Alzheimer’s patients deserve the full truth about Aduhelm, a $56,000 drug that probably doesn’t work

The head of the Food and Drug Administration wants an investigation into the approval of Aduhelm, and it can’t happen quickly enough.

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The acting head of the FDA has asked for an investigation into the controversial approval of Alzheimer’s treatment Aduhelm.

The acting head of the FDA has asked for an investigation into the controversial approval of Alzheimer’s treatment Aduhelm.

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In the five weeks since the Food and Drug Administration approved a controversial new treatment for Alzheimer’s, the fallout hasn’t stopped.

Just days after the drug aducanumab was approved on June 7, three members of an FDA panel that had previously rejected the treatment quit in protest. Ten of the 11 panel members had voted against the drug, saying the data from clinical trials showed insufficient evidence that it worked.

One of the three FDA panelists, Dr. Aaron Kesselheim of Harvard Medical School, called out the FDA’s green light as “probably the worst drug approval decision in recent U.S. history” in a resignation letter to acting FDA Commissioner Janet Woodcock.

And now, in the wake of reporting from the health news outlet STATNews on the cozy relationship between a top FDA official and executives from Biogen, the drug’s developer, Woodcock has taken an unusual step:

Last week, she called for a full investigation by the FDA’s Office of the Inspector General into the approval of Aduhelm, the brand name for aducanumab.

Editorials bug

Editorials

An independent investigation cannot come quickly enough. This editorial board was immediately critical of the FDA’s decision, our skepticism based on widespread opposition from medical experts who had reviewed the clinical data.

Now, to be blunt, we have to wonder if the fix wasn’t in from the beginning.

Woodcock likely felt the pressure immediately, and rightly so, from health policy experts and independent watchdogs who began clamoring for such an investigation in the wake of the STATNews report.

Consider this: “It was previously known that Biogen and the FDA worked together on Aduhelm. But STAT has learned that the back-channel relationship between the two started earlier and was far more extensive than disclosed.”

Any evidence of back channels and too-cozy relationships demands an official accounting that lays out how and why the FDA gave Aduhelm a green light — when its own experts advised otherwise.

As Woodcock acknowledged on Twitter, an independent investigation is the only way “to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures.”

A search for treatment, mostly in vain

More than 6 million Americans — 44 million worldwide — are now living with Alzheimer’s, an incurable disease that causes memory loss and other debilitating symptoms. Over 99% of new Alzheimer’s drugs fail in clinical trials, one study found.

The FDA last approved a new drug for Alzheimer’s in 2003, so it’s no wonder that some patient advocates hailed the FDA’s decision to grant “accelerated approval” to Aduhelm. We understand. New, effective treatments are desperately needed.

Indeed, Aduhelm in one sense represents a new frontier in treatment. The drug targets the disease process itself, by helping to reduce the presence of amyloid beta plaques — abnormal proteins — that form in the brains of Alzheimer’s patients.

But here’s the big question: It’s still unclear whether reducing those plaques will ease Alzheimer’s symptoms. Numerous medical experts have said the data from Aduhelm’s clinical trials show the drug — which has a price tag of $56,000 a year — is ineffective at reducing those symptoms.

The FDA granted “accelerated approval” to Aduhelm, which means Biogen must conduct additional clinical trials to determine definitively whether the drug is effective.

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In theory, we would likely favor the accelerated approval of such a drug, with the goal of quickly getting innovative new treatments to suffering patients.

But as Kesselheim, the former FDA advisor, said after the FDA’s Aduhelm decision, “accelerated approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”

All of this makes a full investigation even more urgent.

And if follow-up clinical trials fail to prove conclusively that Aduhelm works, the FDA must revoke its approval.

There’s no room for false promises.

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