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Mixed Sentiments For FDA’s Approval Of Aduhelm for Alzheimer’s Disease In America

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DigitalIntelligence
DigitalIntelligence
 10 days ago

Alzheimer’s disease is a devastating disorder affecting 6.2 million Americans. And many more millions are affected globally. It is a debilitating human condition, especially for the aging population.

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There is a new drug that is finally approved by the FDA (Food and Drug Administration). It was a piece of uplifting news for many. However, the approval created massive concerns about its expedited approval. The biggest concern is the prohibitive cost and affordability of those who need the medication the most.

From my reviews of recent articles, an interesting summary of concerns was made by NeuroCentrix. It is a private neuroscience facility dedicated to evidence-based assessment, treatment and research of memory and mood disorders in Australia.

The news posted today by Luke Edenfield, titled Controversy over approval of Aduhelm for Alzheimer’s Disease, highlights: “In a hypothetical scenario where the 44 million current Alzheimer’s patients receive Aduhelm, that’s $3.7 trillion a year, or almost half of the world’s entire health budget. By 2050, it would be $12.6 trillion – or $400,000 per second, every second. If Biogen receives the merest fraction of that, they have quite the windfall indeed.

The purpose of this article is to introduce a drug named aducanumab branded as Aduhelm by Biogen in the United States. I aim to provide perspectives covering a broad range of thoughts and sentiments by professionals and the public as reflected in traditional and social media. Media sentiments demonstrate both celebration and apprehension.

I wrote many articles and papers about dementia. The most recent one was on News Break titled “Everyone Desires Longevity, But Nobody Wants Living With Dementia”. In this article, I touched on the culprits for dementia and introduced cognitive reserves and preventative measures. In addition, I pointed out the contributing factors such as neurological decline, other health conditions, environmental impact, particularly toxins, and genetics. However, even though genetics is mentioned, scientists are still yet to find the gene codes causing dementia.

Wearing my cognitive science hat and concerning my aging brain, I celebrate this event for compelling reasons. Our brain is the most critical organ, and our mental health determines our happiness and satisfaction in life.

The news about this controversial drug was released in the press and widely discussed in major TV channels, YouTube, and multiple other social media platforms.

When I searched Google, 871,000 results appeared. The top ten entries on the first page related to the FDA. The first entry was titled “FDA Grants Accelerated Approval for Alzheimer's Drug | FDA - FDA.gov”. This key artefact is the FDA news release dated June 07, 2021. I read the news release. I also read several other articles and comments on social media. I watched the news on several channels.

I want to base my perspective on a specific quote. Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, is quoted in this news release by FDA.

According to Cavazzoni:

Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones. Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. In addition, as we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation”.

This critical quote from Dr Cavazzoni brings us on the same page. The message is clear.

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Alzheimer’s disease is a devastating illness. It affects not only the patients but also their loved ones. The critical information in this quote is that current therapies only treat the symptoms, and this new drug is the first therapy to target and affect the disease process.

Many people criticize the FDA for approval of this first of a kind drug. Some people believe that the FDA lowered the bars to approve this controversial drug, as depicted in social media sentiments.

It is wonderful to have opposing views about critical topics. It is the beauty of democracy. Different perspectives help us see hidden aspects of a reality construct. Only with multiple perspectives, we can see our blindspots.

In my opinion, FDA justified the reason for this expedited approval. Here is the statement: “The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need. Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain)”.

I respect the criticism mainly stemming from drug administration, financial aspects and economic implications of the drug. However, a more helpful and useful perspective can be to look at the issue from a utilitarian angle for future outcomes.

Let’s face it. Humanity is in desperation because of this illness. Millions of people suffer from having no hope. A drug might not be perfect as nothing is perfect in this world. However, we need to start from somewhere. Unless we have a baseline, it is not viable to assess and make progress for a concept.

FDA confirmed its position on an approval basis and its plan.

Here is the formal conclusion:

FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease”.

My understanding from Dr Cavazzoni’s quote, the FDA approved this drug with a plan for more research leading to innovation. Only with a vision, strategy, and collaboration can we ignite innovation.

Let’s remember that only after May 1954, when Banister (a medical student) broke the world record for four minutes per mile barrier in sprinting, the other athletes had started breaking the record. Until then, the record stayed the same for many years, and people thought that it was impossible to break this record.

Unknowns bring fear and anxiety. It is embedded in our primitive brain. However, there is nothing to be in this world but just to be understood, as articulated by Marie Curry.

Yes, the drug is expensive as a massive effort and an organization invested time. A team of scientists, business people, and support people contributed to creating it. It is the reality of the business world. Time and effort come with a cost. We cannot change the reality. Truth prevails.

What could be more beneficial for us now is to focus on what “aducanumab” can do and how this ingredient can be further researched and enhanced. Scientists and researchers can apply various techniques such as reverse engineering, and we can leverage the power of biotechnology supported by artificial intelligence, machine learning, and big data analytics.

Learning from clinical trials and further research can generate new ideas and breakthroughs. With more research and input from patients, we can see the light at the end of this dark tunnel for humanity.

Thank you for reading my perspectives.

Related article on News Break
Everyone Desires Longevity, But Nobody Wants Living With Dementia