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Welcome to the May 2012 homepage edition of i2P-Information to Pharmacists. Rollo Manning has been having some time out having staples removed from the site of his open heart surgery.He is now at home recuperating in Darwin, having arrived home last Friday, beating a cold and hasty retreat from Canberra.We all wish him a speedy recovery and hopefully, he will be fit enough to contribute by next month.
This month, Pharmedia discusses the toll that is taken when someone complains about you to an authority without good cause. Well, the good news is that you can now take action to protect yourself if such a complaint is made, and that may even include action for defamation. Read about a recent case involving two doctors, with Mark Coleman drawing on personal experience to illustrate.

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

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	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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