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Off-label use of the cancer drug Avastin

Canada’s Macular Degeneration Treatment Controversy

 By Alan Caruba  Saturday, April 28, 2012

Having known friends experiencing macular degeneration (AMD), a medical condition that can lead to blindness, my attention was caught by news of a growing trans-Atlantic controversy regarding an off-label use of the cancer drug Avastin, which has not received formal approval as an AMD treatment in Canada, the European Union, England, and the United States.

Avastin, an approved drug for chemotherapy and intended for intravenous therapy for cancer treatments, is being used by some doctors who extract smaller, sometimes imprecise amounts for injection into the eye. It is a risky treatment that even the manufacturer has warned against.

Eye care journalist Marilyn Haddrill reported on the news site All About Vision that at one point, the manufacturer “cited safety issues as the reason for halting sales of Avastin to compounding pharmacies that have been dividing Avastin into the smaller quantities used for treating the eye.” Those sales have resumed and the drug is still available to individual doctors.

The situation in Canada is particularly acute.  As early as 2008, it was reported that off-label use of Avastin caused outbreaks of serious eye inflammation at four Canadian health centers where people had received eye injections for macular degeneration. Further risks were found in an April, 2011 study by the European Alliance for Access to Safe Medicines which reported that between 2007 and 2009, unlicensed use of Avastin for AMD resulted in 105 adverse reactions in Canada alone, more than any other nation in the study’s report.

In January, the website My Vision Test further reported that Health Canada had issued a warning to the public and doctors “about cases in the U.S. that have been linked to off-label use of the drug Avastin.”

The website, JunkscienceMom, praised by Fox News’ John Stossel and the American Council on Science and Health, posed a provocative question in an April 26 posting:  “Imagine, if you will, that your elderly relative—say your grandmother—comes down with a serious, degenerative health condition. There are two treatment options. A doctor can give her an FDA-approved drug that has a long track record of success. Or a doctor can take a vial of medicine that’s used to treat a different disease, extract a small amount out of that vial (increasing the risk of both bacterial contamination and dosage error), and then apply it to your grandma—in a way the drug was never intended to be used.”  It’s a valid question.

Canada is not alone in trying to manage this risk.  The U.S. Food and Drug Administration (FDA) has issued an alert cautioning that “repackaged Avastin may pose infection risks” based on a cluster of serious eye infection cases that occurred in Miami after its use. Clusters of a similar nature have been spotted elsewhere in Florida, as well as in Tennessee and California, and several patient lawsuits have been filed.

The situation in America was further complicated as recently as April 26 when the FDA sent letters to doctors in 12 states, requesting they cease using Avastin and acquiring it from a foreign distributor known for selling unapproved and counterfeit drugs.

The difference in cost between Avastin and Lucentis, which is FDA approved for AMD treatment, may explain why some eye doctors have recommended Avastin to their AMD patients. In the U.S., Medicare and insurance company co-payments have added to the controversy while in nations where public health services put a high priority on containing costs, such as Canada and England, the temptation to use Avastin is further increased.

For now, those suffering from macular degeneration are being asked to choose between the two drugs, mostly based on cost, and at the risk of Avastin-related complications. The increase in reported cases of infections and blindness is a very bad choice. The Hippocratic Oath, “first do no harm”, is being ignored.

© Alan Caruba, 2012

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Alan Caruba  Bio
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Alan Caruba has a daily blog called Warning Signs. His latest book is Right Answers: Separating Fact from Fantasy.
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