Wednesday, May 30, 2018

Trump Signs Misnamed "Right to Try" Law

A LAW FOR WRONGS, NOT RIGHTS
"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time." Donald J. Trump
President Trump signed the so-called Right to Try bill, S-204, passed by Congress, into law today.

The website for the 115th Congress describes the law with this official summary: [1]
"This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must report annually to the Food and Drug Administration (FDA) on any use of the drug in accordance with these provisions. The FDA shall post an annual summary report of such use on its website. The bill limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill."
The new law provides that any patient diagnosed with "a life-threatening disease or condition..." who has "exhausted approved [by whom?] treatment options..." as certified by a physician who is not compensated by a drug company, may benefit from the experimental treatment's exemption from FDA licensing.

The law also correctly requires, in section (1)(C) that the written Informed Consent of the patient or guardian be obtained.

Unfortunately the new law restricts its benefits only to pharmaceutical drugs that have already gone through FDA-approved Phase 1 testing or certain other procedures. This law does not apply to the many natural remedies or to medicines used in other countries. [2]

The law specifically exempts drug companies from liability for harm to the patient and provides that the FDA may not, in normal circumstances, use the outcome of the Right to Try to delay or deny drug approval. The law concludes with a Statement of the Sense of the Senate that the the law does not "establish a positive right to any party or individual..." and that any "use of experimental treatments under the criteria and procedure described in such section 561A involves an informed assumption of risk..."

Thus, what appears on first look as an act of compassion by Congress and the Administration, when viewed more closely, is a law made to protect drug companies without securing for Americans the Right to Try natural remedies that are not subject to FDA approval in the first place!

This new law does not expand Freedom of Choice and is at best a half-way measure that might benefit a few individuals. It does not address the excess power already possessed by an Agency of which former Congressman Ron Paul once said, to the effect, "the more power it has, the more power it has to abuse."
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Also posted at:  http://www.opensourcetruth.com/trump-signs-misnamed-right-to-try-law/

[1] https://www.congress.gov/bill/115th-congress/senate-bill/204
[2] There are other legal provisions which do allow some limited access to other remedies.  I have written about two of them here:
     Medical Foods:  http://vitaminlawyerhealthfreedom.blogspot.com/2013/05/medical-foods-under-orphan-drug-act.html
     Personal Importation:  http://www.lifespirit.org/perimport.html

Wednesday, May 16, 2018

Will Blockchain Social Media Make Facebook and YouTube Obsolete?


Freedom Advocates Seeking Better Connections

Health Freedom, Vaccine Choice and other social reform advocates need to face the facts: it’s not just governments that seek to censor Internet expression. 

The “big boys” of the World Wide Web actively seek to restrict expressions of opinion that do not meet current “standards” of Political Correctness and Identity Politics[1].  It’s not just the “Great Firewall of China” that restricts worldwide political expression: the imposition of “community standards” by private companies simply as a cover to arbitrary, and maybe politically motivated, decisions by anonymous corporate hacks somewhere in some Internet boiler room out there... but, there may be a technical fix for this political problem.

Blockchain technology, which is the basis for Bitcoin and other crypto currencies, is a secure system of decentralized information distribution and verification.

The easiest way to think about blockchain is a massively distributed network that can’t be controlled by any entity and has no single point of failure. Every time there is a transaction or event in this network, every single node in the network is notified and updated. Each update is a “block” of data, creating a massively distributed ledger of data that is shared by every member of the network.[2]

Its business model is not like that of the centralized social media systems such as Facebook and YouTube, which rely on profiting from user-provided content. The new social media developing on the Blockchain, like Minds.com, Synero, Yoyow[3] or Steemit[4], recognize that the users are the content providers.

Though “the medium is the message” it is the content that is monetized. Currently companies like Facebook, YouTube, Instagram or Snapchat profit by selling advertising that appears along with user-generated content, offering “relevant” commercial information to the consumers of that user-generated content.

The corporate social media owners reap the advertising revenue reward while the volunteer content-makers create the value that the users seek. The Blockchain social media model proposes, instead, to reward the user-content-creators without the intermediation of corporate owners -- or at least with a much bigger share of the advertising pie.

In its purest form, such a network would lack a central body creating profit from the platform and therefore be unrestrained by the goal of appeasing advertisers. Like Bitcoin, it could be modelled on a system where those who invest most time and effort in the network have the greatest influence on its evolution.”[5]

The model proposed by the now-in-beta-testing Minds.com, for example, rewards user/contributors with a new crypto currency, the Minds Token, which can be used to boost postings, purchase at the Minds.com store, and, after the beta period, be converted to Bitcoin.

Minds.com founder Bill Ottman commented,

“I always knew that an open-source social network was inevitably going to emerge and become competitive with the top establishment social network... It also became clear that the mainstream social networks were not rewarding people — were not incentivizing people. They weren’t giving revenue opportunities. They’re restricting people’s reach — they’re spying on people! So it became sort of obvious that there’s a market requirement for this space that we’ve filled.”[6]

The economics of the social media is becoming a struggle between these two visions:

[1] Corporate advertising built on the intellectual efforts of (mainly) volunteer contributors, versus
[2] Decentralized systems where the advertising revenue is distributed, via the Blockchain, to the users.

At the same time, the propensity of the corporate sponsors to engage in “private” censorship of social media content is becoming of ever greater concern to the users of the media. After all, the purpose of engaging in the social media is to communicate ideas and information. That use is at odds with corporate censorship.

I’ve previously written about Privatizing Tyranny, the efforts of various governments to empower private entities in restricting the ideas which may be expressed openly.[7] Those private entities act “under color of law” as arms of government when blocking, down-throttling or down-grading the expression of certain ideas to which the governments object. If no one can see your comment your right to freedom of communication is meaningless.

Blockchain-mediated, decentralized social media are unable to be so manipulated. The would-be tyrants have no technical means to impose restrictions on such content.

This is a real threat to the centralized media, which appear to have been created, or at least boosted by government intelligence agencies (consider DARPA-connected, Facebook investor James Breyer).[8]  

Once the powerful financial link between the corporate overseers and the social media is broken by Blockchain decentralization, the ability of governments to use their corporate proxies to censor social media expression will begin to fade.

Will the Blockchain build a social media stronger than the controls even the most powerful of governments impose?  Does it matter to you as an advocate that you are being censored by government or by what claim to be “private” companies?

“Facebook, Twitter, YouTube, and Instagram are prohibited by the Chinese government. Why does the Chinese government cut off its citizens' channels of communications with the outside world? What is it afraid of?” [9]

Freedom advocates must join in that question: “What are the huge social media corporations afraid of?” To ask this question is to answer it. They fear free people capable of asking that question!

The answer implies how we can Push Back and break free: boycott the “official” social media, whether directly government-affiliated as, for example, Yoyow may be[10], or whether corporate creatures of the state that pretend to be independent, like Facebook or YouTube. But boycotting is just the first step.

To be able to utilize the extraordinary power of the social media to protect freedom and effectuate change, you must patronize the Alt Social Media, and that means relying on the Blockchain for the privacy protection that it offers.

I’ve begun to shift my attention from Facebook and YouTube to Minds.com and other Blockchain Alt Social Media.  It is my attention that profits the centralized social media, so ultimately, it is my choice.

We each have that choice.



Ralph Fucetola JD is a retired lawyer, consultant – www.ProfessionalSafetyDossier.com – President of the Institute for Health Research – www.InHeRe.org – and VP of the Natural Solutions Foundation – www.GlobalHealthFreedom.org



[6] ibid Techworld
[10] ibid Bitconnect

Monday, April 9, 2018

Identity Politics: The Superstition that Divides


Wikipedia tells us “The term identity politics has been used in political discourse since at least the 1970s.” and “Identity politics refers to political positions based on the interests (sic) and perspectives of social groups with which people identify.” [1]

An example of identity politics is the policy of “affirmative action” (including racial preferences) as practiced by American educational institutions.

Affirmative action in the United States is a set of laws, policies, guidelines, and administrative practices "intended to end and correct the effects of a specific form of discrimination." These include government-mandated, government-sanctioned, and voluntary private programs that tend to focus on access to education and employment, specifically granting special consideration to historically excluded groups such as racial minorities or women...”[2]

The legal history of “Affirmative Action” is replete with complaints that preferences for certain identity groups must result in discrimination against other identity groups.  

Asian-Americans are, for example, victims of institutional efforts to redress perceived previous discrimination against others.[3]

Why, with the good intention of righting earlier wrongs, has identity politics lead to new forms of discrimination? Perhaps the cause is hidden in plain sight.  

When the subjects of identity politics are categorized by listing certain “accidents” of the human condition, such as race or gender[4], and then these categories (“social groups”) are said to have “interests and perspectives...” you know you are getting far away from the actual conditions of human action and into a land of superstitious beliefs where collective nouns can engage in action and have property interests, just as if they were individual persons.

But that is just the beginning of ascribing to collective nouns the attributes of personhood.  The discrimination and unfair treatment that such a political stand requires must further divide the population into competing combinations, seeking to damage their perceived opponents in order to benefit themselves.  Such a politics must descend to the vicious infighting so often seen in tyrannical societies.

Consider for example how politics was played in Nazi Germany or Stalin’s Soviet Union. Stalin was the great master in the practice of identity politics, finely parsing this group and that ethnicity, assigning some to Socialist Heaven, such as it was, and some to ... the Gulag. The “Night of the Long Knives”[5] and, of course, the Holocaust, are the norm for such systems of governance and are examples of identity politics at its worst.

Whole civilizations have been built on identity politics. Consider, for example, the Caste System of India, where every ethnicity and every occupation was locked in place with family ties.

So “identity politics” – the politics of what the Founders called “faction” are among the most violent of politics, and for good reason.  The other faction is seen as the enemy – if it is favored by the state, then the group with which one identifies will be disfavored by the state. And, in such societies, all "favors" flow from the state!

Every political issue becomes a matter of life or death.  The other faction must be demonized, dehumanized and ...ultimately liquidated. “Pick the target, freeze it, personalize it, and polarize it.”[6]

Thus, identity politics must divide, must reduce social peace and must reduce social utility.  We are all poorer and less free as a result of such an approach to politics.

Rather, the approach of the Founders, even with all the “baggage” they brought, such as the “Four Great Monopolies” decried by Lysandor Spooner[7], remains the only approach that allows for peaceful human development. 

A limited, constitutional republic that respects individual rights and recognizes the primacy of such rights over the limited powers granted the government is perhaps the one last hope for those who still believe in the efficacy of public authority. 

All the forms of statist politics, including “Identity Politics” as practiced in the old Soviet Union or in the new American Empire lead to dire results and further prove the necessity of overthrowing the coercive state as a superseded social structure that has long outlived its supposed benefits.

As one commentator put it: “Should one expect an answer about identity to be anything other than a exploratory one, then one is seeking power, and is propounding and prescribing definitions that are self-serving.” [8]

Only individual humans feel, think, plan and act. The rest is superstition.



[4] “Examples include social organizations based on age, religion, social class or caste, culture, dialect, disability, education, ethnicity, language, nationality, sex, gender identity, generation, occupation, profession, race, political party affiliation, sexual orientation, settlement, urban and rural habitation, and veteran status. Not all members of any given group are involved in identity politics. Identity politics are used by minority and civil rights organizations to form a coalition with members of the majority.” https://en.wikipedia.org/wiki/Identity_politics
[7] State churches, chattel slavery, the institutional inequalities of women and government trade monopolies

Monday, February 26, 2018

Church, State and Trump


CHURCH AND STATE IN TRUMP'S AMERICA


The Constitution says Congress has no power to legislate restrictively about religion.  By linking religion with speech, communication ("the press"), assembly and redress, the First Amendment creates what the Supreme Court has come to refer to as "Expressive Association."

"Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances."

Religious organizations have come to rely on the powerful language of the First Amendment to assure their independence from political authority in America. 

The prohibition against Congress making any law prohibiting "free exercise" combined with our first Supreme Court's admonition that "the power to tax is the power to destroy" is the basis for the tax exemptions of churches. I wrote about this in 1998:

“Yeshua the Nazarite taught his followers to "render unto Caesar the things which are Caesar's". He was adroitly avoiding, as the incident in the Bible makes clear, expressing an opinion regarding the Roman Empire's taxes. Jesus continued, "...and render unto God the things which are God's". Ever since, the question of the State's authority and Religion's right has been of central concern in Western religious and legal philosophy. We have seen how this conflict has been resolved, at present, in America. The tax (and other laws) we have discussed are part of that resolution, for, as our first Supreme Court said, "the power to tax is the power to destroy," and Congress has made it the law that the government may never use this power to destroy the independence and capacity to act of American churches. This is the Law of the Land and should be defended by all freedom-loving and religiously oriented people.” [1]

There have been few attempts to restrict religious speech in US history and all but one, the infamous 1954 Johnson Amendment, have fallen away.  That clause, imposed by LBJ while still a member of Congress, attempts to prevent churches from engaging in political speech. That is old law unlikely to be fully enforceable.

Congress adopted the RFRA, the Religious Freedom Restoration Act of 1993 (P.L. 103-141). In this enactment Congress determined that "governments should not substantially burden religious exercise without compelling justification..." and that "laws 'neutral' toward religion may burden religious exercise..." Therefore Congress determined to protect the free exercise of religion as follows:

"Sect. 3. Free Exercise of Religion Protected. (a) In General. -- Government shall not substantially burden a person's exercise of religion, even if the burden results from a rule of general applicability, except as provided in subsection (b). (b) Exception. -- Government may substantially burden a person's exercise of religion only if it demonstrates that application of the burden to the person -- (1) is in the furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest. (c) Judicial Relief. -- A person whose religious exercise has been burdened in violation of this section may assert that violation as a claim or defense in a judicial proceeding and obtain appropriate relief against a government..."

Under that law the courts have allowed churches great leeway. Examples include sponsoring peyote rituals and even asserting exemptions from certain Obamacare insurance requirements.

Recently people have been more strongly asserting their right to have their religious beliefs accommodated in reference to government and employer vaccine mandates. I’ve written about that and helped develop a form Demand for Religious Accommodation. [2]   

This trend has been further strengthened by actions taken by the Attorney General and President Trump. [Let it be understood that I am not a particular fan of either, and consider their old-fashioned views regarding the health benefits of Hemp to be particularly egregious.]

Attorney General Jeff Sessions had this to say on October 6, 2017: [3]

“Religious liberty is not merely a right to personal religious beliefs or even to worship in a sacred place. It also encompasses religious observance and practice. Except in the narrowest circumstances, no one should be forced to choose between living out his or her faith and complying with the law.”

The Attorney General Continues, in Point 2 of his Opinion

“2. The free exercise of religion includes the right to act or abstain from action in accordance with one’s religious beliefs.

“The Free Exercise Clause protects not just the right to believe or the right to worship; it protects the right to perform or abstain from performing certain physical acts in accordance with one’s belief. Federal statues, including the Religious Freedom Restoration Act of 1993 (“RFRA”), supports that protection, broadly defining the exercise of religion to encompass all aspects of observance and practice, whether or not central to, or required by, by a particular religious faith.”  [4]

Last May President Trump signed an Executive Order essentially nullifying the Johnson Amendment, except for actually endorsing political candidates.

"The order, which Trump inked during a ceremony in the White House Rose Garden, directs the IRS not to take "adverse action" against churches and other tax-exempt religious organizations participating in political activity that stops short of an endorsement of a candidate for office. But pastors are already free to deliver political speeches, and regularly do. Churches and other tax-exempt organizations are restricted from endorsing or explicitly opposing political candidates under the 1954 Johnson Amendment, but the executive order Trump signed Thursday makes clear that those activities would still not be permitted." [5]

The wording of the Order states:

"Section 1. Policy. It shall be the policy of the executive branch to vigorously enforce Federal law's robust protections for religious freedom. The Founders envisioned a Nation in which religious voices and views were integral to a vibrant public square, and in which religious people and institutions were free to practice their faith without fear of discrimination or retaliation by the Federal Government. For that reason, the United States Constitution enshrines and protects the fundamental right to religious liberty as Americans' first freedom. Federal law protects the freedom of Americans and their organizations to exercise religion and participate fully in civic life without undue interference by the Federal Government. The executive branch will honor and enforce those protections." [6]

Subsequently, in January 2018, the President created a "Conscience and Religious Freedom Division in HHS:

"Social conservatives and religious liberty leaders have anticipated conscience and religious freedom protections to come out of HHS, and the work of the new division, which will fall under the purview of the Office of Civil Rights, will likely pave the way for health care workers to refuse specific types of care, like birth control or abortion, based on their religious or conscience objections." [7]

Bottom Line:  restrictions on religious involvement in public affairs, which IMHO always violated the absolutist language of the First Amendment (or as Justice Hugo Black was accused of saying, "No law means no law."), are becoming unenforceable.  Similarly, the right to assert conscientious objections to acting contrary to one's religious beliefs is becoming more respected by the civil authorities.

This may apply not only to conscientious objection to decorating wedding cakes, but also to submitting to vaccination or other demands of an ever more intrusive bureaucracy. These are highly significant developments.

Rev. Ralph Fucetola JD


Friday, February 23, 2018

Stop FDA Attack on Homeopathy


FDA ATTEMPTING TO
KILL HOMEOPATHY [HERBS NEXT!]
IN ILLEGAL ACTION WE MUST STOP!
MUST ACT BY MARCH 20, 2018
Short Link to this Message

https://tinyurl.com/FDA-homeopathy

TELL FDA “NO!” START WITH THIS LINK!
Subscribe for Regulations.gov Comment Link:
https://my.officevp.com/s/27312

The UK's National Health "Service" used to run special homeopathic hospitals and herbal dispensaries. Not any more, now the "single payer" will no longer pay for either and they are now being closed. [1]
---------------------------

Unsurprisingly, the FDA is following suit, despite the fact that Homeopathy and the US Homeopathic Pharmacopoeia (USHP) are protected by specific statutes in the US.

Did Health Freedom end when 2017 made its exit? Yes, if the FDA has its way!

Bottom Line: If you are ready to take action to protect natural remedies, read on...

We have until March 20th to file formal comments with FDA.  Docket FDA-2017-D-6580 – scroll down to find the Comment Link.

This past year the DEA and the FDA came out publicly saying, for example, that Cannabidiol, CBD, a neurotransmitter produced by mammalian (including human) bodies, was not a lawful nutrient, although the agencies have stopped short of raiding health food stores [as FDA used to do in the 1990s, before the Dietary Supplement Health and Education Act (DSHEA)] to enforce their dictate. [2] 

Right now, although there is a century of laws protecting homeopathy, FDA is attacking homeopathy to “protect” you. They are the government and they are here to "help" — Big Pharma.

On December 18th of this past year FDA issued new regulations that attack homeopathic oral and injectable remedies despite the fact that they are protected by long-standing law. This blatant attack on your health freedom choices is part of a long-term, well-financed conspiracy and, sadly, comes as no surprise. [3]
On your behalf we told FDA, when they started their “regulatory review” of homeopathy to let our natural remedies alone! The attack began “innocently enough” during the previous presidential administration.  

FDA asked for comments on how it should “modernize” homeopathy regulations. That’s the government’s first step toward ratcheting-up control.

That’s the step to which we had previously replied, telling them, among other things:

"FDA does not have authority from Congress to interfere with traditional homeopathy, nor does Congress have authority to permit such interference. Individuals have the right, under international humanitarian law binding on the United States, of Informed Consent to exercise their Freedom of Choice in health care without government burdening that fundamental right." [4]

These new regulations followed similar recent action in the UK by its “one payer” nationalized health care system. The UK National Health “Service” has ended its long-standing history of support for safe, gentle and effective homeopathy and herbalism (the UK even has special homeopathic hospitals and homeopathic/herbal dispensaries) in favor of dangerous, deadly and ineffective pharmaceuticals. This trend for medical tyranny has “crossed the pond” as the FDA has attacked legally protected homeopathy in the USA.

This was done in three steps that I have documented.

First in 2015, when the FDA asked for public comments about regulating homeopathy. That's when we submitted the comments referenced above. By the way, by submitting comments telling FDA they were acting illegally, we preserved the legal right to complain to the courts; we preserved "standing to sue."

Second, as noted in a blog entry I posted January 2017, FDA was toying with the idea of requiring "disclaimers" on homeopathic products, disclaimers not required by the statute that protects homeopathy in the USA [5].

Third, the most recent action, which illegally attempts to treat HPUS standard homeopathic remedies as unapproved pharmaceutical drugs, requiring a "risk/benefit analysis" which will effectively ban many, if not most, homeopathic remedies. This pseudo-scientific analysis starts with the false claim that homeopathic remedies have no benefit and alleges a "risk" that people using such remedies will fail to use Big Pharma's government approved, dangerous "side-effect" drugs.

What risk? Since government approved pharmaceutical drugs are the main cause of preventable death in the USA, what risk? [6]

The natural product industry has two choices: let Big Pharma and the globalists have their way or force them back, step by step.  I am sure that large producers of homeopathic remedies will realize they have no choice but to challenge the regulation. Strong public support for natural remedy freedom will encourage resistance to agency overkill.

Since we have preserved the right to object to this latest FDA action, cooperation between the industry and the health freedom movement during 2018 may be the only way to preserve our access to homeopathy, and, while dodging the FDA's left punch, we'll need to watch it's right arm for the next attack on herbs and other nutrients, like CBDs.

The new President, failing to keep his promise to "drain the swamp" seems to be appointing swamp-creatures to run the FDA and empower it to further attacks!

We must choose to force them back. I know you will want to do so, too.

FIRST -- Subscribe here: https://my.officevp.com/s/27312 to be linked directly to the Regulations.gov web page for comments. This is where you can tell the FDA “NO!”
Share this link on social media!

SECOND -- Contact me directly if you or your company want to be part of the advocacy and litigation that will likely be needed to stop this latest FDA outrage. Our half century of health freedom advocacy positions us to coordinate this urgent action.  We need your support -- email me here: ralph.fucetola@usa.net
 
File your comments prior to March 20, 2018

When you Subscribe you will be sent to a link that you can click to file your comment to the FDA.


It is simply bad science to apply the "risk/benefit" analysis that may be appropriate for the dangerous drugs and interventions of modern medicine to traditional nutritional, herbal and homeopathic approaches to achieving and maintaining health.  

Biological individuality suggests that the "risk/benefit" analysis will miss the benefits of these natural modalities, giving the governing authorities an excuse to ban the natural competition to treatments that are known to cause harm. Let us remember that a large portion of the FDA's budget comes from large pharmaceutical companies. [7]  The risk of systemic corruption is so high that the agency should refrain from interfering with freedom of choice in health care. [8]

Ralph Fucetola JD
President
Institute for Health Research
www.InHeRe.org
www.VitaminConsultancy.com
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