Replies to post #48045 on Biotech Values

[poorgradstudent]

I do hope they get sued over this.

Any patient that entered a Telik trial after EOY 2006 has a serious case against the company.

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One more point that makes this a rather despicable story is IR's claim that they passed up the interim analyses that were designed into assist-1 and 2. Assist-2 made sense due to the competitive landscape, but there was little reason to pass up the interim analysis for assist-1. Given that they've proven they have no ethics, it's hard not to conclude that they did look at assist-1 and saw it inverted and probably started assist-3 pronto after that little surprise.

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As a general comment, I think the FDA needs to revamp the clinical trials process. There is nothing that I can think of that is proprietary in regards to clinical trial results. Since trials have to be approved by the FDA, the agency also needs to ensure that results are completely, transparently, and promptly disseminated to the public. I just see no reason why a company should be allowed to sit on the primary safety and efficacy endpoints of a trial.

This transparency would also expose frauds like Telik for what they are. If there was an interim analysis for assist-1, then the FDA knows and should hold a sponsor's feet to the fire. Otherwise, the agency becomes complicit by neglect.

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Finally (!)

For those who want the drug approval process to be governed by the theory that drugs should get on the market so that patients have unhindered choices... that only applies if there is outright transparency with regards to the data. Unfortunately, desperate patients will take anything, so the only thing saving them from abuse would be the ethics of management (!).