Tuesday, April 2, 2019

Sanofi Pasteur: Dengvaxia Causing Death in Children (April 2016)

Sanofi Releases a Deadly Vaccine

     Sanofi Pasteur is the vaccines division of the French multinational pharmaceutical company Sanofi.  In April of 2016, Sanofi Pasteur released a new vaccine for the disease Dengue called Dengvaxia. Dengue, also known as “Break Bone Fever”, is a mosquito born viral infection that affects more than 400 million people and kills 250,000 people in tropical and sub-tropical climates world wide each year. The virus has multiple symptoms such as pain behind the eyes, joint pain, and other flu like symptoms. Dengue has four strains: Dengue 1, Dengue 2, Dengue 3, and Dengue 4 which is also known as Severe Dengue. If strain one is left untreated, it has the potential of developing into Severe Dengue and causing hemorrhage or death. Before Dengvaxia existed, there was no licensed vaccine for Dengue.  
     One of the countries that purchased the Dengue vaccine was the Philippines. The Philippine government mandated that 830,000 school children get the vaccination. Once the vaccination process was well underway, some of the children began to fall very ill and ended up dying. Because of these deaths, the vaccinations were immediately suspended and the Philippine government reported it back to Sanofi. Once the reports of the deaths reached Sanofi, they then released a side effect of Dengvaxia that was previously not made public. The side effect was that if an individual were to receive the vaccination with no prior exposure to the Dengue virus and then later on came in contact with it, they would be at an elevated risk of developing one of the more severe strains of the disease. Sanofi failed to release this information before it released the actual vaccine. When this information was made public worldwide, Dengvaxia was banned for sale, distribution and imports from there on out. 
The Philippine government was furious at Sanofi for withholding the information from them until after they had already begun their vaccinations. In response to the situation, the Philippine government called on Sanofi for a refund of 3.5 billion Philippine pesos, which is about the equivalent of 69 million U.S. dollars. The government also called on Sanofi to set up a fund to cover the treatment of any child who developed Severe Dengue as a result of getting the vaccine. Sanofi did not give assistance to any of the families that were affected by what had happened or any families whose children developed Severe Dengue after the fact. Sanofi also never gave the Philippine government the money they asked for as a refund for the vaccines.
     The people of the Philippines felt as though they were taken advantage of and used with no remorse as to what could happen. Leovon Duneyro, a father whose youngest son was given the vaccine at his school, claims that Sanofi knew about the risks all along. “We weren’t told it was not safe… they made my son and other students as their guinea pigs,” said Duneyro. He also made some accusations that Sanofi could have possibly conspired with corrupt Philippine officials to circumvent regulations, but Sanofi denied all these claims. 
     In this case there are several stakeholders. They include Sanofi Pasteur, pharmaceutical companies, the Philippine government and the country as a whole, the families of the children vaccinated along with the children themselves, and other people withe Dengue around the world. Sanofi Pasteur is the biggest stakeholder because their reputation on all aspects is now ruined. They will be known for sending out a vaccine that clearly was not ready to be used and killing innocent schoolchildren in the process. On a pharmaceutical level, companies that would normally purchase vaccines from Sanofi might now find another company to buy from since they may believe that the vaccines they are purchasing might not be as safe as Sanofi claims they are. The Philippine government is also affected in this situation because it is there people who were injected with a vaccine that they purchased and mandated. Another stakeholder in this case would be all the families of the children vaccinated and they children themselves. Those children were given a vaccine in confidence that it would help protect them and it ended up doing the exact opposite, it made everything worse. The final stakeholder in this case is the people in other parts of the world that have Dengue. These people witnessed what happened in the Philippines and now if a new vaccine ever does surface, they will always have this disaster lurking in the back of their minds.
     This specific case will be analyzed using four ethical theories. The first theory used is individualism. Individualism focuses on maximizing profit as much as possible as long as the law permits it. Within individualism there are two different perspectives: Milton Freidman’s and Tibor Machan’s. Freidman’s view states that there is only one goal of a business and it is to generate as much profit as possible for its owners and stockholders. Friedman says that something is wrong if it does not fall within the law or “within the rules of the game”. Tibor Machan shared the same view when it came to maximizing profits; he believed that maximizing profits was by far the most important thing however a business can have other goals that are not exactly aimed at profits. In both of these perspectives, the main goal is to maximize the profit while still abiding by the law. When applied to the Saonfi case, these perspectives say that what Sanofi did was not right. They were trying to maximize profit, but they did not do it within the law. Sanofi released a vaccine that had severely detrimental side effects to solely maximize their profits. They knew that because Dengue is such a popular disease, countries would be willing to pay a lot of money to get their citizens a vaccine that would protect them. Sanofi advertised that this vaccine would do that, but it did the opposite.
     The second ethical theory used to analyse the case is Utilitarianism. Utilitarianism is an ethical theory that’s main goal is to maximize happiness in yourself, others and all other conscious beings. According to utilitarianism one must choose the action among alternatives that gives the best consequences for all in the present and the future. The reasoning behind this is that if happiness is valuable, there is no difference morally speaking between one’s own happiness and others. Happiness or pleasure are the only two things in utilitarianism of intrinsic value. If a utilitarian were to analyze this case, they would have several problems with it. To start, Sanofi failed to fully disclose how dangerous the vaccine could be. They were putting their own profit before the happiness and well-being of people all over the world. They knew that there could be detrimental consequences if someone who had never been exposed to Dengue got vaccinated, but they didn’t say anything because they wanted to profit by selling the vaccine. Even when they did get the chance to make things right and bring some happiness into the families’ who were affected lives, they denied their opportunities. Sanofi believed that if they helped the families who suffered in the situation, they would be admitting that they did something wrong, and they did not believe that they were in the wrong.
     Kantianism is the third ethical theory that is being used to analyze this case. Kantianism is all about giving people what they need in order to make their own rational decisions, nothing should be hidden from or influencing someone making a decision. The Formula of Humanity states that people should treat other people as equals, never treat someone as if you are superior. It restates Kant’s main ideas about treating people with respect and giving all the information needed to make decisions when decisions need to be made. A Kantian would not agree with what Sanofi did. Sanofi hid a crucial piece of information that would have drastically changed the decision-making process of the Philippine government when they were deciding whether or not they wanted to purchase the vaccine. They hindered the decision-making process which according to Kant is morally wrong. Sanofi also did not treat the people of world suffering from Dengue the way they would have wanted to be treated. They used the people of the Philippines with the disease as lab rats and used them to maximize their own profits. If the Sanofi officials were the ones with a possibly life-threatening disease, they would have wanted people who were working their very hardest to find a cure, not people who were working their hardest to earn a bigger pay check. 
      The final theory that is being used is called the virtue theory. The four main virtues within the virtue theory are courage, honesty, temperance/self-control, and justice/fairness. Aristotle believed that in order for someone to be virtuous and have a virtuous filled life, they must have a rational sense of mind. This rationality will help them function in their everyday lives well and if something achieves their function that thing is said to be happy. When looking at Sanofi from the perspective of a virtue theorist, they did not follow any of the core virtues. Starting with courage, Sanofi did not have any at all. They were given countless opportunities to own up to what they did and make it right, but they denied all of those chances. Sanofi refused to provide assistance to the families that suffered through their mistake because they did not have the courage to own up to the fact that they did in fact make a mistake. They released a drug without fully disclosing its side effects and that was wrong. The next virtue that Sanofi broke was honesty. They failed to be truthful about how dangerous their vaccine could be to a person who had never been exposed to the disease beforehand. Sanofi lied to everyone they sold Dengvaxia to because they said it was a safe vaccine when it was not. Once they released how dangerous the vaccine was, they lied again by not admitting to the fact that they did anything wrong. The third virtue that was broken by Sanofi was regarding temperance and self-control. Sanofi had the chance to tell the world the truth about the vaccine before they released it for sales, but if they did that they would not have been able to release it and thus they would have lost a lot of money. They did not have the self-control needed to do the right thing; instead they gave in and did the thing that would maximize their profit. The final virtue in the virtue theory that was broken by Sanofi was regarding justice and fairness. By not giving the public all the information they needed to make proper, rational, decisions, Sanofi was being unfair. They were clearly only thinking about benefiting the company and not taking into consideration that people lives were on the line. Overall, Sanofi broke every main virtue in virtue theory which means that a virtue theorist would consider what they did to be unethical. 
     After analyzing the case thoroughly, it is clear to me that what Sanofi did was extremely unethical. What Sanofi did should never have been done by any company and should never be done by any company again. They deliberately hid an important piece of information about one of the side effects of the vaccine Dengvaxia. The side effect was that if the vaccine was given to an individual who had never been exposed to the disease Dengue and was then later exposed to the disease post vaccination, they would be more likely to develop the severe strain of the disease which could lead to death. Sanofi did this because they saw an opportunity to maximize their profit; they didn’t take a step back and think about the consequences of their actions. What Sanofi did was selfish, disrespectful, and overall very unethical. 
      After the recent backlash from the public about the Dengvaxia scandal, a good idea to help the company bounce back would be to reinvent the company, starting by changing their mission statement. Currently, Sanofi’s mission statement is as follows: “Our mission. Protecting and improving human health worldwide is our main mission. We have to serve an active role by providing superior, innovative vaccines for the prevention and treatment of disease and by playing an active role in the immunization community to maximize vaccination”. Their new mission statement should find a way to incorporate their mistake to make sure nothing like it ever occurs again. An example of what their mission statement could be is as follows: “Our mission. Protecting, improving, and informing the public about human health worldwide is our main mission. We have to serve an active role by providing honest, superior, fully tested, and innovative vaccines and information about our vaccines for the prevention and treatment of disease and by playing an active role in the immunization community to ensure that the vaccination information is correct and fully provided to everyone we service,”. This new mission statement touches on every aspect of what Sanofi should be trying to emphasize that they are, honest, superior, caring, and concerned with the diseases people battle around the world daily.
     Along with instating a new mission statement, Sanofi should reevaluate their core values. Some ideas for new core values could be honesty, customer safety, and selflessness. Honesty should be a core value because after everything that happened, Sanofi is going to need to regain their customers’ respect. They lied about a crucial piece of information regarding a vaccine’s side effects thus regaining their customers trust should be a number one priority. The willingness of their remaining customers to purchase new vaccines from them will be slim so it is important that Sanofi starts working towards that honesty. Customer safety should be another value because of how many of their recent customers in the Philippines were hurt or killed. Even if the people of the Philippines didn’t directly buy the vaccine from Sanofi, they were still recipients of something that Sanofi created thus making them their customers. Having customer safety be a core value will remind the officials working that the first priority should always be the customer, never themselves. The third core value that Sanofi should instate would be selflessness. During the recent case with Dengvaxia, Sanofi was pinned as a selfish company that only thought of themselves and ignored the well being of its customers. Adding selflessness to the list of things to work on would show the world that they are trying to change for the better and they do in fact realize that what they did was wrong. 
          In order to prove to the public that the company is trying its best to better itself, drastic changes should be made. To start, the company should let go of any executive employees that had majors roles in the decision to put the vaccine Dengvaxia on the market. Once all problematic employees are gone, new ones should be hired. In the hiring process there should be an ethical examination to ensure that these new employees won’t fall into the same traps that the old ones did. Next, all employees that were lucky enough to keep their jobs should have to go through the same ethical examination. If they do not meet the standards set but higher executives, there place in the company will be taken away. These ethics examinations should be made a regular thing that employees must pass; this will be a constant reminder to all employees to make sure that they are doing the right thing. While all this is going on, the marketing department should be publicizing these new advances to prove to the pubic that they are doing everything in their power to fix what is broken within their company. The marketing department should also focus in on Sanofi’s new mission and their core values.
      If all of these things do occur and have the hoped outcome, Sanofi should be able to correct their poor image. The marketing will be a crucial part in the whole situation because they are really going to have to emphasize that the company is trying to reinvent itself. Once the company’s image starts to get fixed, profits will start to increase. The plan solely focuses on bettering the company and improving their image and making sure that a disaster like the Dengvaxia incident never happens again.    

Gabrielle Delos

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