Big Pharma Corporation*
Big Pharma Corporation (BPC) is a global pharmaceutical company with $50 billion in revenues. Its research and development budget is around $ 8 billion a year. BPC is the producer of many popular drugs on the market for common twenty-first century illnesses such as arthritis, depression, high blood pressure and cholesterol. It is estimated that it takes about twelve to fifteen years to develop new medicines, and the cost of developing a new drug varies from $800 million to $2 billion (Masia, 2008). Once the drug is developed, however, it is relatively easy and economical to reproduce. A patent on a drug gives the patent holder exclusive rights for twenty years (35 U.S.C. § 154(a) (2000).
BPC developed an antibiotic known by the trade name ”Maxicin.” Sales for Maxicin were projected to be over $1 billion a year. BPC decided to test the drug on children in
Varoom, a country in Africa experiencing an epidemic of bacterial meningitis, measles, and cholera in the very poor city of Vagos. After notifying the Food and Drug Administration and obtaining a letter of permission from the Varoomian government, BPC started to test the drug.
BPC selected a group of children aged one to thirteen who showed symptoms of neck stiffness, joint stiffness, high fevers, and headaches. BPC obtained consent from the children’s parents and divided the children into two test groups. Half of them were treated with Maxicin and the other half were supposed to be treated with one-third of the recommended dosage of “Mocid” another FDA-approved drug shown to be effective in treating meningitis.
BPC’s study protocol supposedly required the children to have their blood tested on arrival and then five days later. If a child was not responding well to the Maxicin, they were supposed to be switched to Mocid. However, the patients claimed that BPC did not analyze their blood samples and therefore failed to determine if a patient had a negative reaction until after the patient showed visible and permanent injury.
After two weeks, BPC’s team left Vagos and did not return for any follow-up evaluations. Sadly, five children who received Maxicin and six children who were treated with low doses of Mocid died. Other children became paralyzed, deaf, and/or blind. Prior to Vagos, only one child had ever been treated with Maxicin, and then only after all other antibiotics failed; no child had ever received Maxicin orally.
BPC applied for approval to market Maxicin in the United States for treatment of pediatric infectious diseases. The FDA informed BPC that it planned to deny BPC’s application for the use of the drug against epidemic meningitis because of inconsistencies in the data. BPC did receive approval for Maxicin for treating adults, however; and it launched the drug. Shortly after the drug went on the market, BPC received reports that Maxicin damaged patients’ livers. The FDA recommended that Maxicin be prescribed only for patients suffering from a life-threatening disease. A few months later, the FDA announced that it received more than 100 cases where Maxicin patients exhibited clinically symptomatic liver toxicity. BPC agreed to limit distribution of Maxicin to hospitals and long-term nursing facilities; the European Union’s Committee for Proprietary Medicinal Products suspended all sales of Maxicin.
The Vagos study patients and their guardians sued BPC in the U.S. District Court seeking compensation for alleged injuries and, in some cases, death, as the result of their participation in the Vagos study. In their complaint, plaintiffs alleged that they suffered grave injuries from Maxicin, an experimental antibiotic, which was administered without informed consent and that BPC conducted tests in Vagos, Varoom, even though prior animal testing indicated that Maxicin might cause significant side effects in children, including joint disease, abnormal cartilage growth, and liver damage. The legal basis for the complaint is the Alien Tort Claims Act. Basically, the plaintiffs allege that BPC committed violations of the law of nations as set forth in the Nuremberg Code, the Declaration of Helsinki, Article Seven of the International Covenant on Civil and Political Rights (ICCPR), and customary international law.