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Sunday, December 4, 2016

Will the FDA Cave and Allow Off-Label Use of Drugs and Medical Devices? │ America's Sinking Health Care │ A-Fib Patients Taking Warfarin at Big Risk of Dementia

Not only did I have yesterday's latter evening all to myself, but I spent the night in the house all alone, too.

It was nice having the Christmas lights on as I watched T.V. in the otherwise dark.

But such a cold day today ─ clear skies and brilliant sunshine notwithstanding!

I can't understand why there is no frost.  Can it possibly be that this is a dry cold?  That would be most unusual for these parts.

I probably should have gotten out today and done some grocery shopping, but I just didn't feel like it.  Besides, setting up a new post at one of my six hosted websites took me into the early afternoon.

Also, part of my supper last evening were three slices of the pizza my eldest step-son Tho had bought, and I sprinkled turmeric over them.  And now my fingernails, the latter stretches of some of my fingers, and the unshaven area around my mouth are stained yellow ─ dramatically so.

I would need to do a good cleansing ere venturing anywhere.  And again, I just don't feel like it.

Since there really is nothing else to report thus far about my day, I will post some more photos that my wife Jack took while in Bangkok ─ I think on October 29, the first day that the Grand Palace was opened to the Thai populace to file through and view the funeral urn of their late King Bhumibol Adulyadej.

You can read about it at capitalfm.co.ke, if you are unacquainted with the event:  Tens of thousands queue to pay respects to late Thai king.

I have yet to learn if Jack and those from her home village of Nong Soong who were there with her were able to travel to Bangkok from Udon Thani for free ─ I had read that at least some trains were transporting people to the capital without cost.

Obviously the thousands of people need to eat, and Jack took a number of photos in an extensive area where food was apparently prepared, prompting me again to wonder if it was being offered to the people for free.


I see that it is the Ruamkatanyu Foundation who are involved in those immediate photos above.


The Sirivadhanabhakdi Foundation (as identified on the edging of the tent roofing in the photo above) was founded by Charoen Sirivadhanabhakdi, "Thailand's second richest entrepreneur."

And I shall stop there for today ─ there are just too many more photos to possibly include here.

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You may be somewhat familiar with off-label use of a drug or medical device.  It is commonplace.

In the States, the FDA recently heard submissions by pharmaceutical companies and medical device makers who petitioned to be given freer reign in promoting their products for uses other than what the FDA has thus far approved.

There were others present who staunchly testified as to why this should never be done.

This is an in-depth report on what went on over those two days last month:

CNN.com
When it comes to medical devices, Madris Tomes, a former public health analyst with the FDA, who now runs her own company Device Events, testified that she used the agency's own database to pull data about adverse events related to off-label uses.
She found that for the past 20 years or so, there have been at least 23,809 adverse events reports that reference off-label use of a medical device. Over 14,000 involved injuries, and 777 patients died. And that's only reported incidents, which are probably on the low side: A 2009 report from the Office of the Inspector General found that only 14% of adverse events are reported to the FDA, and 99% of those reports went through the manufacturer first.
The situation with medications is probably as bad.  As NewMarketHealth.com stresses when it comes to prescriptions from one's doctor:
...You should ask him if the drug is being prescribed off-label. Find out what the med was actually approved for and why he thinks it will help your condition.

Many grieving family members wish their loved ones had done that. Only now it's too late.
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I recently read a good evaluation of the U.S.'s medical system ─ the piece should rile just about any American who reads it:

DrMicozzi.com

Why do politics and graft have to figure into just about everything that goes on down there?

The article referenced this October 2015 report at CommonwealthFund.orgUS Spends More on Health Care Than Other High-Income Nations But Has Lower Life Expectancy, Worse Health.

I believe that I recently read that the life expectancy of Americans has been going down over the last few years (as evaluated by insurance actuaries).

It's impossibly dire.  People have to learn to think and research for themselves ─ they cannot rely on assurances about the safety of basics like food and water.

It just isn't true. 

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There is bad news for people taking warfarin and who suffer from atrial fibrillation (a-fib) ─ they are at double or even triple the risk of developing dementia than are other folks taking warfarin, according to a recent study.

These two reports tell of the study:

MedicalXpress.com

MedicalNewsToday.com

Perhaps the advice given in the related report at JacksDailyDose.com merits consideration:  Warfarin ups dementia risk in a-fib patients.

I just can't imagine needing to take such a drug.  I thank God that I have what health I do.

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I am going to close off now with a journal entry from 41 years ago when I was 26 years old, and living in a basement housekeeping unit in New Westminster.

I was renting the small unit in a house located on Ninth Street near Third Avenue.

I had made it to bed at 6:50 p.m. the evening prior to this journal entry.
THURSDAY, December 4, 1975

I got up about 3:20 a.m. feeling stiff and underslept.

About 4:00 a.m. I left for my 12 laps, dropping off the supermarket food book at the library and mailing 3 letters (for lottery tickets, some gifts from TP Products, and to Ron); the weather was cool and windy.

I walked to Woodward's and bought 2 money orders:  $10 for an Olympic Lottery ticket; $22.91 American for B. Peppin's Fantastic Age of Fantasy Illustrations and some paperbacks.

I returned home by way of Bill's in order to leave him a note suggesting we bake bread Sunday at his place; but his car was not there.

Fooling with my oven as I have lately been doing, I actually got it going!  Now Bill won't be so necessary.

I typed up Jean a letter.

From about 3:00 p.m. - 4:30 p.m. I rested up in preparation for 2 hours of TV tonight.

I'll be retiring at 9:00 p.m.
I rose early partly to do my running at the New Westminster Secondary School track.  I needed to be long done before any students started showing up for school.

One of the letters I had mailed was to a U.S. pen-pal I had named Ron Bain.  I was later to type up a letter to another U.S. pen-pal named Jean M. Martin (née Black).

The trip to Woodward's was later that morning.  It no longer exists, but it used to be located where the Royal City Centre Mall is now on Sixth Avenue.

My old friend William Alan Gill was renting a bachelor suite around three or four blocks from where I was living.

I had just the previous Saturday created a wonderful batch of bread that I mixed up entirely from scratch ─ no shortcuts whatsoever.  I think it was my first experience, but I had done it at my mother Irene Dorosh's home off in Surrey.   

I was hoping that Bill would want to get involved so we could use his stove.  This is the first time I mentioned that my oven was not functioning; but somehow, I managed to correct it.
 
Now I could do my own baking anytime I wanted ─ and also use it for cooking things.
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