Category Archives: Endnote

Comment by the Collector In Chief

ENDNOTE: Don’t allow Big Pharma to turn supplements into drugs


The Pulse of Natural Health Newsletter
Stay informed about what is hot in Washington and the states about natural health

FDA Turned Your $10 Supplement into a $40,000 Drug

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Earlier this year, we told you about an FDA back-channel that allows drug companies to turn supplements into drugs—and remove the supplement versions from the market. This has happened to a popular and medically important version of vitamin B6 (pyridoxamine), and with the FDA’s approval of a new drug to treat sickle cell anemia, the same could happen to L-glutamine. Unless we close a back-channel at the FDA, more and more supplements will be turned into expensive drugs, and consumers won’t be able to manage their health cheaply and naturally with the supplement versions.

Last year, the FDA announced the approval of Endari, a drug for sickle cell disease. Endari is an oral powder comprised of L-glutamine, an important amino acid currently available as a supplement. The drug company, Emmaus Medical, Inc., filed an investigational new drug (IND) application—demonstrating their investigation of L-glutamine as a drug—on May 15, 1997. This is important because there is no new dietary ingredient (NDI) notification for L-glutamine. (Think of an NDI notification as a “new supplement” notification; by law an NDI notification must be filed on supplements that came to market after 1994.)

Enter the FDA back-channel. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug. Currently, a 120-pill bottle of L-glutamine can be purchased for less than $10; a year’s worth of Endari will reportedly cost consumers more than $40,000.

If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides that L-glutamine was in the market “in or as” a supplement before 1994. To make matters worse, the FDA has not completed its policy that lets companies know what is and isn’t grandfathered, or even how to file an NDI notification. Given how the current draft of the FDA’s proposal is written, there’s even a real danger that supplements most people would think of as “grandfathered” could require NDI notifications. All of this creates confusion that only helps drug companies further exploit this back-channel.

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And, here’s a great example of why I feel that the Gooferment’s FDA should be an “advisory” function at best.


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ENDNOTE: Putting the “goof” in Gooferment


Ohio woman’s driver’s license is suspended for three months for not paying child support… even though she DOESN’T have kids

  • Nekia Jones got a traffic ticket for a seat belt violation in July
  • When she went to pay, her license was suspended for failure to pay child support
  • The Columbus, Ohio, woman says she has never had kids nor been pregnant 
  • She says she has been in ‘limbo’ with the courts and uses ride-sharing apps  

PUBLISHED: 15:38 EDT, 4 October 2018 | UPDATED: 16:20 EDT, 4 October 2018

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I’m not even going to quote from this article so as not to waste your time, my time, and the electrons to store the absurdity.

Of course, one set of bureaucrats blames the other and visa versa. 

These are the folks who put the “goof” in Gooferment.

I just shake my head and wonder where the common sense went.

Doesn’t the Motor Vehicles bureaucrat report to the Governor?   I suggest that Ohio folks question the competence of their Governor.  As a subject of the Pepuls Republik of Nu Jerzee, I’d be glad to send them ours.


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ENDNOTE: Darwinism itself a pseudoscience?


Darwin’s Vigilantes, Richard Sternberg, and Conventional Pseudoscience
By Fred Reed — September 24, 2018

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Science is supposed to be objective study of nature, impelled by a willingness to follow the evidence impartially wherever it leads. For the most part it works this way. In the case of emotionally charged topics, it does not. For example, racial intelligence, cognitive differences between the sexes, and weaknesses in Darwinian evolution.  Scientists who do perfectly good research in these fields, but arrive at forbidden conclusions, will be hounded out of their fields, fired from academic and research positions, blackballed from employment, and have their careers destroyed.

A prime example is Richard  Sternberg, a Ph.D. in biology (Molecular Evolution) from Florida International University and a Ph.D. in Systems Science (Theoretical Biology) from Binghamton University. He is not a lightweight. From 2001-2007 he was staff scientist at the National Center for Biotechnology Information; 2001-2007 a Research Associate at the Smithsonian’s National Museum of Natural History. 

Hell broke loose when he authorized in 2004 the publication, in the Proceedings of the Biological Society of Washington, an organ of the Smithsonian Institution, of a peer-reviewed article, The Origin of Biological Information and the Higher taxonomic Categories by Stephen Meyer. It dealt with the possibility of intelligent design as an explanation of aspects of  Darwinism not explainable by the conventional theory. This is a serious no-no among the guardians of conventional Darwinism, the political correctness of science.

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Pseudoscience? Does not Darwinism itself qualify as pseudoscience?  It is firmly based on no evidence. For most readers this assertion will seem as delusional as saying that the sun revolves around the earth. This is because we have been indoctrinated since birth in the Darwinian myth. But look at the facts.

We are told that life arose by chance in the primeval oceans. Do we know of what those oceans consisted? (Know, not speculate, hope, it stands to reason, must have been, everybody says so). No, we do not. Do we know of what those oceans would have had to consist to bring about life? No. Do we even know what we think evolved? No. Has the chance appearance of life been replicated in the laboratory? No. Has a metabolizing, reproducing chemical complex been constructed in the laboratory, showing that it might be possible? No. Can the chance appearance be shown to be mathematically probable? No.  Can Darwinism explain the existence of irreducibly complex structures? No. Does the fossil record, particularly of the Ediacaran and Cambrian, support Darwin? No.

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As a fat old white guy injineer, I was taught to be rational.  In the math classes, we learned about limits.  What one can say with certainty is the there is a lot we human beings don’t know.  And what’s worse, we don’t know what we don’t know. (That famous Quadrant IV of the Johari window!)

That being said. It’s all a lot of “theories”, and a fair amount of speculation.  

Hence, my general reluctance to make any pronouncements on much of anything.  But, of one thing I am very sure, I don’t want to waste what little time I left on this Earth fighting about matters of faith and someone’s “heresies”.  Most of there are a wide variety of topics that I don’t care about.  Of those, like sexual orientation, who’s “millionaires playing for billionaires” are better, and what the latest internet kerfuffle is all about.  I don’t want to know about it and I certainly don’t want to pay for it.

It’s Darwin’s Theory of Evolution and the Law of Gravity.  If you can’t tell the difference, then there’s no hope for you.


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ENDNOTE: EIGHT prior drunken-driving convictions leads to a fatal NINTH!


Ohio woman, 47, charged with fatal DUI crash had EIGHT prior drunken-driving convictions

  • Heather Tapia indicted on aggravated vehicular homicide and operating a vehicle under the influence of alcohol with repeat OVI offender specifications
  • Tapia is accused of causing July 14 crash in Columbus, Ohio, that killed her passenger, 39-year-old Audrey Gartin 
  • Prosecution says Tapia had blood alcohol content nearly twice the legal limit 
  • She has racked up eight OVI convictions since 1991, most recently in 2016 and was under five-year suspension of her license  

PUBLISHED: 10:27 EDT, 20 September 2018 | UPDATED: 10:59 EDT, 20 September 2018

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An Ohio women with eight prior drunken-driving convictions in her criminal record has been charged with causing a crash that killed her passenger in July.

Heather Lynn Tapia, 47, on Tuesday was indicted by the Franklin County grand jury on counts of aggravated vehicular homicide and operating a vehicle under the influence of alcohol with repeat OVI offender specifications.

According to Franklin County Prosecutor Ron O’Brien, Tapia had a blood alcohol concern of 0.138 per cent, which is almost twice the legal limit in Ohio, when she got behind the wheel on the morning of July 14.

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Sorry, but this is the Gooferment’s fault.  They can’t protect the public from an obvious repeat offender, then why should we treat them with any credibility at all.

This woman should have been in jail UNTIL there was a way to ensure she was no longer a threat to innocent people.

Perhaps an ankle bracelet that could detect when she was in the driver’s seat of a car.  Cars that can detect alcohol.  A tattoo on her forehead “DUI”?  Or just keep her locked up.

We keep reading stories of these multiple offenders, but the cops seem to focus on casual drinkers.


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ENDNOTE: A “catholic” politician’s ethics?


Come clean and apologize, Gov. Cuomo
By Post Editorial Board
September 19, 2018 | 7:41pm | Updated

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Was there anyone involved with Gov. Cuomo’s re-election campaign or his office who didn’t know about that infamous mailer tarring Cynthia Nixon as anti-Semitic?

The Post keeps uncovering ever more evidence showing the gov’s team played a major role in crafting and OKing the hit piece, which Cuomo himself calls “slimy.” His excuses and denials just don’t hold up.

The Post’s Nolan Hicks and Carl Campanile cite documents and interviews showing that Adam Steinberger, a top aide to Cuomo’s campaign manager, Maggie Moran, was heavily involved in the mailer’s creation. Moran and an executive aide to the governor, Jill DesRosiers, were also copied on at least one early e-mail discussing a mailer. (Abbey Collins of the campaign insists neither woman saw any of the radioactive stuff.) Former Cuomo aide David Lobl ginned up talking points used to create the mailer.

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If the “Catholic” hierarchy will not rebuke a “Catholic politician” for his stand on “women’s reproductive rights”, then where is the “Catholic” laity to do their job for them?

Hard to believe that a politician could survive losing both the Catholic and Jewish vote.

Time for voters to punish bad conduct!

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ENDNOTE: Archbishop Carlo Maria Viganò’s letter indicts and convicts Pope Francis


BONUS Ep. 1231 The Crisis in the Catholic Church
1st September 2018 — Tom Woods

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With the abuse crisis exploding in recent weeks, culminating in the atomic bomb of a letter released by Archbishop Carlo Maria Viganò, I decided it was time for another bonus episode. My guests are Roger McCaffrey, president of Roman Catholic Books and founding publisher of The Latin Mass magazine, and Steve Skojec, publisher of the OnePeterFive blog.

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The Archbishop’s letter is IMHO the death knell of the “Organizational Church”.

Read it for yourself.

As was said during the podcast, this scandal is a multigenerational disaster.

Referring to oneself as “Catholic” implies that enormity of the situation can be in someway minimized.


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ENDNOTE: “Who am I to judge?” The successor to Peter with power!


A Cancer on the Papacy?

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This summer, the sex scandal that has bedeviled the Catholic Church went critical.

First came the stunning revelation that Cardinal Theodore McCarrick, former Archbishop of Washington and friend to presidents, had for decades been a predator-priest who preyed on seminarians and abused altar boys, and whose depravity was widely known and covered up.

Came then the report of a Pennsylvania grand jury that investigated six dioceses and found that some 300 priests had abused 1,000 children over the last 70 years.

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If the Church’s highest priority is to coexist peacefully with the world, it will modify, soften, cease to preach, or repudiate these beliefs, and follow the primrose path of so many of our separated Protestant brethren.

But if she does, it will not be the same Church that over centuries accepted martyrdom to remain the faithful custodian of Gospel truths and sacred tradition.

And how has the embrace of modernity and its values advanced the religious faiths whose leaders sought most earnestly to accommodate them?

The Church is going through perhaps its gravest crisis since the Reformation. Since Vatican II, the faithful have been departing, some leaving quietly, others embracing agnosticism or other faiths.

“Who am I to judge?” said the pope when first pressed about the morality of homosexuality.

Undeniably, Francis, and the progressive bishops who urge a new tolerance, a new understanding, a new appreciation of the benign character of homosexuality, have won the plaudits of a secular press that loathed the Church of Pius XII.

Of what value all those wonderful press clippings now, as the chickens come home to roost in Vatican City?

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I’d venture an opinion that it’s too late.  The organizational “Church” is destroyed and has lost its way and any moral authority it had.

Perhaps, the laity can reform as a grass roots movement with no “hierarchy”?  After all wasn’t that how it started?

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