Gilenya patient DEAD , Thanks Novartis , bye bye MS salesforce

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FDA joins probe into Gilenya patient's sudden death
December 21, 2011 — 10:09am ET | By Tracy Staton

FDA is now investigating the death of a multiple sclerosis patient who'd just taken Gilenya for the first time. The agency joins Novartis ($NVS) in probing the 59-year-old patient's death within 24 hours of starting treatment. The patient had been monitored for 6 hours after that first dose, as required by Gilenya's label, without any apparent ill effects.

As InPharm points out, Gilenya has been tagged with some serious potential side effects
 




































Anonymous said:
Yo dipshit, this patent application is for a titration kit for another s1p modulator in development. No proof that 0.5 is cardiotoxic. Read the whole link before you make stupid assumptions!!
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Idiot! Guess why Eric has filed this patent. He said several times that there are potential cardiac issues with FTY at any dose. He is waiting for the long term safety data to confirm his hypothesis.
 






what about the other TEN that died in EU? my problem with all this is that Novartis does not seem to be very open with what's going on with their patients.

Biogen on the other hand was very upfront with the issues with PML and Tysabri and keeps their customers up to date on all PML related instances.

at least with PML, you have some symptoms that can give you a warning. not so with Gilenya and their 'heart issues'. your heart either works or it doesn't. even if I were JC Virus positive, I think I would take my chances with Tysabri over Gilenya.
 






Anonymous said:
what about the other TEN that died in EU? my problem with all this is that Novartis does not seem to be very open with what's going on with their patients.

Biogen on the other hand was very upfront with the issues with PML and Tysabri and keeps their customers up to date on all PML related instances.

at least with PML, you have some symptoms that can give you a warning. not so with Gilenya and their 'heart issues'. your heart either works or it doesn't. even if I were JC Virus positive, I think I would take my chances with Tysabri over Gilenya.
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ok great buyogen philosopher go back to your own part of cp.
 






Anonymous said:
ok great buyogen philosopher go back to your own part of cp.
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Well at least Gilenya puts patients out of their misery if a SAE occurs! I'll take sudden death over having tysabri turn my brain into a turnip with a round of PML. Hell, don't most of us say we would rather die in our sleep than be on life support for a year?
 






1 death within 24 hours of starting the med - 11 other deaths while on the med in Europe.
that's 12 deaths in 36 months. That doesn't sound great. But that is only 12 deaths of 28,000 patients who have taken the drug. That's only a .0428 % death rate. If we put all MS patients on the med and since "MS affects about 2.5 million people worldwide" then it would take 625.000 years for all 2.5 million to succumb to the negative side affects of gilenya. Did I get the 'math' right ?
 






Anonymous said:
One out of 28,000. Do the math on that percentage. Non-story.
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1 death within 24 hours of starting the med - 11 other deaths while on the med in Europe.
that's 12 deaths in 36 months. That doesn't sound great. But that is only 12 deaths of 28,000 patients who have taken the drug. That's only a .0428 % death rate. If we put all MS patients on the med and since "MS affects about 2.5 million people worldwide" then it would take 625.000 years for all 2.5 million to succumb to the negative side affects of gilenya. Did I get the 'math' right ?
 












Anonymous said:
Well at least Gilenya puts patients out of their misery if a SAE occurs! I'll take sudden death over having tysabri turn my brain into a turnip with a round of PML. Hell, don't most of us say we would rather die in our sleep than be on life support for a year?
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Why bother with euthanasia when you can do it yourself at home with a month's supply of Killenya all at once! Just wash it down with the beverage of your choice! No tedious decaying turnip procedure necessary! You've got Killsabri beat there!
 






Anonymous said:
1 death within 24 hours of starting the med - 11 other deaths while on the med in Europe.
that's 12 deaths in 36 months. That doesn't sound great. But that is only 12 deaths of 28,000 patients who have taken the drug. That's only a .0428 % death rate. If we put all MS patients on the med and since "MS affects about 2.5 million people worldwide" then it would take 625.000 years for all 2.5 million to succumb to the negative side affects of gilenya. Did I get the 'math' right ?
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According to EMA website, 11 deaths in total and > 30,000 patients have been exposed:

'In addition to the unexplained death in the US, six other unexplained deaths (including three cases of sudden death) after starting treatment with Gilenya have also been reported. Other reports include three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, it is not clear if these were caused by Gilenya or not.'

Unexplained deaths and sudden deaths - that does not sound good. It won't be so much about the total %, it will be more about a pattern of confounding factors and risk factors that could explain the deaths and if the benefit risk remains positive if you introduce a black box warning (in the US) or exclude certain patients (add a contraindication). I guess it will also play a role in the FDA's and EMA's decision how the cardiac safety profile looks as a whole, ie how many cardiac serious adverse events have been reported from post-marketing experience, and how many in previous and ongoing studies, and the timely relationship of administration; EMA communication does not mention the time of the additional 10 deaths.
 












Anonymous said:
According to EMA website, 11 deaths in total and > 30,000 patients have been exposed:

'In addition to the unexplained death in the US, six other unexplained deaths (including three cases of sudden death) after starting treatment with Gilenya have also been reported. Other reports include three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, it is not clear if these were caused by Gilenya or not.'

Unexplained deaths and sudden deaths - that does not sound good. It won't be so much about the total %, it will be more about a pattern of confounding factors and risk factors that could explain the deaths and if the benefit risk remains positive if you introduce a black box warning (in the US) or exclude certain patients (add a contraindication). I guess it will also play a role in the FDA's and EMA's decision how the cardiac safety profile looks as a whole, ie how many cardiac serious adverse events have been reported from post-marketing experience, and how many in previous and ongoing studies, and the timely relationship of administration; EMA communication does not mention the time of the additional 10 deaths.
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Eric Legangneux knew it all and could have spoken up. He could have, but, well, he decided to fool everyone and file his infamous patient.
 






Perhaps this is part of the gilenya brand value proposition to payors. Save health care dollars and improve outcomes by killing patients quickly with cardiac crisis rather than brain-turned-turnip slowly! Let's hope payors don't research the adem, seizures, pneumonia, and debilitating vague neurological syndromes that are also "unexplainable" and eventually, fatal with young healthy patients taking GYA
 






I worked with Rebif when Tysabri had their initial PML deaths. Please, biogen trolls, go back under your bridge, the manner in which PML was handled was abysmal and took far longer than the current week Novartis has had to look into the deaths.
 






Problem is Neuros have no idea how to treat an actual patient... too busy doing "diagnose and adios" scans. MS is the bane of their existence.

Maybe we can get Psychs to treat MS. They are completely comfortable with drugs causing QTc prolongation and having patients drop dead. But since the patients were either a) crazy b) demented or c) depressed they don't really sweat it.
 






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