Does The FDA Have Your Back... Or Big Pharma's?
Jan 23, 2022
Recently, the FDA approved a new drug for Alzheimers amongst rabid controversy in the research world. The drug is designed to reduce the beta-amyloid plaques found in the brains of Alzheimer's patients. Unfortunately, removing amyloid plaques is NOT the same thing as slowing symtpoms of dementia.
The drug was fast-tracked in the FDA's "accelerated approval" program that per the FDA website "allows for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint."
The controversy surrounds the drugs efficacy and its VERY dangerous side effects. In fact, after the approval, 3 of the advisory board members resigned. The argument for not approving the drug lies in the drugs purported efficacy, shown not to be very efective. One of the Phase 3 trial showed LITTLE benefit, and one of the Phase 3 trial showed NO BENEFIT and in fact, the trials were stopped prematurely secondary the lack of positive evidence.
Another crux of the controversial approval is the DANGERS associated with the drug. The risks involved with this new drug include brain bleeding and swelling (experienced by 40% of the Phase 3 trial participants receiving the high dose protocol). Now, when mixed in with the actual anemic efficacy of the drug - remember, the previous trials were stopped due to its poor efficacy - is it worth it to expose patients with cognitive impairment to a drug that may cause stroke, worsened brain injury, or even DEATH?
Just two years ago, the drug was reported as a stunning failure. But once again, in questionable ethical fashion, the
FDA is approving a drug that will likely generate BILLIONS of dollars for yet another pharmaceutical company - while potentially harming thousands of patients with little evidence of benefit. This is
the FIRST time that a drug was given approval in spite of the advisory panel recommending a resounding NO! Ten of the eleven panelists stated there is not enough evidence to approve the drug and the 11th panelist voted "uncertainty."
From a NYT article “There’s so little evidence for effectiveness,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who helped conduct one of the aducanumab trials. He added, “I don’t know what caught the F.D.A.’s fancy here.”
Could it be the fact that the drug costs $56,000 per year? Or how about the fact that it was only studied on patients with mild cognitive impairment - but the opening line of the package insert states it is "indicated for the treatment of Alzheimer's." Pretty vague... And open opening itself up to a potential market of 30-45 million patients over the next 10-15 years? Or how about the fact that once a drug has approval, it is unlikely that said drug will ever be recalled.
The silver lining in all this kerfluffle is that now, potentially new modalities may begin to emerge in this debilitating disease arena. But, the best treatment is avoidance. Remember, "
an ounce of prevention is worth a pound of cure." ALWAYS!! There are multiple MDs available who specialize in the prevention of neurodegenerative disease. Dr. David Perlmutter
who is a abest-selling author and
a widely respected integrative neurologist specializes in
neurodegenerative diseases. He is more about prevention
than the cure. Check out his webiste here: https://www.drperlmutter.com/
Another spectacular doctor helping people prevent neurodegenerative decline is Dr. Dale Bredesen.
Dr. Bredesen has published over 200 papers on cognition, is another best-selling author and he is the principal investigator for the Alzheimer's Disease Research Center at UCLA and helped establish the ADDN (Alzheimer's Drug Development Network). His Bredesen Protocol improves brain health and prevents neuriodegenerative decline using diet and lifestyle modifications - hint, hint: Keto...
Also, to decrease your chances of future cognitive decline, sign up for the LeakyGut Solution protocol which I have developed. Learn everything you need to know to lose weight, improve cognition, and avoid chronic disease for good - all in a natural, nearly failure-proof, and easy to follow 12 week program. Your health and wellness will thank you. --> https://www.leakygut-solution.com/register
To Your Health!!