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Wednesday, November 23, 2016

☠ 💀 Questionable Medical Devices │ Steer Clear of Psoriasis Medication Enbrel │ Alarmist Study: Prostate Cancer Surgeries Down

My wife Jack finally got in touch with me early last evening ─ she got back on Monday from her four-week absence to visit her family in Thailand.  I believe that she said that she would pay us a visit from Vancouver tomorrow ─ she had promised one of her friends that she would help the friend with something today.

So when did I get to bed last night?

The wretch in me took over, and it was after 2:00 a.m. before I left this machine and called it a night.

Today has been one lost day.  Even if I had slept long and well (I did not), I felt too remorseful to face the public.  And there were early sunny breaks out there.

The cloud has ruled, however; and at least a couple of times there have been periods of light rain.

Also fouling my morning through into the early afternoon has been that unforgivably noisy brown hound beyond our backyard fence, baying, barking, and whining incessantly.

I wish it the most wicked ill.

There really is nothing else to say of today ─ it ought not to have happened.  The local shopping I had planned will have to get done tomorrow.

At least both of my step-sons went to work today, so I have had that much peace.

I am looking forward to accessing my wife Jack's new trove of photos from her trip.  But for now, I will post this shot of her taken early in the afternoon of September 8 near the back left corner of our home: 


Incidentally, when I logged into my AdSense account just prior to commencing this post, there was not as yet a cent accrued today; but thanks to 3¢ that accrued yesterday, the month's total evened out to one cent a day for this entire month thus far ─ 23¢ in total so far this month as of November 23.

I am retrograding ─ for the same period last year, my account accrued 44¢.

Why did I ever believe those 'experts' who claimed that blogging pays in time?  I have been blogging since September 2008.

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Under Wikipedia's article for the (U.S.) Federal Food, Drug, and Cosmetic Act, there is a section titled Premarket notification (510(k), PMN) that basically tries to explain that ─ where medical devices are concerned ─ new ones can be marketed if the FDA is notified 90 days ahead of time that the device is essentially similar to one already approved.

If the FDA accepts that claim, then the new device can be marketed without the requirement to prove that it is safe or effective.

The FDA website has its own explanation headed 510(k) Clearances

There are many who believe this process is a mistake ─ here is one involved article discussing this issue:

CardioBrief.org

That article ends with this:
For now, the potential problems with the cardiac devices approved on weak grounds remain theoretical. But if any of those devices turn out to be harmful, the backlash could be powerful and immediate. Currently, the most worrisome device is the Absorb stent, especially since the release last week of troubling data. One interventional cardiologist, who tweets under the name “Jeddacath,” said he wouldn’t “sugarcoat” the data and call it “worrisome.”

“Cardiologists should really think hard on why they would use it in a given patient,” he said. “I expect 1-800-SUE-ME soon asking patients ‘Did you get a BVS and have a heart attack? Then call us now.’”
"BVS" was probably a reference to the Absorb bioresorbable scaffold stent (BVS) that was identified much earlier in the article.  

If you or anyone you love is faced with heart surgery, NewMarketHealth.com has this advice concerning medical devices:
If your cardiologist has been talking about any procedure to put a new device inside you, it's time to start asking some questions and doing some research. Why, we spend more time finding out about a car before we buy it than something that's put inside our body!

Find out all you can about when the device was approved, how long it has been used and if it has really been proven to be safe, rather than simply rushed into use so some company can start raking in the big bucks.
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The Wikipedia article for psoriasis says the following:
There are five main types of psoriasis: plaque, guttate, inverse, pustular, and erythrodermic. Plaque psoriasis, also known as psoriasis vulgaris, makes up about 90% of cases.
I didn't know that there were those various categories.

I bring this up because a drug called etanercept has been approved for children as young as four years old who have plaque psoriasis ─ which are apparently 90% of the cases:

Medscape.com

That glowing piece of course does not venture into talk of potential side-effects ─ you can see those for yourself at Drugs.comEnbrel Side Effects.

The truly nasty stuff is down in the section For Healthcare Professionals.  There are some horrific conditions listed.

And so what if they are not common?  They have happened!  Who can say any of them will not happen to your child if he or she is ever prescribed this drug for psoriasis?  

That long, long list ends with the disclaimer that not all side-effects have likely been reported.

The FDA Medication Guide for the drug ─ a TNF inhibitor or blocker ─ warns:
Rarely, people who use TNF-blocker medicines have developed nervous system problems such  as multiple sclerosis, seizures, or  inflammation of the nerves of the eyes.
And:
Low blood counts have been seen with other TNF-blocker medicines.  Your body may not make enough of the blood cells that help fight infections or help stop bleeding.
And:
New or worse heart failure can happen in people who use TNF-blocker medicines like Enbrel.
And can you believe this?:
Some people using Enbrel developed new psoriasis or worsening of psoriasis they already had.
Once more, NewMarketHealth.com has something to say about Enbrel:
If your child or teen has been diagnosed with psoriasis, heavy-duty, immune zapping drugs such as Enbrel should not even be on your radar.

Psoriasis is an autoimmune disease, and like others such as RA or Crohn's, following an anti-inflammatory diet is a must. And one, very frequently used option for psoriasis is exposure to good old-fashioned sunlight or even types of light therapy.

But a med that's linked to seizures, heart and blood problems, fatal infections, deadly cancers and even "new or worsening psoriasis" is one that should have never ever been approved for kids in the first place.
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Back in 2012, the United States Preventive Services Task Force strongly recommended against prostate cancer screening ─ that is, prostate-specific antigen (PSA)-based screening.

You can see that recommendation here, although there is currently a review taking place that may well result in a change.

This was their conclusion:
Although the precise, long-term effect of PSA screening on prostate cancer–specific mortality remains uncertain, existing studies adequately demonstrate that the reduction in prostate cancer mortality after 10 to 14 years is, at most, very small, even for men in what seems to be the optimal age range of 55 to 69 years. There is no apparent reduction in all-cause mortality. In contrast, the harms associated with the diagnosis and treatment of screen-detected cancer are common, occur early, often persist, and include a small but real risk for premature death. Many more men in a screened population will experience the harms of screening and treatment of screen-detected disease than will experience the benefit. The inevitability of overdiagnosis and overtreatment of prostate cancer as a result of screening means that many men will experience the adverse effects of diagnosis and treatment of a disease that would have remained asymptomatic throughout their lives. Assessing the balance of benefits and harms requires weighing a moderate to high probability of early and persistent harm from treatment against the very low probability of preventing a death from prostate cancer in the long term.

The USPSTF concludes that there is moderate certainty that the benefits of PSA-based screening for prostate cancer do not outweigh the harms.
Well, a review has recently been published sounding an alarm against the reduction in prostate surgeries because of the USPTF stand on prostate screening:  National Trends in Prostate Biopsy and Radical Prostatectomy Volumes Following the United States Preventative Services Task Force Guidelines Against Prostate-Specific Antigen Screening (doi:10.1001/jamasurg.2016.3987).  

That is only the abstract of the findings, but you can read about the review here:

ScienceDaily.com

News.Weill.Cornell.edu

These are the professionals behind that review or study:
Author Affiliations: Department of Urology, Weill Cornell Medicine, New York, New York (Halpern, Shoag, Hu); Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York (Artis, Ballman, Sedrakyan); Herbert Irving Comprehensive Cancer Center, Columbia University College of Physicians and Surgeons, New York, New York (Hershman, Wright); Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston (Shih).

Corresponding Author: Jim C. Hu, MD, MPH, Department of Urology, Weill Cornell Medicine, 525 E 68th St, Starr 900, New York, NY 10065 (jch9011@med.cornell.edu).
Everyone seems well-involved in urology (the folks who do prostate screenings) and the 'Cancer Industry.'  

That was not lost on this editorialist:

JacksDailyDose.com

Will the vested interests manage to sway the USPTF from their recommendation against PSA-based screening?

I hope not.

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Wow!  It is presently 5:45 p.m., and I have been home alone ever since my youngest step-son went to work around 8:45 a.m. this morning.

What a rare treat!

But I will close 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 little unit in a house located on Ninth Street at Third Avenue.

However, as of the evening two days earlier, I was spending my nights at the home of my younger brother Mark and his girlfriend Catherine Jeanette Gunther, who were renting their house on Bentley Road very near to the King George Highway in Whalley.

They had gone to Calgary.  The Grey Cup championship game between Edmonton and Montreal was being held there, and Mark and Jeanette wanted to participate in the wild festivities.

I had been left a note on my door by Mark requesting that I look after their German shepherd Daboda while they were away.

Thus, I was going to be doing a great deal of hiking back and forth from my room to their home.

As it was, the day before this entry, I had walked to my room from Whalley, and then continued on to visit my father Hector at 6038 Imperial Street in Burnaby.

And then I had returned to my room to update my journal.

I wrote that I was going to try and retrieve a hairbrush I had left in my old friend William Alan Gill's car or apartment a couple of nights before that ─ Bill lived maybe three or four blocks from my room.  So I did not know if I would be walking all the way back to Whalley, or if Bill would be home and offer me a ride.
SUNDAY, November 23, 1975

Last night, Bill's light was on, but I couldn't get a response or see his car; so I walked. 

I expected to get to bed early, and started running a bath after arriving.

As I was unbuttoning my shirt and making ready to extinguish the kitchen light so as to bathe unbothered, Bill knocked.

He'd been running all over searching for Mark & Cathy.

So, I stayed up viewing TV, not retiring till perhaps 10:15 p.m.

I arose, well, I don't really recall.

Bill & I are to get together for some sort of feed ─ perhaps Albert's chicken.

I walked home, arriving about 10:50 a.m. in the rain, and after tending to requirements here, I shall rouse Bill and try to get things mobile so we can catch most of the noon Grey Cup Game. 

I plan to loose Daboda when we get back, it being his first opportunity as I've not yet had time or else it was dark; I saw a dead German shepherd-type dog towards Lee's Market below the King George Hill.

I'll suggest to Bill our buying our own chicken and frying it, and possibly some ground beef as well; more flesh for our dinara

I got hold of Bill.

After transporting his neighbour to Burnaby, we decided to check out IGA's prices for chicken.  What resulted was that we bought each a pot roast (89¢ lb), and I bought some liver while he bought some chicken plus some onions.

We went to Mark's to cook and watch Edmonton barely win the Grey Cup from Montreal (actually, we barely saw any of the game, cooking mostly).

Bruce phoned, and invited Bill to bring us on over.  Bill hemmed and half-promised.

Nell called thereafter.  Seems they had beer.  But Bill and especially I stuffed so heavily ─ our meat was escorted by about, well, certainly a mess of spuds, carrots, and onions ─ that I would not agree to accompanying him to the bash at Nell's, so we went nowhere.

Mom & Alex dropped in just before 8:00 p.m. to ascertain if I got Mark's going-away message and was indeed there to tend the dog.

I retired perhaps 9:30 p.m.
Albert's chicken was a close approximation of the chicken at Kentucky Fried Chicken. 

I no longer remember a "Lee's Market."  Too bad for the dead pooch I saw.

But poor Daboda.  He probably had not been let loose from his chain for any exercise since Thursday, three days earlier.

I ate rather poorly back at my room, so anytime I was exposed to lots of good food I was helpless and could not resist gorging until I was physically incapacitated and unable to do anything for the remainder of the day.

My maternal cousin Bruce Halverson first phoned and spoke with Bill; and then it was Bruce's mother, my Aunt Nell Halverson, who next phoned.

Bill was virtually incapable of denying anyone, so he was an easy target for wheedling.  But so was I ─ in all likelihood I probably avoided the calls and let him take it all on. 

It was a big deal to have beer on hand on a Sunday.  At that time, there were no liquor, wine, or beer sales ─ apart from something ordered with a meal in a licenced restaurant.

Nell's crew were partiers ─ that they had any beer remaining that late into a Sunday was a huge achievement.

I guess my mother Irene Dorosh and her husband Alex had been asked by Mark and Jeanette to ensure that I was looking after Daboda, for Mark and Jeanette had left with no direct contact with me.  A note on my door could easily have disappeared.

I was updating my journal each time I returned to my room.  Everyone who knew me marveled at the amount of walking I undertook all the time.

Anyway, it is now 6:39 p.m. in the present, and I am still happily alone in the house!
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