The TEDMED 2020 theme is Make your way to wonder, and we look forward to convening our community and embracing the wonders of our time, the amazing accomplishments, the incredible possibilities, and the extraordinary potential for the future. So we were thrilled when the United States Pharmacopoeia (USP) decided to celebrate 200th anniversary with TEDMED. After all, today’s wonders are built on a solid foundation of scientific discoveries. And, humanity is especially anxious for those innovations that will help people everywhere to live longer and healthier lives. In anticipation of USP’s presence at TEDMED in March, we spoke with Ronald T. Piervincenzi, Ph.D., CEO, about the organization’s history, its current work, and its focus on building trust. future of medicine, supplements, and food.
INFORMATION: We are pleased that you and USP are joining the TEDMED community, especially on the occasion of such a monumental milestone: the 200th anniversary of USP.
Ronald T. Piervincenzi: Thanks. I’m excited to introduce USP to the TEDMED audience and look forward to meeting attendees in Boston in March.
TM: What made you choose TEDMED to celebrate this important anniversary?
RP: Today we are witnessing an unprecedented transformation in healthcare. USP’s 200-year legacy is based on trust and confidence in health care systems and on anticipating and responding to emerging health challenges. Our founders came together in 1820 to protect patients from a prevalence of poor quality medical products. The backdrop today is different in scale, geography, modalities and many other factors. But the value of our work is the same. We are exploring how to build confidence in future medical advances. There are many in the TEDMED community from whom we can learn and interact as we imagine what the future holds.
TM: This is exactly what TEDMED is all about! Let’s dive in. What is a pharmacopoeia and what does the USP do?
RP: Simply put, a pharmacopoeia is an official publication that includes a list of medicines and contains how to prepare them, instructions for use, and tests to assess the quality of medicines. The U.S. National Pharmacopoeia Form, published by the USP, is the official quality standard for drugs marketed in the United States. It is also used in more than 140 other countries. USP is the leading independent non-profit scientific organization working with the world’s best experts in health and science to develop quality standards for medicines, dietary supplements and food ingredients. Through our standards, advocacy and capacity building, USP helps increase the availability of quality medicines, supplements and food to billions of people worldwide. As the world gets smaller and more connected, quality issues are affecting everyone. Diseases travel. Drug resistance is growing. Counterfeit drugs kill. The quality foundation we are building helps address these and other global health challenges. Whether we reduce the prevalence of lower quality drugs or help curb antimicrobial resistance, we are there in 10 global places working to protect the health of people around the world.
TM: It seems like a very modern approach to medicine. Why did the US need a pharmacopoeia in 1820?
RP: Today, people are confident that U.S. drugs are among the safest in the world, but that has not always been true. In 1820, the United States was a new country. Medications were made individually and differently by doctors or pharmacists. There were no regulations or, more importantly, no standards, to ensure that what you receive in one city is the same as in another. The strength, quality, and even identity of a drug varied greatly depending on where it was made. Simply put, before our founding in 1820, there was no way to make sure that what was on the drug label was what was actually on the bottle. Our founders, 11 independent and advanced physicians, were concerned about this lack of uniformity and acted to protect patients from poor quality medicines. Three of our founders were not only doctors, but also American senators: they were the voice the U.S. needed to ensure the quality of the drugs that Americans used. They established the U.S. Pharmacopoeia Convention, which published the first U.S. Pharmacopoeia. Much has changed since our founding, but the importance of having quality standards for new drugs and other therapies remains; now, our work is much more global.
TM: This year’s TEDMED theme, “Opening the Wonder,” explores how medicine and healthcare are changing. Is it a topic that resonates with you?
RP: Absolutely. Marvel and scientific discovery make medical advances possible. But trust makes them popular. More than 800 independent volunteer scientists bring their experience to develop and pass USP standards. They help build trust by setting clear quality expectations for medications, dietary supplements, and foods. In turn, USP standards help manufacturers around the world bring higher quality, affordable products to market, benefiting people everywhere. A recent study from Johns Hopkins University found that, on average, drugs with a public quality standard from the USP had about 50% more generic manufacturers compared to drugs without that standard. The study also found that quality standards helped ease pharmaceutical competition and reduce the cost of prescription drugs in the U.S.
TM: How is a 200-year-old organization preparing for the future?
RP: New technologies and treatments — precision medicine, digital therapy, 3D printing, immunotherapy, gene and stem cell therapies, and artificial intelligence — have arrived or are underway. As we prepare for spectacular breakthroughs, we must work to ensure that trust and quality are established as part of these breakthroughs. Unfortunately, confidence is generally in a precarious position in all sectors. Our history has taught us that for innovation to become a widespread reality, both quality and trust are critical to its widespread acceptance. USP along with hundreds of our stakeholder and partner organizations are already working to build confidence in future developments and to anticipate and address where the gaps will be. We know that when a public USP standard is available, we help manufacturers better adopt the new technology, which is often a significant cost savings. In addition to conducting workshops and roundtables on topics such as cell and gene therapies and digital therapy, USP works with the MIT Center for Collective Intelligence and more than 100 health and science leaders in around the world to explore developments and the role that trust will play in shaping people’s health from now until 2040. We will explore the project conclusions of this “Trust CoLab” with the TEDMED 2020 community.
TM: We look forward to hearing more about Trust CoLab. Until then, what else should the TEDMED community know about USP?
RP: I mentioned our volunteer scientists earlier. I invite members of the TEDMED community to commit to making the world healthier, to being scientifically rigorous, and to working independently of politics or the private sector, to consider becoming a Champion of Confidence. You can get more information by visiting our website or visiting the USP Lounge at the TEDMED Social Hub. I also encourage everyone to learn more about USP’s past, present, and future, and opportunities for other collaborations with us at www.usp.org/200.
TM: Thank you, Ron, and best wishes for the beginning of the third century of the USP.