Editor’s Letter

What’s Working — And What Isn’t

At the Center for Drug Evaluation and Research (CDER) of the FDA, Director Janet Woodcock has some disquieting observations on the healthcare industry: “It’s not working, and it won’t work in the future.” She recently said to an audience of industry execs at Breakthroughs in Medicine “I don’t want to bum everyone out. The science is fabulous, but that’s not enough.” What was she talking about? Mostly pricing, but a lot more. She said that putting a premium on secrecy was driving up the cost of research, while avoiding studying important NEIL GREENBERG aspects of the drug when there is no clear commercial gain to be had. “You can’t just develop breakthroughs and then throw them over the wall to practitioners,” she said. “We need the whole system to evolve and change if we’re going to help every patient feel better and live longer. Is the guy living under the bridge going to get a $2-million CAR-T cell curative treatment?” she asked. “If that guy can’t get the drug, then we’ve failed.” Curiously, she echoed a sentiment we hear often from the biggest companies today: “The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.” What’s the cure? Woodcock called for major reforms in the scientists’ relationships with regulators, doctors and one another. In addition, she said the process of creating and commercializing a drug suffers from corporate secrecy. When the science is valuable and “not to be shared,” drug trials are fragmented and costly. She also pointed to patient access. Other industries focus on making their products cheaper. But in healthcare, high failure rates and expensive clinical trials have led to drugs far beyond the financial reach of those in need. There’s also a conflict between the increased focus on rare diseases and a move away from conditions like cardiovascular illness, addiction and antimicrobial resistance, now less attractive candidates for research, even though they affect far more people. She urged everyone to leverage big data — such as electronic health records — to study those diseases with efficient, universal protocols. Lots to consider. And a lot of it is already happening. She’s on our side — but it’s obvious that we have to take reform seriously.

We try to keep up with all this, and bring you the people who have a grasp on change. We hope that it will be informative, and assist you in furthering the work you do every day. Let us know what topics will be most useful to you!

Neil Greenberg, Editor

To become an HS&M contributing author or provide feedback, please email me at ngreenberg@hsandm.com.

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