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Clinical Trials

Clinical Trials

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Published by Amy Gaylord-Preston
Letter to Aglukkaq and Beaudet from CCSVI Ontario July 1, 2011
Letter to Aglukkaq and Beaudet from CCSVI Ontario July 1, 2011

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Published by: Amy Gaylord-Preston on Jul 04, 2011
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The CCSVI Ontario Executive encourages you to
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
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
 _____________________________________________________________________________1 July 2011Hon. Leona Aglukkaq Dr. Alain BeaudetMinister of Health President, Canadian Institutes of Health Research460 Confederation Building 160 Elgin Street, 9
Floor, Address Locator 4809AOttawa, Ontario Ottawa, OntarioK1A 0A6 K1A 0W9Dear Minister Aglukkaq and Dr. Beaudet,The announcement on Wednesday, 29 June 2011, that the Harper Government will fund clinicaltrials 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 areplanning to put in place can be trusted.
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?
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?
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?
Linda Hume-Sastre Amy Gaylord Preston Anna Delorme Judy Filipkowski Diana PricePresident Vice-President Director Director Directorwww.CCSVIOntario.ca Facebook: C.C.S.V.I. Ontario I.V.C.C. Ontario
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 experts youwill 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 havebeen 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 sideeffects or risks are part of future decisions that will be made on providing testingand treatment for CCSVI?
What are the timelines for the activities in Item 2?
What are the timelines for beginning and ending each phase of the clinical trials?
What are the criteria for selecting participants for the trials? Who will make theselection?
Who will assess the participants before and after testing and treatment for CCSVI? Whatwill this assessment include and what is the period of time for the assessment? How willthe assessments be recorded (irrefutable objectivity and honesty are essential)?
Who will interpret the data collected from the clinical trials? What are the criteria forinterpretation?
Where will the data collected from these trials be deposited and how will the data beused?
. When will the data be made public (without the names of participants)?
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?
. Will Canadians with MS be allowed access to treatment on compassionate groundsoutside of clinical trials?
Linda Hume-Sastre Amy Gaylord Preston Anna Delorme Judy Filipkowski Diana PricePresident Vice-President Director Director Directorwww.CCSVIOntario.ca Facebook: C.C.S.V.I. Ontario I.V.C.C. Ontario

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