Saturday, May 30, 2009

The Bible Revolution (Bible History) 2007

First shown on Channel 4 in April 2007 - This documentary, presented by Rod Liddle, explores the life and times of the visionaries who fought a powerful and violent church establishment to publish the Bible in English. Their vocation, tenacity and sacrifice left a lasting impression on the language and literature in the centuries that followed. Julia Bard reports.

The struggle to translate the Bible into a language that everyone could understand was part of a challenge to the medieval Catholic Church, which conducted its rituals in Latin and invested huge authority in the Pope. Those who wanted to reform the church believed that each individual could relate directly to God, without the mediation of priests, but to do so they needed access to the scriptures.

In 1370 John Wycliffe, a scholar at Oxford University, challenged the central role of the Catholic Mass. He said that the Bible was the sole source of Christian authority, not the Pope. The Church declared him a heretic and called his followers Lollards (mutterers). But they could not suppress his message: that the people could be trusted to read the Bible for themselves and through that, relate directly to God. By translating the Bible into English, Wycliffe, and those who followed him, not only opened that door to the scriptures, they also started to rescue and define the English language which had become overlaid by French and Latin since the Norman Conquest.

Wycliffe’s translation of the Bible was banned, and possession of a copy was considered evidence of heresy – punishable by burning to death. This even extended to Wycliffe being condemned as a heretic after his death, and his body dug up and burned. Nevertheless, the Lollard Bible continued to be passed from hand to hand and many copies survive today.

HERE'S THE VIDEO LINK
Download, Extract with Winrar,
Watch it with Media Player
English | XviD | 640 x 352 @ 25fps | MP3 | 128Kbps |
LINK 1 * LINK 2 * LINK 3 * LINK 4
LINK 5 * LINK 6 * LINK 7 * LINK 8


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Change across Europe.
During the reign of Henry VIII, frustration at the Church boiled over simultaneously with a flowering of scholarship and, perhaps most significantly, the invention of printing. There was also a growing challenge to the Catholic Church across Europe from those who believed that the wealth and power of the Church was a betrayal of the people, and that salvation could not be attained by performing rituals or acts of charity.

In Germany, Martin Luther was leading a growing reformation of the Church, with the protection of the local ruler. This inspired the scholar William Tyndale to translate the New Testament from the original Greek into a form of English that would sound familiar to ordinary people. But unlike Luther, he had no powerful protectors, and, in the spring of 1524, he fled from England to Germany. There, in August 1525, he completed his translation of the New Testament and took it to Cologne to be printed. Despite a raid on the printer, a few months later his Bible was printed, and thousands of copies of the compact book found their way to England to be handed round in secret, despite vicious suppression.

Tyndale moved to Antwerp, which was a relatively safe haven, and had an enormous printing industry. The printers boosted their profits by smuggling the new Bible to England as single pages hidden in bigger books. By the time Tyndale died, it is estimated that some 50,000 copies had reached England in this way.

At home, the conflict within Christianity took a new twist when Henry VIII declared himself to be the divinely appointed head of the Church in England. But the reformers still had powerful enemies, and Tyndale was betrayed, arrested and incarcerated in a castle in Brussels before being burnt at the stake in October 1536.

The Bible comes home

His execution did not defeat his mission to bring the Bible directly to English-speaking people, though. A few months after his death, the Archbishop of Canterbury, Thomas Cranmer, recommended that people read Tyndale’s Bible and, in turn, wrote the Anglican Book of Common Prayer.

This set the tone for the English Reformation, but it was to turn violent as Thomas Cromwell led the destruction and looting of the monasteries on behalf of Henry VIII. Eventually two versions of the English Bible were licensed: The Matthew Bible and The Great Bible, both largely based on Tyndale’s translation. Not only were they permitted, every parish in the country was forced to buy a copy. This act of defiance against the old Church emphasised the belief that everyone stands before God without the need for clergy – a fundamental aspect of British Protestantism.

Politics and intrigue

During the short reign of Henry’s 9-year-old son, Edward, the destruction of the monasteries and all the art and objects they contained gathered pace. The backlash came after Edward died and was succeeded by Mary. Cranmer was arrested and the Catholic Church’s leading intellectuals were brought in to persuade him to recant – but he turned the tables on them by changing the final paragraph of the speech he had promised to make. He was burnt at the stake in 1556, but the English Bible survived.

In 1558, Elizabeth came to the throne. A sophisticated politician, she presided over the development of a new kind of Protestantism which contained compromises with some Catholic traditions and saved the remaining cathedrals. Some Protestants could not accept these compromises. In an attempt to maintain their support, Elizabeth’s successor, James, commissioned a new Bible, again, largely based on Tyndale’s work. This was the King James Version, which set a standard and influenced writers for four centuries.

Across the Atlantic

This did not stop the divisions and rancour worsening and developing into the English Civil War. When peace, and the throne, were restored, the Bible wars were over, in Britain at least. In America, though, the debate continued among Protestants from all over Europe who had fled persecution. Among their descendents are the USA’s 125,000 English-speaking Protestant churches, which range from champions of Civil Rights to the right-wing Evangelical leaders who preach with missionary fervour that there is no other means to salvation than the Bible.

Perhaps its most important legacy, though, is the Protestant notion put by Jefferson: ‘God hath created the mind free.’ This underpinned the separation of church and state, the constitutional guarantee of freedom of expression and the right to fight for freedom of choice, freedom of conscience and freedom of speech.

NOTE:
This Documentary will clearly reveal how we got our Bible. Most Atheists Ignore this "Bible History" because they will find The Living God, The Creator of the Universe.


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The Aztec Massacre Revealed (HDTV 2008)

A grisly discovery of more than 400 mutilated bodies in Mexico is turning history on its head. Aztec Massacre paints a new picture of the violent relations between the Aztecs and the Conquistadors and rewrites much of what we thought we knew about the Aztec civilization.

A Firefly Production for Thirteen/WNET New York and ITVS International in association with Five, Channel Four International and History Channel (UK).

HERE'S THE VIDEO LINKS
Download, Extract it with
Winrar
watch it with Media player
with Divx6 Codec
LINK 1 * LINK 2 * LINK 3 * LINK4

Interview With A Cannibal - 2007

This Documentary is a follow-up Video from "The Man who Ate His Lover", but this time... We have the actual Interview of the Cannibal himself Armein Weiss. On this footage, you will see how He didn't like the killing, but rather the eating of another man. This will reveal the actual scene where they make love, and where he butchered his lover, and where he put the body for future consumption.

Armin Meiwes, the German cannibal serving a life sentence for killing and eating a man who begged to be devoured, has described how the meat tasted of pork and how he prepared an elaborate meal of human steak in a green pepper sauce with croquettes and Brussels sprouts.

In his first television interview, broadcast on Monday night on the RTL channel, Meiwes, 46, looked relaxed and healthy as he spoke about his decades-long yearning to consume another man.

HERE'S THE VIDEO LINK
Download, Extract with Winrar, Use the password below, Watch it with Media Player or Divx6 Player to watch avi File

LINK 1 * LINK 2 * LINK 3 * LINK 4 * LINK 5
password: www.ziddufacts.blogspot.com


The case came to light in December 2002, and the grisly details made world headlines. Meiwes filmed himself killing, disembowelling and cutting up the corpse of computer engineer Bernd Brandes, 42, whom he had met after posting messages in Internet chatrooms seeking "men for slaughter."

"Yes, people who can't think their way into this find it monstrous. But in principle I'm a normal human being," he told his interviewer Günter Stampf, who has written a book, "Interview with a Cannibal," based on 30 meetings with Meiwes in jail. The interviews were approved by the Frankfurt district court that convicted him.

"I sauteed the steak of Bernd, with salt, pepper, garlic and nutmeg. I had it with Princess croquettes, Brussels sprouts and a green pepper sauce," said Meiwes. He said the meat was a little tough. He froze meal-sized portions of Brandes, some in the form of minced meat, and ate more than 20 kilograms of it in the months following the March 2001 killing.

Lifelong Fantasies
During his two trials in 2004 and 2006, Meiwes said he had always dreamt of having a younger brother -- "someone to be part of me" -- and had become fascinated with cannibalism as a way to fulfil that obsession. His desires were fuelled by the Internet, where he had contact with around 400 men interested in cannibalism.He found a perfect match in Brandes, who was obsessed with being eaten. "The first bite was of course a peculiar, indefinable feeling at first because I had yearned for that for 30 years, that this inner connection would be made perfect through this flesh," Meiwes said in the interview.

"The flesh tastes like pork, a little bit more bitter, stronger. It tastes quite good," he said.

He said that when he was a child, he had enjoyed his mother reading him the fairy tale "Hansel and Gretel," about a witch who traps two children and prepares to eat the boy. "The bit where Hansel is to be eaten was interesting. You wouldn't believe how many Hansels are whizzing around the Internet."

Police estimate that around 10,000 people in Germany alone share Meiwes' fascination with cannibalism -- either eating human flesh or being eaten. Meiwes, serving his sentence in a prison in Kassel, central Germany, could be eligible for parole after serving a mandatory 15 years in jail. A psychiatric examination conducted ahead of his trials concluded that he is not insane but has a "severely disturbed soul."

"I want to undergo therapy, I know I need that and I hope it will be done at some point," said Meiwes.


NOTE:
Armein admittted that he don't know whom to call upon (GOD or the Devil) when is doing this Cannibalism act. This reveals that there's an active Invisible Force behind him to do good or evil. But I guess the devil won this time, but who knows on Judgement Day - on the Great White Throne?

Extraordinary People - The Boy With an Incredible Brain.2005 HDTV

Daniel Tammet
A remarkable young man, exhibiting stunning mental abilities. Daniel Paul Tammet born 31 Jan 1979 claims to see colours and sparks, which he can somehow relate to words and numbers. Scientists consider him a gold mine to further investigation into the understanding of brain activity and potential.

Daniel claims that since the age of four, he has been able to do huge mathematical calculations in his head. So the makers of this documentary put him to the test, asking him to calculate 37 raised to the power of 4. He completed this in less than a minute, giving the correct answer of 1,874,161.Daniel Tammet While considering the question, it was observed that, he appeared to be drawing shapes on the table with his finger. When asked about this, he explained that he could see the numbers as shapes and colours in his mind. This breakdown or confusion of the senses is known as synethsesia.

Next he was asked to divide 13 by 97. This time the researchers had the answer to 32 decimal places, Daniel gave the answer and continued beyond 32. He claims he can do the calculations to 100 decimal places. He appears to be doing the mathematical calculations without actually thinking about it, which seems preposterous, but if true, blows away scientific theory.

HERE'S THE VIDEO LINK
Download, Extract with Winrar,
Watch with Media Player with Divx6 codec
(download the links per day to keep it Alive)
LINK 1 * LINK 2 * LINK 3 * LINK 4

Daniel's talents do not stop at numbers. He is very gifted with words and speaks nine languages and claims to be able to learn a new one in just seven days. To put this to the test, the documentary team shipped Daniel off to Iceland for a week. His Icelandic tutor described their language as immensely complex and considered it an impossibility for anyone to learn in only one week. Daniel Tammet was to appear on an Icelandic talk show at the end of his week to discuss his experience in their native tongue. Although he appeared to struggle to begin with, in the last few days his tutor said "He was like a sponge, absorbing all words and grammar at a phenomenal rate". He made his television appearance with great success.


In March of 2004 Daniel had his own surprise, in Oxford, England, he would recite the number Pi to 22,500 decimal places, in public in front of a team of invigilators to verify his accuracy. After just over five hours he had completed this extraordinary memory feat.

OrlandoHis childhood holds a clue to his unbelievable brain. As a small child he suffered a number of severe seizures which were later diagnosed as epilepsy. Ever since this time he has been able to see the patterns in numbers. While this is rare, there are other cases where individuals have suffered injury to the brain only to emerge with a similar startling talent. Orlando Serrill was just 10 years old when he was hit, hard, on the side of the head by a baseball. Since when, he has been able to recall the day, date and weather of every day since the accident.

The scientific community refer to people with these extraordinary memory skills as savants of which there are only a handful in the world. The conditionDaniel as a baby is often associated with autism. Professor Simon Baron-Cohen a Cambridge University neuroscientist describes autism as a mix of ability and disability. However, Daniel displays the ability with no obvious sign of disability. Daniel, as a baby, cried constantly up until the age of two. He could only be soothed by being rocked in a blanket forming a hammock. Soothing by repetitious movement is, according to Prof. Baron-Cohen, indicative of autism. By most measures, Daniel is autistic but he has managed to develop the social skills to blend in.

He said:
"I have always thought of abstract information—numbers, for example—in visual, dynamic form. Numbers assume complex, multidimensional shapes in my head that I manipulate to form the solution to sums or compare when determining whether they are prime or not. For languages, I do something similar in terms of thinking of words as belonging to clusters of meaning so that each piece of vocabulary makes sense according to its place in my mental architecture for that language. In this way, I can easily discern relations between words, which helps me to remember them. In my mind, numbers and words are far more than squiggles of ink on a page. They have form, color, texture, and so on. They come alive to me, which is why as a young child I thought of them as my “friends.” I think this is why my memory is very deep, because the information is not static. I say in my book that I do not crunch numbers (like a computer). Rather I dance with them."

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Thursday, May 28, 2009

Scientific Invalidity of Goji Juice

Scientific Invalidity of the FreeLife GoChi Juice Study.
A Model Critique for Industry
Paul M. Gross, PhD
November 10, 2008

Introduction

Published: Amagase H, Nance DM. A randomized, double-blind, placebo-controlled, clinical study of the general effects of a standardized Lycium barbarum (Goji) Juice, GoChi. Journal of Alternative and Complementary Medicine 2008 May; 14(4):403-12, sponsored by FreeLife International LLC, manufacturers of Himalayan Goji Juice and GoChi Juice. Both authors are affiliated with FreeLife.

This publication reports that daily consumption of 120 ml (4 oz.) of a wolfberry (goji, Lycium barbarum L.) juice blend with grape and pomegranate juices called GoChi Juice (1) has extensive effects on mood, energy, neurological functions and digestion. Publication of the article in a peer-reviewed journal supported by internet headlines and the FreeLife website trumpeting its results (1-3) may induce members of industry and consumers to accept the research.

When critiqued objectively, however, numerous deficiencies are detectable. The FreeLife GoChi Juice study raises general concerns as an example of low scientific quality applied in the design, conduct, interpretation and peer-review of work intended to describe physiological effects of a simple juice blend.

The intent is transparent -- in the masquerade of publication in a journal with questionable editorial practices, this report appears as a brazen marketing implement intended to induce purchases of the GoChi product, potentially persuading consumers in need of therapies to substitute GoChi juice instead of physician-prescribed medicines.

Against a template of federal guidance documents referenced below, this critique is an objective analysis of the GoChi study's unscientific suppositions and exposed weaknesses. The critique serves as vigilance on quality control for the consumer message about superfruit juices, a growing multibillion dollar global market widely influencing consumer dietary choices (4-7).


FreeLife GoChi Juice Study
The main conclusions of the FreeLife study were that consumption of 120 ml (~ 4 ounces) per day of the GoChi juice over a 2 week period caused a general 13-variable benefit summarized by:

1. increased feelings of well-being
2. improved neurological and psychological performance
3. improved gastrointestinal regularity

The FreeLife GoChi study can be tested for its underlying scientific substantiation using publicly available documents prepared by the US Federal Trade Commission (FTC, governs consumer advertising) and Food and Drug Administration (FDA, governs safety of dietary supplements).

Using the FreeLife GoChi study as an example in the superfruit juice industry allows analysis of how significant scientific agreement is an essential foreground of natural products research. The critique will show that FreeLife and the report's authors, Haru Amagese, PhD and Dwight Nance, PhD, ignored these guidelines and exaggerated the importance of both the undeveloped science on goji berries and interpretation of the study results.

Guidance documents for assessing scientific credibility of reports like the FreeLife GoChi study are:

a. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

The Federal Trade Commission enforces laws governing unfair or deceptive advertising acts or practices, attempting to ensure that consumers have accurate information about dietary supplements allowing informed purchase decisions (8).

b. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html

For nutritional supplements like the FreeLife GoChi Juice, the FDA has a role in governing labeling. Combined with the FTC overview on advertising, it is appropriate to reference published regulatory documents to apply scientific scrutiny to the FreeLife GoChi report. Both agencies have the goal to ensure that claims stated or implied to consumers are presented truthfully and have adequate scientific support (9).

c. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html

This document presents the system of scientific standards needed in support of health claim petitions about the relationship between a food like FreeLife GoChi Juice and a disease or health-related condition (10, 11). Although the FreeLife publication was not part of a health claim application, its intent and interpretations address physiological changes subsequent researchers and consumers may expect from regular use of the juice. Examining the basis and interpretations of the study in light of whether it is established in significant scientific agreement provides a template for future research on superfruit juices.


Critique
Scientific substantiation is the backbone for validating concepts for product development and marketing product health claims. It reflects the consensus of expert scientific opinion leading to another benchmark for scientific acceptance -- totality of evidence (9,10).

Although the FreeLife GoChi study was discussed neither as an advertisement nor as a health claim petition, the intent seems obvious -- to assert its findings directly for marketing purposes used identically by FreeLife since the 2003 publication of the goji booklet by Mindell and Handel (12).

Conspicuous from the 13 primary results highlighted in Figure 1 of the report, Amagase and Nance make interpretations of the results indistinguishable from marketing claims for the FreeLife first-generation product, Himalayan Goji Juice (1,12). All these conclusions have no basis of significant scientific agreement (10) and are identical to unsupported marketing statements on the FreeLife website (1).

In recent additions to the FreeLife website, http://corporate.freelife.com/gochi/usa/19reasons.html

6 additional benefits are added, indicating the company's belief of enhanced immune and antioxidant functions from drinking the same dose of GoChi Juice over 30 days.

FreeLife claims the 19 total benefits are physiologically interrelated responses called the “GoChi Effect,” a concept having no basis in science or plausible biological significance.

What is scientific substantiation? It is defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” (8,9)

Reflecting the FTC and FDA guidance documents (8-11), this critique challenges the basis and conclusions of the FreeLife GoChi Juice study with five questions

1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994 (8)?

2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement (10) about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?

3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide early-stage clinical trials (13,14)?

4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?

5. Was the FreeLife GoChi study conducted mainly as a marketing tool in disguise as pseudoscience to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and potentially misleading about actual health benefits to consumers?

The critique will demonstrate that the FreeLife GoChi report misleads consumers to believe there are health benefits from drinking GoChi juice having no plausibility for a beneficial effect.

The six main findings of the 2008 FreeLife GoChi Study, contained in successive paragraphs in the report's Discussion, are listed below. The italicized terms are identical to those listed on page 5 of the 2003 booklet by Mindell and Handel (12) obtained in promotional material from a FreeLife distributor. According to Amagase and Nance, GoChi Juice:

1. increases endurance and energy; reduces fatigue

2. has effects on the brain and neuronal function, produces psychological and neurological effects; has anti-aging properties

3. facilitates recovery of red blood cells, so relates to increased endurance and decreased fatigue

4. may provide benefits to eye health and vision

5. modulates metabolism, improving physical performance and gastrointestinal function; contains polysaccharides, improving regularity

6. has anti-diabetic effects and in vivo antioxidant benefit, reducing blood glucose levels and DNA damage, elevating blood levels of superoxide dismutase, and so is beneficial for treatment of diabetes and metabolic diseases.

Discussion in the Results section of the FreeLife GoChi report indicates the authors examined other potential benefits as postulated in the 2003 booklet by Mindell and Handel (12) -- increases sexual energy, relieves menstrual pain, improves quality of sleep, and increases feelings of happiness among other subjective benefits proclaimed in the 2003 booklet (bold italics indicate use of same benefits emphasized in FreeLife marketing).

None of these supposed effects of drinking GoChi Juice or Himalayan Goji Juice is supportable by current science. All of the investigational questions of the FreeLife GoChi Juice study derived from in vitro studies (published mainly in Chinese and translated only into English abstracts typically insufficient in detail to judge scientific quality), preliminary animal research or fabrications published in the original Mindell and Handel booklet.

For example, the company's long-held position restated in the FreeLife GoChi Juice report that polysaccharides of goji berries (identified in the report as Lycium barbarum polysaccharides or LBPs) are “master molecules” involved generally in human physiology (1,12) has no foundation in science. FreeLife claims itself as pioneer and world leader of goji science, the “driving force for international goji research ... to unlock goji’s secrets for the betterment of mankind,” especially for polysaccharides marketed as the most important ingredient of their two juice products, http://corporate.freelife.com/index.cfm?fuseAction=usa.CID_01_001_06

To this author’s knowledge, FreeLife personnel have never published scientific research on goji polysaccharides or any aspect of the fruit's properties. There also is no independent scientific evidence that goji polysaccharides are unique from any other fruit polysaccharides, nor that they can survive digestion chemically intact or have any biological significance in laboratory animals or humans.

In the Discussion of the FreeLife GoChi Juice report, the authors make leaps of interpretation from in vitro or animal results to conclusions about positive human behavioral outcomes which happen to be consistent with FreeLife marketing literature.

This report and FreeLife's marketing of misinformation would therefore appear to violate the FTC “truth in advertising” law which states (8) http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

“The FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.”

A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment.”

Accordingly, this may suggest that the FreeLife GoChi report and information on the company website represent deception, making “miracle” health claims about drinking GoChi Juice. This in turn could suggest that the publication falls into the category of consumer fraud as reported in (15) http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm

which states, “consumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope. It promises quick cures and easy solutions to a variety of problems, from obesity to cancer and AIDS. But consumers who fall for fraudulent "cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health. Fraudulently marketed health products can keep people from seeking and getting treatment from their own healthcare professional.”

The FreeLife GoChi report needs to be subjected to scrutiny and skepticism, a screen that should have been applied before the project began in its design-planning stage, and especially by the editor and referees of the Journal of Alternative and Complementary Medicine during the article review process, as they are the final doorway to public media.
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Summary of Expected Scientific Substantiation
Scrutiny can be readily applied by the test of “scientific substantiation” of the FreeLife GoChi study as outlined by the FDA (9) using several criteria:

1. meaning of the claim being made
2. relationship of evidence to the claim
3. quality of the evidence
4. totality of the evidence


Scientific substantiation: meaning of the claim. The FTC and FDA guidance documents (8-10) outline that a company, such as FreeLife, proclaiming health benefits from its product must clearly identify each implied and expressed claim, and that each interpretation of benefit must be substantiated scientifically.

From (9): “The firm's clear understanding of the meaning of the claim is useful in ensuring that the evidentiary basis for substantiation is appropriate for the claim. Understanding the claim's meaning will help identify the appropriate study hypotheses and measurable endpoints, which can be used to ensure that the firm has appropriate studies to substantiate the claim. For example, a firm making a claim that a dietary supplement "helps maintain blood vessel tone" or "supports healthy immune system" should have a clear understanding of the claim's meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.”

Assessing the FreeLife report and website information about GoChi juice, it is evident that neither the company nor the authors of the article have an understanding of scientific substantiation, as clear hypotheses and measurable physiological endpoints were not used, or at least have not been identified.

Absent of such rigorous background, consumers seeking information about goji berries or GoChi Juice (1-3) may come to the following conclusions about drinking just 120 ml (~ 4 ounces) of GoChi Juice daily for 2 weeks; also see article Figure 1 and corporate website, http://corporate.freelife.com/gochi/usa/19reasons.html

1. have more energy, less fatigue, more capability for athletic performance
2. feel less stress, more calm, greater feeling of contentment, healthier and happier
3. experience better sleep, easier wake up, better focus and mental acuity
4. have improved gastrointestinal regularity

Based on the FTC truth-in-advertising law (8,15), it can be argued that not one of these benefits purported from taking GoChi juice meets scientific substantiation.

The following challenges about FreeLife's background for these claims can be itemized in bold below from the FDA guidance on scientific substantiation (9)

1. Have the studies specified and measured the exact dietary component of GoChi juice that is the subject of these results? No definitive ingredients list or components actually in the juice were demonstrated. The Nutrition Facts label for GoChi does not show it is anything other than barren of nutrient content (1).

2. Have the studies appropriately specified and measured the nutritional deficiency, structure/function or general well-being that is the subject of the GoChi Juice results? No specifications of nutritional deficiencies in the subjects were identified, and the results of “well-being” were merely subjective and testimonial in nature.

3. Do the results of the GoChi study accurately convey the extent, nature or permanence of the effect achieved and the level of scientific certainty for that effect? None of these study outcomes was satisfied. Weak design, unconvincing results and unscientific explanations create serious doubt that the study could be replicated by independent experts.


Scientific substantiation: relationship of quality and totality of evidence to the claim of benefits from drinking GoChi Juice.

What are the types of evidence that would substantiate the FreeLife GoChi juice claim of beneficial effects?

Although numerous aspects of the FreeLife study design are doubtful, a brief summary of critiques for this study can be drawn from the FDA document on substantiation for dietary supplements (9)

* bias and confounders. Design of the FreeLife GoChi study leaves open numerous weaknesses of experimental design replete with bias and confounders, including additional deficiencies below.

* lack of appropriate randomization and blinding. The subjects and authors were FreeLife employees already with knowledge and experience of the GoChi Juice; therefore, they were vulnerable to selection bias.

* inadequate number of subjects to assure inference to the general population.

* variables affecting reproducibility of the study were not controlled using rigorous selection criteria and independent subjects.

* primary variables concerning the subjects' diets and daily routines were inadequately controlled or explained. For example, food selection was unregulated, complicating nutritional conformity, and many subjects smoked during the study.

* dietary compliance in the protocol was subject to recall error

* the study did not involve a cross-over design and washout period that would have confirmed any true effect.

* the study interpretations are confounded by numerous factors, including the quantity and undefined content of the GoChi Juice ingredients, and other dietary factors that could have accounted for any results apart from those of the GoChi Juice.

Overall, substantial bias and numerous uncontrolled confounders of the FreeLife GoChi study prevent any measured outcomes from being attributed unequivocally to the GoChi juice. Yet the authors were still able to identify 13 benefits now used in a FreeLife promotional video entitled, New Goji Studies Released, http://corporate.freelife.com/gochi/usa/media.html

Consistent with this assessment, other FDA requirements to establish scientific substantiation, such as overall quality and totality of research evidence underlying the project hypothesis to be tested (9), were not met by the FreeLife GoChi study. Quoting the FDA document (9): “the mere fact that the study was published does not necessarily mean that the research was competent and reliable evidence adequate to substantiate a particular claim.”

To list a few among numerous elements of significant scientific agreement (10) missing from the FreeLife GoChi Juice report are

* an insufficient base of science to indicate plausibility of biological actions by the GoChi Juice polysaccharides or any ingredients

* a retrospective observational (testimonial) design, rather than an interventional design, for detecting subject responses

* biomarkers reliable for detecting specific biological responses supporting interpretations used in the Discussion

* research evidence allowing interpretation about a mechanism of action

* specificity of the proposed effects, such as by “dechallenging” the subjects (9)

* efficacy of the proposed effects, such as by using higher doses of the GoChi Juice to evoke greater responses.

By example of recently published FDA guidelines for dietary antioxidants (16,17), attributing GoChi polysaccharides or any other nutrient to the effects observed requires a) evidence the goji bioactives are available in the body, b) a defined mechanism of their biological action, and c) an established Dietary Reference Intake value. Contrary to what one might believe from FreeLife marketing material and the rationale for the GoChi Juice study, none of these qualifiers exists.


Reviewing Challenges to the Authors and FreeLife

1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994?

The study would seem to be a violation of these guidelines and good scientific practice, containing exaggerated statements and absent or misinterpreted science.

2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?

The study fails every qualification for significant scientific agreement, total body of evidence and scientific substantiation (9,10).

3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide clinical trials?

This study, at best, represents preliminary pilot work and therefore bears no resemblance to a well-controlled, expert-designed clinical trial (13,14).

4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?

The final obligation and responsibility to the industry and consumers for publication of such a study rests with the journal, its Editor and Editorial Board (18) who neglected rigorous scientific standards to allow publication of this article.

5. Was the FreeLife GoChi study conducted mainly as a marketing tool to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and misleading for providing actual benefits to consumers?

Given that the conclusions of the FreeLife GoChi Juice report support long-standing marketing statements by the company, one could surmise that the study conclusions were drawn up before the study was conducted. Members of the nutritional supplements industry or public not applying skepticism could be readily misled about the stated health benefits of GoChi Juice.

By consequence, the GoChi report, its authors, and FreeLife International appear vulnerable under the Federal Trade Commission Act which prohibits "unfair or deceptive acts or practices," and "any false advertisement" that is "misleading in a material respect." FDA's authority is embodied in the Federal Food, Drug, and Cosmetic Act which prohibits "labeling [that] is false or misleading in any particular” (13,19). http://www.ftc.gov/bcp/policystmt/ad-food.shtm and http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm


References

1. FreeLife International website, Ingredients of GoChi Juice, FAQ, last item, http://corporate.freelife.com/gochi/usa/faq.html

2. Heller L. Goji berry juice improves energy, happiness -- study. NutraIngredients.com-Europe, July 22, 2008, http://www.nutraingredients.com/Research/Goji-berry-juice-improves-energy-happiness-study

3. Healthy living. Drink goji juice to your health. August, 2008. http://www.napsnet.com/articles/59022.html

4. Soft Drinks International, Focus - Soft drinks makers reap superfruit dividend, February 8, 2008, http://www.fda.gov/cder/guidance/7086fnl.htm

5. Associated Press, Exotic "super fruit" juice spawns $1B nutrition business for one company; experts doubtful, February 12, 2008, http://www.iht.com/articles/ap/2008/02/12/business/NA-FEA-FIN-US-Exotic-Juice-Claims.php

6. Sohn E. Superfruits, super powers? Los Angeles Times, March 10, 2008, http://www.latimes.com/features/health/la-hew-superfruit,0,5060388.story?page=1

7. Halliday J. Superfruits disturb the five-a-day balance, warns Datamonitor, FoodNavigator.com-Europe, August 4, 2008, http://www.foodnavigator.com/Financial-Industry/Superfruits-disturb-the-five-a-day-balance-warns-Datamonitor

8. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

9. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html

10. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html

11. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 1, 1995, Dietary Supplement Health and Education Act of 1994, http://www.cfsan.fda.gov/~dms/dietsupp.html

12. Mindell, E., Handel, R. Goji -- The Himalayan Health Secret, VideoPlus Inc., Momentum Media Health Series, 2003, Lake Dallas, Texas, ISBN 0-9672855-2-6.

13. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies, Pharmacology/Toxicology, January, 2006, http://www.fda.gov/cder/guidance/7086fnl.htm

14. Wikipedia, Clinical trial design, http://en.wikipedia.org/wiki/Clinical_trial#Design

15. US Federal Trade Commission, Facts for Consumers, 'Miracle' Health Claims: Add a Dose of Skepticism, October, 2001, http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm

16. FDA Food Labeling; Nutrient Content Claims; Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/hpotguid.html

17. Heller L. FDA issues guidance on antioxidants, NutraIngredients.com-USA, July 21, 2008, http://www.nutraingredients-usa.com/Regulation/FDA-issues-guidance-on-antioxidants

18. Editor-in-Chief, Journal of Alternative and Complementary Medicine, http://www.liebertpub.com/eboard.aspx?pub_id=26

19. US Federal Trade Commission, Enforcement Policy Statement on Food Advertising, May, 1994, Introduction, paragraph 2, http://www.ftc.gov/bcp/policystmt/ad-food.shtm


Author: Paul M. Gross, PhD in physiology from the University of Glasgow, Scotland, has contributed science-based articles and conference presentations on superfruits since 2006. He is a founding member of the International Berry Health Association based in Oregon and currently sits on the steering committee.

As a scientist and expert on cardiovascular and brain physiology, Dr. Paul has done extensive award-winning, published research on the brain, cardiovascular system, bones and antioxidant drugs. The Karger Foundation of Switzerland recognized his research on brain blood vessels with their 1986 Memorial Award while the Heart and Stroke Foundation of Ontario appointed him as Research Scholar for 1987 -- 1992.

Dr. Paul has published 85 peer-reviewed science reports over a 25-year career in medical research, and co-founded four nutritional supplement or biotechnology companies. He is the senior author of a 2006 book on the goji berry (Lycium barbarum L) entitled Wolfberry: Nature's Bounty of Nutrition and Health (Booksurge Publishing, Amazon.com). Two additional books are underway, both of which are focused in the antioxidant functional foods and phytochemical arena.

Awarded a First Dan black belt in the Korean martial art of Taekwondo at age 53, Dr. Paul maintains a high level of careful nutrition and physical fitness daily.

Dr. Paul is currently a consultant living in Ontario, Canada.



SOURCE: breathe.org


Saturday, May 16, 2009

Goji Juice and Mendell Exposed

GOJI JUICE
A well known product in Hollywood, Canada and up to Asian Countries. Mr. Mendell claims that this Goji Juice can CURE Cancer and all other ailments, and that they will let all the Hospitals be closed - for Goji Juice is the answer for our health. Nice opinion, but further investigation tells us that it's ALL A BIG LIE (with a capital "L"). Even his title as a "DOCTOR" is a big lie. Remember Mr. Mendell is a nutritionist (not a medical doctor). His PhD is in nutrition from an unaccredited university, "meaning his PhD might not be recognised by government employers and other universities."

You may click the following VIDEO Links to download the Video footage done by a Canadian TV Program hosted by the brave Wendy Mesley.

HERE'S THE VIDEO:
Download, Extract with WINRAR and watch with Media Player
LINK 1 * LINK 2 * LINK 3


Excerpts from the Video:

"Thousands of Canadians are drinking a new product made from a 'miraculous berry', that suggests powerful benefits. Wendy Mesley reveals the real deal behind the new craze and travels to Hollywood to pose questions to the Canadian-born nutritional guru involved.

Summary:
Dr Steven Sager looked at many of the studies on the Goji berry. He researches natural health products for cancer treatment at McMaster University, Ontario: "Modern science has not anywhere near proven that the goji berry has any effect on practically any of the ailments that they are claiming it has an effect on. They are extrapolating out of context some laboratory
studies... You have to be quite suspicious that it's really being overhyped." He says that the polysaccharides in Goji could have health benefits but without more human studies there's little proof to back up the hype. He continues, "If you're going to market something and say it
does something and you haven't done the research to show that, then it's basically deceipt ... expensive deceipt for people who are buying it for that particular purpose".

Dr. Earl Mindell is not a medical doctor. His PhD is in nutrition from an unaccredited university,
"meaning his PhD might not be recognised by government employers and other universities."

Dr. Earl Mindell apparently claims his Himalayan Goji Juice product is possibly the most nutritionally dense food on the planet. The CBC's laboratory tests showed this about Himalayan Goji Juice:

~ vitamin C: it has a little more than orange juice
~ beta carotene: undetectable
~ vitamin B & E: barely detectable
~ protein: negligible, almost no protein.

Marketplace reports:
"When it comes to the most basic nutrition this $50 bottle is pretty similar to other juices. The berry might have more nutrition but they're selling juice, not the berry."

Freelife literature and agents claimed that the infamous Memorial Sloan
Kettering Cancer Institute uses goji juice on it's patients. A spokesperson for the Institute states: "They are making false claims. The data do not support the use of this product for cancer patients... No-one here has ever done any research on goji juice or lycium barbarum. And no-one here has ever given or prescribed... either of these substances to any of our patients."

A study by a Dr. Bradlow is often used to imply that goji can prevent
cancer. Marketplace interviewed Dr Bradlow and he was shocked to hear he was being misrepresented. He states: "We never said [goji] prevented cancer. We said it inhibited the growth of cells in a dish... A little dish
like this isn't the same as a person.... There's no justification for
encouraging people to take this as an anti-cancer drug... It's
misrepresentation of the facts."

Bob, a former Goji customer who had bought over $2000 worth of Goji Juice for his father with terminal cancer: "He's (Dr Mindell) affecting someone I really care about... If you're promising people that this juice is going to help fight cancer and then 6 months or a year down the road
somebody dies... that's what bugs me the most... I'd like to punch him!"



Note: The following products have the same concept like GOJI Juice as over-priced fruit juice scams like Xango, Tahitian Noni, Acai, Mona Vie etc.

* * * * *


Scientific Invalidity of the FreeLife GoChi Juice Study.
A Model Critique for Industry
Paul M. Gross, PhD
November 10, 2008

Introduction

Published: Amagase H, Nance DM. A randomized, double-blind, placebo-controlled, clinical study of the general effects of a standardized Lycium barbarum (Goji) Juice, GoChi. Journal of Alternative and Complementary Medicine 2008 May; 14(4):403-12, sponsored by FreeLife International LLC, manufacturers of Himalayan Goji Juice and GoChi Juice. Both authors are affiliated with FreeLife.

This publication reports that daily consumption of 120 ml (4 oz.) of a wolfberry (goji, Lycium barbarum L.) juice blend with grape and pomegranate juices called GoChi Juice (1) has extensive effects on mood, energy, neurological functions and digestion. Publication of the article in a peer-reviewed journal supported by internet headlines and the FreeLife website trumpeting its results (1-3) may induce members of industry and consumers to accept the research.

When critiqued objectively, however, numerous deficiencies are detectable. The FreeLife GoChi Juice study raises general concerns as an example of low scientific quality applied in the design, conduct, interpretation and peer-review of work intended to describe physiological effects of a simple juice blend.

The intent is transparent -- in the masquerade of publication in a journal with questionable editorial practices, this report appears as a brazen marketing implement intended to induce purchases of the GoChi product, potentially persuading consumers in need of therapies to substitute GoChi juice instead of physician-prescribed medicines.

Against a template of federal guidance documents referenced below, this critique is an objective analysis of the GoChi study's unscientific suppositions and exposed weaknesses. The critique serves as vigilance on quality control for the consumer message about superfruit juices, a growing multibillion dollar global market widely influencing consumer dietary choices (4-7).


FreeLife GoChi Juice Study

The main conclusions of the FreeLife study were that consumption of 120 ml (~ 4 ounces) per day of the GoChi juice over a 2 week period caused a general 13-variable benefit summarized by:

1. increased feelings of well-being
2. improved neurological and psychological performance
3. improved gastrointestinal regularity

The FreeLife GoChi study can be tested for its underlying scientific substantiation using publicly available documents prepared by the US Federal Trade Commission (FTC, governs consumer advertising) and Food and Drug Administration (FDA, governs safety of dietary supplements).

Using the FreeLife GoChi study as an example in the superfruit juice industry allows analysis of how significant scientific agreement is an essential foreground of natural products research. The critique will show that FreeLife and the report's authors, Haru Amagese, PhD and Dwight Nance, PhD, ignored these guidelines and exaggerated the importance of both the undeveloped science on goji berries and interpretation of the study results.

Guidance documents for assessing scientific credibility of reports like the FreeLife GoChi study are:

a. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

The Federal Trade Commission enforces laws governing unfair or deceptive advertising acts or practices, attempting to ensure that consumers have accurate information about dietary supplements allowing informed purchase decisions (8).

b. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html

For nutritional supplements like the FreeLife GoChi Juice, the FDA has a role in governing labeling. Combined with the FTC overview on advertising, it is appropriate to reference published regulatory documents to apply scientific scrutiny to the FreeLife GoChi report. Both agencies have the goal to ensure that claims stated or implied to consumers are presented truthfully and have adequate scientific support (9).

c. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html

This document presents the system of scientific standards needed in support of health claim petitions about the relationship between a food like FreeLife GoChi Juice and a disease or health-related condition (10, 11). Although the FreeLife publication was not part of a health claim application, its intent and interpretations address physiological changes subsequent researchers and consumers may expect from regular use of the juice. Examining the basis and interpretations of the study in light of whether it is established in significant scientific agreement provides a template for future research on superfruit juices.


Critique
Scientific substantiation is the backbone for validating concepts for product development and marketing product health claims. It reflects the consensus of expert scientific opinion leading to another benchmark for scientific acceptance -- totality of evidence (9,10).

Although the FreeLife GoChi study was discussed neither as an advertisement nor as a health claim petition, the intent seems obvious -- to assert its findings directly for marketing purposes used identically by FreeLife since the 2003 publication of the goji booklet by Mindell and Handel (12).

Conspicuous from the 13 primary results highlighted in Figure 1 of the report, Amagase and Nance make interpretations of the results indistinguishable from marketing claims for the FreeLife first-generation product, Himalayan Goji Juice (1,12). All these conclusions have no basis of significant scientific agreement (10) and are identical to unsupported marketing statements on the FreeLife website (1).

In recent additions to the FreeLife website, http://corporate.freelife.com/gochi/usa/19reasons.html

6 additional benefits are added, indicating the company's belief of enhanced immune and antioxidant functions from drinking the same dose of GoChi Juice over 30 days.

FreeLife claims the 19 total benefits are physiologically interrelated responses called the “GoChi Effect,” a concept having no basis in science or plausible biological significance.

What is scientific substantiation? It is defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” (8,9)

Reflecting the FTC and FDA guidance documents (8-11), this critique challenges the basis and conclusions of the FreeLife GoChi Juice study with five questions

1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994 (8)?

2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement (10) about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?

3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide early-stage clinical trials (13,14)?

4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?

5. Was the FreeLife GoChi study conducted mainly as a marketing tool in disguise as pseudoscience to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and potentially misleading about actual health benefits to consumers?

The critique will demonstrate that the FreeLife GoChi report misleads consumers to believe there are health benefits from drinking GoChi juice having no plausibility for a beneficial effect.

The six main findings of the 2008 FreeLife GoChi Study, contained in successive paragraphs in the report's Discussion, are listed below. The italicized terms are identical to those listed on page 5 of the 2003 booklet by Mindell and Handel (12) obtained in promotional material from a FreeLife distributor. According to Amagase and Nance, GoChi Juice:

1. increases endurance and energy; reduces fatigue

2. has effects on the brain and neuronal function, produces psychological and neurological effects; has anti-aging properties

3. facilitates recovery of red blood cells, so relates to increased endurance and decreased fatigue

4. may provide benefits to eye health and vision

5. modulates metabolism, improving physical performance and gastrointestinal function; contains polysaccharides, improving regularity

6. has anti-diabetic effects and in vivo antioxidant benefit, reducing blood glucose levels and DNA damage, elevating blood levels of superoxide dismutase, and so is beneficial for treatment of diabetes and metabolic diseases.

Discussion in the Results section of the FreeLife GoChi report indicates the authors examined other potential benefits as postulated in the 2003 booklet by Mindell and Handel (12) -- increases sexual energy, relieves menstrual pain, improves quality of sleep, and increases feelings of happiness among other subjective benefits proclaimed in the 2003 booklet (bold italics indicate use of same benefits emphasized in FreeLife marketing).

None of these supposed effects of drinking GoChi Juice or Himalayan Goji Juice is supportable by current science. All of the investigational questions of the FreeLife GoChi Juice study derived from in vitro studies (published mainly in Chinese and translated only into English abstracts typically insufficient in detail to judge scientific quality), preliminary animal research or fabrications published in the original Mindell and Handel booklet.

For example, the company's long-held position restated in the FreeLife GoChi Juice report that polysaccharides of goji berries (identified in the report as Lycium barbarum polysaccharides or LBPs) are “master molecules” involved generally in human physiology (1,12) has no foundation in science. FreeLife claims itself as pioneer and world leader of goji science, the “driving force for international goji research ... to unlock goji’s secrets for the betterment of mankind,” especially for polysaccharides marketed as the most important ingredient of their two juice products, http://corporate.freelife.com/index.cfm?fuseAction=usa.CID_01_001_06

To this author’s knowledge, FreeLife personnel have never published scientific research on goji polysaccharides or any aspect of the fruit's properties. There also is no independent scientific evidence that goji polysaccharides are unique from any other fruit polysaccharides, nor that they can survive digestion chemically intact or have any biological significance in laboratory animals or humans.

In the Discussion of the FreeLife GoChi Juice report, the authors make leaps of interpretation from in vitro or animal results to conclusions about positive human behavioral outcomes which happen to be consistent with FreeLife marketing literature.

This report and FreeLife's marketing of misinformation would therefore appear to violate the FTC “truth in advertising” law which states (8) http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

“The FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.”

A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment.”

Accordingly, this may suggest that the FreeLife GoChi report and information on the company website represent deception, making “miracle” health claims about drinking GoChi Juice. This in turn could suggest that the publication falls into the category of consumer fraud as reported in (15) http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm

which states, “consumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope. It promises quick cures and easy solutions to a variety of problems, from obesity to cancer and AIDS. But consumers who fall for fraudulent "cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health. Fraudulently marketed health products can keep people from seeking and getting treatment from their own healthcare professional.”

The FreeLife GoChi report needs to be subjected to scrutiny and skepticism, a screen that should have been applied before the project began in its design-planning stage, and especially by the editor and referees of the Journal of Alternative and Complementary Medicine during the article review process, as they are the final doorway to public media.


Summary of Expected Scientific Substantiation

Scrutiny can be readily applied by the test of “scientific substantiation” of the FreeLife GoChi study as outlined by the FDA (9) using several criteria:

1. meaning of the claim being made
2. relationship of evidence to the claim
3. quality of the evidence
4. totality of the evidence


Scientific substantiation: meaning of the claim. The FTC and FDA guidance documents (8-10) outline that a company, such as FreeLife, proclaiming health benefits from its product must clearly identify each implied and expressed claim, and that each interpretation of benefit must be substantiated scientifically.

From (9): “The firm's clear understanding of the meaning of the claim is useful in ensuring that the evidentiary basis for substantiation is appropriate for the claim. Understanding the claim's meaning will help identify the appropriate study hypotheses and measurable endpoints, which can be used to ensure that the firm has appropriate studies to substantiate the claim. For example, a firm making a claim that a dietary supplement "helps maintain blood vessel tone" or "supports healthy immune system" should have a clear understanding of the claim's meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.”

Assessing the FreeLife report and website information about GoChi juice, it is evident that neither the company nor the authors of the article have an understanding of scientific substantiation, as clear hypotheses and measurable physiological endpoints were not used, or at least have not been identified.

Absent of such rigorous background, consumers seeking information about goji berries or GoChi Juice (1-3) may come to the following conclusions about drinking just 120 ml (~ 4 ounces) of GoChi Juice daily for 2 weeks; also see article Figure 1 and corporate website, http://corporate.freelife.com/gochi/usa/19reasons.html

1. have more energy, less fatigue, more capability for athletic performance
2. feel less stress, more calm, greater feeling of contentment, healthier and happier
3. experience better sleep, easier wake up, better focus and mental acuity
4. have improved gastrointestinal regularity

Based on the FTC truth-in-advertising law (8,15), it can be argued that not one of these benefits purported from taking GoChi juice meets scientific substantiation.

The following challenges about FreeLife's background for these claims can be itemized in bold below from the FDA guidance on scientific substantiation (9)

1. Have the studies specified and measured the exact dietary component of GoChi juice that is the subject of these results? No definitive ingredients list or components actually in the juice were demonstrated. The Nutrition Facts label for GoChi does not show it is anything other than barren of nutrient content (1).

2. Have the studies appropriately specified and measured the nutritional deficiency, structure/function or general well-being that is the subject of the GoChi Juice results? No specifications of nutritional deficiencies in the subjects were identified, and the results of “well-being” were merely subjective and testimonial in nature.

3. Do the results of the GoChi study accurately convey the extent, nature or permanence of the effect achieved and the level of scientific certainty for that effect? None of these study outcomes was satisfied. Weak design, unconvincing results and unscientific explanations create serious doubt that the study could be replicated by independent experts.


Scientific substantiation: relationship of quality and totality of evidence to the claim of benefits from drinking GoChi Juice.

What are the types of evidence that would substantiate the FreeLife GoChi juice claim of beneficial effects?

Although numerous aspects of the FreeLife study design are doubtful, a brief summary of critiques for this study can be drawn from the FDA document on substantiation for dietary supplements (9)

* bias and confounders. Design of the FreeLife GoChi study leaves open numerous weaknesses of experimental design replete with bias and confounders, including additional deficiencies below.

* lack of appropriate randomization and blinding. The subjects and authors were FreeLife employees already with knowledge and experience of the GoChi Juice; therefore, they were vulnerable to selection bias.

* inadequate number of subjects to assure inference to the general population.

* variables affecting reproducibility of the study were not controlled using rigorous selection criteria and independent subjects.

* primary variables concerning the subjects' diets and daily routines were inadequately controlled or explained. For example, food selection was unregulated, complicating nutritional conformity, and many subjects smoked during the study.

* dietary compliance in the protocol was subject to recall error

* the study did not involve a cross-over design and washout period that would have confirmed any true effect.

* the study interpretations are confounded by numerous factors, including the quantity and undefined content of the GoChi Juice ingredients, and other dietary factors that could have accounted for any results apart from those of the GoChi Juice.

Overall, substantial bias and numerous uncontrolled confounders of the FreeLife GoChi study prevent any measured outcomes from being attributed unequivocally to the GoChi juice. Yet the authors were still able to identify 13 benefits now used in a FreeLife promotional video entitled, New Goji Studies Released, http://corporate.freelife.com/gochi/usa/media.html

Consistent with this assessment, other FDA requirements to establish scientific substantiation, such as overall quality and totality of research evidence underlying the project hypothesis to be tested (9), were not met by the FreeLife GoChi study. Quoting the FDA document (9): “the mere fact that the study was published does not necessarily mean that the research was competent and reliable evidence adequate to substantiate a particular claim.”

To list a few among numerous elements of significant scientific agreement (10) missing from the FreeLife GoChi Juice report are

* an insufficient base of science to indicate plausibility of biological actions by the GoChi Juice polysaccharides or any ingredients

* a retrospective observational (testimonial) design, rather than an interventional design, for detecting subject responses

* biomarkers reliable for detecting specific biological responses supporting interpretations used in the Discussion

* research evidence allowing interpretation about a mechanism of action

* specificity of the proposed effects, such as by “dechallenging” the subjects (9)

* efficacy of the proposed effects, such as by using higher doses of the GoChi Juice to evoke greater responses.

By example of recently published FDA guidelines for dietary antioxidants (16,17), attributing GoChi polysaccharides or any other nutrient to the effects observed requires a) evidence the goji bioactives are available in the body, b) a defined mechanism of their biological action, and c) an established Dietary Reference Intake value. Contrary to what one might believe from FreeLife marketing material and the rationale for the GoChi Juice study, none of these qualifiers exists.


Reviewing Challenges to the Authors and FreeLife

1. Does the overall study of GoChi Juice effects contain competent and reliable scientific evidence that meets advertising guidance of the FTC and FDA's Dietary Supplement Health Education Act of 1994?

The study would seem to be a violation of these guidelines and good scientific practice, containing exaggerated statements and absent or misinterpreted science.

2. Does the science of the FreeLife GoChi Juice study provide assurance of totality of evidence for significant scientific agreement about the foundation for conducting the study and conclusions regarding nutritional or health properties of goji berries or blended juice?

The study fails every qualification for significant scientific agreement, total body of evidence and scientific substantiation (9,10).

3. Does the FreeLife GoChi Juice study apply acceptable design and implementation qualities of bona fide clinical trials?

This study, at best, represents preliminary pilot work and therefore bears no resemblance to a well-controlled, expert-designed clinical trial (13,14).

4. Did the editor, editorial board and referees for the Journal of Alternative and Complementary Medicine fulfill their obligation to subject the FreeLife GoChi study to rigorous review and high publication standards?

The final obligation and responsibility to the industry and consumers for publication of such a study rests with the journal, its Editor and Editorial Board (18) who neglected rigorous scientific standards to allow publication of this article.

5. Was the FreeLife GoChi study conducted mainly as a marketing tool to confirm long-term promotional statements used by FreeLife? Were conclusions of the study persuasive and misleading for providing actual benefits to consumers?

Given that the conclusions of the FreeLife GoChi Juice report support long-standing marketing statements by the company, one could surmise that the study conclusions were drawn up before the study was conducted. Members of the nutritional supplements industry or public not applying skepticism could be readily misled about the stated health benefits of GoChi Juice.

By consequence, the GoChi report, its authors, and FreeLife International appear vulnerable under the Federal Trade Commission Act which prohibits "unfair or deceptive acts or practices," and "any false advertisement" that is "misleading in a material respect." FDA's authority is embodied in the Federal Food, Drug, and Cosmetic Act which prohibits "labeling [that] is false or misleading in any particular” (13,19). http://www.ftc.gov/bcp/policystmt/ad-food.shtm and http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm


References

1. FreeLife International website, Ingredients of GoChi Juice, FAQ, last item, http://corporate.freelife.com/gochi/usa/faq.html

2. Heller L. Goji berry juice improves energy, happiness -- study. NutraIngredients.com-Europe, July 22, 2008, http://www.nutraingredients.com/Research/Goji-berry-juice-improves-energy-happiness-study

3. Healthy living. Drink goji juice to your health. August, 2008. http://www.napsnet.com/articles/59022.html

4. Soft Drinks International, Focus - Soft drinks makers reap superfruit dividend, February 8, 2008, http://www.fda.gov/cder/guidance/7086fnl.htm

5. Associated Press, Exotic "super fruit" juice spawns $1B nutrition business for one company; experts doubtful, February 12, 2008, http://www.iht.com/articles/ap/2008/02/12/business/NA-FEA-FIN-US-Exotic-Juice-Claims.php

6. Sohn E. Superfruits, super powers? Los Angeles Times, March 10, 2008, http://www.latimes.com/features/health/la-hew-superfruit,0,5060388.story?page=1

7. Halliday J. Superfruits disturb the five-a-day balance, warns Datamonitor, FoodNavigator.com-Europe, August 4, 2008, http://www.foodnavigator.com/Financial-Industry/Superfruits-disturb-the-five-a-day-balance-warns-Datamonitor

8. US Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry, June, 2007, http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm

9. US Food and Drug Administration, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Division of Dockets Management (Docket No. 2004D-0466), November, 2004, http://www.cfsan.fda.gov/~dms/dsclmgui.html

10. US Food and Drug Administration, Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, Division of Dockets Management (Docket No. 99D-5424), December 22, 1999, http://www.cfsan.fda.gov/~dms/ssaguide.html

11. US Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 1, 1995, Dietary Supplement Health and Education Act of 1994, http://www.cfsan.fda.gov/~dms/dietsupp.html

12. Mindell, E., Handel, R. Goji -- The Himalayan Health Secret, VideoPlus Inc., Momentum Media Health Series, 2003, Lake Dallas, Texas, ISBN 0-9672855-2-6.

13. US Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies, Pharmacology/Toxicology, January, 2006, http://www.fda.gov/cder/guidance/7086fnl.htm

14. Wikipedia, Clinical trial design, http://en.wikipedia.org/wiki/Clinical_trial#Design

15. US Federal Trade Commission, Facts for Consumers, 'Miracle' Health Claims: Add a Dose of Skepticism, October, 2001, http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea07.shtm

16. FDA Food Labeling; Nutrient Content Claims; Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods, Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/hpotguid.html

17. Heller L. FDA issues guidance on antioxidants, NutraIngredients.com-USA, July 21, 2008, http://www.nutraingredients-usa.com/Regulation/FDA-issues-guidance-on-antioxidants

18. Editor-in-Chief, Journal of Alternative and Complementary Medicine, http://www.liebertpub.com/eboard.aspx?pub_id=26

19. US Federal Trade Commission, Enforcement Policy Statement on Food Advertising, May, 1994, Introduction, paragraph 2, http://www.ftc.gov/bcp/policystmt/ad-food.shtm


Author: Paul M. Gross, PhD in physiology from the University of Glasgow, Scotland, has contributed science-based articles and conference presentations on superfruits since 2006. He is a founding member of the International Berry Health Association based in Oregon and currently sits on the steering committee.

As a scientist and expert on cardiovascular and brain physiology, Dr. Paul has done extensive award-winning, published research on the brain, cardiovascular system, bones and antioxidant drugs. The Karger Foundation of Switzerland recognized his research on brain blood vessels with their 1986 Memorial Award while the Heart and Stroke Foundation of Ontario appointed him as Research Scholar for 1987 -- 1992.

Dr. Paul has published 85 peer-reviewed science reports over a 25-year career in medical research, and co-founded four nutritional supplement or biotechnology companies. He is the senior author of a 2006 book on the goji berry (Lycium barbarum L) entitled Wolfberry: Nature's Bounty of Nutrition and Health (Booksurge Publishing, Amazon.com). Two additional books are underway, both of which are focused in the antioxidant functional foods and phytochemical arena.

Awarded a First Dan black belt in the Korean martial art of Taekwondo at age 53, Dr. Paul maintains a high level of careful nutrition and physical fitness daily.

Dr. Paul is currently a consultant living in Ontario, Canada.



SOURCE: breathe.org


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