I have a different spin on this, perhaps because I did some outcome research.
There is no question that there is experimental bias because researchers, being people, root for their hypotheses. In this case, because of the huge, and documented pressure for Imclone to market their drug, they thought that tumor shrinkage was sufficient for approval. Frankly, I think they are entirely correct given that people are dying of colorectal cancer and that no significant side effects were established. Remember the 60 Minutes program criticizing IMCL for witholding the drug to terminal pts.? IMO, the FDA may be killing people by witholding the drug. However, if the drug had significant side effects, I could understand their conservatism. So IMCL is motivated both by saving lives and by the good 'ol All-American profit motive.
Furthermore -- all shareholders, including me--had the option of selling our 20%. Because I thought the tender price was fair, I profited. Does that mean that I was guilty of inside information or fraud? Indeed, I though it unusual that management gave all shareholders the opportunity to tender rather than just themselves. My personal tender was based on the fact that 70 was a high price and I wanted to lock in some gains because of the reality that all new technologies are very risky. Now, everyone who states that the Waksals tendered does so by attributing malevolent motives to them. If true, I don't see it.
Furthermore, I think that BMY has one hell of a pair of balls to claim that they were deceived. HORSESHIT! They looked at the data and the protocol and it looked positive to them. As pointed out by a previous post, the FDA changed criteria and wanted more controls. Since my mother died of head and neck cancer, perhaps I'm responding personally, but I don't want others to die if the drug does indeed work. Certainly highly qualified people have testified that it does work, and as stated before, they unquestionably are subject to experimenter bias, but the question remains that the FDA can err by witholding a drug that saves lives or allowing a drug that doesn't do harm, but doesn't work. I think IMCL should rush to market, but that they should have justified the "refractory" diagnoses much better.
If Erbotux does work, how many people would be saved by the FDA? However, both as an investment, and as a life-saver, the only relevent question is the effectiveness of Erbotux.
fred |
