Archive for the ‘Diabetic Retinopathy’ Category
Is the FDA the Bad Guy when a Beneficial Drug fails to get approved?
12.13.2011
The United States Food and Drug Administration (FDA) acts as the caretaker of the public, working to help bring new drugs to market while protecting the health and safety of the American population.
Drug companies create a mountain of paperwork and steps that required to successfully bring a drug to market, a costly endeavor that is possible only for the largest and most well financed companies.
The biggest criticisms against the FDA are that it fails to bring promising drugs in a short enough amount of time, and that it turns a blind eye to helpful treatments shown in studies that don’t follow its protocol.
But the stakes are high. And doctors are taught to follow The Hippocratic Oath, which says, “I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.”
So when another product was shot down by the FDA, despite visual benefits, one has to evaluate the entire picture to have a measured response.
Alimera Sciences was notified by the Food and Drug Administration (FDA) that two more clinical trials would need to be conducted to proved that their new drug, Iluvien is safe and effective for diabetic macular edema. This ruling by the FDA will result in a multiyear delay if Alimera would choose to proceed with the new trials and would necessitate a large investment of capital which Alimera does not currently have.
Iluvian is a tiny tube which is implanted into the eye and releases low daily doses of fluocinolone acetonide (a steroid) for up to three years. Laser treatments are the current standard of care to halt or slow leaking blood vessels in the retina. Side effects from the laser treatments include partial loss of peripheral and night vision.
While Alimera believes that Iluvien has a manageable risk to benefit ratio, the FDA decided that the risks of side effects were substantial and the benefits of the drug did not outweigh those risks.
Diabetics getting fewer eye problems, but experts still worried.
12.11.2011
A recent study released by the Centers for Disease Control (CDC) shows a decline in diabetics reporting vision problems. Researchers found a drop from 26 percent in 1997 to 18.6 percent in the number of diabetics reporting vision problems.
Better blood glucose control, blood pressure control and cholesterol management seem to be the factors contributing to the decreased incidence in vision problems among diabetics.
While the report is encouraging, researchers caution it may lead to a false sense of reassurance. The percentage of diabetic patients with impaired vision might increase substantially after newly diagnosed diabetics have lived with their condition for five or ten years. Researchers point out that one deficiency in the study is that the data was self-reported so the seriousness of the vision problems are unclear.
The study which was published in the November 18, 2011 issue of the CDC’s Morbidity and Mortality Weekly Report evaluated data from the 1997-2010 National Health Interview Survey. This survey of diabetics asked if they had any trouble with their vision and if they had seen an eye care professional in the last year.
In the United States, diabetes is the leading cause of blindness and the best way for diabetics to lessen their risk of vision problems is to regulate their blood sugar and see their eye doctor once a year.*
November is National Diabetes Month – Annual dilated eye exams encouraged
11.10.2011
November is National Diabetes Month and the National Eye Institute recommends that people with diabetes get annual dilated eye exams. One of the most prevalent and incapacitating complications of diabetes is diabetic retinopathy and a dilated eye exam is crucial in diagnosing and treating the condition early.
In addition to diabetic retinopathy, people with diabetes are at a higher risk for cataracts and glaucoma. Diabetic retinopathy typically has no symptoms until vision loss occurs which is why it is so crucial for diabetics to have dilated eye exams. Early detection can help prevent 90% of diabetes-related blindness.
Throughout National Diabetes Month, free diabetic eye disease resources are being distributed by the National Eye Health Education Program (NEHEP) to health professionals and community organizations that serve people with diabetes. You can visit http://www.nei.nih.gov/nehep to learn more about the NEHEP and get materials.*
Elise Ervin
Staff Writer
Free Eye Health Book this month to first 100 people that sign up
08.05.2011
We’re giving away my eBook, Ultimate Insider’s Guide to Eye Health this month only to the first 100 subscribers. To sign up for this free offer, go to http://www.visivite.com/get-free-ebook.html. It’s packed with insider’s information, advice and recommendations about Lasik, Contact Lenses, Dry Eye, Cataract Surgery, Glaucoma, Macular Degeneration, Diabetic Retinopathy, and more.
Paul Krawitz, M.D., President
Vitamin Science, Inc.
Can a Tuberculosis vaccine cure insulin dependent diabetes?
07.22.2011Results of a Phase 1 clinical trial offer hope to type 1 diabetic patients of a possible cure for type 1 diabetes. Researchers found that the generic drug BCG was able to temporarily reverse Type 1 Diabetes in humans.
Presently, BCG is approved by the FDA for use as a vaccine for tuberculosis and for the treatment of bladder cancer. The drug is now starting Phase II trials. In the Phase 1 trial, the BCG vaccine reversedType 1 Diabetes by elevating the tumor necrosis factor which is what is responsible for ridding the body of abnormal white blood cells which in turn are the proposed cause of type 1 diabetes. The BCG vaccine therefore enables the pancreas to produce insulin which keeps the blood sugar levels at acceptable levels.
BCG has been used for 90 years and is an inexpensive drug. The success of the Phase 1 trials offers hope to Type 1 Diabetic patients.*
Elise Ervin
Staff Writer
