Reporting duo investigates industry sway over the FDA
Feb 10, 2025
By Mary Chris Jaklevic, February 10, 2025 | From: Association of Health Care Journalists
Reporters Jeanne Lenzer and Shannon Brownlee have been collaborating on articles that take aim at problems with medical evidence since they met at an AHCJ conference in 2005.
Their latest work is a three-part series on industry influence at the FDA. It’s being published in The Lever, an investigative outlet focused on exposing corporate corruption.
The first installment, “The Deadly Secrets Behind ‘Breakthrough’ Alzheimer’s Drugs,” highlights patients who died or became disabled while taking Leqembi (lecanamab) and Kisunla (donanemab-azbt), amyloid-busting drugs that gained approval despite showing no meaningful benefits.
According to their reporting, drugmakers and the FDA exaggerated the drugs’ benefits and downplayed risks such as brain bleeding and swelling while news outlets amplified positive industry messaging.
Their piece coincides with other critical Alzheimer’s research coverage including reporter Charles Piller’s book, “Doctored.” Piller will speak during an AHCJ webinar Feb. 26.
In an interview, the reporting team discussed the challenge of finding an outlet to publish their work, what their two future installments have in store, and their sometimes contentious but fruitful working relationship.
Combating the drug industry narrative
A few months ago, Brownlee and Lenzer said they were worried their investigation wouldn’t see the light of day. Several major news organizations declined to run it.
In some cases, editors didn’t want to contradict stories about the Alzheimer’s drugs that their staff had already written, echoing the favorable messaging of industry-backed experts and advocacy groups, they said.
One top editor deemed their reporting “too prosecutorial.” At another outlet, the publisher was enthusiastic about their pitch but nixed the story once he read it, griping that no obvious crime was committed.
“It was really hard to overcome the corporate narrative,” Lenzer said, noting that positive industry messaging often dominates Google search results for drug information, echoing statements by industry-funded patient advocacy groups and medical experts.
Misleading journal abstracts that obscured drug harms were another stumbling block. At one point, a fact checker questioned their findings after reading summaries of industry-backed studies, telling a top editor that the reporting team and their expert sources had it all wrong.
They finally clicked with editors at The Lever after being wowed by its Master Plan podcast about how legalized corruption infiltrated the U.S. government.
“What we’re talking about in the (regulatory) capture of the FDA is perfectly legal corruption, so they pretty quickly got it,” Brownlee said.
Alzheimer’s drugs are part of a bigger problem
Alzheimer’s is emblematic of the FDA increasingly approving expensive and potentially dangerous drugs that offer little if any benefit, according to Brownlee and Lenzer.
They found evidence contradicting industry claims about drugs that target amyloid plaque in reports by the FDA’s internal and external expert reviewers, who are charged with evaluating clinical studies. Yet that evidence was absent from industry summary documents and news releases, they found.
There were other problems, such as companies being allowed to determine whether a patient’s death was related to the study drug without conducting an autopsy.
To tell the story, they scoured letters to the editor of medical journals and case studies to find experts whose voices had not been widely heard. One, a neurologist in Paris, had written an article in a French medical journal.
The second installment, tentatively scheduled to be published in late March, will take a broader look at drug approvals. It will include a database that will allow anyone to look up a drug approved over the last decade and determine whether the sponsor provided sufficient data to evaluate whether a drug works and is safe.
Lenzer and Brownlee said they expect the database to be a resource for journalists and anyone who wants to understand the quality of evidence for recently approved medications.
The final story will describe how the FDA fell into regulatory capture — the term for when an agency acts in the interest of the industry it’s supposed to regulate.
Without giving away details, Brownlee described the FDA’s descent as a series of tales: “You can pinpoint the beginning and then a whole series of events that have unfolded since.”
Why their long-standing partnership works
When Brownlee and Lenzer met two decades ago, the fact that many treatments are not backed by good science was not widely discussed, they recalled.
“We began writing together because we realized we had stumbled onto a view of medical evidence that wasn’t widely shared,” Brownlee said.
Over the years, they consulted on each other’s books and embarked on many joint reporting projects, such as a deep dive into prostate cancer screening for the The New York Times Magazine, a review of flu vaccines and flu treatment for The Atlantic, and an investigation of alleged ethical and regulatory lapses by researchers at Columbia University for the Huffington Post Investigative Fund.
Brownlee praises Lenzer’s ability to dig into medical studies and reports; Lenzer extolls Brownlee’s knack for explaining the big picture.
“We’re two pieces of a puzzle,” Lenzer said.
Yet they acknowledge there have been tears and disagreements.
Crafting the Alzheimer’s story, the pair battled over a physician’s quote about the harm of patients with early-stage disease being “tethered to the hospital” by tests and procedures related to drug treatment instead of fully enjoying their lives.
Brownlee thought the quote was way too long and wouldn’t pass muster with editors; Lenzer insisted it was beautifully stated and should run verbatim.
“We had this big fight over it,” Brownlee said. “In the end it’s in there almost verbatim, this full quote, and it really makes the story.”
She quipped to Lenzer: “I’ve got to listen to you more often.”
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