Blindness in the News

[rducasey]

hoosier said:

Last night's person of the week on ABC news was Eric Weihenmayer, the blind climber. He recently took a group of blind and visually impaired people to Peru to climb to Manchu Picchu. He said that his father took him there after his mother passed away. He said he hated it, he fell and stumbled all the way but the end result was what got him interested in doing climbing. He said he wanted others to experience what he did, saying that "to the blind, the out of doors is chaos" or words to that effect. Quite an individual.

I saw this too Hoosier. It was very interesting. What I found a little disconcerting was that each blind person was paired with a sighted person and they had bells on the sighted person to make them easier to follow. I guess I only found it disconcerting in light of Marty's rude comments to Jim in Rub a tub tub.

[mlm828]

awlrite4now said:

If you will cut and paste the entire line, that is the link. For some reason, this site isn't letting me put the entire line in a link. Please try again; it's worth reading.

Thanks for the suggestion. I read the article, and now I'm even madder than before. I assume the company will try to do the same thing in the U.S., if it hasn't already done so, with the help of the FDA, which is cozily in bed with the pharmaceutical companies.

[awlrite4now]

Since there is so much going on with World Cup Football/Soccer, this BBC article was of interest:

www.bbc.co.uk/ouch/closeup/world_cup_facts.shtml

And, has anyone ever seen a goalball match? The big tournament for that is going to be held in Spartansburg, SC.

www.worldgoalball.com/page2.htm

[bjobsessed]

Wow! I didn't know there was disability soccer. It sounds like so much fun and soccer just happens to be my favourite summer sport. Too bad there's nothing like that around my place.

I used to play soccer in the backyard with my nephews when they were younger. We never worried about shin pads until I went for the ball, missed, and hit their shins instead. Talk about ouch! They always wore shin pads after that.

It was a lot of fun, but playing on a real team would be awesome.

[bjobsessed]

mlm828 said:

awlrite4now said:

If you will cut and paste the entire line, that is the link. For some reason, this site isn't letting me put the entire line in a link. Please try again; it's worth reading.

Thanks for the suggestion. I read the article, and now I'm even madder than before. I assume the company will try to do the same thing in the U.S., if it hasn't already done so, with the help of the FDA, which is cozily in bed with the pharmaceutical companies.

All I can say now that I've had a chance to read the article is that I totally agree. I don't expect that Canada will be any different if/when it gets here.

[inuvik]

awlrite4now said:

Since there is so much going on with World Cup Football/Soccer, this BBC article was of interest:

www.bbc.co.uk/ouch/closeup/world_cup_facts.shtml

And, has anyone ever seen a goalball match? The big tournament for that is going to be held in Spartansburg, SC.

www.worldgoalball.com/page2.htm

Neat stuff! I also hadn't heard of worldgoalball.

[awlrite4now]

I wanted to post a medical breakthrough notice here from the Foundation Fighting Blindness, which sponsors a lot of research grants.

Lucentis, vision-preserving treatment for wet AMD, approved by FDA
By Ben A. Shaberman
June 30, 2006

Genentech announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis(TM) for the treatment of wet age-related macular degeneration (AMD).

"This is great news for the millions of older Americans at risk of losing their vision to wet AMD. People affected by wet AMD have had few alternatives," says Stephen Rose, Ph.D., Chief Research Officer, Foundation Fighting Blindness "Lucentis is not only a new option, it appears to be safe and highly effective."

Two-year results from the MARINA study showed that Lucentis halted vision loss in more than 90 percent of individuals with wet AMD. The treatment restored some vision in 33 percent of individuals receiving the higher of two doses (.5 mg). In the MARINA study, participants received Lucentis monthly via intravitreal injection (injection into the eye).

Lucentis is the second FDA-approved alternative in an emerging group of wet AMD treatments, which are said to be "anti-angiogenic," a term given to treatments that inhibit or block the growth of vision-robbing blood vessels under the retina. Approved in late 2004, Macugen(R) was the first FDA-approved anti-angiogenic treatment for wet AMD.

Lucentis works by inhibiting Vascular Endothelial Growth Factor-A (VEGF-A), a protein that is believed to play a major role in the development of leaky, vision-robbing blood vessels under the retina. Growth of these unhealthy blood vessels is the hallmark of wet AMD.

AMD is the leading cause of legal blindness in Americans who are 55 years of age or older. Approximately nine million people in the U.S. are affected by AMD. The number of people affected by AMD is expected to double by 2020, because of the aging of the Baby Boomer population.

AMD occurs in two forms: wet and dry. The wet form causes significantly more cases of severe vision loss than dry. However, people with dry AMD are at risk of developing the wet form.

The urgent mission of The Foundation Fighting Blindness is to drive the research that will provide preventions, treatments, and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases.

For more information about The Foundation and retinal degenerative diseases, visit www.FightBlindness.org.

[mlm828]

Isn't this the same drug you posted about earlier -- the one that was going to be sold in the UK for many times its cost in its original form? It's certainly good news that it's effective, and the FDA has approved it. I only hope the people who need it will be able to get it.

[awlrite4now]

Yes, it's the same drug. Here is the article from The Guardian that many could not get to link:

Drugs firm blocks cheap blindness cure

Company will only seek licence for medicine that costs 100 times more

Sarah Boseley, health editor
Saturday June 17, 2006
The Guardian

Eye surgery
An ophthalmologist prepares a patient's eye for surgery.

A major drug company is blocking access to a medicine that is cheaply and effectively saving thousands of people from going blind because it wants to launch a more expensive product on the market.

Ophthalmologists around the world, on their own initiative, are injecting tiny quantities of a colon cancer drug called Avastin into the eyes of patients with wet macular degeneration, a common condition of older age that can lead to severely impaired eyesight and blindness. They report remarkable success at very low cost because one phial can be split and used for dozens of patients.

But Genentech, the company that invented Avastin, does not want it used in this way. Instead it is applying to license a fragment of Avastin, called Lucentis, which is packaged in the tiny quantities suitable for eyes at a higher cost. Speculation in the US suggests it could cost £1,000 per dose instead of less than £10. The company says Lucentis is specifically designed for eyes, with modifications over Avastin, and has been through 10 years of testing to prove it is safe.

Unless Avastin is approved in the UK by the National Institute for Clinical Excellence (Nice) it will not be universally available within the NHS. But because Genentech declines to apply for a licence for this use of Avastin, Nice cannot consider it. In spite of the growing drugs bill of the NHS, it will appraise, and probably approve, Lucentis next year.

Although Nice's role is to look at cost-effectiveness, it says it cannot appraise a drug and pass it for use in the NHS unless the drug is referred to it by the Department of Health. The department says its hands are tied.

"The drug company hasn't applied for it to be licensed for this use. It wouldn't be referred to Nice until they have made the first move," said a Department of Health spokeswoman. "They need to step up and get a licence. If they are not getting it licensed, why aren't they?"

New drugs for the condition are badly needed: those we have now only slow the progression to blindness. With Avastin, many patients get their sight back with just one or two injections.

Avastin was first used on human eyes by Philip Rosenfeld, an ophthalmologist in the US, who was aware of animal studies carried out by Genentech that showed potential in eye conditions. This unlicensed use of Avastin has spread across continents entirely by word of mouth from one doctor to another. It has now been injected into 7,000 eyes, with considerable success.

Professor Rosenfeld has published his results and a website has been launched in the US to collate the experiences of doctors from around the world. But although the evidence is good, regulators require randomised controlled trials before they grant licences, which generally only the drug companies can afford to carry out.

Prof Rosenfeld said the real issue was drug company profits. "This truly is a wonder drug," he said. "This shows both how good they [the drug companies] are and on the flip side, how greedy they are." He would like to see governments fund clinical trials of drugs such as Avastin in the public interest.

Rising drug bills are a big problem on both sides of the Atlantic. In the UK, said David Wong, chairman of the scientific committee of the Royal College of Ophthalmologists, doctors are fighting battles to persuade primary care trusts to pay for drugs to stop their patients going blind while they wait for Nice to decide on Lucentis and another expensive drug called Macugen. That decision is not expected before the end of next year.

About 20,000 people are diagnosed with age-related macular degeneration in the UK each year. "From the patient's point of view, if they have an eye condition that deteriorates very quickly, there is no question of waiting," said Professor Wong. "We're talking about days and weeks, rather than months. The question is should we do nothing and say there is no randomised controlled trial to prove Avastin is of value?" He called for primary care trusts to agree to pay for the planned phasing-in of new drugs for the condition.

Last night Genentech said its main concern over the use of Avastin to treat eye conditions was patient safety. "While there are some small, single-centre, uncontrolled studies of Avastin being performed, safety data on patients who are treated with Avastin off-label is not being collected in a standard or organised fashion," said a spokeswoman for the company.

Pharmaceutical firms say they need to launch drugs at high prices because of the hundreds of millions of pounds spent on developing them. Critics point out that the company's calculations also include the marketing budget.

[awlrite4now]

And from The New York Times

FROM TODAY'S NYTIMES...
June 29, 2006
Questions Over New Eyesight Drug That May Be as Good as Older, Cheaper One
By ANDREW POLLACK

A drug that can restore eyesight to some elderly people, even allowing them to read or drive again, is expected to win federal approval this week.

But for patients, doctors, Medicare and other insurers, the drug's arrival will pose a conundrum. That is because the medicine, Lucentis, is expected to be 10 to 100 times as expensive as a similar drug that many ophthalmologists say is every bit as good.

Lucentis, made by Genentech, is the first drug demonstrated in clinical trials to improve vision in people with so-called wet macular degeneration, a form of bleeding behind the retina that is the leading cause of blindness in people over 65. The condition afflicts an estimated 1.2 million people in this country, with an 200,000 new cases each year.

While the drug is not a cure and does not help everyone, specialists say it represents a breakthrough against a disease that once almost inexorably led to an incapacitating loss of eyesight.

"I have people who are reading the paper every morning who would have been totally legally blind two years ago," said Dr. Julia A. Haller, a professor of ophthalmology at Johns Hopkins University, who has had patients testing Lucentis.

But the big question is whether insurers and patients will consider Lucentis worth prices that may be $10,000 a year or higher, compared with around $1,000 or less for the drug already on the market that many ophthalmologists say is just as good.

That drug, Avastin, is approved only to treat cancer. But used for the eye condition, which is legal and known as an off-label use, it works the same way as Lucentis. In fact, Lucentis is a derivative of Avastin tailored to be used in the eye. Like Lucentis, Avastin was developed by Genentech.

With Lucentis not yet available, off-label use of Avastin has become the treatment of choice for macular degeneration. Since last fall, thousands of eye patients have been treated with Avastin, with good results and minimal side effects, experts say.

But Genentech has no interest in getting Avastin approved for macular degeneration, because that would undermine the sales of Lucentis, which some analysts predict will have annual sales of several hundred million dollars.

Avastin is not a cheap drug. It costs about $50,000 a year when used intravenously to treat colon cancer.

But for an injection into the eye to treat macular degeneration, only about $20 to $100 worth of the drug is needed.

Genentech has not announced the price for Lucentis, which the F.D.A. is widely expected to approve by tomorrow. But retina specialists expect an injection of Lucentis to cost from $1,500 to well over $2,000.

For both drugs, an injection is needed as often as every four weeks.

The number of patients with wet macular degeneration is expected to mushroom as the baby boomers age. About 85 percent of people with wet macular degeneration are covered by Medicare, Genentech says.

Use of Avastin instead of Lucentis could save patients and insurers hundreds of millions of dollars a year. Yet, despite the potential cost savings, several specialists said they expected most doctors to switch to Lucentis after its approval because there are solid data from clinical trials on the safety and efficacy of that drug. Using an approved drug, instead of using another drug off-label, also means less paperwork and less risk of malpractice lawsuits. What is more, apportioning Avastin into small sterile doses for ophthalmic use requires its repackaging by special druggists known as compounding pharmacists.

"The whole experience really opens your eyes to how our whole health care system is operating," said Dr. Philip J. Rosenfeld, an associate professor of ophthalmology at the University of Miami who pioneered the use of Avastin for macular degeneration. "We could be incentivized to use the most effective therapy at the most reasonable cost. But that's not how our system is set up."

Genentech's disinclination to test Avastin as an eye treatment has angered some doctors. "The part that really bothers me most is that Genentech has steadfastly refused to do a head-to-head study between Avastin and Lucentis," said Dr. Raj K. Maturi, a retina specialist in Indianapolis.

But Dr. Susan Desmond-Hellmann, the president of product development for Genentech, said the company's priority was "to innovate and do better things for patients" — not to show one drug was equivalent to another.

Dr. Desmond-Hellmann said Lucentis would save the health care system money by preventing blindness, which can lead to other injuries and to nursing home admissions. She also said the company would support programs to help patients with their insurance copayments for Lucentis and would provide the drug free to patients who could not otherwise pay for it.

Wet-form macular degeneration is characterized by abnormal, leaky blood vessels that form under the retina, the light-sensing part of the eye. The vessels leak fluid into the eye, causing warped vision, and damage the macula, the part of the retina responsible for the straight-ahead vision used for tasks like recognizing faces, reading, driving and watching television. People with the condition usually retain some peripheral vision.

"I could look at my husband but not see his face unless I looked to the right to bring him into view," said Helen Nicolosi, 77, of Marathon, Fla., whose eyesight was affected by the disease.

She said monthly injections of Lucentis in a clinical trial improved vision in her affected eye to 20/50 from 20/150, letting her drive again and do the crossword puzzles she loves. Both Avastin and Lucentis work by stopping the growth of new blood vessels. That retards the leaking in eye vessels, and in cancer it halts the supply of nourishment to tumors. Lucentis is a smaller-protein version of Avastin, designed to penetrate the retina better.

In clinical trials, one-quarter to one-third of patients who received Lucentis gained three or more lines of vision on an eye chart, benefits that have lasted two years so far with continued injections. About 40 percent of the patients ended up with at least 20/40 vision, the usual minimum for a driver's license. Only about 10 percent had a degradation of vision of at least three lines on the eye chart after two years.

By contrast, the two drugs already specifically approved for macular degeneration — Visudyne from QLT and Novartis, and Macugen from OSI Pharmaceuticals and Pfizer — slow the deterioration of eyesight but do not usually improve vision.

Copyright 2006 The New York Times Company

[carl1951]

Microsoft Vista

I've heard the new VISTA from Microsoft has a JAWS-type version in its the program. I haven't had the oportunity to find out more.
If it does the same as JAWS, it certainly would make it more a widely available to people with limited resources.

Has anyone used the new system or heard about it?

[awlrite4now]

carl1951 said:

Microsoft Vista

I've heard the new VISTA from Microsoft has a JAWS-type version in its the program. I haven't had the oportunity to find out more.
If it does the same as JAWS, it certainly would make it more a widely available to people with limited resources.

Has anyone used the new system or heard about it?

I scanned their site msdn.microsoft.com/windowsvista/ and found nothing to indicate a reader program, but they are touting their new voice recognition program that is supposed to eliminate mouse clicks and keystrokes as it learns your speech patterns.

The new Vista is just that...highly visible information output. It appears that it will have 3D thumbnails of the windows you have open so you can select what you want better than with the file name there is now at the bottom of the page.

Get Lucy to take a closer look at the above link and see if she finds anything more about a screen reader.

Wish I could have gotten down to Dallas this weekend for the NFB national convention. Anything that is available would be showing down there.

[carl1951]

Thanks, Alice, I will.

Later, Carl

[mlm828]

There was an interesting article in this morning's paper about a "talking" prescription bottle:
www.signonsandiego.com/uniontrib/20060706/news_1n6rex.html

[bjobsessed]

That is awesome! When you think about it, it makes sense and you wonder why no one thought of it before. Talking picture frames have been around for quite a while now and this is the same idea. Here's to one more small way to be independant and safe.