Tuesday, April 2, 2019

Sanofi Pasteur: Dengvaxia Causing Deaths of Children(2016-Present)

       Sanofi Pasteur is a global life science company committed to improving healthcare access worldwide. The non-profit company believes in a world where no one suffers or dies from a disease that has a preventative vaccine. Dengvaxia, is a vaccine researched and developed by Sanofi to combat the dengue virus. The dengue virus is a mosquito born virus that is indigenous mainly in Latin America, Southeast Asia and the Pacific islands but occurs worldwide. More than one third of the world is at risk of infection and the symptoms of the virus are flu like. Severity of the virus can vary from no symptoms to hospitalization in extreme cases leads to death. In early December of 2017, the French company faced backlash after failing to inform the public that the vaccine could potentially increase the risk for some to develop a severe form of the disease. The Philippines suspended the vaccine after the public grew anxious over its safety. After being used on 830,000 school aged children during 2016-2017, Sanofi Pasteur received negative publicity worldwide.

       This case drew attention to the rest of their business leading researchers to believe that the drug makers could not be trusted. The Philippine's government began looking for more information regarding the campaign for the vaccine to determine if it was misleading. Dengvaxia was approved in 19 countries and was the first to combat the virus. Death rates of dengue were about 90% in the Philippines and the highest death population was in children. This is clear evidence as to why Sanofi had a high motive to release the vaccine. What the company failed to do was properly inform the public. Those who had never had dengue were put at risk if given the vaccine. Without any way to test for the disease it puts anyone without the dengue at risk.

       The controversy continued for over a year and a half. In March of 2019, the Philippines government officially released it would be filing criminal charges against Sanofi Pasteur. Prosecutors in this case claimed that Sanofi approved the vaccine too soon and the public was not aware that the vaccine did not pass clinical trials. Prosecutors also alleged that the personnel who administered the vaccine were under qualified. Francisco T. Duque III, Philippine health secretary, claims that the government demanded a refund from Sanofi for 3.5 billion Philippine pesos. This is equivalent to about $69 million dollars. The Philippine government also requested that Sanofi created a fund to contribute to the treatment of any children who developed a severe case of dengue after taking the vaccine. Children and families trying to prevent the dangers of dengue put trust in Sanofi to be protect them. However, the vaccine ended up putting them at an even higher risk. “It’s been very devastating for almost the entire country”, said Dr. Leonila Dans, an epidemiologist at the University of the Philippines in Manila. Sanofi acted unethically on multiple occasions. Sanofi should have been more aware of the risks they were taking, especially while holding the lives of millions in their hands. They tried to justify their actions by emphasizing the benefits the vaccine did have, even though it was obvious the vaccine was not completely safe. As a result of this major controversy, Sanofi lost about $117 from decreasing sales. Michel De Wilde, the former Senior Vice President of Research and Development at Sanofi Pasteur addresses the incident as “a huge disappointment” and a “big lesson in humility."

       In this conflict, a stakeholder is any person or organization that was affected by the outcome of the decisions the company made. This also includes anyone who contributed to the choices that were made. Sanofi Pasteur and the Philippine Government are both major stakeholders in this case due to one funding the vaccine and the other administering it. Other stakeholders include the children and families of all who received the vaccine for being put at risk. The scientists who created the vaccine, the Food and Drug Administration (FDA), and the Department of Health (DOH) are all responsible for creating and releasing this vaccine without guaranteed safety.

       Individualism, originally written by Friedman, focuses primarily on increasing and maximizing profit. Meaning, for a business to reach its maximum potential and be most successful, its main vision is generating the highest possible amount in profit. Individualism also states that reaching maximum profit must be done within the constraints of the law, in order to be ethically permissible. According to the theory of individualism, Sanofi Pasteur’s actions would be deemed as ethically impermissible. A company devoted to vaccines decision to administer a vaccine, that resulted in the deaths of 14 children, cannot be ethically acceptable. Although the company claims that there was no direct link to the vaccine and death, there was also no strong scientific evidence to prove their statements to be true. Moreover, to state something that may or may not be true to the public, especially when the lives of many are on the line, is highly impermissible. These actions do not stay within the constraints of the law nor does it focus on generating profit effectively. By having the vaccinations be government funded, the focus was more on the effects of the vaccination and not focused on receiving the most money they could from each vaccination. A more effective way to generate profit long term would have been to wait to administer the vaccine until it was known to be safe and there were no health-related risks associated with it. This way, the company could have flourished and saved more people and themselves in the long run.

       The goal of Utilitarianism is to maximize self-happiness and the happiness of others. According to utilitarian, happiness is the natural end of human life, so the desire to have maximum happiness needs no justification. Under the theory of Utilitarianism, Sanofi failed to act ethically. As mentioned previously, Sanofi deemed it their mission to help prevent suffering in a world where it is possible to create vaccines. This logic resembles the intentions of Utilitarianism because it seems as though they want to spread happiness by creating vaccines for deathly diseases. Even after the company experienced backlash, they tried to stray from the negative attention and focus on the positive attributes of the vaccine. This failed to increase the public’s happiness even more because they grew confused and anxious over the intent of the company. It was unclear whether or not Sanofi was trying to take advantage of them or persuade them in a misleading manner. A more effective way to respond would have been to release a press statement apologizing for their terrible mistakes and the tragedies they caused. Sanofi’s actions caused feelings of fear, anxiety, confusion, mistrust and devastation over those who were affected by the vaccine. The fact that the lives of children were put in danger was extra devastating because it is tragic for young lives to be put at risk or taken away making this very unethical.

       The economic theory of Kantianism places emphasis on the importance of having clear and honest motivation. An ethical company, under this theory, must communicate its intentions in the products, services or ideas they are selling to users. Companies must act fairly and with the intent of benefiting and helping others. In this case, Sanofi Pasteur’s initial intentions seemed rational and honest. Although their intent may have been pure, they did not follow through in their actions. They failed to clearly communicate the risks and dangers of the vaccine they created. This leads into the Formula of Humanity stating that people or customers must never be treated as a mean to an end. When considering a goal, the affected users or customers must be treated with respect, and not considered as just subjects in terms of the greater good. This involves not taking advantage of people or customers. If customers are treated any less, just to make the situation easier, it is no longer permissible. Furthermore, if the company withholds any information in order to adjust the outcome of a situation, their actions would be considered unethical under this theory. Sanofi Pasteur failed to act ethically in this situation because they did not ensure the safety of those who received the vaccine. They also failed to display rational thinking when they denied the connection between their vaccine and the deaths of 14 children. Ultimately, Sanofi Pasteur did treat these people as a mean to an end. In Salazar’s Kantian Business Ethics, the Kantian approach emphasizes respecting all autonomous beings. A major factor when considering a Kantian approach is the Formula of Universal Law.

       When determining if a conflict is ethical, the four virtues of character are considered. These characteristics are courage, honesty, self-control, and justice. Sanofi initial actions could be seen as courageous. They released the first vaccine known to combat the deadly disease. However, once the controversy began in 2016, the company did not act so courageously. It was discovered that they did not take proper precaution when administering the vaccine. Also, they did not respond effectively when the vaccine was linked to the harm and even deaths of those who took it. According to this characteristic, Sanofi failed to be virtuous. Similarly, it is unclear if the company displayed honesty throughout the controversy. They seemed hesitant to acknowledge the harms of their vaccines and it was up to outside researchers to search for further information. Under these terms, Sanofi failed to be completely honest. In regards to self-control, Sanofi did have reasonable desires. Their vaccine was somewhat effective and their desire was to simply provide a vaccine to prevent dengue. On the other hand, their expectations were not reasonable. It seems as though they expected their vaccine to work efficiently without taking preliminary measures. After the controversy began, it was clear that their expectations did not match up with the reality of the situation. Thus, Sanofi did not act virtually throughout this situation. Lastly, the characteristic of justice must be analyzed. Sanofi did demonstrate good ideas with the goal of preventing dengue. However, they did not fulfill this ideas because they did not create a quality product (vaccine). The vaccine they created had health risks associated and caused a public uproar. It is unclear whether or not Sanofi “worked hard” throughout this process. Since it is not clear, Sanofi’s actions cannot be considered actions demonstrating justice.  Therefore, Sanofi’s actions must be considered as unethical according to the Virtue Theory.  

       Sanofi Pasteur’s core values are accessible vaccinations, research and the health of their customers. It is evident that they display these values in their work and that they are motivated to find vaccines for diseases, like dengue, that are killing millions worldwide. Sanofi’s mission statement is “to provide vaccines to those in need. To research illnesses and strive to find ways to cure those who are suffering”. The major issue in this case are the deaths of the children related to the vaccine that Sanofi administered. Other issues raised by this case are the ethical actions displayed by the company. To prevent this in the future, the company needs to ensure that all patients are in full understanding of what is associated with the vaccines they are receiving. Sanofi must also make it public that that will be taking preventative measures from now on and that this case has opened their eyes. They must ensure the public that they are going to reevaluate their processes and procedures. This can include more in depth, preliminary testing and thorough research. This could help prevent the first human trial from having so many potential harms and risks. In order to move on from this, those responsible for not properly informing patients should be fired from the company. They must also fire any under qualified personnel and the scientists responsible for approving the vaccine. These actions will help to restore their image as a company. Sanofi needs to promote their new methods and measures. This will help to diminish some of the negative publicity. With this plan, Sanofi will be able to continue producing the vaccines that people need while simultaneously ensuring their safety. Sanofi must focus on patience and keeping the health of their customers as their number one priority. If Sanofi adopts more thorough methods of testing the vaccines and hiring only qualified personnel, they should be able to develop into the successful company they strive to be. This will help them to achieve the statements in their mission and also help make up for the damage they caused in this controversy.  
-Tyler Clark

Work Cited:
Dyer, Owen. “Philippines to Charge Sanofi Staff and Government Officials over Dengue Vaccine.” The BMJ, British Medical Journal Publishing Group, 7 Mar. 2019, www.bmj.com/content/364/bmj.l1088.
Grady, Denise, and Katie Thomas. “Drug Company Under Fire After Revealing Dengue Vaccine May Harm Some.” The New York Times, The New York Times, 17 Dec. 2017, www.nytimes.com/2017/12/17/health/sanofi-dengue-vaccine-philippines.html.
Hackett, Don Ward. “Philippines Dengue Outbreak Claims 28 Lives During 2019.” Precision Vaccinations, Precision Vaccinations, 20 Feb. 2019, www.precisionvaccinations.com/dengue-virus-outbreak-philippines-has-reached-epidemic-levels.
Hackett, Don Ward. “'Where Is the Proof Dengvaxia Vaccine Linked to Philippines Deaths' Says Sanofi.” Precision Vaccinations, Precision Vaccinations, 7 Feb. 2018, www.precisionvaccinations.com/dengvaxia-vaccine-may-make-future-dengue-episodes-more-severe.
“Questions and Answers on Dengue Vaccines.” World Health Organization, World Health Organization, 24 Apr. 2018, www.who.int/immunization/research/development/dengue_q_and_a/en/.
“Sanofi Updates Information on Dengue Vaccine in Philippines.” Press Statement by Sanofi Pasteur Philippines, 2017, www.sanofi.ph/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-PH/Home/press-room/Sanofi-updates-information-on-dengue-vaccine-in-Philippines.pdf.
staff, Science X. “Philippines to Charge Sanofi Officials over Dengue Vaccination Deaths.” Medical Xpress - Medical Research Advances and Health News, Medical Xpress, 1 Mar. 2019, medicalxpress.com/news/2019-03-philippines-sanofi-dengue-vaccination-deaths.html.
VogelApr, Gretchen. “A New Dengue Vaccine Should Only Be Used in People Who Were Previously Infected, WHO Says.” Science, 19 Apr. 2018, www.sciencemag.org/news/2018/04/new-dengue-vaccine-should-only-be-used-people-who-were-previously-infected-who-says.

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