New lease on life? The ethics of offshoring clinical trials
This article touches some of the key, current issues surrounding the ethics in the pharmaceutical industry. Due to a growing globalized economy, pharmaceutical industries are seeing the need to "off-shore" clinical trials. In other words, drugs that were once produced, and mainly targeted for people in the Western World, are now being demanded by Eastern countries. This has lead many companies, including Novo Nordisk and Glaxo Smith Kline's to include international patients into their trials. This, ultimately has led trials to be analyzed under strict scrutiny under legal and ethical lenses. On the plus side however, having a larger pool of candidates to choose from is allowing testing to speed up and getting the approval quicker. Global acceptance of drugs provided by pharmaceutical companies has also lead to an increasing search of globalized volunteers for the trials. For example, Aztra Zeneca is highly accepted in China and Japan, but not numbers aren't quiet as high in the Western World.
Certain drugs may be tested on a population from a specific country, but, since rules and legal regulations are different in each nation, it may take a longer time for the drug to reach that specific country once the drug has been already authorized in other nations. Due to this globalizing effect, many regulators, such as the FDA, are establishing offices in Eastern countries.
Moreover, many companies are willing to allow regulators to pursue Phase 4 of the trials. Drugs that have higher approval ratings by the FDA are ultimately selling more and bringing more profit into the company. These "extra" regulations are giving drugs higher credibility rates, which allows the company to raise the price on specific drugs.
As Andrew Jack states in his article:
"As the number of patients from the developing world increases, researchers, regulators and ethicists alike need to be careful to get the right balance of benefit and justice."
Jimena, this blog post is especially interesting because I realized how avid off-shoring is especially with companies that are involved in our project! The fact that the FDA is establishing offices in Eastern countries shows as positive reinforcement through a business lens because that way the pharmaceuticals are clearly doing well and spreading their client base. I would be interested to find out more about this off-shoring process and the ethics behind it.
ReplyDeleteHi Jimena,
ReplyDeleteGood post! This off-shore practice does seem to pose some ethical questions. For future posts, I would like to see more analysis. For example, do you think off-shoring clinical trials poses ethical questions, even if there are participants from the Western hemisphere? Why or why not?
Also, please make the comments on other members' posts longer. The comments should be about a paragraph (5-7 sentences) and can include your own analysis and questions.
ReplyDelete