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August 1, 2013 | Posted By Bruce D. White, DO, JD

Recently, The New York Times in a series of reports has alerted the world to many of the ethical difficulties in marketing drugs globally. The titles of the articles alone hint at many of the issues: “Drug Research in China Falls Under a Cloud; “Glaxo Says Executives May Have Broken Chinese Law; “For Global Drug Manufacturers, China Becomes a Perilous Market.

Moreover, phrases used contextually in the articles are even more alarming: “Glaxo’s problems may go beyond the sales practices that are currently at the center of a bribery and corruption scandal”; “the company fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data”; “[research] supervisors did not always ensure that the work done there was of high quality”; “auditors came across six [animal] studies whose results had not been reported, even though early trials in humans were already underway”; “auditors found that Glaxo employees failed to record whether the [human subject] research participants had signed new consent forms”; “Glaxo said that employees were properly monitored trials but that they were not adequately documenting their work”; “[Glaxo] used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales.”

China, India, and Brazil are fast becoming critically important to giant international pharmaceutical companies like GlaxoSmithKline, AstraZeneca, Merck, Roche, Abbott, Nestle, and Lilly. Per The New York Times, “China is poised to surpass Japan as the world’s second-largest pharmaceutical market.” “Multinational drug companies now employ more sales agents in China than they do in the United States, their largest market.” And clearly, China “is interested in building a very strong, homegrown industry” to meet its population’s growing healthcare delivery needs and become more completive globally with India and Brazil in supplying drug products to Third World nations.

Of course, there will be numerous struggles in these emerging markets as international drug manufacturers expand simply because the product quality assurance and regulatory affairs infrastructure in China, India, and Brazil is so remarkably different from the more mature, complex systems in the U.S., Europe, and Japan. But patient safety and product integrity are key features of any drug delivery system – from the most simple to the most sophisticated – and cannot be compromised as markets sort out. It would be very troubling to think that compromised standards are ethically appropriate when marketplaces are less sophisticated and it is impossible for buyers – on their own – to beware of the dangers involved.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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