There are many who suffer from multiple sclerosis (MS) in the United States who are upset with the FDA for not approving of the drug Alemtuzumab, otherwise known as Lemtrada.
To the point where a petition was made to fight the ruling.
This, on top of Genzyme appealing the ruling, it looks like it is going to be an on-going issue for the MS community and some have been looking into going to other countries to receive the treatments; a bit like what some patients have done for chronic cerebrospinal venous insufficiency (CCSVI) just a couple years ago.
Other countries, like Canada and those in the E.U., have approved Lemtrada for a therapy but the United States is digging in its heals.
When used for therapy for those with MS, the medication is administered over a five-day period. This is followed by a three-day course one year later with a final dose in the third year and has been in the news off and on these last two years due to many issues.
One being last month’s class action suit brought by Lieff Cabraser Heimann and Berstein, LLP stating there were “misleading statements on the safety and efficacy of the multiple sclerosis drug Lemtrada.” They filed on behalf of those who had purchased contingent value rights (CVRs) from Sanofi.
Sanofi is a global pharmaceutical group that deals in research and development, manufacturing and marketing of healthcare products and they had bought Genzyme a few years ago.
It was with the purchase of Genzyme where Lemtrada came into play because the drug came with it and shareholders received CVRs that were linked to Lemtrada’s future success.
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Most studies are usually double-blind, meaning those who administer the actual drug and those who are receiving it typically do not know what is the placebo and which is not; and the lawyers pointed out the Lemtrada study was not handled this way.
There are lawyers on top of doctors on top of those in the FDA who have all pointed out the same thing: no double blind is an issue.
This may not have been an issue with the lawyers but for doctors there is also the safety issue: six trial participants developing thyroid cancer, three were diagnosed with melanoma and five deaths that were possibly related to the treatment (the other three deaths were considered unrelated) along with the infusion reactions.
This drug may be found to be too costly for the manufacturers to try to keep alive here in the U.S. Especially if the appeal doesn’t succeed.
It had been noted that doctors “could provide off-label prescriptions and give patients Campath”, but this isn’t going to be a viable action as Sanofi is already twenty steps ahead of this.
They pulled Campath off the U.S. and E.U. markets and renamed it Lemtrada. They were that confident that their non-double-blind studies were going to garner them success.
Well, that and Campath’s treatment for B cell chronic lymphocytic leukemia sales had been “declining for some years” anyway so the money grabber would’ve been with this disease anyway.
It looks as if the other ‘option’, the traveling out of the country, is going to be the only option because fighting MS along-side Gilenya and Tecfidera may end up being too costly.
*note above video: to be fair, the FDA bureaucracy seems to get in its way sometimes, "The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health. Under this mandate, it regulates drugs and medical devices for their safety and...on.aol.com"
For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Google Maps
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Sources: http://seekingalpha.com/instablog/957061-chris-demuth-jr/2602351-lemtrada-petitions; http://www.postcrescent.com/article/20140126/APC0101/301260376/, Ariel Cheung; http://www.pharmatimes.com/article/12-08-21/Sanofi_withdraws_Campath_in_US_and_EU.aspx