When I first learned that a vital drug for transplant patients — the one that keeps them alive — had generic versions that might not be effective, I called a specialty pharmacist at a Virginia hospital. Adam Cochrane had written a journal article on the problems with generics.
The medication is called tacrolimus and prevents a transplant patient’s body from rejecting a donated organ. I was surprised to learn that Cochrane had several patients who he thought had died in part because their generic tacrolimus had not worked properly.
He told me about Hannah Goetz, although he didn’t initially disclose her name. It would become the center of interest of a story I published recently It’s part of a larger investigation into how the Food and Drug Administration has done for years allowed risky medications in your medicine cabinet.
Hannah was 17 when she underwent a double lung transplant due to complications from cystic fibrosis, a genetic disease that fills the organs with mucus. She died in 2023 at just 21 years old, he said. And she had taken a bad generic.
He agreed to see if his mother would be willing to talk with me. When I met Holly Goetz at her home in Portsmouth, Virginia, she was open and friendly. She was angry too. Hannah had died too young. She appreciated the opportunity to tell her daughter’s story. “I was excited, because someone was going to research this,” Holly told me recently. “Maybe change things.” Before we met, she was told that she had no legal recourse to pursue legal action over Hannah’s death, despite the problem with the credits. Lawyers told Holly it was impossible to draw a straight line between Hannah’s death and a generic drug manufacturer.
I knew that by telling Hannah’s story in detail, I would also be telling the broader story of tacrolimus, and more importantly the systemic failures of the FDA. ProPublica’s reporting typically focuses on exposing wrongdoing in hopes of spurring change. I wasn’t sure our reporting would bring Holly the accountability she yearned for, at least not in a tangible way. I was hoping that the experience of Holly sharing an intimate and tragic part of her life wouldn’t end up being a disappointment.
Holly was by Hannah’s side, advocating for her since she was diagnosed with cystic fibrosis and throughout the four-year journey following the transplant. For several hours, as the sky darkened that February day, she told me everything that had happened – from Hannah’s sudden need for a transplant where she nearly died, to her doing well enough to take college classes and enjoy her first (and only) real boyfriend, to her unexpected decline just three and a half years after the successful transplant.
“It was hard, because I was reliving everything all over again,” Holly said of our first interview at her home. “Then again, I was able to talk to someone else about Hannah, who she was, not just her in the hospital.”
As she showed me Hannah’s peachy bedroom that day, with its dozens of stuffed animals and the hair bows she wore every day when she was at school, Holly shared that when Hannah was little, she started sticking her tongue out in photos. Holly laughed, saying she thought for sure Hannah would outgrow the habit, but it became her signature pose. Today, one of those photos hangs in Holly’s rearview mirror in her car, one of many touchstones. There are photos and memorabilia of Hannah all over the house. I felt privileged to walk into Holly’s room to see the pink urn with angel wings that contains Hannah’s ashes.
During our conversation, I realized that my reporting had given me access to key details about Hannah’s death that Holly did not know. I resented being the messenger who informed her that Hannah had taken not one but actually two suspect generic versions of tacrolimus, that she had had the misfortune of taking exclusively those that doctors, pharmacists, or the FDA had deemed problematic. Holly’s eyes widened. I also had to share that the FDA revoked the generic status of a version just two months after Hannah passed away.
The two manufacturers of the generic drug Hannah was taking, Accord and Dr. Reddy’s, both maintain that their tacrolimus is safe and effective. An Accord spokesperson said in a statement that the company could not comment on individual cases but was “dedicated to patient safety, product quality and regulatory compliance.” Dr. Reddy’s said in a statement that it had not received any complaints “indicating concerns regarding patient safety.”
The next day, as I made the three-hour drive back to Washington, D.C., where I live, I called one of ProPublica’s editors, Tracy Weber, whom I’ve known for years. I cried as I described my conversation with Holly. An essential aspect of my job is that I often ask people about the worst things that have happened to them. In my two decades as a journalist – many of those years spent covering the wars in Iraq and Afghanistan – I have sat at many kitchen tables with grieving mothers. Speaking with Holly, however, was the first time I had done it myself as a mother. His grief hit me differently.
For the next nine months, I would be a constant presence in Holly’s life. We texted hundreds of times. She dug up old photos and videos and gave me access to Hannah’s private Instagram account. One of the hardest moments was listening to a recording Holly sent of doctors telling Hannah shortly before she died that they couldn’t give her a second transplant.
An investigative journalist’s question is never simply: “Tell me about your loved one.” Our work requires careful details and all invoices. I had to recruit Holly to spend a lot of time helping me with my reporting.
I had to undergo four years of medical treatment to write this story, which meant asking Holly to track down records from two hospitals and, most importantly, the pharmacy where Hannah got all her medications. It was not a simple task.
Hannah was an adult when she died, so Holly was not automatically entitled to her records. Although Hannah signed an advance directive giving Holly power of attorney before her death, including the ability to request records, Holly still could not access them.
She had to hire a lawyer friend and go to probate court to get Hannah’s hospital records for me. “What I had to go through to get them was ridiculous,” Holly said. I first asked about the records in February. It took until May for her to be named executor of Hannah’s estate, and then several more months for the hospitals and pharmacy to respond to Holly’s request and send her the records. We didn’t get them until July.
There were over 13,000 pages, all of which she shared with me. Sometimes the recordings required me to ask Holly uncomfortable questions. Why, for example, didn’t Hannah consistently take her medication for her pancreas? Did that mean she hadn’t taken tacrolimus either? (Answers: She didn’t like how the pancreas medication made her feel, and Holly was so insistent on making sure her daughter took her tacrolimus that she FaceTimed her while taking the pills away from home.) Holly wasn’t fazed by even the toughest questions. She and Hannah were alike in this way: there was no shying away from the world. Holly made my job much easier; she didn’t have to.
I hesitated every time I had to reach out, wondering if texting about Hannah in the middle of the day would be offensive. What was it like for Holly to check her phone during her break from teaching high school students and be greeted by a message that would take her back to Hannah’s final days in the hospital? To my relief, Holly later told me she looked forward to my texts or calls. “I love sharing everything about Hannah,” she said.
Holly said she agreed to speak to ProPublica because she thought talking to me and the resulting story might bring her a sense of closure. It’s done ? I asked him.
“Yes, because more and more people now know what really happened,” she said. “The real story.”
