Wednesday, July 24, 2019

Genentech's move to restrict the use of its drug Avastin, its Cancer Essay

Genentech's move to restrict the use of its drug Avastin, its Cancer Drug, by ophthalmologists on Eye - Essay Example in disallowing physicians and pharmacists from obtaining Avastin from wholesale distributors1, there are still questions pertaining to the motives which need clarification. Why do they have to restrict the distribution of Avastin for off-label use? Why did they have to refuse the proposal of the American Ophthalmologist Community to conduct a comparative study between Avastin and Lucentis in AMD? What are their motives in doing this decision? We cannot hastily justify, so we are not yet certain whether they are just protecting their own financial interests, or there might be other reasons behind this decision which necessitates such action. Even though the FDA approved the use of Avastin not for ophthalmic use, there is no issue of legality should physicians use the drug other than its recommended indication2, when the physician believe it to be appropriate, under his own risks of doing a medical malpractice3. Due to the drug’s anti-angiogenesis property, it was being used by physicians in treating various eye disorders precipitated by the leak caused by the blood vessels in the eye causing detachment of the retina4. The studies regarding the use of Avastin in eye disorders thru Pubmed search (limited to clinical trials and RCT and published within 3 years) reveals positive beneficial effects, yet requiring further long-term clinical studies. An attempt to investigate the long-term comparison between the two drugs was still on-going, yet an early result of the prospective randomized controlled trial reveals no difference between Avastin and Lucentis in effectiveness for choroidal neovascularizaton secondary to AMD5. Genentech’s decision to allow or suppress the availability of Avastin to the market may have legal implications that would threaten the company. The FDA approves the indication for the drugs after undergoing extensive research, toxicological assessments and clinical trials6. However, using the drugs beyond its indicated use, called

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