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Biogen likely to come up empty despite getting its two Alzheimer's drugs approved
The FDA recently rush-approved two Biogen drugs aimed at reducing the presence of amyloid proteins in the brain. Amyloid proteins were previously thought to be the cause of Alzheimer’s disease but that concept has basically fallen apart in recent years. Not only have ~16 drugs that reduce the presence of the protein failed to reduce the effects of Alzhiemer’s but it turns out that some of the research the amyloid hypothesis was built on was actually fraudulent.
Despite all of this, the FDA rush-approved two Biogen Alzheimer’s drugs (Aducanumab and Lecanumab). These drugs are excellent at reducing the presence of amyloid proteins but unfortunately they (a) have severe side effects, (b) may not be effective at reducing Alzheimer’s disease, and (c) cost thousands of dollars every month.
Despite pulling off this “heist” as Dr. Robert Howard, an old age psychiatrist at UC London, calls it in getting the drugs approved, it appears that Biogen may not have any success selling their drugs. There has simply been too much push back from providers and researchers. Many people are up in arms about the whole thing.
For example, Doctors for America put out an open letter calling on the FDA to bring in a formal advisory committee to investigate the effectiveness of the drug. We spoke with Dr. Andrea An of Neurology Associates Neuroscience Center and she indicated that her practice would likely not be able to use the drug because (a) the side effects are severe and (b) it’s very expensive. Medicare has already declined to cover aducanumab and they’re still just considering covering lecanumab. Add to this doubts about whether either drug even reduces the effects of Alzheimer’s disease. It seems clear that Aducanumab doesn’t do anything at all about Alzheimer’s and the jury’s still out for lecanumab. Dr. An also indicated that her peers are saying the same things. There is generally a lot of hesitation to prescribe these new Biogen drugs.
A big concern to come out of what is now looking a lot like a fiasco is the question of whether high-trust groups like the FDA and the Alzheimer’s Association will lose credibility for cheer-leading these drugs. Dr. Alberto Espay, a neurology professor at University of Cincinnati compared the FDA’s failure to the failure of the SEC to stop Bernie Madoff.
As for Biogen, they will likely be the biggest losers in all this because they’ve invested so many resources into developing Alzheimer’s drugs that appear to be useless. And physicians and researchers aren’t buying it and the drugs aren’t being prescribed.