ELN/BIIB made the decision to suspend, temporarily, as a result of the litigeous envoronment the FDA and Pharm industry is in as a result of the pathetic legal system run amok. The Vioxx situation, $20bil in lawsuits that will take years and God knows how much to settle, is ridiculous. I have yet to meet a physician that didn't think Vioxx was a wonderful drug(it's coming back on the mkt). 14 cases are now preventing hundreds of thousands from gaining relief from Vioxx. Now we have two EXTREMELY unique cases keeping 400,000+USA MS sufferers from living a decent life. Thanks scumbag legal community, I hope your dollar grabbing is worth it as YOU will have YOUR day of reckoning! The monotherapy data is nothing short of TREMENDOUS (MS, RA, Crohns). Many years and thousands of patients and dosings and not so much as an adverse event! Deutshe bank called Tysabri's approval the "drug breakthrough of the decade"! It has been nothing short of a miracle for the MS patients on it. Two patients in combo therapy develop the extremely rare PML. 9 of 10, yes 90% of PML patients have full blown AIDS. It affects 5% of the AIDS population and is often sighted as official cause of death. In a conversation w/ a neurologist, he said, "we didn't even know about PML until the AIDS epidemic"! These patients were worsening on Avonex which caused them to be put into combo therapy. they were taking MASSIVE doses of steroids along w/ several other drugs to combat an assortment of other ailments. Sounds like AIDS to me folks! 1st, there is still NO direct link whatsoever to Tysabri! The steroids suppress your immune system and could've caused this. AIDS could've caused this. Because they are VERY similar diseases, they could've already had PML. The 'numerous' other drugs could've caused this or yes, the combo is possible. Any or all of the above could be the culprit. Remember, NOT even one adverse event in all the years and thousands of dosings in the monotherapies! That's solid folks, and very rare when developing a new drug such as this mono clonal antibodie, Tysabri. I spoke w/ a friend who passionately tells me Tysabri gave him his wife back. two years ago he thought she would be better off dying. Now, he is VERY ANGRY, his wife is terrified she won't get the drug back. She can barely talk about it! THAT is the CRIME SCUMBAG, $ grabbing , Moral-less, ambulance chasing atty's!!! I hope it's worth it because, you're KILLING the very people you claim to be helping! YOU're ONLY helping YOURSELVES! SCUM! 400,000+ US MS sufferers can make a lot of noise! SCREAM TO THE TOP OF YOUR LUNGS! call your CONGRESSMAN! YOU, MS patients have rights too! YOU are entitled to a decent quality of life! A statistically INSIGNIFICANT number of "questionable adverse events, 2" has taken these peoples lives away. Th analyst whores have lowered their peak sales numbers. THAT is a joke, whores!nothing but after the fact CYA! These people are SO DESPERATE, they will do anything to get a decent life and they are screaming to get Tysabri back even wanting to sign waivers! The physicians I've talked to, because of the UNDENIABLE safety and efficacy of the monotherapy laugh at the notion patients and neurologists won't use as much Tysabri w/ it's EMINENT return to mkt! My bet, after 10-15% of the patient reviews, an adequate sampleset, ELN/BIIB/FDA could very well allow the continuation of the monotherapy trials. ELN could double at that point. The all important 2 year data will be presented at a Neurological gathering the 2nd week in April. The companies are in daily contact w/ these neurologists and have provided some 2 year data to them. they are saying it's QUITE promising! If so, and I have no reason to doubt, you could almost double again! It is time to allow the free people of the world to make their own, adult decisions. The data shows irrefutably, that Tysabri works and works safely and twice as good as the next best therapy.
A good friend of mine lost a brother to MS a year ago, his last few years were horrible, I can not help but think that Tysabri would of brought some kind of improvement, not only to him but to many. The demonstration of humanity of late in this country is baffling, shorts praying many more die for their profit, so many being denied therapy due to perceived fear of law suits, I fully concur wildwillie so few keep so many from a decent life. One last thing, was not it an attorney over at Biogen who sold his options prior to public release of suspension, and subsequent firing?, and then made a public comment "I did nothing wrong".
Tysabri and every other fixative from hot packs to aspirin hurts somebody in the multitude of people treated. Hot packs burn, and aspirin creates ulcers.
So what? What happened to the good of the many outweighing the one? In this case 2998 to 2, and those two might have adjunctive reasons that have nothing or little to do with Tysabri effects.
What a great victory for the marketplace, to smother efficacy and life preserving therapy!
Not everything is solved by the marketplace. The marketplace has no morality or sense of right and wrong.
But we do, so let your voice be heard to every Congressman and Senator in the land.
wildwillie, I believe it's been established that both PML pts. were HIV-. Pretty sure I've read that on this board.
But I agree wholeheartedly with everything you said about dirtbag lawyers who keep innocent patients from getting good, effective drugs they need. It's an abomination. If they understand what they're doing, they're more evil than those who rob with a gun and shoot a mere one or two persons. They're bringing about death and unspeakable suffering for many. It would take more integrity to rob banks.
According to the neurologists I've spoken w/ there has not been a confirmation of AIDS in the two patients. in fact, they said if that was the case, it could very well exonerate Tysabri. That's just what I was told and I haven't read any concrete confirmation that would suggest otherwise. privacy issues and perhaps the ridiculous AIDS stigma. the post that got my attention was the one suggesting both patients were at the same hospital. Now THAT could be significant. they might have been mis diagnosed or any other number of things. Appreciate your response. i have a lot riding on this one. best of luck.
My mother had M.S. and passed 8 years ago after spending the last 7 years of her life in a nursing home. The majority of that time was spent in a bed. Just how effective is Monotherapy for M.S. patients? I am asking a general question here not trying to make a buy or sell point.Does Tsabri help patients regain some function or just stabilize their condition? TIA
The friends wife I mentioned would have been better off dying, sccording to my friend, prior to being put in the monotherapy trials. he said the drug gave him his wife back. It saved her life. She's funtioning and is scared to death she won't get the drug back. if you know of a group or groups of MS patients, they need to organize. They need to contact their Congressmen and demand they have the right to choose. It improved my friends quality of life to such a degree he said i have a relationship w/ my wife again. Cry out as loud as you can. I wish you nothing but the best. Bless you and good luck.