MHRA Orders Removal of Gillian Mc Keith’s Illegal Products

Dr Gillian McKeith’s organisation has had to detox its own products after MHRA officers discovered it was advertising and selling goods without legal authorisation whilst making medicinal claims about their efficacy. Dr McKeith’s products, ‘Fast Formula Wild Pink’ for women and ‘Fast Formula Horny’ for men promised to deliver wonders for all in the bedroom.

The MHRA determined that both products were medicines because of the presence of some well-known medicinal herbs and because of the claims being made by Dr McKeith’s organisation. Only licensed medicines may be advertised to the public.

David Carter, Manager of the Medicines Borderline Section said 'Companies who place products on the market have a clear duty to ensure that those products comply with all relevant legislation. As Dr McKeith’s organisation had already been made aware of the requirements of medicines legislation in previous years there was no reason for all the products not to be compliant with the law. The MHRA has a comprehensive website with information on the legislation it administers, including the law on herbal products. Furthermore, free advice on the likely status of products is available from staff in the Medicines Borderline Section. It would have been a very simple matter for them to have sought our opinion.'

Scientists to Probe B-vitamin Osteoporosis Link

Researchers at the University of Ulster are recruiting women for a new study to see if B-vitamin supplements could reduce their risk of developing osteoporosis.

Osteoporosis is estimated to affect about 75m people in Europe, the USA and Japan. According to the International Osteoporosis Foundation, the total direct cost of osteoporotic fractures is €31.7bn in Europe, and 17.5bn in the US (2002 figure). The total annual cost of osteoporosis in the UK alone is over £1.7bn (€2.5bn), equivalent to £5m (€7.3m) each day.

The most widely used supplements for the prevention of the disease and to help strengthen bones after diagnosis are calcium, which is well-known building-block of strong ones, and vitamin D, which has been shown to boost calcium absorption.
There is also a growing body of science linking vitamin K, considerably less well-known than vitamins A to E, to benefiting bone health as it influences the secondary modification of osteocalcin, a protein needed to bind calcium to the bone matrix.

The new University of Ulster-funded study is aiming to determine if post-menopausal women with a particular genetic make-up can benefit from B-vitamin supplementation to lower homocysteine levels and, therefore, reduce the risk of osteoporosis.

'Individuals who have a poor dietary intake of B-vitamins tend to have high homocysteine levels. In addition, some people have a genetic make-up that causes them to have a higher homocysteine level. Such people may have a greater risk of developing osteoporosis,' said Professor Helene McNulty, from the Northern Ireland Centre for Food and Health (NICHE).

'Studies have found that when B-vitamin intake is improved, homocysteine levels are lowered and this offers the possibility of a novel way to reduce osteoporosis,' she said.

PhD student Claire Whittle, working under the supervision of Professor McNulty, said that she will screen about 1,000 women in order to find 100 with a specific genetic make-up – the c677T polymorphism in the methylenetetrahydrofolate reductase (MTHFR) gene, which affects folate metabolism and is associated with increased homocysteine levels.

High levels of the amino acid homocysteine (hyperhomocysteinemia) are most commonly used as a marker for heart disease and thought to be a risk factor for atherosclerotic disease, which contributes to heart attacks higher risk of heart disease and strokes. Additionally, high levels of the amino acid have been linked to increased cognitive decline. Indeed, the Framingham study reported that people with homocysteine levels above 14 micromoles per litre of serum had twice the risk of dementia.

A growing body of science is also linking high homocysteine levels to an increased risk of osteoporosis, with studies reporting high levels significantly raise the risk of both hip fracture and other broken bones resulting from osteoporosis.

The project will divide the women into four supplementation groups – riboflavin plus folic acid, riboflavin plus placebo, folic acid plus placebo, and placebo plus placebo – for 24 weeks. The doses are equivalent to the recommended daily intakes for the vitamin (2 milligrams for riboflavin and 200 micrograms for folic acid).

Those women deemed suitable will be given a free DEXA bone scan which is the most accurate way of assessing bone health. Whittle said the first results are expected in 2008.

Web: http://www.nutraingredients.com

Stem Cells may Mend Arthritis Damage

Scientists have used stem cells to repair arthritis damage in mice.

They tweaked the stem cells' genes to pump up production of a bone-building protein called BMP-4. When mice with knee injuries got those stem cells, their knees healed better than other mice with the same injuries.

The finding comes from doctors including Ryosuke Kuroda, MD, PhD, of Children's Hospital of Pittsburgh and the University of Pittsburgh.

The experiment, described in Arthritis & Rheumatism, only included mice, not people. Joint damage is a hallmark of arthritis, and scientists don't have a way to make arthritis-damaged joints as good as new.

Healing an Injured Knee
Kuroda's team took stem cells from mouse muscles, placed the stem cells in chemical ‘glue’ and used the mixture on mice with knee injuries.

Some mice got stem cells that had been genetically altered to make more BMP-4. Others got stem cells with normal genes. A third group just got the chemical ‘glue’ with no stem cells.

The mice could move freely around their cages as their knee injuries healed. Their knees were checked after four, eight, 12, and 24 weeks.

The mice that got the genetically altered stem cells healed best by the study's end.
They made glossy, white tissue that repaired the joint damage quite well, the study shows.

Healing attempts didn't go as well in the other mice. Their joint repairs were rougher and didn't last as long, like a half-hearted attempt to patch a hole in a wall that later crumbles.

The ‘glue’ helped, write the researchers. Basically, the glue worked like spackle, putting the stem cells in the right spots and filling in little gaps. The glue might work better than solid grafts of tissue, write Kuroda and colleagues.

The results are ‘encouraging,’ writes Mary Goldring, PhD, in a journal editorial. Goldring is on staff at Harvard Medical School and the New England Baptist Bone and Joint Institute in Boston. She didn't work on Kuroda's study.

FDA OKs New Rheumatoid Arthritis Drug By Miranda Hitti, reviewed by Louise Chang, MD

Illegal Chinese Medicine Targeted in North London

Chinese medicine shops in London selling products made from endangered animals are being targeted by a new police campaign.

The crackdown comes as the demand for products made from tiger bone, rhino horn and bear bile - devastating these animal populations - continues to grow.

As part of Operation Charm, posters are urging people not to fuel the trade by buying illegal medicines.

Businesses are also being encouraged to display a sticker backing the campaign.

To coincide with the start of the scheme on Friday, Operation Charm has announced its new website.

Tiger skins
Operation Charm is the Metropolitan Police's ongoing campaign against the illegal trade of items made from endangered species.

Officers said although most of the trade in traditional Chinese medicines is legal, some products are still made from endangered species.

Andy Fisher, head of the Metropolitan Police's wildlife crime unit said: ‘It is quite unacceptable that illegal acts in London are contributing to the decline of creatures like the tiger.’

Backing the scheme, president of the Federation of Traditional Chinese Medicine (FTCM), Professor Bo-Ying Ma, said the organisation was ‘not utilising or selling such materials in any form’.

The Register of Chinese Herbal Medicine also supported the campaign saying it had ‘always condemned the illegal trade in endangered animal and also plant species.’

Since Operation Charm was launched 10 years ago it has seized more than 30,000 items made from endangered species being sold illegally in London.

Earlier this month fur coats thought to be made from tiger, leopard and snow leopard skins were found during a raid at a fur dealers.

A complaint objecting to a magazine ad for a follow-on milk for babies from Nutricia Ltd t/a Cow & Gate Ltd, was upheld in one of the two objections according to information published by the Advertising Standards Authority (ASA).

Complaint:
Objection, from a doctor, to a magazine ad for a follow-on milk for babies. The ad showed a picture of a baby surrounded by Cow & Gate products; text stated "Not sure how to help build your baby's natural defences if you're not breastfeeding? That's why Cow & Gate are here to help ... Important notice: Breastfeeding is best for your baby. Cow & Gate follow-on milks should be used as part of a mixed diet and not as a breast milk substitute before 6 months ... Our range of follow-on milks all contain a bunch of goodies called prebiotics to help build natural defences. Prebiotics are the special ingredients naturally found in breast milk, which of course is the best form of nutrition you can give your baby. But if you're not breastfeeding, our follow-on milks can still help your baby build strong defences...’

1. The complainant, who believed there were over 100 different prebiotic structures found in breast milk that could not be reproduced commercially, objected that the ad misleadingly implied that the addition of prebiotic compounds to follow-on milk had an equivalent effect on a child's defences against illness and infection to those in breast milk.

2. The complainant thought that, although breast milk was rich in prebiotics, the reduced incidence of infections in breast-fed babies was not solely attributed to prebiotics. She believed there was insufficient evidence for many of the claims made about the health benefits of prebiotics, particularly in children who had been weaned.

Adjudication:
Cow & Gate pointed out that the ad clearly stated that breast-feeding was best for a baby and that follow-on milk should be used only as part of a mixed diet and not as a substitute for breast milk before six months. They asserted that the ad made clear it was aimed only at people who were already using formula milk.

They argued that the ad did not state that prebiotics (non-digestible food ingredients that stimulated growth and/or activity of one or a limited number of bacteria in the colon) in follow-on milks could have the same effect as those in breast milk, or that the reduced incidence of infection in breast-fed babies was solely attributed to prebiotics; the ad merely stated that the product contained prebiotics which could, among other things, help a baby build their defences.

Cow & Gate said 'Natural defences' was a general term used to describe the ways in which the body protected itself. They asserted that the blood-based immune system was commonly misquoted as being the body's only form of defence and that the body had a variety of equally important defence mechanisms to stop pathogens entering, growing and spreading within the body. They argued that that array of defences was particularly important during infancy, when the immune system was still developing.

Cow & Gate pointed out that the ad did not claim to increase or strengthen natural defences but to ‘help build’ them. They said all infants were born with an immature system of natural defences that naturally built and developed in the first years of life; they asserted that their mix helped and supported the normal process of building natural defences that occurred in every infant and that their mix made a positive contribution to the defensive functions that exist within infants. They maintained that the claim was not intended to imply the reduction of infection or allergy.

Cow & Gate asserted breast milk contained many oligosaccharides, which had a prebiotic effect, that were not commercially available. They said the aim of their own prebiotic mix was not to resemble those structures but to mimic the prebiotic effect and size distribution of breast milk oligosaccharides. They said their prebiotic mix had been approved by the Scientific Committee for Food for use in infant and follow-on milks on the basis of safety and the suitability of the blend of prebiotics for infants. They asserted their product was intended to increase the number of friendly bacteria in a baby's intestine in a similar way to breast milk. They maintained that they had developed a unique oligosaccharide mix, which was proven to be an effective prebiotic.

Cow & Gate sent double-blind, placebo-controlled trials to show that infants fed with a follow-on milk that contained their mix showed a significant growth in the number of bifidobacteria and lactobacilli (referred to as ‘friendly bacteria’) and that the levels seen were close to those of breast-fed babies; the increase was seen for infants both before and during weaning. They said it was established that organisms such as bifidobacteria played an important role by competing with harmful bacteria, maintaining the mucosal gut barrier and interacting with the specific immune system. The evidence also showed that infants fed on their formula had reduced levels of a strain of bifidobacteria (bifidobacteria adolescentis) which had been found in separate studies to be indicative of an increased risk of allergy.

Cow & Gate sent evidence to show that an increase in friendly bacteria suggested an impact on the immune system and its development. The evidence stated it was thought that supplementing an infant's diet with friendly bacteria could help prevent diarrhoea and intestinal infection and could also help mature the immune system. They sent evidence to show that healthy infants tended to have a high level of friendly bacteria whilst infants who had developed allergic symptoms had lower levels of bifidobacteria and lactobacilli in their gut.

Cow & Gate said their product led to beneficial effects on an infant's markers of natural defences. They sent evidence to show that their mix reduced the pH of an infant's stool, which they argued contributed to the suppression of pathogens in the infantile gut. They also sent evidence which showed their mix reduced the number of clinically relevant pathogens such as Clostridia and E. coli, which they argued was important because such pathogens caused many serious diseases.
They sent in vitro studies and a randomised controlled trial which showed their mix modulated the pattern of short chain fatty acids to one similar to that of breast-fed infants. They said an increase in the level of acetate inhibited the growth of pathogens and helped promote the development of the protective mucous layer lining the GI tract. They asserted that that indicated a healthier gut and was important because it could result in fewer infections and allergies.

Cow & Gate also sent a study published in the Archives of Disease in Childhood which they said showed that their specific prebiotic mix had reduced the incidence of atopic dermatitis in infants during the first six months of age. They also referred to an unpublished trial which they believed showed their mix was directly responsible for reducing the incidence of infections and diarrhoea.

1. Not upheld
The ASA considered that the ad and particularly the text ‘Important notice: Breastfeeding is best for your baby. Cow & Gate follow-on milks should be used as part of a mixed diet and not as a breast milk substitute before 6 months’ and ‘... naturally found in breast milk, which of course is the best form of nutrition you can give your baby’ made clear that breast-feeding was the best option for a baby; it did not imply that Cow & Gate follow-on milk had an equivalent effect to breast milk or that they could reproduce all the prebiotic structures found in breast milk.

On this point, we investigated the ad under CAP Code clause 7.1 (Truthfulness) but did not find it in breach.

2. Upheld
We noted the ad did not claim that prebiotics in breast milk were solely responsible for the reduced incidence of infections in breast-fed babies. We considered, however, that the ad implied that the prebiotics in Cow & Gate's follow-on formula milks helped build an infant's immunity to the everyday illnesses or conditions to which they were susceptible (e.g. colds, viruses, stomach bugs, eczema, ear and eye infections) in a way that formula without the prebiotics did not. We noted the unpublished trial had been accepted for publication in abstract form in the Journal of Paediatric Gastroenterology. We considered that, because Cow & Gate were unable, for confidentiality reasons, to send us the full write-up of the trial, we could not properly evaluate it. We noted the evidence sent by Cow & Gate showed that their product was capable of stimulating the growth of friendly bacteria; we noted other evidence showed that an increase in friendly bacteria could be beneficial, could compete with harmful bacteria and could have an impact on the immune system.

We took expert advice. We showed the expert the reports Cow & Gate had sent us on the benefits of an increase in friendly bacteria. We understood from the expert that the evidence sent did not show the direct effects of prebiotic consumption on the immune system and general health. The expert believed that to substantiate the claim Cow & Gate would have to show a direct link between the consumption of their infant formula and a positive effect on the immune system and general health. We also sent the expert the study on atopic dermatitis. The expert said the study was well designed and showed that Cow & Gate's prebiotic mix had reduced the incidence of atopic dermatitis in infants in the first six months of age.

We noted much of the evidence sent by Cow & Gate was associative, rather than showing causality. We considered that Cow & Gate had shown that their mix could build an infant's defences against atopic dermatitis. We noted, however, that atopic dermatitis was only one condition from which an infant might suffer.
Because they had not sent evidence to show a direct link between an infant taking their formula and it helping to build defences against a number of everyday illnesses or conditions to which they were susceptible, we considered that Cow & Gate had not substantiated the claim. We told Cow & Gate to amend the ad to make clear that the product could help build ‘some’ and not ‘all’ natural defences.

On this point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & beauty products and therapies).

Five complaints objecting to a TV ad for a probiotic yogurt drink from Danone UK Ltd, London were upheld according to information published by the Advertising Standards Authority (ASA).

Ad
A TV ad, for a probiotic yogurt drink, showed a child and her mother on a bus. At one point, the child licked the window of the bus. Her mother pulled her away saying ‘ ... that's dirty.’ Another scene showed a representation of good and bad bacteria in the gut with the image of a wall of beige coloured spheres. Gaps in the wall were shown being plugged by Actimel, and bad bacteria represented by blue spheres were then shown bouncing off the wall. The voiceover stated ‘Every morning, I like to give my kids Actimel to help support their bodies' natural defences. There's bad bacteria everywhere but kids will be kids ... Actimel tops up their natural good bacteria, making life harder for the bad bacteria. Actimel. Help support their natural defences.’

Issue
Five viewers challenged whether the ad misleadingly implied that children given Actimel would be protected from germs in general.

Response
Danone UK Ltd (Danone) said the intention of the ad was to show that Actimel had benefits for children as well as adults. They said the claims ‘tops up their natural good bacteria making life harder for the bad bacteria’ and ‘helps support their natural defences’ had been assessed and approved by a board of independent medical experts; they explained that the board's findings were supported by peer reviewed, published clinical studies, which they submitted along with their response. Danone asserted that the role of Actimel was to support the activity of a child's natural defences, not to replace them. They argued that the ad did not imply the product would protect children from bad bacteria or prevent them from catching diseases.

The Broadcast Advertising Clearance Centre (BACC) told us the evidence submitted by Danone had been reviewed by their nutritional consultant, who was satisfied that the product could support the natural body defences that were already there. The BACC believed the words in the ad such as ‘helps support’ and ‘making life harder for the bad bacteria’ did not claim prevention from catching contagious bacterial diseases.

Assessment
Upheld
The ASA noted the evidence submitted by Danone, including studies on children, and the comments from the BACC. We accepted Actimel had a proven probiotic effect. Nevertheless, we considered that the images of the child licking the window and the bad bacteria bouncing off the good bacteria, coupled with the claims ‘Actimel tops up their natural good bacteria, making life harder for the bad bacteria’ and ‘help support their natural defences’, implied that Actimel could help prevent children from catching bacterial infections. Although we acknowledged that Danone had not intended to imply that, and had not therefore sought to prove that implication, we concluded that the ad could give a misleading impression of the health benefits of the product.

The ad breached CAP (Broadcast) TV Advertising Standards Code rule 8.3.1 (Accuracy in food advertising) but not 8.1.1 (Assessment of claims).

Action
The ad must not be shown again in its current form.

Adjudication of the ASA Council (Broadcast)

Three new discussion forums have just been opened under Forums on the Sports Therapy website.

These include three sections covering Soft Tissues, Sports Injuries and Electrotherapy. If you are interested in sharing information about particular conditions or case studies, selling equipment or finding sources of information, this could be the place for you to add your message. Log on regularly to http://www.sportstherapyuk.com and see how your 'discussion' is going.

Holistic Veterinary Clinic Aims to Help Ailing Pets

When Jimmy, a 13-year-old pug, had a stroke in July, one side of his face became paralysed so severely he couldn't blink. Ann Dey of San Francisco knew she needed to do something before her dog lost his eye to infection.

‘I was open to anything that would help,’ she said.

At Pets Unlimited, a nonprofit animal hospital that plans to open the city's first all-holistic veterinary medical clinic, Jimmy received a month of acupuncture. Now, his face is fine.

As alternative approaches like acupuncture and herbal remedies have moved further into the mainstream for humans, veterinarians have made those same techniques increasingly available for pets.

According to animal-care officials, pet owners have been persuaded by their own positive experiences that their pets should also enjoy the benefits of alternative techniques.

‘Seeing is believing,’ said Pets Unlimited hospital administrator Sally Wortman, standing near a row of scented candles on the new clinic's reception desk.

A Japanese fountain, soft lights, and walls painted in soothing tones of sage, ochre and salmon augment the clinic's calming atmosphere, one floor down from the city's only 24-hour-a-day emergency room for pets.

The $230,000 in renovations have a therapeutic effect on pets, Wortman said, but added it was just as important to create a setting where owners also felt relaxed.

‘The practitioner can only help the animal through the person,’ she said.
Still, the push for the new treatments - also known as holistic or complementary medicine - has not come so much from vets, whose medical training is still steeped in the rigors of the Western scientific tradition.

‘It's been more consumer-driven,’ said Joe O'Hehir, the executive director of Pets Unlimited.

Marilyn Chartrand of Alameda is one of those consumers.

‘I do holistic things for my body. So I thought, how exciting that they're doing this for animals,’ said Chartrand, who adopted a cat from Pets Unlimited.

Chartrand said that she treats her cat with aromatherapy when she gets sick, offering her different scents to inhale. ‘She knows which ones her system needs,’ Chartrand said.

That holistic medicine for animals would catch on in an alternative oasis like San Francisco, which also ushered in the modern no-kill movement in animal shelters in the 1990s, comes as little surprise. But alternative practices are now in use among veterinarians across the country.

The Maryland-based American Holistic Veterinary Medical Association claims more than 800 members from Florida to Alaska. Chartrand learned about an alternative treatment called therapeutic touch from her sister, a veterinarian who uses the technique on horses in eastern Kansas.

Still, despite broadening acceptance, alternative medicine for animals faces continued skepticism. The American Veterinary Medical Association said in recent guidelines on alternative medical techniques for animals that the organisation is ‘open to their consideration.’

But the group stressed that the quality of research into different methods varies, saying some practices ‘may differ from current scientific knowledge.’

Beth Schneider, an animal acupuncturist for Pets Unlimited, said one positive experience with alternative techniques can be enough to persuade doubters.

‘They see how beneficial it is to the animal,’ she said. ‘And they want to start going to acupuncturists themselves.’

Health Advantages of Diet, Exercise are Compared

Exercise offers extra benefits for health compared to calorie restriction. Both diet and exercise are important factors in weight loss and most experts recommend a combination of the two to shed the pounds and keep them off. In an intriguing new study, researchers at Saint Louis University do a direct comparison of the impact of diet and exercise as a way of losing weight.

A group of 34 participants either reduced their calorie consumption or increased their energy expenditure through exercise. Their goal was to reduce calories by 16 per cent in the first three months, then by 20 per cent for the next nine months. The exercisers burned 16 per cent more calories in the first three months, then 20 per cent for the next nine months.

Both groups lost about ten per cent of their body weight - a significant achievement in terms of improving health. But the exercisers also increased their muscle mass, strength and aerobic capacity. The dieters actually lost muscle mass, which is not a good thing. So exercise may be the best overall way of losing weight. However, the researchers warn that diet is important - exercisers should not start eating more as this will wipe out the weight loss benefits of increased energy expenditure.

Source: Journal of Applied Physiology online 16th November 2006
Reported by Susan Aldridge, PhD, medical journalist

Five Years after DOHA, Drug Prices are on the Rise

Drug prices are on the rise five years after the historic signing of the Doha Declaration on TRIPS* and Public Health at the 2001 World Trade Organisation (WTO) Ministerial meeting in Doha, Qatar, the international medical humanitarian organisation Médecins Sans Frontierès (MSF) stressed recently.

Getting drug prices to decrease will require countries to make more extensive use of the TRIPS flexibilities enshrined in the Doha Declaration, which sought to ‘...protect public health and (...) promote access to medicines for all.’

The case of AIDS illustrates the trend. While fierce generic competition has helped prices for first-line AIDS drug regimen to fall by 99% from $10,000 to roughly $130 per patient per year since 2000, prices for second-line drugs - which patients need as resistance develops naturally - remain high due to increased patent barriers in key generics producing countries like India.

In a country such as South Africa, where MSF has been providing antiretroviral therapy for five years, treating 58 patients on second-line drugs costs the same as treating over 550 patients on first-line. In addition, newer HIV medicines that are recommended by WHO can cost up to 50 times more, if they are even available in countries. These drugs will be impossible to use unless generic competition drives down prices and helps increase availability.

‘In our projects, we feel the effect of higher drug prices on our budget,’ said Dr. Tido von Schoen-Angerer, Director of MSF's Campaign for Access to Essential Medicines. ‘We're seeing many countries make use of the Doha Declaration to import medicines, but what is the use if soon there are no generics to buy? Countries where drug producers are based need to take steps to allow generic production and export of new essential medicines. If this doesn't happen we'll be back where we started in no time because treatment will become unaffordable again.’

The report released in April by the World Health Organisation Commission on Intellectual Property, Innovation and Public Health concludes that, contrary to what its proponents often claim, intellectual property protection has not led to increased innovation and access to treatment for people in developing countries.

‘Time has come to rethink the way new medicines are developed and paid for. The current system based on patents and high prices to pay for innovation leads to rationing and leaves huge health needs neglected’ said Ellen 't Hoen, Director of Policy & Advocacy at MSF's Campaign for Access to Essential Medicines. ‘The upcoming talks at the WHO on a action plan and framework for essential health research and development in December offer an opportunity to start this process.’

* Trade Related Aspects of Intellectual Property Rights

Canada Gives Vitamins to Malnourished Afghan Kids

International Cooperation Minister and Minister for La Francophonie and Official Languages, Josee Verner, announced on 17th November that Canada will support efforts to help save tens of thousands of Afghan children from mental impairments by supplementing their diets with necessary nutrients. Minister Verner announced a $750,000 contribution to the Micronutrient Initiative, a Canada-based internationally-recognised not-for-profit organisation dedicated to eliminating vitamin and mineral deficiencies worldwide. Minister Verner made the announcement in her address to a meeting of the 52nd NATO Parliamentary Assembly.

‘Millions of Afghan children suffer from vitamin and mineral deficiencies that hinder their development and potential,’ said Minister Verner. ‘Through simple, affordable strategies such as iodising salt or fortifying foods with iron, we can make sure that children have access to the much-needed micronutrients that can dramatically increase their chances to lead healthy, productive lives.’

The funding, which builds on existing successful programmes, will provide:

- $500,000 over two years for salt iodisation programmes for some 10 million Afghans. Iodine deficiency - prevalent in Afghanistan - causes many infants to be born mentally impaired, and lessens the ability of children and youths to learn and work. CIDA's support for similar salt iodisation programmes worldwide has already saved seven million children from mental impairment. This initiative in Afghanistan is expected to prevent over 100,000 children from being born mentally impaired.

- $250,000 over one year to fortify flour with iron, thereby increasing the nutritious value of bread for some 2.5 million Afghans. This will reduce anemia due to iron deficiency, which affects 65% of Afghan children under five, and 61% of women aged 15 - 49. Anemia lessens children's ability to succeed in school and hinders their cognitive and physical development, and causes 2,600 maternal deaths per year in Afghanistan.

‘We are pleased that the Canadian government continues to invest in cost-effective micronutrient programmes that have the power to reach millions of children in the world's poorest countries,’ said Venkatesh Mannar, President of the Micronutrient Initiative. ‘In Afghanistan, where the prevalence of iodine deficiency is among the highest in the world, eliminating vitamin and mineral deficiencies is critical for people's health and well-being as well as to national economic development.’

SOURCE: Canadian International Development Agency - CIDA

Do's & Don'ts for Safe Body Piercing

While body piercing remains a popular trend for today's youth, recent cases of life threatening infections have once again called into question the health and safety issues of this practice.

Earlier this month, it was reported that an 18-year old Indiana woman lost a breast due to a rare infection that developed as a result of nipple piercing. A diabetic, the woman's mother complained that the piercing shop did not adequately question her about personal risk factors, or take the necessary safety precautions, before the piercing was performed.

Just this past October, a Massachusetts woman was convicted of child abuse because she failed to seek medical attention for her teenage daughter who nearly died from an infection that developed from a belly button piercing.

If people are not properly screened, or if the equipment is not properly sterilised, then conditions such as hepatitis, HIV or tetanus could result.

Understanding that piercing carries inherent risks, what can a person considering facial or body piercing do to ensure that the procedure is performed safely and that they are not subjecting themselves to health risks?

The Association Professional Piercers provides general information for both piercers and the public. Before you go for your piercing, you should visit this web site and review the ‘bill of rights’ referenced by the APP. It gives an excellent checklist of the things one should ask before instruments are applied. Most recommendations are just good common sense, but the list would be particularly helpful if someone is nervous about piercing.

For example, it advises a potential piercer to know that piercing guns are never appropriate and can be dangerous when used on any body part, including earlobes.

Make sure every question you have regarding proper after-care is answered thoroughly, both verbally and in writing. Many piercings which have resulted in health injuries could have been prevented if there had been adequate screening about a person's health conditions before the piercing, and proper instructions about sanitary cleaning post-piercing.

Utopia, a piercing studio in Hicksville, N.Y., provides a detailed brochure of APP's aftercare guidelines to its customers.

‘You need to be sure that you are being pierced in both a hygienically safe environment and by someone who is a professional piercer,’ said Allegra Hall, Utopia's manager.

With any piercing, following behaviour that promotes healing is important.
Here is a list of Do's and Don'ts everyone getting a body piercing should follow:

--Revisit your piercer for a followup evaluation
--Practice good hygiene
--Follow any aftercare guidelines your piercer provides
--Take Iron and Zinc supplements

There are also some ‘don'ts’ when it comes to preventing problems after a piercing. Some behavior that prevents proper healing:

--Excessive touching of the piercing
--Contact with bodily fluids
--Smoking and drinking alcohol after an oral piercing
--Exposure to some cosmetics, lotions, or perfumes
--Immersing in pool water or natural water

Botox Treatments Prompt Warning

Doctors have issued a warning about the dangers of using excessively high doses of the potentially fatal toxin botox in cosmetic treatments.

The Journal of the American Medical Association reports four cases where patients were given doses many times higher than the estimated lethal dose.
The treatments were given using toxin intended for laboratory use.

Experts said UK patients were at risk from delays in deciding if those who can give botox should be restricted.

Lethal doses
Botulism is a rare paralytic illness caused by the botulinum toxins.

Left untreated, it may result in respiratory failure and death.

In the four cases reported to the Centres for Disease Control and Prevention (CDC), in Atlanta, the patients were found to have been injected with a highly concentrated, unlicensed preparation of botulinum toxin A.

It had been intended for laboratory research, and was not intended for human use.

But a doctor at one unnamed clinic gave the three patients - and himself - courses of four to six injections as facial cosmetic treatments.

All four eventually reported symptoms of progressive weakness and abnormalities in the nerves that control functions such as movement of the facial muscles and swallowing.

Two also experienced shortness of breath.

The CDC researchers say the patients may have received doses 2,857-times the estimated human lethal dose by injection.

Although the precise lethal dose is not known, researchers point to primate studies suggesting it is around 40 micrograms per kilogram of body weight.

Tests prior to treatment showed three out of the four had blood serum toxin levels equivalent to 21 to 43 times the estimated lethal dose. Data for the fourth patient was not available.

The researchers say the patients did not die because they received prompt hospital treatment.

The doctor involved in the case pleaded guilty to misbranding a drug and was sentenced to three years in prison.

'Negative attention'
The team, led by Daniel Chertow, said: ‘Physicians and patients must be aware of the hazards associated with illegitimate use of unlicensed botulinum toxin products.

‘Only licensed products should be used clinically.’

In the UK, an expert working group submitted a report to the government in January last year calling for powers to regulate the cosmetic treatment industry, including who should be able to give botox treatments.

But there has so far been no decision on whether or not these recommendations will be accepted.

Paul Stapleton, head of the Mapperly Park Clinic, part of the Independent Healthcare Advisory Service which has backed calls for tougher regulation, said: ‘Problems like this case reported in the US could occur in the UK.

‘Without regulation, there is nothing to stop unqualified and untrained people giving botox treatments.’

He added: ‘We have been working for a number of years to bring regulation to a sector that has run rampant, bringing both damage and risk to public health.
‘There is clearly a direct link between the huge growth in this sector and the rise in medical problems, complaints and negative media attention.’

A Department of Health spokeswoman said: ‘We are still considering the form of regulation that would provide the best approach for both treatment providers and their patients and will publish further information in due course.’

Used Wisely, Therapies Can Offer Hope

As a group, people with cancer have expressed more interest in, and use of, complementary and alternative medicine (CAM) than perhaps any other class of patient. As it relates to cancer treatment, CAM encompasses a wide variety of therapies that traditionally have been considered outside mainstream oncology care - everything from acupuncture and herbal supplements to meditation and macrobiotic diets, among other things.

CAM's popularity among cancer patients is understandable. A cancer diagnosis is a life-changing - and frequently a life-threatening - event. Often, it involves a loss of control over many aspects of life. The decision to use certain CAM modalities, such as meditation or choice of a diet, may allow a patient to regain some of the control turned over to doctors during treatment.

Cancer treatment also can have profound effects on quality of life. Patients may experience hair loss, fatigue, nausea and vomiting, loss of appetite, severe pain and other side effects. Certain CAM modalities - such as acupuncture for chemotherapy-induced nausea - may effectively address quality of life issues without relying further on medications.

Finally, there's the issue of hope, which can be an important ingredient in a person's struggle against cancer. By utilising CAM, a cancer patient may be holding out hope that a particular herb, vitamin or supplement may be the missing piece of the puzzle in the search for a cure.

There are many sound reasons why a cancer patient would seek out complementary and alternative therapies in a struggle with cancer. However, the use of CAM in cancer can be very complicated, and should be approached with caution. The science supporting many CAM therapies is either in its infancy or doesn't yet exist. Further, many seemingly innocuous treatments may have significant effects (sometimes negative) on a patient's conventional treatment regimen. The herb St. John's Wort, for example, may blunt the potency of certain kinds of chemotherapy. High doses of antioxidants - for example, vitamin C or co-enzyme Q10 - may decrease the effectiveness of radiation therapy.

Here are some general guidelines for patients interested in CAM therapies and cancer treatment:

First, be an educated consumer. The media often hype new studies about this or that diet or supplement and its effect on cancer. It's rare that a single study is sufficient evidence to recommend a change in practice.

Look to reputable sources, such as the National Cancer Institute's Office of Cancer Complementary and Alternative Medicine (http://www.cancer.gov/cam), for what the scientific evidence says about various CAM modalities.

Second, talk openly with your physicians. Many experienced physicians trained at a time when CAM either did not exist or was considered nonsense. Despite this, many are becoming more open to CAM because their patients are demanding it and because the science behind it is improving. It is important, for the reasons mentioned above, that your physician know whether you are using CAM.

Third, seek out experts. If you're interested in exploring the use of herbs or other modalities as an adjunct to your treatment, ask around and find the experts in your area. A naturopathic doctor, for example, is a specialist in the use of nutrition and diet in the treatment of medical disease. Others may be nonphysicians, but many are tremendous resources for information about complementary treatment of cancer.

Fourth, be extremely cautious with herbs and other supplements. While some may indeed boost immune function or help control the side effects of treatment, others can render chemotherapy or radiation treatments less effective. Do not use these without expert guidance.

Fifth, pursue good nutrition, not a fad diet. Adequate calories and protein are two of the most important dietary needs for cancer patients. And although a recent study demonstrated that a low-fat diet may help prevent recurrence of breast cancer in women who have had the disease, there's no overwhelming evidence that any particular kind of diet changes the course of cancer. Your best bet is a nutritious, well-rounded diet with a variety of foods. If you're concerned about toxins in your food, you may want to consider buying organic produce and meats, although prices are usually higher.

Finally, cultivate balance between your mind and body. Utilising mind-body therapies, such as meditation, tai chi, yoga and other techniques, can reduce anxiety, improve mood and even decrease pain. These therapies are generally safe, can be practiced at any time and can significantly improve quality of life.

• Dr. Seth Torregiani practices holistic medicine, osteopathic manipulative medicine and acupuncture in Newark.

Defra Investigates Fraud in Egg Industry

The Government has called on the egg industry and retailers to ensure that the eggs they are selling are correctly labelled.

The move follows investigations by Defra into alleged illegal practice in the egg industry involving the incorrect labelling of eggs, including the labelling of non-free range eggs as free range.

Although formal investigations are on-going and may lead to prosecutions, Defra decided, in the public interest, in meetings this week, to ask the egg industry and retailers to satisfy themselves immediately that such practice is no longer taking place and that all the produce on shop shelves is accurately labelled.

From inspections carried out by Defra, under the EC Egg Marketing Regulations, the Department had become concerned about possible illegal practice in the egg industry. In the course of investigations information has come to light confirming that eggs have been incorrectly labelled.

The investigation is targeted on the collection and supply of eggs; not the original production. Departmental ministers are being kept informed.

Insomniacs Turn to Mind-body Techniques and Herbal Therapies

Whether meditating before bed or sipping a kava kava nightcap, more than 1.6 million Americans use some form of alternative medicine when they have trouble sleeping.

In analysing data from 31,000 Americans interviewed for the 2002 National Health Interview Survey, researchers found that nearly one-fifth of adults reported difficulty sleeping in the last 12 months, and of those, about 5 percent used complementary and alternative medicine to treat their sleeplessness. The majority of those who tried the therapies said they helped, with nearly half saying they helped ‘a great deal.’

Nearly 65 percent of people using alternative methods to help them sleep used ‘biological therapies,’ such as herbs or supplements, and 39 percent used ‘mind-body therapies,’ such as self-hypnosis, guided imagery or other relaxation techniques.

The report, published in the Archives of Internal Medicine, was part of a larger look at U.S. sleep habits. Researchers also found a strong connection between reports of insomnia or sleep troubles and other health conditions, such as obesity, hypertension, congestive heart failure and anxiety or depression.

Although the report didn't rank the popularity of specific herbal or behavioural remedies, doctors who recommend complementary and alternative medicine said some therapies - such as melatonin, kava kava and valerian - can be effective in treating sleep problems and are typically safer than sleep drugs.

Dr. Jay Udani, who runs the Integrative Medicine Programme at the Northridge Hospital Medical Centre, said he would recommend anyone with sleep problems start with mind-body techniques such as self-hypnosis, meditation or guided imagery. If that were not sufficient, he might recommend mind-body techniques combined with a herbal remedy - and melatonin would be his first choice. Even a low dose (1 to 5 milligrams) of melatonin can be effective, he says.

But doctors cautioned against mixing sleep-inducing herbs or supplements with sleep drugs. Consumers should talk with their physicians first, they said.

Significant Advances in Dietary Supplement Research

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) announces the release of the 2005 issue of the Annual Bibliography of Significant Advances in Dietary Supplement Research. This seventh issue of the Bibliography includes abstracts of 25 noteworthy dietary supplement research papers published in 2005, as judged by an international team of reviewers.

Compared with previous issues of the Bibliography, this issue has more papers testing the efficacy of commercially available products against their marketed claims. The 2005 Bibliography also includes papers on the efficacy of botanicals, effects of B-vitamins, calcium, and vitamin D on fractures, interaction of mineral supplementation on mineral status, and the effects of vitamin E on cardiovascular disease. Each of the 25 papers reports a study result that is of importance to the field of supplement research, as it describes mechanisms by which supplements act to create a health effect or provides a better understanding of the health effects in individuals.

The Bibliography is part of the ongoing commitment by the Office to meet the information needs of a wide variety of audiences on the subject of dietary supplements. ‘Each year, the bibliography provides a snapshot of key scientific research published in the field.’ said Paul M. Coates, Ph.D., director of ODS. ‘It is important to remember that the entire collection of scientific literature on a particular topic, not the results of a single study, must be considered when making research or health care recommendations.’

In their introduction to the 2005 Bibliography, the editors highlight the need for researchers to better characterise test materials used in research. ‘Even though the best work in the field is highlighted in the bibliography, there were several methodological issues with the studies. But these issues are not unique to dietary supplement research,’ said Rebecca B. Costello, Ph.D., co-editor of the Annual Bibliography.

‘Researchers need to sufficiently describe the supplements being tested in their studies, as this enables other scientists in the field to duplicate the study findings,’ said Leila Saldanha, Ph.D., R.D., co-editor of the Annual Bibliography.

To assist authors and editors working in the area of natural products research, ODS has compiled this list of valuable resources that can be accessed through its website: http://ods.od.nih.gov/Research/ProductQualityResources.aspx.

Of more than one thousand papers that were considered from 58 peer-reviewed journals, 261 were sent for evaluation to an international team of 50 scientific reviewers. The selection of the 25 papers to be included in the Bibliography was based on the rankings of these scientists, who are recognised experts in the fields of nutrition, botanical sciences, and public health.

This year's issue was released September 17th, 2006 at the Food & Nutrition Conference & Expo of the American Dietetic Association.

Copies of the Annual Bibliography of Significant Advances in Dietary Supplement Research 2005 may be downloaded from the ODS website at http://ods.od.nih.gov/Research/Annual_Bibliographies.aspx. Copies may also be requested by e-mail (ods@nih.gov), or by writing to the Office of Dietary Supplements, National Institutes of Health, 6100 Executive Blvd., Rm. 3B01, MSC 7517, Bethesda, Maryland 20892-7517, USA.

The mission of the NIH Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population. For additional information about ODS, visit http://ods.od.nih.gov.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centres. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH.

Additional information is available at http://www.nih.gov/icd/od/.

The Vocational Training Charitable Trust (VTCT) has announced the appointment of two new Directors as part of its expansion programme and commitment to service.

Bev Williams is appointed as Director of Operations from September 18th 2006.

Bev was previously responsible for setting up and directing PremierIQ, an awarding body in the Health and Fitness sector. Prior to this she gained extensive experience in the design and delivery of vocational courses and quality assurance. She has a B.Ed (Hons) degree and started her career in secondary school education.

Lori Randall is appointed as Director of Business Development from September 18th 2006.

Prior to working for VTCT, Lori was Director of her own private training college in Bristol for 10 years, delivering vocational courses in health and fitness.
Subsequently she worked at City of Bath College for five years as Course Co-ordinator/Lecturer for qualifications in Sport, Health and Fitness. Most recently Lori has worked as Director of Business Development for PremierIQ.

Lori has a Cert.Ed. and a vast degree of experience in external verification.

Web: http://www.vtct.org.uk

The World Health Organisation (WHO) supported the World Federation for Mental Health's World Mental Health Day, 10th October 2006, which focused this year on 'Building Awareness - Reducing Risk: Mental Illness and Suicide'. It calls attention to suicide as a leading cause of premature and preventable death. WHO recognises the need to build awareness and reduce risks in the areas of suicide and, more broadly, mental illness.

‘All too often, suicide represents a tragic consequence of failing to diagnose and treat serious mental illness’, said Dr Anders Nordström, Acting Director-General of WHO, ‘It requires a concerted public health response globally, nationally, and also from communities and families, to reduce suicide by reducing mental illness. World Mental Health Day is an important opportunity to recognise the magnitude of the problem, as well as the necessary steps towards the solutions.’

An estimated 873 000 people commit suicide every year, which represents 1.4% of the global burden of disease. The proportion of the global disease burden due to suicide varies regionally, from 0.2% in Africa up to 2.6% in the Western Pacific Region. Suicide among young people is of significant concern: in some regions, suicide is the third leading cause of death in the age group 15-35 years. Suicide is the leading cause of death for this age group in China and the second in the European region.

‘More than 90% of all cases of suicide are associated with mental disorders such as depression, schizophrenia and alcoholism’, notes Dr Benedetto Saraceno, Director of the Department of Mental Health for WHO, ‘Therefore, reducing the global suicide rate means effectively addressing the serious and growing burden of mental illness around the world.’

At any time, 450 million people worldwide are affected by mental, neurological or behavioral problems, and the rate is steadily rising. In spite of existing knowledge about effective treatments for most psychiatric disorders, huge gaps in treatment and resources exist. For example, a recent WHO study in 14 countries showed that, in developing countries, between 76 to 85% of serious cases of mental illness did not receive any treatment within the prior year. Furthermore, data from the WHO Mental Health Atlas 2005 show a tremendous human resource gap in the developing regions of the world.

In order to effectively address these gaps, mental health policy, plans and legislation must be integrated into national health systems. Promoting mental health, preventing mental disorders, mainstreaming cost-effective interventions in primary health care, promoting community care, and engaging with local communities should be key components of national mental health plans and policies.

WHO provides guidance to reduce the burden of mental disorders and suicide worldwide. WHO has initiated a global action programme to assist countries to create and implement coherent and comprehensive mental health policies, plans and legislation, and to ensure adequate mental health care is available at the community level, including development of human resources for mental health.

The U.S. Food and Drug Administration (FDA) again warned consumers about the serious risks of using decorative contact lenses without the appropriate involvement of an eye care professional.

These contact lenses, sometimes called Plano or non-corrective lenses, do not correct vision and are intended solely to change the appearance of the eye, but carry serious risks, including permanent eye injury that may lead to blindness.

Consumers should only use decorative contact lenses if they have seen an eye care professional and have obtained proper lens fitting and instructions for use.

Decorative contact lenses also carry the same risks as corrective contact lenses, including conjunctivitis (pink eye); corneal (the eye's outermost layer) ulcers; corneal abrasion; and vision impairment or blindness. Further, sharing of contact lenses prescribed for one person can also lead to infections, abrasions, allergic reaction or blindness.

FDA has received reports of corneal ulcers associated with the wearing of decorative contact lenses, especially when worn overnight. Corneal ulcers, an infection of the eye, can progress rapidly if left untreated. Uncontrolled infection can lead to corneal scarring and vision impairment. In the most severe cases, this condition can result in blindness and eye loss.

FDA has received reports of decorative contact lenses being marketed and distributed without a prescription directly to consumers through sources such as beauty salons, flea markets, convenience stores, beach shops and the Internet. Marketing of decorative lenses may increase during the Halloween season.

On November 9th, 2005, the Food, Drug and Cosmetic Act was amended to classify all contact lenses—including decorative ones—as medical devices under FDA's regulatory authority. Contact lenses distributed without appropriate involvement by eye care professionals are now considered misbranded devices under the law. FDA will aggressively use the full range of its statutory authorities to prevent the improper distribution of these potentially dangerous products.

Consumers should report any problems with decorative contact lenses to their local FDA office. For a listing of FDA offices, visit http://www.fda.gov/opacom/backgrounders/complain.html. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at http://www.fda.gov/medwatch.

For more information, visit http://www.fda.gov/cdrh/contactlenses/types.html#plano.

Senate Bill 3546, introduced in the 2nd Session of the 109th US Congress, may be cited as the ‘Dietary Supplement and Nonprescription Drug Consumer Protection Act.’ This Bill will create a serious Adverse Event Reporting mechanism (AER) for nonprescription drugs. The herbal products used and prescribed by AAOM members are currently covered by this bill.

The trade groups involved in the herb trade, the AAOM BOD, and the HMC have examined this bill and support the passage of this bill. This bill will place no burden on and have no impact on health care providers and will reflect a proactive stance on the part of vendors of OM herbal products.

All responsible parties involved in the commerce and use of nonprescription drugs support a reasonable information gathering device which will chart possible interactions and the tracking of possible public exposure to products that fail to meet appropriate quality control standards. This tracking mechanism, when recording an alleged AER, will include information from the consumer regarding what prescription drugs, alcohol, recreational drugs and additional supplements were taken during the time period reported. This bill will keep reports confidential until such time that there is a consensus reached by the appropriate experts that that the product reported may indeed be considered a hazard to public health.

SB 3546 allows OM Professional Associations to demonstrate responsibility in tracking adverse events. It also allows business members, who are also AAOM members to be closely involved in helping to revise this bill. This will be to the benefit of business members and will exclude any affects on health care practitioners.

On November 7th, 2006, Stephen E. Straus, M.D., Director of the National Centre for Complementary and Alternative Medicine (NCCAM), stepped down from his leadership of the Centre for health reasons. Straus will become Senior Advisor to National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D.

‘Steve Straus has done a tremendous job in creating and leading NCCAM. His total dedication, superb intelligence, extraordinary vision, high energy, and singular wit are all qualities that make him an extraordinary leader,’ said Dr. Zerhouni. ‘Steve has been one of my most trusted advisors, and I will continue to rely on his experience and perspective.’

During his tenure as NCCAM's first Director, Dr. Straus built a comprehensive research enterprise, championing the efforts to establish the safety and efficacy of complementary and alternative medicine (CAM) practices while upholding the rigorous standards of science for which the NIH is known.

Under his term of leadership from 1999-2006, CAM research at NIH grew threefold.

Dr. Straus led the evolution of CAM science beyond the advocacy and skepticism and polarisation it once engendered to earned legitimacy as a research area.

Studies encompassing a wide range of CAM practices including mind-body medicine, biologically based and manipulative practices, whole medical systems, and energy medicine have resulted in more than 1500 papers published in peer-reviewed journals. Results of NCCAM's first large clinical trials showed the effectiveness of acupuncture and glucosamine/chondroitin for osteoarthritis of the knee.

Dr. Zerhouni has named Ruth L. Kirschstein, M.D., formerly the Acting Director of NIH, to be the Acting Director of NCCAM. Dr. Kirschstein has also served as the director of the National Institute of General Medical Sciences.

The National Centre for Complementary and Alternative Medicine's mission is to explore complementary and alternative medical practices in the context of rigorous science, train CAM researchers, and disseminate authoritative information to the public and professionals. For additional information visit http://www.nccam.nih.gov.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency -includes 27 Institutes and Centres and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programmes, visit http://www.nih.gov

Whole Systems Research

The opportunities and methodological challenges inherent in a whole systems research approach to the study of complementary medicine were the focus of a roundtable discussion as part of the recent North American Research Conference on Complementary and Integrative Medicine, and the discussion was published in the November 2006 issue (Volume 12, Number 9) of The Journal of Alternative and Complementary Medicine, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The Roundtable Discussion is available free online at www.liebertpub.com/acm.

George T. Lewith, MD, PhD, from the University of Southampton (UK), identified the most important methodologic issue facing whole systems research: ‘The big issue is getting whole systems research accepted as an entity in itself: Does it have any scientific validity at all?’

The discussion, moderated by Charles Elder, MD, MPH, from Kaiser Permanente Centre for Health Research (Portland, OR), centred on the need to define more clearly the questions that studies should aim to answer and to describe in greater detail in published reports the methodologies used. This should include identifying the appropriate outcomes to measure, including conventional outcome measures that can serve as a basis for comparison.

Determining how to analyse within-patient data is another pivotal challenge. Researchers should also focus on pattern analysis and looking for patterns of outcomes. Additionally, the participants, including Mikel Aickin, PhD, Iris R. Bell, MD, PhD, and Cheryl Ritenbaugh, PhD, MPH, from the University of Arizona (Tucson), Vinjar Fønnebø, MD, PhD, from the University of Tromsø (Norway), and Marja Verhoef, PhD, from the University of Calgary (Canada), emphasized the importance of connecting with researchers in related disciplines and leveraging the opportunity to link up with the emerging area called complex systems science, or network science.

The discussion, also revolved around whole systems clinical trial design and especially the methodological and ethical issues related to control groups and placebo interventions. Participants reinforced the need to educate the biomedical community and funding agencies about whole systems research.

‘It is evident that the model of the double-blind randomised controlled cross-over clinical trial not only does not but cannot adequately evaluate the complexity of interaction inherent in complex systems,’ says Journal Editor Kim A. Jobst, M.A., D.M. ‘The need to be able to do this is of ever growing importance.

The explorations of some of the greatest minds and most active researchers in the field of holistic integrated healthcare research and clinical delivery are contained in this Roundtable Discussion, which distills the essence of their deeply focused and serious debate on methodology, and makes available to all those interested in research, in clinical care delivery and in policy generation, some of their most recent and relevant conclusions. It is essential reading for anyone seriously interested in understanding whole systems thinking and research.’

Web: http://www.liebertpub.com/acm

Obese mice on a high-fat diet got the benefits of being thin - living healthier, longer lives - without the pain of dieting when they consumed huge doses of red wine extract, according to a landmark new study.

It is far too early to know if this would work in people, scientists said. But several, excited by the findings, called it promising and even ‘spectacular.’

The study by the Harvard Medical School and the National Institute on Aging shows that heavy doses of the red wine ingredient, resveratrol, lowers the rate of diabetes, liver problems and other fat-related ill effects in obese mice.

Fat-related deaths dropped 31 percent for obese mice on the supplement, compared to fat mice that got no treatment. The mice that got the wine extract also lived longer than expected, the study showed.

And astoundingly, the organs of the treated fat mice looked normal when they shouldn't have, said study lead author Dr. David Sinclair of Harvard Medical School.

‘They're chubby but inside they look great,’ Sinclair said. ‘You have to pinch yourself to make sure that this is all real, but the study involved 27 different researchers, each of whom had a `Eureka!' moment.’

Sinclair said other preliminary work still under way shows the wine ingredient has promise in extending the lives of normal-sized mice as well.

Sinclair has a financial stake in the research. He is co-founder of a pharmaceutical firm, Sirtris Pharmaceuticals Inc., which is testing to see if the extract can be used safely to treat people with diabetes.

For years, red wine has been linked to numerous health benefits. But the new study, published online in the journal Nature on Thursday, shows that mammals given ultrahigh doses of resveratrol can get the good effects of cutting calories without actually doing it.

‘If we're right about this, it would mean you could have the benefit of restricting calories without having to feel hungry,’ Sinclair said. ‘It's the Holy Grail of aging research.’

Even though he called the work ‘tantalising,’ Dr. Howard Eisenson, director of the Duke University Diet and Fitness Centre urged people not to get too excited.

‘All of us who practice medicine have learned that we can't leap from studies in the lab - particularly in lab animals - to what will happen in humans,’ Eisenson said.

Resveratrol, produced when plants are under stress, is found in the skin of grapes and in other plants, including peanuts and some berries.

The 55 resveratrol-treated obese mice were on a high-calorie diet - what one scientist called a ‘McDonald's diet’. Not only were they about as healthy as normal mice, they were also as agile and active on exercise equipment as their lean cousins, demonstrating a normal quality of life that was unexpected for such obese creatures, said study co-author Rafael de Cabo of the Institute on Aging.

‘These fat old mice can perform as well on this skill test as young lean mice,’ Sinclair said.

The only major body measurement that did not improve, aside from weight, was cholesterol, and that seemed not to matter to the overall health of the mice, Sinclair said.

The study is so promising that the aging institute is strongly considering a repeat of the same experiment with rhesus monkeys, a closer match to humans, said institute director Dr. Richard Hodes.

Hodes cautioned that it is too early for people to start taking nonregulated resveratrol supplements because safety issues have not been adequately considered.

Sirtris Pharmaceuticals is working on a high-dose resveratrol pill that, unlike unregulated supplements on the market now, would be used as a drug and require Food and Drug Administration approval, said company chief executive officer Dr. Christoph Westphal. That development and federal approval is about five years away, he said.

Sirtris is aiming the research at diseases of aging, which include diabetes.
Sinclair's results are so promising that he rushed the study into the science journal while the obese mice still are alive, not waiting several more weeks or months until they die. That raises some misgivings, including specific figures about mortality, but is understandable, said outside experts. The obese mice still lived past the median age for mice of their weight.

Even would-be competitors are praising the study.

‘It's a fairly spectacular result,’ said University of Wisconsin medical professor Dr. Richard Weindruch, who co-founded another biotech company that looks at the genetics of aging and drugs that could expand life spans. ‘People will go to McDonald's, and afterwards they'll do super-sized resveratrol.’

‘This is fantastic,’ said Brown University molecular biology professor Stephen Helfand, who was the first reviewer for the journal Nature and not part of the team. ‘This is a historic landmark contribution.’

Helfand said he won't be taking red wine extract supplements, but he has put his elderly parents on them. Such supplements are available at health food stores and online, but not at dose levels equivalent to what the mice in the experiment got, which was equal roughly to 100 bottles of wine a day in humans.

Mice, he said, are good initial test subjects for human drugs because their bodies function similarly to humans in many ways. However, the differences between mouse and man can prove crucial, he said.

Sinclair said he takes resveratrol supplements, but does not recommend it for others.

Resveratrol works by spurring activity and regrowth in cells' mitochondria, which Sinclair called ‘the energy powerhouses of the cell.’

Some scientists, such as Weindruch and Hodes, worry that the research may encourage people to forget about their diets and wait for a red wine cure-all that may never come.

‘It's not an excuse to overeat,’ Sinclair said. But he added that for mice at least, this shows you can be ‘fat, happy, healthy and vigorous.’

Web: http://www.nature.com/nature

Fishy Diet Fights Age-Related Brain Decline

People who ate the most fish on a weekly basis - putting them in the top quarter of a study population - were nearly 50 percent less likely to develop the mental deterioration known as dementia over time than participants in any of the other three quarters.

The observational study was led by Ernst J. Schaefer, an Agricultural Research Service-funded scientist. ARS is the U.S. Department of Agriculture's chief scientific research agency. Schaefer is a physician specialising in nutrition and health with the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Mass.

He and co-authors were looking for a relationship between blood levels of the fatty acid DHA and the risk of developing dementia. DHA is short for docosahexaenoic acid, a so-called ‘heart-healthy’ omega-3 fatty acid. Several different studies have linked either low DHA, or low fish intake levels, with the incidence of dementia.

The study was published in the November 13th issue of the Archives of Neurology. Schaefer and colleagues analysed available dietary questionnaires and blood levels of DHA of nearly 900 men and women, aged 55 to 88, who participated in the longitudinal Framingham (Mass.) Heart Study.

At the beginning of a nine-year period, all of the participants were found to be free of dementia. Using proportional regression analysis, the researchers determined the relative impact not only of blood levels of DHA, but also of potential ‘confounding’ variables such as age, gender, homocysteine and apolipoprotein-E levels, genotype and education.

They found that the participants who reported consuming an average of about three servings of oily fish a week - equivalent to blood levels of DHA at 180 milligrams daily - were associated with a significantly reduced risk of developing dementia of all types, including Alzheimer's disease. No other fatty acid blood level was independently linked to the risk of dementia.

The study suggests that relatively higher fish consumption over time correlates with a lower incidence of dementia in the over-55 set.

WHO and Partners Accelerate Fight against Counterfeit Medicines

On 15th November the World Health Organisation (WHO) and more than 20 international partners launched a comprehensive package of measures to help national authorities safeguard their populations from the dangers of counterfeit medicines.

At the opening of the first official meeting of IMPACT (the International Medical Products Anti-Counterfeiting Taskforce) in Bonn, WHO and its partners unveiled a programme covering legislation, law enforcement, regulation, technology and communication. IMPACT is also issuing a warning against buying medicines from rogue web sites as well as cautioning governments that existing laws against medical counterfeiters are inadequate and do not act as deterrents.

Counterfeit medicines range from products containing no active ingredients to those containing highly toxic substances. They can harm patients by failing to treat serious conditions, can provoke drug resistance and in some cases kill.

The latest estimates jointly elaborated by WHO, the OECD, and the Pharmaceutical Security Institute show that more than 30% of medicines in some areas of Latin America, South East Asia and Sub-Saharan Africa are counterfeit. In emerging economies, the proportion is estimated at 10% but in many of the former Soviet republics it can be as high as 20%. In wealthy countries, with strong regulatory mechanisms, counterfeits account for less than 1% of the market value, but 50% of illegal Internet sales are counterfeit.

‘The impact on people's lives behind these figures is devastating,’ said Dr Howard Zucker, WHO Assistant Director-General for Health Technology and Pharmaceuticals. ‘Whether rich or poor, many patients trustingly taking medicines may end up sicker or die. In addition, precious resources spent on these medicines go to waste.’

The legal systems of most countries do not consider the counterfeiting of medicines a more serious crime than counterfeiting luxury items such as handbags or watches. Their laws are designed mainly to protect trademarks than people's health. In some industrialised countries, counterfeiting t-shirts receives a harsher punishment than counterfeiting medicines.

WHO and its IMPACT partners will present guiding principles for model legislation to help countries adapt their laws to the gravity of the crime. ‘A major objective is for countries to agree that counterfeiting is a crime against human security and incorporate that principle into their laws,’ added Dr Zucker.

Legislation, regulation and enforcement also provide the basis for dealing with the sale of counterfeit medicines on the Internet, which is already rife in industrialised countries and is growing in a number of emerging economies in Latin America and Asia.

Some Internet pharmacies are completely legal operations, set up to offer clients convenience and savings. They require patient prescriptions and deliver medications from government licensed facilities. Other Internet pharmacies operate illegally, selling medications without prescriptions and using unapproved or counterfeit products. These rogue Internet pharmacies are operated internationally, they have no registered business address and sell products that have an unknown or unclear origin.

‘This area needs more work,’ said Dr Valerio Reggi, WHO Coordinator of IMPACT. ‘But the message for now is: do not take the risk of buying your medicines from unknown sources, such as the Internet. If you must buy from the Internet, ensure that the website is that of a pharmacy you know and trust.’

In the technology area, WHO has launched a challenge to technology providers to come up with new technologies or adapt existing ones to prevent counterfeiting and detect and track counterfeits on markets and on web sites.

WHO is currently looking at proposals from three mobile telephone companies to apply their technologies to check the authenticity of medical products. DNA-based technologies, nanotechnology and other approaches will be assessed by IMPACT in the first quarter of 2007.

To improve communication, a small group has been created to continuously update global data on medical counterfeiting and share the information with IMPACT partners. In addition, advocacy campaigns including public service announcements, short descriptive films and other awareness raising materials have begun targeting different professional sectors likely to come across the problem of counterfeits.
Organisations representing health professionals and consumers are supporting these initiatives.

Three countries with a high proportion of counterfeits have already started tackling the problem with IMPACT's support. Indonesia and Mali have begun wide communication campaigns to educate the general public on the dangers of counterfeits and to dissuade people seeking treatment from buying on the black market. Vietnam is establishing mechanisms to coordinate more effectively between regulatory, police, customs and provincial authorities in order to improve detection of counterfeit medicines and counterfeiters.

‘It is clear that action in a single sphere, like legislation or technology is not enough to deal effectively with the problem,’ said Dr Reggi. ‘This is why we need to act on five axes - legal, enforcement, regulatory, technology and communication. It's also why we need to coordinate action at a global level. But the fact that individual countries are already taking this on bodes well for the future.’

By the end of 2007 IMPACT aims to have all 193 WHO Member States formally collaborating to stem global and national counterfeiting of medical products.

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