Johnathan Nagle: CIHR Director, SPER: "I'm following-up on my email yesterday regarding the request that the Minister's Office received from XXXX. They are requesting a meeting with the Minister's Office to discuss CCSVI treatment and a new MS drug treatment."
"This is a new oral drug treatment for MS patients that is currently in phase 3 of its clinical trial. XXXX tells me that XXXX are well respected and have a solid reputation with the MS Society but that there is no linkage between this drug and CCSVI.
Links to Cladribine http://mssociety.ca/en/research/medmmo_20090128.htm
Knowing this, would you recommend that the Minister’s Office proceed with the requested meeting?
Thanks
Jon
June 22 2010 email from CIHR Director Johnathan Nagle asking about getting EMD Serono a meeting with Health Ministers Office.
MS Society memo copied from their site on June 30 2012.
MS Society of Canada Medical Update Memo - January 28 2009
Summary: Oral cladribine (Merck Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 "CLARITY" study of 1,326 people with relapsing-remitting MS.
Details: Oral cladribine has been designated by the U.S. Food and Drug Administration as a "Fast Track Product," which should expedite its future review. The company plans to file for FDA approval of oral cladribine in mid-2009.
Background: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine is used to treat hairy cell leukemia. Studies have suggested a benefit in MS. In addition to the completed CLARITY study, other ongoing studies of oral cladribine funded by Merck Serono include:
- The ONWARD study, an investigation of the safety and effectiveness of adding high or low doses of oral cladribine to Rebif® (interferon beta-1a, EMD Serono Inc. and Pfize.
- The ORACLE MS study, designed to evaluate the safety and effectiveness of oral cladribine in people who have experienced a neurological episode that puts them at risk for developing MS.
The CLARITY Study: For the first year of the study, 1,326 participants were randomly assigned to receive a low dose of cladribine (two treatment cycles per year, each cycle consisting of one tablet per day for four to five consecutive days), a high dose (four cycles) of cladribine, or inactive placebo. In the second year, both treatment groups received a low dose of cladribine. The primary endpoint was the drug's effect on relapse rate at two years compared with placebo. Secondary endpoints included effects on disease activity, as detected by MRI scans, the proportion of relapse-free participants, and disability progression.
The relapse rate was reduced significantly more than placebo in both treatment groups (by 58% in the low-dose group and by 55% in the high-dose group). The company reports that secondary endpoints of the CLARITY study were also met, although the details of these are not provided in the press release. Additional study results will be submitted for presentation at an upcoming scientific meeting. Lymphopenia - a reduction of white blood cells - was the most frequent adverse event, and occurred more frequently in the groups on cladribine. Other adverse events reported in all three groups were headaches and cold symptoms.
With information from the National MS Society (USA)
National Research and Programs
End of the road for Merck KGaA's MS pill cladribine World News | June 22 2011
“Merck KGaA has decided to cut its losses and will no longer seek approvals for its oral multiple sclerosis treatment cladribine, as attempting to satisfy regulators would require fresh long and costly trials.
The German firm says that the decision has been made based on discussions with the US Food and Drug Administration at an end-of-review meeting for cladribine. In March, the agency issued a complete response letter and asked for further information on the analyses submitted or for new studies to be carried out.
Merck believes that data from ongoing clinical trials "are very unlikely to address the FDA requirements and will not provide a basis for approval". The US regulator's feedback was consistent with that received from the European Medicines Agency, which confirmed its negative opinion on cladribine earlier this year.
Related Links Merck KGaA s MS pill turned down by FDA Merck KGaA withdraws filing for oral MS drug in Europe Stefan Oschmann, head of the Darmstadt-based group's Merck Serono unit, said that "considering the time it would take to complete a new clinical trial programme and the significant risk that such a study would not result in sufficient data".
You got to wonder why the CIHR is trying to help EMD Serono get a meeting with the Ministers Office to talk about Cladribine and CCSVI.
What the hell does EMD Serono have to do with CCSVI?
Did the CIHR ever try to help vascular experts get a CCSVI meeting on Parliament Hill?
If I remember correctly they went out of their way to block people with CCSVI expertise joining their Panel of Experts. In fact, at the highest levels of the CIHR they said: “Inviting Dr. Z would be highly inappropriate the scientists will be discussing how one could best evaluate his work.”
The CIHR never wanted any IR’s or vascular doctors who have actually performed CCSVI angioplasty to be part of their so called Panel of Experts?
Then you got to wonder why the MS Society has all this info on a EMD Serono drug, when it was abandoned for MS treatment a year ago. Why would Big Pharma abandon even trying to get FDA approval, when their literature talks about how amazing and beneficial this new MS drug is?
The CIHR tries to help promote a drug that ultimately crashed and burned, and yet they aren't capable of getting an angioplasty clinical trial going, in a timely fashion.
Sadly, year after year goes by, and people with MS are blocked from a simple angioplasty treatment that is safe and freely available for people who don't have MS.
We have the higest levels of Government helping Big Pharma, while at the same time we see an email trail exposed by Maclean's, that shows how they try to manage the optics of this political hot potato called CCSVI.
It really is a CCSVI Cold War.
WaYnE