I reached one of the most important decisions in my MS today. As Mom was driving to the neurologist's office this afternoon, I opened up about how I felt on continuing with the Tysabri. Dad couldn't accompany us as he was waiting for some workers to finally show up at their house to work on their swimming pool, so it was just us two girls.
I've never been completely comfortable with this treatment and Mom is fully aware of this, as is Dr. Short. I will confess that one of my main incentives for continuing with Tysabri has been a less than noble one. I learned after the first infusion that a private insurance policy I have, called Hospital Income, would pay me $100 each time I underwent treatment. I've had this policy for many years and it has come in handy whenever I've been hospitalized with MS problems or for anything else but I hadn't even considered being paid for the Tysabri! Being as broke as I am, $100 extra in my account was a large amount and allowed me to pay for, at least, my Jinger's monthly hyperthyroid medication. When I mentioned this to my mom on the way to my appointment, she was visibly shocked. She had absolutely no idea that this was why I had chosen to continue with a questionable treatment I was really not in favor of being on. The way my mom is, she didn't tell me to stop taking it immediately as this was a ridiculous reason to stay on it, but said that I needed to really think about what I thought was best before continuing with it.
When I was called in to see Dr. Short, we talked for a few minutes and I mentioned how I wished he had brought up the TENS unit a while back as it has been helping me quite a bit and has lowered my pain from an 8.5 or 10 down to a 7 on most days. That's quite a bit of improvement as I can function much better now. I then spoke with Dr. Short about the Tysabri. He wasn't surprised at my apprehension to continue but then I mentioned how one of the inventors of Tysabri had been opposed to the FDA approving it. This in itself should make ANYONE apprehensive to take it or recommend it! But it wasn't even just this that led me to my decision. I have know that Tysabri can lead to the deadly PML virus (lethal brain infection) but I'm at a point in my life where I am at peace with myself and my MS. If Tysabri had been available 15 or 20 years ago, death would not have deterred me from taking it but I am not that same person anymore. I have too much to live for! I have my wonderful, kind, loving parents. I simply adore my three little kitty daughters and can't imagine a day without them. I love my brothers. I love my extended family, even though I am not able to see them, but I know they are there and know they love me, too. I love all my friends! Life is good! Why would I want to risk my life over a medication that may or may not help me when I am only slightly disabled compared to how horrible it really could be? I would rather take my chances with the MS and face it head on than hide behind a drug that could potentially make me worse or kill me. I'm worth more than that. So all this being said, I did not continue with my scheduled infusion and will not receive any more treatments.
I'm including the article I read, which helped me reach my final decision.. although I believe I would have come to this conclusion in the end.
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?”
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.
Her biggest concern is that some patients who want to take drugs such as Tysabri might be acting on unrealistic fears about their prognosis and are poorly informed about the drug’s dangers.
(note: drugs are tested on RRMS patients, rather than progressive patients, because pharma knows these patients have natural remissions, and this favorably effects the drugs' results. This is the "natural course of the disease" argument used against positive results for venoplasty for CCSVI--yet not against drugs.)
Sadly, history has shown us, the FDA ignored these warnings about Tysabri. As a matter of fact, they approved Tysabri by a vote of 12-0. At the time, it was said that Tysabri "waltzed through FDA approval." The independence of the FDA panel was called into question by the legal team of one of the patients who died.
According to a New York Times article in March 2005-
Dr. Steinman said he had expressed his apprehensions about the drug in speeches and in an article in the journal Science in July and had been asked by Biogen executives to tone down criticism of the drug.
And just this January, the FDA granted a label modification with a more specific warning for Tysabri, so that it can continue to be sold- making Tysabri a "blockbuster" drug.
The Food and Drug Administration approved the revision that would help doctors identify patients with the highest and lowest risks of developing deadly brain infections linked to the drug, the agency said today in a statement.
The label change may push Tysabri’s global sales to $2.5 billion to $3 billion by 2016, Michael Yee, an analyst at RBC Capital Markets in San Francisco, said in an interview yesterday. Without the modification, sales may have reached $1.5 billion to $2 billion that year, Yee said. Biogen, based in Weston, Massachusetts, and Dublin-based Elan split the drug’s revenue.
And deaths and injury from central nervous system PML, herpes encephalitis, CNS lymphoma, metastic melanoma, cryptococcal meningitis 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. Most of these neurologic infections do not show up until after two years of therapy.
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.
