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Archive for April, 2008

New BPA evidence piles pressure on FDA to set exposure limits

Note: The dangers and concerns about bisphenol A are described in my book, Raise a Smarter Child by Kindergarten.

David Perlmutter, MD, FACN

FromFoodNavigator.com

Pressure is growing on the US Food and Drug Administration to set new restrictions on the use of the chemical bisphenol A (BPA) in food packaging following a new safety study. A report from the US National Toxicology Program (NTP) concluded that there was “some concern for neural and behavioural effects in foetuses, infants, and children at current human exposures” to BPA, which is used extensively in the plastic lining in food cans.

A report from the US National Toxicology Program (NTP) concluded that there was
to BPA, which is used extensively in the plastic lining in food cans.According to the NTP, there was evidence that BPA could induce cancer in humans at current exposure levels, although it stressed that “more research is needed”.

The report, published earlier this week, has already prompted calls from senior US politicians for rapid action from the FDA, which has previously cleared BPA for use in food packaging.

Existing concerns

This is not the first study to suggest a link between cancer and BPA. A report published last year by Environmental Working Group (EWG), a non-profit environmental research organisation, showed that the chemical could leach into canned food at levels reaching 200 times the ‘acceptable’ amount.

As yet, the FDA has set no maximum exposure levels for BPA - EWG’s ‘acceptable’ level was based on government studies on rodents, with human exposure typically set to between 1000 to 3000 times the levels that harm lab animals.

But it is the NTP’s suggestion that BPA could be harmful even at ‘normal’ exposure levels that has prompted calls for the FDA to finally set some form of maximum intake level, in line with regulators elsewhere.

The European Food Safety Agency last year set a tolerable daily intake (TDI) level for BPA of five milligrams/kg body weight/day - but stressed that current exposure levels were just 30 per cent of the TDI.

Industry

Can makers insist that there is insufficient evidence to show that the chemical is a health risk given the current exposure levels.

Robert R. Budway, president of the US Can Manufacturers Institute, whose members account for around 80 per cent of all the cans produced there, told FoodProductionDaily.com last year that the levels of BPA in food found during the EWG study were well below the TDI level set in Europe.

“In fact, the single highest value they reported is approximately 10 times lower than the EU allows,” he said at the time.

But in many ways the harm has already been done: “Reduce your use of canned foods,” the NTP recommends to consumers wanting to avoid BPA, adding “when possible, opt for glass, porcelain or stainless steel containers, particularly for hot food or liquids” - a recommendation that could prove highly damaging for the US can manufacturing sector if producers also start to seek alternative packaging sources.

Budway said that despite the lack of concrete evidence surrounding a BPA health risk, it was likely that can makers were looking for alternative solutions, although he was “not aware of any specific cases” at the time.

Meanwhile, health officials in Canada are reported to be considering banning all use of BPA in food packaging - a decision could be made as early as this week, according to press reports - making it the first country to declare the chemical unsafe.

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Vitamin D status linked to artery health: study

From FoodNavigator.com

Increased levels of vitamin D may improve cardiovascular health and reduce the prevalence of peripheral arterial disease (PAD), suggests a new study.

Moreover, the relationship was consistent across the difference subgroups. “The consistency of the results in these subgroups is noteworthy,” wrote the researchers.

The authors note that the relationship does not prove that increased levels of vitamin D protect against PAD directly, and that higher vitamin D levels may be a marker of general or specific lifestyle practices.

Mechanism

The potential mechanism by which vitamin D may improve cardiovascular health is not known and is “controversial,” wrote the authors.

“In some studies, low 25(OH)D levels have been associated with increased prevalence of coronary heart disease (CHD), stroke, and congestive heart failure. However, low 25(OH)D has been associated with a protective association in other studies,” they stated.

Dr. Melamed added: “We know that in mice, vitamin D regulates one of the hormone systems that affects blood pressure. Since cells in the blood vessels have receptors for vitamin D, it may directly affect the vessels, although this has not been fully worked out.”

The researchers called for large randomised clinical trials to address if vitamin D supplementation could offer protection against PAD.

Vitamin D refers to two biologically inactive precursors - D3, also known as cholecalciferol, and D2, also known as ergocalciferol. The former, produced in the skin on exposure to UVB radiation (290 to 320 nm), is said to be more bioactive. The latter is derived from plants and only enters the body via the diet, from consumption of foods such as oily fish, egg yolk and liver.

Both D3 and D2 precursors are hydroxylated in the liver and kidneys to form 25(OH)D, and 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active form that is tightly controlled by the body.

Source: Arteriosclerosis, Thrombosis, and Vascular Biology

Published online ahead of print, April 2008, doi:10.1161/ATVBAHA.108.165886

“Serum 25-Hydroxyvitamin D Levels and the Prevalence of Peripheral Arterial Disease. Results from NHANES 2001 to 2004″Authors: M.L. Melamed, P. Muntner, E.D. Michos, J. Uribarri, C. Weber, J. Sharma, P. RaggiAuthors: M.L. Melamed, P. Muntner, E.D. Michos, J. Uribarri, C. Weber, J. Sharma, P. Raggi

Authors: M.L. Melamed, P. Muntner, E.D. Michos, J. Uribarri, C. Weber, J. Sharma, P. Raggi

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Delaying DPT Vaccination May Reduce Incidence of Childhood Asthma

FromMedScape

Childhood asthma is reduced by half when the first dose of diphtheria, pertussis, and tetanus (DPT) is delayed by more than 2 months vs given during the recommended period, according to the results of a retrospective longitudinal study reported in the March issue of the Journal of Allergy & Clinical Immunology.

“Early childhood immunizations have been viewed as promoters of asthma development by stimulating a TH2-type immune response or decreasing microbial pressure, which shifts the balance between TH1 and TH2 immunity,” write Kara L. McDonald, MSc, from the University of Manitoba in Winnipeg, Manitoba, Canada, and colleagues. “Differing time schedules for childhood immunizations may explain the discrepant findings of an association with asthma reported in observational studies. This research was undertaken to determine whether timing of diphtheria, pertussis, tetanus (DPT) immunization has an effect on the development of childhood asthma by age 7 years.”

The investigators analyzed data from the complete immunization and healthcare records of a cohort of children born in Manitoba in 1995, from birth until age 7 years. Using multivariable logistic regression, they computed the adjusted odds ratio for asthma at age 7 years according to the timing of DPT immunization.

Among 11,531 children who received at least 4 doses of DPT, the risk for asthma was halved in children in whom administration of the first dose of DPT was delayed by more than 2 months. For children with delays in administration of all 3 doses, the likelihood of asthma was 0.39 (95% confidence interval [CI], 0.18 - 0.86).

“We found a negative association between delay in administration of the first dose of whole-cell DPT immunization in childhood and the development of asthma; the association was greater with delays in all of the first 3 doses,” the study authors write. “The mechanism for this phenomenon requires further research.”

Limitations of this study include possible ascertainment bias; findings not yet confirmed with the diphtheria, acellular pertussis, tetanus (DaPT) vaccine; and inability to refute the issue of early-life infections as an explanation for the association between delayed immunization and protection against the development of asthma.

“Further study is vital to gain a detailed understanding of the relationship between vaccination and allergic disease, because a perception that vaccination is harmful may have an adverse effect on the effectiveness of immunization programs,” the study authors conclude.

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Antibiotics Modestly Effective in Treating Acute Sinusitis

From MedScape

For treatment of acute maxillary sinusitis, the potential, but small, benefits of antibiotics should be weighed against the risk for adverse effects and development of resistance, according to a Cochrane review of 57 studies reported in the April 16 issue of the Cochrane Database Systematic Review. Although this review showed a small treatment effect in primary care patients with uncomplicated acute sinusitis who had symptoms for more than 7 days, 80% of those who were untreated improved within 2 weeks.

“Expert opinions vary on the appropriate role of antibiotics for sinusitis, one of the most commonly diagnosed conditions among adults in ambulatory care,” write Anneli Ahovuo-Saloranta, DDS, from the Finnish Office for Health Technology Assessment/FinOHTA, National Research and Development Centre for Welfare & Health/STAKES, in Tampere, Finland, and colleagues.

“Treatment recommendations for acute sinusitis are divided and range from only treating patients with severe or persistent moderate symptoms and specific bacterial sinusitis findings with narrow spectrum antibiotics; to treating all patients with acute bacterial sinusitis with broad spectrum antibiotics. The purpose of antibiotics is to decrease symptoms and restore the normal function of the sinuses, in order to prevent complications and the development of chronic sinusitis.”

The goal of this review was to assess the efficacy of antibiotics in treating acute sinusitis, and if efficacy were shown, to determine which antibiotic classes are the most effective. The reviewers searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, 2007, Issue 3), MEDLINE (1950 to May 2007), and EMBASE (1974 to June 2007) for randomized controlled trials comparing antibiotics with placebo or antibiotics from different classes for acute maxillary sinusitis in adults.

Trials with clinically diagnosed acute sinusitis were included, regardless of whether diagnosis was confirmed by radiography or bacterial culture.

Two or more review authors independently screened the search results, extracted data, and determined the quality of the included trials. To assess whether the administered treatment was a success or a failure, risk ratios (RR) were calculated for differences between the intervention and control groups. For meta-analysis of placebo-controlled trials, data were combined across antibiotic classes. The main endpoints were the clinical failure rates at 7 to 15 days and at 16 to 60 days follow-up.

Of 57 studies included in the review, 6 were placebo-controlled trials, and 51 were studies comparing different antibiotics classes. There were 5 studies, enrolling a total of 631 participants, that provided data allowing comparison of antibiotics with placebo in terms of clinical failure, defined as a lack of cure or improvement at 7 to 15 days follow-up.

In these studies, there was a slight statistical difference favoring antibiotics over placebo, with a pooled RR of 0.66 (95% confidence interval [CI], 0.44 - 0.98). Clinically, however, this result was of equivocal significance because cure or improvement rate was high in both the placebo group (80%) and in the antibiotic group (90%).

There were 6 studies in which clinical failure was defined as a lack of total cure. In these, antibiotics were significantly better than placebo, with a pooled RR at 7 to 15 days follow-up of 0.74 (95% CI, 0.65 - 0.84). None of the antibiotic preparations was superior to any of the others.

“Antibiotics have a small treatment effect in patients with uncomplicated acute sinusitis in a primary care setting with symptoms for more than seven days,” the review authors conclude.

“However, 80% of participants treated without antibiotics improve within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level.”

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FDA Quietly Acknowledges Medical Benefits of Honey

From NaturalNews.com

In an Associated Press story dated December 27th 2007, it was revealed that the U.S. Food and Drug Administration had quietly approved a line of honey-based wound dressings during the fall of that year. Derma Sciences, Inc., a New Jersey manufacturer of medical wound and skin care supplies, was then able to market their MEDIHONEY product. MEDIHONEY is a line of wound dressings consisting chiefly of an absorbent alginate (which is a component of brown algae) pad, covered in Manuka (Leptospermum) honey.

Using honey to treat wounds is nothing new; even ancient civilizations used it in this manner. However, this is the sort of thing that usually gets relegated to “folk healing”. It seems scientifically obvious: honey is very acidic (antibacterial), and it produces its own hydrogen peroxide when combined with the fluid which drains from a wound! The extremely high sugar content of honey means it contains very little water. So, it draws the pus and fluid from the wound, thereby speeding the healing process. Furthermore, the honey contains powerful germ-fighting phytochemicals from the plants that produced the pollen harvested by the honeybees. Having already been accepted by the overseas mainstream medical community for some time, North America finally caught on. MEDIHONEY is, according to Derma Sciences’ website, “the first honey-based product cleared for use by Health Canada and also the first cleared for use by the FDA.”

Manuka (Leptospermum scoparium) is a New Zealand tree, related to the Tea Tree (Melaleuca). Much like tea tree oil, native New Zealanders have taken advantage of the Manuka’s natural medicine for generations. It turned out that the honey produced from this plant’s pollen has powerful antibacterial, antifungal, and antimicrobial properties. Doctors found it very useful for treating burn and injury patients in Iraq. Widespread applications include treatment of surgical sites, trauma wounds, skin grafts, burns, and skin sores.

Doctors are even finding that Manuka honey works on drug-resistant infections. As pharmaceutical antibiotics become less and less effective, natural cures may be taken more seriously. Ironically, they have also discovered that these honey dressings can prevent the development of MRSA in an open wound (See Natural News Article Honeybees and Almonds, Pigs and MRSA: The Deadly Connections for another story linking MRSA and honeybees). It’s very disturbing to consider the fact that we may be killing off the very methods by which we can defeat our pharmaceutically resistant 21st century superbugs!

While browsing Derma Sciences’ website, I noticed that they also manufacture a product which incorporates “antimicrobial silver” into wound dressings. This product, ALGICELL Ag, has also been approved by the FDA. Could they be getting around to recognizing the benefits of colloidal silver, at long last? Perhaps even the FDA shall have to re-examine its position on nutraceuticals and holistic treatments, as it’s becoming glaringly evident that Big Pharma doesn’t have all the answers.

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