Lucentis & Avastin, pt. 2

USA Today

In November, I published a post about the drugs created by Genentech, Lucentis and Avastin.  Lucentis is most commonly used to treat macular degeneration and costs about $2,000 an injection.  Avastin is only approved by the FDA to treat cancer, but studies have shown that it is as effective as Lucentis when used to treat macular degeneration, so it is commonly prescribed off-label because it only costs about $50 per injection.  This cost difference ended up saving the government and patients more than hundreds of millions of dollars each year.

My previous post discusses the ethics of using drugs off-label in return for kick backs from pharmaceutical companies, but the point of this post is to illustrate why I am always wary of the use of drugs off-label.  This story by Andrew Pollack in the New York Times reinforces my original thought.

According to Pollack, about 21 patients located in Miami, Nashville and Los Angeles that have been treated with Avastin for macular degeneration and other eye diseases have experienced serious side effects including: eye infections, loss of vision and brain damage.

The infections are thought to be caused by bacterial contamination of the drug, which can happen easily because "to use Avastin for eye disease, a vial meant for a cancer patient must be divided into numerous tiny doses and each dose placed in a syringe for injection into the eye. The extra handling increases the risk of bacterial contamination and other problems" (Pollack, 2011b).

Because these problems occurred when the drug was being used off-label, Genentech is not accepting responsibility for the infections:

"Genentech said it would not comment on the litigation, but said that it had always cautioned against use of Avastin in the eye.  'Avastin is not manufactured or approved and to date has not been proven safe for use in the eye,' a spokesman for the company said Tuesday" (Pollack, 2011a).

Even though drugs that are approved by the FDA are sometimes recalled or are found to cause harmful side effects after approval due to a longer "testing period" on actual consumers/patients, I think that this example proves that doctors and pharmaceutical companies need to be more careful when promoting the use of drugs off-label.  One thing important to point out, however, is that "the 12 cases of lost vision in Miami had been traced to a single compounding pharmacy" (Pollack, 2011b) and Avastin has been prescribed over the past 6 years with few problems.