New GILENYA OPPORTUNISTIC INFXN

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Anonymous said:
If you supress the immune system there is always a risk of opportunistic infection. This is not a giant leap in scientific thinking. Why is anyone surprised?
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The surprise here is the FDA and Novartis. You are right when you suppress the immune system long enough you are at risk of depending opportunistic infection therefore why isn't there a black box warning?
 










































In order to get 2 you have to start with 1. This is just the start. And last I checked, if your going to give a patient something with risk the benefit needs to be there. And that's why drugs like Tysabri and eventually campath will crush Gilenya over the long term.

Now go to sleep little primary care rep. Go to sleep.
 












Yes this is a good point. I really think we should take a step back and wait for this mystery case to be confirmed. After all, even though cns toxoplasmosis is diagnostic of aids according to the WHO, it is reasonable to think this patient may have been on placebo, misdiagnosed while presenting to the er with seizures and delirium, or just eating a lot of cat turds. People if it walks like a duck quacks like a duck I gotta break it to you. It's a duck. And this duck is an OI. Don't believe the brand or medical they don't know shit either. Just a wake up call for y'all that don't want your intelligence insulted. I know I don't! Still a groundbreaking drug but we need to be straight shooters!
 












The company is being silent on many issues. OI's, birth defects and many other complications. It will eventually all get out there and the physicians will not take this information lightly. The reps have no idea what medical knows.
 
























The culture of this company over the past 3 years has been perceived as one of silence, poor communication, and lack of transparency.

Does anyone truly thinks that Novarts is going to disclose all the relevant facts with regards to the various cases of opportunistic infections presenting in patients on Gilenya ?

That information is perhaps discussed behind close doors - Betsy, Trevor, and who knows what other conspirator - the facts are perhaps carefully massage, documents prepared, and endless correspondance and teleconferences with the FDA - all a very well orchestrated delay tactic, perhaps....while, the Salesforce drives prescriptions and revenues (who cares about the patients ? ....Mr Heinz ?)

They perhaps knew that the dose selected may have been too high - but that might have undermined the efficacy results in the pivotal studies and weaken the competitive stance of Gilenya vs the interferons. They perhaps knew that it would take a few years for OI to show...so they are perhaps banking that they are going to have data on the low dose study (if ever completed) - and then, re-negotiate with the FDA ...thus at the end, able to save their "blockbuster".

But at whose expense ?
The patients ? perhaps ?

Too bad whistleblowers, perhaps, will be executed.
Blood in the floor....won't be Heinz Ketchup.....Unfortunately...but perhaps, mine, yours and the patients.
 












Anonymous said:
The culture of this company over the past 3 years has been perceived as one of silence, poor communication, and lack of transparency.

Does anyone truly thinks that Novarts is going to disclose all the relevant facts with regards to the various cases of opportunistic infections presenting in patients on Gilenya ?

That information is perhaps discussed behind close doors - Betsy, Trevor, and who knows what other conspirator - the facts are perhaps carefully massage, documents prepared, and endless correspondance and teleconferences with the FDA - all a very well orchestrated delay tactic, perhaps....while, the Salesforce drives prescriptions and revenues (who cares about the patients ? ....Mr Heinz ?)

They perhaps knew that the dose selected may have been too high - but that might have undermined the efficacy results in the pivotal studies and weaken the competitive stance of Gilenya vs the interferons. They perhaps knew that it would take a few years for OI to show...so they are perhaps banking that they are going to have data on the low dose study (if ever completed) - and then, re-negotiate with the FDA ...thus at the end, able to save their "blockbuster".

But at whose expense ?
The patients ? perhaps ?

Too bad whistleblowers, perhaps, will be executed.
Blood in the floor....won't be Heinz Ketchup.....Unfortunately...but perhaps, mine, yours and the patients.
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Good lord we know the drug has issues but its not PML. We are in a new era of MS drugs there will be risk with everything new. If your looking for a drug like Tysabri with no side effects forget it will never happen. Teva has been trying to scare the crap out of my docs but my SRF's have been stronger then ever.
 






Sorry but the case of toxoplasmosis showed up in the patient after they were on FTY for less than a week but they were also another cytotoxic agent that hindered their immune system........I think FTY will be fine after the autopsy.....there can be no proven link.
 






Anonymous said:
Sorry but the case of toxoplasmosis showed up in the patient after they were on FTY for less than a week but they were also another cytotoxic agent that hindered their immune system........I think FTY will be fine after the autopsy.....there can be no proven link.
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Sorry, but there has been more than one case of toxo.
 






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