Dr Byers, supplements and increased cancer risk – Same turgid old stuff.

It seems every five years or so, someone is appointed to jump up and warn us all about Vitamin Supplements and their dangers.

This time Dr Byers got the short straw.

The problem is that we’ve heard it all before, the same research, the same generalisations – and we know the answer.

Out comes the same one-off research study (following an indicative study) on beta-carotene and smoking. Then there is research on vitamin E which has little benefit and may even do harm.

Neither supplement would I touch anyway. Both mass market supplements in the main are deficient, synthetic copies of the real thing. In nature beta-carotene is available in cis- and trans- forms, but only one is used in the common supplement. Vitamin E is worse. Most studies involve synthetic alpha-tocopherol, just one of the eight variants found in nature. In my book it should not even be called vitamin E (it’s fraud).

Synthetic vitamins, for me, carry the same basic risks as synthetic drugs. Natural vitamin E is easy to come by. Put out a bowl of nuts and seeds – a handful of sunflower and pumpkin seeds will give you the four tocotrienol vitamin Es – shown to be much better than tocopherol in fighting cancer anyway.

Folate supplementation is, quite possibly, a threat to all these highly profitable cholesterol-lowering statin drugs, which are under soooo much pressure at the moment from leading heart specialists. They have been linked to a range of secondary illnesses from diabetes to eye sight problems; and research is now questioning whether they do lower death rates from heart attacks and strokes.

Folate, again, is a vitamin you should get from your diet – eat your greens!!!! If you are short you are in trouble. If you have a healthy microbiome (gut bacteria) and eat properly you will be fine; too much you might be in trouble. It has an RDA in ‘micrograms’ for that reason.

But what I love is the way the ‘research’ extrapolates a study on synthetic beta-carotene and smoking to warn the listeners on supplements in general. It would be like me saying that since one drug, Vioxx, killed 48,000 Americans and is now banned, people should be careful when using any drugs because their benefits are questionable and there is clear evidence of significant risks.

Mass market vitamin supplements have limited benefits, although Centrum produced a study a couple of years back showing their multivitamin reduced cancer risk by 7 per cent – this would extrapolate to 22,000 less people with cancer in the UK alone next year. In 2003, the French produced the Su Vi Max study which had followed 17,000 people on selenium and zinc, vitamins E and C and beta-carotene – that showed 31% fewer male cancers (but little change for women); and 37% less deaths overall from cancer over the study period.

I am much more interested in bioactive natural compounds such as vitamin D, curcumin, fish oils, sulforaphanes, CLA, MCP and another 60 with Epigenetic benefits. Now they are interesting. Even Dr Young S. Kim of the NCI in her research on foods that could stop cancer stem cells re-growing, said these could be taken as quality supplements.

Ok. It’s diary time. Which doctor, or preferably professor wants to author this same study on the risks of supplements in 2020?

I’ll have this Junk Science article ready to re-run then too.

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Now lemons beat cancer

People come up to me (usually the moment I have finished a speech) and ask if I have heard about B-17, Shark Cartilage; Coral Calcium as a ‘cancer cure’. I sigh.

Recently I have received more than 20 copies of an e mail doing the rounds. It’s about lemons. It suggests that eating whole lemons is a cancer cure – all you have to do is freeze them and then you can eat them as some sort of delicacy. Job done. Now, it is true that lemon skins contain limonene (not mentioned in the article) and that does have an effect in research on cancers. It is a natural oil that seems to be able to detoxify the liver and parts of the intestine from certain carcinogens and animal studies show an effect with mammary tumours. And lemons are very alkalising and research shows alkaline bodies tend to stop metastases while acid bodies promote it. But eating a frozen lemon to cure a cancer? Oh dear.

I know of no single compound – drug, natural compound, vitamin, whatever – that is a cancer cure. If you push me I can think of a couple of treatments with potential for solid tumours like ablatherm; and I can think of some natural compounds like vitamin D and curcumin that can play an important part in an integrated treatment programme (which might include a drug or surgery too).

I find research; and it (via links to over 100 cancer centres around the world) finds me.

So let’s start:

Coral calcium: Your body does need calcium. If you have polyps in your intestine it seems to help reduce the risk of them becoming cancerous.
There is research showing that mass market calcium supplements can increase heart problems (see www.canceractive.com) but then I detest high street cheap supplements – they are usually synthetic, often deficient and poorly absorbed.

Which takes me to Coral Calcium. There is no research that I have come across that says it cures or helps cure cancer. Its proponents normally provide half a dozen pieces of random information and try to join the dots. Yes. Okinawans live a long time and much of this has been scientifically linked to calorie restriction and a diet high in natural minerals (they probably came late to mobile phones, EMF’s, and environmental toxins too). Some salts (rather than the refined table salt or sea salt) contain not just sodium chloride but up to 20 per cent as other minerals (like calcium, magnesium and other salts). All are essential to our health and, yes, research shows the general population to be deficient.

Then there’s the acid body argument. Let’s be clear. A normal healthy body is slightly alkaline. If it becomes slightly acid, if its oxygen levels are lowered, there will be a health risk. But just taking coral calcium is not going to change that dramatically. Inside the centre of a tumour the pH is about 6.2 caused by the inefficient energy production process. Research has shown that in more acidic conditions there is more metastases and the metastases tend to form new cancers more. Could coral calcium help? Possibly as a part of a total package of activities to correct your acid body, Yes. But is it a cure for cancer, No. There is also no research that shows lobbing in supplements or minerals on their own can alkalise the body sufficiently to stop the cancer reaction centre inside the tumour, although there are some clinical trials about to start with sodium bicarbonate.

So, is coral calcium a cure for cancer? No. It could play a small part in a much, much greater integrated package if you had a body deficient in calcium, and minerals in general, and you were acidic.

B-17: Let’s get a few things straight. There is research on B-17, but not much, and mostly with animals. And there are no phase III clinical trials; but then there aren’t for chemotherapy treatments for the under 12s, cyberknife or brachytherapy for breast cancer, but that doesn’t seem to stop orthodox medicine men using them.

Krebs did a research study claiming it cured people, which he presented to the Senate, but they were unimpressed. I know there are conspiracy theories over this and the Sloan-Kettering Trial.

Krebs called it a vitamin, but that’s debatable.

I have looked into B-17 in some depth. I have also spent a long time talking to people who use it, notably Contreras at the Oasis of Hope.

The biochemical logic is reasonably sound, that an enzyme unique to cancer cells (glucosidase) breaks down the molecule of B-17 to benzaldehyde and cyanide which promptly kills the cell. Looking for unique proteins and enzymes in a cancer cell is exactly what drug companies are doing right now.

The skeptic mantra (as trundled out by the fictitious Josephine Jones) of ‘it contains cyanide and kills people’ is ignorant. Run away, if someone says that to you. Many natural compounds could be equally said to contain cyanide in the plant world if you use their duff science. And we need these compounds for our health. Contreras has never heard of anyone dying of cyanide poisoning from B-17.

The other Skeptic point of ignorance is that none of them (the fictitious Josephine Jones and troll Guy Chapman) seems to have sufficient science knowledge to distinguish between natural B-17 (amygdalin) and synthetic (laetrile). The fact is that, correctly, the FDA has refused to pass/banned laetrile for general use because it is synthetic and is thus a drug. It ain’t got any research to support it, so it can’t be approved. Full stop.

The natural compound is called amygdalin. I have talked to loads of people who eat apricot kernels – I take 6 a day with my breakfast. We need nitrilosides in our diet. And there is some very general evidence that they are helpful.

Contreras uses B-17 but as a part of a ‘Metabolic Therapy’ package. This is a bit like chucking the alternative therapy kitchen sink at a cancer, and can include B-17, Intravenous vitamin C, pancreatic enzymes, oxygen therapy and more. Which bit works (there is little doubt that they do have satisfied customers) – no one seems to know! But Contreras himself says that B-17 has no effect with brain tumours, liver cancer or sarcomas.

I have had grown men come up to me who were visibly yellow/grey – they were trying to consume 50 apricot kernels for breakfast as they had prostate cancers. The problem is that you need a healthy liver to detoxify the by-products of B-17 and cancer patients don’t have a healthy liver. Also Nutrition Almanac recommends no more than 35 a day, nor 5/6 in a 90 minute period.

So does B-17 cure cancer? No sorry. No evidence to support it at all. Could it play a role in your anti-cancer programme? Yes, a small role but be very, very careful. Heed the Nutrition Almanac advice and have someone qualified watch over you.

Shark Cartilage: There was research done using a ground concentrate of shark cartilage that showed some evidence of preventing blood supplies forming in cancer tumours. BUT. The guy who did the research had a TV documentary made on his work, and this prompted a hundred supplement companies to turn out shark cartilage tablets. But ‘Sharks don’t get cancer’ – who says? And they don’t use toxic toothpaste and carry mobile phones either.

One report I read was that, if the shark cartilage was ground to the original standards, you would anyway have to consume three bottles or more of the pills a day just to come close to the original research. And anyway, it could be the calcium levels in the cartilage. Didn’t that shark just swim past some coral?

The American Cancer Society States: One shark cartilage product, called AE-941, was studied as an investigational new drug. Although some laboratory and animal studies have shown that some components in shark cartilage have the ability to slow the growth of new blood vessels, these effects have not been proven in humans. The clinical studies of shark cartilage products published to date have not proven any benefit against cancer.
I could talk about zeolite, vitamin C, and acai berries but I’d get bored. And so would you.

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Fish oils claimed to beat breast cancer drug for effectiveness

The omega-3 essential fatty acid known as docosahexaenoic acid (DHA) is more effective at reducing the size of breast cancer tumours than the chemotherapy drug cisplatin, and can also reduce that drug’s harmful side effects, reports a new study published in the journal Cell Division. However, readers should not jump up and down in excitement quite yet in our view: The research was done on mice not humans: The lead researcher A.M. El-Mowafy of Egypt’s Mansoura University claimed, “Our results suggest a new, fruitful drug regimen in the management of solid tumours based on combining cisplatin and possibly other chemotherapeutics with DHA. DHA elicited prominent chemo-preventative effects on its own, and appreciably augmented those of cisplatin as well. Furthermore, this study is the first to reveal that DHA can obliterate lethal cisplatin-induced nephrotoxicity (kidney damage and renal tissue injury).” In animals who received 125 milligrams per kilogram of DHA, tumour growth was 38 percent less than in animals who received a placebo. Animals receiving cisplatin had 55 percent less tumour growth, while those treated with 250 milligrams per kilogram of DHA had 79 percent less. The combination of DHA and cisplatin not only reduced tumour growth by 81 percent compared with a placebo, it also returned white blood cell counts to normal levels. The 250 milligram per kilogram dose of DHA was nearly as effective at restoring a normal white blood cell count as the DHA-cisplatin combination. It is up to you to make your own mind up. (Source: Natural News)





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In the same week that the MHRA has advised that parents and carers should not give oral echinacea to the under 12s, a government study has found that at least a third of all drugs given to the same age group have never been through clinical trials for children, nor are they approved or licensed for anything other than adult use.

It seems like only a couple of weeks ago GSK was being fined in America for kids using its unapproved drugs. So are the UK Government going to take action?

Not quite yet. The Department of Health report, ‘written by leading child health experts’ is calling for an investigation by the drugs’ watchdog (the Medicines and Healthcare products Regulatory Agency). Could this be the same MHRA?

Believe it or not, prior to 2007, drugs companies had no obligation to test medicines on children!

New drugs must now be tested on kids before being licensed but drugs already out there? Don’t be silly.

So the EU and MHRA effectively ban echinacea ‘due to the possible risk of rare allergic reactions in under 12s’, but 30 per cent of all drugs given to under 18s, and 95 per cent of all drugs given to babies in intensive care haver NEVER been tested on children.

Is there any chance of a ‘rare allergic reaction’ from any or all of these adult drugs used on a three day old baby? The list would include painkillers, antibiotics, asthma inhalers and even, yes you’ve guessed it, those perfectly safe cancer drugs, that have never been known to cause a side-effect even in an adult.

In a statement which sounded dangerously like it had been borrowed from a herbalist or a vitamin salesman, Warren Lenny, a professor of respiratory child health was quoted in the press as saying ‘By no means are we using dangerous medicines. If a medicine has been on the market for 30 years, no company is going to spend millions of pounds testing it on children.’ However, he went on to say that it has been shown that using an unlicensed drug on children does indeed increase the risk of side-effects.

Another Professor, Ian Lewis of Alder Hey Children’s NHS Trust, sounded even more like a herbalist when he said, ‘Most of the drugs we use in Children’s cancer like leukaemia have not been formally tested in children but have cured many of them’.

Apparently, we are going to get a formal response from the Dept of Health later this year.

The world is becoming a very weird place.

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Niacin outperforms heart drug

Cholesterol beating drugs are all the rage. Statins are routinely dished out to reduce heart attack risk blah, blah. There have even been claims that statins reduce lung cancer risk – subsequently shown to be false. Now, with more than a hint of embarrassment, Clinical Trials have been halted in the USA because an anti-cholesterol drug, was outperformed by a B vitamin, niacin.

The study published in the New England Journal of Medicine showed that niacin out-performed Merck´s drug Zetia for preventing the build-up of arterial plaque, a symptom of cardiovascular disease. Patients taking niacin showed a “significant shrinkage” in artery wall thickness, while those on Zetia showed no such improvement. The rate of ‘cardiovascular events’ (that’s heart attacks to you and me) in the niacin group was only one-fifth that in the Zetia group.

Leave the drugs behind; eat whole grains. Natural Compounds are best!



http://www.canceractive.com/cancer-active-page-link.aspx?n=3206&Title=The Safety of Viamins Versus drugs



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Prevent Alzheimer’s for 10 pence a day. It’s just 6 sents.

In a recent survey in Britain, the fear of developing Alzheimer’s overtook the fear of developing cancer for the first time. This increased fear is a direct consequence of many more stories in the media, and even movies about Alzheimer’s. Most people also know someone who has, or has died from, Alzheimer’s and know it’s not a pretty sight. It’s extremely worrying, in fact. We are living longer and the odds of developing dementia in your 80s, most of which is Alzheimer’s anyway, are one in five. (Dementia is diagnosed on the basis of symptoms – losing your memory etc; Alzheimer’s is diagnosed with a brain scan showing brain shrinkage in certain key areas.)

With an ever-ageing population, at least in the Western world, one in five is a lot of people. Already the cost of looking after people with Alzheimer’s, estimated at £23 billion and growing, is more than the cost of all cancer and heart disease combined. These levels of ever increasing healthcare costs are giving health regulators and economists sleepless nights.

The 10p-a-day vitamin supplement that tackles dementia

With these kind of costs and massive public concern there’s potentially big bucks to be made if you could come up with a drug that prevents Alzheimer’s. It already exists – except it’s not a drug. It’s a combination of inexpensive B vitamins that might cost you 10p a day.

The discovery, made by Professor David Smith and his team at Oxford University is that raised blood levels of homocysteine can predict Alzheimer’s risk, can cause the damage in the brain and, most importantly, can be lowered with high doses of B vitamins, well beyond the RDA, simultaneously stopping further memory loss or accelerated brain shrinkage, precisely in that area of the brain that is the hallmark of Alzheimer’s. It’s a major discovery but there’s no money in this for the big guys.

Innocently, you might think that health officials would be swinging from the rooftops to get any genuine prevention plan into action. The cost savings would be immense. I asked Professor David Smith what needs to be done. He replied, “Although we proved that those people with raised homocysteine levels above 10 (which is about three quarters of all people over age 70) suffering from mild cognitive impairment (MCI) can have substantially reduced brain shrinkage and memory loss by taking B vitamins, the next step needed is a trial of 1,000 people with MCI to see if B vitamins prevent the conversion to dementia over a two-year period. Can AD be beaten? I am optimistic.”

Why are we wasting billions?

But he can’t get the money.

Despite David Cameron, the UK prime minister, doubling spend on Alzheimer’s research, neither the UK Medical Research Council nor the US National Institutes for health will put up the money to prove, once and for all, this incredibly important discovery. Instead, it’s more money for drugs.

The whole political and healthcare system is so tied up with the pharmaceutical industry that any talk about an approach that threatens the massive potential drug market is going to be actively suppressed. It’s the same old story. They want a patentable, profitable drug.

There’s just one problem. And it is a major problem: None of the drug trials has worked. Vast sums of money have been wasted.

In 2010 there was an article in the Lancet headed ‘Why are drug trials in Alzheimer’s disease failing?’ David Smith wrote in saying “You suggest several reasons why trials in Alzheimer’s disease are failing but you do not consider an obvious one: That the hypothesis on which most Alzheimer’s trials are based might not be valid. If a scientist does several experiments on the basis of a hypothesis and they all fail, he will abandon the hypothesis. Why are we so reluctant to do this in medicine?’

So, how much is enough, when it comes to B vitamins

Despite over 70 studies all confirming the homocysteine memory loss connection, it is extraordinary (or to be expected depending how you look at it) how much this breakthrough is being ignored. See the evidence [link to www.foodforthebrain.org/hcyevidence] The solution is as simple as increasing your intake of B vitamins.

But be clear: We are not talking about a ‘well balanced diet’ level of B vitamins. The levels of B vitamins that have been proven to both lower homocysteine and stop this accelerated brain shrinkage and memory loss are up to a hundred times higher that the basic RDAs. You need 20mg of B6 (the RDA is 2mg), 800mcg of folic acid (the RDA is 200mcg) and 500mcg of B12 (the RDA is 1mcg/2.4mcg in the US). The reason for the need for these high amounts, especially for B12 is that the older you get the less well you absorb it from your foods.

Here are a few of the factors known to increase your need for B vitamins and/or to raise dangerous homocysteine levels:

• Coffee

• Lack of exercise

• Lack of vegetables

• Lack of fish and eggs

• Diabetes drugs (metformin)

• Antacid drugs (PPIs)

• Stress

• Smoking

Of course, the majority of people over 50 will tick at least half these boxes. This is why it is essential to supplement more B vitamins as you get older, as well as improving your diet and lifestyle.

Early screening is essential

In an enlightened health care system we would be testing everyone over 50 for early signs of cognitive decline, and if positive, checking for raised homocysteine. If that was above 10mcmol/l, which is the level above which there is clear evidence of accelerated brain shrinkage, we would be prescribing high dose B vitamins.

How long, in reality, will it take for this to happen?

If it takes 10 years, with 18,000 people in the UK being diagnosed with dementia every year, that’s another 180,000 people who could have been helped, but weren’t.

So our charity, the Food for the Brain Foundation, decided to build a free on-line Cognitive Function Test, with the guidance and tests developed by two of the world’s leading experts in cognitive function testing. To validate it we had a group of people perform the accepted paper and pencil tests used to diagnose cognitive impairment, as well as our own on-line Cognitive Function Test. The results were identical.

The Cognitive Function Test went live in the spring of 2011 and, largely thanks to a front page in the Daily Mail, over 150,000 people have now taken this simple test. It is available at www.foodforthebrain.org. If you don’t score so well you get a letter to take to your GP recommending that they investigate further and test your homocysteine level.

I should point out that all this work – running a free Cognitive Function Test, promoting valid steps to take to help prevent Alzheimer’s, running a website that close to a million people visit every year – costs money and we get absolutely no help from government agencies who continually talk about the urgent need for ‘prevention’.

We also need to further research and improve the Cognitive Function Test.  David Smith and other homocysteine researchers struggle to get money to do their vital, independent research,.

If you would like to know more about what you can do right now to prevent Alzheimer’s, you could also read my book The Alzheimer’s Prevention Plan [link to http://www.patrickholford.com/index.php/shop/bookdetail/289/. In a nutshell there are four main drivers of brain damage – a lack of homocysteine lowering B vitamins, not enough omega 3 fats, too much sugar and carbs, a lack of antioxidants. Correcting these is what’s going to make a real difference. Not failed drugs.

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Having read a report of the Dartington Debate which took place recently on the subject of Integrated Medicine, I was interested to read that some of the assembled gathering concluded that the only treatments that they would consider were those that had passed the ultimate medical gold standard test: The randomised, double blind, placebo controlled Clinical Trial. These people are sadly living in cloud cuckoo land.

First, for those of you that don’t know the term let me explain. This Clinical Trial involves two identical groups of people, one group taking the test treatment, the other taking a ‘placebo’ – an identical injection or pill just containing sugar. It is blind, because the recipients don’t know which they are receiving.

The test is double blind because the scientist doesn’t know which he is giving to whom either. And finally, it is randomised because a computer has assigned the people to each group in a matched way, but randomly.

An unequal playing field

This sort of test, according to Pharmaceutical companies, is very, very expensive to run. And thus it is very, very unlikely that any purveyor of a herb or vitamin would ever have the money to run such a test. Last year Astra Zeneca made over $8.6 billion in profit. The entire supplements industry in the UK was worth peanuts compared to that figure. I know of only one such UK ‘supplements’ test in the last year or so – A Leeds University Clinical Trial on concentrated fish oil omega 3 with pre-cancerous colon polyps (it worked and reduced the size of the polyps). This level of Clinical Trial demands serious funding, something simply beyond the means of the supplements companies – face facts!

Another reason that natural compounds and supplements are ruled out is because the drug companies are unlikely to help. The Leeds University trial prepared the omega-3 as if it were a drug, but others aren’t so fortunate. Professor Robert Thomas of Addenbrooks has been working with newly diagnosed prostate cancer patients and noted that those who followed a programme of broccoli and tomato consumption plus daily exercise pushed the evil date for surgery further into the future. To make any claims he needed to prove this observation scientifically and so he started to dry his broccoli and tomatoes. Ah, but if you want to do a proper trial you need to prepare them in pill form, so they are now classified as drugs and require a drugs company to prepare them. How easy do you think it is to get a drugs company to help with a test on natural compounds which can reduce the usage of their profitable drugs?

These anomalies would only be resolved in the UK if we had a properly Government-funded Institute of Complementary Health as they do in the USA. This needs to include someone responsible collating the information and providing guidelines.

Dubious selection criteria

You may feel that the ‘randomised’ selection process in the randomised, double blind, placebo-controlled test is fool-proof. You’d be completely wrong. New drugs tend to be compared against existing treatments which are used by the sick in all shapes, sizes, ages, smokers and non-smokers and so on. For the new Clinical Trials however, the participating company may well insist that the scientist rule out anybody who may have had a negative reaction in a previous trial, obese people, people with heart problems or anything that might jeopardise a good result. Thus the Clinical Trial can be a random sample chosen from a selected sample. Often a drug trial is conducted with young, healthy people (you’ve probably heard the radio ads recruiting volunteers) with 75 per cent of the volume of the resultant drug used by sick over 65 year olds, who will have a significantly different biochemical profile.

So let’s rule out all those treatments that haven’t passed this gold standard

Well of course curcumin as a preventative cancer treatment is ruled out. But then so are most statins – including those for the seemingly healthy to avoid unexpected heart attacks. But Doctors recommend the statins, don’t they?

Actually, come to mention it, about 95 per cent of drugs in use today would be ruled out, not just complementary and alternative therapies.

Two thirds of cancer patients have surgery but there has never been a randomised, double blind, placebo controlled Clinical Trial on any of it. And increasingly there is evidence that surgery may even spread cancer (See: http://www.canceractive.com/cancer-active-page-link.aspx?n=2976)

Next time your Doctor offers you a drug, ask him if it has been through a randomised, double blind, placebo controlled Clinical Trial and see what he says. If it is a serious condition it is very likely that he will want to give you three or four drugs. Don’t even bother asking about whether the combination has passed the gold standard test. As a cocktail it is almost certain not to have done, which may explain, in part, why prescription drugs are now the highest cause of death in states like Florida with a higher incidence of older people.

Level of evidence?

If, like me you believe that ‘research is for the guidance of wise men and the obedience of fools’, you may consider that there is actually enough evidence to warrant all of the over-50’s in the UK being offered statins along with overweight kids too. As a doctor you may feel the evidence is enough, even if all the Dartington audience using their gold standard filter may not have agreed.

But if you feel it is enough and you offer statins to all, why not consider telling people with pre-cancerous colon conditions about fish oils or curcumin? Both are known to help prevent colon cancer – the former also has Clinical Trials, the latter has a stack of evidence on its side and is even being used as a treatment in some US cancer hospitals.

Why do oncologists offer surgery at the outset of cancer yet they don’t think to offer immune boosting herbs like astragalus or supplements like resveratrol and grape seed extract, which do have good supporting evidence behind them?

Why do some oncologists even criticise cancer patients when they correct their diets? The research is quite clear; ‘overwhelming’ according to the American Cancer Society. Diet and exercise can increase survival times.

A clear legal duty

Only recently we had two women in a week tell us that their oncologist had refused to discuss complementary therapies with them as ‘He may get struck off’. Actually the opposite is true. Your oncologist has a legal duty to inform you fully of all your treatment options. Omitting treatments deliberately is illegal. Ignorance is no defence. Oncologists had better start wising up on complementary and alternative therapies fast. The patient backlash is just around the corner.

The sting?

As part of my preparation for this article, I looked up the ‘randomised, double blind, placebo-controlled Clinical Trial’ on my Internet search engine. Five of the top six listings were definitions but one was actually a trial for a treatment. Here it is. Unfortunately I think some of the ‘skeptic’ attackers of complementary medicine at Dartington might find it a little embarrassing:

Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.


Zabolotnyi DI, Kneis KC, Richardson A, Rettenberger R, Heger M, Kaszkin-Bettag M, Heger PW.
Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.

There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).
The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.
A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week post treatment observational phase.
Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.
Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.
From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P < .0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week post treatment observational phase.
This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.
[PubMed - indexed for MEDLINE]

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Don’t you just love the French?

Leaving Chamonix after the family ski trip we were all talking about just how many shops sold local mountain cheese made from lait cru or raw milk. There has been a massive hullabaloo in America because of the banning of raw milk sales with prosecutions of farmers and retailers. Not so in Europe where the total ban came off in 2004 and basically it is down to member states to allow or restrict raw milk products. Where it is allowed, strict health policies are in place (Annex II Section IX to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin). Many people believe raw milk to be healthier and the EU documentation refers to research showing less asthma, allergies and eczema particularly in children.

Later, the conversation turned to herbs and the EU restrictions.

When we arrived in Ste Maxime sure enough there had been a complete removal from Carrefour’s shelves, where once there had been 60 different herbs on sale – the hole has been filled by mass market slimming powders and ‘detox’ liquids, obviously important, highly beneficial and proven-beyond-all-doubt to be health-giving, unlike those dangerous herbs. That’s the European Directive on Traditional Herbal Medicinal Products in action, (THMPD), I suppose.

The mega-store near St Raphael was the same. That is, until we popped into the spacious in-store pharmacy, which had neither pharmacist nor anybody else serving or on duty. There we found every one of the missing herbs lined up on the shelves. Pick up your medicinal herbs here, put them in your shopping basket and head off to the check out as usual. Not quite what the formulators of the EU directive had in mind, I guess.

The next day I popped into a big specialist pharmacy in St Raphael for some eye drops for my wife. Three ranges of herbs covered a whole wall. And claims of health giving properties – both overall and for specific medicinal herbs – jumped out at you.

So I asked the lady behind the desk about her astragalus, milk thistle and artichoke medicines. Had she heard of the EU directive? A puzzled look presaged the response. “No”

Did she know that retail sales of medicinal herbs were stopped a year ago? The look became more one of ‘you’re crazy’, this time followed by a Gallic shrug.

Then the pharmacist came across to adjudicate on the commotion. I wondered how the EU law might have affected her product range and retail sales.

“Medicinal Herbs?” she whispered quizzically. “But these are just plants”. Another shrug, and off she went.


Readers might like to check out an article on 20 herbs that may help you fight cancer in some way: http://www.canceractive.com/cancer-active-page-link.aspx?n=3054

We are sorry you cannot post comments to this article – you have a hacker to thank since they tried to shut the site down by swamping it with replies. They didn’t affect us – just you and your right to reply. Absurd.

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This article is from The Alliance for Natural Health, Europe.

Poorly written or implemented laws always lead to chaos, especially when they apply across a huge and diverse geographical and political area like the European Union (EU). And once again, the EU’s Traditional Herbal Medicinal Products Directive (THMPD) is proving itself to be one of the most flawed pieces of legislation yet devised by the EU – which, given the competition, is quite an achievement!

Puppet on a string

In the UK, the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is showing just how ‘independent’ and ‘unbiased’ is its interpretation of the THMPD. It has begun to crack down on ‘unlicensed medicines’ via the THMPD and EU medicines law – and its interpretation of those laws appears to be at the bidding of a shady campaign aimed at protecting the profits of the bigger companies that can buy their way into the narrow regulatory regime, built around their specific types of product. A far cry from the MHRA’s proclaimed virtues of integrity, openness and impartiality, we would say!

Predator becomes prey?

The latest victim of the MHRA is a sports nutrition company, Predator Nutrition. Predator was in the news recently after the MHRA became the first EU Member State competent authority to begin targeting companies selling products containing 1,3-dimethylamylamine or DMAA. DMAA is taken before a workout to help boost performance, and controversy has raged over possible links to liver damage and the deaths of two US servicemen – as well as over whether the substance is artificial or derived from the geranium plant.

Casting the net wider

It appears that the MHRA may be using the DMAA furore as a convenient ‘foot in the door’ at Predator, since it has also told the company that it must cease selling products containing milk thistle, valerian, clary sage and many other herbal ingredients. Some of the herbs in Predator’s products are on restricted lists in the UK, such as Ephedra spp. and Pausinystalia yohimbe (yohimbe). Therefore, the MHRA could be said to be only doing its job by targeting these products. The same cannot be said for herbs like milk thistle, with centuries of safe use in the UK and elsewhere – but the MHRA doesn’t see it like that. “The MHRA has told us that if our products contain higher doses of herbal ingredients than are found in foods, then they’re medicines and should be licensed under the THMPD,” Reggie Johal, Predator’s founder, told ANH-Intl. And that’s not all. “They’ve also told us that any herbs we’re using in our products that have never been eaten in the UK are medicines,” continued Mr Johal. A double whammy from the medicines regulator that could see many of Predator’s products disappear from the UK.

In justifying its draconian policy on herbal ingredients, the MHRA is sticking to a familiar position – but it appears to have expanded its enforcement strategy. Its opinion that herbal doses in excess of what can be obtained from foods are medicinal is explained in Figure 1, which represents our interpretation of the second limb of the EU medicines directive. This limb defines any substance as medicinal if it, “….may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action” (Article 1(2), Directive 2004/27/EC). This covers everything in the red zone of Figure 1 – anything that acts to bring the human body back to normality from a position of dysfunction, or illness – and includes doses of herbal ingredients beyond those obtainable from foods. It is also an astonishingly broad definition that technically classifies a glass of water as a drug: a loaded gun for regulators to use on products they don’t like. And the MHRA is as trigger-happy as they come.

Figure 1. The effect of the Human Medicinal Products Directive. Everything in red is defined as a drug.

A disputed history of food use

The MHRA has also long used ‘history of food use’ as a basis for deciding whether or not herbs are medicinal. In the past, a history of food use has meant that the herb can be sold as a food supplement. But in the case of Predator Nutrition, the MHRA is calling even benign herbs like milk thistle and clary sage medicinal – even though its own guidance document clearly states they have a history of food use!

According to UK-based magazine The Ecologist, “Milk thistle is another weed that can prove a tasty addition to your supper…raw shoots can…be eaten as crudités”, while the National Toxicology Program of the Department of Health and Human Services in the USA declares that, “Milk thistle has a long history of European cultivation for food”. As for clary sage, the Oxford English Dictionary entry for the plant reads, “An aromatic herbaceous plant of the mint family, some kinds of which are used as culinary and medicinal”.

So, what we have here are two herbs with obvious histories of food use. So, the only argument the MHRA has left is that the amounts of active ingredients within the herbal products – i.e. the silymarin in milk thistle and, say, the sclareol in clary sage – are way higher than those that could normally be consumed in food. Their evidence for this? We’re not sure they have any.

MHRA: the enforcement arm of Big (Phyto)Pharma

So, the MHRA is contradicting its own guidance and the published historical data by declaring certain herbs as drugs. Why might that be? Well, cackling gleefully in the background of this story is one Simon Mills, spokesman for the Herbal Quality Campaign (HQC). “It’s what we’ve been asking for,” he gloats. Behind the thin modesty veil of the HQC’s ‘public safety’ stance hides a campaign designed to protect the profits of companies, such as Schwabe and Bionorica, who invested heavily in the THMPD and are unhappy that the MHRA hasn’t been forcing the non-THMPD-registered competition, i.e. botanical food supplements, off the market. It seems that pressure from the HQC – whether direct or via UK Members of Parliament (MPs), who have been the main target of the HQC’s lobbying – might be persuading the MHRA to crack down. Never mind that its justification is spurious, or that the herbs, as opposed to the products, being targeted are perfectly safe and legal.

In a lovely example of synchronicity, George Monbiot wrote an article on conflicts of interest in public bodies for the UK’s Guardian newspaper on Monday 12th March – and guess who was one of the corrupt bodies he pointed to? “While the [MHRA] board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme, it includes no one from a patient group, or any other body representing people whose health could be damaged by its decisions,” Monbiot wrote, drawing an instant response from the MHRA. Since the MHRA is entirely funded and partly staffed by the pharmaceutical industry, it’s difficult to see how its regulatory strategy could avoid being biased toward Big Pharma interests – which raises an interesting question. Now that they are being officially regulated by the MHRA, will phytopharmaceutical companies and HQC backers contribute to the MHRA’s upkeep in the same manner? It seems only fair for ‘services rendered’.

Alliance for Natural Health: http://anh-europe.org/

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Junk Science Number 6: Statins save the world

A friend went to his UK doctor. The conversation went like this:
Doctor: ‘I recommend you start taking statins.’
Patient: ‘But what about the side-effects?’
Doctor: ‘There are none.’
Patient: ‘Well I heard they can affect your muscles and heart.’
Doctor: ‘No problem, we monitor those for you.’

The research evidence suggests that statins depress coenzyme Q10 levels. A Merck study (1990) showed statins reduce CoQ10 production. Co Q10 is found in the mitochondria – the power stations in every cell in your body. The more active the tissue – muscles, heart, brain etc – the more mitochondria and the more Q10. Co Q10 is also believed to play an important role in the ‘health’ of the mitochondria, not just in its power generating activities. Mitochondria possess the power to cause cell death if something negative arises – for example, in genetic malfunction. In cancer, the mitochondria shut down and lose the ability to cause cell death, making cancer cells virtually immortal.

Co Q10 levels decline anyway as you age.

Statins are a 25 billion dollar world wide business. They are designed to reduce cholesterol levels and reduce cardiovascular disease.

New research links statins to increases in diabetes – Jan 10th 2012
A new study from the Massachusetts Medical School confirms a new and potentially dangerous side effect of statin drugs – diabetes. (Archives of Internal Medicine)

The research report analysed more than 153,000 postmenopausal women who enrolled in the Women’s Health Initiative study in the 1990s. None of the women had diabetes at the outset, but 7 per cent were taking statins.

15 years later the women were followed up and nearly 10 percent of women taking statins had developed diabetes, compared to only 6.4 percent in women who took no statin drugs.

Further analysis by Harvard shows that women over the age of 45 are 50 per cent more likely to develop diabetes if they’re taking a statin drug.

Given the already widespread use of statins, and the push to encourage all people over 50 to consider taking them for heart issues and cholesterol problems, this finding is deeply concerning. The impact on Western populations could be huge.

Several reports have made the diabetes connection before – for example, the first in 2008 was a study of the drug Crestor; and in June 2010 a report in the Journal of the American Medical Association analysed five additional randomised trials and concluded the increased risk was small but real for people taking higher doses of any statin.

In 2009 a Diabetes Care a meta-study warned: ‘Although statin therapy greatly lowers vascular risk, including among those with and at risk for diabetes, the relationship of statin therapy to incident diabetes remains uncertain. Future statin trials should be designed to formally address this issue’, such were the mixed results.

But with the new and worrying research findings there seems already to be an attempt to down play the significance.
Dr. Steven Nissen, cardiology chairman at the Cleveland Clinic, who wasn’t involved with the Harvard research opined, “We don’t want these drugs in the water supply, but we want the right people treated. When they are, this effect is not a significant limitation.” ( http://www.foxnews.com/health/2012/01/10/study-statins-linked-with-diabetes-risk/)

In the Lancet, volume 375, under the heading of ‘The new risk – diabetes’, Christopher P Cannon states: All drugs have side-effects. Indeed, all interventions (including even exercise programmes) have side-effects. The balance in medicine is to evaluate the benefits and weigh them against the risks. For statins, the benefits in reducing clinical events have been shown in a multitude of trials with more than 500 000 patient-years of treatment. This benefit has led to their inclusion in national guidelines as a key component of both primary and secondary prevention.

So that’s aright then.

At the US National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.

So that’s definitely alright then!

Deaths from heart disease are not in decline, and nor is type 2 diabetes. Worse the official website for the American Heart Association says, “Adults with diabetes are two to four times more likely to have heart disease or a stroke than adults without diabetes.”

According to the American Diabetes Association, there are numerous trials showing a benefit from statin therapy in primary and secondary prevention of cardiovascular disease and mortality. However, their report goes on to say that there is no evidence that statins reduce all-case mortality.

If statins are confirmed as causing a 50 per cent increase in diabetes, it could prove a huge cost to the world, both to patients and government purses.  

The American Medical Association 2009 report on statins and diabetes calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year – and there would be one additional case of diabetes for every 498 patients treated. So three saved from heart attack for each new type-2 diabetes sufferer.

The final word belongs to Dr. Yunsheng Ma of the University of Massachusetts Medical School, who led the study of postmenopausal women: “The statin should not be seen as the magic pill.”  

It could be a bit late for that.


Read also

Links to  liver damage, kidney failure and cataracts ( http://www.naturalnews.com/030317_statin_drugs_liver_damage.html ).
Links to memory loss and depression
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