From  MedScape

Women who have ever taken alendronate (Fosamax, Merck), the bisphosphonate widely prescribed for preservation of bone density that recently went off patent, have an increased risk of developing atrial fibrillation (AF), according to a population-based, case-control study in the April 28, 2008 Archives of Internal Medicine [1].

In multivariate analyses, the odds ratio (95% CI) for incident AF associated with current or past alendronate use among nearly 1700 women in a clinical practice setting was 1.86 (1.09 - 3.15), with a disproportionate share of the risk concentrated among those who were previously but are no longer on the drug.

“Bisphosphonates have been proven to prevent fractures in people at very high risk of fracture,” lead author Dr Susan R Heckbert (University of Washington, Seattle) observed for heartwire, and for those people, “the benefits in fracture prevention from taking alendronate will outweigh the possible risk of atrial fibrillation.”

For others, including patients “maybe at only moderate risk of fractures or for patients who are at particularly high risk of atrial fibrillation, such as those with coronary disease, heart failure, or diabetes,” she said, “they and their physicians need to do the best they can with the available evidence to weigh the benefits and risks.”

Heckbert et al observe that their work supports two prior studies that had suggested bisphosphonates might promote AF; published last year and reported then by heartwire, they were the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) trial of zoledronic acid (Zometa, Novartis) [2] and the Fracture Intervention Trial (FIT) using alendronate [3]. In contrast to those studies, according to the group, the current analysis shows increased risk of AF overall and also specifically in the acute-care setting.

An accompanying editorial [4] lists several notes of caution regarding the group’s findings, including some related to the study’s observational nature (such as the possible presence of uncontrolled confounders, like hyperthyroidism) and the fact that “the association [between alendronate and AF] has not been consistently reported and the biological plausibility of the finding is uncertain.” Conclude the authors, Drs Jane A Cauley and Kristine E Ensrud (University of Pittsburgh, PA), “At this time, it seems that the benefits of bisphosphonate treatment in patients with osteoporosis outweigh the risk of AF.”

Heckbert studied 719 patients with AF, classifying them according to duration of the arrhythmia and whether the diagnosis had been made in an outpatient or acute-care setting. They were matched with 966 non-AF controls according to age, treated hypertension, and calendar year of diagnosis.

Hazard ratio* for atrial fibrillation for users of alendronate compared to those who had never used alendronate

*Adjusted for age, treated hypertension, and calendar year of diagnosis (all matching variables) and for the diagnosis of osteoporosis and any cardiovascular disease

The AF risk didn’t vary by history of cardiovascular disease, treated hypertension, or age. Significantly increased AF risks were observed among patients who used statins and among diabetics, but there were so few patients involved, little can be made of the observations, according to Heckbert.

The bisphosphonate-AF link observed in the current analysis and the HORIZON and FIT studies, she said, “was and still is a completely unexpected effect,” whose mechanism, if the effect is real, remains undefined. Speculating, Heckbert said infusions of the drugs could cause an inflammatory response, “and inflammation is known to be related to the development of atrial fibrillation.” Or, she said, the treatment may affect the metabolism of calcium or other ions to which the atrium may be sensitive.

Heckbert said she knows no reason why their findings wouldn’t apply to men. “We would have liked to study this in men,” she said, but in their database, “you could count on one hand the number of men who had atrial fibrillation and were taking a bisphosphonate.”

From FoodNavigatorUSA 

 The food crisis is neither new nor sudden. The several underlying causes have been independently, steadily gathering speed and have collided in a perfect storm not seen for generations. It is going to take a coordinated, long-term effort to untangle them.

At FoodNavigator.com we have been reporting on rising costs since 2003. Reducing costs and protecting margins has been a long-term battle for manufacturers.But in recent weeks the situation has reached new shades of gloom, as governments around the world have taken steps to reduce the impact on their populations (and protect their own positions of power).No-one wants to be the next Jacques-Edouard Alexis, the Haitian prime minister dismissed by the senate after wide-spread rioting over food prices.

Even so, the life sentence in prison faced by anyone found to be hoarding rice in the Philippines is extreme, at least by Western judicial systems.

And yet, the World Food Programme’s stark warning that the world’s poorest folk are facing starvation rather puts our grumbling about the upward creep of grocery bills in context. 

Various solutions have been bandied about in the last week. In fact, finding the solution has become a battleground of ideologies.

US and European policy to increase use of biofuels - once seen as the great hope for reducing reliance on fossil fuels and environmental protection - could now be on course for a U-turn.

It is generally agreed that biofuels’ demand on corn and other grain supplies is not the main or only cause of the current situation. Experts have estimated that their contribution to the current scenario is between 10 and 30 per cent.

The EU’s target that 10 per cent of energy should come from biofuels by 2020 may well need to be put on ice, at least until second generation biofuels based on cellulose from waste materials are developed to an industrial level.

Elsewhere, an editorial in The Lancet criticised rich countries for “dumping subsidised produce into the markets of poor nations, wrecking the livelihoods of local farmers in those countries.”

French agriculture minister Michel Barnier, meanwhile, said in an interview with The Financial Times that he would not allow European subsidies and trade barrier system to be blamed for high commodity prices.

Rather, he recommends that Africa and Latin America adopt their own versions of the European Common Agricultural Policy - and he believes the EU should be providing money and know-how to help them develop parallel policies.

The Economist said that, as a first step, rich countries should be bridging the $700m gap in the World Food Programme’s funding this year that has emerged as a result of higher prices for the rice and other basics it distributes to famine-struck regions.

$700m is not a lot in the grand scheme of things. It’s about one 148^th of the annual turnover of Nestle, the world’s largest food company.

The newspaper admitted that such funding would be a palliative and that a longer-term approach to stopping trade distortions. But The Lancet has said that hand-outs, however well-meaning, are ineffectual if the countries making them do not “stand up to their own farmers” and abolish subsidies.

Such debate, whether conduced through the media or at a world summit as proposed by UN secretary general Ban Ki-moon, is crucial.

But the problem is only going to be solved if political consensus can be reached and a multi-lateral, international strategy is put in place - and fast.

For almost a decade we (in the West, at least) have been growing fat and arrogant on low-cost food, believing that, at last, we have got food supply licked.

It’s time to put arrogance aside and take the first steps down what looks to be a long road to a brand new model for global food supply.

From Arch Intern Med

Background The Dietary Approaches to Stop Hypertension (DASH) diet has been shown to lower blood pressure, but little is known about its long-term effect on cardiovascular end points. Our objective was to assess the association between a DASH-style diet adherence score and risk of coronary heart disease (CHD) and stroke in women.

Methods In this prospective cohort study, diet was assessed 7 times during 24 years of follow-up (1980-2004) with validated food frequency questionnaires. A DASH score based on 8 food and nutrient components (fruits, vegetables, whole grains, nuts and legumes, low-fat dairy, red and processed meats, sweetened beverages, and sodium) was calculated. Lifestyle and medical information was collected biennially with a questionnaire. The Cox proportional hazard model was used to adjust for potential confounders. The study population comprised 88517 female nurses aged 34 to 59 years without a history of cardiovascular disease or diabetes in 1980. The main outcome measures were the numbers of confirmed incident cases of nonfatal myocardial infarction, CHD death, and stroke.

Results We documented 2129 cases of incident nonfatal myocardial infarction, 976 CHD deaths, and 3105 cases of stroke. After adjustment for age, smoking, and other cardiovascular risk factors, the relative risks of CHD across quintiles of the DASH score were 1.0, 0.99, 0.86, 0.87, and 0.76 (95% confidence interval, 0.67-0.85) (P

From USATODAY.com

The osteoporosis drug Fosamax appears to double a woman’s odds of developing atrial fibrillation, a chronic irregular heartbeat, a study reported Monday.

The study raises fresh concerns about a popular drug taken by millions of postmenopausal women and puts patients and their doctors in a bind: Fosamax is the only drug known to build bone in women who are prone to osteoporosis. Research has shown that it reduces hip fractures by 63%.

Even lead author Susan Heckbert of the University of Washington cautioned women not to stop taking Fosamax without talking to their doctors. “For women at high risk, the drug’s benefit will vastly outweigh the risk of atrial fibrillation,” she says.

BETTER LIFE: Health news and wellness tips

Heckbert and colleagues decided to study the link between Fosamax and atrial fibrillation after a report last year linking an intravenous drug from the same class, Reclast, with a high risk of the abnormality. Atrial fibrillation causes fatigue, dizziness and fainting, but it isn’t life-threatening.

The Reclast study, called Horizon, was published last year along with novel analysis from a study of 6,459 patients called FIT (Fracture Intervention Trial) that first appeared in 1997. The new analysis found that patients who took Fosamax were more prone to severe atrial fibrillation than those taking a placebo, though the link wasn’t conclusive.

The drug’s maker, Merck & Co., and independent experts reviewed the evidence from FIT and results from 28 Fosamax trials and concluded that a link with atrial fibrillation was “unlikely.”

Arthur Santora, Merck’s director of clinical research, says: “In FIT, we did look pretty specifically at atrial fibrillation.” Researchers who carried out the study held all the data and published the study without interference from Merck, he says.

Heckbert, a cardiovascular epidemiologist, says she hoped to resolve the uncertainty using data from a long-term study of atrial fibrillation at Group Health, a statewide health care provider in Washington. The study, which involved more than 1,700 women, found that 6.5% of 719 patients with atrial fibrillation took Fosamax, compared with 4.1% of more than 900 women who did not take the drug, according to the study in Archives of Internal Medicine.

Women who had taken the drug had an 86% higher risk of atrial fibrillation than those who never took Fosamax, the study found. But these results too were far from conclusive, doctors say. Fosamax accounted for 3% of the atrial fibrillation cases, and 97% were the result of other causes.

“We need more data to know if this is coincidence or if it’s real,” says Ethel Siris, president of the National Osteoporosis Foundation. “You should certainly treat women who need to be treated, because fractures are serious. And if you’ve ever taken the drug, you’re already at risk, so stopping it won’t help you.”

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.