New Drug Approved? Really? Why?

Can We Believe Anything These days?

On June 7, 2021, the FDA granted approval to a drug that no one on the expert panel–selected by the FDA to oversee this decision–approved of.

Yep, you read this right! Of the panel of experts the FDA selected to evaluate whether this new drug should be approved or not, all said: NO. So what did the FDA do? Well… but of course! It approved it! Since then, one member of this expert committee has resigned–likely more to follow.

And you and I… well… we don’t count.

Alzheimer’s Disease

There is not a person on this planet who doesn’t fear Alzheimer’s Disease (AZD). It often comes from nowhere, no one seems to know the cause. It appears to just happen and it can strike anyone at any time for no apparent reason. Of course, there are many theories!

Today many scientists (the majority, in fact) seem to agree that AZD is a form of diabetes, in fact Type 2 Diabetes (T2D) of the brain, which they call T3D–the 3 is standing specifically for T2D causing AZD. There are hundreds of articles on this. See some here, here, and here.

Perhaps 6-7 years ago, I was watching the Sunday night TV program 60-Minutes, in which a scientist (Claudia Kawas, MD) was interviewed from University of California Irvine (UCI) about a specific study of how and why AZD may start, what may be the cause, how may it be treated, prevented, or cured. I never forget how some of the 90+ year olds were talking to 60-Minutes as well and how many of them were shown to have the following conditions:

  1. No visible signs of any condition, no AZD on the test, full of energy, and verbose
  2. Clearly serious AZD showing up on the test and some noticeable changes in talking and comprehending.

These 90+ participants are/were members in a senior center who all volunteered for the study and donated their brain for research on AZD after their death, so the researchers could see the before, during, and after states and see connections–if any–of AZD to lifestyle or other factors.

Their Findings

The next time I saw the same team on 60-Minutes was several years later. At this time, the same leading scientist explained that what they have found was absolutely stunning (see their published articles listed here). Many of the participating elders have died in the past years and so they could examine their brain and see what physiological and anatomical AZD symptoms they had in the brain. They findings took my breath away:

  1. Some of those diagnosed with AZD while alive, had no amyloid plaques at all, yet amyloid plaques are typical of what we understand the AZD brain dies from. So clearly, one can have AZD without amyloid plaques.
  2. Some of those testing absolute perfect scores (meaning no AZD) while alive, had their brain full of amyloids. Meaning: if amyloids is always present–and is a causal factor in AZD–then these elderly must have had AZD given that they had amyloids, but they had no cognitive decline, so they had no AZD.
  3. Some of those testing with AZD had amyloid plaques, as expected.

Based on their findings, the lead scientist concluded–on 60 Minutes television program–that clearly amyloid plaques seem to be an independent factor and don’t cause AZD. In fact, some research suggest that amyloid plaques provide protection against AZD (see here, here, and here).

FDA Announcement

OK… so I just showed one research group who concluded that amyloid is not a causal factor to AZD, and that amyloid plaques may, in fact, play a protective role against AZD, yet the FDA announced on June 7, 2021, that it approved a drug for AZD that “addresses the cause of Alzheimer’s disease” by blocking the formation of amyloid plaques, reported BBC, NBC, the NYT, and probably all news outlets around the world! (see here)

Yep! The very thing that doesn’t exist in many Alzheimer’s brains, and if it exists in a brain it may provide protection against AZD, is going to be blocked. It appears that amyloid plaques may develop specifically to help the brain cope with whatever causes AZD and yet this drug is there to prevent it!

Indeed, this very drug has failed previously and the pharmaceutical company has pulled it out of trials.

Is the FDA shifting its rules on how it considers drug approvals and why? It appears they are shifting, and likely not without interest, but.. of course.. we don’t know who is getting richer–the Alzheimer’s Association was brought to my attention by a scientist. I didn’t think about the protentional role they play, but since they are funded also by big pharma, we must consider the influence. You can see some of the collaborators listed here, though no specific list of where their funds come from is described on their website.

What we do know is that there was a 10-member expert panel put together (by the FDA) to evaluate the worthiness of this new drug for approval. Of the 10 experts, 9 completely and 1 conditionally recommended to NOT approve the drug (see here). Yet the FDA disregarded the opinions of the very experts they have asked to make the decision and approved the drug anyway.

What was the next step? One of these experts resigned immediately on the 8th of June, 2021.

In Summary

I have always been a person of scientifically critical mind and find it extremely had to understand what happened here and why. I sense some criminal activity here but I am unsure where to place the blame. It is criminal, because if the amyloid plaques do provide protection from the development of AZD, then this drug hastens the disease stage of those afflicted and literally chaperones them to their death faster.

The US Pharmaceutical Industry is one to watch under the microscope for every single step they take. Clearly the FDA is not an unbiased entity that they present themselves to be. We all knew this but I think not to this extent. The decision to overrule the experts in favor of the pharmaceutical industry is a negligent act, in which the FDA is acting as an “expert agent”, which it is not.

Another point of importance:

I bet we will not hear about this “criminal activity” on the part of the FDA on any news outlets that announced that the cure for AZD was found and this new drug is it! I bet that not one, not BBC, NBC, CNN, or any of the others, will revisit the subject to announce that the FDA approved a drug the experts on the committee unanimously voted against.

Comments are welcome, as always, and are moderated for appropriateness.

Angela

About Angela A Stanton, Ph.D.

Angela A Stanton, PhD, is a Neuroeconomist focusing on chronic pain--migraine in particular--physiology, electrolyte homeostasis, nutrition, and genetics. She lives in Southern California. Her current research is focused on migraine cause, prevention, and treatment without the use of medicine. As a forever migraineur from childhood, her discovery was helped by experimenting on herself. She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic variations of all voltage dependent channels, gates, and pumps (chanelopathy) that modulate electrolyte mineral density and voltage in the brain. In addition, insulin and glucose transporters, and several other variants, such as MTHFR variants of B vitamin methylation process and many others are different in the case of a migraineur from the general population. Migraineurs are glucose sensitive (carbohydrate intolerant) and should avoid eating carbs as much as possible. She is working on her hypothesis that migraine is a metabolic disease. As a result of the success of the first edition of her book and her helping over 5000 migraineurs successfully prevent their migraines world wide, all ages and both genders, and all types of migraines, she published the 2nd (extended) edition of her migraine book "Fighting The Migraine Epidemic: Complete Guide: How To Treat & Prevent Migraines Without Medications". The 2nd edition is the “holy grail” of migraine cause, development, and prevention, incorporating all there is to know. It includes a long section for medical and research professionals. The book is full of academic citations (over 800) to authenticate the statements she makes to make it easy to follow up by those interested and to spark further research interest. It is a "Complete Guide", published on September 29, 2017. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in Economics with dissertation in neuroscience (culminating in Neuroeconomics) at Claremont Graduate University, fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers, certification in LCHF/ketogenic diet from NN (Nutrition Network), certification in physiology (UPEN via Coursea), Nutrition (Harvard Shool of Public Health) and functional medicine studies. Dr. Stanton is an avid sports fan, currently power weight lifting and kickboxing. For relaxation (yeah.. about a half minute each day), she paints and photographs and loves to spend time with her family of husband of 45 years, 2 sons and their wives, and 2 granddaughters. Follow her on Twitter at: @MigraineBook, LinkedIn at https://www.linkedin.com/in/angelaastantonphd/ and facebook at https://www.facebook.com/DrAngelaAStanton/
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12 Responses to New Drug Approved? Really? Why?

  1. Emily says:

    Since you don’t want me to reply in the regular thread I thought I would it here.

    “Emily, unfortunately that’s not how it works.”

    Because some are happy to blog about it and tell those who want more aggressive measures that it isn’t “how it works”.

    “Tim Noakes, Dr. Gary Fettke, and Dr. Paul Saladino.”

    I am familiar with all of them. They are brave but their actions were called for and they did what was necessary. It shouldn’t be expected that people are going to “wimp out” when the tough calls need to be made. Doctors get plenty of money…they should be able to rebound. They just want the money to keep rolling in. By apologizers making excuses for them… they get to continue doing so. This lives on the line. No one should be doing anything but loudly calling them out. If we all did it things would need to change.

    Like

    • Emily, there is no other way to respond on my website, but this way.

      In terms of the statement “It shouldn’t be expected that people are going to “wimp out” when the tough calls need to be made. Doctors get plenty of money…they should be able to rebound. They just want the money to keep rolling in. By apologizers making excuses for them…” has a ton of problems with it, so let me break this up into chunks and explain these to you.

      “It shouldn’t be expected that people are going to “wimp out” when the tough calls need to be made.” This is incorrect. There is no job–other than medical–today where people are called “wimpy” if they don’t defy the regulations. The medical boards of each state in the US–and I am sure it is the same way everywhere–are there to stop the doctor from giving advice to anyone that is outside of the regulation. If every doctor stepped outside and did what these three did, we would have no licensed medical doctors, because the medical board is much more powerful than any doctor. In Canada, there were 1000 doctor that signed their names on a petition to be able to provide the type of healthcare they wanted, and what happened? It takes even longer to get medical care–a simply X-ray may take 9 months of wait. Likely some doctors have lost their job in the process of trying to change the system.

      “Doctors get plenty of money…they should be able to rebound.” I am not sure where you get this information. After the medical school itself costing a quarter to over a half a million dollars for the 4 years, and then 10 years of residency in which they make barely enough to survive, Here is a residents salary table that I copy past–this is from California, where currently, very tiny single family homes 20 miles from the beach cost over a million to buy:
      Percentile Salary Location
      25th Percentile Medical Resident Salary $53,543 CA
      50th Percentile Medical Resident Salary $60,107 CA
      75th Percentile Medical Resident Salary $67,009 CA
      90th Percentile Medical Resident Salary $73,293 CA

      I don’t see much money here… I was making more than this when I was straight out of my MBA program in 1998, starting to work for Intel! They don’t make much money for many years. Once they are a “real doctor” they make more but it takes more than half of their lives to repay the educational loan.

      And lastly, you are blaming me: “By apologizers making excuses for them”.

      I think you may be a lovely person “in person” but are very quick to judge. No one is making any excuses for anyone. This blog article is criticizing the system and is trying to help changing the grassroots and is certainly not providing an apology for anyone. But as a professional myself, I understand the system better. There is zero point of making the lives of those who cannot help miserable, which is what you are doing.

      Careless actions are not only useless but are harmful. We don’t want our doctors to be fired and sued and chase them to suicide! It’s not the fault of the doctors that they are taught garbage in medical school and that the academician that set up the dietary guidelines (they are not medical doctors but PhDs in the field of nutrition) all have conflict of interest and chose a dietary guideline that benefits their pocketbook! It’s not the MDs you are after but the system. Chasing MDs will not get you anywhere.

      I consider your action weak because even after you are informed that it is the wrong place to raise the red flags, you are continuing to raise the red flags into the faces of the wrong people. So your actions are harmful! It appears to be like the Cancel Culture’s radical movement: harmful for all.

      Angela

      Like

  2. mslarma says:

    Hi. Thanks for your article. Very interesting and timely as about 2 nights ago there was a news piece on our television here in new zealand about this drug. I am not really a tv watcher but it caught my ear and i listened to it. I was immediately intrigued as after reading Dale Bredesons book on Alzheimers and listening to lots of drs and researchers about it i wondered how good the medicine would be seeing as how they have not managed a drug so far. I was going to start doing some research and found your article in my inbox. Thank you!!! It is very concerning as i have a friend who has the disease and they will all probably think this is going to help. I was going to try and look at the trial and see what side effects it has. Do you know what they were??
    I love your articles. thank you so much. cheryl

    Liked by 1 person

    • Thanks for your comment mslarma. Indeed, the brain swelled for a large number of participants. As I noted in the article, the plaques that this drug is after may actually have a protective role in the brain. I suspect that the protective role may be to keep the inflammation down, and so when the drug removes or blocks the formation of amyloid plaques, it may prevent the brain’s natural anti-inflammatory mechanism from working.

      There are studies on what helps AZD, and alongside Dr. dale Bredesen’s nutritional approach, there are even stricter nutritional approaches. Here is one article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6720297/ but I also searched the NIH PubMed with the keywords “Alzheimer’s disease” AND “ketogenic” (type this exactly as I did, and you will get 1724 articles. This link may work the that list of articles: https://www.ncbi.nlm.nih.gov/pmc/?term=%22Alzheimer%27s+disease%22+AND+%22ketogenic%22

      I am a true believer that all of our modern diseases that are not in the category of communicable diseases (contagious, like Covid or cold or Hep C) are caused by nutritional insufficiencies–a malnutrition even when we eat more than plenty but eat the wrong foods–and so the cure and prevention is in changing nutrition rather than popping a pill.

      Good luck,
      Angela

      Like

  3. Emily says:

    Honestly I am so angry about the corruption here I have considered going to doctors offices and standing outside with fact sheets. My parents are no longer living due to a combination of big pharma and medical malpractice… but I know so many older people who don’t know how to use the net and are completely snowed by “whatever the doctor says”. I often go to doctors “prisons” (large medical complexes) as I call them for my work and I see so many 1/2 dead people coming out… I say we form and organization to volunteer standing outside of large doctor complexes with fact sheets and scientific studies and hand them out to the elderly. Seriously. That would end it.

    Liked by 1 person

    • I think though it is not the fault of the doctors. They can only do what they are told to do and they are not scientists. A degree in medicine is in the “Art of Medicine” so it is not a science degree. They really only know what they learned in med school or what they can learn later that can be used as continuing educational credits, and most of those–not all–are also junk.

      There are some accredited organizations, such as the Nutrition Network, for example, where I also teach 3 classes on migraines, that doctors can take and they can learn, but they are still obligated to practice within the regulations of the governing agencies and insurance companies.

      So working with doctors is great, but may not get us far. We clearly cannot work with pharma or the government, because they will not work against their own financial interests! Our only choice is working grassroots by the people so they can change their lifestyles such that their need for treatment reduces or disappears. When people stop having T2D, CVD, cancer, etc., and simply have no complaints other than an occasional cold or flu or broken bones, the industry will then change.

      And, in order to achieve this, the people have to change what they eat and drink, and since food industry is demand driven, this is the one that will have to change to drive health. 🙂 So educate the people around you and they will educate the people around them. That’s the best way! ❤

      Like

      • Roald Michel says:

        Re: “So educate the people around you ……..” For years now I’m doing just like that, including the doctors I visit(ed). And I’ve never met a doc who didn’t look at me in disbelief when I told him/her your salt and/or cholesterol story 😈

        Liked by 1 person

      • Emily says:

        Disagree. Just like any profession it is their job to police themselves. Doctors even have people who obsess on “ethics” but they take no responsibility as to the rot and corruption in their own profession. It is not that way in other professions. For example law. Corrupt attorneys are quickly weeded out and many are prosecuted. The highest judge USSC take an interest in their profession to a higher degree than money. To put it on the back of the people that are going to doctors for help imho is shameful. Many have followed the advice and are now very ill. Until society starts prosecuting corrupt doctors (Tony Faucci the highest paid Federal Employee) and taking down medical networks that are clearly out for money – patients will be on their own.

        Liked by 1 person

        • Emily, unfortunately that’s not how it works. I understand your frustration but do you know the names and stories of some of the doctors who did stand up and recommended a change of diet instead of surgery or medicines? I am thinking of 3 of them on the spot: Dr. Tim Noakes, Dr. Gary Fettke, and Dr. Paul Saladino.

          Dr. Noakes (South Africa) was sued and nearly lost his livelihood–luckily won the trial and got his job back, though he lost millions of dollars that the attorneys and others cost him.

          Dr. Fettke (Tasmania) was disciplined by the board and told that he opens his mouth one more time about nutrition, he will lose his license. He fought this and it was turned over… but again, time, money, and lots of mental anguish.

          Dr. Saladino was reported to the medical board by a fellow doctor (a vegan, who shall remain nameless–you can watch his YouTube videos from last year I think this happened to find out more). He literally had to take the board exam again to not lose his license. Shortly after this he moved from my state (California) to Texas, and now to Costa Rica, so not sure he ever got his license back to practice in the US.

          There you go! this is what happens when doctors stand up for what they believe! They literally place their entire livelihood on the line. And it truly isn’t right and it is the wrong approach. The right approach is to change the patients. They are on their own as it is because the medical system is killing them if they visit a doctor and the doctor cannot do anything about it unless the doctor is ready to end up becoming a dishwasher or similar. It is really not a question of ethics but that of survival.

          Like

  4. Roald Michel says:

    Re: “Can We Believe Anything These days?” No! Reason why I’m also very cautious when it comes to all the (often contradictory) info about Covid-19 that is put on my plate.

    Many years ago, I already suffered from a trust disorder 😊

    Re: “I bet that not one, not BBC, NBC, CNN, or …..” Maybe you could inform these news outlets about your view on the matter?

    Liked by 1 person

    • “Maybe you could inform these news outlets about your view on the matter?”… yeah right.. lol Roald. If they don’t listen to other already published science–which never makes the news–why on earth would they listen to me? I won’t waste my breath on that.. I rather count the number of dust particles on my book that I should be focusing on and updating to the 3rd edition. 😉

      Like

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