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Avastin Update 5 NIH Considers Trial Comparing Lucentis and Avastin

In my continuing efforts to keep interested people informed on the latest information about Avastin, I requested and received permission to re-publish the following article that originally appeared in the August 7th issue of Ophthalmic Market Perspectives.

NIH Considers Trial Comparing Lucentis and Avastin
By: Dru Thomas, Managing Editor, Ophthalmic Market Perspectives

Amidst a controversy about treatment prices, the NIH is considering funding a study to compare results of AMD therapies with Lucentis and with Avastin.

Lucentis, Genentech's long-awaited anti-angiogenic therapy for age-related macular degeneration (AMD), received FDA regulatory approval on June 30, and the Company immediately shipped $10 million worth of the drug. However, the rosy prospects for Genentech and for wet AMD sufferers took a more convoluted path in mid-July. The US National Institutes of Health (NIH) indicated it was considering funding a clinical study that compares the efficacy of Lucentis with that of Avastin, Genentech's anti-cancer agent that has also shown very positive results in off-label use against wet AMD.

In terms of both science and medical advancement, the two drugs might seem to present a win-win situation, but the reality of the marketplace creates a decidedly more complicated scenario. Genentech, a biotech powerhouse, has created two drugs that may each offer a quantum leap forward in successful AMD treatment, yet the Company faces a unique situation in which its own highly-successful anti-cancer drug may undercut the revenue stream of its proven anti-AMD agent. The crux of the issue is money.

Genentech developed Avastin and received FDA regulatory approval for its use as a systemic treatment for colorectal cancer. Avastin is central to the Company's revenues-both present and future-and the drug is currently involved in scores of trials concerning as many as 25 types of tumors. It is also used off label for some cancers.

Recognizing that the anti-angiogenic Avastin molecule might have potent applications in AMD, Genentech created Lucentis by deriving a fragment from the larger Avastin molecule. This smaller fragment was genetically engineered to create a higher binding affinity than Avastin and to penetrate the retina more effectively when administered by intravitreal injection.

As Lucentis made its way through FDA clinical trials, some doctors were impatient to offer real help to their AMD patients. Buoyed by promising reports regarding the closely-related drugs, they began treating wet AMD patients with intravitreal injections of small amounts of Avastin, an off-label use of the drug. As evidence of positive outcomes accumulated, the practice spread.

Now, with Lucentis available in the marketplace, pricing for AMD therapy is causing quite a stir. Clearly, Genentech has invested significant R&D dollars in both Avastin and Lucentis, including years of testing and clinical trials. Avastin is currently sold as an intravenous treatment and commonly costs a colorectal cancer patient approximately $50,000 per year. Lucentis is injected intravitreally and typically costs an AMD patient between $9,750 and $13,650 per year. But here is the rub-when Avastin is used in the small dosages appropriate for intravitreal injection in AMD patients, the yearly cost is less than $1,000.

There is an enormous difference in price between these two AMD treatments. As health care providers, insurers and public health systems in many nations feel the pressures of mounting health care costs, there is clearly incentive for further examination of AMD therapy using Avastin.

Meanwhile, the NIH has given no timetable for its decision about funding a comparative study, but if the study takes place and if Avastin is proven to be as effective as Lucentis, findings may jeopardize Lucentis' future earnings. However, these are big "ifs," and any study will take years to conduct. At present, doctors may choose between two Genentech drugs that appear to be remarkably effective against wet AMD. One, Lucentis, is used on label and is eligible for reimbursement; the other, Avastin, involves non-reimbursable, off-label use that might increase a doctor's liability if anything goes wrong. For the time being, Lucentis has a clear edge in the marketplace.

(Reprinted with permission from Market Scope. For information on subscribing to Ophthalmic Market Perspectives, please go to www.marketscope.com.)

Author’s Note on Avastin

Since the original posting on January 31, 2006, I have now added eight updates on this important drug for treating age-related macular degeneration. In addition to the posting you are reading, here is a listing (with links) to the others:

Avastin: A New Hope for Treating AMD (January 2006)

Avastin Update: Medicare not Likely to Cover its Use (March 2006)

Avastin Update II: AAO supports Medicare Coverage for Off-label Avistan Use (April 2006)

ARVO 2006: A Further Update on Both Avastin and Lucentis for Treating AMD (May 2006)

Avastin/Lucentis Update 4: FDA Approves Lucentis for Treating Wet AMD (July 2006)

Avastin/Lucentis Update 6: Latest Results Published in NEJM and Another Call for a Trial Between Them (October 2006)

Avastin/Lucentis Update 7: BREAKING NEWS – NEI/NIH Will Fund Comparative Study (October 2006)

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Aging Telomeres and Yoga New Study by Elizabeth Blackburn and Dean Ornish

by Baxter

Telomere Caps

A while back, we reported on an interesting potential marker in the body for aging of the cells connected to the genes called a telomere (see Stressed Mind, Stressed Cells and Science, Aging and Yoga). A telomere is like a tail on the end of DNA strands found in our cells, and an enzyme called telomerase influences the length and activity of the telomere. Studies done a few years ago by a Dr. Elizabeth Blackburn at UCSF in San Francisco began to show a connection between telomeres and cell longevity—the longer the telomere, the longer the cell life. Her work garnered her a Nobel Prize in Medicine.

Now Dr. Blackburn has teamed up with Dr. Dean Ornish to see what effect his life-style changes approach to prostate cancer has on telomeres and telomerase activity. Dr. Ornish has already shown that a combination of dietary changes (vegan diet with less than 10% fat per day), exercise in the form of walking for 30 minutes most days, and stress management tools that include regular yoga asana and breath work, mindfulness meditation and once a week group stress reduction sessions can reverse heart disease and diabetes, and can stabilize prostate cancer and stop its progression.

In their most recent study, published in Lancet Oncology (see Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study), the two researchers looked at how the lifestyle program impacted the cellular genetic level in regards to telomere length and enzyme activity. What they found was that the 10 men studied had longer telomeres in the short (as quickly as three months!) and long run, if they stuck to the program, and the 25 men who were controls had shorter telomeres. And they also looked at gene activity in their ten study subjects, and found that 500 genes were turned on, and all were beneficial, according to Ornish. 

Even though telomeres may be an indicator of longer cell life, and by extension, longer overall lifespan, this has not been definitively concluded, so more studies will need to be done, looking at much larger numbers of people. But the early evidence is promising, and even if the telomere/aging cell theory does not pan out, it seems evident that yoga, diet, exercise and stress management do have significantly positive impacts on health, disease progress or remission, and are therefore worth the effort. And as Dr. Ornish noted, his study participants found the lifestyle plan easy to follow, with 85-90% compliance, much better than most pharmaceutical based treatment plans. Why, you might ask? Well, has he says, it’s because it’s pleasant and comprehensive and “most people feel so much better they change their lifestyle.”

To read more, you can check out articles at ucsf.edu and today.com—among others—which reported these new findings.

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Upcoming Featured Poses Upper Body Strength and Flexibility!

by Nina (with Baxter)

Baxter and I have been excitedly planning (and photographing) the next group of poses we’re going to feature on our blog. Inspired by the popularity of my post Building Upper Body Strength the Easy Way, we decided to focus on the upper body for the next several months. We’ll be presenting several basic, easily accessible poses, all with several modifications, that will help you both build your upper body strength while you increase flexibility in your arms, shoulders, chest, and upper back.

Before getting started with the individual poses, we thought we’d take a moment to say something about why upper body strength and flexibility is so important for healthy aging.

With our current shift to more sedentary work styles, for many of us, our upper bodies are typically underused. Because we’re no longer carrying, lifting, and reaching on a regular basis, our upper bodies are not at their optimal levels of strength and function. And even those of us who exercise regularly by walking, running, or cycling, can become imbalanced due to neglecting our upper bodies.

I think that it’s important to most if not all of us that we maintain our independence as we age. For the elderly, upper body weakness has a significant effect on everyday activities, including the most basic ones, such as getting out of a chair, taking care of your home, and carrying your groceries. We also need to work on upper body flexibility, as people who are tight in upper back, shoulder and chest areas can have difficulty taking items off shelves or even dressing themselves.

Working your upper body also helps optimize your circulatory system, keep the connective tissue around your nerves mobile, and facilitate communication between your upper body and your brain, all of which will contribute to keeping your body healthier as you age.  

So stay tuned! Hmmm, what is Baxter doing with that block?

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New Theory About the Purpose of Sleep and Why Its So Important to Get Sound Sleep

by Ram

Sleep by Francisco Goya

According to Ayurveda philosophy, sleep is one of three pillars that endow the body with strength, complexion, and healthy growth, which can continue through the full span of life. The Ayurvedic texts also describe the maladies that can result from poor-quality sleep, including but not limited to misery, emaciation, weakness, brain fog, memory loss, and fatigue. It is believed that good quality sleep is essential for the well-being of any individual as the body utilizes the sleep time to repair itself of damage sustained during the waking hours.

In this hypercompetitive world, many of us complain of a lack of good quality sleep. We’re a world of unhealthy sleepers. If one were to compare the world statistics of insomnia and poor quality sleep, it is interesting to note that the numbers are nearly similar throughout the world. Within the USA, 30 percent of us have trouble falling asleep (insomnia) and 50 percent can sleep but have trouble maintaining sound/quality sleep due to tension, work, stress and/or emotional upheaval. 

Nearly 10 million people in the U.S. use prescription sleep aids. Several recent studies have shown that lack of sleep or a discontinuous sleep during the night may be deleterious for the brain, and may trigger dementia and increase the risk of stroke symptoms. For more on sleep and suitable interventions, check our earlier posts on these topics including: sleep and memory by Nina Sleep, Alzheimer's Disease and Yoga and The Importance of Good Sleep and natural interventions for good sleep 5 Tips for Better Sleep. 

The type of sleep and how we are affected by it is of great interest to sleep researchers. Sleep researchers have provided a number of reasons for why we sleep. Sleep helps to maintain a healthy immune system, balance our appetites, makes us less susceptible to degenerative diseases or infections, improves memory, and enhances cognition. Recent research work points to another interesting fact about why we sleep. Published just a week ago, a pair of papers offers evidence for another theory: Ultrastructural evidence for synaptic scaling across the wake/sleep cycle and Homer1a drives homeostatic scaling-down of excitatory synapses during sleep. 

According to these researchers, sleep helps us to forget some of the things we learn each day. Learning requires new neuronal connections or neuronal branching in our brains, which help neurons to communicate with neighboring neurons quickly and efficiently. Furthermore, these new neuronal branches also store firsthand memories of impressions that we draw in each day through our five senses. However, some of this information is redundant and does not require being stored. For example, you do not need to know what clothes you wore to work on a Thursday couple of weeks ago. Similarly, the people you saw at the airport terminal is not a value for the brain. 

In the first study Ultrastructural evidence for synaptic scaling across the wake/sleep cycle scientists from the University of Wisconsin-Madison proposed that neuronal branches grow so wildly during the day with all our experiential learning that our neuronal circuits actually get “noisy” (in neuroscience, “noisy” refers to the constant bombardment of electrical activity in neurons that can be measured by sophisticated machines). These scientists further added that when we sleep soundly, the brain discards all the unnecessary noise and consolidates only the relevant signals. In one experiment, scientists grew neurons in a lab dish and fed the neurons with a drug that stimulates the excess noise (that is, growth of extra neuronal branches). Twenty four hours later, the neurons had pared backed some of the branches. In a follow up experiment, the scientists surveyed brain tissue slices from mice that slept soundly and compared them to tissue slices from mice that were forced to keep awake. The neuronal branches in the mice that slept were much smaller and far less “noisy” compared to neuronal branches from mice that were forced to stay awake.

The second study Homer1a drives homeostatic scaling-down of excitatory synapses during sleep, led by scientists from Johns Hopkins University, explored the same theory with a different set of experiments. In this case, the researchers created a tiny window through which they could peer into mouse brains. They added a chemical that would light up each time a new neuronal branch developed, suggesting a new learning had triggered electrical activity, resulting in a noise. 

Looking through the window, they found that the chemical lit up very few times in mice that were asleep, suggesting that the brain was discarding all the extra branches resulting in reduced noise. This suggested that sleep turned on the pruning machinery to pare back the excess neuronal branches. More importantly, this sleep-induced pruning of neurons helped in consolidating memories. Mice that were not allowed to sleep ended up with less pruning of the branches, more neuronal noise, and fuzzy memories. Interestingly, the pruning machinery was very specific; it did not prune the well-established old neuronal connections. 

To provide an analogy, I am reminded of what the computer folks always advise us when the computer starts functioning erratically. Before thinking of any expensive repairs, the first thing they do is to switch off the computer and reboot it. The reasoning is that the processor discards and clears the hard drive of all of the unnecessary and not-needed information. So the take-home message is that we do not need to harbor all the information that we encounter briefly on a day-day basis, especially the bad, unpleasant, sad, and negative events. 

Every day we encounter brief negative thoughts/experiences —when we typically experience a brief bout of anger—that do not need to be consolidated. For example, while driving you may have encountered someone who speeded wildly and overtook you without signaling, or maybe your waiter took a long time to bring the lunch order and you got delayed for your next important meeting. These situations need not be stored as it is not helpful—it is a noise that we need to erase by sleeping soundly.

If we cannot discard these negative experiences through sound sleep, these disharmonious memories can keep lurking in the brain for a long time, and create the excess noise through the numerous unwanted neuronal branches and erratic electrical activity that will have deleterious effects on the brain. 

Sleep experts are now busy trying to discover medicines that might precisely target the molecules to induce sleep, ensuring that neuronal branches get properly pruned and all the junk information is purged. However, as yogis we know what works better naturally than medicines: a good sleep. Remember, good sleep is essential for a person’s health and wellbeing and if you are experiencing sleep problems, there is quite a price to pay.

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