Biotech Values

[Biowatch]

>Companies could theoretically get sued or have liability esp if they're actively promoting off label. But this is a rare case where the drug company has a large disincentive to encourage an off label use.<

Yes, the company has ZERO financial incentive to promote Avastin for off-label use in AMD. Correct me if I am wrong, but doctors rarely get sued for off label use of a drug, as an individual doctor doesn't have the deep pockets of a company.

A particular doctor might be subject to liability for eye infections if they didn't store the Avastin properly, as one vial is suitable for use in multiple patients for a two week period after it is used initially. One infection that might occur even if a vial was only used once might be blamed on improper storage or mishandling.

Then again, given that this was an eye disease that led to legal blindness a few years ago, it is nice to have several treatments available to slow or even reverse the problem.

The claim that:
Since a single cancer infusion of Avastin contains a large volume of the drug, breaking that same dose down into the small aliquots needed for the eye injections is literally pennies on the dollar, making the government's study of it -- when it was clearly not designed for eye treatments -- a matter of cost containment. Surely if Avastin ends up harming those eyes -- a plausible consequence of this off-label, if not illegally "compounded" use -- it won't be Uncle Sam on the hook with product liability lawyers, but Genentech.

raises the question of why Avastin is so much cheaper to produce on the scale needed to treat AMD, and why it couldn't be packaged in smaller single use vials for AMD thus eliminating the "compounding" issues.

Yes, Avastin is a smaller protein, thus potentially slightly more capable of crossing the retinal-blood barrier, but the chance of it getting into the bloodstream in sufficient quantity to do harm elsewhere is almost nil, in my humble opinion.