The FDA’S Approval Of Biogen’s Alzheimer’s Drug, · Parkinson's Resource Organization

UPDATE ON THE ROAD TO THE CURE - The FDA’S Approval Of Biogen’s Alzheimer’s Drug, Aduhelm – A Cruel and Dangerous Decision

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UPDATE ON THE ROAD TO THE CURE

A REAL-TIME SCIENCE REPORT

Ram S. Bhatt, PhD., Chief Science Officer

 

The FDA’S Approval Of Biogen’s Alzheimer’s Drug, Aduhelm – A Cruel and Dangerous Decision

On June 8, 2021, the US Food and Drug Administration (FDA) approved Biogen’s Aduhelm for treating Alzheimer’s disease despite the committee’s overwhelming rejection of the drug after reviewing clinical trial data that did not support its therapeutic efficacy. None of the eleven FDA’s advisors saw a reason to approve the drug. Thus, Aduhelm has little data indicating it is effective in treating Alzheimer’s and it comes with a hefty risk of painful and potentially dangerous brain swelling and bleeding. In fact, Aduhelm initially flunked out of two randomized, double-blind, placebo-controlled Phase III clinical trials in 2019. An early analysis dubbed the drug “futile” and Biogen ended the trials early.

            In a powerful statement of disagreement with the FDA’s approval of Biogen’s controversial Alzheimer’s drug, three high-profile scientific advisors have resigned from the independent committee that advised the agency on the treatment. Dr. Aaron Kesselheim, who resigned from an FDA advisory committee soon after the FDA announced its decision said, “This might be the worst approval decision that the F.D.A. has made that I can remember”. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, submitted his resignation after six years on the committee. Two other members of the committee resigned the same week, expressing dismay at the approval of the drug against the committee’s approval.

            Dangerous and Cruel Decision ~     The FDA’s decision to approve Aduhelm, which has not demonstrated any therapeutic efficacy, is only disgraceful but also a dangerous and cruel sham. The decision is dangerous because of the potential serious side effects such as brain inflammation and bleeding. By setting the approval bar as low as seen with Aduhelm, the FDA has set up a dangerous precedent for the approval of a future CNS drugs - the drugs with no benefit to the patients. The decision is cruel because the hopeful patients and loved ones will likely find after 12 to 18 months’ treatment that their great expectations are dashed to the ground as the treatment would not either slow down the disease progression or improve cognition.

            The main question is why the FDA would approve a drug against the recommendations of its advisors? The answer may appall everyone. What most of us don’t know is that the “Biopharmaceutical Industry Provides 75% of The FDA's Drug Review Budget. Is This A Problem?” [Forbes, June 28, 2018].

            Caroline Chen of Pro Publica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three-quarters of the FDA’s budget used for the drug review process. This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backward to meet the needs of its financial backers”.

            Likewise, last year, FDA approved Gilead’s Remdesivir for COVID-19 despite WHO found that the drug does not provide benefits to the patients. It turns out Gilead is a big donor to the FDA. Thus, the confidence of the scientific community in the FDA has eroded as the drug approval is being made using data that does not support the effectiveness of the drug.

            About Aduhelm ~ Aduhelm is a mouse monoclonal antibody raised for human brain plaque made of amyloid-beta.

            Unfortunately, mouse monoclonal antibodies are notorious for extremely low brain uptake that has been documented to be no more than 0.1%. With such a poor brain uptake it is impossible to achieve therapeutically effective brain concentrations of any drug, which may be one of the reasons why the FDA advisors failed to observe clinical effectiveness in the data obtained from the patients treated with Aduhelm. Besides, by the time amyloid plaque appears in the brain most of the neurons have already been compromised as the disease process started long (10-20 years) before the appearance of the plaque. So, clearing the plaque is not likely to improve cognition.

            Biogen’s Aduhelm vs ICBII Amyloid-beta-SMART Molecule ~ Treatment with Aduhelm has to be administered for about 18 months at a high dose to see some decrease in the levels of amyloid plaque in the brain of patients, though the FDA advisors were not convinced. Assuming Biogen’s claim to be true, 18 months is too long of treatment with a drug that has dangerous side effects such as brain inflammation and bleeding.

            ICB International, Inc., “ICBII”, has developed its own amyloid-beta antibody, referred to as amyloid-beta-SMART Molecule (Aβ-SM). In animal studies Aβ-SM has obtained a 60% reduction of amyloid-plaque with as few as one weekly low dose (2 mg/Kg) for twelve weeks, thereby demonstrating superior therapeutic performance to available mouse monoclonal antibodies such as Aduhelm that target brain amyloid-plaque. ICBII, however, does not believe that attenuation of amyloid-plaque alone will improve cognition without rejuvenating processes and mechanisms that became dysfunctional 10-20 years earlier before the clumps of aggregated amyloid-beta appeared in the brain. Thankfully, ICBII scientists have devised a solution to potentially repair such faulty processes that lead to the death of neurons in the brain of debilitating neurodegenerative Alzheimer’s, Parkinson’s, and other central nervous system disease patients. 

            WOULD YOU LIKE TO HELP get ICBII’s drugs to market faster? The joy of being a part of this historical event can be had by helping ICBII find the funds to bring these trials to fruition through your investing, and by finding others with the financial ability and humanitarian mindset to accomplish the - until now - impossible. Please contact ICBII directly through their website http://icbii.com/ or by phone at 858-455-9880 or contact Jo Rosen at PRO for a personal introduction to the scientists.

IMAGINE the world without Parkinson’s, MSA, or Alzheimer’s disease. JUST IMAGINE.

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Updated: August 16, 2017