New Alzheimer’s drug may cause serious side effects

All this week, I’ll be reporting on how to protect your brain against devastating brain diseases, like dementia and Alzheimer’s disease (AD), as you get older.  

Because despite two, billion-dollar, “decades-of-the-brain” research projects, mainstream medicine still has no safe, effective solutions. Even the new drug aducanumab doesn’t work as intended! 

In fact, last month, amidst great controversy, the U.S. Food & Drug Administration (FDA) approved this new drug to treat AD. And it’s garnered a great deal of attention in the mainstream press, as it’s the first new drug approved for the treatment of this dreaded brain disease in nearly 20 years. 

But it will cost $56,000 a year (for life) and require monthly intravenous treatments…all for a “treatment” that doesn’t really work. They might as well call the drug abracadabra—instead of aducanumab—because they developed it using smoke-and-mirrors…not the latest science. 

Let me explain… 

New drug targets wrong problem 

The new drug supposedly works by breaking up amyloid protein plaques, which some experts still claim cause the cognitive decline experienced by AD patients. 

But I’ve been questioning the role of amyloid plaques in the development of AD for a very long time now, and I’m not the only one…  

I first noted a problem with it decades ago when I worked as a hospital pathologist and observed amyloid build-up in virtually every tissue of the body…not just in the brain. Sometimes, there was dysfunction in the organs with a lot of amyloid. And other times, the presence of amyloid didn’t appear to be significant at all; it was a purely incidental finding.  

Then, a few years ago, autopsy studies began to show that 50 percent of people diagnosed with AD and dementia do not have amyloid buildup in the brain. And half of people who do have amyloid in the brain do not have dementia! 

And just last year, a study published in the prestigious journal Neurology found that amyloid buildup begins AFTER the onset of memory decline. 

So, at best, amyloid seemed to be an incidental or inconsequential side effect of aging—in some people. And it’s certainly NOT the cause of dementia.  

Therefore, trying to thwart amyloid by taking the new drug (or by any other artificial means) is rather like “trying to lock the barn door after the horses have gotten out.” 

Clearly, the flawed theory behind the drug doesn’t hold water…so it should come as no surprise that actual clinical testing on the drug was a bust, too… 

Biogen performs great, big, dazzling illusion  

Biogen, the developer of aducanumab, had to pull the plug on two, identical, phase III clinical drug trial studies back in March 2019, when a data monitoring and safety analysis determined the drug was unlikely to outperform the placebo. (Outperforming the placebo is already a pretty low bar for the FDA.) 

Then, in October 2019, Biogen said a review of a previously unavailable subset of data magically appeared (“now, for my next magic trick”) and showed the drug did reduce cognitive decline in one trial (but not in the other). They also said people in this new subset of data who took the highest dose of aducanumab saw a small reduction in amyloid plaques over 78 weeks.  

Biogen called this reduction a “surrogate” outcome for aducanumab. And they applied for FDA approval using this “surrogate” argument. (In the past, big pharma has effectively used this same kind of argument to gain FDA approval for its disastrous cholesterol-lowering statin drugs.) 

But remember, as I explained earlier, amyloid isn’t the cause of AD. At best, it’s an innocent bystander in some people’s brains.  

Not to mention, there was still another problem with Biogen’s wonder drug… 

About 40 percent of the people who received the high dose of aducanumab in that subset of data also developed brain swelling! 

No wonder an independent FDA advisory committee of AD experts recommended against approving aducanumab in November 2020! In fact, they stated that there was “no compelling substantial evidence” that the drug treated or slowed the disease. (Actually, none of the committee members voted “yes” for approval. Ten voted “no,” and one was “uncertain.”)  

Despite all the lack of evidence and the advisory committee’s long list of serious concerns, the FDA went ahead anyway and approved the drug in early June 2021.  

Experts far and wide have called the FDA’s decision “disgraceful” and “irresponsible.” And—as of this writing, three of the 10 experts on the FDA’s independent advisory committee have resigned. 

One is a former student of mine from the University of Pennsylvania, Dr. Aaron Kesselheim. In addition to advising the FDA, Dr. Kesselheim serves as a professor at Harvard Medical School and director of the regulation, therapeutics, and law programs at Brigham and Women’s Hospital. And in a blazing letter sent to acting FDA Commissioner Janet Woodcock, he called the FDA’s decision, “probably the worst drug approval decision in recent U.S. history.”  

Of course, the FDA’s decision makes me angry too… 

For one, we know the drug just doesn’t seem to alter the course of the disease. And the so-called “surrogate” argument just doesn’t hold water. (Just as it didn’t hold water with statin drugs, either.) 

Plus, we know for certain that the drug causes great harm in 40 percent of people who take it as prescribed. So, it sets a horrible precedent for approving more ineffective, dangerous drugs. 

But most of all, I’m angry because this latest illusion distracts attention away from the natural, SAFE solutions that we know really do work, based on all the science… 

Safe, natural approaches backed by years of research  

Seven years ago, researchers with UCLA published groundbreaking clinical research showing that dementia could be reversed in nine out of 10 people who follow a dozen simple lifestyle steps. Unfortunately, even though this research began in earnest years ago, most primary care physicians still don’t know about it.   

So, before giving into the mainstream headlines and resorting to any dangerous, ineffective mainstream drug, I urge you to become your own advocate and check out my Complete Alzheimer’s Fighting Protocol. This innovative learning tool includes all of the natural steps and nutritional advice used to fight and reverse AD, as outlined in the original UCLA protocol.  

Plus, it contains important, additional steps, which I added based on 40 years of my own, personal research. Including specific recommendations for supplementing with berberine, folic acid, grape extract, lutein, thiamine, turmeric, and vitamins B6 and B12. To learn more about this comprehensive protocol, or to enroll today, click here now.

P.S. Tune back in tomorrow to learn how the UCLA protocol is now offered at additional medical centers around the country!  

Sources: 

“Three experts resign as FDA advisers over approval of Alzheimer’s drug.” Arstechnica, 

6/11/21. (arstechnica.com/science/2021/06/three-experts-resign-as-fda-advisors-over-approval-of-alzheimers-drug/) 

“In controversial decision, FDA approves first new Alzheimer’s disease drug in nearly 20 years.” CNN, 6/7/21. (cnn.com/2021/06/07/health/alzheimers-drug-aducanumab-fda-approved-wellness/index.html) 


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