The FDA: Approving Treatments of Unfamiliarity

I subscribe to the FDA updates by email on many subjects. Here is an email I received today:

FDA email on obesity device

FDA email on obesity device

It is hard to read since it is long but note the first paragraph last sentence: ” The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.”

Should the FDA approve a medical treatment it does not understand?

Should we not know how a device works before we are told it is safe to use? Is it safe? I have heard of other procedures where the lack of understanding made them fail–slipping of the band away from the place it originally was placed, for example, and several other types of injuries. Should these not be tested for some time in a proper laboratory setting as well as in life on volunteers before it is approved as a procedure? I can hardly wait to see the first lawsuits pop up!

But more importantly: should we not prevent obesity the first place?

Instead of preventing obesity, the FDA apparently supports its development and encourages even more people to become obese!  We know what causes obesity: added sugar into every single food items we eat proved and encouraged by the amazing number of enticing advertisements on TV, billboard, newspapers, junk mail, Internet, EVERYWHERE.

Have more sugar!

The FDA is now about to take this obesity encouragement a step further! We now have new FDA label proposal that will change labels to reflect the serving size of what people eat as opposed to what they should eat! Here is what the new label is recommending:

proposed serving size labeling

proposed serving size labeling

So if you now find 2 sizes of soft drinks, say a can of 12 oz and a bottle of 2 liters of the same thing side by side, both will say one serving! I think the FDA confuses selling size with serving size. As will the people who buy them! Today it is still clear that a serving size of sot drink is 8 oz or less but with the new label the serving size will reflect whatever is in the bottle. This provides encouragement and reinforcement to those who buy the larger serving size that it is approved to drink that much by the FDA so it is OK!

I think that we are heading into a very dangerous era where the FDA is beginning to look more and more like an agency serving those industries that lobby more feverishly at Congress. The FDA does not represent the people at all! It represents a disease industry whose business is to cause disease! It is to manage how sick you should get! Quite a turnaround from its original purpose to its final function!

I think the FDA needs a big overhaul! I also think that Congress should eat up their recommended serving sizes of an entire bucket of ice cream several times a day each day so each member gets a good chance to look from the inside what it is like to be obese and have diabetes! Perhaps then the serving sizes will reflect healthy reality–if there is in fact any health associated with eating sugar

Those of us outside are left for our own common sense–or educated guesses–to decide what is right or wrong for us to eat or drink and in what quantity!

Added sugar should be 0 (as in ZERO) grams for all. We do not need to eat sugar. Our bodies need to re-learn how to make blood-sugar by using insulin for conversion from complex carbs like fruits and vegetables. Learn how and what to eat from understanding food and not what the FDA recommends since clearly they are not serving our interests!

Comments are welcome as always!

Angela

About Angela A Stanton, Ph.D.

Angela A Stanton, PhD, is a Neuroeconomist focusing on chronic pain, electrolyte homeostasis, and genetics. She lives in Southern California. Her current research is focused on migraine cause, prevention and treatment without the use of medicines. As a forever migraineur from childhood, her discovery was helped by experimenting on herself. She found the cause of migraine to be at the ionic level, associated with disruption of the electrolyte homeostasis, resulting from genetic variations of all voltage gated channels that modulate electrolytes and voltage in the brain, insulin and glucose transporters, and several other related variants, such as the MTHFR variants of the B vitamin methylation process and many others. Migraineurs are glucose sensitive and should avoid eating carbs as much as possible. As a result of the success of the first edition of her book and new research and findings after treating over 4000 migraineurs world wide, all ages and both genders, she is now finishing the 2nd edition. The 2nd edition is the “holy grail” of migraines, incorporating all there is to know and also hypotheses. It includes an academic research section with suggestions for further research. The book is full of citations to authenticate the statements she makes to be followed up by those interested and to spark further research interest. It is a "Complete Guide". Due out in the summer of 2017. Dr. Stanton received her BSc at UCLA in Mathematics, MBA at UCR, MS in Management Science and Engineering at Stanford University, PhD in NeuroEconomics at Claremont Graduate University, and fMRI certification at Harvard University Medical School at the Martinos Center for Neuroimaging for experimenting with neurotransmitters on human volunteers. For relaxation Dr. Stanton paints and photographs. Follow her on Twitter at: @MigraineBook
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7 Responses to The FDA: Approving Treatments of Unfamiliarity

  1. Gail Kaufman says:

    And speaking of food labels, big food companies are lobbying against GMO food labeling. It’s outrageous that these companies may succeed in hiding behind their marketing while concealing what their products contain. I just signed a petition circulating from a group called “Just Label It” to fight for our right to know.

    Liked by 1 person

  2. Roald Michel says:

    Years ago I stopped motivating people. I found it to be a waste of time, and making me cranky. Who am I to tell people what to do? If you want to delve into a bucket of ice cream? Go straight ahead. If you want to devour one burger after another? Be my guest. If you’re enticed with the new labeling? Then down that gallon of fruit juice.

    So these days I simply share my thoughts (well…..um…..when in the mood, eh?) on a variety of things. If you like them? Great. If you don’t? All the same to me. And that’s that.

    It comes close to that other aha-Erlebnis I once had: Don’t try to improve stuff you’re bad at. It’s boring and frustrating. Instead do the things you’re passionate about. Excellence will follow in no time. So, if being fat is your thing, get fatter. You’ll probably die “before your time” but at least you “had a life”.

    Liked by 1 person

    • True as said Roald. I just think that those of us wanting to make sense out of it all (in the US) are pushed down by doctors, for example, when we want to come off of a medicine–many of my migraine group members have been given the wrong drug reduction schedules in order to make them feel horrible and ensure that they go back on the drug–the doctors get paid or get lunches or whatever gimmick big pharma is now doing.. pedicure.. I don’t care! The grip of the pharmaceuticals is really big on people and on doctors. They already killed my mother… yes, autopsy came in showing the doctors were all full of BS with their diagnosis and my diagnosis was correct… but of course I was reminded that I am “just” a PhD and not an MD so what do I know… right? Well screw that! I am teaching my own doctors and they are MDs.. Why do I have to teach them??? Didn’t they go to school the same way I did.. of yeah.. duh.. they only went to school for 4 years and a PhD can take up to 10 to complete… excuse me.. I forgot I was only a PhD…

      In any case.. the system is messed up; now people are experimental puppets. They are guinea pigs! Off-label prescriptions are rampant.. there are more medicines prescribed off label than on…

      Everyone in my migraine group has to quit sugar… guess what? When they do, most of their migraines are gone… I have the answers. Not only do they lose their migraines but they also lose weight, their high BP if they have any goes down, cholesterol goes back to normal.. heck I just had a physical and I have never had a better test result in my life and no migraines now for 5 years–and no meds of any kind!

      What the FDA is doing now is the dumbing down of America! Now people can just pick a bottle of any size and say “yay… my size” never mind that in a year they will be on the operating table for double bypass and since they have no money of course, guess who will pay for that… so no… I have to get involved. This is my passion, my money, and damn it my right to have my life the way I want it! And I want it healthy and past the level of a 12-year old for food label reading… I don’t see my granddaughter spending her earned money spent on food bills! So make the labels easier to read for ME since I pay for them!

      Like

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