For those who may want to see what goes on during the development cycle of a new drug, please see the attached Gilenya Assessment Report PDF. The data and quotes below, speak for themselves.
Page 88 - 2.6.3. Serious adverse event/deaths/other significant events Deaths
"A total of 84 deaths were reported in the clinical development program including 12 patients in the MS and ongoing studies (cut off date: 30 September 2009) and 72 in the renal transplantation completed studies."
Page 90 - Serious adverse events (SAE)
"A total of 1962 patients (of whom 190 remain blinded in the MS studies) experienced SAE in the clinical development program including 12 patients in all completed studies, 615 patients in the MS and ongoing studies (cut off date: 30 September 2009) and 1335 in the renal transplantation completed studies."
Gilenya Assessment Report: London, February 17 2011:
http://tinyurl.com/3zo8ny5
Dr. Mark Freedman:
“Gilenya brings with it many advantages. The obvious one, is that it’s easily tolerated, once a day pill, with no immediate side-effects.”
First oral treatment for people with multiple sclerosis approved in Canada:
(Please check Novartis video with Dr. Freedman)
http://smr.newswire.ca/en/novartis-pharmaceuticals-canada-inc/first-oral-treatment-for-people-with-multiple-sclerosis
The Canadian MS Society:
"A few participants experienced a transient reduction in heart rate and partial blockage of heart conduction (second-degree atrioventricular conduction block) after the first dose of the medication which normalized spontaneously after several hours. During the second month of therapy, a slight increase in blood pressure was reported in some of the participants. Occasional instances of macular edema (swelling of the center of the retina inside the eye) were seen especially in those on the higher dose of Gilenya in both studies. Skin cancers were reported more frequently in those on Gilenya in the one-year TRANSFORMS study, but not in the longer 2 year FREEDOMS study. Malignancies were more common in those on placebo in the two-year FREEDOMS study.
Elevations in liver enzymes, without accompanying symptoms, were common in those receiving Gilenya. In both studies, a small number of herpes infections occurred such as shingles and there were two deaths from herpes infections that occurred in the TRANSFORMS trial in people taking the higher (not approved) dose of Gilenya.
The safety of Gilenya during pregnancy is uncertain but the drug could potentially cause birth defects."
In their press release, the MS Society seems to praise the benefits, and downplay the number of complications seen during the drug trials. Why didn't they mention the total death rate? Please check their press release.
Canadian MS Society: First Oral Disease-Modifying Therapy Approved in Canada
http://mssociety.ca/en/research/medmmo_20110310.htm
Why is this drug approved when a simple CCSVI angioplasty treatment, that has been done safely in over 12,000 patients, is considered too dangerous?
WaYnE