of the treatment,the impact on quality of life, the duration of the treatment, and possible side effects or risks are part of future decisions that will be made on providing testingand treatment for CCSVI?

5.

What are the timelines for the activities in Item 2?

6.

What are the timelines for beginning and ending each phase of the clinical trials?

7.

What are the criteria for selecting participants for the trials? Who will make that selection?

8.

Who will assess the participants before and after testing and treatment for CCSVI? What will this assessment include and what is the period of time for the assessment? How will the assessments be recorded (irrefutable objectivity and honesty are essential with no bias eithe way)

9.

Who will interpret the data collected from the clinical trials? What are the criteria for interpretation?

10.

Where will the data collected from these trials be deposited and how will the data beused?

11

.When will the data be made public (without the names of participants)?

12.

How much money is available for each phase of the trials? Who will decide on theallocation of the money? What are the criteria for allocating the money?

13

Will Canadians with MS be allowed access to treatment on compassionate groundsoutside of clinical trials?

14.

Bill S-204 also calls for the Minister of Health to ensure that health care is not refusedto a person on the grounds that the person is seeking or has obtained the treatment forCCSVI outside Canada. Follow-up care is a critical issue, especially in the case of blood clots, and the following questions require immediate answers:

what protocols are in place now to ensure that health care is available to Canadians who are or who have been treated for CCSVI outside Canada?

will a panel of experts who have been or who are actively engaged in testing andtreating CCSVI be convened to develop a follow-up health care protocol?

will the Minister and CIHR ensure that Canadian doctors, hospitals andemergency units do not refuse follow-up care to Canadians who have been treated for CCSVI outside Canada,

will the Minister and CIHR ensure that the follow-up protocol (established byCCSVI experts) is disseminated and honoured by Canadian doctors, hospitals and emergency units? We believe that it is imperative that professionals with expertise in testing and treating CCSVI lead the development of the clinical trials, and the clinical trials themselves. These experts include, but are not limited to, Dr. Sandy McDonald, Dr. David Hubbard, Dr. Mark Haacke,Dr. Bill Code,   Dr. Christopher Guest, Dr. Gary Siskin, Dr. Kenneth Mandato, Dr. Salvatore Sclafani,  Dr. Joseph Hewett, Dr Michael Arata, Dr. Marian Simka, and Dr. Paolo Zamboni.

Sincerely,

This is where you insert your name address and email info :-)

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