Vaccines and Pharmaceuticals

Declining cancer death rates, promising research, and innovative technology suggest the tide may be turning in the long war against cancer. Clinical trials using CRISPR technology to modify immune system cells are increasing, cancer vaccines are the next frontier for immunotherapy, and blood tests capable of detecting early signals of multiple types of cancer appear promising. Optimism is percolating as investigators identify new therapeutic targets, learn more about how to reprogram cells, and harness the body’s own defense systems as an attack agent. CEOs of leading cancer centers report on what we know, what’s missing, and the advances that lie ahead.

An entire generation of children in some of the world’s poorest countries are now protected against deadly infectious diseases, thanks largely to Gavi: The Vaccine Alliance. Impact: more than 16 million lives saved, vast healthcare cost savings, and greater global health security. A leading force behind the push for equitable access to COVID-19 vaccines, Gavi has played a critical role in reaching remote, impoverished, and conflict-ridden regions with resources to combat the pandemic. As he steps away from 12 years at Gavi’s helm, Seth Berkley talks about what’s been learned, how the pandemic affected routine immunizations, and where vaccine gaps remain to be filled.

When he was sworn in as 25th commissioner of the US Food and Drug Administration in February 2022, Robert Califf knew the assignment would be intense because he had held the post before. With its oversight of more than $2.7 trillion in medical products, food, and tobacco—one-fifth of the nation’s economy—the FDA is always under pressure. Today, artificial intelligence, breakthrough pharmaceuticals, misinformation, vaping, the nicotine content of cigarettes, and critical drug shortages, including a scarcity of life-extending chemotherapies, are only a sampling of the issues that demand strategic decision-making and knowledge at the frontiers of science from the FDA.

New research designs that use biomarkers, genetic testing, digital health devices, and artificial intelligence can modernize clinical trials so cutting-edge therapy can reach those who need it much more quickly. Jonathan Jackson, executive director of the CARE Research Center at Massachusetts General Hospital, and Amy Abernethy, president of Clinical Research Platforms at Veril, talk about the need for scientific innovation, more efficient techniques to aggregate and analyze data from electronic health records and wearable devices, and strategies for accessing clinical trials remotely. Alexis Madrigal, KQED host and Atlantic contributor, moderates the conversation.

The stark differences between the availability of COVID-19 vaccines in high-income and low-income countries has underscored the imperative of new approaches to global health equity. Investing in local manufacturing and scientific capacity, bolstering the public health infrastructure, prioritizing community engagement, and developing alternatives to the costly mRNA vaccine are key. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine, Peter Hotez, dean of Baylor’s National School of Tropical Medicine, and Priti Krishtel, cofounder and executive director at I-MAK, discuss opportunities to ensure equitable access to COVID-19 vaccines. Helen Branswell, senior writer for STAT, moderates the conversation.

Although Purdue Pharma gained particular notoriety for the deceptive marketing strategies that fueled the opioid epidemic, it did not act alone. To expose the culprits who made fortunes from dangerously addictive, pain-relieving drugs, relentless investigators cultivated whistleblowers, poured through hundreds of thousands of documents, and demanded accountability in court. Pitted against an adversary with almost unlimited resources and lobbying power, they found a semblance of justice for those who had been harmed. Beth Macy, author of Dopesick: Dealers, Doctors, and the Drug Company that Addicted America and Sari Horwitz, Washington Post reporter, talk about how it happened. Kate Snow, senior national correspondent at NBC News, moderates the conversation.

More than $2.7 trillion worth of food, medical products, and tobacco, representing 20 percent of every dollar spent by US consumers, is regulated by the Food and Drug Administration (FDA). Always in the public eye, the FDA is as likely to be lauded as lambasted for its swift authorization of COVID-19 vaccines, its decision to ban menthol from cigarettes, and the risk/benefit calculation it made before shutting down an infant formula manufacturing plant. The agency’s limited authority over dietary supplements, its inability to influence drug prices, and the resource shortfalls that curtail its inspection of food imports also fuel controversy. FDA Commissioner Robert Califf talks about what it takes to protect the public’s health.

Despite the swift development of vaccines to combat COVID-19, large swaths of the global population are unvaccinated and the prospect of viral variants remains a deadly threat. Lori Rose Benson, executive director and CEO of Hip Hop Public Health, Darrell Gray, chief health equity officer at Anthem, and Lauren Smith, chief health equity and strategy officer at the CDC Foundation, talk about the need to empower community-led collaborations and trusted messengers, strengthen local infrastructure, conduct targeted research, and enact appropriate policy changes to ensure equitable access to vaccines and curb the worldwide spread of infectious diseases. John Trizzino, executive vice president at Novavax, moderates the conversation.

Six former FDA commissioners come together to talk about the challenges to an agency that regulates over one in every four dollars that American consumers spend, including many foods and virtually all drugs, devices, cosmetics, veterinary products, and tobacco. In response to a question by moderator/journalist Jackie Judd, all six agreed that the FDA should become an independent federal agency. Their consensus sparked an 18-month HMS project to document the issues and develop concrete recommendations for achieving that goal.