"The patient had received 8 doses of TYSABRI over an 18 month period and prior medication history included multiple courses of immunosuppressant agents."
What else is new? How the *^**% do you test a drug as a single point success with multiple drug interaction scenarios?
"and prior medication history included multiple courses of immunosuppressant agents."
How long ago were they??
That was obviously thrown in to raise the possibility of those agents having some action on the PML even though they screened everyone before they were enrolled in the study for suppressed immune systems.
What are they setting the shareholders up for now? "Tysabri is safe as long as the doctor is sure the patient has NEVER taken any immunosuppressant agents." Isn't Avonex an immunosuppressant agent?
Well, I'm probably not the best one to answer this question because I have never had any side effects on the Betaseron, only some site reactions, but none of the flu like symptoms or depression that some folks experience.
Tysabri is shown to reduce exacerbations by 66 percent. CRABs (copaxone, rebif, avonex, and betaseron) reduce exacerbations by 33 percent.
Those numbers are means or averages. Some people will have more relief than the 33 percent with an interferon, some less. Some people will have more than the 66 percent relief with the Tysabri, but some less.
That aside, let's just talk about steroid treatment, or how did you refer to it, "a fix."
Put yourself in an MS patient's place .
Now, you are supporting a family, or at least contributing to the family income. Your MS flares, which is more than likely, because even Tysabri doesn't reduce all exacerbations.
You lose the ability to stand, you have to go from getting up and going to work to staying in bed, getting assistance to get to the bathroom, in and out of the shower, etc.
You obviously can't go to work, you can't even drive. MS is such a variable thing, this flare might be over in a week, but on the other hand, it might take a month to six weeks for it to remit, maybe longer.
So you take some sick leave, sit around for a week or so, and still no leg power. (some research and some neuros believe that without steroids the damage from an exacerbation is greater, I, personally haven't seen anything to convince me of that).
But now you're out of sick time, and you start to use your vacation time. You could go on short term disability, but that's only partial salary.
If you call your neuro, he'll recommend steroid treatment. And if you get in home infusion of solumedrol for 5 days, you're more than likely to be back on your feet in no time.
Do you do it? Can you still call it a "fix" when it is a recognized treatment that will restore your ability to function?
You make the call, what would you do?
This is the decision that Ms patients will be facing if Tysabri is returned to market with a warning not to use with a steroid.
But if T reduced exacerbations because it allowed nerves to heal, wouldn't you rather heal and work thru no steroidal assistance in the hope of improved function and reduced exacerbation incidence? I have been reading posts from folks that really get sick on interferon.
Or is it interferon is working, and--or--the steroidal fix too much of a lure?
Be honest. This is a hard one.
We don't care whether we cure the rats and mice.
Thats why we say clinical study and not experiment.
No clinical study will ever be perfect. Even the best mono study will have variable past histories and medicines, genetic backgrounds, astrologic signs, etc.
These results confirm that TY should be a stand alone treatment and perhaps given to naive (free of any immunosuppression, etc) patients only. The results are consistant with the other 2 cases.....a bad combination that has a theoretical basis behind it. This like so many other drugs (alcohol and tylenol...aspirin in children -> Reyes Syndrome and so forth) have contraindications.
What makes me think that this is the last negative result (I hope) is that they are reviewing deceased cases - as one would expect, but only after all enrolled patients have been reviewed. One would think that if any new cases of PML amongst the living were present, something would have been said by now.
I sincerely believe that TY will return in a limited role and will need to be nursed along to find its potential. This medication is prescribed by specialists who are a little more in tune with the perils of therapy of auto immune diseases.
We don't care whether we cure the rats and mice. Thats why we say clinical study and not experiment. No clinical study will ever be perfect. Even the best mono study will have variable past histories and medicines, genetic backgrounds, astrologic signs, etc
No good, neuro. It is a black and white experiment to the stockholder, because that is what is expected of the scientists. You pick your control group to try to measure the efficacy of as close to one variable as possible.
You can make a second control group with as many therapies and alternative remedial modalities as you like, but the center of mass ought to do the job of as close to one variable as can be managed.
This type of testing "once it is dirty, it might as well be filthy" "in for a dime in for a dollar" is excuse laden and misapplied logic at the most basic level, otherwise NOTHING is going to get a go ahead, and we're stuck with crap science. If that isn't the way it is done, than that is the way it should be done.
All the rest of those factors you mentioned are drivel or uncontrollable and unavoidables.
You might as well include palsied people as nuclear disarmers,--sorry, the sloppiness of the control group's collected histories and separate modalities makes this one huge risk factor.
You can't get toothpaste thru trials like this--if you are measuring the efficacy on those from the Ozark Mountains and three rotting teeth left.
Sorry, it won't wash