IT SHOULD BE OUR CHOICE TO TAKE IT OR NOT.
I totally agree with you..but....in order for a person to make an informed decision, he/she must be given the proper data and information to do so. And there lies the problem for Tysabri.
Up until PML showed up, Tysabri "appeared" to be relatively safe. The drug was approved on one year data from 2 of 99 world wide trials going on at the time. The FDA wasn't totally convinced and one condition of approval was that Biogen/Elan had to complete the Phase III trials and submit that data and safety information to continue the approval.
But what happens...2 MS patients come down with PML. And Biogen/Elan sure knew about the sepsis patients that died. So they had no choice but to "voluntarily" pull Tysabri and step back to see what happened and try and figure things out. By that time, some 5000 general population patients had started on Tysabri and they were left hanging as well.
Now let's speculate on what may have happened if Biogen/Elan had waited to complete their Phase III trials at the end of December, 2004. It would have taken them until approx April,2005 to collect all the trial data and submit it to the FDA approval process. But 1/2 way through that period, the PML patients would have been discovered. I suppose it's impossible to know how the FDA would have reacted to that information while they were about to consider the approval. You can bet that Biogen/Elan would have scrambled and done everything possible to minimize those PML events and presented a much different approval request. But at least there wouldn't have 5000 patients that started then had to stop receiving the drug. And when the drug likely would have approved down the line, MS patients and docs would have had the information available to them to make that important choice.
All very speculative but interesting, to say the least.