Op-Ed: Causing Blindness

September 7, 2011

By Alan Regenberg


Last Tuesday, the NY Times published an article entitled “Avastin injections are reported to cause blindness”. This is a great example of a terrible headline. A less misleading/more accurate headline, “Contaminated Avastin injections from a single pharmacy are reported to cause infections, blindness in at least 12 patients”.  I should note that the remainder of this article presented the story in a reasonably accurate and balanced manner.

 

By way of some very brief context – the sad chapter described in this article adds to an already depressing saga about drug pricing, health policy, and the drugs Avastin and Lucentis for the treatment of a form of age-related macular degeneration (wet-AMD).

 

As the article indicates, the off-label use of Avastin to treat wet-AMD costs about $50 per injection as compared to $2000 for an injection of the virtually identical Lucentis (Lucentis is FDA approved for the treatment of wet-AMD).  The budgetary/health policy implications of being 40 times as expensive can be further magnified by the approximately 250,000 patients treated for wet-AMD annually in the US alone.

 

A Genentech spokeperson correctly notes that Avastin is not manufactured or approved for use in the eye. The spokesperson, however, also asserts that Avastin has not been ‘proven safe’ for use in the eye. Like the headline, this statement is misleading.

 

The most recent major study comparing Avastin and Lucentis appeared in the New England Journal of Medicine this past May. This study again demonstrated that Avastin and Lucentis had similar effects when used to treat wet-AMD. The study did show a statistically significant increase in the Avastin group for certain types of adverse effects. But, the actual rates of adverse effects, in either case, was consistent with both drugs being deemed ‘safe’. In addition, the study didn’t include enough subjects to be able to offer decisive evidence about these sorts of adverse effects, more study is required. The NY Times article also notes that there is vast experience with Avastin in practice, with an estimated two million injections into eyes in the US alone since 2005.

 

The irony in this particular case is that while Genentech’s spokesperson is voicing concerns about the safety of Avastin, their policies can be seen as, at least, partially responsible for this particular mishap (with contaminated doses infecting and blinding patients). It seems just as reasonable to say ‘Genentech’s pricing policies cause blindness’ as ‘Avastin injections cause blindness’. If this manufacturer were primarily and broadly concerned about safety, they could either seek FDA approval for the use of Avastin for wet-AMD, allowing them to sell carefully prepared $50 doses manufactured in their facilities with carefully monitored good manufacturing practices (this ought to still result in profits, assuming that their initial pricing of Avastin was sound business). Alternately, they could simply reduce the price Lucentis to a level where it’s reasonably competitive with Avastin eliminating the incentive to use Avastin for wet-AMD.

 

Without going too far down a complex path, what might be required is more stringent regulation of drug pricing in the US. We should expect a for-profit corporation to be primarily motivated by maximizing profits, thus we should have a robust mechanism to restore balance when profits inevitably collide with concerns like health and safety, such as is the case here.

 

Alan Regenberg, MBe, is the Bioethics Research Manager at the Johns Hopkins Berman Institute of Bioethics. He is currently developing strategies to use social media as a tool for broad public engagement around issues in bioethics. You can follow him  @bermaninstitute or, using his inside voice @aregenberg.

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