…against the advice of its own expert panel, ensuring another windfall for Big Pharma at the expense of patients and taxpayers.
The FDA has approved the first new Alzheimer’s drug in years—a drug which will reportedly cost more than $56,000 per year. The FDA’s treatment of this drug—which is incredibly expensive and comes with real dangers—is in stark contrast to the skepticism and attacks that characterize the federal government’s treatment of supplements.
The approval of the new Alzheimer’s drug, which will be sold under the trade name Aduhelm, is steeped in controversy. This is due mostly to the fact that an FDA expert advisory committee overwhelmingly voted last November that the evidence supporting the drug’s efficacy was inadequate. One of the main reasons was that, of the two clinical trials on the drug, only one showed positive results, and those only emerged from an analysis of additional data after the trials were stopped because the drug didn’t appear to be working. Three members of the advisory committee have in fact resigned in protest over the agency’s decision to approve the drug.
The committee’s stance contrasted with optimism from FDA officials, who said that the “evidence supporting [the drug’s] approval appears strong.” Dr. Scott Emerson, another committee member and a professor emeritus of biostatistics at the University of Washington, said he was “very disturbed” that the FDA seemed to be “starting out with the assumption that the treatment works,” adding that the agency position seemed “weighted” toward the drug company. What a surprise!
The price tag of the drug is $56,000 a year. The Institute for Clinical and Economic Review, a nonprofit that independently evaluates the relationship between a drug’s price and how well it improves patients’ lives, said the drug should cost $8,300 a year given the insufficient evidence supporting its benefits. Note too that the real cost to patients will likely be more, since patients on the drug will need regular brain scans to detect bleeding or swelling in the brain, both of which are side effects of this drug.
Taxpayers will also be paying for this drug. One analysis estimated that if just one-third of eligible patients are prescribed the drug, it will cost Medicare $112 billion a year, far more than Medicare spends on any other medication.
Compare the FDA’s treatment of this drug to its treatment of supplements. On one hand, we recently reported on a government review listing hundreds of studies showing the plausibility of using supplements like vitamin D and others to fight COVID—yet despite all this data, the conclusion is they can’t make a recommendation one way or the other for these supplements. On the other hand, we have inconsistent data on the effectiveness of a drug, with an expert committee recommending against approval—and the FDA approves it anyway. It’s episodes like this that demonstrate very clearly who the FDA works for.
There are natural ways of addressing dementia and Alzheimer’s. We’ve written before about the work of Dr. Dale Bredesen who is pioneering this field. Dr. Bredesen thinks there are three forms of Alzheimer’s with at least 36 contributing factors to the disease. Individualized protocols must be developed to address these factors. Dr. Bredesen uses an analogy of a leaky roof with 36 holes to illustrate his approach, where the size of the different holes depends on genetics and environment. Each “hole” will be a different size in each person, meaning some may not need to be addressed while others do. But plugging just one of the holes will not stop the rain from getting in—this is why Big Pharma’s approach fails. One drug may address one of the contributing factors for Alzheimer’s, but the rest of the “holes” remain.
Dr. Bredesen identifies three types of Alzheimer’s. One type is caused by inflammation; another is caused by a lack of hormones and nutrients necessary to maintain brain plasticity; another type is caused by exposure to stress and environmental toxins, like mercury or mycotoxins from mold.
We’re also seeing research suggesting that Alzheimer’s can be understood as Type 3 diabetes to reflect the fact that Alzheimer’s represents a form of diabetes that selectively involves the brain and has features that overlap with type 1 diabetes and type 2 diabetes. Aging is the strongest risk factor for Alzheimer’s, but emerging data suggest that type 2 diabetes is another significant risk factor. Getting blood sugar under control, then, is potentially an important way to prevent Alzheimer’s.
There is also potential for humble coconut oil to help reverse Alzheimer’s.
Until we embrace the ability of natural medicine to regenerate health, we will keep seeing this cycle repeat: Big Pharma producing “blockbuster” drugs that are expensive, dangerous, and don’t work for large swaths of patients. Medicine and health can and should be transformed from treating sick people to creating health through diet, lifestyle, and affordable natural medicines. Drugs have their place, but they should not always be the reflexive choice of our healthcare providers.
5 thoughts on “FDA Approves Expensive, Ineffective Alzheimer’s Drug”
Great write-up on this new drug! It’s expensive and doesn’t work — seems to be par for the course when it comes to the FDA. All they really care is making money for Pharma.
This is as insane, or worse that BIG PHARMA, BILL GATES & MONSANTO will approve & keep adding more & more EXCITOTOXINS & GLYSOPHATE in most to all neurological drugs on the market, while keeping all metals, like Aluminum & Mercury and more toxins in these drugs as well. In 1960 at 3 MONTHS OLD I got my shots, as seizures started 2 months later at 5 months old, THANKSGIVING DAY 1960 it all began. 2 weeks ago it still happens another seizure. My grandmother & mom could not keep using ALUMINUM pots & pans & other cookware with ALUMINUM,, BUT the foods then were safe & was real foods until all Aluminum & Mercury that may had been in our cookware, started showing up in foods, drinks & drugs we consume today & for the past 55 years, as OTC non-drug & non-food items have all these toxins that are brain chemistry, brain cell & heart health killers. Let’s NOT FORGET just what NITRITES & NITRATES do to brain & heart health. 24/7 to all people without a brain or heart condition, as those with a heart or brain condition WILL SUFFER from any fraction from all EXCITOTOXINS, NITRITES, NITRATES, & metals of ALUMINUM & MERCURY along with TALC, TITANIUM & other toxic chemicals, that USDA & FDA both call GKAS ingredients which is nothing but A LIE. Read the book EXCITOTOXINS,,, The Taste That Kills, written by Dr. Russell Blaylock a retired brain surgeon, who knows the FACTS & TRUTHS about these TOXIC POISONS that DO DESTROY both brain & heart health at a very slow & quiet way that only FDA, USDA & CDC approves of to keep MONEY coming to doctors, so BIG PHARMA gets that much MORE MONEY through doctors & drug prescriptions. Case & Point, since JAN 1961, I have been taking ASD’s & not 1 has ever stopped my seizures for life, after 60 years & 5 months. My brain chemistry is as bad as it’s ever been since JAN 1961 when taking these drugs started at 7 months old. NOBODY so it seems that I CAN HOLD ACCOUNTABLE & RESPONSIBLE in over 60 years now, that I can make all the drug makers of these drugs I have taken since 1961 accountable & responsible for my brain chemistry today AND ADD AS WELL these food chemical makers that have been making ALL HEALTHY FOODS TOXIC FOODS, since the end of WW2 when it all started in the late 1930’s & really got their boost of fast & quick serving foods in the early 1940’s, because they felt THEY HAD TO HELP MOTHERS & KIDS AT THE HOME FRONT, because the fathers & husbands were in the WW2. So all vaccines 1st MUST GO TO EVERY DEMOCRAT POLITICIAN & FDA, USDA & CDC person,, ”’let them have them 1st if they feel cheated they wont get any..” I know what my seizure activity WILL BECOME LIKE, if just the normal FLU SHOT will be given to me, as I denied that 6 years ago, when my doctor ALLOWED ME TO READ that list of TOXINS IN THAT & I said NO WAY I am taking a flu shot,, UNLESS as I said to the doctor,, YOU ACCEPT WHAT HAPPENS TO ME LATER when more seizures will happen in the future, & I will have a GRAND MAL seizure before midnight that night. He then said to me,, NO I do not want any seizure happen to you, or make any seizure condition WORSE IF you really believe that will happen. As I told him then THE BRAIN NEVER LIES,, IF you know HOW it talks to you & HOW you listen to it. I KNOW and it is like that with every human brain IF a person is capable to understand WHEN their brain is speaking, in ways it WILL do that in any or every issue where HEALTH I$$UE$ matters most, and it isn’t all over money, but PEACE OF MIND more than anything, which is a HEALTHY BRAIN in the end. Oh I am a 3rd class person. I am not a citizen to the FDA, CDC & NIH.
Another sneaky lying government agency! The FDA has not been doing an honest days work for a long time! Anytime I hear it proclaimed that something is FDA approved I scoff and wonder who the next victims will be of their fraud!
My personal opinion is that they have rushed this drug through even with the toxic side effects because of all the potential dementia patients there will be that are caused by the RMNA experimental jabs. The cost of this alone will leave many patients out in the cold, and that probably is in essence a good thing for them even though they may not think so. Big Pharma’s usual play again – cause the problem then create a god awful drug to treat it that does absolutely no good and that will bankrupt you too. This is really getting out of hand and I wish there was some way we could just shut them down. I think the drug companies don’t know anything about the human body or if they do then they are intentionally trying to harm us.
This is standard procedure for the approval and use of most cancer drugs that end up making billions for pharma before it is determined they are practically useless. The same will happen with this drug. How is one to trust the FDA, CDC and big pharma when this is how drugs are approved? I can take dozens of supplements, and in doses much higher than the minimum requirements and never experience a negative effect. With almost all drugs, there are accompanying side effects. That tells me they are not wanted or desired by the body. Their main purpose is to make big pharma richer and more powerful. Health and rehabilitation is not a concern to pharma or much of the medical mafia.