I have 25 articles on this controversy, as well as several updates on the CATT Study, sponsored by the NIH/NEI that is in the process of comparing the two drugs for treating the wet stage of age-related macular degeneration.

For easy access to the articles, just print “menu” into the search box in the upper left hand corner of the home page and all of the menus containing the articles will show up.

Irv Arons

Williams also identified the 2006 FDA warning letter to the compounding pharmacy in question (the New England Compounding Pharmacy), although the link has succumbed to linkrot, as the FDA now apparently only keeps two years of the letters on the Web. (Which is stupid in its own right.) According to his account, the letter wasn’t primarily about Avastin, which was mentioned fourth in a list of concerns.

Genentech’s explanations for its treatment of Avastin here still don’t make sense, particularly in light of the FDA correspondence leaked by Kohl’s office (which still isn’t available on the Web so far as I can tell). Coupled with its refusal to participate in the head-to-head NEI trial, which of course pushes up the cost to the federal government, it looks very much like the company is fighting a rearguard action to put up as many obstacles to ocular use of Avastin as possible.

I’ve written more here.

While the company is no longer selling to compounding pharmacies there is nothing to stop doctors from buying the drug and making an arrangement with a compounding pharmacy. This would be off-label use.

And, again - I don’t think Genentech is right to charge Lucentis 40x what Avastin costs for the same treatment.

You are mistaken in this case.

They have absolutely no incentive to promote the off-label use of Avastin in direct competition with their own Lucentis product.

The two compounds are closely related, so a fraction of a vial of Avastin can be used instead of a much costlier dose of Lucentis.

There is a big difference between off-label use and *promotion* of off-label use.

And I don’t know what Senator Kohl is thinking - is he berating the company for not breaking the law? Not that I think Genentech is wholly innocent - they’ve obviously got the $$$ in their eyes.

The criticism is not about off-label promotion. It’s about an attempt to limit legitimate off-label use of one product in order to stimulate demand for a vastly more expensive, yet very similar product.

Issue #1: Avastin has never been studied for ophth use, so there is no data on efficacy or safety or dosage or AEs or anything. So not sure how anyone can be expecting the company to promote it for that use. If they di, I am sure they would have the feds at the door in no time.

Issue #2: As I understand it, compounding pharmacies have been taking vials of Avastin and taking little bits and putting into other vials to sell to ophthalmologists who inject the product off-label. The report posted by Ed seems to indicate that people are worried about having a product not tested in the eyes used there.

Can’t have it both ways: criticize companies for promoting off-label and at the same time criticizing companies for not promoting off label.

The statements above are a bit confusing as I thought the rationale for not having Avastin for off-label use was because loss of several lots created a “shortage” so restricted distribution availability.

Biopharmaceuticals are expensive. Genentech’s drug Avastin for cancer costs 100,000 a year, as well as for off label macular degeneration, with minimal benefit. Avastin for the eye disease is from 100 to 200 dollars a dose. Thier newer Lucentis, that is very similiar to Avastin, is being charged about ten times the price of Avastin.

Biotechs in general need to justify thier cost. With cancer biotech therapies, they generally extend life by only a few months for cancer pts and are used with chemotherapy.

I’m not sure it is worth that amount of money for such minimal benefit.