USA TODAY International Edition

10% of cleared meds fall short of FDA goals

- Ken Alltucker

One in 10 new drugs were cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.

The study by Harvard and Yale researcher­s found that of 210 new therapies approved by the Food and Drug Administra­tion from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or end points, that weren’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.

Researcher­s said the findings raise questions about whether the federal agency’s drug approvals lack transparen­cy about some products’ safety and effectiveness.

Dr. Reshma Ramachandr­an, an assistant professor at Yale School of Medicine who co- wrote the study, said doctors, patients and health insurers depend on the FDA to rigorously vet new drugs. The federal agency needs to reassure the public that “the rubber stamp that they gave – considered the gold standard around the world – really means the drug has been proven to have safety and efficacy that outweighs any risks,” she said.

The study reviewed FDA documents to evaluate whether the clinical trials met their main “end points,” or goals that measure whether a drug works. Of the 21 drugs that did not meet goals:

● Four targeted different types of cancer.

● Three targeted influenza and other infectious diseases.

● Three were psychiatri­c drugs, including for schizophre­nia and ADHD.

● Others targeted blood cancers, Alzheimer’s disease, and lung, digestive and genetic diseases.

The FDA’s controvers­ial approval of the Alzheimer’s drug aducanumab prompted researcher­s to find how often the agency approved drugs treatments despite clinical trials with failed or mixed results. In 2021, Biogen’s aducanumab gained approval despite two clinical trials that were ended early and yielded mixed results. The approval became the target of a congressio­nal investigat­ion that concluded that the FDA sidesteppe­d outside experts who said trials failed to prove the clinical benefit of the drug.

Biogen initially charged $ 56,000 a year for the drug but slashed the price in half amid criticism that it was too expensive. The Centers for Medicare and Medicaid Services refused to pay for the drug outside clinical trial.

 ?? PROVIDED BY BIOGEN VIA AP ?? Aducanumab, sold under the name Aduhelm, drew scrutiny for its approval and pricing.
PROVIDED BY BIOGEN VIA AP Aducanumab, sold under the name Aduhelm, drew scrutiny for its approval and pricing.

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