Aducanumab: Sticking It To The Seniors And To The Taxpayers (While government does nothing to protect either)
The new Alzheimer’s drug that could break Medicare
Public Citizen, as usual, has been on this. A summary of their articles.
“The overall tenor of the FDA’s briefing document for this meeting reveals that the agency is actively working hand-in-hand with Biogen, the maker of aducanumab, to rush to market an unproven biologic drug to treat Alzheimer’s disease that could bankrupt our health care system.
“Two similar large studies compared aducanumab to a placebo. Both studies were stopped early because a planned interim analysis found that they were unlikely to show that the drug works. Nevertheless, Biogen subsequently pursued analyses of data from the studies that were, from a scientific standpoint, highly susceptible to bias. One study appeared to show that the drug works, but the other clearly showed the drug doesn’t work.
“FDA staff and Biogen now are trying to convince advisory committee members and the public that the negative study should be ignored and that the drug should be approved based on the one positive study. Such an approach is seriously biased and unscientific.
“Only the FDA statistician who reviewed the aducanumab study data appears to wisely recognize the recklessness of approving the drug based on the available data, noting the following in her assessment: ‘if we select only the better study, our estimate is very likely biased, and we already know not consistently repeatable in our experience. Thus, excluding data from a large trial without sufficient justification is unscientific, statistically inappropriate and misleading.’
Source/Full Article:
FDA Approval of Aducanumab to Treat Alzheimer’s Disease Would Be a Reckless Disregard for Science, Damage Agency’s Credibility
If the government were serious about tackling Alzheimer's, antiperspirants containing any ingredient starting with alum____ would be banned (different names are given to aluminum ingredients used in antiperspirants). Substances injected into the body would be banned from containing aluminum of any type. Mercury dental fillings would be banned.
Further, there would be comprehensive genuine research on ways of getting aluminum and mercury out of the body. (Actually, there are numerous inexpensive ways of doing that already, but where are the obscene profits and ease of elimination of the Useless Eaters in that?)
TLC
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