Pen's Nest

Posted by Megan Rose

https://www.propublica.org/article/tacrolimus-fda-death-mothers-story

When I first learned that a critical medication for transplant patients — one that keeps them alive — had generic versions that might not be effective, I called a specialty pharmacist at a hospital in Virginia. Adam Cochrane had written a journal article about the problems with the generics. 

The drug is called tacrolimus, and it keeps a transplant patient’s body from rejecting a donated organ. I was surprised to hear that Cochrane had several patients he thought had died in part because their generic tacrolimus hadn’t worked right.

He told me about Hannah Goetz, though he didn’t divulge her name initially. She would become the focus of a story I published recently that’s part of a larger investigation into how the Food and Drug Administration has for years allowed risky drugs into your medicine cabinet. 

Hannah was 17 when she had a double lung transplant because of complications from cystic fibrosis, a genetic condition that fills the organs with mucus. She died in 2023 at just 21 years old, he said. And she had been taking one of the bad generics. 

He agreed to see if her mom would be willing to chat with me. When I met Holly Goetz at her home in Portsmouth, Virginia, she was open and personable. She was angry, too. Hannah had died too young. She welcomed the chance to tell her daughter’s story. “I was excited, because someone was going to research this issue,” Holly told me recently. “Possibly turn things around.” Before we’d met, she’d been told she didn’t have any legal recourse to sue over Hannah’s death despite the issue with the generic. Lawyers told Holly it was impossible to draw a straight line from Hannah’s death to a generic manufacturer.

I knew that in telling Hannah’s story in detail, I’d also be telling the larger story about tacrolimus, and larger still about the systemic failures at the FDA. ProPublica’s reporting typically focuses on exposing wrongdoing in the hopes of spurring change. I wasn’t sure whether our reporting would bring Holly the accountability she yearned for, at least not in a tangible way. I hoped Holly’s experience sharing an intimate, tragic part of her life wouldn’t end up being a disappointment.

Holly had been by Hannah’s side, advocating for her since she was diagnosed with cystic fibrosis and through the four-year journey after the transplant. Over several hours as the sky turned dark that February day, she took me through all that happened — from Hannah’s sudden need for a transplant where she almost died, to her doing well enough to take college courses and enjoy having her first (and only) real boyfriend, to her unexpected decline just three and half years after the successful transplant. 

“It was hard, because I was reliving everything over again,” Holly said of our first interview at her home. “Then again, I got to talk to someone else about Hannah, who she was, not just her in the hospital.” 

As she showed me Hannah’s peach bedroom that day, with its dozens of stuffed animals and the hair bows she wore every day when she was in school, Holly shared that when Hannah was a little girl she started sticking her tongue out in pictures. Holly laughed, saying she thought for sure Hannah would outgrow the habit, but it turned into her signature pose. Now, one of those pictures hangs from 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 step into Holly’s own bedroom to see the pink urn with angel wings that holds Hannah’s ashes. 

During our conversation, I realized that my reporting had given me access to key details about Hannah’s death that Holly didn’t know. I didn’t relish being the messenger who informed her that Hannah had taken not just one but actually two different suspect generic versions of tacrolimus, that she had the misfortune of exclusively taking ones that doctors, pharmacists or the FDA had found problematic. Holly’s eyes widened. I had to share, too, that the FDA had revoked one version’s generic status just two months after Hannah had died. 

The two manufacturers of the generic medication Hannah was taking, companies named Accord and Dr. Reddy’s, both maintain that their tacrolimus is safe and effective. An Accord spokesperson said in a statement that the company cannot comment on individual cases but that it is “dedicated to patient safety, product quality and regulatory compliance.” Dr. Reddy’s said in a statement that it hasn’t received any complaints that “indicated any concerns in 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 managing editors, Tracy Weber, whom I’ve known for years. I cried as I described my conversation with Holly. One unavoidable aspect of my job is that I’m often asking people about the worst things that have happened to them. In my two decades as a reporter — quite a few of those years spent covering the Iraq and Afghanistan wars — I’ve sat at many kitchen tables with grieving mothers. Talking with Holly, though, was the first time I’d done so as a mother myself. Her sorrow hit me differently. 

Over the next nine months, I’d 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 the doctors telling Hannah shortly before she died that they couldn’t give her a second transplant.

The ask from an investigative reporter is never just, “Tell me about your loved one.” Our work requires meticulous detail and all the receipts. I had to recruit Holly to take considerable time to help with my reporting. 

There were four years of medical care I needed to comb through to write the story, which meant asking Holly to track down records from two hospitals and, crucially, the pharmacy where Hannah had gotten all her medications. It wasn’t a simple task. 

Hannah was an adult when she died, so Holly wasn’t automatically entitled to her records. Although Hannah had signed an advance directive giving Holly power of attorney before her death, including the ability to request records, Holly still couldn’t get access.

She had to recruit a lawyer friend and attend 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 get appointed as executor of Hannah’s estate, and then several more months for the hospitals and pharmacy to fulfil Holly’s request and send her the records. We didn’t have them until July. 

There were upwards of 13,000 pages — all of which she shared with me. Sometimes, the records meant I had to ask uncomfortable questions of Holly. Why, for example, didn’t Hannah consistently take her medication for her pancreas? Did that mean she also didn’t take her tacrolimus? (Answers: She didn’t like how the pancreas drug made her feel, and Holly was so insistent on guaranteeing her daughter took her tacrolimus that she made her FaceTime when she took the pills away from home.) Holly was unfazed by even the most difficult questions. She and Hannah were alike that way: There was no shrinking from the world. Holly made my job a lot easier; she didn’t have to.

I hesitated each time I had to reach out, wondering if texting about Hannah in the middle of the day would be jarring. What was it like for Holly to check her phone on her break from teaching high schoolers and be greeted with a message that would take her back to Hannah’s final days in the hospital? To my relief, Holly told me later she looked forward to my texts or calls. “I like sharing everything about Hannah,” she said. 

Holly said she had agreed to talk to ProPublica because she thought speaking to me and the resulting story might bring her a sense of closure. Did it? I asked her. 

“Yes, because more people know now what really happened,” she said. “The real story.”

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The post Her Daughter Died After Taking a Generic Version of a Lifesaving Drug. This Is What She Wants You to Know. appeared first on ProPublica.

https://www.propublica.org/article/tacrolimus-fda-death-mothers-story