FDA's 'Independent' Reviewers Of Alzheimer's Drug Had Ties To Drug Companies

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Health Berita

Alzheimer's,Donanemab,FDA

An investigation by the BMJ has revealed that seven out of eight doctors appointed by the US Food & Drug Administration (FDA) to review donanemab, a new Alzheimer’s treatment, received direct payments from drug companies. This raises concerns about potential bias in the FDA's decision to approve the drug.

A BMJ investigation found seven of the eight doctors appointed by the US Food & Drug Administration to review donanemab received direct payments from drug companiesHealth CorrespondentA “game-changing” new Alzheimer’s treatment was approved for use in the US by “independent” scientists who had received funding from the drug’s manufacturer’s, an investigation by theDonanemab, made by pharmaceutical company Eli Lilly for people with a diagnosis of mild cognitive impairment or early-stage...

“There was also no information on health outcomes in those patients other than death, nor the causes of the deaths,” he said, adding that the “failure to formally follow patients who stopped treatment was a significant design flaw, particularly when that discontinuation was partly due to adverse drug effects.”, even if it is granted a license by the medicines regulator.

But three months after the FDA’s decision, UK officials have not yet decided whether to approve donanemab. If granted a license, the NHS spending watchdog would then decide whether it should be made available on the health service.: “MHRA will rigorously and robustly review the safety and clinical effectiveness of donanemab, playing a critical role in protecting patients

Donanemab, like lecanemab, is a type of drug called a monoclonal antibody. Antibodies form part of our immune system and bind to harmful proteins to destroy them. Donanemab contains antibodies that bind to a protein called amyloid, which builds up in the brain in the early stages of Alzheimer’s disease.

 

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