Taking The Pulse Of Healthcare Regulations

Taught by leading industry experts, the Master of Science in Management of Health Industries course at ESSEC Asia-Pacific gives students a behind-the-scenes understanding of how healthcare is regulated.

AsianScientist (Aug. 7, 2017) – Before a drug can be sold in pharmacies everywhere, it has to go through many rounds of clinical trials to prove that it is safe and effective. However, once released ‘into the wild,’ unexpected side effects can sometimes show up.

In some cases, these side effects can be so severe that it leads to the drug being pulled from the market. This is the tale of US drug manufacturer Merck’s blockbuster painkiller, Vioxx. Touted as an effective painkiller that, unlike other pain-relieving drugs, does not cause gastrointestinal problems, Vioxx was widely prescribed and earned Merck over US$2.5 billion a year.

Unfortunately, the daily use of Vioxx was ultimately found to increase the risk of heart attacks, and was linked to an estimated 88,000 heart attacks and 38,000 deaths in the US alone.

The Vioxx scandal highlights how drug safety is understood differently by the general public and the US Food and Drug Administration (FDA), said Mr. Peter Pitts, who served as the USFDA Associate Commissioner for External Relations from 2002 to 2004.

“Most people think that drugs approved by the FDA are 100 percent safe, but in fact, safety is a ratio between risk and benefit—there is no such thing as zero risk,” explained Pitts, who teaches at a module under the Master of Science (MSc) in Management of Health Industries program offered by ESSEC Business School, Asia-Pacific. “How you communicate that risk is very important.”

An insider perspective

Pitts, who is president and co-founder of the New York-based non-profit organization Center for Medicine in the Public Interest, uses the Vioxx example to bring to life the complex and challenging issues faced by the USFDA, which has to balance the need to get drugs to patients quickly with the need to rigorously test each drug.

“The case study helps students understand why broader, clearer and more regular communications on every drug is important, whether it’s from a doctor to a patient or even through marketing techniques,” said Pitts.

Handling the tricky topic of risk communication is just one of the skills students can hope to learn from Pitts, who oversaw public relations for the USFDA as part of his role as Associate Commissioner.

Drawing on his unique insider insight, Pitts gives students a behind-the-scenes peek into how the USFDA impacts every aspect of the ever-evolving US healthcare environment, as well as how what happens in the world’s largest healthcare market is felt by countries further afield.

“In many respects, regulatory policy in the US drives the rest of the world,” Pitts said. “But the beautiful thing about talking about what’s happening in the US regulatory environment is that the same ecosystem exists anywhere in the world that you go. Size, scale and budgets all change, but the priorities and problems remain the same.”

Lessons for Asia

“It’s not necessarily about telling the rest of the world to do things exactly the same way as the US does, but to understand why we do things in certain ways and to adapt that to fit the given nation or culture,” he continued. “Equally important is learning from the mistakes of the US makes so you don’t repeat them.”

In particular, one area Asia could benefit from is pharmacovigilance, the monitoring of drugs that have been approved for use. Acknowledging that the US could do a “much better job” on pharmacovigilance as seen in the example of Vioxx, Pitts said that infocommunications and other new technologies could give Asia and the developing world a leg up.

“I think Asia has the opportunity to leapfrog over more advanced places because of technology. New medical technologies are complete game-changers, so it’s a good time to start thinking seriously about new ways of creating access and regulating healthcare,” he said.

“Rapid economic growth and the increasing focus on health policy in the Asia-Pacific region is heralding new, dynamic opportunities for healthcare industries,” added Mr. Joe Caputo, Associate Director, Institute of Health Economics and Management Asia-Pacific and Executive Program Director, MSc in Management of Health Industries at ESSEC.

“Increasingly, the health sector will need professionals who are equipped with global and regional insights, as well as leadership and management capabilities to handle the region’s complex and demanding healthcare environment,” he said.

“ESSEC is proud to offer a world-class faculty, including leading industry figures such as Peter, to support the development of aspiring healthcare leaders across the region, and impart their knowledge and experience which will give program participants this vital competitive edge.”

About ESSEC Business School

ESSEC Business School, founded in 1907 in France, is one of the world’s top international business schools. In 2014, ESSEC Asia-Pacific launched the MSc in Management of Health Industries program at its Singapore campus located in one-north. This one-year part-time program is the first-of-its-kind in Asia, combining global health insights with regional best practices. The next intake is in October 2017. For more information, please download our program brochure.

Asian Scientist Magazine is a media partner of ESSEC Asia-Pacific.


Copyright: ESSEC Asia-Pacific.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

Asian Scientist Magazine is an award-winning science and technology magazine that highlights R&D news stories from Asia to a global audience. The magazine is published by Singapore-headquartered Wildtype Media Group.

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