Over the last several months, since late May actually, I have been confronted by a challenging conundrum affecting a critical factor in my well-being: my eyesight. I am blessed to have access to a new miracle drug thanks to the biotech industry. At the same time I have gotten a glimpse of few inches of the underbelly of the pharmaceutical industry, and how decisions are made about what treatments are covered by insurance, or not. Interestingly in this case, I believe that even the insurance companies are getting screwed, as hard as it may be for some of us here to believe that.
This is a story about a miraculous but very expensive drug, Lucentis, manufactured by Genentech, about the advantages of having health insurance, about a celebration of still having vision in my left eye... and
About a question, not to be answered conclusively in this diary, about whether or not Genentech is preventing the use of another drug it makes, Avastin, which many doctors say works as well as Lucentis, but cost perhaps one-thirtieth as much per dose as Lucentis.
Good News/Bad News Summary
The bad news is: Having known that I was at relatively high risk of developing macular degeneration, I suddenly developed the wet form of macular degeneration in late May. Up until quite recently, there was not much that could be done for this condition, and I would have lost vision in that eye very quickly, probably 100% eventually.
The good news is: There is a drug that has been on the market for about three years, which stops the progression of this disease in 90% of cases, and in 30% actually reverses the disease and improves vision compared to the point at which treatment started.
The bad news is: The drug has to be injected directly into the eyeball monthly for at least several months. The manufacturer says monthly for two years. My doctor recommended stopping after 8 shots.
The good news is: The experience of getting a shot in the eye is not that bad, not as scary as you’d think, incredibly uncomfortable and irritating at first, but the worst of it is over about an hour after the shot. Considering blindness as the alternative, and the fact that I got to take a whole day off from work each time, I decided to say that I, um, enjoyed, shot days, sorta...
The bad news is: The shots cost about $3000 a pop, plus the fees of the highly skilled retina specialist and his technicians, which amounts to anywhere from $300 to $700 a visit depending on whether they are taking angiogram pics inside my eye that day.
The good news is: I have a job with benefits and a generous health plan, and these treatments are covered with only minor co-pays on my part.
The great news is: The deterioration in vision in my left eye, which had progressed very quickly in the ten days or so between when I noticed something and the first injection, stopped. It stopped getting worse the weekend after the first shot. And then, four days later, over the course of a half day, it improved dramatically, and improved incrementally some more in the ensuing months. So not only am I one of the 90%, I’m one of the 30%! I have nothing but praise for the retina specialist and his staff. With some ambivalence and qualifications, as explained further on, I have nothing but praise for the scientists and researchers in the biotech industry who developed this new miracle drug.
The bad but it could definitely be worse news: Most people who are successfully treated for wet macular degeneration will "fall off the wagon" at some point, have a reoccurrence, and need another series of injections.
The "interesting" news: The same company that manufactures Lucentis also manufactures a drug called Avastin. Avastin was developed to treat something else entirely: colon cancer. But many are reporting results that match Lucentis, when Avastin is broken down into much smaller doses and injected.
What’s the problem? The problem is that Genentech refuse to seek FDA approval for Avastin to be injected into the eye. Without FDA approval, health insurance companies will not cover such an "off label" use of a drug. So, if you have health insurance like I do, no problem. If you don’t and can’t possibly afford Lucentis at $3000-$4000 a pop, some doctors will offer to use Avastin. They will still charge a lot for the office visit, diagnostics and injection, but the dose of the drug itself will be more like $150 rather than $3000.
While getting the treatments, I read a lot on the web, but basically kept my mouth shut. I was the beneficiary of a miracle drug, no question about that! But this Lucentis/Avastin controversy has been bugging me.
What is macular degeneration?
It’s an increasingly common age-related condition, that depending on the form it takes, causes either slow, gradual loss of vision (dry macular degeneration), or rapid deterioration (wet MD).
Age-related macular degeneration, often called AMD or ARMD, is the leading cause of vision loss and blindness among Americans who are age 65 and older. Because people in this group represent an increasingly larger percentage of the general population, vision loss from macular degeneration is a growing problem.
AMD is degeneration of the macula, which is the part of the retina responsible for the sharp, central vision needed to read or drive. Because the macula primarily is affected in AMD, central vision loss may occur.
About 1.75 million U.S. residents currently have advanced age-related macular degeneration with associated vision loss, with that number expected to grow to almost 3 million by 2020.
About the dry kind:
Dry Macular Degeneration (non-neovascular). Dry AMD is an early stage of the disease and may result from the aging and thinning of macular tissues, depositing of pigment in the macula or a combination of the two processes.
Dry macular degeneration is diagnosed when yellowish spots known as drusen begin to accumulate in and around the macula. It is believed these spots are deposits or debris from deteriorating tissue. Gradual central vision loss may occur with dry macular degeneration but usually is not nearly as severe as wet AMD symptoms. However, dry AMD through a period of years slowly can progress to late-stage geographic atrophy (GA) — gradual degradation of retinal cells that also can cause severe vision loss.
No FDA-approved treatments are available for dry macular degeneration, although a few now are in clinical trials.
About the wet kind:
Wet Macular Degeneration (neovascular). In about 10 percent of cases, dry AMD progresses to the more advanced and damaging form of the eye disease. With wet macular degeneration, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes permanent damage to light-sensitive retinal cells, which die off and create blind spots in central vision.
Choroidal neovascularization (CNV), the underlying process causing wet AMD and abnormal blood vessel growth, is the body's misguided way of attempting to create a new network of blood vessels to supply more nutrients and oxygen to the eye's retina. Instead, the process creates scarring, leading to sometimes severe central vision loss.
Here’s the source, a good website on the subject:
all about vision
What does macular degeneration "look" like?
It’s a very unique kind of distortion of the central part of your vision. If you go to the website link above, scroll down a bit to the animated version of the Amster Grid. It’s a kind of bending and squishing of your vision towards the center, and results in a concentrated dark spot somewhere in the middle that you can’t see through. As it progresses, the spot gets bigger and you can only see around the edges of it. In my case, the distortion was from the lower left corner towards the center, and there was a small spot.
Four days after the first injection, over the course of one morning, I watched that spot dissolve and disappear! Out! Out Damn, etc....! And the distortion, which was pronounced, became very slight, and I basically don’t notice it most of the time although it’s still there.
So as I said and please believe me, I am in no fucking position to complain, am I? If I could meet the dedicated biotech scientists, technicians, lab rats, whoever, that contributed to the development of Lucentis, I would buy them dinner, hug them, kiss them, and blubber emotionally all over their lab coats.
Now then, does the name Genentech ring a bell? Of course it does! It’s a subsidiary of the pharma giant Roche Group. Any chance they were in the news recently in relation to Health Care Reform?
What do you think?
Of course they were!
New York Times, Nov. 19, 2009
WASHINGTON — In the official record of the historic House debate on overhauling health care, the speeches of many lawmakers echo with similarities. Often, that was no accident.
Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genentech, one of the world’s largest biotechnology companies.
E-mail messages obtained by The New York Times show that the lobbyists drafted one statement for Democrats and another for Republicans.
So my opinion of the company itself does begin to slip a bit when I look past the dedicated and talented people actually trying to develop new high tech treatments for previously untreatable diseases, to the management, owners and their lobbyists. To be expected of course...
Now to the Lucentis vs. Avastin controversy.
This has been raging in the ophthalmology profession since 2006-2007. Here’s a summary from one website, All About Vision which is fairly objective.
When Lucentis (ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.
With about 200,000 new cases of advanced, age-related macular degeneration (AMD) identified each year in the United States*, many older Americans with more severe or "wet" forms of AMD endured inevitable, gradual loss of central vision.
Now, there is new hope for many who once faced certain blindness. Lucentis in clinical trials has been shown to stop and, in many cases, reverse at least some vision loss in most people with advanced AMD. These positive findings clearly make Lucentis by far the most effective FDA-approved treatment currently available for more damaging forms of AMD.
But some eye doctors argue that a drug closely related to Lucentis, known as Avastin (bevacizumab), also has been shown to be a highly effective and far cheaper alternative for lower-income individuals with advanced AMD. The problem is that Avastin is FDA-approved only for treatment of colon and other cancers, but not for macular degeneration. As an alternative, many eye doctors have been using Avastin as an off-label treatment.
Genentech Restricts Sales of Avastin for Ophthalmic Uses
In October 2007, the company that markets both Lucentis and Avastin announced a strategy that limits availability of Avastin for ocular uses as of Jan. 1. The company, Genentech, cited safety issues as the reason for halting sales of Avastin to compounding pharmacies that have been dividing Avastin into the smaller quantities needed for treating the eye.
Although Genentech tried to prevent doctors from even using Avastin for wet macular degeneration, they relented. Doctors are using it off label. The problem is that Genentech won’t ask the FDA to approve it for this purpose, and so insurance companies will not cover this off-label use of a drug approved for an entirely different purpose. Lucentis is the only drug my health insurance company will cover for my condition, despite the enormous price difference. That’s why I said at the beginning of this diary that I think that Genentech is managing to screw the insurance companies and Medicare & Medicaid as well.
This issue has caught the attention of at least one elected official. Senator Herb Kohl (D-WI) has been asking questions, writing letters, and trying to raise this issue, as this article indicates because of the cost to Medicare. Sen. Kohl wants to know what the deal is
There are lots and lots of further sources, some objective and some advocating an opinion on the matter. Just google "Lucentis Avastin" and off you go.
Studies are now underway that may resolve this and determine whether or not Avastin works as well as Lucentis. Results will not be known until 2011
So what’s a guy with wet macular generation to do with all this?
Eh?
I take my special vitamins that have been clinically proven to slow or prevent the development of macular degeneration. I wear sunglasses in direct sunlight and eat lots of leafy green vegetables. I test myself regularly with the Amster Grid. And I’ve adjusted in little ways to the relatively minor deterioration in my vision. I can drive, read, blog, do anything, just being careful for an occasional distortion in the lower left corner of one eye. My vision is 20-30 in that eye, not bad for what I’ve been through.
Mostly I am grateful every day for my doctor, who has been both a medical wizard and trusted advisor, and for this drug Lucentis, at whatever the fucking cost. I can see. I know that I’m not "cured" and that I’ll probably be dealing with this again. But ten years ago, someone with this condition would have basically lost the use of an eye at this point.
But somehow, Genentech does not come out smelling of roses in all this. Do they?