Oh.........sorry. I haven't been around here for quite a while, so I've missed quite a bit, I guess. The date on these said July 25th at the bottom, so I thought they were newly released. That's me, though.............a day late and a dollar short!
I had said one other time a while ago (regarding the combination of drugs clinical trial patients were allowed to take), or I should say "asked", "WHO was this person's head study doctor?" The head study physician (and the patient's regular neuro) also has something to say and has quite a bit of leeway in treating these clinical trial participants while they are in the trial. If I were an attorney, I'd bring in the head study doctors, also, as a defendant in the lawsuit.
Have things gotten a little bit "lax" or what? How many times have we
here on thisisms put two and two together and come up with very valid questions, ya know? If I were a physician, I would DEFINITELY say "hold the phone" as soon as I realized someone's white blood cell count was out of range, etc. etc. (Just like you did, Arron.)
God, that's scary!!
And this is pure pondering on my part, of course, but why would any person (like this poor woman) logically submit herself to taking such POTENT medication when she wasn't that bad? WAS she told exactly how potent each drug (Avonex and Tysabri) was ALONE, nevertheless the fact that this was combining the two. Whether it "worked" or not, it was still an extremely potent combo. Tysabri ALONE is a very strong immuno-suppressant. Not saying that is bad at all, but like I mentioned before months ago.............if you do NOT have any inflammation going on, you need to think twice, three, four times before taking any drug that messes with your immune system, nevertheless one that also subjects you to such a large margin of infection.
You know, immunosuppressants like Tysabri and Novantrone will not only possibly
sway your body to be much more susceptible for having the JC virus get out of control, but definitely
also leaves a person open for ANY infection to get out of control. Let's not forget that part.
Now, that's "ok" (if that's the word to use), IF a person knows that up front before they take the drug. And I don't mean just throwing percentages at someone, either. Open to infection means open to infection. ANY infection that your body would normally be able to resist or keep in check. And some infections (and we have many laying dormant in our systems, not just JC) are nasty devils, not to mention the contagious ones we might pick up just travelling around town!
Here's a comment from a medical expert (isn't this one of the men involved in the investigation above?) who says:
...."In the patients who received natalizumab and also had other medications such as Avonex, it's likely that the prevention of normal migration of the lymphocytes in the tissue allows the virus to replicate without being contained, and finds its way to the brain and causes the disease," said Dr. Kralnick, who co-authored an editorial accompanying the NEJM case reports.
"It is also not entirely ruled out that some people have the virus latent in the brain and in certain circumstances need to have the trafficking of lymphocytes to prevent the virus from reactivating within the brain." ....
I had posed this back in November about Tysabri:
...."The other possible problem, though, is the fact that it doesn't allow ANY T-cells to cross. Hence why it says that over time, the body switches to a mainly TH1 immune response. In MS, you want to keep your immune system predominantly TH2. Plus, this allows a HUGE margin for infection, etc. to run rampant should you ever pick something up.
My question also then is...........you DO want the "good" interleukines to do its work in MS (i.e. such as IL10, and other anti-inflammatory cytokines), so if you take Antegren as a monotherapy, how long WILL it take before it stops working? And especially since Antegren only works via ONE mechanism of action, where are the balancing mechanisms that you need to balance out what it's doing?" ....
Gee, was my concern valid, even back then? Even using Tysabri as a monotherapy. Are we CERTAIN that even using Tysabri as monotherapy might not eventually still result in the same risk? Take Novantrone for example. There is a limited amount of time you can even take it.
I wrote to the NMSS and my first neuro asking that same question above, and I couldn't get any medical "expert" back then to answer me. That frustrates me. How COULD any clinical trial patient be fully "informed" in order to give fully informed consent when their questions aren't even answered when asked?
I will never forget the answer I received when I was about to participate in a clinical trial comparing Copaxone with Betaseron with DOUBLE dose Betaseron. My question to my neuro/head study doc was: WHY are they testing a DOUBLE dose of Betaseron? The answer I got was not medical at all. The answer I got was this: "Well, it's just like chemotherapy. If a little is good, then more is better." How stupid is that for an answer? In other words, they are clearly simply working totally blind and possibly subjecting patients to extreme risk without providing enough information.
And the burden of being fully informed does NOT lie with the patient. It is on the side of the study sponsor and head study doctor. It is up to them (by law) to FULLY inform a patient of any and ALL possible risks. If I knew the possible risks, someone else MUST have! But no patient should have to dig for the information like I had to last November.
What an unfortunate nightmare!