Tuesday, October 27, 2015

FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

The Oregon Attorney General, the FDA, and Sen. Claire McCaskill are targeting two supplements, but they don’t have their facts straight. Action Alert!

You will recall how 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.”

Interestingly, it appears to us that the US Food and Drug Administration (FDA) is actually the instigator of this action, even though they have all the power they need to take action against GNC themselves. So what is going on here?

There are two substances involved, BMPEA and picamilon. They are different and should not be lumped together. While BMPEA is a powerful synthetic stimulant, 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.

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 with tragic results.

The AG’s lawsuit follows a recent call from Sen. Claire McCaskill (D-MO) to pull both picamilon and vinpocetine (a substance useful for the brain) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements. The FDA may well be behind this too.

Why is picamilon being targeted right now? It has no serious side effects, so it clearly isn’t a safety issue. We do know that a potential blockbuster drug for Alzheimer’s is in phase three of FDA trials, and if the drug is successful it has been estimated to bring in $7.6 billion in sales by 2024. Perhaps the FDA is trying to remove any natural substances that help the brain before this new drug is approved? That has happened before. For example, the agency banned the natural substance tryptophan, which is needed for our bodies to make serotonin, just before approving the first synthetic serotonin re-uptake inhibitor drug (SSRI) for depression. And we believe this is just the tip of the iceberg, as you’ll read in our related story.

We know the FDA is involved in all this because it submitted an affidavit to the Oregon AG saying that picamilon is not a dietary ingredient. This is a puzzling position, given the fact that if the FDA thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else?

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.

Take-Action



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