The Genentech Conundrum: Profits or Access to Medications?
Biotech giant Genentech is moving towards restricting the use of its cancer drug Avastin to treat wet age-related macular degeneration (WMD), the most common cause of blindness in the elderly. Currently, many ophthalmologists use Avastin to treat WARMD even though it was not approved by the US Food and Drug Administration (FDA) for that indication. For those of you who may not know, physicians who are licensed to practice medicine in the United States are permitted to use approved medications to treat any disease or condition if they believe that the medication is in the best interests of a patient. Genentech said it is restricting Avastin use because it recently won approval for a new drug called Lucentis to treat WARMD. Many ophthalmologists started using Avastin (which has the same mechanism as action as Lucentis) before Lucentis won approval from FDA in June 2006. The New York Times reports that Lucentis is being used to treat 55 percent of new patients with WMD and Avastin accounted for most of the rest of the patients — or nearly half the market.
From a medical and regulatory standpoint, Genentech is justified in restricting the use of Avastin to treat WMD because it was not approved for that indication. Further, promoting or encouraging off-label use medications is a big regulatory no-no! Nevertheless, many ophthalmologists suspect that business rather than medical reasons are what is driving Genentech’s decision to restrict the use of Avastin—Lucentis costs about $2,000 per dose whereas Avastin only costs $50 per dose.
The WMD market is a large one with 200,000 new cases of wet macular degeneration diagnosed in the United States each year. Analysts report that sales of Lucentis were $209 million in the second quarter of 2007 which means that using Lucentis instead of Avastin could easily add more than $1 billion a year in annual revenues for Genentech.
Many physicians choose to treat WMD with Avastin rather than Lucentis because the high cost of Lucentis inhibits its use because of drug formulary restrictions and onerous insurance co-pays. This leads me to posit the following questions:
Is it ethically and morally acceptable to block patient access to the best available medical care simply because a company wants to maximize its profits and keep its stock price high?
Or should biotech companies price their products at more affordable levels?
I will let you decide.
Until next time….
Good Luck and Good Job Hunting!!!!!!!!!!!
