Expected New “Blockbuster” Alzheimer’s Drug

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.