Fighting for Breath: The FDA’s Lax Generic Drug Rules Put Her Life at Risk

Series: Rx Roulette: The FDA’s Dangerous Gamble on America’s Drugs More in this series Wrapped in a flashy fur coat she’d found at a thrift store for the occasion, Hannah Goetz blew out the candles on her favorite red velvet cheesecake. It was her 21st birthday. The celebration with her family that evening in February 2023 was a milestone not just for her age, but because she was alive. Three and a half years before, her lungs had collapsed from cystic fibrosis. She was saved by a double-lung transplant that had been allowing her to breathe deeply. Hannah had slowly worked her way back to stable health, overcoming infections and, every day, taking a crucial medication to protect her donated lungs from rejection. Her doctors were optimistic. Hannah had been feeling well enough to sing karaoke, work as a nanny while taking college classes and begin her first adult relationship, with a Navy sailor. Her 21st birthday gift from her mom was a trip to Nashville, Tennessee, where the two of them and their friends could explore the city’s music scene and cavort in its bars. Just days after her birthday, though, she was back in the hospital. She’d been feeling her chest tighten, and she struggled for air. By March, Hannah felt as if she were breathing through a straw. Tests showed she was taking in less than half the oxygen of a healthy person. One of the first questions came from her transplant team’s pharmacist, who had overseen her medications since her operation. “Did the tacrolimus pills you take change?” he asked. Most people have never heard of tacrolimus. But to anybody who has received a transplant, it’s nothing short of a miracle. The medication prevents organ rejection. Without tacrolimus, a simple capsule taken twice a day, cells in the blood identify the transplanted organ as a foreign invader and treat it like an infection, trying to rid the body of it. That attack can be fatal. A team of Japanese scientists discovered tacrolimus in the 1980s, in a fungus found in the soil of a lush, purple-hued mountain north of Tokyo. Along with another similar drug, tacrolimus radically improved the long-term prospects of transplant patients. The chances that a donated organ would still work after a year roughly doubled for those who used the drugs. Recipients of kidney, heart and liver transplants started living years longer. So did lung patients, but the challenges of those transplants meant the increases in lifespan were smaller. By the numbers, if Hannah made it past her first year, she could expect her new lungs to give her nine more years of life. Hannah was upbeat during regular two-week hospital stays — she dances here during one visit in 2015 — which were often needed to treat infections after she was diagnosed with cystic fibrosis. Courtesy of Holly Goetz Hannah was in fourth grade in 2012 when doctors figured out that her regular bouts of bronchitis and her struggle to gain weight...

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