Drug Companys Restriction of Distribution of a Drug: A Genentech on Avastin Restriction - Case Study Example

Drug Company’s Restriction of Distribution of a Drug: A Case Study of Genentech on Avastin Restriction to Ophthalmologists on Eye Introduction This paper will investigate the ethical and legal views of Genentech’s (Genetic Engineering Technology, Inc.) move in restricting Avastin’s distribution due to ophthalmologists’ use of the drug beyond its intended purpose in suppressing the growth of metastatic tumors through anti-angiogenesis. An analysis will uncover the issues on Genentech’s apparent financial interest against the public interest in obtaining an efficient but more cost-effective alternative to Lucentis. Although there is success in revoking the previous decision of Genentech 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. Optical Usage of Avastin 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. Legal Issues 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 ”off-label” use, is not illegal, only at the physician’s risk, depending on when he thinks of it to be appropriate. The drug is made for anti-cancer purposes but not for optical use intravitreously. There are barriers established by FDA for off-label use of drugs, yet not formal evaluation was established. The FDA prevents companies from advertising drugs beyond the indicated use, but will not prevent physicians to prescribe and administer the off-label use of the drug. Within three months, more than a thousand of AMD patients receive Avastin treatment, according to the Los Angeles Times7. It is not illegal for physicians to use the drug on ophthalmic use. However, it is uncertain whether Genentech will face any legal consequence should adverse effects occur for patients due to off-label use, other than the physician who administers it. Still, Genentech restricted the distribution of the drug even if it is not illegal for physicians to use it beyond the drug’s indication. What is known was that Avastin is not intended to be used intravitreously neither there were studies conducted by Genentech for this purpose. As long as Genentech does its “duty to warn”8, in informing the public of its possible danger when used beyond its indication, what legal consequences are they afraid of, if any? As cigarette manufacturers do their duty to warn by labelling “Government Warning: Cigarette Smoking is Dangerous to your Health” to their packaging, they will not face legal consequences should cigarette users manifest lung cancer, emphysema, and others. The same case in Avastin: placing as warning label on its packaging as “Not for Optical Use” will prevent them from undergoing legal consequences should ophthalmologists use the drug to the eye. Ethical Issues Although it has nothing to do with the ethical dimensions in treating study participants, the same ethics concepts can be applied to Genentech’s move. The ethical principles of beneficence and nonmaleficence9 shall be assessed regarding the decision made by Genentech to restrict Avastin distribution. Beneficence. Genentech is aware on the potential benefits of Avastin in the field of ophthalmology, and the researches done that suggest positive effects of the drug. It might be true that using the drug in an off-label purpose might be dangerous when used intravitreously (though no evidence so far), but the potential benefits outweigh the risks. Have they made an effort to reformulate Avastin for ophthalmology use? Can they just consider this drug to be just an alternative, if not the best, to the more expensive Lucentis? They are aware on how many patients with AMD would benefit from using the drug off-label, so this will be an issue that the decision does not consider the principle of beneficence. Nonmaleficence. If not for financial interests, perhaps Genentech’s concern would be the prevention of unnecessary risk or harm in using their product for off-label purpose. Their research of Avastin on optical application is not as extensive as what they did to Lucentis, so they are still uncertain if the drug is safe to use intravitreously. As an effort to minimize the dangers it may entail, Genentech made efforts to restrict the distribution of the drug to prevent the harm to patients due to its off-label use. They explained the risks involved in using the drug for optical purposes. However, should there be potential harm in using the product for optical use, what research have they made to test the safety and efficacy of Avastin administered intravitreously? If they can perform rigorous clinical trials for the more expensive Lucentis, why can’t they perform the same extensive research to the optical use of Avastin? Nonmalificence might be a factor, but not sufficient enough to justify their decision. Analysis The question remains about Genentech’s intents, if not to prevent legal consequences. Critics only see its financial intentions in restricting Avastin distribution, despite the company’s defence to this10. They are aware on how Avastin was be used by ophthalmologists as the mechanism of action between the two drugs are identical, only designed differently. If Avastin manifested positive effects in improving the condition of patients with AMD, why should they make a move to suppress it? Why do they refuse participating in comparative studies between Avastin an Lucentis in treating eye disorders11? The use of Avastin beyond its indication is not illegal and Genentech will not face legal repercussions should physicians decide to use it other than oncological purpose, yet they take action to restrict the distribution, if not totally phase it out from the market nor to disallow ophthalmologists to prescribe Avastin for ocular conditions. No wonder why many question their motives in doing so. If their concern is sincere, they won’t do anything to prevent the discovery of a less-costly alternative other than the more expensive product they are trying to market. Conclusion It is still uncertain whether Genentech’s motive was just to protect their financial interests in restricting Avastin distribution for ophthalmology or whether they are simply concerned about the risks due to non-intended use. The decision might be rooted from the principle of nonmaleficence in preventing unnecessary harm due to off-label use of the drug, but beneficence is ignored, knowing the potential benefit of the drug for optical use. This move was almost 3 years ago, and since the restriction was not successful, it is no longer necessary to conduct an in-depth case study as this won’t give much benefit than conducting a randomized clinical trial to compare the safety and effectiveness of the two drugs. More prospective, long-term, randomized clinical trials are recommended instead of putting too much emphasis on past issues which are already resolved. Read More