Avastin/Lucentis Update 13: Genentech’s Two Headed Monster: Lucentis and Avastin
The article below was just posted on a web site called HealthDot@scribemedia.org. It contains a fifteen minute interview with Dr. William Rich, Medical Director for Health Policy, for the American Academy of Ophthalmology (AAO). It is well worth listening to.
The website is:
health.scribemedia.org/2007/03/03/lucentis-avastin/
Genentech’s Two Headed Monster: Lucentis and Avastin
March 3rd, 2007 | Category: Pharmaceutical
Genentech, the Biotech powerhouse, has a problem. They’re too good at what they do. The company has two drugs that both do a fantastic job treating the same disease - age-related macular degeneration (AMD), the leading cause of vision loss and blindness in Americans age 65 and older.
One drug, Lucentis, received its FDA approval to treat macular degeneration in June 2006. Lucentis costs $2,000 per injection (the drug is injected into the eye). Avastin, the other drug, has been around for a few years to treat various forms of cancer, such as colon cancer, and only costs $20 per injection. While treating age-related macular degeneration is an off-label use for Avastin, doctors who treat the disease believe that both drugs are fairly comparable. And many have used Avastin while waiting for Lucentis to receive approval.
The problem for Genentech? By the time Lucentis was finally approved, so many doctors were using the cheaper off-label Avastin that the drug had significant market share. And what doctor is going to tell an elderly patient with limited savings that they will now be switched to a drug that cost 100 times more than their current drug?
If you were Genentech, which drug would you rather sell? The one that costs as much as a night at the movies with your main squeeze? Or the one that costs an arm and a leg…or an eye??
Again, roll-playing Genentech, imagine that the National Institute of Health announces that for the first time ever they are going to do a head to head comparison of two commercial drugs that treat the same condition. And both drugs are yours! You’re the winner. A trend setter of sorts. Yay! Once and for all it will be proven beyond a reasonable doubt (because there currently is doubt) that your more expensive drug is clearly the superior drug and, therefore, millions of seniors should be lining up around the block to receive their monthly injections. Prepare the cash registers and the Brinks armored trucks.
But wait…Genentech is a no-show to this Lucentis coming out party. They claim the study is a waste of time and money, that public funds could be better spent elsewhere.
The National Eye Institute, a part of the NIH, is leading the study and has, barring any last minute interference by those that shall remain unnamed, the support of the Center for Medicare Services (CMS), which foots the bill for most age-related macular degeneration. This makes sense, given that Medicare represents seniors, and most people who have AMD are over 65, a large and growing population.
What is significant for the Pharma industry is that if this trial goes through, it could lead to more head to head trials between, say two drugs that both treat diabetes, or four that treat heart disease. While every other industry endures similar head to head comparisons, for example, between two compact cars, or two SUVs, Pharma has been insulated from this type of scrutiny. What if the new blockbuster, which took years and billions to develop, is no more efficacious than the generic already on the market? All the direct to consumer advertising can’t help that drug out.
To shed some light on the Lucentis/Avastin trial, I talked to Dr. William Rich, Medical Director for Health Policy, American Academy of Ophthalmology, and a no-bullshit straight shooter.
Peter Cervieri
(The audio interview can be heard in its entirety at the web site linked herein.)
The website is:
health.scribemedia.org/2007/03/03/lucentis-avastin/
Genentech’s Two Headed Monster: Lucentis and Avastin
March 3rd, 2007 | Category: Pharmaceutical
Genentech, the Biotech powerhouse, has a problem. They’re too good at what they do. The company has two drugs that both do a fantastic job treating the same disease - age-related macular degeneration (AMD), the leading cause of vision loss and blindness in Americans age 65 and older.
One drug, Lucentis, received its FDA approval to treat macular degeneration in June 2006. Lucentis costs $2,000 per injection (the drug is injected into the eye). Avastin, the other drug, has been around for a few years to treat various forms of cancer, such as colon cancer, and only costs $20 per injection. While treating age-related macular degeneration is an off-label use for Avastin, doctors who treat the disease believe that both drugs are fairly comparable. And many have used Avastin while waiting for Lucentis to receive approval.
The problem for Genentech? By the time Lucentis was finally approved, so many doctors were using the cheaper off-label Avastin that the drug had significant market share. And what doctor is going to tell an elderly patient with limited savings that they will now be switched to a drug that cost 100 times more than their current drug?
If you were Genentech, which drug would you rather sell? The one that costs as much as a night at the movies with your main squeeze? Or the one that costs an arm and a leg…or an eye??
Again, roll-playing Genentech, imagine that the National Institute of Health announces that for the first time ever they are going to do a head to head comparison of two commercial drugs that treat the same condition. And both drugs are yours! You’re the winner. A trend setter of sorts. Yay! Once and for all it will be proven beyond a reasonable doubt (because there currently is doubt) that your more expensive drug is clearly the superior drug and, therefore, millions of seniors should be lining up around the block to receive their monthly injections. Prepare the cash registers and the Brinks armored trucks.
But wait…Genentech is a no-show to this Lucentis coming out party. They claim the study is a waste of time and money, that public funds could be better spent elsewhere.
The National Eye Institute, a part of the NIH, is leading the study and has, barring any last minute interference by those that shall remain unnamed, the support of the Center for Medicare Services (CMS), which foots the bill for most age-related macular degeneration. This makes sense, given that Medicare represents seniors, and most people who have AMD are over 65, a large and growing population.
What is significant for the Pharma industry is that if this trial goes through, it could lead to more head to head trials between, say two drugs that both treat diabetes, or four that treat heart disease. While every other industry endures similar head to head comparisons, for example, between two compact cars, or two SUVs, Pharma has been insulated from this type of scrutiny. What if the new blockbuster, which took years and billions to develop, is no more efficacious than the generic already on the market? All the direct to consumer advertising can’t help that drug out.
To shed some light on the Lucentis/Avastin trial, I talked to Dr. William Rich, Medical Director for Health Policy, American Academy of Ophthalmology, and a no-bullshit straight shooter.
Peter Cervieri
(The audio interview can be heard in its entirety at the web site linked herein.)
posted by Irv Arons @ 11:05 PM
2 comments
2 Comments:
The following statement is astonishing for it's wealth of ignorance:
" if this trial goes through, it could lead to more head to head trials between, say two drugs that both treat diabetes, or four that treat heart disease. While every other industry endures similar head to head comparisons, for example, between two compact cars, or two SUVs, Pharma has been insulated from this type of scrutiny"
WHAT! I've been involved in Clinical Trials for twenty plus years and in almost all cases approvable drugs are tested for their safety and efficacy relative to the current standard of care, i.e. what is the most widely prescribed treatment option. In fact the FDA regularly rejects new drugs for not showing a substantial benefit relative to the current standard of care. This blogger has no credibility: he's obviously a fraud who has little or no experience in the industry.
Although I disagree with the anonymous commenter, I've decided to allow his/her comment since he/she is permitted to share his/her opinion.
I personally don't think his/her comment applies to this blog poster, since both drugs have been widely used for treating AMD and the upcoming CATT Study is meant to show if their is truly a difference in efficacy, safety, and in dosing regimens.
It appears in anecdotal testing, that Avastin may be longer lasting in the eye and fewer doses required to stabilize the eye in treating wet AMD.
Again, the CATT Study should bear this out.
Irv Arons
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