Tysabri is a dangerous drug

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Tysabri is a dangerous drug

Postby Andromeda » Fri Mar 14, 2014 9:10 am

Brief background, I used to work in the FDA program that handled drugs monitored under the Risk Evaluation and Mitigation Strategy program. The FDA requires that if a death (or adverse event) arises from the drug, it must be reported. BUT, they do not require the drug companies to proactively obtain that information. So the only way we recorded death info is if the doctor causally calls about ordering forms, and just so happens to mention that the patient dies. We have to ask a series of questions about the patient to record it. Most doctors offices do not have the time to stay on the phone and discuss this information, so it doesn't get recorded. Every once in a while, a family member will call in to report it, but because it is a family member and not a medical professional, we have to refer them to the drug company, and who knows if they record that information. I am very suspicious that the cases of PML is much much higher than what is reported.
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Re: Tysabri is a dangerous drug

Postby cheerleader » Fri Mar 14, 2014 10:50 am

THANK YOU for confirming what I've been concerned about and covering, Andromeda. We really have no idea how many people are being affected with PML.

The FDA DOES NOT compile a list of adverse effects in a timely or efficient manner, and Biogen is not mandated to actively look for cases of PML.

I learned this week that it is not possible to get the real numbers from the FDA as a consumer---because their site is not searchable. You have to download their full reports of ALL drug side effects every 3 months...each pdf is 25MB!! And they are only current to the first quarter of 2013. Here's the FDA Adverse Events Reporting System site. http://www.fda.gov/Drugs/GuidanceCompli ... 082193.htm

https://www.facebook.com/notes/ccsvi-in ... 1616067211

This is why the numbers on the consumer safety site, eHealthMe are SO important.
On Mar, 5, 2014: 90,305 people reported to have side effects when taking Tysabri. Among them, 2,943 people (3.26%) have Progressive Multifocal Leukoencephalopathy.
http://www.ehealthme.com/ds/tysabri/pro ... phalopathy

cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Tysabri is a dangerous drug

Postby Andromeda » Fri Mar 14, 2014 12:12 pm

No, thank you, I didn't know about the ehealthme website. I was schedule to take my 1st tysabri infusion next week, but after reading the medical guide, I've was shocked my neuro even prescribed this to me. Even worst, I'm JC positive. I know why I was prescribed this, because just days earlier a Tysabri henchman took my neuro out for an expensive dinner (cleverly disguised as seminar). That speaks volumes.
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Re: Tysabri is a dangerous drug

Postby HarryZ » Sat Mar 15, 2014 7:00 am

Andromeda wrote:No, thank you, I didn't know about the ehealthme website. I was schedule to take my 1st tysabri infusion next week, but after reading the medical guide, I've was shocked my neuro even prescribed this to me. Even worst, I'm JC positive. I know why I was prescribed this, because just days earlier a Tysabri henchman took my neuro out for an expensive dinner (cleverly disguised as seminar). That speaks volumes.


And some people wonder why I have been "anti Biogen" for so many years when following MS research!! These people are in business for one reason only...to make money. Now there is nothing wrong with that at all but when you possibly sacrifice the health of MS patients to make that black line bigger, you have to question their methods. And keeping the true PML numbers lower than what they appear to be is one of those methods.
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Re: Tysabri is a dangerous drug

Postby Andromeda » Sat Mar 15, 2014 6:07 pm

Harryz, you are correct to be anti-Biogen. The tape tells it all. Their stock is trading well over $300 per share, so they will hide whatever data possible to keep the green rolling in. I saw the link to Angela's video, and its tragic to see how in the beginning she was so optimistic about Tysabri, only to be left with PML in the end. I hope the FDA sees her video and reconsiders their decision for allowing this experiment on the market.
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Re: Tysabri is a dangerous drug

Postby centenarian100 » Wed Mar 19, 2014 9:37 pm

Yeah...there are certainly more cases of PML than have actually been reported. You would think that the TOUCH program would capture most cases, but I'm sure there are some that never get reported, and biogen ultimately controls the numbers.

I don't particularly believe the numbers at ehealthme either, but that's besides the point.

If biogen were truly concerned about safety, they could limit the drug to individuals who are JCV Ab negative.

Angela's video is absolutely heartbreaking
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