A New Drug for Alzheimer’s - Really?
Botanical CBD Overlooked and WHY
The Federal Drug Administration (FDA) has just approved a new drug, June 7, 2021, that says it will help to take away some of the beta amyloid accumulation(picture left) which is believed to be the substance that blocks neural transmission and responsible for cognitive impairment, better known as Alzheimer’s Disease (AD). This is the first drug in the last two decades to be approved by the FDA for the treatment of early Alzheimer’s disease. There is a lot of contention that this drug does not show reversible traits of AD and does not make claims of healing the disease.
The FDA’s decision to green-light this drug marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other medications available for the debilitating condition and they only address dementia symptoms for a matter of months. This is at a price tag of $56,000 per year for this new drug!
But since at least last fall, several respected experts, including some Alzheimer’s doctors who worked on the aducanumab clinical trials, have said the available evidence raised significant doubts about whether the drug is effective. They also said that even if it could slow cognitive decline in some patients, the suggested benefit —the risk-gain to the brain is not achieved. Medicare is expected to shoulder much of the cost for the new drug and all the ancillary costs associated with taking the drug, i.e. MRI, Brain CT scans, etc.
Overlooked Parallel and WHY
A quick parallel of another class of drugs was patented 18 years ago in 2003 and has never had the favor of the FDA mainly because of its control under the DEA. This botanical substance was studied during a timeline where there were legal prohibitions placed of the whole specie of this plant Cannabis Sativa L. However, 4 researchers in the late 1990s, working at the National Institutes of Health (NIH) showed that there were neuroproliferative, neuroprotective and antioxidant capabilities as an anti-inflammatory agent for brain health in this botanical.
This group of medical researchers did the work and applied for a patent in 1999 based on their research. A patent was granted in 2003. The patent was granted to Health & Human Services (HHS) with patent number 6630507-1B. How and why the HHS holds this patent is another story for another time, ask Willie Nelson (Picture right). HHS held oversight on this patent until it expired in 2019. The FDA has never given approval of this medicine for Alzheimer’s disease or any other neurological maladies despite the homeostatic neurotransmission and protective elements which was the basis of the patent. However, it appears this botanical, Cannabidiol (CBD), attacks some of the major components of Alzheimer’s Disease, oxidative stress, free radical accumulation and the subsequent buildup of beta amyloid.
Compelling evidence from basic molecular biology has demonstrated the dual roles of microglia in the pathogenesis of AD. On one hand, microglia are involved in AD pathogenesis by releasing inflammatory mediators such as inflammatory cytokines, complement components, chemokines, and free radicals that are all known to contribute to beta-amyloid (Aβ) production and accumulation. Sounds like prevention might be the best cure! “Have you had your daily VitaminCBD™ today to support your mental clarity and bone health.” My credo and mantra since I started formulation of this VitaminCBD ™ line!
Where Researchers Do Not Agree
The highlights of this new AD medicine known as ADUHELM (picture left) is supposed to treat the root cause of all of the disease which is accumulation of beta amyloid. Trying to eliminate the amyloid after it gets into the glial cells sounds like “closing the barn door after the horse got out”. “This might be the worse approval decision that the FDA has made that I can remember,” said Aaron S. Kesselheim, MD JD MPH, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after drug approval and after six years on this FDA committee. Two other physician members of the committee also resigned earlier this week, expressing dismay at the approval of the drug despite the committee’s overwhelming rejection of it after reviewing the clinical trial data in November 2020.
David S. Knopman, MD, a clinical neurologist at the Mayo Clinic, another FDA committee member who resigned last week, wrote in an email to the FDA sighting that “Biomarker justification for approval in the absence of consistent clinical benefits after 18 months of treatment is insensible.”
Peter Stein, MD who directs the FDA Center for Drug Evaluation and Research for New Drugs, said a provision for approval is if data over the next nine years (9) proves the drug does not work then its approval could be withdrawn by the FDA…. nine years!
Where Researchers Do Agree
Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new-found property makes cannabinoids useful in the treatment and prophylaxis of a wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.
One of the researchers of the 2003 CBD patent was Julius Axelrod, PhD, (picture right) who received the 1970 Nobel prize for Chemistry and Medicine for his work on neurotransmitters and pharmacology. Axelrod’s prize-winning research led to the development of Prozac, which blocks the reuptake of neurotransmitter serotonin as a treatment for mental illnesses such as depression and anxiety.
Nonpsychoactive cannabinoids, such as cannabidiol (CBD), are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is a formula wherein the R group is independently selected from the group consisting of H (hydroxy), CH 3( alkyl), and COCH 3 (acetyl).
Renate Myles, an NIH spokeswoman, told The Cannabist a cannabis journal that the patent does not prevent investigators from conducting research on the effects of cannabinoids as treatments for neurological diseases, but that Kannalife is the only entity licensed by HHS to develop cannabinoid-based drugs for those purposes. The 2003 patent expired in April 21, 2019 which will bring new light to the possible cannabis market place once legalization is passed. CBD is a force to nature and a natural supplement which does not need a cartel to develop Cannabinoid-based drugs.
While the DEA has rescheduled CBD products approved by the FDA, all non-FDA-approved cannabinoid extracts (even if they are non-psychoactive) are still considered Schedule I substances based on a 1961 international treaty called the Single Convention on Narcotic Drugs, which designated all cannabis, cannabis resins and extracts illegal.
Here is a paradox, wait nine years to see if a FDA approved medicine works sounds a little bit oxymoronic. However, this conundrum can be attacked now! If we go back to basics, Cannabidiol (CBD) has a number of characteristics that can prevent the build-up of by products in the brain resulting, in trauma, oxidative stress and free radicals. I will repeat, “Have you had your daily VitaminCBD™, today to help support your mental clarity and your bone health”. We know that the cannabis sativa L plant has a number of neuroprotective characteristics. What are you waiting for. Hopefully not nine years. Please and thank you.
Authored by
Eric I. Mitchell, MD MA FACPE CPE
Botanical CBD Overlooked and WHY
The Federal Drug Administration (FDA) has just approved a new drug, June 7, 2021, that says it will help to take away some of the beta amyloid accumulation(picture left) which is believed to be the substance that blocks neural transmission and responsible for cognitive impairment, better known as Alzheimer’s Disease (AD). This is the first drug in the last two decades to be approved by the FDA for the treatment of early Alzheimer’s disease. There is a lot of contention that this drug does not show reversible traits of AD and does not make claims of healing the disease.
The FDA’s decision to green-light this drug marked the first approval of an Alzheimer’s treatment in 18 years. Patient advocacy groups had pushed for approval because there are only five other medications available for the debilitating condition and they only address dementia symptoms for a matter of months. This is at a price tag of $56,000 per year for this new drug!
But since at least last fall, several respected experts, including some Alzheimer’s doctors who worked on the aducanumab clinical trials, have said the available evidence raised significant doubts about whether the drug is effective. They also said that even if it could slow cognitive decline in some patients, the suggested benefit —the risk-gain to the brain is not achieved. Medicare is expected to shoulder much of the cost for the new drug and all the ancillary costs associated with taking the drug, i.e. MRI, Brain CT scans, etc.
Overlooked Parallel and WHY
A quick parallel of another class of drugs was patented 18 years ago in 2003 and has never had the favor of the FDA mainly because of its control under the DEA. This botanical substance was studied during a timeline where there were legal prohibitions placed of the whole specie of this plant Cannabis Sativa L. However, 4 researchers in the late 1990s, working at the National Institutes of Health (NIH) showed that there were neuroproliferative, neuroprotective and antioxidant capabilities as an anti-inflammatory agent for brain health in this botanical.
This group of medical researchers did the work and applied for a patent in 1999 based on their research. A patent was granted in 2003. The patent was granted to Health & Human Services (HHS) with patent number 6630507-1B. How and why the HHS holds this patent is another story for another time, ask Willie Nelson (Picture right). HHS held oversight on this patent until it expired in 2019. The FDA has never given approval of this medicine for Alzheimer’s disease or any other neurological maladies despite the homeostatic neurotransmission and protective elements which was the basis of the patent. However, it appears this botanical, Cannabidiol (CBD), attacks some of the major components of Alzheimer’s Disease, oxidative stress, free radical accumulation and the subsequent buildup of beta amyloid.
Compelling evidence from basic molecular biology has demonstrated the dual roles of microglia in the pathogenesis of AD. On one hand, microglia are involved in AD pathogenesis by releasing inflammatory mediators such as inflammatory cytokines, complement components, chemokines, and free radicals that are all known to contribute to beta-amyloid (Aβ) production and accumulation. Sounds like prevention might be the best cure! “Have you had your daily VitaminCBD™ today to support your mental clarity and bone health.” My credo and mantra since I started formulation of this VitaminCBD ™ line!
Where Researchers Do Not Agree
The highlights of this new AD medicine known as ADUHELM (picture left) is supposed to treat the root cause of all of the disease which is accumulation of beta amyloid. Trying to eliminate the amyloid after it gets into the glial cells sounds like “closing the barn door after the horse got out”. “This might be the worse approval decision that the FDA has made that I can remember,” said Aaron S. Kesselheim, MD JD MPH, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after drug approval and after six years on this FDA committee. Two other physician members of the committee also resigned earlier this week, expressing dismay at the approval of the drug despite the committee’s overwhelming rejection of it after reviewing the clinical trial data in November 2020.
David S. Knopman, MD, a clinical neurologist at the Mayo Clinic, another FDA committee member who resigned last week, wrote in an email to the FDA sighting that “Biomarker justification for approval in the absence of consistent clinical benefits after 18 months of treatment is insensible.”
Peter Stein, MD who directs the FDA Center for Drug Evaluation and Research for New Drugs, said a provision for approval is if data over the next nine years (9) proves the drug does not work then its approval could be withdrawn by the FDA…. nine years!
Where Researchers Do Agree
Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new-found property makes cannabinoids useful in the treatment and prophylaxis of a wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.
One of the researchers of the 2003 CBD patent was Julius Axelrod, PhD, (picture right) who received the 1970 Nobel prize for Chemistry and Medicine for his work on neurotransmitters and pharmacology. Axelrod’s prize-winning research led to the development of Prozac, which blocks the reuptake of neurotransmitter serotonin as a treatment for mental illnesses such as depression and anxiety.
Nonpsychoactive cannabinoids, such as cannabidiol (CBD), are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is a formula wherein the R group is independently selected from the group consisting of H (hydroxy), CH 3( alkyl), and COCH 3 (acetyl).
Renate Myles, an NIH spokeswoman, told The Cannabist a cannabis journal that the patent does not prevent investigators from conducting research on the effects of cannabinoids as treatments for neurological diseases, but that Kannalife is the only entity licensed by HHS to develop cannabinoid-based drugs for those purposes. The 2003 patent expired in April 21, 2019 which will bring new light to the possible cannabis market place once legalization is passed. CBD is a force to nature and a natural supplement which does not need a cartel to develop Cannabinoid-based drugs.
While the DEA has rescheduled CBD products approved by the FDA, all non-FDA-approved cannabinoid extracts (even if they are non-psychoactive) are still considered Schedule I substances based on a 1961 international treaty called the Single Convention on Narcotic Drugs, which designated all cannabis, cannabis resins and extracts illegal.
Here is a paradox, wait nine years to see if a FDA approved medicine works sounds a little bit oxymoronic. However, this conundrum can be attacked now! If we go back to basics, Cannabidiol (CBD) has a number of characteristics that can prevent the build-up of by products in the brain resulting, in trauma, oxidative stress and free radicals. I will repeat, “Have you had your daily VitaminCBD™, today to help support your mental clarity and your bone health”. We know that the cannabis sativa L plant has a number of neuroprotective characteristics. What are you waiting for. Hopefully not nine years. Please and thank you.
Authored by
Eric I. Mitchell, MD MA FACPE CPE
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