As more and more cases of central nervous system viruses in those treated with Tysabri are documented, it's important to go back in time and note that one of the creators of this drug, Dr. Lawrence Steinman, realized the potential dangers of this treatment and warned the FDA not to approve it.
From a press release in 2006--Stanford Doctors Spotlight Fatal Flaw in MS Drug Trial
Steinman was involved early on in the development of the drug, publishing on its effects in 1992. Even then, he had suspicions that the drug’s mechanism of action — blocking the entry of immune cells into the nervous system — might also make patients more vulnerable to infections. Indeed, PML is an infection that usually affects people whose immune systems are compromised.
“It was a shocking development that a drug that had so much promise and so many potential benefits ended up causing two deaths and one very serious injury,” said Steinman. “It is kind of a cruel Greek drama, something that may be more beneficial than anything yet developed for multiple sclerosis, but yet may be far more dangerous than those other approved drugs.”
In fact, the inventor and co-author warned about Tysabri returning to the market in 2006. They questioned the wisdom of the FDA's approval of this drug.
But Steinman and Langer-Gould expressed reservations about the drug returning to the market. They noted that its effects, while impressive, are in general not much better than what is seen with other available drugs: The risk of relapse dropped from an average of two relapses every three years using other approved multiple sclerosis drugs to one every three years with Tysabri.
“Do you want to expose someone to the risk of death for eliminating one relapse every three years?” said Steinman. “I say no.”
“I’m not sure if it is wise to re-approve it,” added Langer-Gould. “The question is, will the FDA rise to the occasion and admit their mistake and try to prevent future mistakes or are they going to ignore it?”
link to press release
Here is an interview with Stanford neurologist Annette Langer-Gould, co-author of the Lancet paper on Tysabri, about why she spoke up after her patient developed PML in a clinical trial---the title is "So Not Worth It."
Profoundly affected by her experience with this patient, Langer-Gould, a Stanford clinical instructor, now advocates testing new drugs only on people who have exhausted their other treatment options and who have indications that their disease is progressing.
So in March, when an FDA advisory committee recommended that the drug be returned to the market, she took action. She approached multiple sclerosis specialist Lawrence Steinman, MD, a Stanford neurology professor, about writing an article arguing that if a drug has a known risk of death, it should be given only to those patients who are likely to suffer severe disability from their disease. That is almost the reverse of what happened in the Tysabri trials, which excluded the most severely affected patients.
(note: drugs are tested on RRMS patients, rather than progressive patients, because they have natural remissions, and this favorably affects the drugs' results. This is the "natural course of the disease" argument used against positive reults for venoplasty for CCSVI--yet not against drugs.)
link
Sadly, history has shown us, the FDA ignored these warnings about Tysabri. And deaths and injury from central nervous system PML, herpes encephalitis, CNS lymphoma, metastic melanoma and other assaults on unwitting PwMS continue daily. It is not enough to know your JC virus status. We are only at the tip of the iceberg understanding the long-term implications of this drug.
At Jeff's yearly neurologist appointment (which he needs to continue his copaxone treatment), his doctor again tried to talk him into beginning Tysabri infusions. Even though Jeff has no active inflammation, no new lesions, no new MS progression, and has only healing since venoplasty three years ago, with normal gray matter on MRI---his neurologist utilized scare tactics to make him doubtful about his future.
"You are a man, you are bound to progress faster. It's simply the facts. Tysabri is the best medication we have. You should start it now to prevent future damage"
Jeff said, thanks, but no thanks.
In light of this sales pitch, the continuing and growing numbers of those with PML (242 with the disease, 52 deaths as of May) , and Marie's post on the neurological activation of the herpes virus in the brain of someone on Tysabri---I think we need to go back and document the history of this drug. I suggested to Jeff that he print out Steinman and Langer-Gould's warning and bring it to his neuro next year. I hope this information might help some of our readers. Please share it with your friends and caution them.
Because the inventor of Tysabri thinks it's too risky for you to take it. He would know.
Joan
Annette Langer-Gould and Lawrence Steinman question why a clinical trial for a multiple sclerosis drug used subjects who had no active symptoms of the disease, putting their lives at risk for little immediate benefit.
http://www.facebook.com/notes/ccsvi-in-multiple-sclerosis/tysabri-drug-creator-warned-fda-of-fatal-flaw/10150921616067211