Biotech Values

[gofishmarko]

DNDN --- Warning : Myriad Posting Alert

>> The FDA already has trouble enforcing post-marketing trials, and if we leave it to big pharma, they're going to work at a snail's pace, and game their trials <<

This is what big pharma does right now with surrogate markers--- in early studies they look for indications and surrogate markers where they can reliably demonstrate a benefit , which is much easier and cheaper than if they're limited to looking at markers of real clinical benefit. It's front-end data-mining. They know they'll make big bucks after approval regardless of how the confirmatory trial comes out , assuming it's even done in the first place. The FDA is a strict arbiter of a travesty.

For anyone who has stayed awake thru a biochem lecture or two , the following will be obvious , but others may benefit by giving it some thought :

Every biological process or pathway is , directly or indirectly , related to every other , and to Kevin Bacon. For any marker of disease , say tumor volume , there are many , many pathways , with many intermediates in each , that might provide a target for a drug to effect shrinkage of that tumor. The problem is , because of the interconnectedness , that drug-induced tumor shrinkage can be accompanied by an earlier requirement for funeral arrangements. For each drug , you're never sure about the real benefit of surrogate marker effects until you confirm that benefit in controlled trials.

Everyone readily accepts HCV viral load as a surrogate for clinical benefit , but , as Thomas said , it's not so clear-cut. Many people live for years , even decades , with HCV without even knowing. They know immediately when they've been dosed with interferon plus ribavirin , and they wonder if HCV is really so bad after all. When they get ifn-induced autoimmune disease they really begin to wonder. We may be nearing the time when HCV nonresponders will go on lifelong anti-HCV therapy. That will be another travesty if there is not convincing evidence that there is a clinical benefit to doing so , for each new approach. If a trial is done showing that new HCV drug "A" is not as effective in suppressing virus long-term as new drug "B" , but that it improves survival ( not an endpoint , it was noted as "dropout due to death" ) compared to "B" or to no treatment , the FDA will grant full approval to "B" and will tell the makers of "A" to find a drug that suppresses virus better. Sorry , but that's just nuts.