Ethics of offshoring: Novo Nordisk and Clinical Trials in Emerging Economies

Ethics of Offshoring: Novo Nordisk and Clinical Trials in Emerging Economies

        Clinical trials in undeveloped countries have been a hot topic as the world has become “flatter.” News of unethical trials can quickly be spread, and consumers may quickly shame companies involved in doing so, resulting in decreased sales and a poor company image. However, ethical behavior cannot be viewed through one lens as what’s unethical in the United States may be perfectly ethical in another country. Furthermore, locals in an undeveloped country may even appreciate the money that is paid to them for the clinical trials it affords them more opportunity to provide for their families. Novo Nordisk, a manufacturer of insulin, believed that all clinical trials should be conducted according to the Helsinki Declaration (Meyer, 2009). The Helsinki Declaration states that “It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject” (Meyer, 2009, p.11). To that end, should Novo Nordisk be concerned when the media wants to interview them regarding their clinical trials in undeveloped countries?

        New medications are developed for the purpose of being able to offer a more effective, safe, and easier treatment for the patient (Meyer, 2009). However, new medication also has to be approved by both the Food and Drug Administration in the United States, and the European Medicines Agency in the European Union. These organizations check to verify that a particular drug has gone through the necessary testing that ensures the medication – from a scientific perspective – is safe, and can achieve its desired effect without undue harm to the patient (Meyer, 2009). To provide such proof, companies such as Novo Nordisk rely on clinical trials with each trial going through three to four phases. Phase 1 consists of a small number of healthy volunteers to assess the drug’s movement and the patients’ tolerance of the drug. Phase 2 is done with a larger group than Phase 1 to ensure that the properties and effects observed in Phrase 1 remain consistent with a larger sample size. Phase 3 takes the sample size in the thousands to further verify the drug’s effect and the drug’s safety. The data from those three phases is then sent the Food and Drug Administration as well as the European Medicines Agency for approval. After approval is granted the drug can then be sold to consumers. There’s also a Phase 4 that the drug can go through in order to apply its use to other diseases (Meyer, 2009). Phases 3 and 4 of the clinical trials can be the most costly as there can be as many as 400 to 800 patients during those phases, and it can take almost 8 years to complete a clinical trial (Meyer, 2009). Considering that it costs roughly DKr 150,000 (or ~$21,000) to move a patient through a clinical trial in the United States, and DKr 80,000 (or ~11,000) to move that same patient in through a trial in Denmark, one could see the appeal for conducting clinical trials in an undeveloped country as the cost would likely be a fraction of either of those numbers (Meyer, 2009). However, is it ethical to conduct clinical trials in an undeveloped country to decrease costs, and because their ethical standards may be lower than the home country?

        On paper, Novo Nordisk’s policies on their clinical trials look great. In the theme of transparency, Novo Nordisk published is global guidelines and recommendations on its website. Furthermore, Novo Nordisk audits ten-percent of all of its clinical trials with the Food and Drug Administration as well as the European Medicines Agency monitoring roughly one-percent of their clinical trials. Such audits have not found any issues which should be calming to any investigator as Novo Nordisk uses a standardized process for its trials – regardless of country (Meyer, 2009). Sites for a trial are selected based on the amount of regulatory authorities, ethical review processes, and medical practices. Additionally, only patients who have a need for the drug are selected for the trial, and those same patients are granted access to the drug after the trial. Finally, Novo Nordisk only conducts trials in countries with the aptitude to organize and monitor the trial (Meyer 2009).

        While generally thought of as harmless, more and more attention has been drawn towards placebo trials. In these trials patients are given a placebo (typically a sugar pill) while a separate group is given the active drug. The purpose of the trial is usually to prove the drug’s effectiveness as the group with the active drug should see more improvement than the group who received the inactive drug (Meyer, 2009). However, there’s also another form of placebo trials where the control group receives a previously marketed drug, and the effects of that drug are compared against the group with the new drug. In this scenario, tensions may rise as the patients in the control group come to understand they have been given a drug that won’t improve their condition. For that reason, the Helsinki Declaration states that placebo trials should not be conducted unless certain circumstances require a placebo trial or if no alternative treatment of the illness is available. Per the guidelines, ethics review boards are reluctant to approving placebo trials which leads some companies to conduct the trials in undeveloped countries where approval is easier to obtain (Meyer, 2009).