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Wednesday, May 27, 2015

Multivitamin/Mineral Supplements Proven to Boost Mood Quickly │ U.S. Pharmaceutical Company Lawsuit Against FDA Seeking Unlimited Liberty in Their Drug Claims

Due to having to sit up last evening to complete yesterday's post here, I believe that it was well past midnight ere I made it to bed ─ maybe more like 12:30 a.m., if not a wee bit later.

I slept fairly well, and did not have my sleep break until around 4:50 a.m. ─ so I made a bathroom visit.  My younger brother Mark had apparently just finished his shower and was moving about in his bedroom, dressing for work.

Sleep for me was intermittent thereafter, but I was most comfortable in bed ─ that is an imperative. When finally I arose around 8:15 a.m., I had been lying in bed for at least a quarter of an hour struggling with that choice ─ it was good lying there, and I even believed that if I tried, I could sleep yet a little further.

Tho had gone to work, and Pote was readying for school ─ there could well be some awkwardness for him in light of his uncategorical rejection of any romantic prospect with of an unfortunate schoolmate who had come to visit him early last evening.

He rebuffed her outside the closed front door just ahead of 8:00 p.m. as I was turning on T.V. to watch American Idol.  I heard her wail, and then saw her running across our lawn for the alleyway beside the house where she would access 96th Avenue here in Surrey.  

As he told me afterwards when he came into the house, she had been pressing him for a relationship for possibly a couple of months, and he finally decided to be absolutely blunt ─ he told her that he had no interest in her whatsoever.

He probably should have softened the blow by keeping the friendship option before her, but he did not think to submit that ameliorating clause ─ it likely sounded to her as if he did not even desire her friendship.

And now I hear him home from school ─ it is just after 10:00 a.m.  He must only have had one class this morning.  This is his second week of work-experience, so he will be heading off to do a shift at a Starbucks this afternoon ─ school is thus done for the day.  It is undoubtedly fortunate that the term if nearing its finish.

I feel sorry for the girl.

She went from having such a high Monday evening when she partook of the commencement ceremonies for the Grade XII graduating students of Queen Elizabeth Secondary, and in doing so discovered that she had been awarded a scholarship of some sort.

And now 24 hours later, her wee heart was being trashed by a fellow graduate.

Note:  I am creating this post sectionally (i.e., piecemeal) over the day.  I hope that doing so will relieve me of the overload I find myself with when I wait until the latter afternoon to begin working upon it.

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A report published by Dr. William Campbell Douglass II three or so days ago dealt with rather surprising results from a study (very recently published) which found remarkable mood benefits in very short order from multivitamin/mineral supplementation.

As is often the case with these published studies, only the abstract or summary is available to the general public without payment, but this is it:  Acute mood but not cognitive improvements following administration of a single multivitamin and mineral supplement in healthy women aged 50 and above: a randomised controlled trial (DOI: 10.1007/s11357-015-9782-0). 

I discovered that it is possible to "Look Inside" the AGE periodical pictured at that Web-page and thereby see the first two pages of the 10-page study:
It is not especially technical, so laymen shouldn't need to be struggling to fathom the information.

I found the description of the participants to be both interesting and instructive:
Participants were 76 women aged 50-75 years (M=63.6 years, SD=6.4 years) who were not engaged in full-time employment. All participants were non-smokers, with no history of diabetes, cardiovascular disease, dementia, stroke, other neurological conditions, head trauma, alcohol abuse, clinically diagnosed anxiety, depression, and psychiatric disorders and were not currently using anti-depressant medication, high-dose anticoagulants, anti-cholinergic drugs or acetylcholinesterase inhibitors.  Participants were required to abstain from supplementation with vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, and St John's Wort for 4 weeks preceding the study visit.
I know that 'M' stands for mean (63.6 years was the participant mean or average in terms of the age range of 50-75 years); but although I learned that 'SD' stands for standard deviation, I have insufficient understanding of how the term is applied to arrive at the figure of 6.4 years.

Is it not enough to know that any one participant in a collective sense was an average of 63.6 years of age?

Anyway, here is Dr. Douglass' report on the study:

Boost your mood and beat stress with this simple vitamin secret
"Expensive urine." If you take vitamins, your own doc has probably thrown that term in your face in an attempt to get you off your supplements and onto prescription drugs.

Maybe he's even said it enough times already that you're starting to worry that your vitamins really are going in one end and out the other.

Well worry no more, friend -- and I mean that literally!

New research shows how just one swallow of the most basic supplements of all -- your daily multivitamin -- can chase your worries away, helping to ease anxiety and stress and boost your mood.

Women in the new study were given either a multivitamin with minerals or a placebo, and then took the Depression Anxiety Stress Scale.

If the ones who took supplements were simply making "expensive urine," they should have had the same exact results as those on the placebo.

But that's not what happened.

Women who got the real deal felt a real difference, with measurable improvements on the DASS -- and the biggest boost of all came in perceived levels of mental stress.

Ready for the most amazing part? This wasn't some benefit that took days or weeks to appear. It kicked in immediately, because the study measured the effects of just a single dose.

If that's what a multi can do for you when taken just once, imagine what it can do for you if you take it every day. Better yet, don't imagine -- make sure you take your vitamins, and don't miss a day, because the effects go far beyond busting up that stress.

Multivitamins help establish your first line of defense, giving your immune system the power it needs to fight chronic disease, which is why a study earlier this year found that a multivitamin with minerals slashes the risk of heart disease in women by 35 percent.

Other studies have shown that multis can cut the risk of cancer in men and women alike.

The key is to make sure you don't take El Cheap-o pills and get the real deal: a quality multivitamin with the right levels of key nutrients, including essential minerals.

Will you pay a little more? Yes, a little -- but it's worth the extra scratch, because you're not saving any money if you're buying a vitamin that's useless. That's how you really do make "expensive urine."

Your stress buster,

William Campbell Douglass II, M.D. 
This next report I have is discouraging ─ especially if you are an American.  Imagine drug companies being able to say absolutely anything they want in their advertising about their medications!

The public slaughter will be enormous.

This revelation was published two days ago by the Health Sciences Institute (HSI):

Don't tread on us
It's Memorial Day and I hope you and your loved ones are taking some time to remember those who sacrificed their lives for our freedoms.

They say the price of freedom is vigilance, and right now there's a legal battle happening in New York that we all need to watch closely.

Because our freedom... particularly our freedom to protect our health and lives from risky and unapproved drugs... is under attack.

A small company most people have never heard of has just sued our government on behalf of the entire drug industry. They're claiming they have a Constitutional right to claim whatever they want about their drugs -- even if those claims have never been approved (or have been outright rejected) by the FDA.

Now, a district court judge in New York holds the key to possibly opening that risky and lucrative door for Big Pharma. But I'm sure this wasn't what our founding fathers had in mind when they sought to protect our right to free speech.

"If this lawsuit were to prevail, it would be devastating for drug safety," said Dr. Michael Carome, an expert on prescription drugs and the FDA.

He's talking about a federal lawsuit Amarin Corp. filed against the FDA earlier this month, claiming it has a First Amendment right to say whatever it wants about any medication it produces -- even if those claims have never been approved by the FDA.

If Amarin doesn't ring a bell, you're not alone. It's a small company that makes just one drug, Vascepa, that's only been approved for very high triglyceride levels linked to diabetes, kidney failure and pancreatic cancer.

And when the FDA wouldn't let Amarin expand the drug's use without some supporting science and clinical trials, the company lawyered up.

But the lawsuit isn't about one company or one drug. Amarin is going to bat for the entire drug industry, which has long claimed it should be able to say anything it wants to doctors.

Big Pharma even wants to present information such as early clinical trials -- which have been paid for by drug companies and have never been peer reviewed -- to promote a wide and unapproved range of uses for its meds.

It's a billion-dollar scheme called off-label marketing, and it's not (quite) legal. Not just yet, anyway.

Right now, doctors are free to prescribe drugs off-label at their discretion. Like the use of risky antidepressants for hot flashes. Or a med intended to lower blood pressure being prescribed to calm your nerves.

But drug companies like Amarin are demanding the right to directly promote these off-label uses to doctors and encourage them to prescribe drugs for unapproved -- and potentially dangerous -- uses.

Being able to offer that information is worth billions to the drug companies -- and it's long been their holy grail.

There's even a coalition called the "Medical Information Working Group," made up of the biggest names in the business like Eli Lilly, Pfizer and Sanofi. Its entire purpose is to push the envelope when it comes to being able to tell doctors whatever they please.

Dr. Joshua Sharfstein, who once worked at the FDA and is now an associate dean at Johns Hopkins, said that people do not realize that the consequences of this new approach to free speech "will be measured in lives."

But the drug industry has been pressuring the FDA over off-label marketing for years, and previous rulings have already set some dangerous precedent.

A 2012 decision, for example, overturned the conviction of a drug salesman for promoting the off-label use or a narcolepsy drug to physicians, citing the First Amendment.

As a result, the FDA has said it's looking to "realign (its) regulatory posture." Translation: even the agency isn't sure how much it can police what Big Pharma says anymore.

So it looks like drug companies will try this maneuver again and again until they succeed. Or until the FDA gives up and gives in.

For Dr. Rita Redberg, editor of JAMA Internal Medicine, the issue of giving drug companies carte blanche to claim whatever they want about their meds comes down to a pretty simple principle.

"You don't ask the barber if you need a haircut."

She's watched drug sales reps push the envelope with wild, unproven claims for years -- and then she banned them from her medical center.

But companies like Amarin know there are still plenty of doctors out there that they can reach. In fact, Amarin wrote a letter to doctors letting them know that it has new training and promotional materials it's ready to send right away -- if it wins its suit.

As a columnist for Forbes said about the Amarin case, "free speech is paid for, often handsomely."

And the more than $24 billion a year Big Pharma spends on drug marketing can buy an awful lot of it.
This would be a nightmare if allowed.

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I spent much of the early afternoon finishing up the work of getting a new post ready for publication at my Siam-Longings website, and that fairly enjoyable chore was completed:  Pattaya Thailand.

And although the morning was mainly overcast, the afternoon became very sunny and warm.  During the latter afternoon, I spent at least 30 minutes sitting in a lawn-chair in the backyard wearing just a pair of shorts, and with my face to the delightful Sun.

At this point in the day, it is 5:39 p.m.  I am going to close this post with an entry from my journal of 41 years ago, for I am feeling the need to try and take care of a preoccupation that is likely only going to have me sitting up tonight if the appetite is not quelled.

In May of 1974, I was 24 years old, and had been forced to rent a cheap housekeeping room in New Westminster for that month because the old rented house my friend William Alan Gill and I had been living in had either been sold or was slated for demolition ─ we had been given notices to vacate a month or two earlier.

Despite taking on that room, early in the month I  had bought a set of weights that were impossible to exercise with due to my cramped quarters.  So my younger brother Mark and his girlfriend Catherine Jeanette Gunther ─ who were then renting a home together out in Whalley ─ had offered that I could keep the equipment at their place and come over anytime I felt like.

All references I make to "Cathy" are actually to Jeanette.  I just happened to really like her first name, whereas she preferred to be called Jeanette.

As for my mother Irene Dorosh, she and her husband Alex also lived in Surrey, but  in the Kennedy Heights area ─ the wee home is now gone, but the address had been 12106 - 90th Avenue ─ it was my mailing address, so I frequently visited there.

It was a decent walk from New Westminster ─ and particularly if I had to walk all the way back to New Westminster later on.
MONDAY, May 27, 1974

I expected the day to be mostly cloudy, so instead of going to Burnaby Lake, I went to see mom.

I found the bird I met up with twice Saturday; dead.

Mom left a note saying she'd gone to the spa, and should be back by 2:00 p.m.  A catalog of history and archaeology books awaited me from Holt, Rhinehart, & Winston.  A few minutes after my arrival, Cathy & kids pulled in.  She took me out for an 80¢ snack; a chili dog and orange pop.  Having to go to work, I was left with the kids c. 2:30 p.m., as mom wasn't back.  About 4:00 p.m. Alex showed; mom came about 4:30 p.m. plus.  

Mark finally came towards 5:30 p.m., and I went with him to Whalley for my work-out.  I stayed late, c. 12:30 a.m. plus, talking with Cathy who detests yesterday's new car; Mark had retired shortly past 10:00 p.m.  They both gave me a snack.

The big news:  Angelina phoned me c. 6:30 p.m.  She really is serious.  Fortunately Art's speedy return home cut the call short.

I mailed a letter to Jean on my way home, and will mail one to Ron Bain on my way to S.A.N.E. come morn.  

Running over the bridge, a station wagon stopped and drove me to Pine Street.  The driver was bearded, probably French.

Again 'tis near 2:00 a.m.
The Burnaby Lake hike I aborted was no slight undertaking.  I would hike to it ─ circle entirely around it ─ and then return home.  The full outing took a number of hours.
    
When I would hike to my mother's home, I would take to the B.C. Hydro Railway tracks shortly after crossing the Pattullo Bridge.  I would follow the tracks to where they crossed Scott Road just before 99th Avenue, at the top of the steep Scott Road hill.  And then I would follow Scott Road to my mother's home.

Anyway, on my previous visit to her home, I had passed an apparently flightless bird as I trekked the railway tracks.  And it was still there when I made the return journey to home some few hours later.

This day, I found it dead.

Jeanette had two beautiful young daughters.  And since both she and Mark worked at different jobs ─ and often different shifts ─ they frequently required someone to babysit.

It sounds as if I had charge of the girls from about 2:30 p.m. until my mother's husband Alex got home around 4:00 p.m.  He loved the little tykes, as did my mother ─ they were Grandma and Grandpa, after all!

Jeanette must have had the 3:00 p.m. to 11:00 p.m. shift.  Mark at this time clearly had a day shift, and showed up at 5:30 p.m. to collect the girls.

These are the two girls ─ youngest Pamela Susan Gunther is at the top; older sister Michelle Lee Gunther at the bottom.  The photos  may have been taken in 1974 or possibly 1975.

Michelle was missing a couple of front 'baby' teeth.



And so I returned to his home with Mark and the two little girls.

This is the first time I mention anything about Jeanette acquiring a new car.  I wonder why the change was felt to be necessary?

The phone call to their home ─ Angelina to me ─ at about 6:30 p.m. was from the wife of a co-worker of mine, Art Smith.

He and I both worked part-time for a New Westminster charitable organization called S.A.N.E. (Self Aid Never Ends), usually serving as truck swampers on S.A.N.E.'s blue pick-up truck.

Although he was older than I ─ he was in his early 40s ─ his wife Angelina was 33.  And she had taken a nearly insurmountable shine to me.

I had thus far managed to weather her advances, and no harm had been done.  But she was seeking to escalate things by visiting me directly, rather than just flirt with me whenever I was Art's guest.

Art, you see, always seemed to need to have an extremely long nap while I would be visiting ─ he could be out for several hours.  It was then that Angelina would flirt heavily, even though she had a young son and two daughters.  The oldest girl might have been 10 or 11, if not even 12.

I said in that entry that I would be going to S.A.N.E. the next day ─ a Tuesday.  My usual work day there was Friday, so I have no idea now what was up.    

Incidentally, today S.A.N.E. is known as Fraserside Community Services Society.  It certainly figured largely in my life for a couple or so years.

The letter I mailed on my way back to New Westminster was to my U.S. pen-pal Jean M. Black.  Ron Bain was a new U.S. pen-pal.  We all had in common a great love of Marvel Comics, and it was due to fan letters that we managed to have published in one or another issue of various comics series that brought us together.

I find it curious that a stranger offered me a ride when I was jogging over the Pattullo Bridge late in the a.m.  What is especially unusual is that the bridge sidewalk was on the far side of the bridge from any traffic heading into New Westminster.

That he would have stopped on the opposite side of the bridge from me to offer me the ride ─ wow!

I think my address in May 1974 was 333 Pine Street, so getting the lift to my street was a bit of a boon, I suppose.
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