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US regulator fast-tracks dementia drug

RT | January 6, 2023

The US Food and Drug Administration (FDA) on Friday fast-tracked  the approval of lecanemab, a drug to treat the early stages of Alzheimer’s disease. Made by Japanese drugmaker Eisai and Biogen and marketed as Leqembi, the drug allegedly delays cognitive decline caused by the disease, though trials have shown some alarming side effects.

While a clinical trial of lecanemab’s efficacy in early Alzheimer’s published in November found it slowed cognitive and functional decline better than a placebo, the researchers noted that it was “associated with adverse events” and recommended “longer trials” to “determine the efficacy and safety of lecanemab in early Alzheimer’s disease” – an unusual call for caution in a study co-funded by the drug’s manufacturers.

Around 17% of those who took lecanemab experienced brain bleeding during the trials, while nearly 13% suffered brain swelling or effusions, compared to 9% and 2% in the placebo group respectively, according to the New England Journal of Medicine study. Some 7% of the trial participants stopped taking the drug due to the side effects.

Lecanemab’s high price point – $26,500 for a year’s worth of treatment – has also raised concerns. The Institute for Clinical and Economic Review suggested $20,600 as the price ceiling, arguing a cost-effective rate could be as low as $8,500. The company suggested it could lower the dosing frequency to cut costs.

Biogen is no stranger to controversy over its Alzheimer’s drugs. In 2021, several FDA board members resigned over concerns that Aduhelm, which the company had developed as the first drug designed to target the plaque buildup then believed to be the underlying cause of Alzheimer’s, had not demonstrated sufficient efficacy in treating moderate-to-severe dementia. While not a single member of the advisory panel responsible for reviewing the drug supported its approval, the FDA did so anyway, side effects and $56,000 annual price tag notwithstanding.

A congressional investigation that concluded last week found the approval process “rife with irregularities,” noting the FDA had “inappropriately collaborated” with the company it was supposed to be regulating.

Last year, it emerged that parts of the research that established the current plaque-based disease model of Alzheimer’s were possibly fraudulent, suggesting that the amyloid plaques found in the patients could be a symptom, rather than the cause, of the illness.

January 7, 2023 - Posted by | Corruption, Science and Pseudo-Science | ,

2 Comments »

  1. “Lecanemab’s high price point – $26,500 for a year’s worth of treatment – has also raised concerns. The Institute for Clinical and Economic Review suggested $20,600 as the price ceiling, arguing a cost-effective rate could be as low as $8,500”.

    Pardon my cynicism, but, given the Covid 19 “Pandemic”, and the ineffectiveness of the “Vaccines” to eliminate the “Virus”(which no one has been able to isolate as yet), it’s not too hard to imagine that the World (illegal drug trade), maybe, is done by the World’s largest Drug companies themselves.
    If Dr Fauci is any indication, I wouldn’t trust that guy as far as I could kick his ‘ass’.
    Of course, the drugs would have to be produced outside of the USA/Europe, but, that is already happening anyway. Labour is very cheap in India etc.

    My trust in what I thought was the “way the world worked” has been shattered by Covid. Even the WHO has it’s dirty fingers in on the deal. And, when you have a brain dead idiot as POTUS, God only knows who is actually running this Planet.

    And too top it off, “The War on Drugs” has been spectacularly unsuccessful.

    Like

    Comment by brianharryaustralia | January 7, 2023 | Reply

  2. Dementia and Alzheimer’s are caused by the accumulation of nano particle Aluminum crossing the blood brain barrier. Trials of Aluminum stopped in 1979 prior to human tests. Aluminum is found in blood, bone and brain and is typically much higher in the bone and brain than what’s found in a blood test.
    The natural element found is Alum. It becomes Aluminum after processing. It has to be asked how so many people are breathing or ingesting Aluminum? In a Nano particle size?
    This is another human inflicted “disease” without the proper testing, just like covid, that bigjew pharma have all the remedies.

    Like

    Comment by raggs12 | January 8, 2023 | Reply


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