Drugs firm blocks cheap blindness cure
Company will only seek licence for medicine that costs 100 times more
Sarah Boseley, health editor
Saturday June 17, 2006
A major drug company is blocking access to a medicine that is cheaply and effectively saving thousands of people from going blind because it wants to launch a more expensive product on the market.
Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin [link added] into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients.
But Genentech [link added], the company that invented Avastin, does not want it used in this way. Instead it is applying to license a fragment of Avastin, called Lucentis, which is packaged in the tiny quantities suitable for eyes at a higher cost. Speculation in the US suggests it could cost £1,000 per dose instead of less than £10. The company says Lucentis [link added] is specifically designed for eyes, with modifications over Avastin, and has been through 10 years of testing to prove it is safe....
Sometimes, reports such as this are exaggerated. I just saw this, and have not looked into any more than just reading the news article. But it appears to convey a valid, serious, concern.
Comments
Not to excuse this behavior (for example Genentech recently ratcheted up the cost of Avastin for cancer patients so much that even oncologists started taking it to task), the writer of the article didn't define what "considerable success" meant in the 7,000 patients supposedly treated this way. Worse, there's not even a single retrospective study as far as I can tell, much less anecdotal work. In other words, it's by no means a slam dunk that Avastin is as wonderful as this article makes it seem. As one the investigator for one recently reported trial stated:
In other words, it's not at all clear how much the anatomic improvements noted result in improvements in visual acuity.
If Avastin is as effective in slowing macular degeneration as these preliminary results suggest, it wouldn't take a very large or very prolonged randomized trial to show its value. That trial should be done.
Posted by: Orac | June 17, 2006 9:53 AM
Physicians are free to prescribe Avastin for any off-label indication supported by the clinical literature. However, whether one's insurance company reimburses you or the doc for the off-label use is another question entirely.
My guess would be that Genentech is not entirely trying to be a profiteer, although this does smell bad on the surface. Unlike small organic molecules, there would be a concern about the stability of reconstituted Avastin that is then split and used for multiple patients - the protein can unfold over time and be a potential hazard if injected in this form.
Posted by: Abel Pharmboy | June 17, 2006 10:22 PM
Tried to comment before and it never showed up.
Abel's point is well-taken. Avastin is a humanized mouse monoclonal antibody against VEGF. I do not know what preservative is in it. Splitting a vial is a good way of increasing the risk of bacterial contamination, and injecting bacteria into the eye is something that you don't want to do.
Let's also remember that this is all based on anecdotal evidence and small patient series, as well, with a large component of a bandwagon effect thrown in for good measure. While there is evidence that Avastin can slow the anatomical changes that occur in macular degeneration, unfortunately the evidence that it has much effect on the thing that really matters, namely visual acuity, is not as strong. In the end, if it doesn't save visual acuity, then it doesn't really do what the patient really wants it to do.
If Avastin is as potent as these opthamologists claim, it wouldn't take a very large randomized trial to show it.
Posted by: Orac | June 18, 2006 9:24 AM
In retrospect I see I was a little hasty posting this without putting more thought into it. Obviously, the ideal thing in this situation is to have single-dose vials, and to have at least two good placebo-controlled randomized trials with improved visual acuity as the endpoint.
On the other hand, even if it does not improve acuity, but halts (or even slows) progression, that might be good enough to justify an NDA.
Posted by: Joseph j7uy5
| June 18, 2006 4:22 PM