When I first learned that a critical medication for transplant patients \u2014 one that keeps them alive \u2014 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.\u00a0<\/p>\n
The drug is called tacrolimus, and it keeps a transplant patient\u2019s 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\u2019t worked right.<\/p>\n
He told me about Hannah Goetz, though he didn\u2019t divulge her name initially. She would become the focus of a story I published recently<\/a> that\u2019s part of a larger investigation into how the Food and Drug Administration has for years allowed risky drugs into your medicine cabinet<\/a>.\u00a0<\/p>\n 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.\u00a0<\/p>\n 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\u2019s story. \u201cI was excited, because someone was going to research this issue,\u201d Holly told me recently. \u201cPossibly turn things around.\u201d Before we\u2019d met, she\u2019d been told she didn\u2019t have any legal recourse to sue over Hannah\u2019s death despite the issue with the generic. Lawyers told Holly it was impossible to draw a straight line from Hannah\u2019s death to a generic manufacturer.<\/p>\n I knew that in telling Hannah\u2019s story in detail, I\u2019d also be telling the larger story about tacrolimus, and larger still about the systemic failures at the FDA. ProPublica\u2019s reporting typically focuses on exposing wrongdoing in the hopes of spurring change. I wasn\u2019t sure whether our reporting would bring Holly the accountability she yearned for, at least not in a tangible way. I hoped Holly\u2019s experience sharing an intimate, tragic part of her life wouldn\u2019t end up being a disappointment.<\/p>\n Holly had been by Hannah\u2019s 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 \u2014 from Hannah\u2019s 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.\u00a0<\/p>\n \u201cIt was hard, because I was reliving everything over again,\u201d Holly said of our first interview at her home. \u201cThen again, I got to talk to someone else about Hannah, who she was, not just her in the hospital.\u201d\u00a0<\/p>\n As she showed me Hannah\u2019s 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\u2019s 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\u2019s own bedroom to see the pink urn with angel wings that holds Hannah\u2019s ashes.\u00a0<\/p>\n During our conversation, I realized that my reporting had given me access to key details about Hannah\u2019s death that Holly didn\u2019t know. I didn\u2019t 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\u2019s eyes widened. I had to share, too, that the FDA had revoked one version\u2019s generic status just two months after Hannah had died.\u00a0<\/p>\n The two manufacturers of the generic medication Hannah was taking, companies named Accord and Dr. Reddy\u2019s, 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 \u201cdedicated to patient safety, product quality and regulatory compliance.\u201d Dr. Reddy\u2019s said in a statement that it hasn\u2019t received any complaints that \u201cindicated any concerns in patient safety.\u201d\u00a0<\/p>\n The next day as I made the three-hour drive back to Washington, D.C., where I live, I called one of ProPublica\u2019s managing editors, Tracy Weber, whom I\u2019ve known for years. I cried as I described my conversation with Holly. One unavoidable aspect of my job is that I\u2019m often asking people about the worst things that have happened to them. In my two decades as a reporter \u2014 quite a few of those years spent covering the Iraq and Afghanistan wars \u2014 I\u2019ve sat at many kitchen tables with grieving mothers. Talking with Holly, though, was the first time I\u2019d done so as a mother myself. Her sorrow hit me differently.\u00a0<\/p>\n Over the next nine months, I\u2019d be a constant presence in Holly\u2019s life. We texted hundreds of times. She dug up old photos and videos and gave me access to Hannah\u2019s 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\u2019t give her a second transplant.<\/p>\n The ask from an investigative reporter is never just, \u201cTell me about your loved one.\u201d Our work requires meticulous detail and all the receipts. I had to recruit Holly to take considerable time to help with my reporting.\u00a0<\/p>\n 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\u2019t a simple task.\u00a0<\/p>\n Hannah was an adult when she died, so Holly wasn\u2019t 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\u2019t get access.<\/p>\n She had to recruit a lawyer friend and attend probate court to get Hannah\u2019s hospital records for me. \u201cWhat I had to go through to get them was ridiculous,\u201d Holly said. I first asked about the records in February. It took until May for her to get appointed as executor of Hannah\u2019s estate, and then several more months for the hospitals and pharmacy to fulfil Holly\u2019s request and send her the records. We didn\u2019t have them until July.\u00a0<\/p>\n There were upwards of 13,000 pages \u2014 all of which she shared with me. Sometimes, the records meant I had to ask uncomfortable questions of Holly. Why, for example, didn\u2019t Hannah consistently take her medication for her pancreas? Did that mean she also didn\u2019t take her tacrolimus? (Answers: She didn\u2019t 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\u2019t have to.<\/p>\n 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\u2019s final days in the hospital? To my relief, Holly told me later she looked forward to my texts or calls. \u201cI like sharing everything about Hannah,\u201d she said.\u00a0<\/p>\n 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.\u00a0<\/p>\n \u201cYes, because more people know now what really happened,\u201d she said. \u201cThe real story.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"When I first learned that a critical medication for transplant patients \u2014 one that keeps them alive \u2014…\n","protected":false},"author":2,"featured_media":412185,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[97,252,253],"class_list":{"0":"post-412184","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-care","8":"tag-health","9":"tag-health-care","10":"tag-healthcare"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/412184","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=412184"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/412184\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/412185"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=412184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=412184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=412184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}