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UrduBecause Alzheimer’s disease is such a serious concern for seniors, any advocacy group’s recommendations for a drug company’s proposed therapy must be science-based and above reproach, says Leslie Norins, MD, PhD, FIDSA, CEO of Alzheimer’s Germ Quest.
On January 29, the FDA granted Biogen an extension, until June 7, to add to or recalculate existing data for its candidate drug, aducanumab.
Concurrently, the CEO of the Alzheimer’s Association (AA), Harry Johns, issued to its executives, supporters, and others a national e-letter endorsing the compound, saying in it, “We believe the publicly released scientific data..” However, he offered no details, or a reference, as to how, and by whom, his organization arrived at a conclusion different from that of the FDA expert advisory committee, which voted 10 to one against approval of the drug in November.
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Moreover, since any further results from trials are not yet public, it is unclear if AA used fresh “insider” information for a new analysis, or was merely reasserting its original endorsement—the derivation of which remains a mystery. |
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The new e-letter, like the previous one, also failed to disclose information that nowadays is routinely required for any medical journal article or government appointment; namely, could there be a potential conflict of interest?
Evidence indicates that Biogen-Esai has given AA and its lobbying arm several million dollars over the past few years. AA has ignored a prior plea for this amount to be established by outside auditors, and released for public scrutiny, so it could be weighed in any AA endorsement of the company’s drug.
The Johns letter also repeated a few indirect motivations for approval, which nobody would disagree with, including the dire need for a drug to halt or cure AD. “But other than repeating these platitudes,” says Dr. Norins, “there is no new ‘meat’”.
Dr. Norins concluded, “We are left with the embarrassing situation of the leading Alzheimer’s advocacy group apparently touting for a drug company which gives it hefty monies.”
Alzheimer’s Germ Quest is a privately held independent organization. It is not affiliated with, or endorsed by, any other group. Its focus is encouraging research into the possibility that infectious agents playa role in the causation of Alzheimer’s disease.
