Sanofi Pasteur: Dengvaxia Controversy (April 2016 - Present)

       In 2015, the Philippine Food and Drug Administration approved the sale and distribution of a drug produced by the French drug company, Sanofi Pasteur. The drug is dengvaxia and it was supposed to help as a cure to the very widespread disease in Latin America and South America known as dengue. Dengue, also known as, “Break Bone Fever” is spread by mosquitoes and affects more than 400 million people worldwide while leaving nearly 500,000 people hospitalized yearly. Approximately 20% of those hospitalized, end up passing away due to the disease yearly. Infection rates in the Philippine’s alone can get as high at 90%. Symptoms of break bone fever can be very excruciating and can range from throwing up, pain behind the eyes, fevers, lingering weakness and joint pain. On the severe end of the spectrum, dengue can cause hemorrhage or shock that can result in death.

Jes Aznar for The New York Times

       Not too long after the first vaccination drive in schools, people started to figure out the dangers of the dengvaxia vaccination. Christine Mae de Guzman was one of the first students to receive the vaccines because she went to school in one of the regions that were given the vaccination drives at school. The vaccination is given in three doses, six months apart. Christine just finished up her second dosage when she started to have a throbbing headache. Days after having the second dosage and the throbbing headache, Christine passed away. Her death was the first event that sparked concern in the Philippine people and the Philippine government of the possible hidden dangers that the dengvaxia vaccine actually holds within. After his daughter’s death, Christine’s father said, “It was for health” when asked if he approved of the vaccination at the time.
       After concerns of the vaccine sparked, that is when Sanofi Pasteur released information about the vaccine that should had been released much sooner. They said that if you were not currently infected with dengue that you should not receive the vaccination because it can cause a worse strain of the infection that may lead to death. The people of the Philippine's began to feel as if they were the guinea pigs of Sanofi Pasteur.

Aaron Favila

The Philippine government stopped all vaccinations immedietly and demanded a refund from Sanofi Pasteur. Sanofi refused because they said they would then be accepting defeat when in fact people over nine that were not already infected, the vaccine was 66% effective in preventing dengue. While, people over nine that were already infected and then given the vaccine, it was 81.9% effective.
       Almost four year after the approval of the vaccine and almost three years after the first vaccination drive, the Philippine government is bringing Sanofi Pasteur to court to hold them accountable for what they hid and did to the country. The government is filing six criminal charges against Sanofi Pasteur officials over the death of fourteen children that were given the dengvaxia vaccine and passed away due to it. The Philippine justice department has found positive grounds that will allow them to hold Sanofi officials liable for, “Reckless imprudence resulting in homicide”.
       There are many stakeholders that are involved in this case. Some for bad reasons and others because Sanofi Pasteur put them in a bad situation. The biggest stakeholder is clearly Sanofi Pasteur because their name is now known as the one who released a vaccination that killed innocent children and kept the risks a secret for almost a year. This will affect their reputation, their trustworthiness and will cause their sales and business to drop for the years to come. Another set of stakeholders are all of the children that were given the vaccination because their lives are literally at stake. They were given a vaccination that could, in fact, take their lives from them because the vaccine could put a worse strain of the infection in their body. The Philippine government is the final stakeholder because they were the ones that bought all of the vaccines and distributed them to the children. They could lose the trust of their citizens due to the fact that they distributed something that could harm people when it’s supposed to help them. Even though the government didn’t know of the risks, citizens may still be hesitant to trust them because they may think it could happen again without the government pushing to really find out all side effects and risks of the drug they are giving out.
       Basic principles of Kantianism state that people should act rationally and to not consider yourself exempt for the rules of law or humanity. Kantianism says that you should allow and help people make rational decisions for themselves and respect other people’s individual needs and differences. The Formula of Humanity states, “Act in such a way that you treat humanity, whether in your own person or in the person of another, always at the same time as an end and never simply as a means” (Kant, MM 429). Simply put, through The Formula of Humanity, Kant is saying that you should treat people as another person. Do not treat them as an object and do not t treat them as if they are less than you are. Treat people the way you would like to be treated. If you would not do a certain action towards yourself then do not do it towards someone else. A Kantian would say what Sanofi Pasteur did to the Philippine people is clearly unethical. Sanofi distributed a drug for their own sake to make money and see how it would work because they knew it could get passed and distributed to the people affected by Dengue. They knew the possible harm that the vaccine could cause people who received it but did not tell the world for almost a year because they were using the people as test dummies (guinea pigs). By Sanofi not releasing the risks to the public in the beginning, they took the ability away from people for them to make their own rational decisions knowing what the risks are. Title 42 300aa-26 clearly states in section c that every company has to release all risks associated with the vaccine to the people before their vaccination. By taking away the ability to make rational decisions from the Philippine people, Sanofi did not respect people or their individual differences and needs.What Sanofi Pasteur did goes directly against the basic principles of Kantianism and The Formula of Humanity. They treated the Philippine people directly as a means and not as an end. Under the view of a Kantian, what Sanofi Pasteur did, is, in fact, UNETHICAL.
       The equation for individualism is, Individualism = Egoism (Selfishness) + Rights-based Constraints. This equation in words is saying that everyone has the right to pursue their own interests but they should not pursue them in a way that will hurt other people and that will take the ability away from other people to make decisions for themselves.In business ethics, there are two different types of individualistic views. One of those views is by Milton Friedman. Friedman said that the only goal of a business is to profit and to maximize profit for the owner and the stockholders. Friedman’s individualism does not consider a few things. Those things are; the identity of the company and leaders prior to investors, the motivation f investors to invest in socially responsible businesses and the motivation of customers and employees to choose socially responsible businesses. The other individualistic view is by Tibor Machan. Machan’s individualism says that the only direct goal of business is to profit, and the primary obligation of the businessperson is to maximize profit. Machan also states that the direct goal of profiting may have to be met by pursuing indirect goals first that are not directly aimed at profiting. On top of that, Machan’s individualism acknowledges that sometimes business people may have to prioritize goals other goals for the business over top of the goal to maximize profit. In the case of the dengvaxia controversy, a follower of Friedman’s individualism and Machan’s individualism would disagree with what Sanofi Pasteur did. Even though Sanofi Pasteur did what was in their best interest to maximize profit, they did not do it within the law or for the heath/safety of others. Sanofi released the dengvaxia vaccine because they knew it would make them a lot of money in countries that dengue is a large issue in.

This is because it was the first vaccine approved for use to help cure the infection. If you did not analyze the case any further past that point then someone following Freidman or Machan's individualism would find this case to be ethical because they did what they had to do to maximize profit for the business. Further analysis would show that there was very important information that Sanofi kept from the public. Sanofi hid important information from the public that could have possibly saved many more people from getting sick and saving fourteen young lives. When Sanofi did not release the facts about the use or side effects of the vaccine before distributing, they were maximizing profit without doing it within in the law. They hid important facts such as; you were not supposed to receive the vaccination if you were not infected and that if you did receive the vaccination without having the dengue infection then there was a ten percent chance you could get a much worse strain of the infection. Sanofi Pasteur had multiple chances to release vaccination information to the public before distributing the vaccine. They passed up on all of these opportunities so they could maximize profit for themselves but they did not do it within the law. They did not allow people to make choices for themselves; they made choices for the people, which is against all individualistic views and the equation of individualism. After much analyzation, under Friedman and Machan’s individualism, what Sanofi Pasteur did, is, in fact, UNETHICAL.
       The headline of utilitarianism is to maximize happiness in yourself and others. Studies have shown that the reason behind this is, if happiness is valuable, there is no difference morally speaking between my happiness and yours. John Stuart Mill was a very important voice for utilitarianism in the 1800’s and he said, “We ought to bring about happiness and pleasure in all beings capable of feeling it (and do so impartially). Utilitarianism in the dengvaxia controversy can be confusing in a way but overall, it is very easy to evaluate. Starting with how it can be confusing, people could argue that Sanofi Pasteur was giving this vaccine out to maximize their happiness by making money and maximizing happiness in others because it was giving them a cure to an infection that affects 400 million people worldwide. What Sanofi did was not maximizing happiness in others. They were selfish and did not release important vaccination information to the public because it made them millions of dollars and made themselves happy. Clearly, fearing death is not a sign of happiness, it is a fear of possible anger and sadness, which is the complete opposite of what utilitarianism, says. What Sanofi Pasteur did with the dengvaxia vaccination maximized happiness in themselves but not in the Philippine people or anyone else, that was receiving the vaccination. A person who closely follows utilitarianism would easily say that was Sanofi Pasteur did, is, in fact, UNETHICAL.
       Virtues are defined as the characteristics that allow things to function properly. Virtues depend on the things functions and the things circumstances. The virtue theory follow guidelines similar to those of Kantianism but in virtue theory, a follower would focus more on the means and less on the ends. A virtue theorist cares about a person’s character and how their actions define them as a person. Sanofi broke many important virtues that can show how strong or poor a business’s character is. To begin, honesty and trustworthiness are two big virtues that Sanofi Pasteur broke. They were not honest in any sense about the harm and risks of being vaccinated with dengvaxia. The Philippine government and citizens are not going to trust the company anymore because they were dishonest about a product that went to the extent of killing fourteen innocent schoolchildren.

Moderation is another important virtue that Sanofi violated. Sanofi Pasteur clearly lacked moderation because they released dengvaxia before it was fully functional and safe to vaccinate people. They rushed the release of the vaccination because they knew they could make a lot of money on it if people did not know the risks. That is when the vice of selfishness comes into play in this case. Sanofi Pasteur was all about that the money and the release that they would not even set up a fund for the families affected by the vaccination because they wanted to keep all of the money they could. In addition, when the Philippine government asked for a full refund, they refused because they said that they would be admitting defeat on the vaccine that in fact worked for some people. Finally, it was selfish of them to begin to release a vaccine that had side effects that could cause death and they did not even inform anyone about it until people started to get sick form it. From the perspective of a virtue theorist, what Sanofi Pasteur did in the dengvaxia controversy, is, in fact, UNETHICAL.
       What Sanofi Pasteur did to the Philippine people was completely disrespectful and inhumane. Under all of our ethical evaluations, there was not on theory that had any evidence or viewpoint to pass the dengvaxia controversy as ethical. Sanofi has their personal reasons to think that what they did was completely fine but they know deep down that they were doing it for the money and not for the fact that it could make millions of people feel better in a country where at one time 90% of the whole country and be infected with dengue at once. Most other business that did a lot of research on this case and knew what Sanofi did, would also say that this case is beyond unethical because of the way Sanofi treated other people and it resulted in the death of fourteen innocent children that could had been easily prevented if Sanofi forgot about the money and acted ethical.
       Sanofi Pasteur’s current issue is that they are under fire for hiding certain information from the public about their dengvaxia vaccine and what effect it has on people who receive the vaccination even if they are not infected with dengue. Sanofi’s current mission statement is, “Our Mission. Protecting and improving human heath worldwide us our main mission. We have to service an active role by providing, innovative vaccines for the prevention and treatment of disease and by playing an active role in the immunization community to maximize vaccination.” After the dengvaxia controversy, Sanofi Pasteur should change their mission statement to, “Our Mission. Make all humans knowledgeable of our vaccination information. To be honest about the side effects of our vaccinations, to protect and to improve the health of all humans that depend on us. This mission statement differs from their current mission statement because in this new one, we acknowledge how important the knowledge of our customers are and how we want to be seen as honest while also protecting the health of many just like in the prior statement. Sanofi should also consider smke new core values such as:

1. Customer Safety – This would tie in well with their mission statement of protecting and improving the health of all humans. Customer safety should be Sanofi’s main core value after the controversy because they need to make sure all of their customers are safe when receiving their vaccinations. Otherwise, controversies like this will come up repeatedly, resulting in money loss and possibly resulting in a shut down.
2. Honesty – Sanofi Pasteur making honesty one of their core values would be the smartest thing they could do. It would make everyone in their business see that every day and remind them of what the dengvaxia controversy did to their customers and their company. Seeing honesty everyday would make the company want to release all information about their vaccines to their customers so they can make their own decisions and see the risks of putting the vaccination into their body.
3. Happiness– Happiness would be a great core value for Sanofi. It would make them see happiness next to honesty and it would remind them of the dengvaxia controversy every time. It would show that not only is their happiness important but the happiness of their customers is even more important. It could remind people of different reasons to be happy even if it is something outside of work but that overall their mission is to make other people happy by helping their health.

       The company as a whole, Sanofi Pasteur should hire new executive employees and rethink their marketing department. Hiring new executive employees will allow the company to start fresh with new employees that they can give ethical training to. Rethinking their marketing department means they need to start marketing their new mission statement, core values and new executives instead of their products. This will show the world that they are trying to change and become a improved company ethically.

       To this day, the dengvaxia controversy is still going on. Sanofi officials are currently in court and on trial for reckless imprudence resulting in homicide. The action plan will help Sanofi Pasteur get back onto the right track profitably and ethically while the people of the Philippines get justice through the punishment of the old Sanofi Pasteur officials. Many innocent lives were at risk because of Sanofi’s actions and it affected many families for a long time. Using Kantianism, Individualism, Utilitarianism and Virtue Theory, the case is UNETHICAL.

By: Casey Rutkey

Works Cited:

       Caceres, Marco. “Dengvaxia Vaccine May Lead to More Cases of Dengue.” The Vaccine Reaction, 2 Jan. 2018, thevaccinereaction.org/2018/01/dengvaxia-vaccine-may-lead-to-more-cases-of-dengue/. Daniel, Ellen, and Ellen Daniel. “Sanofi Sued over Alleged Vaccine Death in Philippines.” Pharmaceutical Technology, 6 Feb. 2018, www.pharmaceutical-technology.com/news/sanofi-sued-vaccine-death-philippines/. 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. Murdoch, Lindsay. “Controversial Dengue Vaccine in Spotlight after Death of Filipino Children.” The Sydney Morning Herald, The Sydney Morning Herald, 6 Jan. 2018, www.smh.com.au/world/controversial-dengue-vaccine-in-spotlight-after-death-of-filipino-children-20180106-h0edmv.html. 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. “Vaccine Information Statements (VISs).” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 5 July 2017, www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.