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Steven Fowkes
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Health educator (nutrition and metabolism) and nanotechnologist
Health educator (nutrition and metabolism) and nanotechnologist

230 followers
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Jonathan Emord Goes Round Two with the FDA on Electroshock Devices

WASHINGTON, Aug. 24, 2017 /PRNewswire/ -- Attorney Jonathan Emord and his co-counsel Kendrick Moxon have filed a Supplement to their Citizen Petition of August 2016, protesting the FDA's Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give "shock-treatment." The reclassification would make it easier for doctors to give the treatment. Shock treatment is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo's Nest. More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence. Memory loss and brain damage are the central issue in the attorneys' filing.

For 40 years, the FDA has been responsible to ensure evaluation of the shock devices, which send up to 460 volts through a person's brain. Although federal law and FDA orders in the 1970s required manufacturers of these devices to prove they were both safe and effective, the FDA never enforced the order. This, according to Mr. Moxon, has "allowed millions of persons over decades to be permanently damaged." He further states, "Rather than enforce the law now, the FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided."

The original Citizen Petition was filed on behalf of 5 persons damaged by electroshock treatments. It requests that ECT be banned from the market or, at the least, that the Proposed Order be withdrawn as the manufacturers have never done pre-market clinical trials to prove it is a "safe and effective" device. No other treatment in medicine is so subject to objection and protest by patients – so much so that when the reclassification was proposed, thousands of patients, deeming themselves to be victims of the treatment, objected.

Mr. Emord, who has successfully litigated against the FDA more times than any other attorney in the US, stated, "The FDA has utterly ignored clear-cut evidence of brain damage, memory loss and death resulting from ECT treatments. ECT is barbaric and should be removed from the market." It is only fair to note that even the manufacturers have stated that a "risk" of the device is brain damage and severe memory loss.

The attorneys claim there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by the FDA to support its proposed "declassification" of ECT devices. Mr. Moxon says, "The FDA used 'junk science' to propose reclassifying ECT machines out of the most dangerous category of all devices, in which it has been classified since 1978. Worse, the FDA ignored contrary studies by researchers who did not have conflicts of interest."

This is shaping up to be a David and Goliath scenario with individuals damaged by ECT on one side and the FDA, under pressure from the industry that profits from ECT, on the other.

Mr. Emord stated that the proposed reclassification is a radical and irrational departure from FDA's prior precedent demanding rigorous clinical proof of safety before Class III devices (deemed the highest risk) are reclassified to permit more common use. He expects a challenge to the FDA's proposed order would be upheld in federal court, if the FDA attempts to move forward with the proposed reclassification.

The Supplement to the Citizen Petition can be viewed in full here: http://emord.com/blawg/wp-content/uploads/2017/08/Supplement-to-Citizens-Petition-29-July-17.pdf

Contact: Dr. Linda Lagemann, Liaison to the Petitioners (415-640-7343)

SOURCE Emord & Associates, P.C.
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Here's revisiting an interesting proposal to bootstrap space power development. I've been following a few discussion groups by people working on the idea, dealing with the logistical, political and economic issues, which are all huge. The investment is so large as to boggle the mind, even in this day-of-added-zeroes, so bootstrapping it by a step-one "demonstration" project might give us ecologically minded folk a solution to global weather change that does not cause catastrophic effects, either through misjudgment of what is really happening (a long-standing concern of mine) or through unintended consequences (those we-have-to-do-SOMETHING people). In my opinion, space development and space-derived electricity is the best option for long-term peace at a high standard of living, AND the best way to mitigate both global warming and ice-age scenarios.

https://www.youtube.com/watch?v=VEkZkINrJaA
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Looks like Wisconsin is protecting its milk industry. It appears that retailers have been informed that KerryGold butter from Ireland does not meet state laws and is hereby banned. It is not a safety issue but rather a bureaucratic process that only in-state butter producers can conveniently meet.

A couple of people have decided to boycott Wisconsin butter in response. I agree. No more Wisconsin butter, milk or cheese for me until they alter their policies to conform to free-trade agreements.
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The collagen protein in bones has the lowest glutamate of any bulk protein. Roughly 10%. Meats and veggies have glutamate levels that are two to three times higher. This is why collagen peptides (predigested or hydrolyzed collagen protein) are as widely tolerated as they are when other protein peptides (vegetable protein hydrolysates, meat hydrolysates) cause excitotoxic reactions. But consider that bone broth is not only bone, it is marrow, too. Marrow has lots of MSG in its proteins.
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A well done video now up on Youtube which describes the magnitude of the energy problem and an arguably reasonable way out. If you've not seen a space-based energy proposal in the last ten years, it's time to catch up. The cost estimates are down to 3 cents per kWh for delivered electricity. What are you currently paying? 15 cents? 25 cents? 35 cents? Ouch!

What I like in addition to the balancing of the Earth's temperature is the resulting glut of ultra-cheap petroleum, which I believe will jumpstart the nanostructured plastics and atomic-precision materials industries. Imagine "uncrushable" automobile frames with the density of balsa wood, batteries that last twice as long per charge and charge in half the time, and agricultural and potable water unlimited by regional rainfall.

https://www.youtube.com/watch?v=VEkZkINrJaA
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There are many joys in my life. This is a glimpse of one. Play the video about halfway down the page.

Spending three days with visionary scientists in a free-for-all discussion of possibilities for a better life is truly one way that "it does not get any better than this." This video is of last year's Foresight Conference on the future of biomedical applications. This year, it's energy applications.

Value beyond quantification.
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The mid-day light was beautifully diffuse from a thin layer of cloud cover. The fallen log was green-carpeted at one end and yellow-fungus carpeted at the other end. The yellow color was luminous, especially against the background dark-brown leaf mulch and dark-green mossy growth. It was like somebody had put down a tarp on either side of the log and splashed yellow paint with glee, then pulled up the tarps.  Any local (SF Bay Area) photographers want to re-visit this site on Sunday afternoon on the 31st of January?

Photo by Ken Fowkes, originally posted on January 16th.
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There are many myths in science that I have found while researching the literature. Here's another one: the idea that brain size or brain volume defines the number of brain cells.

A colleague sent this old-but-good review (2010) of an earlier, longitudinal brain-scan study (2003, http://www.ncbi.nlm.nih.gov/pubmed/12716936, and associated literature) of the shrinking brain with age. This article and the associated literature make the unwarranted assumption that brain shrinkage is caused by loss of neurons. I have also heard clients say that their doctors have told them the exact same thing.

But it just ain't so.

I'm not saying that loss of neurons does not take place. I'm saying that short-term brain shrinkage is primarily a matter of brain hydration, and that undiagnosed short-term brain dehydration produces long-term brain shrinkage.

When brain cells become dehydrated, the brain shrinks in the skull. Fluid accumulates around the brain. This is, in real essence, brain edema; the accumulation of fluid in the tissue, which in the case of the brain, accumulates between the brain and the skull.

Several of the cited studies have found that simple nutritional supplements of relatively low potency counteract the "the loss of neurons" associated with brain shrinkage. I suggest that the supplements are merely normalizing hydration mechanisms. There are good reasons for doubting otherwise, (1) the time course is quite fast, (2) the doses of nutrients are low, and (3) the brain can actually grow substantially in size.

So if you have a relative or friend with an unfortunate brain scan, don't automatically believe that it's the result of loss of neurons (an irreversible process), but rather entertain the alternative hypothesis that it's a simple dehydration condition that is fully reversible. I'll bet that in nine of ten cases, you will find that the latter will be true.

Here's a hint from 80 years ago: cellular dehydration is correlated with potassium over-utilization. Emanuel Revici found this in cancer patients with edema, that their serum potassium was lowered in the absence of a potassium deficiency. The potassium was lowered in serum and increased in cells. This over-utilization of potassium by cells was in proportion to the degree of edema in each patient.

Most of the mythology of Alzheimer's disease as an irreversible condition is based on brain-shrinking observations. If this is wrong, maybe alzheimer's disease is reversible? Those of you who have been following my writings know that I believe that Alzheimer's disease is readily reversible.

For skeptics, here's a challenge: look at the serum potassium readings in your significant other (or yourself, if you want to take a pro-active stance for your own brain) and see if the longitudinal trend is downward (4.0 or lower mEq/L) and then test the hypothesis by having a cellular potassium test performed. With this condition, it will be predictably high.

If you are being medicated with potassium, be warned. Normalization of serum potassium in a potassium over-utilizer results in extremely high cellular potassium levels, which can cause end-stage organ failure symptoms (e.g., heart failure). So insist that a cellular potassium test be performed to confirm that you actually have a potassium deficiency and not potassium over-utilization.

Best wishes to you all.
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My presentation at this year's Bulletproof Biohacking Conference (2015) started with two quotes from Stephen Porges' book The Polyvagal Theory as introduction to my talk about my own biohacking of stage fright and subsequent designer-brain exploration. Now, hear Dr. Porges interviewed by Dave Asprey. Very nice, indeed! A very important aspect of the understanding of health and wellness.
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