Is this why brain supplements are suddenly under attack? Action Alerts!
Does the FDA want to clear away competition for the new drug?
This wouldn’t be the first time this has happened. Just as the first SSRI anti-depressant drug was coming out, the agency banned the amino acid tryptophan. The SSRIs prevented the body from removing serotonin. Tryptophan is used by the body to make serotonin, so the natural supplement was seen as unwanted competition for the drug. The agency used a bad batch of the tryptophan made in Japan as its rather flimsy excuse. Years later, when SSRIs had made billions for drug companies, the agency allowed tryptophan again, but only in a more expensive formulation.
At the present time, Eli Lilly has a potential blockbuster drug for Alzheimer’s in the third and final phase of FDA trials. Currently called solanezumab, if approved it could bring in $7.6 billion in sales by 2024—and that might be a conservative estimate. This is despite evidence the drug doesn’t work that well, at least in later stages of the disease. But if it can be shown to have some benefit for the early stages, that could be enough to make it a huge moneymaker and turn around Eli Lilly’s earnings. The stock has already risen on the prospect. Biogen also has an Alzheimer’s drug in trials. The drug companies view Alzheimer’s as one of their very best potential markets.
Meanwhile, natural therapies are already showing great promise against Alzheimer’s. We covered some of this in an earlier article. Since then, Dale Bredesen, MD, who works at the Center for Alzheimer’s Disease Research at UCLA, has published a paper reporting success with natural therapies in treating nine out of ten patients. The thrust of Bredesen’s thesis is that as powerful as natural therapies are, they are even more powerful when individualized to the patient, an idea which is complete anathema to the drug companies and their allies at the FDA. More importantly, use of natural therapies could undercut potential drug profits.
We regard all of this as important background for understanding two recent attacks on brain supplements. Ellen Rosenblum, the Oregon attorney general, and Sen. Claire McCaskill (D-MO) are at the moment leading the charge, but as you will see there is clear evidence the FDA is behind what the AG is doing. It is unlikely the senator would be moving without at least FDA approval.
Unfortunately none of these people seem to have their facts straight. Let’s start with the Oregon AG.
You will recall how recently the New York AG went after some herbs claiming they weren’t actually in the supplements sold. He got considerable egg on his face when it was shown that he had used the wrong test when assessing the supplements, and that scientists almost unanimously agreed that his conclusion were utterly incorrect.
The Oregon AG apparently learned nothing from that fiasco. According to USA Today, she has now filed a lawsuit alleging that “GNC, one of the world’s largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs.” The AG states that he is relying on an affidavit supplied by the FDA.
There are two substances involved, BMPEA and picamilon. They are different and should not be lumped together. The FDA earlier sent warning letters about BMPEA to five different companies, although not to GNC. It is a powerful synthetic stimulant.
In sharp contrast, picamilon isn’t synthetic at all. It is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3). The combination is much more effective in crossing the blood-brain barrier than GABA alone. Although the combination of the two natural supplements GABA and B3 has usually been sold under the name picamilon, it has also been sold under the two names together.
GABA is produced by our own bodies and is the natural way we calm ourselves. It is by far the best remedy for anxiety, but is rarely used by conventional doctors, who generally favor toxic and usually ineffective drugs, often, as we have reported, with tragic results.
The FDA working through the Oregon AG is especially bizarre. If the agency thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. It has full power to do so. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else? The real reason that the agency would work through the Oregon AG is to try to test the waters and keep a lower profile. It is doubtful that the Oregon AG understands any of this.
The AG’s lawsuit follows a recent call from Sen. McCaskill to pull both picamilon and vinpocetine (another supplement for the brain, especially useful to promote blood flow there) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements. As noted, we think the FDA is behind this too.
Action Alerts! Tell the FDA (and if you’re in Oregon or Missouri, tell the Oregon AG and Sen. McCaskill too) that picamilon is not a synthetic drug but a combination of natural ingredients that must continue to be freely available to consumers. Please send your message immediately.
Expected New “Blockbuster” Alzheimer’s Drug
Is this why brain supplements are suddenly under attack? Action Alerts!
23 thoughts on “Expected New “Blockbuster” Alzheimer’s Drug”
Wonder what the side effects are on this drug. All other Alzheimer’s drugs haven’t helped and have side effects.
Take out the fluoridated water; stop eating fast food, drinking sodas and stop eating sugar. Get a moderate amount of exercise; sleep and eat healthy.
That’s a start and maybe it won’t help with those in the later stages but it can certainly help those unaffected or in the early stages maybe. Get rid of CAFO farm products too and no I’m not vegetarian or vegan either. I enjoy a good roast or a good steak.
My mom has Alzheimer’s and diagnosed very young (showed symptoms at 55, diagnosed a 56, now she’s 61). We gave her medications until I read that they barely effective at best. We didn’t noticed effects so we discontinued them. After that, we tried many supplements, and none work. I started her on turmeric (curcumin) with piperine (black pepper extract for curcuminoids to absorb). It’s been about 2 months and we’ve been pleasantly surprised to noticed improvements. She’s more responsive, more aware of what’s going on around, she’s repeating words and movement that others do (wasn’t doing that before). We’ve gone past the phase where we think it’s only that we’re seeing or noticing is from wishful thinking. Now many of our friends and family have started to notice. I thought I would contribute my testimonial here.
Praise God, and thank you for sharing. The good Lord designed us to heal, and gave us all the plants, herbs, roots, minerals, trace minerals, insects, animals……he has provided all the raw material we need. The blessings come from heeding to his ways, and not the ways of greed and dishonesty, deception, great danger and risk for profit. Competing with God is the height of foolishness, arrogance and rebellion. All of us collectively, have power by following God’s will…and overcome all the trespasses against us. In Jesus name Amen.
Can’t tell if serious..
Greed in healthcare is frustrating to put it nicely, especially since so many medications available have been from natural sources (aspirin, some antibiotics, even chemo drugs!) But if pharma industry can’t profit, there is no interest, as natural compounds can’t be patented. 🙁
Have you tried very good size doses of taurine?
Hi Bruce, actually I have not tried that. I’ll research taurine and may give it a try. Thank you!
That is awesome Jose! May it continue to help. My Mom passed away 2 years ago at age 79 but showed symptoms in her early 60’s. By the time I learned about curcumin it was pretty late in the game. I take it myself now and also use coconut oil every day. It can’t hurt, hey? Alzheimer’s is one of the worst diseases because we are pretty much helpless unless they give us meds that work. It is time to take matters into our own hands.
None of your sharing links seem to work.
Copy and paste the address.
When I read the headline my first thought was about tryptophan. About 6 months after we found it worked wonders for my wife’s migraine symptoms they took it off the market! Why? Because ONE company in Japan made a bad batch or that was the excuse. As the article states, the timing was very suspect.
I don’t know if GABA has any effect on Alzheimer’s, but it certainly works wonders on extreme PMS if taken along with Inosital. It relieves the cramping and the stops the crazy brain issues.
It’s an interesting hypothesis, that emergence of an SSRI (Prozac) onto the U.S. market was the impetus behind the FDA’s action against Tryptophan. The standard story is that contaminated 5-hydroxy tryptophan (5-HTP) made by the Japanese company Showa ended up in hundreds of various products and caused thousands of cases of eosinophilia-myalgia syndrome (EMS) with severities ranging from mild soreness to severe chronic pain to death. The culprit “Contaminant X” that was later identified via chromatography was incorporated into proteins, causing an auto-immune reaction. That much is real. For the FDA to put a hold on 5-HTP sales was reasonable, even necessary, at the time. But I’ve always thought for the FDA to extend the ban to Tryptophan was an overreaction. I guess their question was whether a similar synthetic process (that made the defective indole ring in Showa’s 5-HTP) could also lead to contaminated Tryptophan. For both molecules, if the supplement were derived directly from natural sources there would never be a problem (from high-Tryptophan proteins; or Griffonia extract for 5-HTP). I began recommending Griffonia-derived 5-HTP to my patients in the late 1990’s when there was still a cloud over it. If I am going to believe this “conspiracy theory” at all, it would be that they didn’t want to see a head-to-head study of 5-HTP vs Prozac for depression, so went on a smear campaign. Or maybe Eli Lilly had already secretly done such a study and had found 5-HTP was just as good?
I had understood the eosinophilia “outbreak” was from Japanese produced L Tryptophan, and that the Griffonia derived 5-HTP was the only alternative.
The FDA and the AMA thinking is bases on false science. MD’s for decades have blatantly control natural Vitamin B by forcing it off the market, until a synthetic version could be created and marketed. Prenatal vitamins are way below the recommended dosage to support good brain and nervous health. Shame on em!
The FDA needs to be more intensive in its efforts to prevent Americans access to non-toxic, non-drug dementia diminishing modalities. Last year’s UCLA study showed multiple techniques–including diet, exercise and supplementation–could reduce the severity of symptoms of moderate dementia patients. The FDA needs outlaw UCLA. How dare they come up with a non-Big Pharma methodology to help American seniors? Coconut oil should be banned as soon as possible. The mid-chain triglycerides can cross the BB barrier and provide the brain with the metabolic energy required to eliminate Tau proteins and plaque. Every senior that meets an early end from dementia or other preventable or reversible conditions is a senior not getting any government money–which should be spent on taking more of our freedoms away. (Or so think our politicians.)
I contacted the FDA’s head shill, er, guy. Every time I contact them, I just have to ask something like, “Why not serve the people of the USA in your time at the FDA? The drug companies don’t need your help. Perhaps, though, you are not so wealthy you don’t need their help in some sad quid pro quo?”
Funny, they don’t invite you to cocktail parties inside the Beltway when you accuse them of being deceitful crooks. Oh, well.
Thank you for sharing that. I had read about coconut oil (and about that Dr’s husband.) We tried that, and didn’t see any results, despite giving her both coconut oil and MCT (the fatty acids in coconut oil thought to be effective) for over 6 months. So far, the only noticeable change has been from turmeric. A lot of the time is either trial and error, and keep on trying. The list of things I’ve tried is extensive, I’ll name a few such as: niacin, lecithin, phosphatidylcoline and phosphatidylserine, vitamins b-complex, D, C, ginkgo, aloe (a special kind used in a study, APMC), and I’m sure that’s only a fraction.
But coconut oil seems effective enough that there is a prescription nutritional supplement that Dr’s can prescribe (prescription only) which is a modified fatty acid from coconut oil. I’ve been lucky enough to have had Dr’s supportive of our choices.
From experience, the best is to keep on trying until something works. And like everything, not one compound, herb, or vitamin is going to work for all. But I hope that anyone that reads this is not to give up!
Dr. Mary Wood on you tube
Cured Husband of alzheimers
with coconut oil. she explains
exactly how she did it.
Article is right on. First statin by Merck was preceded by discrediting Niacin as a natural cholesterol lowering nutrient. SSRI’s discredited tryptophan, It is an art form by the Lilly and others to manipulate the prescribing habits of physicians through PR firms that hire researches to spin the truth in the favor of the drug manufacturer. Lilly got NIH though George Bush Senior to run the women’s health Initiative to discredit estrogen for bone health so their bone freezing cancer drug would grow in profit. It will never stop when we have the FDA managed as a political entity of the drug manufactuers. I spent over 50 years in the drug business learning how you can be a legitimate crook.
An astute neurosurgeon has recognized that Vitamin D, 2 grams of Resveratrol and B-Complex Vitamins and Fish Oil in sufficient quantity stops the progression of dementia and Alzheimer’s. The problem is it is not proprietary and you can’t make billions on recommending it.
If it isn’t a proprietary drug that has a patentable life span, it is consider a quack remedy.
There is a study that demonstrates that 2 grams of Resveratrol taken daily stops the progression of Alzheimer’s. The brain inflammation disappears. Also, sufficient brain nutrients such as Vitamin D, B Vitamins including B3 and B12 and Fish Oil, all contribute to restoring brain health. It is the toxins in our food supply as well as our drug remedies that have driven up the number of cases in the last decade by 1000%. Stopping the chronic ingestion of toxins is key to reversing this epidemic. The root causes can be found in the 21st Century life style that has been embraced in the United States.