The Worst FDA Drug Approval In History – No, It’s NOT the Covid Vaccine

The US Food and Drug Administration (FDA) approved the pharmaceutical company Biogen’s monoclonal antibody aducanumab (Aduhelm) on June 7 for the treatment of early stage Alzheimer’s disease. It was the first new therapy approved for the neurodegenerative disorder in nearly 20 years. It is a very expensive drug, costing $56,000 a year and works by removing some of the plaque which has built up in the brain, a mechanism felt to contribute to this devastating disease, now the 3rd leading cause of death in the US.

Why has it been that long? Because unfortunately, drugs don’t work against Alzheimer’s Disease.

Despite over 400 drug trials and more than $1.4 billion spent, not a single medication to treat Alzheimer’s Disease has ever been shown to have any specific benefit. And many have actually been detrimental.

In fact, research and development in Alzheimer’s Disease management has been abandoned by many pharmaceutical companies because of how little benefit drugs have shown and the price for development is a losing business.

The approval of Aduhelm has now been called “the worst approval by the FDA in its history”. The studies showed no benefit, but because of the concept of “the right to try” prompted by desperate families, as well as the lack of any obvious harm in studies, it was fast-tracked.

Alzheimer’s is the most common form of dementia but even if you carry the genes which make getting it inevitable, you can delay it’s onset, slow its progression, and in the case of other forms of dementia, potentially prevent them from occurring in the first place. Lifestyle is the key. The changes in the brain leading to all forms of dementia start 20-30 years before symptoms start to develop, at which time it is too late. Now is the time to implement healthy lifestyle strategies to prevent this disease, which will likely bankrupt our healthcare system, if some other pandemic doesn’t or climate change doesn’t before. Treatment of Alzheimer’s, which is basically psychosocial support for patients and their families, is the most expensive disease to manage and often bankrupts many families.

A phenomenal book describing the steps you can take to minimize the risks of developing dementia is “The Alzheimer’s Solution” by Dr.s Dean and Ayesha Sherzai, co-directors of the Dementia program at Loma Linda University in California. In a nutshell, some of the strategies proven to prevent cognitive changes and dementia include:

• Eating a plant based diet, reducing fat, especially saturated fat. Yes, that means healthy, whole food plant-based diets are the healthiest. Minimize processed foods and sugars. Minimize animal products.
• Regular exercise, and it doesn’t take much.
• Proper sleep. This is such a crucial component.
• Psychosocial support.

PLEASE don’t use this misstep by the FDA as ammunition to argue against the Covid vaccine. Apples and oranges. The vaccines were developed quickly, but safety was established and has borne out after 6 billion doses and it’s efficacy has been proven as the incidence of severe disease, hospitalization and death is almost exclusively in unvaccinated people.

Stay safe and be well. 

AC

There is a persistent argument that the vaccine is not trustworthy because of how new it is and how quickly it was developed. This is partly true but there is a lot of misunderstanding about this topic.

Yes, it went through all the regular approval steps much faster than a typical medication, but the point is that it went through ALL the regular approval steps, with no steps skipped. It is just that certain steps, mostly administrative and infra-structural, which are usually the most time consuming and costly, were expedited with the assistance of the government.

First of all, the development of the mRNA vaccine first began over 15 years ago, at the time the first SARS and MERS epidemic started. The adenovirus technology, used by J&J was developed, and has been used since the early 70’s. The average timeframe for drug inception to consumer consumption is 12 years, so this vaccine has already been in the pipeline for longer than average. Because of the limited need for such a vaccine, partly because of the limited spread of SARS-1 and MERS, it never went on to be fully developed. Neither infection had the potential to become a world-wide epidemic. That all changed with SARS-CoV-2, a much more infectious, albeit less dangerous virus. The sheer numbers of infected people, along with the overwhelming impact it has on our medical system, is what makes it so impactful. Our need to get a vaccine up and running as fast as safely possible was imperative.

One of the big costs and stumbling blocks in drug development is the building and development of the infrastructure to make and distribute the new drug, or in this case, vaccine. New production plants and lines. New means of distribution, storage, insurance coverage… These are massive costs and risks and most companies will not take those steps until the drug shows significant promise in terms of efficacy and safety. The government had relieved these pharmaceutical companies of these burdens and risks by guaranteeing financing and assisting in these other areas of distribution and reimbursement so everything was in place to start the vaccine roll-out as soon as the vaccines were tested, reviewed and approved for emergency use.

In addition, to make drug studies significant, you need enough volunteers and have a disease which can be studied easily to be of any value. We just did not have enough SARS-1 and MERS patients for such studies. Again, that all changes with SARS-CoV-2. Lots of infection with easy spread made studies easier to get up and running.

As I mentioned in previous posts, we never really know long term side effects until we have long term data. All we can do is look at the information we have and make the best decisions we can. Many drugs have been approved after having undergone human trials with no issues, only to be withdrawn years later, after it was determined that they were actually dangerous. In fact, one of the most commonly used antibiotics, Augmentin, is one of the top drugs causing liver damage. This complication is rare and was not apparent early on, but the drug is still used (or more accurately overused) because it is effective when prescribed appropriately and for the majority of people, safe.  Many surgical procedures were approved for use, only to be abandoned because, although early studies were positive, long-term results were not. Asbestos was used to insulate pipes, until we learned that it caused lung cancer. Lead was used in pipes, until we learned that it was toxic. BPA is still used in plastics and cans, despite the fact that it clearly is toxic, disrupts hormone function and it is completely unnecessary to use.

Again, all we can do is make decisions based on the available information and the balance of risks and benefits.

To me, vaccination is clearly our best option if you consider avoiding infection, limiting degree of infection, limiting spread all while trying to return to, and maintain some semblance of lifestyle which we have become accustomed to. Are we willing to COMPLETELY isolate for 2-3 weeks, worldwide? That would eliminate the virus, but clearly that will never be accepted.

We all need to do the best we can.

Enjoy this gorgeous weekend (at least in the Philly area).

Stay safe and be well.

AC