Hallo ich habe gerade diesen Artikel gefunden.
Ich habe leider keine Zeit den ganzen Artikel zu übersetzen.
Wo es drauf ankommt
Der 1. PML Fall soll angeblich noch Imuran im Blut gehabt haben und dadurch sei PML ausgelöst worden.
Der 2.PML Fall ist angeblich gar nicht bestätigt.
Laut dem Artikel wäre es möglich, dass es keine neuen PML Fälle durch Tysabri gibt.
Ich habe den Artikel bei Wallstreet online gefunden.
Ich kenne keine Originalquelle und weiss nicht ob da etwas dran ist.
Ich stelle das einfach mal so ein ohne irgendeine Verantwortung zu über- nehmen!!! Es könnte im worst case sein, dass ein Aktien-Pusher dies alles erfunden hat!!!
PML Primer for ELN Investors
1.PML is a ‘deadly brain virus’ that occurs in nature, the virus is present and dormant in the majority of humans.
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Incidents of PML have been associated with the use of autoimmune disorder medications, the most highly publicized is Tysabri.
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There is an ‘early warning system’ set up by the FDA, AE’s may be sent to the FDA identifying Adverse Events with use of any medication. AE’s can be sent to FDA by anyone, including physicians, nurses, family members, et al.
AE’s, when posted on FDA website, can be published by anyone, for any purpose, whether or not they resulted in a clinical finding of, say PML, that was verified by scientific inquiry. They can and will appear in financial journalism reports.
- PML may be considered, as part of the drug labeling process required by FDA, as a ‘black box warning’. Numerous drugs carry such a ‘black box warning’ including the risk factors for PML. Some drugs have been implicated in PML related deaths in double digit numbers, but these are not reported when each death occurs by the drug makers because they are not Tysabri.
5.Tysabri is the most efficacious medication available for MS. Studies have . shown that it arrests advancement of the disease better than any competing drug. However, Tysabri is best known to the public as the ‘drug that causes deadly brain virus’. Tysabri is defined by the media, regardless of the clinically proven efficacy, as a very dangerous and potentially life-threatening medication.
- There have now been 5 cases publicized implicating Tysabri as a causative for PML. 2 of the cases, publicized in 2005, were patients who were placed on a combination of Tysabri and Avonex, at the request of Biogen.
Another case was a patient who had also been prescribed a very potent autoimmune formulation called Imuran.
Two new cases of Tysabri related PML have very recently been publicized, and were brought forward by Biogen-Idec, although it had earlier been determined, as the FDA had set a 1-1000 ratio of expected PML incidence when allowing Tysabri back on the market 2 years ago, that Adverse Events would not necessarily be publicized UNLESS the number of events exceeded the 1:1000 ratio.
At this point, one of the two new PML cases has been found to have been prescribed Imuran for a protracted period. It is expected that Imuran may not have ‘cleared’ from this patients system, thus the prospect that he/she should never have been prescribed Tysabri, due to the known risks from the previous Patient #3 in 2005. In Europe, there is no TOUCH program, and physicians who are not neurologists may prescribe Tysabri
The second new case is now being debated in terms of whether a proper diagnosis of PML was made. The patient completed a procedure to ‘cleanse’ blood to clear Tysabri and is stable. It may yet be made known that this second case was not a proper diagnosis of PML, as it is known that misdiagnosis is common. AE’s reported to the FDA are often found to be innaccurate diagnosis of PML.
SUMMARY: Tysabri is the most efficacious medication available for MS. Tysabri is publically considered the most deadly medication for MS, regardless of recorded side effects, including PML found with patients taking other MS medications.
Tysabri is held to the highest standard for risk of PML of any drug on the market.
Tysabri uptake has primarily been driven by patient satisfaction with their results in recovery with this medication. Tysabri uptake has been curtailed by first, a two year removal from the market due to 3 cases of PML(2 with combo Avonex, one with combo Imuran); and second a ‘black box warning’ for PML.
During the first two years of use since Tysabri was allowed to be put back on the market in 2006, no cases of PML were discovered. Upon the second anniversary of Tysabri back on the market, two new cases of PML were publicized, one with combination of Imuran, one with indeterminate diagnosis of PML to date.
Significant effort has been made by Biogen to contact neurologists nationwide with information regarding the two new cases.
CONCLUSION: It is not yet known, but it may be known soon, that there are still NO cases of PML with mono use of Tysabri.
In the absence of confirmation of correct diagnosis of PML for one of the recent cases reported, ELN’s market capitalization has been reduced by a factor of 70%, and that reduction remains in that range to date.
ELN is not capable of controlling it’s destiny as regards Tysabri, and will never be able to do so, as Tysabri is held to a higher standard than any other drug for a serious disease, and will continue to be subjected to essentially rumors of deadly side effects, which are either combination effects or misdiagnosis.
The FDA system of AE’s is broken, and is easily used as a tool to cast doubt, through the media, on the safety of medications that provide tremendous benefit to patients.
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