A letter from the executive editor: The Aduhelm Files

Dear Reader,

From STAT’s first investigations in June 2021 revealing why the FDA gave the go-ahead for a marginally effective Alzheimer’s drug manufactured by Biogen, we have relentlessly stayed on the story. We’ve reported on the disastrous financial and leadership consequences for a one-time biopharma behemoth, as well as the dashed hopes of millions of people with dementia who had heard of a new drug called Aduhelm.

Today, an even darker picture emerges with the release of an 18-month investigation by two committees of the U.S. House of Representatives. STAT journalists who have covered drug development and Alzheimer’s disease for decades — whose findings in part spurred the House investigations — are back today with three stories based on new revelations about one of the most contentious drug approvals in decades.

• First is the story of Biogen and its rollout of the drug, Aduhelm. Our reporters piece together from the House documents how a drug company chose to maximize its potential profits at the expense of patients and taxpayers.
• Then there is the FDA story. We show through the documents how the agency’s review and approval of Aduhelm was, according to House investigators, “rife with irregularities,” including dozens of undisclosed calls and emails with Biogen.
• And the “takeaways” story distills the congressional investigation — based on 500,000 documents — with eight key takeaways.

From the beginning, our most ground-breaking coverage of Aduhelm has been available only to STAT+ subscribers. I hope you’ll consider buying a subscription so you can have access to such important journalism and support our tough-minded examinations of the business of making medicines, health tech, science, public health, politics and policy, and chronic diseases — stories like one published today on what happened to Eric Lander, President Biden’s science adviser, who left that job amid accusations of workplace bullying.

We are offering a special end-of-year rate to readers of this letter; get your first three months of STAT+ for just $30. We also offer academic and nonprofit rates, as well as group subscriptions and licenses. You can get more information here.

STAT’s coverage of the Aduhelm debacle was recognized this year with many honors, including the George Polk award and the top award from NIHCM, the National Institute for Health Care Management Foundation.

Here are some of the stories leading up to the release of today’s House investigations:

• Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug
• How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug
• Biogen’s reckoning: How the Aduhelm debacle pushed a troubled company and its fractured leadership to the brink
• FDA’s Woodcock is just ‘not that concerned’ about the criticism over Biogen’s Alzheimer’s drug, Aduhelm
• In a sudden move, Al Sandrock, the man behind Biogen’s Aduhelm, to retire
• Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations
• Listen: Two Alzheimer’s experts with opposing viewpoints on Aduhelm
• For the ‘godfather’ of biotech, saving Biogen is the final act of a singular career
• Biogen’s new CEO, clear-eyed about company’s challenges, prepares to take the reins

Thank you for reading STAT, and please reach out to me with any feedback.

I hope you have a happy and healthy new year.