<<< Back to Cures Naturally Articles
<<< Back to Cures Naturally Prescription Drugs
Posted on Sun, Nov. 16, 2003
Macular degeneration drug trials prove disappointing
By Andrew Pollack
The New York Times
ANAHEIM, Calif. - An experimental drug can slow vision loss caused by one form of an eye disease that is the leading cause of blindness among the elderly, accounting for more than 2 million cases annually, researchers have found.
But in a large trial, the drug did not meaningfully improve vision, they said, which contradicts earlier results that had sent patients flocking to doctors for a cure.
The drug, Macugen, is intended to treat the wet form of age-related macular degeneration, which is characterized by the growth and bleeding of abnormal blood vessels across the macular area of the eye, robbing people of the ability to read, to drive and to watch television. More than 200,000 cases are diagnosed each year in the United States.
There is only one drug on the market for macular degeneration, and it is approved for the treatment of one subtype representing a minority of cases. Macugen, developed by Eyetech Pharmaceuticals of New York, appeared to work for more types in a large clinical trial, said Dr. Carmen A. Puliafito.
"There's a large number of patients for which there really is no approved treatment," said Puliafito, chairman of the Bascom Palmer Eye Institute at the University of Miami. "It really means that Macugen might be the first treatment with the potential to help all" patients with the wet form of macular degeneration.
But some doctors and patients had hoped for even better results. In early, smaller trials, Macugen and a similar drug being developed by Genentech -- Lucentis -- not only slowed vision loss but also improved it for about 26 percent of participants.
But in the larger trial, only 6 percent of those getting Macugen had significant improvements, compared with 2 percent in a control group.
Experts said it was not unusual for results in a large trial with a control group to be worse than those in a small, uncontrolled trial.
The new results are from a Phase III trial, typically the last stage before a company can seek approval from the U.S. Food and Drug Administration. Eyetech and its marketing partner, Pfizer, are expected to apply in the first half of next year for approval, meaning the drug could reach the market by 2005.
Fort Worth-based Alcon is planning to start clinical studies of Retaane Depot, a possible treatment for the dry form of the disease, which isn't as severe but can progress to the more damaging wet form. The FDA has given Retaane Depot "fast-track" status because the treatment would meet a significant unmet medical need, and Phase III trials are slated for January.
Staff Writer Maria M. Perotin contributed to this report.
|
Consider the time and money invested to develop a patentable drug which does not work and may have irreversible side effects such as blindness or death when a natural treatment has been here all along. - CW
"Macular degeneration is not an incurable disease, no matter what you hear from most doctors or read in mainstream media. I have been treating patients with this condition since 1985, and have found a way to preserve and restore vision in 70 percent of the cases.
I know it's hard to believe, but I first published case studies concerning recovery of vision in patients with macular degeneration in the Journal of Nutritional Medicine in 1990. After several more years of experience, Nutrition & Healing covered preserving and restoring vision for individuals with macular degeneration at length in August 1996. My colleague, Tom Dorman, M.D., confirmed my observations in his own newsletter in February 1998. In the 10 years since 1990, literally dozens of physicians, mostly members of the American College of Advancement in Medicine (ACAM); tel. (800)532-3688, have told me that the treatment, pioneered at the Tahoma Clinic, has worked for the majority of their patients too.
So why isn't this treatment better known and much more widely used? As usual, the answer is that it's unpatentable. Pharmaceutical companies aren't interested, and government grants are made available almost entirely to test mainstream medical theories. So there aren't any controlled trial results to make mainstream medicine happy & and there isn't any money given to natural medicine to do the testing. It's a vicious cycle, with patients getting the short end of the stick.
But despite the absence of controlled research, macular degeneration is an important and prevalent health problem. In case you don't know already, this disease involves degeneration of the center of the retina which is called the macula. The macula is the part of the eye capable of our most detailed vision. We use it for reading, driving, recognizing faces, watching television, and all precise work. Macular degeneration is the leading cause of legal blindness in people over 55 and affects 9 percent of us over 70 (according to one prominent eye journal). " Jonathan V. Wright, M.D.
Jonathan V. Wright, M.D. has degrees from both Harvard University (cum laude) and the University of Michigan. More than any other doctor, he practically invented the modern science of applied nutritional biochemistry and he has advanced nutritional medicine for nearly three decades. Thousands of doctors respect Dr. Wright as the author of the best-selling Book of Nutritional Therapy and Guide to Healing with Nutrition, as well as other classics in the field. People travel to his clinic in Renton, WA (near Seattle) from all over the world.
|
|
Back to top of document