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Saturday, July 01, 2006

Drugs: The Generator

About a year ago a very dear and long ago friend from the 60s decided to leave this plane. I have been thinking of him a lot lately. This morning I decided to play the CDs I have of his wonderful music. This also makes me think about how he had so much trouble with his health, knowing part of his decision included these worries.
It doesn't surprise me in the least because I know so many people, especially as they are aging, fear for loss of health.
I am not outside that group, so I try to do things to help maintain my health and prevent any untoward events as much as they remain in my control. This has a lot to do with taking responsibility for my health. I hope that others will do this too, because they can, and should.
This article about vision and drugs takes me back a decade or more when so many research articles were in the media about vitamin C being the best protective treatment to prevent and perhaps reverse macular degeneration.
Vitamin C you say. Yes, you know that dangerous supplement that all humans need, at least about 3000 mg. daily, since we don't make any of our own. That supplement they want to limit your purchase to about 60 mg. daily, only because that amount prevents scurvy, but any more can be dangerous. (Hear my laughter here please!)
Now comes Lucentis at $1950 bucks a pop. And you might have to get it twice a month. This is an alternative to Avastin, a $17 a dose cancer drug used off-label for the same treatment. You know those off-label uses not FDA approved (if that means anything these days) that could very well bring about terryifying long-range problems.
If you read this BLOG, subscribe to herbalYODA Says! or visit the CHI website you probably know that we support natural healing, so we support high dose natural vitamin C. Maybe it might cost up to $30 a month for high quality vitamin C. And of course you get added benefits of health promotion for other concerns like heart health, et al. Then you can consider IV vitamin C too ( which works for many things including HepC, cancer, etc).
So maybe nostaligia wins today. Or maybe the fact that I am in my 60s and the only one in my family that does not wear corrective lenses and I don't have kidney stones from all that vitamin C I've been taking for decades.
Another effective treatment is the use of the Palma Christi. This is an Edgar Cayce remedy that many elderly clients of CHI have used. You could also try the natural eye wash protocol, as it has been around for at least 100 years now, and shows no untoward side effects. We haven't ever found any bodies either.
Now for more music from the heart of "Jon the Generator", please go here.
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Drug approved to combat elderly blindness
By ANDREW BRIDGES, Associated Press Writer Fri Jun 30, 8:44 PM ET

The first drug shown to significantly improve the vision of patients threatened by a major cause of blindness in the elderly won federal approval Friday.

The drug, called Lucentis, treats the wet form of age-related macular degeneration, a disorder where blood vessels behind the retina leak blood and fluid, worsening vision and often causing blindness. An estimated 90 percent of the 1.4 million Americans who have lost their eyesight due to the disorder have the wet form.

Lucentis, made by Genentech, Inc., a South San Francisco, Calif., biotechnology company, inhibits the growth of blood vessels when injected into the eye. Other Food and Drug Administration-approved treatments can arrest progression of the disease, which can lead to blindness in just weeks or months, but none has been shown to significantly reverse deteriorating vision.

Genentech may find Lucentis competing against another of its drugs, the cancer treatment Avastin. Avastin is increasingly used to treat macular degeneration for as little as $17 a dose. Lucentis will cost $1,950 per injection, or more than 100 times as much. Each drug is typically injected monthly or bimonthly.

Lucentis and Avastin both block the same protein believed responsible for the blood vessel growth. Early results from Lucentis trials led doctors more than two years ago to begin experimenting with Avastin to treat age-related macular degeneration, commonly called AMD.

"It gave physicians and patients great hope we are going to be able to improve vision in our patients rather than just slow down the loss of vision," Dr. George Williams, an American Academy of Ophthalmology spokesman, said of the early results.

Since then, at least 10,000 macular degeneration patients have received Avastin injections, a so-called "off-label" use of the drug.

"It's become a worldwide phenomenon," said Dr. Philip Rosenfeld, a professor of ophthalmology at the Bascom Palmer Eye Institute in Miami, who pioneered its use for AMD.

The FDA does not sanction using Avastin to treat macular degeneration. Genentech stresses that it has not studied the safety or effectiveness of Avastin in treating the disease, nor does it plan to do so.

"We believe Lucentis is a much better choice," said Dr. Hal Barron, Genentech's chief medical officer. "I really believe when treating patients, you have to look at the wealth of data supporting its use and the quality of that data."

The National Eye Institute, part of the National Institutes of Health, has received an outside proposal to conduct a study comparing Avastin and Lucentis in treating AMD, said the government institute's Dr. Maryann Redford.

Genentech engineered Lucentis to better penetrate the retina while reducing inflammation, Barron said. Lucentis also clears the body faster than Avastin, and better targets the protein important to vessel formation, he added.

Still, the anticipated cost of Lucentis may constrain its use, since Avastin is far cheaper when vials of the cancer drug are divvied up and used to treat macular degeneration.

"The bottom line is, wherever price does matter, Avastin will probably be used as first-line therapy. But wherever price is not an issue, like in Medicare patients and Medicaid patients, Lucentis will be used," Rosenfeld said.

Neither drug is a cure for age-related macular degeneration. Lucentis is most effective when injected monthly, said Dr. Wiley Chambers, deputy director of the FDA's Division of Anti-infective and Opthalmologic Products. The disease is named for the macula, the central portion of the retina responsible for detailed central vision.

The two other FDA-approved therapies to treat macular degeneration are Novartis AG/QLT Inc.'s Visudyne, which combines a light-sensitive drug and laser therapy to seal leaking blood vessels, and OSI Pharmaceuticals Inc./Pfizer Inc.'s Macugen, which is injected into the eye. Both slow the progression of the disorder but typically reverse its effects in only 5 percent to 10 percent of patients, Chambers said.

Lucentis' most commonly reported side effects include conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation.

In clinical trials, nearly 95 percent of participants given monthly injections maintained their vision at one year, compared with the approximately 60 percent who did after receiving another treatment, the FDA said. Approximately one-third of the Lucentis patients also reported improved vision after a year.

Genentech said it would start shipping Lucentis on Friday.

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