s Pharmedia: Academic Manipulation & the Growth of "Junk Science" | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists

Editorial

From the desk of the editor

Welcome to the July 2014 homepage edition of i2P (Information to Pharmacists) E-Magazine.
At the commencement of 2014 i2P focused on the need for the entire profession of pharmacy and its associated industry supports to undergo a renewal and regeneration.
We are now half-way through this year and it is quite apparent that pharmacy leaders do not yet have a cohesive and clear sense of direction.
Maybe the new initiative by Woolworths to deliver clinical service through young pharmacists and nurses may sharpen their focus.
If not, community pharmacy can look forward to losing a substantial and profitable market share of the clinical services market.
Who would you blame when that happens?
But I have to admit there is some effort, even though the results are but meagre.
In this edition of i2P we focus on the need for research about community pharmacy, the lack of activity from practicing pharmacists and when some research is delivered, a disconnect appears in its interpretation and implementation.

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News Flash

Newsflash Updates for July 2014

Newsflash Updates

Regular weekly updates that supplement the regular monthly homepage edition of i2P. 
Access and click on the title links that are illustrated

Comments: 1

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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

It started with “tablet” computers deployed on shelves inside the retailer Coles, specifically to provide information to consumers relating to pain management and the sale of strong analgesics.
This development was reported in i2P under the title Coles Pharmacy Expansion and the Arid PGA Landscape”
In that article we reported that qualified information was a missing link that had come out of Coles market research as the reason to why it had not succeeded in dominating the pain market.
Of course, Woolworths was working on the same problem at the same time and had come up with a better solution - real people with good information.

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

Editor's Note: The understanding of a pharmacy's presentation through the research that goes into the design of fixtures and fittings that highlight displays, is a never-ending component of pharmacy marketing.
Over the past decade, Australian pharmacy shop presentations have fallen behind in standards of excellence.
It does not take rocket science - you just have to open your eyes.
Recently, our two major supermarkets, Woolworths and Coles, have entered into the field of drug and condition information provision - right into the heartland of Australian Pharmacy.

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The sure way to drive business away

Gerald Quigley

I attended the Pregnancy, Baby and Children’s Expo in Brisbane recently.
What an eye and ear opening event that was!
Young Mums, mature Mums, partners of all ages, grandparents and friends……...many asking about health issues and seeking reassurances that they were doing the right thing.

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

It should be the scandal of the century.
It potentially affects the health of almost everyone.
Healthcare providers and consumers alike should be up in arms. But apart from coverage in a few credible news sources the problem of ‘Marketing Based Medicine,’ as psychiatrist Dr Peter Parry terms it, hasn’t as yet generated the kind of universal outrage one might expect.

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Community Pharmacy Research - Are You Involved?

Mark Coleman

Government funding is always scarce and restricted.
If you are ever going to be a recipient of government funds you will need to fortify any application with evidence.
From a government perspective, this minimises risk.
I must admit that while I see evidence of research projects being managed by the PGA, I rarely see community pharmacists individually and actively engaged in the type of research that would further their own aims and objectives (and survival).

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

Most of us leave a tremendous impact on pharmacies we work for (as proprietors, managers, contractors or employees)—in ways we’re not even aware of.
But organisational memories are often all too short, and without a central way to record that impact and capture the knowledge and individual contributions, they become lost to time.
It is ironic that technology has provided us with phenomenal tools for communication and connection, but much of it has also sped up our work lives and made knowledge and memory at work much more ephemeral.

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Academics on the payroll: the advertising you don't see

Staff Writer

This article was first published in The Conversation and was written by Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney
In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care.
i2P has republished the article as it supports our own independent and ongoing investigations on how drug companies are involved in marketing-based medicine rather than evidence-based medicine.

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

Editor's Note: This is an early article by Mark Neuenschwander we have republished after the soul-searching surrounding a recent Australian dispensing error involving methotrexate.
Hmm. There’s more than one way you could take that, huh? Like Someday when I get around to it (I’m not sure) I may admit that I was wrong about something. Actually, I’ve been thinking about the concept of admitting wrong. So don’t get your hopes up. No juicy confessions this month except that I wish it were easier for me to admit when I have been wrong or made a mistake.
Brian Goldman, an ER physician from Toronto, is host of the award-winning White Coat, Black Art on CBC Radio and slated to deliver the keynote at The unSUMMIT for Bedside Barcoding in Anaheim this May. His TED lecture, entitled, “Doctors make mistakes. Can we talk about it?” had already been viewed by 386,072 others before I watched it last week.

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Dispensing errors – a ripple effect of damage

Kay Dunkley - BPharm, Grad Dip Hosp Pharm, Grad Dip Health Admin, MPS, MSHPA

Most readers will be aware of recent publicity relating to dispensing errors and in particular to deaths caused by methotrexate being incorrectly packed in dose administration aids.
The Pharmacy Board of Australia (PBA), in its Communique of 13 June 2014, described a methotrexate packing error leading to the death of a patient and noted “extra vigilance is required to be exercised by pharmacists with these drugs”.
This same case was reported by A Current Affair (ACA) in its program on Friday 20 June
http://aca.ninemsn.com.au/article/8863098/prescription-drug-warning

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Take a vacation from your vocation

Harvey Mackay

Have you ever had one of those days when all you could think was, “Gosh, do I need a vacation.”
Of course you have – because all work and no play aren’t good for anyone.
A vacation doesn’t have to be two weeks on a tropical island, or even a long weekend at the beach. 
A vacation just means taking a break from your everyday activities. 
A change of pace. 
It doesn’t matter where.
Everyone needs a vacation to rejuvenate mentally and physically. 
But did you also know that you can help boost our economy by taking some days off? 
Call it your personal stimulus package.

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Explainer: what is peer review?

Staff Writer

This article was first published in the Conversation. It caught our eye because "peer review" it is one of the standards for evidence-based medicines that has also been corrupted by global pharma.
The article is republished by i2P as part of its ongoing investigation into scientific fraud and was writtenby Andre Spicer, City University London and Thomas Roulet, University of Oxford
We’ve all heard the phrase “peer review” as giving credence to research and scholarly papers, but what does it actually mean?
How does it work?
Peer review is one of the gold standards of science. It’s a process where scientists (“peers”) evaluate the quality of other scientists' work. By doing this, they aim to ensure the work is rigorous, coherent, uses past research and adds to what we already knew.
Most scientific journals, conferences and grant applications have some sort of peer review system. In most cases it is “double blind” peer review. This means evaluators do not know the author(s), and the author(s) do not know the identity of the evaluators.
The intention behind this system is to ensure evaluation is not biased.
The more prestigious the journal, conference, or grant, the more demanding will be the review process, and the more likely the rejection. This prestige is why these papers tend to be more read and more cited.

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Dentists from the dark side?

Loretta Marron OAM BSc

While dining out with an elderly friend, I noticed that he kept his false tooth plate in his shirt pocket. He had recently had seven amalgam-filled teeth removed, because he believed that their toxins were making him sick; but his new plate was uncomfortable. He had been treated by an 'holistic dentist'. Claiming to offer a "safe and healthier alternative" to conventional dentistry, are they committed to our overall health and wellbeing or are they promoting unjustified fear, unnecessarily extracting teeth and wasting our money?

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Planning for Profit in 2015 – Your key to Business Success

Chris Foster

We are now entering a new financial year and it’s a great time to reflect on last year and highlight those things that went well and those that may have impacted negatively in the pursuit of your goals.
It's also a great to spend some time re-evaluating your personal and business short, medium and long term goals in the light of events over the last year.
The achievement of your goals will in many cases be dependent on setting and aspiring to specific financial targets. It's important that recognise that many of your personal goals will require you to generate sufficient business profits to fund those aspirations

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Attracting and Retaining Great People

Barry Urquhart

Welcome to the new financial year in Australia.
For many in business the past year has been described as a challenging period.
Adjectives are a key feature of the English language.  In the business lexicon their use can be, and often is evocative and stimulate creative images.  But they can also contribute to inexact, emotional perceptions.
Throughout the financial pages of newspapers and business magazines adjectives abound.
References to “hot” money draw attention and comment.  The recent wave of funds from Chinese investors, keen to remove their wealth from the jurisdiction and control of government regulations is creating a potential property bubble in Australia.

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Updating Your Values - Extending Your Culture

Neil Johnston

Pharmacy culture is dormant.
Being comprised of values, unless each value is continually addressed, updated or deleted, entire organisations can stagnate (or entire professions such as the pharmacy profession).
Good values offer a strong sense of security, knowing that if you operate within the boundaries of your values, you will succeed in your endeavours.

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Evidence-based medicine is broken. Why we need data and technology to fix it

Staff Writer

The following article is reprinted from The Conversation and forms up part of our library collection on evidence-based medicines.
At i2P we also believe that the current model of evidence is so fractured it will never be able to be repaired.
All that can happen is that health professionals should independently test and verify through their own investigations what evidence exists to prescribe a medicine of any potency.
Health professionals that have patients (such as pharmacists) are ideally placed to observe and record the efficacy for medicines.
All else should confine their criticisms to their evidence of the actual evidence published.
If there are holes in it then share that evidence with the rest of the world.
Otherwise, do not be in such a hurry to criticise professions that have good experience and judgement to make a good choice on behalf of their patients, simply because good evidence has not caught up with reality.

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Laropiprant is the Bad One; Niacin is/was/will always be the Good One

Staff Writer

Orthomolecular Medicine News Service, July 25, 2014
Laropiprant is the Bad One; Niacin is/was/will always be the Good One
by W. Todd Penberthy, PhD

(OMNS July 25, 2014) Niacin has been used for over 60 years in tens of thousands of patients with tremendously favorable therapeutic benefit (Carlson 2005).
In the first-person NY Times best seller, "8 Weeks to a Cure for Cholesterol," the author describes his journey from being a walking heart attack time bomb to a becoming a healthy individual.
He hails high-dose niacin as the one treatment that did more to correct his poor lipid profile than any other (Kowalski 2001).

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Culture Drive & Pharmacy Renewal

Neil Johnston

Deep within all of us we have a core set of values and beliefs that create the standards of behaviour that we align with when we set a particular direction in life.
Directions may change many times over a lifetime, but with life experiences and maturity values may increase in number or gain greater depth.
All of this is embraced under one word – “culture”.
When a business is born it will only develop if it has a sound culture, and the values that comprise that culture are initially inherent in the business founder.
A sound business culture equates to a successful business and that success is often expressed in the term “goodwill” which can be eventually translated to a dollar value.

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Pharmacy 2014 - Pharmacy Management Conference

Neil Johnston

The brave new world of health and wellness is not the enemy of Pharmacy, it is its champion.
Australian futurist, Morris Miselowski, one of the world's leading business visionaries, will present the Opening Keynote address on Pharmacy's Future in the new Health and Wellness Landscape at 2.00pm on Wednesday July 30.
Morris believes the key to better health care could already be in your pocket, with doctors soon set to prescribe iPhone apps, instead of pills.
Technology will revolutionise the health industry - a paradigm shift from healthcare to personal wellness.
Health and wellness applications on smartphones are already big news, and are dramatically changing the way we manage our personal health and everyday wellness.

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Generation and Application of Community Pharmacy Research

Neil Johnston

Editor’s Note: We have had a number of articles in this issue relating to pharmacy research.
The PGA has conducted a number of research initiatives over the years, including one recently reported in Pharmacy News that resulted from an analysis of the QCPP Patient Questionnaire.
Pharmacy Guild president, George Tambassis, appears to have authored the article following, and there also appears to be a disconnect between the survey report and its target audience illustrated by one of the respondent comments published.
I have asked Mark Coleman to follow through, elaborate and comment:

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Pharmedia: Academic Manipulation & the Growth of "Junk Science"

Neil Johnston

articles by this author...

Introducing current ideas, perspectives and issues, to the profession of pharmacy

Editor"s Note: Global Pharma has an unusual and pervasive influence on politicians, regulators and statutory bodies around the globe.
I’ve always had a philosophy of recognising that when things do not go as they are supposed to, first look at the surrounding politics and then follow the money trail.
In the US the main regulator for drug registration and marketing is the Food and Drug Administration (FDA) which has come under greater scrutiny by industry commentators because of seemingly corrupt and improper decisions increasingly made in favour of drug manufacturers.

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The FDA makes its income from fees charged to the Drug Industry to licence their drugs to market. What has happened since this process first started is that licence fees now accord FDA officials with a lifestyle equating to the rich and famous – a lifestyle that once entered into creates a culture of greed that soon dominates all decision-making.

The same problems beget a sister-organisation, the Centre for Disease Prevention (CDC) that is involved with vaccine licencing and the management /prevention of epidemics/pandemics.

Extraordinarily, vaccine manufacturers are given a greater latitude in respect of the safety profile for each vaccine, with government virtually providing immunity for manufacturers in the case of a severe adverse reaction.

In other words, they are exempt from full safety requirements that can (and do) lead to severe patient damage.

From a Big Pharma perspective, having complementary medicines being treated exactly as regular medicines despite, many being virtually foods or food components, creates a cost to complementary medicine manufacturers they may not be able to justify, resulting in a selling price that moves those medicines to a new threshold. This means that access to consumers becomes more limited.

By driving complementary medicines into a strict regulatory regime, Big Pharma appears to exert more control over the marketing, cost inputs and selling prices (and even the studies developing evidence to support any claims made on its behalf).

Given that the research i2P put in this month for how evidence for medicines is derived and its ability to be manipulated, we asked Mark Coleman for his thoughts on the vitamin E issue that has created recent controversy for the claims that vitamin E increases the risk of cancer.
We follow the evidence trail and an abstract for the contentious study appears below and Mark's comment follow on again.

JAMA. 2011;306(14):1549-1556. doi: 10.1001/jama.2011.1437

J. Michael Gaziano, MD, MPH;

Daniel D. Karp, MD;

Michael M. Lieber, MD;

Philip J. Walther, MD, PhD;

Laurence Klotz, MD;

J. Kellogg Parsons, MD, MHS;

Joseph L. Chin, MD;

Amy K. Darke, MS;

Scott M. Lippman, MD;

Gary E. Goodman, MD;

Frank L. Meyskens, Jr, MD;

Laurence H. Baker, DO

Abstract

Context The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically non-significant increase in prostate cancer risk with vitamin E. Longer follow-up and more prostate cancer events provide further insight into the relationship of vitamin E and prostate cancer.

Objective To determine the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men.

Design, Setting, and Participants A total of 35 533 men from 427 study sites in the United States, Canada, and Puerto Rico were randomized between August 22, 2001, and June 24, 2004. Eligibility criteria included a prostate-specific antigen (PSA) of 4.0 ng/mL or less, a digital rectal examination not suspicious for prostate cancer, and age 50 years or older for black men and 55 years or older for all others. The primary analysis included 34 887 men who were randomly assigned to 1 of 4 treatment groups: 8752 to receive selenium; 8737, vitamin E; 8702, both agents, and 8696, placebo. Analysis reflects the final data collected by the study sites on their participants through July 5, 2011.

Interventions Oral selenium (200 μg/d from L-selenomethionine) with matched vitamin E placebo, vitamin E (400 IU/d of all rac-α-tocopheryl acetate) with matched selenium placebo, both agents, or both matched placebos for a planned follow-up of a minimum of 7 and maximum of 12 years.

Main Outcome Measures Prostate cancer incidence.

Results This report includes 54 464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008); as did 575 in the selenium group (HR, 1.09; 99% CI, 0.93-1.27; P = .18), and 555 in the selenium plus vitamin E group (HR, 1.05; 99% CI, 0.89-1.22, P = .46). Compared with placebo, the absolute increase in risk of prostate cancer per 1000 person-years was 1.6 for vitamin E, 0.8 for selenium, and 0.4 for the combination.

Conclusion Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.

Trial Registration Clinicaltrials.gov Identifier: NCT00006392

 Mark Coleman

Well, the editor certainly throws a diverse range of problems in my direction to develop potential solutions for. This time he did help out by giving me a sneak preview to two articles appearing in this edition of i2P (“Truth in Medicine-Weighing the Evidence” A TGA-Managed Database of Fully Evaluated Complementary Medicines Evidence – a Real Possibility” ), and that assisted greatly.

 What we see here is a study appearing in a very reputable journal (the Journal of the American Medical Association) that does not appear to have been designed to show a fair result.
In fact the design could never deliver other than a sub-optimal result.

The initial report of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) found, in 2009, "no reduction in risk of prostate cancer with either selenium or vitamin E supplements but a statistically non-significant increase in prostate cancer risk with vitamin E."

Then comes the recently released update, which allegedly shows that high doses—400 IU's a day or more—of vitamin E may increase your risk of prostate cancer by 17 percent.

The clue to the flaws in all these vitamin E trials, lies in the form of vitamin E used in the study - all rac-α-tocopheryl acetate -a synthetic petrochemically-derived form of dl-alpha tocopherol, which has known toxic effects.

Why would you use such a substance when it is known not to have health benefits?

And why would journalists (who should know better through their own research) and the original researchers (who are all physicians) publish results that give a distorted perspective?

Advertising revenues from Big Pharma may account for journalistic bias, and Big Pharma pursuit of (to them) a relatively trivial market, may derive from diminished revenue occurring through loss of patent protection on some of their “block buster” drugs. This might have just provided the incentive, in an effort to stem potential revenue leaks no matter how distorted the thinking.
Big Pharma feels under siege with nowhere to go-all the old marketing and research methods are just not producing the results of old.

In nature, vitamin E occurs as a mixture of at least five isomers (alpha through to gamma), with the alpha and gamma forms demonstrating the most biological impact – and different impacts at that.

Synthesised versions of vitamin E simply do not have the same biological effects as the naturally occurring mixtures.

An understanding of the mechanism of the various isomers was published recently in an article by Life Extension:

"In 1997, we announced that taking only the alpha tocopherol form of vitamin E displaces critically important gamma tocopherol in the body. By displacing gamma tocopherol, we feared that high doses of alpha tocopherol could increase cancer risks.

In fact, three years after Life Extension's first warning, the Johns Hopkins School of Public Health released the results of a huge study (10,456 men). The findings showed that men with the highest gamma tocopherol blood levels had a fivefold reduction in prostate cancer risk. This same study showed that selenium and alpha tocopherol also reduced prostate cancer risk but only when gamma tocopherol levels were high. Confirmatory studies document higher levels of gamma tocopherol to be strongly associated with reduced cancer risks.

While both alpha and gamma tocopherols are potent antioxidants, gamma tocopherol has a unique function. Because of its different chemical structure, gamma tocopherol scavenges reactive nitrogen species, which can damage proteins, lipids, and DNA.

… The fact that supplementation with isolated, synthetic alpha tocopherol depletes plasma gamma tocopherol levels means that the researchers who designed the SELECT trial created a biological catastrophe… The fact that higher prostate cancer rates were observed in the group overloaded with synthetic alpha tocopherol in the SELECT trial was predictable and expected based upon fundamental facts Life Extension understood more than a decade ago."

So there you have it.

The role of selenium and vitamin E and their effect on prostate cancer, has been known for over a decade.

Why then was it necessary to produce a contrived trial to disprove facts already established, particularly as the trial was built on the hypothesis that vitamin E and selenium caused higher rates of cancer?

More links relating to this issue can be found here.

The timing of the media hype over this and other flawed studies conveniently coincides with the FDA’s plan to amend the definitions for new dietary ingredients (NDI's) and proposed legislation, (S.1310: Dietary Supplement Labelling Act of 2011), which treats vitamins as if they’re drugs.

Misleading press releases planted within global media publications has ensured a wide coverage that has already been picked up within Australia, without testing the basis for the information provided.
And similar orchestrated calls are being made here in Australia.

More insidiously (and another risk factor) for vitamin E supplements and foods fortified with vitamin E, relates to the fact that it may be derived from genetically modified (GM) plants.

Tocopherol can be produced either by chemical synthesis, or by extraction from:

* Maize

* Soy beans

* Cotton seed

* Rice

* Wheat germ oil

The problem is that a large majority of these plants are now genetically modified—at least in the U.S, but gradually increasing their presence in Australia. In Europe, foods and supplements containing GM-derived vitamin E must be labelled as such. The U.S. however, does not require genetically modified foods and products to be labelled, so there's no telling what you're getting.
GM foods are already producing a range of allergies unknown with the original unmodified molecules.

In Australia, it’s also a “hit and miss” arrangement with labelling of GM products being disguised through the use of code numbers or other vague terminology, or not labelled at all.

Clearly, consumers around the world to not want unproven and unnecessary GM products in their food or their medicine. Yet it happens without any real requirement to prove safety!
Talk about double standards!

Unfortunately, verifying the non-GM status of tocopherols is particularly challenging as many companies that control the supply of vitamin E collect plant oils from pooled sources. 

This is a serious concern for future human health because the GM industry (often associated with the drug industry) uses contamination of crops as a means of denaturing the organic food industry or as a means of confounding the benefits of truly natural materials sourced for complementary medicines use.

Moreover, governments from in all forms (including Australia) seemingly appear blind to the introduction of all this unnatural GM material that is appearing in the Australian marketplace without rigorous scrutiny and without full information to unsuspecting consumers.

The physician study pertaining to vitamin E appears to be junk science at best.

Also, another recent vitamin and mineral study associated a higher death rate in elderly women with taking supplements of those substances.

Because it included vitamin E I have included a link here, but only to demonstrate how data was massaged to fit a preconceived conclusion, as happened for the physician’s trial above for vitamin E/selenium.

It is fairly obvious that integrity is severely lacking in the pharmaceutical industry as a whole and that ethical standards are in a steep decline.

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