Poor Genentech. The company is making the news frequently these days. And it?s not about new drug discoveries or other scientific breakthroughs that is earning the company such press, but rumors of the company being bought out, as well as the controversy that just won?t go away ? namely, the Lucentis versus Avastin argument.?
In case you?ve been asleep regarding macular degeneration treatment for the past few years, here?s a brief recap?
Avastin is a chemotherapeutic drug that works against colon cancer by shrinking the new blood supply feeding the tumor. It does this by working as an antibody against vascular endothelial growth factor, also known as VEGF.
Responsibly, Genentech thought that a similar mechanism would work against the new blood vessels in wet macular degeneration, but if the drug were to be injected directly into the eye, it would have to be a smaller molecule to be able to pass through the delicate retinal tissues.
Unlike Macugen before it, Lucentis really reversed wet macular degeneration, and the United States Food and Drug Administration approved it for that purpose.
The problem? Genentech priced each injection at $2000 U.S. Dollars per dose, and many patients with wet macular degeneration were found to need injections every one to two months.
Enter Phil Rosenfeld, a savvy fellow with a combined Ph.D. and M.D. from the world renowned Bascom Palmer Eye Institute in Miami, Florida. Phil wondered quite curiously whether Avastin, at only $40 per dose, might work as well as its more expensive cousin.
Although Dr. Rosenfeld?s subsequent discovery that Avastin was effective versus wet macular degeneration seems like a choice of simple math, it hasn?t proven to be that at all.
First of all, the FDA only approved Lucentis for AMD, not Avastin, If and when doctors want to use the latter medication, they have to inform their patients that it is an ?off-label? use.
Secondly, Genentech tried to block sales of Avastin to ophthalmologists in late 2007 and early 2008. Can you blame them? Doctors were using Avastin rather than the $2000 jewel that they spent the bank developing.? And Lucentis worked! So why shouldn?t they get rewarded?
The United States government, with a vested interest in the costs of health care, threatened a full senate investigation of the issue. Genentech backed down.
And here is where it has continued to get murkier?
Doctors have been losing money by the boatload when they use Lucentis. Why? Because healthcare in the United States, other than Medicare and Medicaid, is a private enterprise built for company profits. And health insurance companies try every trick they know to delay or deny payments to doctors for the expensive Lucentis so that they can show handsome profits to their shareholders. Even Medicare has proven to be a problematic payer over the past two years, inventing computer ?glitches? while they stockpile money to avoid going broke.
The end result is that ophthalmologists go into debt, having paid for Lucentis to treat their patients, but failing to get reimbursed by the insurance companies for their purchases.
One Long Island retinal specialist I recently spoke to said that her practice was $200,000 in debt.
So she, along with many other medical retinal specialists that I spoke with, did the only thing she could which was financially prudent.? She now uses only Avastin, off-label.
Before you start accusing eye doctors or the American medical system of forcing the use of an inferior ?generic? medication, the facts are that Avastin seems to work equally well, and may actually be superior to Lucentis for the treatment of wet macular degeneration. The battle is so close that no one less than the United States National Eye Institute is comparing the medications in a head-to-head study. The results won?t be known until 2010.
Of course, there are always new wrinkles in the argument. And Genentech must have been jumping for joy when discrete instances of ocular inflammation occurred in some western Canadian patients treated with Avastin. Not surprisingly, the information was rapidly spread by a myriad of news releases. But the quiet tagline on all the news releases was that Lucentis too causes internal eye inflammation in approximately 2% of patients.
I met Dr. Rosenfeld between bagels and coffee at the December 2008 Bascom Palmer Ocular Imaging conference.? Phil is a small and slender man with wire rimmed eyeglasses. He has a wry smile, a terse wit, and a brilliant understanding of the medical literature and political landscape, We had a long discussion about the Pandora?s Box that he opened, and where we think treatment of wet macular degeneration is heading this year.? We?ve had several communications since, and Phil has instructed me to see the editorial he wrote in the upcoming American Journal of Ophthalmology.
Paul Krawitz, M.D., President Vitamin Science Inc