NECC: Meningitis Outbreak (2012)

Controversy

NECC logo

The New England Compounding Center (NECC) is a compounding pharmacy located in Framingham, Massachusetts.  This company, along with a construction debris recycling plant, is owned by Barry Cadden and his family.  Cadden is also a pharmacist himself and president of NECC. The law used to be that compounding pharmacies, like the NECC, are not allowed to manufacture pharmaceuticals for mass production and then in turn market them to hospitals and clinics. Mass production of pharmaceutical drugs would require the oversight of the FDA. Instead, states license compounding pharmacies to make drugs for individuals that would be on call for one patient only through a hospital or doctor.  Although in 1998, Congress exempted compounding pharmacies from the oversight of the Food and Drug Administration allowing centers like the New England Compounding Center to mass produce, and that's exactly what they did. Selling close to 3,000 clients, most being hospitals and clinics, but this is where the NECC and Barry Cadden became greedy and things went wrong.  One drug that was made is a steroid called methylprednisolone acetate, which is made in one of the NECC's many labs named "Clean Room One." Massachusetts Board of Pharmacy inspected the NECC back in 2011 with records showing occasional problems with sterility, but the pharmacy passed. Although there was something wrong with this specific drug.  There was a fungus in the steroid, formed from a type of mold that attacks bone and nerves creating an infection called meningitis that eventually reaches the brain and kills the host. This meningitis outbreak happened in October of 2012 and by September 26th, of the same year, patients started dying and state officials came to inspect NECC.  Because of this fungus there were about 751 cases where patients were diagnosed with meningitis or another infection in 23 different states, and also about 64 deaths were recorded to date do the fungus in this steroid. One patient says that he is taking "60 milligrams of morphine a day with no cure in sight."  The FDA later inspected the NECC and realized the cause of the mold and the fungus was from one of their ventilation vents, being 100 feet from the recycling plant.  Barry Cadden and others are targets of a criminal investigation and the NECC has gone into bankruptcy since the outbreak. Cadden and his partners also withdrew $16 million from the company over the last year, some of it as people were beginning to die.

Individualism

According to Friedman, their is only one goal of business, to profit, so the only obligation that the business personnel have is to the maximize profit for the owner or the stockholders.  This is what the New England Compounding Center and Barry Cadden had in mind when the client numbers jumped to about 3,000 clients. Due to to the pain control industry growing in the past two decades, and steroid spinal injection recipients being close to 2.5 million people on Medicare, profit was booming for a low price, mass producers like the NECC.  It is suggested that some doctors and clinics have turned away from major drug manufacturers and turned to compounding pharmacies, such as the NECC, because they do charge much lower prices than the major manufacturers of drugs.  Also, because more people were wanting spinal injection, it created a higher demand for steroids, like methylprednisolone acetate, that they were mass producing and other major manufacturers who had halted the production of the steroid due to the FDA. Selling each vial at about $25 with over 17,000 vials being sold over 23 states and 73 medical facilities is a great profit in itself.  According to corporate files, the New England Compounding Center raked in about $2.2 million dollars in 2012. Going by the theory of Individualism the NECC was doing it right, they were making a huge profit off the contaminated steroid and would have made an even bigger profit if it was not infected and if the the FDA had not shut them down.

NECC Facility

Utilitarianism
Based upon John Stuart Mill's idea, utilitarianism focuses on ones happiness and pleasure and how to maximize them for yourself, others, and all beings capable of feeling it.  The NECC was definitely trying to maximize the happiness of their company by grossing a large profit from the selling of the steroid, which Cadden had to be happy about as well.  More profit for the company means more profit for him, his family, and most likely his employees as well. By selling this infected drug they may have made others happier, such as their clients, due to the very low prices they were selling them for.  Though the bigger story is who they made unhappy, which are the victims of the meningitis outbreak due to the mold in their lab that created the fungus in the first place. Also it is not only the victims that contracted the virus, and are still suffering to this day, but the patients who died due to it and to the families coping with the losses of their loved ones.  All because the NECC location, next to the debris recycling center, was an awful decision and when they did find mold they would just shrug it off because it had been happening for the past three years.  One man, Joe Connolly who worked in Clean Room One from 2009 up to the incident, recalled his supervisor "shrugged" when he told him about the mold and "that was his response for a lot of our questions or comments or concerns, was a shrug... He'd-- either he didn't care, or he was powerless to change it." Overall maximum happiness was not reached due to the meningitis outbreak.

Kantianism

States that we are all members of humanity and should already have rational and moral values programmed into ourselves and should follow these values, keeping the Good Will in mind, saying that you should always do what is right. The NECC had no rational or moral values when they distributed over 17,000 vials of infected fungus to hospitals and clinics.  If they did have the values that are said to be already programmed in ourselves, they would have stopped production if the steroid and destroyed all the made vials when they found the mold in their laboratory and would have done something about it instead of shrugging their shoulders. It was not right for them to sell these vials, knowing they could potentially harm patients, all because the NECC just wanted to make a profit. Going by the Formula of Humanity, that is stated within Kantianism, says that you must treat yourself and other people as end and never as a means, as well as eliminating lying and deceitfulness of any kind coming from the Formula of Universal Law. The New England Compounding Center seems like they had no sense of humanity or the Universal Law whatsoever.  They treated our countries doctors, hospitals, clinics, and patients as nothing but a means.  The mean to make money and not care about the consequences.  Also the only way they could have sold their steroid was through lying and deceitfulness, by keeping their employees quiet about the mold and they were able to do all this because the FDA did not oversee the making of their drugs because they were a compounding center. The NECC did not follow the Kantian ethics theory.

The black fungus

Virtue Theory

Is based off of four main characteristics courage, honesty, temperance and justice. The first characteristic is courage which means taking risks and the willingness to take a stand for the right actions and ideas.  The NECC did have courage taking the risk to send out the steroid regardless of the consequences and knowing that there was mold in their laboratories. Although they did not take the risk for the right actions or ideas. They took them for the wrong actions, which were to just make a profit not caring what the drug would do to recipients who got the infected steroid.  Honesty is the agreement to be truthful with ones employees, customers and other companies.  The New England Compounding Center was not honest with their employees because they just waved off the mold like it would not impact the productions of the drugs being made inside the lab.  Also they were definitely not honest with their customers and clients because they said nothing about the fungal infection in the steroid, and as a result many people died and/or became sick. Temperance is the ability to set reasonable expectations and desires. They did not show temperance because they were not able to create an infection free steroid, that would not harm the user.  A reasonable expectation for this steroid is an alternative to surgery that could possibly save the lives of the recipients, although the NECC's steroid did the exact opposite. Justice includes hard work, good ideas, and fair practices, which they NECC did not follow either. They may have worked hard to mass produce their steroid for a lower price than their competition, but it was not a good idea to create it in the contaminated mold filled laboratory they did and it was not fair for them to sell it to the 3,000 clients they did. The NECC did not follow any of the four characteristics of the Virtue Theory.

Overall the NECC was deemed ethical on 1 out of the 4 ethical theories. The NECC maximized it profits but failed to maximize happiness. The injection did not follow moral values and did not keep the Good Will in mind. Lastly it did not follow any of the four virtue characteristics. 

References

Grady, Denise, Andrew Pollack, and Sabrina Tavernise. "Scant Oversight of Drug Maker in Fatal Meningitis Outbreak." The New York Times. The New York Times, 06 Oct. 2012. Web. 31 March. 2014.

 "Lethal Medicine Linked to Meningitis Outbreak." CBSNews. CBS Interactive, n.d. Web. 31 March. 2014.

 "Multistate Outbreak of Fungal Meningitis and Other Infections – Case Count." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 23 Oct. 2013. Web. 31 March. 2014.

 "Pharmacy Tied to Fungal Meningitis Outbreak Files for Bankruptcy." NBC News. N.p., 21 Dec. 2012. Web. 31 March. 2014.

Salazar, Heather. "Kantian Business Ethics." 30 March. 2014.