| Q-7312 — June 12, 2012 — — With respect to the multiple sclerosis (MS) drugs, Tysabri and Gilenya: (a) before these drugs were approved for use in Canada, what detailed processes were undertaken to ensure safety, efficacy and quality and historically, (i) how many drugs have been reviewed, (ii) how has the review process been resolved, including, but not limited to, (iii) how many drugs have been pulled from the market, (iv) how many drugs have been given new prescription criteria, (v) how many drugs have been put back on the market; (b) when (start month and year to end month and year) and where (company/research facility and country) did the phase l clinical trials take place for each drug, (i) how many MS patients were enrolled for each trial, (ii) for each trial, how many controls were used, (iii) for each trial, which variables were controlled, (iv) which medical specialists monitored the patients during each trial and afterward, (v) how was a safe dosage determined for each drug, (vi) what was the safe dosage range for each drug, (vii) what side effects were identified for each drug, (viii) why was it decided to move ahead to a phase ll trial for each drug; (c) what, if any, other information was reviewed beyond the phase I trial for each drug; (d) when (start month and year to end month and year) and where (company/research facility and country) did the phase ll clinical trials take place for each drug, (i) how many MS patients were enrolled for each trial, (ii) for each trial, how many controls were used, (iii) for each trial, what variables were controlled, (iv) which medical specialists monitored the patients during each trial and afterward, (v) what was the safe dosage range for each drug, (vi) what evidence was there that each drug was safe, (vii) what evidence was there that each drug was effective, (viii) why was it decided to move ahead to a phase llI trial for each of the drugs; (e) what, if any, other information was reviewed beyond the phase II trial for each drug; (f) when (start month and year to end month and year) and where (company/research facility and country) did the phase Ill clinical trials take place for each drug, (i) for each trial, how many MS patients were enrolled, (ii) for each trial, how many controls were used, (iii) for each trial, what variables were controlled , (iv) which medical specialists monitored the patients during each trial and afterward, (v) what was the safe dosage range for each drug, (vi) what evidence was there that each drug was safe, (vii) what evidence was there that each drug was effective, (viii) what side effects were identified for each drug, (ix) how did the two drugs compare to commonly used treatments, (x) what information was collected that would allow the two drugs to be used safely, (xi) why was it was decided to move ahead to market both drugs; (g) what, if any, other information was reviewed beyond the phase III trial for each of the drugs; (h) Tysabri was known to cause progressive multifocal leukoencephalopathy (PML), a rare brain disorder that usually causes death or severe disability, (i) what was the benefit/risk profile for the drug, (ii) why did Health Canada choose to fast-track the drug, (iii) did the MS Society of Canada support the fast-tracking of Tysabri, (iv) why did Health Canada not make monitoring mandatory, as was done in the United States, (v) was the decision regarding monitoring ever changed and, if so, when, (vi) how does 252 confirmed cases of PML and 52 deaths fit with Health Canada’s benefit/risk profile; (i) Gilenya was known to slow a patient’s heart rate down, especially after the first dose, but the heart rate usually returned to normal within one month, (i) what was the benefit/risk profile for the drug, (ii) did anyone die during clinical trials and, if so, how many people, (iii) what evidence was provided regarding the source of deaths, (iv) how was risk assessed; (j) based on the information in (i), was there any group identified who should not take the drug, (i) particularly those with cardiovascular and/or cerebrovascular disease; (k) what percentage of MS patients have cardiovascular and/or cerebrovascular disease, and (i) when did the information in (k) become known; (l) were Canadian physicians involved in the phase 1-III clinical trials for Tysabri/Gilenya and, if so, (i) did they receive financial assistance from Biogen Idec or Novartis, (ii) did they provide support or recommendation for either of the drugs to the government, (iii) did they ever serve on any expert panel to the government regarding MS; (m) what assistance has Biogen Idec and Novartis provided to the MS Society of Canada or any of the Society’s funded scientists, (i) was there an involvement from the MS Society of Canada in the phase I-III clinical trials for Tysabri and Gilenya and, if so, (ii) did they receive any financial assistance from Biogen Idec and Novartis, (iii) did the Society or any of its board members, scientists or other members provide any support or recommendation for the drugs to the government, (iv) did the Society or any of its board members, scientists or other members serve on any expert panel to the government regarding MS; (n) what phase IV clinical trials have been undertaken for drugs in (i) Canada and by whom, and (ii) internationally; (o) when were the drugs first marketed in Canada, (i) when were the drugs first available in Canada, (ii) when were problems or signals first identified for each drug in Canada and internationally; (p) what do adverse reaction reports in Canada and internationally show for each drug, and what is the (i) Canadian and (ii) international data for each drug; (q) which countries have placed either of the two drugs under review, and for each drug, identify the start date of the review for each country; (r) did Health Canada put Gilenya under review on February 28th, 2012, because (i) safety concerns were identified, (ii) causal relationships were established, (iii) serious adverse events, including 11 deaths reported internationally, or (iv) of other reasons, and, if so, (v) identify the reasons; (s) for what reasons is the continued prescribing of Gilenya permitted despite the incidence of deaths internationally, and have any further deaths occurred since the drug has been under review; (t) what, if any, monitoring takes place to ensure that healthcare professionals are following the Health Canada advisory urging them to continue to follow Gilenya’s labelling instructions closely, particularly with respect to patient monitoring; (u) while Gilenya has been under review in Canada, have other medical agencies internationally provided any additional evidence and warnings, and, if so, what are the details, including whether Canada has followed suit; (v) what are the details of all actions taken by Health Canada to monitor the safety of Tysabri and Gilenya while the drugs have been on the market, including (i) adverse reaction reports in Canada and internationally, (ii) post-market studies, (iii) published data, (iv) international safety data, (v) collaboration with international counterparts; (w) what are the details of all information about Tysabri and Gilenya that has been obtained by Health Canada through (i) adverse reaction reports in Canada and internationally, (ii) post-market studies, (iii) published data, (iv) international safety data, (v) collaboration with international counterparts; (x) what, if any, collaboration takes place between Health Canada and Biogen Idec and Novartis to ensure that the safety profile of the drugs is monitored on an ongoing basis; (y) what are the details of the drug review process in the case of Gilenya, including (i) start and end date, (ii) Canadian and international information to be reviewed, (iii) reviewers, (iv) international partners, (v) benefit/risk profiles and thresholds, (vi) milestones, (vii) other relevant information; (z) what timeline does the government’s policy provide to communicate any new safety information that may arise concerning Gilenya; and (aa) what actions does Health Canada plan to take following the review of Gilenya? |