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Pfizer 'deliberately buried' data showing its arthritis drug might also prevent Alzheimer's (trunc)
daily mail ^ | 6/5/2019 | SAM BLANCHARD SENIOR HEALTH REPORTER FOR MAILONLINE

Posted on 06/05/2019 10:33:08 AM PDT by RummyChick

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To: Gahanna Bob

That’s what I love about surgeons. The FIX shit.


61 posted on 06/05/2019 11:37:19 AM PDT by sparklite2 (Don't mind me. I'm just a contrarian.)
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To: beelzepug

I dont have a problem with Drug companies charging a lot of money to recoup their costs and make a profit.

Where it starts to be a problem is when they charge US users an arm and a leg but other countries get it cheap


62 posted on 06/05/2019 11:39:26 AM PDT by RummyChick
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To: Rocko Jack

1. They and other medical professionals make a ton of cash on selling dementia meds and providing care for patients.


63 posted on 06/05/2019 11:44:16 AM PDT by ThisLittleLightofMine
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To: RummyChick

It’s so simple..!

Of course it would cut into sales of another drug in their pipeline for which they had already spent billions.

It’s like iPhones and tablets:

You want to make them sufficiently different that one cannot substitute for the other, else your competitor is YOU.

Doctors can legally perscribe this other drug for alzheimer’s however that will be an OFF-LABEL percription for which the liability for an unintended outcome would be borne by the invidicual doctor and not by the drug maker.

They CAN start clinical trials for this other drug for Alzheimer’s yes, but most likely it will still take 10 years and $1.3 billion go get through all that.


64 posted on 06/05/2019 11:44:57 AM PDT by gaijin
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To: Cletus.D.Yokel

Yes, Marty Feldman must have been in pain because he did not have surgery to correct his thyroid eye disease. The affliction added to his comic appearance, but he would have had terrible double vision and dry eyes, probably even corneal abrasions.


65 posted on 06/05/2019 11:45:08 AM PDT by Sans-Culotte (If it weren't for fake hate crimes, there would be no hate crimes at all.)
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To: Rocko Jack

Maybe it’s true that they didn’t have enough research/ evidence.


66 posted on 06/05/2019 11:46:23 AM PDT by bboop (does not suffer fools gladly)
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To: edwinland

Here is an 11 year old article on this.

Enbrel May Help Treat Alzheimer’s
Rheumatoid Arthritis Drug May Prompt Rapid Improvement in Alzheimer’s Disease Symptoms

By Jennifer Warner
FROM THE WEBMD ARCHIVES
July 21, 2008 — A drug commonly used to treat rheumatoid arthritis and other immune-based conditions may also be effective at targeting language-related Alzheimer’s disease problems.

Disruption of language abilities, such as difficulty finding words to express thoughts, is a common symptom of Alzheimer’s disease.

A new study shows people with Alzheimer’s disease experienced rapid improvement in language abilities after treatment with Enbrel (etanercept). In fact, researchers videotaped noticeable language skill improvements in Alzheimer’s patients within minutes after receiving the drug.

The small, phase two clinical trial involved only 12 people with mild to moderate forms of Alzheimer’s disease, but researchers say the results merit further study in phase three clinical trials.

New Target for Alzheimer’s Disease Treatment
Etanercept works by targeting a substance produced by the immune system known as tumor necrosis factor-alpha (TNF-alpha). This substance is implicated in attacking healthy tissue and causing inflammation in people with immune system disorders, such as arthritis and certain skin conditions.

In the study, published in BMC Neurology, researchers treated 12 people with mild to moderate forms of Alzheimer’s disease weekly with Enbrel for six months. The drug is usually delivered by injection to the thigh, abdomen, or upper arm, but in this study researchers injected the drug into the muscles surrounding the spinal cord to deliver the drug directly to the nervous system and reduce TNF-alpha levels in the brain.

CONTINUE READING BELOW

The results showed improvements in conversational, naming, and comprehension abilities — and improvements in following spoken commands — began within minutes after injection.

Researchers say the findings may also offer new insight behind the development of Alzheimer’s disease and other forms of dementia and offer new avenues for treatment using immune-based therapies.

For example, researcher Edward Tobinick of the Institute for Neurological Research in Los Angeles and colleagues say elevated levels of TNF-alpha in the brain may interfere with the regulation of neural impulses controlling language in the brain. With further study, these effects may be reversible with drugs like etanercept that target TNF-alpha.

WebMD Health News
Reviewed by Brunilda Nazario, MD on July 21, 2008


67 posted on 06/05/2019 11:56:45 AM PDT by tired&retired (Blessings)
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To: PGR88; RummyChick

“Remember, the media love salacious headlines - EVIL DRUG COMPANY DOES XXX

The US FDA would come down on Pfizer ike a ton of bricks if they claimed their drug treated an “unrelated” disease. Liability potential would be outrageous also. They certainly would NOT be allowed to market the drug for Alzheimers unless years of studies were conducted.”

Yes, both observations are very true.

-—Not the issue. This is not about them making the claim to market the item.

This is about doing clinical trials.-—

By the time clinical trials were done the drug would be off patent. The company would be spending huge amounts of money and resources for other company’s to then make all the money.

The thing to keep in mind is that anyone can fund a clinical trial using an approved drug to determine it’s efficacy for another indication.

Further, any doctor could prescribe the drug for Alzheimer, this is called off label use.

The FDA does not tell doctors how to practice medicine. The FDA does oversee that marketing drugs have been shown to do what they are claimed to do, so any company marketing for Alzheimer’s would have to do long and expensive clinical studies.

I think that in addition to being another “capitalism bad” article there is a purpose to the article in that there is probably a push to make a new law regarding patent rights that would make it easier for a company to gain exclusivity for a new indication.

In other words, here change it so that Pfizer would have protection for Alzheimer use — if Pfizer was able to show it were effective against Alzheimer’s they would retain exclusive rights for that. Then it would be worth them spending the money.

It’s not a bad idea to modify the law for this, but there can always be pluses and minuses in changes such as this.


68 posted on 06/05/2019 11:57:05 AM PDT by ifinnegan (Democrats kill babies and harvest their organs to sell)
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To: onona

“The blood brain barrier blocks 100% of large molecule drugs from penetrating into the brain. Enbrel is a large molecule drug.

It won’t work. It’s that simple”

Not necessarily, especially with immuninological drugs like this.

The drug may not pass the BBB, but cells activated in the periphery by the drug can.


69 posted on 06/05/2019 12:00:03 PM PDT by ifinnegan (Democrats kill babies and harvest their organs to sell)
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To: Bruce Campbells Chin

“Even if the patent was going to run out on Embrel itself, the trials could have resulted in a slightly modified, re-purposed drug for which a new patent would apply.”

That’s a common practice for small molecule drugs, but not as easy for biologicals like Enbrel.


70 posted on 06/05/2019 12:02:40 PM PDT by ifinnegan (Democrats kill babies and harvest their organs to sell)
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To: tired&retired
Journal abstract

Blood-Brain Barrier Penetrating Biologic TNF-α Inhibitor for Alzheimer's Disease. Chang R, et al. Mol Pharm. 2017.

Abstract

Tumor necrosis factor alpha (TNF-α) driven processes are involved at multiple stages of Alzheimer's disease (AD) pathophysiology and disease progression.

Biologic TNF-α inhibitors (TNFIs) are the most potent class of TNFIs but cannot be developed for AD since these macromolecules do not cross the blood-brain barrier (BBB). A BBB-penetrating TNFI was engineered by the fusion of the extracellular domain of the type II human TNF receptor (TNFR) to a chimeric monoclonal antibody (mAb) against the mouse transferrin receptor (TfR), designated as the cTfRMAb-TNFR fusion protein.

The cTfRMAb domain functions as a molecular Trojan horse, binding to the mouse TfR and ferrying the biologic TNFI across the BBB via receptor-mediated transcytosis.

The aim of the study was to examine the effect of this BBB-penetrating biologic TNFI in a mouse model of AD. Six-month-old APPswe, PSEN 1dE9 (APP/PS1) transgenic mice were treated with saline (n = 13), the cTfRMAb-TNFR fusion protein (n = 12), or etanercept (non-BBB-penetrating biologic TNFI; n = 11) 3 days per week intraperitoneally.

After 12 weeks of treatment, recognition memory was assessed using the novel object recognition task, mice were sacrificed, and brains were assessed for amyloid beta (Aβ) load, neuroinflammation, BBB damage, and cerebral microhemorrhages.

The cTfRMAb-TNFR fusion protein caused a significant reduction in brain Aβ burden (both Aβ peptide and plaque), neuroinflammatory marker ICAM-1, and a BBB disruption marker, parenchymal IgG, and improved recognition memory in the APP/PS1 mice. Fusion protein treatment resulted in low antidrug-antibody formation with no signs of either immune reaction or cerebral microhemorrhage development with chronic 12-week treatment.

Chronic treatment with the cTfRMAb-TNFR fusion protein, a BBB-penetrating biologic TNFI, offers therapeutic benefits by targeting Aβ pathology, neuroinflammation, and BBB-disruption, overall improving recognition memory in a transgenic mouse model of AD.

PMID 28514851 [Indexed for MEDLINE]

71 posted on 06/05/2019 12:04:44 PM PDT by tired&retired (Blessings)
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To: ifinnegan
The company would be spending huge amounts of money and resources for other company’s to then make all the money.

When India and China start making knockoffs (if they haven't already) the Washington Post can give it to thousands of Alzheimer's patients in those countries, track their progress, and we'll know for sure.

72 posted on 06/05/2019 12:14:01 PM PDT by PGR88
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To: Innovative

100% correct.


73 posted on 06/05/2019 12:17:32 PM PDT by Hulka
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To: RummyChick
Correlation is not causation. They would have to prove the drug was the cause of the improved observations. The population considered was RA patients (I'm one). Is there something unique about RA that comes with a reduced probability of Alzheimer's independent of using the drug in question? Can the pharmacological mechanism of Embrel be described to explain exactly how it causes an improvement?

RA runs in my mom's family line. There is no Alzheimer's in that family history. My brother-in-law observed his mother institutionalized for years with Alzheimer's. There is no history of RA in his family. Is RA protective against Alzheimer's? I'm sure there will be counter examples shortly indicating the two afflictions are independent, unrelated problems.

74 posted on 06/05/2019 12:18:16 PM PDT by Myrddin
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To: RummyChick

Google “anti inflammatory foods”

EAT THEM

And cut out wheat.

Live on mild, cheeses, FREASH (not processed) meets and fish and poutry and eggs.

TAKE VITAMINS.

Especially pottasium and magnesium and vitamin D

Get some good Cocunut oil. Eat a spoonful in the morning- you’ll be amazed at the energy you have in 15 minutes.

Eat minced garlic and saurkrout. Best antibiotic I’ve ever used.

You’re welcome.

Ps. if you do the above you will not be hungry all the time and you’ll lose weight. A lot of it.


75 posted on 06/05/2019 12:23:15 PM PDT by Mr. K (No consequence of repealing obamacare is worse than obamacare itself.)
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To: Myrddin

I was wondering when Embrel would get the alzheimers attention. About 2011, word got out about an alzheimers patient getting embrel injected into the spine for his arthritis. His Alzheimers symptoms cleared up and his memory got to normal. If the drug was injected intrathecally then the embrel would have gotten into his csf fluid and then into the brain. Others were reporting similar results and the doctors involved were said to start pushing for more trials. I don’t know if the man’s symptoms remained in permanent remission over 8 years but apparently the symptom relief was very dramatic.


76 posted on 06/05/2019 12:36:13 PM PDT by mdmathis6
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To: Rocko Jack

If they had or were spending a crap load of money on an Alzheimer drug this would make sense and yeah these greedy scuzbags would do this.

My Dad is in the very early stages of this disease and the drug they have him on is making no difference that I can tell.


77 posted on 06/05/2019 12:38:50 PM PDT by sarge83
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To: Mr. K

I always knew that stress increased blood brain barrier permeability, but just read a journal article that gut microbiota influences blood-brain barrier permeability.


78 posted on 06/05/2019 12:40:15 PM PDT by tired&retired (Blessings)
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To: RummyChick

Prevention is not the same as cure.

If someone doesn’t get Alzheimer’s, and was taking this drug, nothing is proven.

Nothing is mentioned about whether the drug will CURE someone who already has the disease.

Is it good medical practice to take a drug to attempt to prevent something that one doesn’t have? My answer, is only if there’s a definite indication that the person will get the disease, and that is not the case.


79 posted on 06/05/2019 12:40:24 PM PDT by I want the USA back (Islam, not a religion, a totalitarian political ideology aiming for world domination. -Wilders)
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To: Rocko Jack

Why would a drug company hide a potential market?
Why? The drug company probably made a deal with the insurance companies.
At $5,560.61 for the average price, insurance companies don’t want this.


80 posted on 06/05/2019 12:51:19 PM PDT by BuffaloJack (Chivalry is not dead. It is a warriors code and only practiced by warriors.)
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