Positive Health Online

EU Pharmaceuticals Directive Disastrous for Nutritional Supplements

The ANH identified on 11 December that a Compromise Package developed for the Pharmaceuticals Directive (amending Directive 2003/83/EC), in preparation for its second (and final) reading in the European Parliament could be particularly disastrous for the leading edge of the supplement industry.

This was because this Package, prepared in consultation with the European Commission, the Council of Ministers and Rapporteur for the directive, French MEP Françoise Grossetête (EPP group), would be put forward in place of Recommendations made by the the Committee on the Environment, Public Health and Consumer Policy, lead also by Ms Grossetête. These latter Recommendations included most of the key amendments that had succeeded at first reading of the amending directive, but had ‘fallen away’ in the subsequent Common Position.

Indeed, during the vote on 17 December, the key part of the Compromise Package affecting food supplements (including amendments 60, 63 and 65) was adopted as a whole.

Fortunately, steps were taken before the vote in an attempt to protect the ‘medicalization’ of all supplements in Europe.

On 12 December, ANH consulted with its expert legal Counsel and commissioned a legal Opinion that confirmed the nature of the problem. This Opinion and ANH’s Briefing Note on the subject  were delivered on 16 December, both to the European Parliament and the European Commission in Strasbourg, by a delegation from ANH (including Executive Director Dr Robert Verkerk and Legal Director, David Hinde, as well as representatives from Sweden and France).

ANH’s key concern is that the scope of the pharmaceuticals legislation is so broad that it completely subsumes legislation on foods, food supplements, cosmetics and medical devices, including the Food Supplements Directive itself. Furthermore, the Commission’s attempt to rectify this anomaly would not firmly delineate medicinal from non-medicinal products in law. This is because the Commission indicated in a Recital to the amending directive that medicine legislation should not be applied to products that were “…clearly…” foods, food supplements, cosmetics or medical devices.

The new directive would therefore allow any national authority – whenever it so chose – to consider any product that fulfilled the very broad definition of a medicinal product (including a food, food supplement, cosmetic or medical device) as a medicine and so force its manufacturer to comply with a full drugs licensing regime if it wished to go to market! Given that this regime is prohibitively expensive for most food supplement manufacturers, it would effectively amount to a ban on products – at the whim of the legislators!

Irish MEP Avril Doyle (EPP group) became the key focal point for these issues in the EU Parliament in Strasbourg and raised the issues in the plenary debate on the evening of 16 December. Extracts from her speech and questions as well as the responses from Commissioner Liikanen, are given after the ANH Briefing Note on the website below (See Further Information).

We eagerly look forward to a meeting of stakeholders, in which ANH will be represented, in order that the Commission’s interpretation of the issue of delineation between medicinal and other products can be clarified. ANH, together with other interested parties, wishes to continue to influence the
situation in such a way that a product which is clearly a food supplement cannot be arbitrarily classified as a medicine.

Further Information

Avoiding Visual Degeneration – Part 1

Do physicians really and truly want to help their patients, even if it might cost them a lot of business? Ophthalmologists withheld from two of my friends, information that might have saved their vision.

An article in Journal of the American Medical Association (JAMA) November 2, 1994, sings the praises of spinach. People who ate Popeye’s favorite daily suffered only one-tenth as much age-related macular degeneration (AMD) as those who seldom ate spinach. And for patients with the condition, eating spinach prevented worsening.

Research has now confirmed that three to four portions of spinach weekly can reverse at least early AMD. “Dr Richer, chief of the optometry section at the Dept. of Veterans Affairs in North Chicago, recently tested 14 patients who were showing the first signs of AMD. After just 12 weeks of eating three to four portions of spinach a week, those in the study showed 60% to 80% improvement in their AMD tests. Among the eight who had either a hole or a distortion in their vision, for seven the problem either improved or disappeared completely.”

The macula is a light-sensitive part of the central retinal area near the optic nerve; it provides sharp central visual acuity. AMD is the leading cause of blindness among American, Canadian and English elderly, and it afflicts nearly 40 percent of the more than 10 million Americans with diabetes. AMD is a cousin of coronary heart disease, and shares with it a common ancestor: atherosclerosis. Free radicals promote and speed macular degeneration as well as ageing, heart disease, arthritis, and Alzheimer’s disease, among others.

The benefits result largely from spinach’s numerous carotenoids, which are phytonutrients (plant nutrients) related to and including carotenes. “High concentrations of lutein and zeaxanthin, both of them carotenoids, are found in [and so, presumably, required by] the retina of the eye, explaining why consuming them in diet protects against macular degeneration.” New research finds that eggs may be an especially good source of lutein and zeaxanthin because substances in the yolk make it easier for the body to absorb these compounds. It is already known that eating eggs does not elevate risk of heart attack; in fact, published research found that those who ate more eggs had fewer heart attacks. So such findings strengthen our recommendation to eat whole, natural foods including all the eggs we want.

Besides AMD, many of these fight cancers and other afflictions; and they do it better than beta-carotene, the only carotenoid found in most vitamin supplements. Other dark-green leafy vegetables such as kale, collards, and Brussels sprouts offer much the same multiple nutrients – vitamin/mineral benefits.

Two anecdotes reveal the extent of the eye-specialist problem.

A few years ago a bridge-playing friend of ours went to his eye doctor with early macular degeneration. The doctor never mentioned kale, chard, spinach or green tea. And now our friend can no longer hunt deer, play bridge, repair things, read or engage in other much loved activities.

A neighbour’s mother had very advanced AMD; her eye doctor was using lasers on her and more, yet the condition was worsening. My friend noticed a huge bottle of aspirin in her mother’s house and suggested she stop taking it. After that, her eye condition stabilized. Why?

1.    A letter in New England Journal of Medicine in 1988 reported that aspirin can cause AMD. JD Kingham MD, wrote, “Since 1983 at our clinic, many elderly patients who present with decreased central vision and macular haemorrhage [the most severe form of AMD] have a history of recent ingestion of aspirin and other drugs known to affect platelet function or the coagulation process.”

2.    And patients with blocked arteries to the brain (a dangerous stroke situation) have three times as many strokes from ruptured arteries if they are taking an aspirin a day.

Dr Kingham’s discovery and that reported in Medical Tribune have not been confirmed. But a massive computer literature search by Kirk Hamilton PA, publisher of Clinical Pearls News, Sacramento, CA, found no refutation. So there is at least a caution flag on long-term aspirin.

Fortunately, aspirin’s anti-clotting benefits in lowering risk of heart attack and stroke can be obtained without side effects in at least two ways.

1.    White willow bark, which the Greek physician Dioscorides used in the first century AD. People with a headache long chewed white willow bark. Bayer Co derived aspirin itself from the bark, modifying the molecule to make it patentable. This modification is the source of excess bleeding, digestive upsets, worsened gut permeability and 3,000 US deaths a year from aspirin poisoning, as well as the risk of ultimate blindness.

Jonathan V Wright MD, a leading alternative/integrative practitioner in Kent, WA has found that two 400-milligram capsules of the powdered bark provide about the same amount of salicin, the active ingredient, as a baby aspirin. Four such capsules thin the blood as effectively as an adult aspirin. (See Part 2.)

2.    Another alternative: three glasses daily of purple grape juice can reduce platelet aggregation as much as a daily aspirin. “Blood platelets floating in a juice solution clotted about 30% less than platelets not in the juice, and released three times more chemicals that widen blood vessels and inhibit clots.” And unlike aspirin, the flavonoids in purple grape juice remain effective when adrenaline levels rise. In another test, purple grape juice lowered susceptibility of LDL-cholesterol to oxidation.

Also, a published clinical test showed melatonin lowers eyeball pressure in glaucoma patients. The insomnia age group – for whom its use is safe and appropriate at 1 to 5 milligrams before bedtime – is the same as the glaucoma age group.

Macular degeneration and diet.
1.    In rats, excitotoxins rapidly damage the macula, offering a new slant on burgeoning AMD. They wreak many other ill effects on people consuming processed foods. Monosodium glutamate (MSG), aspartame (Nutra-Sweet®) and nearly all processed foods contain dangerous quantities of glutamate, aspartate, cysteine and related compounds. These excitotoxic drugs, added to foods, discharge nerve cells in the mouth to augment the sensation of flavour. Addictive Aspartame breaks down into carcinogenic, eye-destroying formaldehyde and deadly methyl alcohol.

The public long ago began to be aware of some of the risks of MSG; and so, to hide the deadly character of their products, food processing companies adopted a laundry list of innocent-sounding labels. Avoid all diet foods, diet drinks, and such products as Accent, autolyzed yeast, HVP, hydrolyzed or texturized vegetable protein – especially bad because they contain three excitotoxins – hydrolyzed plant protein, Kombu extract, Chinese seasoning, gourmet powder, RL50, broth, bouillon, caseinate, flavouring and natural flavouring. (It doesn’t have to be labelled when it’s in ice cream.) Any of these are even more dangerous when heated.

‘Natural’ MSG is found in, e.g., tomatoes and mushrooms – but at about 1,000th of the concentration used in food processing. Incredibly, Food and Drug Administration (FDA) rules permit processed foods to contain large amounts of MSG but be labelled ‘no MSG added.’

2.    Eating one ounce of Olestra (Olean®)-containing chips daily for two weeks lowered vision-protective carotene levels by 50 percent.

The eye specialists could perhaps be excused for not knowing about how full spectrum light helps the eyes, and for not knowing that MSG- and aspartame-polluted foods and Olean promote macular degeneration. But both of them probably subscribe to JAMA and New England Journal of Medicine, and so they had no excuse for keeping quiet about kale, spinach and aspirin except their own financial self-interest. They were wrong to deprive their patients of that healing news and should be held responsible. Class-action lawyers might look into this.

Part II

Dr Jonathan V Wright’s treatment.
Dr Wright said to take selenium, taurine, vitamin E and zinc. And put DMSO (dimethyl sulfoxide, a solvent obtainable at health food stores and paint stores) on any part of the skin.

The DMSO, which itself offers powerful healing features, is a necessary part of the procedure: it strongly increases absorption of these nutrients. Some patients of his recovered from macular degeneration using this therapy and have stayed clear of it for as long as four years. The method works better in some cases than others.

The quantities, written on a prescription form:
•    Zinc, preferably picolinate: 30 mg x 2 = 60 mg/day;* zinc is best absorbed when taken half an hour before breakfast; in a few, this timing may cause nausea. The eye contains more zinc than any other part of the body;
•    Vitamin E, 800 mg/day;
•    Selenium, 500 micrograms/day;
•    Taurine: 620 mg x 2 twice a day = 2+ grams/day. The label instructions say not to use this amino acid when taking aspirin or any product containing aspirin; take between meals or before a meal.
•    Taking zinc supplement of this magnitude, you should have a red-blood-cell copper blood test every two months; and 500 mcg of selenium daily cannot continue for a long time.

Full-spectrum light is also effective against seasonal depression (“SAD”). Nonseasonal depression benefits too, but not as much. It has other major health benefits including reduction of tooth decay. It has also greatly improved behaviour of previously UV-deprived
children.

Vitamin D and calcium
Arthur A Knapp MD, used 50,000 units of vitamin D and one gram of calcium on intermittent days. These helped against eye conditions including myopia, keratoconus, cataract, optic nerve atrophy and retinitis pigmentosa.

A related problem affects people with asthma. Inhaled steroids, intended to block or reduce inflammation, were long claimed not to circulate throughout the body. Yet for many older patients they promote glaucoma, the leading cause of blindness in the population. The risk appeared to be elevated by 44 percent compared to matched patients not using inhaled steroids. Lea Davies of Georgetown University Medical Center in Washington DC adds that inhaled steroids may cause about one-third of the 3,000 glaucoma cases developing each year among Americans over 65. Inhaled steroids reduce bone density in the spines of women with asthma. The greater the cumulative dose of inhaled steroids, the greater the reduction in bone mineral density of the spine in women.

“The drugs commonly used in the treatment of allergic conditions, including asthma, have many potentially harmful and dangerous side effects. These antihistamines, steroid hormones, or xanthine derivatives have side effects that may be merely annoying to a child but in many instances are dangerous. For example, steroid treatment of a%sthmatic children has been demonstrated to retard lung maturation and physical growth and to cause a higher incidence of cataracts in children receiving long-term steroid
therapy.”

Further Information

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Vaccines and Autism and Neurological Epidemics

On October 31, 2003 medical doctor and congressmen Dave Weldon wrote to Dr Julie Gerberding the director of the Center for Disease Control (CDC) casting doubt on its internal workings. Dr Weldon found a disturbing pattern of deliberate data manipulates showing conclusions about vaccine injuries that would protect pharmaceutical companies instead of informing the public of real and present dangers to a generation of children. Dr Weldon has called for “thorough, open, timely, and independent review by researchers outside of the CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues.”

Dr Weldon was “very concerned that there may have been a selective use of the data to make the associations in the earliest study disappear,” referring to an important CDC study trying to ascertain whether thimerosal-containing vaccines (TCVs) are actually involved in the creation of an epidemic in autism and neurological developmental delays. Weldon found it highly curious that the first version of the study, produced in February 2000, found a significant association between exposure to thimerosal containing vaccines and autism. The first reports stated that the relative risk factor for autism was 2.48 for those with high exposure levels of mercury-laced vaccines. With the legal standard of proof set at 2.0 this report clearly demonstrated a direct link to the suffering of many thousands of families that have seen their worlds torn apart. This important information, worth billions in damage awards in liability court, was later turned around to make it look like vaccines containing mercury were safe.

Weldon reported to the CDC that a June 2000 version of the study applied various data manipulations to reduce the autism association to 1.69 even though that at a meeting held that same month, involving authors of the study, representatives of the CDC, and the vaccine industry, it was discussed that there was a statistically significant relationship between exposures and outcomes. The author Dr Verstraeten openly stated that the association with language delay was quite large but that this information should be kept confidential and considered embargoed. In reviewing outline transcripts of the meeting Dr Weldon found that the tone of the meeting including statements referring to their ability to “push and pull the data anyway we want to get the results we want”, “We can alter the exclusion criteria any we way we want, give reasonable justifications for doing so, and get any result we want.”

The final version of the study concludes that “No consistent significant associations were found between TCVs and neurodevelopmental outcomes,” and that the lack of consistency argues against an association. Weldon is throwing down the gauntlet at the CDC for depending on studies that internally manipulate data to show “absurd results”. He also pointed out how such a conclusion is not unexpected from an author with a serious, though undisclosed, conflict of interest. (Dr Thomas Verstraeten, worked for the CDC until he left over two years ago to work in Belgium for GlaxoSmithKline (GSK), a vaccine manufacturer facing liability over TCVs.)

Both the CDC and the FDA are standing on top of a mountain of such “scientific” reports that easily have their data manipulated. The potential for scandal is growing in the halls of governmental protection agencies where deceit and fraud seem to be more commonplace than anyone would like to believe. It seems that the conflicts of interest that are so common in both agencies (that have staffs shuttling back and forth between large pharmaceutical companies) is making a mockery of medical science and public safety. When a member of congress who is also a medical doctor casts doubt and calls for an independent investigation we should ourselves in mass take a closer look at subjects that can greatly affect our health and well being.

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Partial Reversal of Autism?

by Vin Suprynowicz
New medical findings indicate many children have a genetic ability to excrete the toxic mercury present as a preservative in many childhood shots – more and more of which are recommended, each year.

But children who become autistic – or who show lesser signs of heavy metal poisoning, such as attention deficit disorder – “are the ones that cannot detoxify,” according to Laura Bono of North Carolina, the housewife and mom who founded the Right to Fight Mercury Damage Campaign.

The Bono family paediatrician had noted in his charts that by age 16 months “Jackson has 25 words, making good progress,” Laura Bono says. “And then it starts to regress within days after the shot, and within two years he’s gone. A child who never needed antibiotics, never threw up, suddenly after August 1990 he’s having all these weird rashes, it was a mercury rash…

“But there was nothing in the literature that autism was anything but mental. It was 1995 before this went from being (categorized as) a mental to a medical/metabolic problem, that they have all sorts of immune deficiencies, we kept saying, `But he’s so allergic to everything… ‘

The good news in finding the apparent cause of autism, of course, is that if the ailment is caused by the presence of toxic mercury, some partial reversal may be achieved if the mercury can be removed.

“Some of them were able to detoxify, and some not,” Laura Bono says. “It’s not black and white. How many have attention deficit disorder or other problems, where autism is just those syndromes to the tenth power? We see so many allergies in society now, and these things all link back to problems with the immune system, so it can be hypothesized that these children ended up with autism, but there are other spectrum disorders and (their rates) are also exploding, children who are just partially neurologically affected – either they got less thimerosal or they were able to detoxify it better. …

“My son is 14, and we’ve been chelating for three years, and the more we get out the more my son comes back. Dr Stephanie Cave in Baton Rouge, Louisiana, (author of What Your Doctor May Not Tell You About Vaccination) has been doing this the longest, and she says, ‘If I can get them from the time they’re five, I can turn them around, they’re nothing like they were if we can catch them early.’

“Go watch (Rep.) Dan Burton’s hearings. He went crazy over this. He said, “You know this is a horrible thing that you’re putting in vaccines,” and they won’t tell him how many doses were delivered by January 2001 that are still out there that could have an expiration date as late as May 2004.

“(Dr and US Sen) Bill Frist argues, ‘These poor vaccine manufacturers, they’re going to be bankrupted.’ Yet, you know what? Vaccines have to be making a lot of money; there are over 400 new vaccines in the pipeline. …Let’s say we do bankrupt them. There are so many others ready to step in. If Firestone Tires goes bankrupt they reorganize and they learn their lessons…

“The government paid people $50,000 apiece who were debilitated by the swine flu vaccine, thousands of them. It wasn’t the pharmaceutical firms that paid, it was the taxpayers. So where’s the financial incentive to improve the vaccines?…

“It is going to cost the taxpayers so much money what they have done, the mass poisoning of thousands of children with this thimerosal.”

Replies Eli Lilly spokesman Ed Sagebiel: “We recognize autism is a devastating disease, but the trial lawyers are not going to find the possible cure for autism. …(We need to) continue to let the science guide this, rather than the trial attorneys. In the current debate around thimerosal and autism, the scientific evidence just does not show a relationship between the two.

“A study at the University of Rochester School of Medicine found ethyl mercury has a half life in the blood of seven days, versus methyl mercury which has a half life of 45 days. This would suggest that ethyl mercury does not persist in the body…

“You have the National Institutes of Health, you have the Academy of Pediatrics, if you go to the Centers for Disease Control Web site you’ll find their statement as well; you just cannot find any scientifically credible organization confirming that type of link,” the Eli Lilly spokesman concludes.

In 1990, the recorded rate of autism in America was 1 in 10,000. Today the Centers for Disease Control report that number stands at 1 in 150. This dramatic rise in autism rates correlates with the increase in mercury-exposure through vaccines given to children in the late 1980s and through the 1990s – especially after a vaccine against hepatitis B was added to the standard formulations, Laura Bono says.

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