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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Ian@SI who wrote (16863)5/19/2005 4:42:24 PM
From: Clarksterh  Read Replies (1) | Respond to of 52153
 
Sadly the WSJ editorials on the drug approval process leave a lot to be desired IMO. If you look at some from, say, more than 5 years ago they promulgate drugs that eventually are shown not to work is any substantive way. Today's editorial continues in the same vein. The sad thing is that I agree with a lot of it, but then they shoot themselves in the foot. Most egregious is:

One way Congress could fight back would be with a law ending the moral travesty of placebo-controlled drug trials for terminal diseases.

???? Has this guy ever tried to predict which cancer drugs would be successful in a phase iii based upon historical comparisons? Apparently not! And especially ironic is that he is espousing this view for mild improvements in efficacy - which will never ever be reliably seen in a historical comparison. I guarantee more people will shorten their lives taking the snake oil that comes with no controlled trials than are dying now due to the time it takes to run a controlled trial.

On a somewhat more controversial note:

True, Iressa helps only about 10% of patients. But those who respond to it respond massively. "I've had patients who have gone from being on oxygen to skiing at altitude," says one doctor of the drug. Genetic tests are being developed to better predict who will respond to Iressa. Yet Dr. Pazdur seems to regard the FDA's Iressa approval in 2003 as an instance of the drug industry getting away with one. Incredible.

Is there any hard data about 'the 10%'? If not it should be easy to show with a landmark comparison of, say, 24 month survival. If there is, then I agree that the FDA should approve, but if not then people are deluding themselves. Snake oil. (BTW - to expand a little and FWIW, I agree that people should be able to buy snake oil if they so desire, but insurance (me) shouldn't have to pay for it and it should be appropriately labeled as having failed in controlled trials.)

Clark