I agree with you that the critical issue is whether IMCL adequately addressed the issue of whether the experimental pts. were refractory to the existing treatment protocol -- the standard. If this was not done, and IMCL admitted poor documentation, it must be done. I have no problem that Erbotux potentiates other chemotherapies, and may be ineffective alone. If giving Erbotux in combinations has an incremental clinical effect, IMO, that is sufficient -- if demonstrated by a valid experimental design.
However, I do see the pressure on IMCL to get a drug to market that both saves lives and makes money. However, that claim must, as you indicate, be empirically documented.
Nevertheless, every article about the Waksul's tendering their shares attributes malevolence to them. The tender was quite open to all shareholders and was handled above-board. The articles I read, particularly in the NY Times had an interesting format. The first 2/3rds of the articles excoriated the Waksuls and the remainder gave somewhat positive interpretations. When the press smells blood, it becomes a feeding frenzy.
I would like to see someone with direct clinical experience to comment on the efficacy of Erbotux. I do remember the red-headed CNBC commentator claim, abt a yr ago, he knew someone saved by the drug.
fred |
