Thursday, March 1, 2012

News and Events - 02 Mar 2012




mrothschild@foodsafetynews.com (Mary Rothschild
29.02.2012 12:59:06
Late last year, Interpol-Europol agents seized hundreds of tons of counterfeit, fake and substandard food and beverages, including champagne, cheese, olive oil and tea, across 10 countries in Europe.
During Operation Opson (opson translates to "food" in ancient Greek , authorities confiscated more than 13,000 bottles of substandard olive oil, 30 tons of fake tomato sauce, about 77,000 kg. of counterfeit cheese, more than 12,000 bottles of substandard wine, five tons of substandard fish and seafood, nearly 30,000 counterfeit candy bars and investigated fake/substandard caviar being sold via the Internet.  
The one-week effort (from November 28 to December 4 involved police, customs agents, regulatory and food-industry officials in airports, seaports, shops and flea markets in Bulgaria, Denmark, France, Hungary, Italy, The Netherlands, Romania, Spain, Turkey and the United Kingdom.
At the time, Simone Di Meo, Criminal Intelligence Officer with Interpol's Intellectual Property Rights program and coordinator for Operation Opson,
said in a news release that counterfeit food is a threat most people are not even aware of, so "one of the main goals of this operation was to protect the public from potentially dangerous fake and substandard food and drinks."

This week in Brussels, food control authorities, police forces, judicial officials and other stakeholders from across the European Union met again to develop strategies for combating food-related crime -- to understand the nature of food counterfeit schemes, to improve detection of these illegal practices and to raise public awareness of the problem to prompt vigilance when shopping.
The conference, held Monday and Tuesday, was part of the EU's Better Training for Safer Food program.
Consumers buying counterfeit goods, either knowingly or unknowingly according to European authorities, put their health at risk because fraudulent foods and beverages are not subject to any manufacturing quality controls and are often transported or stored without regard to safe food-handling standards. 
The problem of counterfeit and substandard products is also a concern in the United States, most visible with fake pharmaceuticals, but also with food items. Cheaper types of fish have been passed off as more expensive, such as tilapia being marketed as red snapper or farm-raised salmon being labeled as wild-caught.
According to the U.S. Food and Drug Administration, olive oil is one of the most frequently counterfeited food products -- it is sometimes sold as "extra virgin" when it is actually mostly soybean oil.  Honey, maple syrup and vanilla counterfeits have also plagued the U.S. market.
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Photo from Interpol-Europol
 



hbottemiller@foodsafetynews.com (Helena Bottemiller
01.03.2012 12:59:07
Researchers have long suspected a link between the E. coli that causes human urinary tract infections and E. coli contamination in meat products, and new research gives more credence to the theory.

A
study published in the Centers for Disease Control and Prevention's Emerging Infectious Diseases journal found genetic similarities between E. coli from animals sampled at slaughterhouses and the E. coli that causes UTIs and concluded that chickens were the most likely reservoir.

Urinary tract infections (UTIs are the second most common type of infection in the body, accounting for 8.1 million visits to health care providers in the United States each year and around $1-2 billion per year in health care costs. Around 85 percent of these infections are caused by extraintestinal pathogenic Escherichia coli, or ExPEC, which doctors long assumed came from patient's own intestines. New research, however, has been looking at outside sources as potentially part of the problem.

The relatively recent emergence of drug-resistant E. coli has made UTI infections more complicated and expensive to treat, which makes understanding E. coli reservoirs even more important.

The latest study, which was conducted by researchers at several Canadian universities,  collected 531 E. coli isolates from people with UTIs in Montreal and another 124 isolates from people across Canada and compared them to 737 isolates from beef, chicken and pork products sampled at the retail level from Montreal and elsewhere. They also took 349 samples from the same food animals in slaughterhouses.

The researchers concluded that beef and pork isolates were much less likely than chicken isolates to be "clonal related" to isolates from humans with UTIs and they hypothesized that food could be a source of transmission.

"This study confirms our hypothesis that chickens are a likely reservoir for ExPEC in humans," reads the study. "However, epidemiologic data, such as diet or other exposures, were not available for the humans with UTIs. This information could have been used to search for other potential routes of transmission (e.g., travel, water sources and to strengthen the connection between poultry consumption and UTI."

The researchers used an ecological design for their study, which means that isolates were systematically and purposely selected, or rather: meat samples were taken near the same communities that suffered the UTIs.

The study's authors said the results from their analysis suggest that "potential ExPEC transmission from food animal sources is likely to be implicated in human infections and that chicken is a major reservoir."

They added: "The possibility that ExPEC causing UTIs and other extraintestinal infections in humans could originate from a food animal reservoir raises public health concern. New interventions may be needed to reduce the level of food contamination and risk for transmission."

Amee Manges, associate professor of epidemiology and biostatistics at McGill University in Montreal told Food Safety News her team is now working on a pan-Canadian study to examine this issue more closely and the study will include collecting epidemiologic information from women experiencing urinary tract infections.

"We will also be comparing the E. coli causing infections in these women to E. coli recovered from retail meat (through the Public Health Agency of Canada's surveillance program entitled Canadian Integrated Program on Antimicrobial Resistance Surveillance from the same geographic areas in which the UTIs are occurring," said Manges. "This should give us more information about the spread of these E. coli and hopefully help establish the existence of a food reservoir."

Asked about whether anything about the findings surprised the researchers, Manges brought up drug-resistance.

We are most worried about the selection and amplification of drug-resistant E. coli on the farms because of improper or overuse of antimicrobials during food animal production," she said. "It may be possible to reduce the level of drug-resistant infections in humans by encouraging rationale and judicious use of antimicrobials on farms. Changing how food animals are produced could help as well.  Other approaches might include treating meats to reduce retail meat contamination by E. coli and encouraging better food handling practices."

"Prevention of E. coli urinary tract infections in people might need to start on chicken farms," read a CDC summary of the study.

The National Chicken Council questioned the findings.

"While we question the overall conclusions of this study, the study's researchers point to improper food handling during meat preparation for food-borne UTIs," said council spokesman Tom Super. "So it is always pertinent to remind consumers about the importance of safe food handling and cooking - washing of hands, cutting boards and utensils, cooking chicken to an internal temperature of 165 degrees F and preventing cross contamination in the kitchen."

This story has been updated to include feedback from researcher Amee Manges.
 





29.02.2012 22:34:00


Photo courtesy of Flickr user
Mr. T in DC.

Grab some chocolate, pop an aspirin and wash it all down with red wine. You're on your way to a heart-healthy life, right? Not so fast.

According to Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, much of the information Americans use as a guide for heart health is little more than folklore.

"It's appalling," he said. "And it's getting worse. These days, you can conduct an Internet search for any heart condition and get a lot of information. The problem is most of it is wrong. And a lot of the common mythology is wrong, too."

In a new book, "
Heart 411," Nissen and his colleague, cardiac surgeon Dr. Marc Gillinov, approach some of the more popular rumors "the way a jury would approach a trial": Is there evidence beyond a reasonable doubt that red wine is good for your heart or that red meat is bad?

On this final day of American Heart Month, Nissen shared some of their verdicts.

Myth 1: Red Wine

"It turns out that there's no information to suggest that red wine is better than any other form of alcohol for your heart," Nissen said. "But there is information to show that moderate alcohol intake of any kind -- red wine, white wine, beer or hard spirits -- benefits patients in preventing heart disease. It does so by raising the good cholesterol, or HDL.

"The myth about red wine came from the so-called French paradox -- that the French drink a lot of red wine and they have a relatively low instance of heart disease, despite the fact that they eat a lot of fat. People began to think maybe red wine was protecting them. And there was a little bit of research in animals showing that an element of red wine known as resveratrol seemed to be protective in mice. But what the public didn't get was that they gave thousands of times more resveratrol to the mice than humans would ever get from drinking red wine, and the research just didn't hold up in additional studies.

"At the end of the day, we don't recommend taking up drinking to benefit your heart. But if you do drink a glass or two of alcohol per day, depending on your body mass, it can be a heart-healthy activity."

Myth 2: Red Meat

"Red meat is a source of saturated fat, and all other things being equal, saturated fat does tend to raise the bad cholesterol, LDL. And so it's not a good thing," Nissen said.

"However, we stress the importance of a diet we call, 'no-fad.' One of the most disturbing current trends promises that if you eat no meat and virtually no fat, you'll become 'heart attack proof.' Our conclusions from the research out there is that this is just utter nonsense -- that there are no 'heart-attack-proof' diets, that completely eliminating fat, including meat, does not have a convincing health benefit, and that in fact a balanced diet is best.

"We advocate what is called the Mediterranean diet -- one that actually has quite a bit of fat -- good fat like olive oil and canola oil, fats that contain polyunsaturated fatty acids and not a lot of trans fats. If someone promises you that a diet will melt away the plaque in your coronary, run as fast away from those diets as you can.

"Eating red meat in moderation is not a problem. It's not good for your heart, but if you don't exceed reasonable quantities -- small amounts of red meat as part of a balanced diet -- it is not something people need to avoid."

Myth 3: Chocolate

"There is a little bit of evidence -- and it's not very strong -- that dark chocolate is probably an OK food for the heart," Nissen said. "There's even a small study that seems to indicate that dark chocolate might lower blood pressure a little bit. But the effects are very small, and all chocolate tends to have a fair amount of calories and a lot of sugar.

"And so to call any chocolate a heart-healthy food is a mistake. This is another example, because it's cutesy, because it's newsy: Whenever one of these poor-quality studies comes out, they get latched upon by the media. But the truth is there are no randomized control trials of any quality on this subject.

"In our book, we talk about the difference between an observational study and a randomized control trial. Most of the alcohol and chocolate studies do not come from randomized control trials, where you would give half the people these substances for five years and half of them would avoid it altogether and you find out who does better. In fact, they come from observational studies, which are inherently flawed. And so the solidity of the evidence is much more limited when you have only observational data."

Myth 4: Work-Related Stress

"It's not a huge factor, but it does appear to play some role in a minority of heart attacks," Nissen said. "We actually have some pretty good scientific data that extreme levels of stress can cause something called
Broken Heart Syndrome, which is caused by a sudden rush of stress.

"The best data comes from some interesting observations that during the Super Bowl, when a person is rooting for his or her team and their stress and anxiety goes up, there appears to be more heart attacks. But even better data comes from places like Israel, during the first Gulf War (and the Scud missile attacks. When people were under tremendous stress, there was a big bump in the rate of heart attacks.

"All of this shows that stress under some circumstances, particularly when it's extreme, can trigger a heart attack. But it is also important to note that we are pretty well-adapted as a species to handle stress. Our ancestors had lots of it. When we were swinging from the trees in the jungle, there were predators chasing after us. And so stress is not just a function of modern life. We don't think chronic stress is good for people. It does seem to raise levels of inflammation in the body. But people should not believe that if they've got some stress in their lives, it's going to make them have a heart attack. Stress is a factor, but it's certainly not the most important factor in heart disease."

Myth 5: Sex

"It's extremely rare, but you can have a heart attack from sex," Nissen said. "There is some data -- and this is perhaps comforting to some spouses in the country -- that sex with your regular partner does not raise the heart rate and blood pressure to levels that are strongly associated with having a heart attack.

"However, sex with a non-regular partner, particularly if you're in an extramarital relationship, does seem to have an association with an increased risk of a heart attack. And I think the reasons that most people have surmised is that there is more excitement involved. There may be a fear of being caught and there's maybe some guilt. For all of those reasons, heart rate and blood pressure go up and may act as a trigger for a heart attack.

"So it's one more reason to stay faithful to your spouse. On the opposite end of the spectrum, don't count on sex as your form of exercise for the day. For most of us, the duration of activity is insufficient to meet the aerobic needs of an exercise program."

Updated March 1: Here is the second set of myths as explained by Nissen:

Myth 6: Dietary Supplements

"Almost all of our patients come in taking dietary supplements, and they believe that it will help their heart health because it says right on the bottle, 'Promotes heart health.' These are products like fish oil, coenzyme Q, and the big rage now, Vitamin D. You know, if you go into the local pharmacy, you can find row after row after row of dietary supplements -- many I haven't even heard of. And none of these claims have been evaluated by the Food and Drug Administration.

"In fact, in a great national tragedy in 1993, Congress passed a law that barred the FDA from regulating dietary supplements. And so we don't even know whether most of the dietary supplements actually contain the ingredients they claim to contain. At the moment, everybody is taking Vitamin D, and there just isn't evidence that it protects the heart. More importantly, it diverts patients away from the real therapies that they need.

"Often when we go on a book signing, we will ask the audience how many people take fish oil. And lots of hands go up. And then we ask them, 'Do you think the fish oil lowers your cholesterol?' and most of the hands go up. Fish oil actually raises levels of LDL cholesterol -- it doesn't lower it, it raises it. But the problem is those claims cannot be regulated because the FDA is virtually powerless. Sooner or later there will be a major national catastrophe.

"We also warn people that these dietary supplements can even interact with their prescription medications, causing them to become toxic or ineffective. And so there are no dietary supplements that we recommend for patients."

Myth 7: An Aspirin a Day

"Another long-standing myth is that it's a good idea to take an aspirin a day for people who are at risk for heart disease. In fact, if you're at low enough risk -- if you're an otherwise healthy 40- or 50-year-old man or woman -- it actually increases your risk of adverse consequences, including bleeding into your brain and into your stomach. That's because aspirin is an anticoagulant, it prevents clotting of the blood. And that is, of course, a benefit but it's also a risk.

"In the stomach, it has been found to irritate the lining by affecting something known as the prostaglandins, which are protective in the stomach. When those prostaglandins are altered, the stomach is more vulnerable to the effects of acid, leading to erosion of the stomach and bleeding. And the second mechanism is that because aspirin is an anti-platelet agent, it actually prevents blood clotting. And so the combination of irritation to the gastro-intestinal tract plus the anti-coagulant effect is what leads to an increased risk of gastrointestinal bleeding, which is quite significant.

"As for the brain, people of certain ages have areas of weakness in the blood vessels of the brain, and if you get a little bit of a break in those blood vessels and your blood clots normally, nothing bad may happen. But if you have an anticoagulant on board, you may have a serious cranial bleed. When you add it all up, for people who are otherwise healthy, the risks exceed the benefits of taking an aspirin a day."

Myth 8: Stress Testing

"This is an often-unnecessary test in which a patient walks on a treadmill and has their electrocardiogram monitored so that the physician can look for changes that may be a consequence of not getting enough blood flow to the heart muscle. It's a test that's very commonly done in America millions of times each year, and many people are having them done who shouldn't. In fact, we strongly discourage it in most cases unless the patient is having chest pain symptoms.

"The problem with it is that there are too many false positives and no evidence that screening people with stress testing actually improves their health. These tests often lead to an angiogram and ultimately, to unnecessary coronary interventions, like a stent. Why is this being done so much? Well I hate to be so cynical, but one of the reasons is that are certainly economic incentives for doctors to over-test. Some people have the test done simply because they tell their doctor they want to start an exercise program and their doctor will say, 'OK, well let's do a stress test on you.' People should push back against those kinds of recommendations if they don't have any of the symptoms of heart disease."

Myth 9: Calcium Testing

"This is another test commonly performed and widely advocated that we don't recommend. People are put in a special kind of CT scan and their doctor looks for calcium in the coronaries of the heart. When you see calcium, it usually means there's plaque in the coronaries, and physicians can then try to prevent heart disease. The problem is that we should be preventing people with risk factors whether or not they have calcium in their coronaries. And so essentially it doesn't give us information that we can use productively to prevent people from dying or having a heart attack.

"Even though it may have some predictive value, it also can lead to more testing and some pretty significantly bad consequences. If a minor blockage is found, the temptation is often very high to do an angiography, to do a catheterization, and sometimes, even to put in a stent. There's no evidence that if you take somebody who doesn't have symptoms and do a heart catheterization, that anything you find will actually benefit the patient. And so it's driving up health care costs. America spends more on health care than any other country by a factor of about two, and this is one of the reasons why."

Myth 10: Women Don't Feel Chest Pain During Heart Attacks

"This one is just pervasive. After a recent article in JAMA (the Journal of the American Medical Association , this has been covered by the media a lot -- that many women who have heart attacks don't have chest pain. While that may be true for some women, it's important to understand that the principal symptom of a heart attack in both men and women is chest pain. About 12 percent of women are more likely not to have chest pain during a heart attack, but that's not a huge difference.

"Women may just have a shortness of breath or dizziness or pass out, but the same is true for a small percentage of men. Men and women are more alike than dissimilar. There are some differences, but they're not as big as people may think. For heart attacks, the same advices should be given to both genders: If you have chest pain, if you have a sudden onset of severe shortness of breath, if you get dizzy, light-headed and sweaty all of a sudden, take it seriously, call 911 and get to the hospital -- whether you're a man or a woman."






NHS Choices
29.02.2012 21:00:00

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the UK body for regulating medical devices. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA issued new guidelines on larger forms of ‘metal-on-metal’ (MoM hip implants. Advice on smaller metal devices or those featuring a plastic or ceramic head has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. The agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused some medical quarters to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines, which must undergo several years of laboratory, animal and human testing before being approved for wider use.

What types of implants are involved?

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. The previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

What about other types of hip implants?

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.
  • Total MoM implants where the replacement ball is less than 36mm wide.
  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. The company made three types of ASR implant.
  • Implants featuring plastic or ceramic heads.

How many people are affected?

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

What exactly is the problem with MoM implants?

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’ to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

How are medical devices regulated?

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. The MHRA audits the performance of private sector organisations (called notified bodies that assess and approve medical devices. Once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

What action have regulators taken?

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants. This meets regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. The agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA says it is gathering additional information about adverse events in patients with MoM implants. In the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

What actions have critics called for?

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. Only once there is enough evidence to suggest that a medicine is reasonably safe can it enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implants, patient groups are calling for more testing before devices are allowed into clinical use, and closer mandatory monitoring schemes to ensure their safety once they enter the market.

Links To The Headlines

Annual blood tests for hip patients over poison fears. The Daily Telegraph, February 29 2012

Hip replacement toxic risk could affect 50,000. The Independent, February 29 2012

MHRA: Metal hip implant patients need life-long checks. BBC News, February 29 2012

Metal scare over hip replacement joints. The Guardian, February 29 2012

Toxic metal hip implants 'could affect thousands more people than PIP breast scandal. Daily Mail, February 29 2012




01.03.2012 0:00:05

One can only hope that Sean Penn returns to acting duties post haste (
Diplomacy, interrupted, 24 February . The past 30 years of Anglo-Argentine-Falkland relationships are vastly more complicated that Mr Penn might imagine, and his very short introduction to US-UK-Latin American relations during the cold war sounds like it has been extracted from the James Bond film, Quantum of Solace.

While the dispatch of the Duke of Cambridge to the Falklands in the runup to the 30th anniversary of the 1982 conflict was an unfortunate piece of timing, it is nonetheless indicative of a broader truism that the British government has a responsibility to ensure that the Falkland Islands are defended and managed in terms of foreign and security affairs. In the past three decades, apart from the welcome departure of a brutal military regime in Argentina, the most dramatic change has come in the shape of the Falkland Islands community itself, which has effectively transformed itself into a democratic society with a noteworthy portfolio of activities. The Falklands are not a colony in any sense – they are a British overseas territory. Having visited (and researched the islands on many occasions, I was struck by how vigorously the islanders promote their right to self-determination without being dictated to by Argentina, Britain or even Sean Penn.

One aspect often lost is that this disagreement over the Falklands is not just about the Falklands per se. At stake is a series of other disputes involving South Georgia and the Antarctic Peninsula region. Interestingly, universities and science minister David Willetts was recently in the Antarctic and the Falklands, and I am told there is a striking photo of him standing next to a series of British flags in British Antarctic Territory. For some Argentines at least, removing the British presence from the Falklands is part of a wider strategy to remove Britain from the wider South Atlantic and Antarctic. This is something that needs to be borne in mind when we discuss the Falklands question.
Professor Klaus Dodds

Author of


Pink Ice: Britain and the South Atlantic Empire

• Is it just me or is anyone else getting fed up with what Sean Penn thinks? But at least I must thank him for making me pay attention to what he says. It is worth noting that British sovereignty over the Falkland Islands was re-established in 1833, and in that year the government in the US instigated the Choctaw Trail of Tears, where between 1800 and 1830 the Choctaw nation was forced to cede over 100,000 sq km of their land, according to Wikipedia.

Obviously that is only one example of what happened, as the then US government took whatever it wanted and moved, starved and killed anyone who stood in its way. The indigenous native Americans have more rights to live on their own land than modern-day Argentina has to the Falklands. Perhaps Mr Penn would be willing to give his own property back to whichever tribe occupied the land prior to 1830, and be equally vocal about native American rights as he is about dubious Argentinian claims over the Falkland Islands.
Mike Darby

Shebbear, Devon

• The declaration by 17 leading Argentine intellectuals challenging President Christina Fernandez de Kirchner's demands for sovereignty of the Falkland Islands is a view shared by many people in Argentina at all levels of society despite public criticism of their declaration.

As the BBC Latin America correspondent from 1979 to 1983, I broadcast globally from Buenos Aires the first news of the invasion and I have visited both Argentina and the Falklands many times since, most recently in February this year.

In Argentina, a young, well-educated Argentine businesswoman I met on a Buenos Aires bus was forthright in her view: "You [the British] won the war. You keep the islands!" Her attitude was echoed by a middle-aged entrepreneur in the tourist industry in the far south, in Ushuaia, capital of Tierra del Fuego province, which Argentine law and the constitution bizarrely claim to incorporate the Malvinas (Falklands within its territory.

The businessman told me that many young Argentines are just not interested in the sovereignty dispute. He went on to predict that "the Malvinas dispute will no longer be an issue for newer generations within 30 or 40 years".

I am not convinced of that refreshing scenario, but my experience, canvassing the views of Argentines over the past 30 years, is that younger people are far more concerned with getting a good education and a job, how to enjoy their next free evening and what mobile telephone to buy next. I detect a growing realism and scepticism, especially about the historical falsehoods and misinformation used in support of Argentina's claim. Its exaggerated rhetoric, not least its accusation of UK "militarisation" of the South Atlantic, is proving counterproductive.

Its submissions to the United Nations have been demolished by the UK's robust rebuttal with a detailed factual account of events going back centuries validating British sovereignty. The Foreign and Commonwealth Office seems to be embarked on a more active campaign to correct misconceptions. It is a welcome contrast to the pre-1982 policy of abject surrender of British sovereignty, brought to an abrupt end by Galtieri's invasion.

I agree with much of
Jimmy Burns's open letter to Sean Penn (in the Guardian about the Kirchner presidencies. I was in Argentina when the two rigs arrived to work in Falkland Islands waters. The Kirchners repudiated not only the 1995 oil co-operation agreement but also later agreements, including co-operation on fishing and preservation of stocks – so vital to the Falklands' economy and also important to Argentina's. It is ironic that the Argentines are now arguing that any oil or fishing resources are theirs. In Chile, I heard much criticism of Argentine threats to disrupt the regular commercial air services from Punta Arenas to the Falklands.

Despite intensification of Argentina's economic restrictions, on my most recent visit I found the islanders in good heart and in a much healthier economic and democratic environment than I found in Argentina, which is beset with unrest and demonstrations, widespread crime, poverty and child starvation in a land of plentiful food, and shortages of goods, including even those mobile phones beloved by the young. The shortages are caused by a controversial government's import restrictions, damaging to and criticised by neighbouring countries which support its Malvinas policies. One woman told me she was taking the ferry to Uruguay to buy a replacement iron, and others to buy essential medicinal drugs.

The Falkland Islanders are hard-working and self-reliant, as I found them before 1982, but now enjoying unprecedented prosperity from fishing, wildlife tourism and sheep-farming. Their children enjoy a happy, active life in a virtually crime-free society, with one of the most generous government-financed education systems in the world, up to and beyond university placements in the UK. Why would they want to be part of Argentina?

They are as resolute as ever to embrace self-determination, reject Argentine sovereignty, and remain British, demonstrating by their conduct and their hospitality and support for 1982 taskforce veterans their abiding gratitude for the sacrifices made in their liberation, and for their defence ever since.
Harold Briley

Battle, East Sussex

• While we live in a media world where celebrity endorsement makes newspaper copy, the intervention of an American film actor over the Falkland Islands is little more than an irrelevance. For Sean Penn the space donated by the Guardian has allowed him to compound his impertinence; for the president of Argentina, deploying his support has the smack of desperate measures. At the same time the country's diplomatic corps has embarked on a mission to seek sympathy for its claim to the islands – a neocolonial claim already rejected under international case law, and which ignores the wishes of the population enshrined by the enlightened mores of today.

Argentina would be well advised to change its tack entirely. As a PR professional, my advice to Cristina de Kirchner and her successors is this: be nice. Do everything you can to be a good neighbour: ease communications, travel, transport and trade; encourage educational, sporting and cultural exchange; help make the islands thrive by allowing your citizens to be employed there and providing the services needed by new industries, including fisheries and oil exploration, and thereby share the prosperity and growth; stop the envy, the hurt pride, the propaganda. Within a generation or two, as the islanders see you as a help not a hindrance, a friend not a foe, as your economies grow together and your people intermarry and settle, Argentina will acquire influence and increasing participation in the Falklands at both a human and institutional level.

You have tried belligerence. You are still trying confrontation. Try intelligent integration. It's slower, it's less macho, it's not a distraction from domestic political problems. But it will be effective. No one will be left to lie under a windblown headstone. And it will attract international respect.
James Darley

London



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2012-02-28 11:03:43
A new study finds that people who take certain commonly prescribed sleeping pills have a five-fold increased risk of death, even among those taking fewer than 18 doses a year. And these drugs are also linked to a significantly increased risk of cancer among those taking high doses, the study, published in the journal BMJ Open, shows. The study, analyzing 10,500 people who took a wide-range of sleeping pills including zolpidem, diazepam and tamazepam, found that the top third of sleeping pill users had a 5.3-fold higher death risk and also had a 35 percent higher risk of cancer. And people who were on higher doses of tamazepam were six times as likely to die in the next 30 months, the study found. “We are not certain. But it looks like sleeping pills could be as risky as smoking cigarettes. It looks much more dangerous to take these pills than to treat insomnia another way,” study leader Daniel F. Kripke, MD, told WebMD. The sleeping pills in question are known as hypnotics and include such brands as Ambien and Restoril. Hypnotic sleeping pills actually cause a person to fall asleep. This is in contrast to other sleeping aids, such as melatonin, which promote sleep through relaxation. Kripke and colleagues said other dangerous hypnotic sleeping aids include Lunesta, Sonata, Halcion, and Dalmane. Kripke, retired professor of psychiatry at the University of California, San Diego, began studying the effects sleeping pills have on the risk of death in 1975. Since then, he has co-published 18 studies finding links between the two. In the latest study, Kripke and colleagues analyzed data from a large Pennsylvania health system from between 2002 and 2007. They obtained medical records for 10,529 people who used prescribed hypnotic sleeping pills and for 23,676 matched patients who were never prescribed sleeping pills. Over an average of 2.5 years, the death rate for those who did not use sleeping pills was 1.2 percent. For those who were prescribed sleeping pills the death rate climbed to 6.1 percent. And after taking into account factors likely to influence the results - including age, sex, weight, lifestyle, ethnicity and previously diagnosed cancer - the study’s results pointed to a 3.6-fold higher death rate in those who only took 18 or fewer doses. Based on their findings, Kripke and colleagues estimate that sleeping pills are linked to between 320,000 and 507,000 US deaths each year. “We think these sleeping pills are very dangerous. We think they cause death. We think they cause cancers,” said Kripke. “It is possible but not proven that reducing the use of these pills would lower the U.S. death rate.” The associations of increased death risk was found in every age group, but were greatest among those aged 18 to 55. Supplemental material published alongside the paper showed that, although the overall numbers of deaths in each group were quite small, there were clear differences among them. For example, there were 265 deaths among 4,336 people taking zolpidem, compared with 295 deaths among the 23,671 people who had not taken sedatives or sleeping pills. Kripke pointed out that studies showing association do not necessarily prove cause and effect, however. But the findings do back up previous research showing an increased risk of death among sleeping pill users, he added. “The meager benefits of hypnotics [sleeping pills], as critically reviewed by groups without financial interest, would not justify substantial risks,” wrote Kripke. “A consensus is developing that cognitive-behavioral therapy of chronic insomnia may be more successful than hypnotics.” Sleeping pills are thought to also increase risk of depression and can impair driving skills. Kripke has passed the study findings on to the US Food and Drug Administration (FDA , the watchdog to the US pharmaceutical industry. The authors of the study said their findings, together with similar findings in previous studies, should be used by authorities to re-assess whether even modest doses of sleeping pills are safe. “Although the authors have not been able to prove that sleeping pills cause premature death, their analyses have ruled out a wide range of other possible causative factors,” wrote Dr Trish Groves, editor in chief of BMJ Open. “So these findings raise important concerns and questions about the safety of sedatives and sleeping pills.” National Health Service (NHS guidelines recommend zolpidem should only be used at the lowest possible dose and for a maximum of up to four weeks. Zaleplon should only be used at the lowest possible dose and for a maximum of up to two weeks, while temazepam should be taken for a maximum of four weeks. Most of those in Kripke’s study were taking Ambien or Restoril. Sanofi-Aventis, the maker of Ambien, noted that Kripke’s study had a number of faults. “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling,” Sanofi told WebMD in a statement. “Ambien should be prescribed in strict adherence to its labeling and patients should take their medication as prescribed. The Ambien labeling carries specific warnings against driving and against intake of alcohol together with Ambien.” And although experts note the Kripke study certainly raises concerns, they said it does not prove that sleeping pills kill. This “very provocative and interesting study raises a lot of questions,” Nancy Collop, MD, president of the American Academy of Sleep Medicine and director of the Sleep Center at Emory University School of Medicine, told WebMD. “You cannot assume, just because you find this kind of association, that hypnotics are killing people,” she said. “People who go on sleeping pills are a sicker population. I know they tried to control for that, but these people simply are not as healthy.” Michael Yurcheshen, MD, head of the sleep fellowship program and assistant professor of neurology at the University of Rochester, NY, noted that much can be missed in a study that looks back at medical records rather than at the patients themselves. “It is implausible to think that so many of these medications, spread across several different drug classes, could have the same biological effects,” Yurcheshen told WebMD. Yet, both Collop and Yurcheshen praise Kripke for raising the issue of sleeping pill dangers. “One part of the Kripke study I really did like is when they point out that part of the problem with hypnotics is they are really best for people with acute, short episodes of insomnia,” Yurcheshen said. “Very few insomnia drugs are approved for long-term daily use. And so it is fair to say that the long-term safety of these drugs has never been explored for use in that way.” Collop said she is torn on the issue of whether hypnotics are “good or bad.” She noted that it can be harmful to be dependent on hypnotic sleeping pills for a long period of time. But they can be very helpful to those who are having great difficulty in falling asleep for some specific reason. She noted that sleeping pills are mainly short-term use aids. “So the ideal patient would be someone with a very high stress level for some reason, such as the recent loss of loved one or a divorce, or for a traveler adjusting to a new time zone. This should be for a limited time period and only as needed, not on a nightly basis. In such situations these drugs are appropriate and effective,” she told WebMD. Kripke, colleagues and the experts all agree that a form of short-term psychotherapy -- cognitive behavioral therapy -- is surprisingly effective for people with chronic insomnia. Collop says it’s time to see a sleep specialist if you have tried sleeping pills and they don’t work anymore. Looking for another brand of sleeping pill will not work. Nina Barnett, spokesperson for the Royal Pharmaceutical Society told The Telegraph: “This is an important study and although it is unlikely to radically change prescribing in the immediate term, it should raise awareness and remind both patients and prescribers to the potential risks of sedative use for insomnia.” “The association between mortality and sedation is not new and this research tells us is that people who took these medicines were more likely to die than people who didn’t take them. However it does not mean that the deaths were caused by the medicine,” she added. “Patients should not stop taking any prescribed medicines straight away. If you are concerned about your medicines discuss this with your pharmacist or Doctor about other ways of getting help with sleep problems so you don’t have to use medicines.” --- On the Net:



jandrews@foodsafetynews.com (James Andrews
29.02.2012 12:59:03
Aiming to help foster safer growing practices for sprout producers, the U.S. Food and Drug Administration announced on Tuesday it would form a one-year partnership and grant $100,000 to the Illinois Institute of Technology's Institute for Food Safety and Health (IFSH to coordinate the
Sprout Safety Alliance (SSA .
The SSA, a public-private organization, will develop outreach programs and training for the sprout industry to prepare growers for upcoming sprout safety regulatory requirements. Sprout-growing operations are subject to unique safety precautions, such as testing spent irrigation water and seed disinfection. 
The organization plans to develop safety training materials for sprout growers, provide tools to allow growers to conduct self-audits of their facilities, and ensure that growers understand the inherent risks associated with sprouts, which have been linked to at least 
44 foodborne illness outbreaks in North America since 1990. The SSA will also serve as a hub for sprout industry resources by providing technical assistance to growers and networking them with buyers, retailers and regulatory agencies.
The FDA's announcement comes within months of three prominent sandwich restaurant chains choosing to remove sprouts from their menus due to a mounting number of foodborne illness outbreaks linked to the food. 
Most recently, Jimmy John's decided to stop serving sprouts after the Centers for Disease Control and Prevention announced on February 15 that the restaurant's sprouts were linked to an E. coli O26 outbreak that has sickened 14 people in six states. It was the fifth outbreak tied to Jimmy John's sprouts in four years.
Earlier this year, Jason's Deli and Erbert & Gerbert's restaurants also dropped sprouts, each citing food safety concerns. Back in October 2010, Walmart stopped selling sprouts in its stores. The warm, wet environments needed to grow sprouts are also conducive to bacterial growth, making sprouts especially susceptible to carrying pathogens.
The IFSH, part of the Illinois Institute of Technology, is an applied research institute that focuses on designing practical approaches to challenges in the food industry.




hbottemiller@foodsafetynews.com (Helena Bottemiller
29.02.2012 12:59:07
The number of food safety and plant health trade barriers plaguing U.S. agricultural exports is way up, Agriculture Secretary Tom Vilsack told a congressional committee recently.

"In the last 10 years, the number of sanitary and phytosanitary barriers we have had to deal with has increased from roughly 650 to close to 1,500 last year," said Secretary Vilsack during a four hour appropriations hearing on the U.S. Department of Agriculture budget.

Countries that belong to the World Trade Organization manage such disagreements under the Agreement on the Application of Sanitary and Phytosanitary Measures, often called the SPS Agreement. This framework is meant to help iron out trade disputes based on food safety and animal or plant health issues.

"The reality is that when you're the number one country in terms of agriculture and agricultural production and exports, countries find a lot of different ways to make things difficult for you," said Vilsack.

The issue came up when agriculture appropriations subcommittee chairman Representative Jack Kingston (R-GA brought up the fact that India continues to block American poultry exports over pathogen issues. Kingston asked if there was something USDA could do to help open the $300 million poultry market there, something that would help U.S. poultry producers.

"It's very complicated and very frustrating," said Vilsack, adding that the U.S. Trade Representative's office has limited resources to fight what he says are unwarranted agricultural trade barriers.

In 2011, USTR published its second annual "
Report on Sanitary and Phytosanitary Measures," a 113 page document that outlines existing SPS issues with each U.S. trading partner.

According to USTR, the annual SPS Report was created "to respond to the concerns of U.S. farmers, ranchers, producers and workers who are running into SPS trade barriers as they seek to export high?quality American agricultural products around the world."

U.S. trade officials are working on a number of SPS issues that limit agricultural exports, including trade bans on genetically engineered crops, and "unreasonable" residue limits for pesticides in a variety of commodities. 

Many countries, including China, also still have restrictions in place out of concern for Bovine Spongiform Encephalopathy, otherwise known as BSE, or "mad cow" disease, and USTR works to eliminate such barriers, arguing that they are not based on science.

Food safety interventions can become SPS issues as well.

Russia continues to ban U.S. poultry over the widespread use of chlorine as a disinfectant during processing, even though USDA public health officials maintain that it completely safe. The European Union has banned chlorine baths for poultry since 1997.

One of the most high-profile and longest-running SPS disputes started in the late 1980s when the United States and EU battled over the use of certain growth-promoting hormones in beef production. The EU banned the practice, citing concerns about health risks, and refused to import beef raised using the drugs. The United States challenged the restriction arguing that it was not based on scientific evidence.

In 1998, a WTO panel found that the EU's ban was not supported by science and therefore was not consistent with its obligation under the SPS Agreement. The EU refused to change its policy. For the next decade, the United States raised import duties on a number of EU products, including chocolate, truffles and cheeses.

In May 2009, the United States and the EU concluded a Memorandum of Understanding (MOU that, according to USTR, "has enabled U.S. producers to gain additional duty?free access to the EU market for high?quality beef produced from U.S. cattle that have not received growth?promoting hormones."

In May 2011, the United States announced that it would drop all remaining punitive duties on EU goods in exchange for greater duty-free access for beef raised without additional hormones.  





01.03.2012 18:16:43
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Approves Four-Strain Flu Vaccine A new nasal-spray flu vaccine approved by the U.S. Food and Drug Administration protects against four...



2012-03-01 10:10:56
US District Judge Richard Leon sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free speech rights under the US Constitution, reports Wendy Koch for USA Today. Leon continued, writing that the requirement would “violate the First Amendment by unconstitutionally compelling speech.” The decision conflicts with a January 2010 ruling by US District Court Judge Joseph McKinley, that upheld the labels’ legality and is expected to end up at the steps of the US Supreme Court for a final decision. In 2009, Congress gave authority to the Food and Drug Administration (FDA to regulate tobacco and approved nine graphic warnings that tobacco makers could rotate on cigarette packs beginning in September. The tobacco products images would include prominent images of rotting teeth, diseased lungs and a corpse with chest staples on an autopsy table. The images, which would cover the top half of the front and back of each pack. In the 19-page ruling, Judge Leon argued that, while educating the public about the dangers of smoking, “might be compelling, an interest in simply advocating that the public not purchase a legal product is not.” Further, Leon said the government has numerous other tools at its disposal to deter smoking such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images, Jeremy Pelofsky reported for Reuters. Matthew Myers of the Campaign for Tobacco-Free Kids said Leon’s ruling that the “graphic images are neither factual nor accurate” is “incomprehensible,” arguing that smoking causes fatal lung disease, cancer and heart disease. Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc, Liggett Group, Commonwealth Brands, which is owned by Britain’s Imperial Tobacco Group, and Santa Fe Natural Tobacco challenged the rule, arguing it would force them to engage in anti-smoking advocacy against their own legal products. “We believe governments, public health officials, tobacco manufacturers and others share a responsibility to provide tobacco consumers with accurate information about the various health risks associated with smoking,” said Martin Holton, general counsel for R.J. Reynolds. “However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the US Constitution,” Holton added in a company statement. --- On the Net:



29.02.2012 16:02:13
From UPI Health News (Business (February 28, 2012 The U.S. Food and Drug Administration approved safety label changes for statins -- a class of cholesterol-lowering drugs known as statins, officials said. Statins, along with diet and exercise,...



2012-02-29 06:16:38
The U.S. Food and Drug Administration (FDA announced on Tuesday that they would be adding memory loss and diabetes warnings to the labels of cholesterol-lowering drugs known as statins. According to Reuters reporters Bill Berkrot and Ransdell Pierson, the label changes come after the agency learned of studies in which taking statins could lead to a small increased risk of cognitive issues such as memory loss or confusion, as well as a slight spike in blood sugar levels and the risk of developing type 2 diabetes. FDA spokesperson Erica Jefferson told Reuters that the changes were "part of our ongoing surveillance." The affected products include Lipitor (atorvastatin , Lescol (fluvastatin , Mevacor (lovastatin , Altoprev (lovastatin extended-release , Livalo (pitavastatin , Pravachol (pravastatin , Crestor (rosuvastatin , and Zocor (simvastatin . Combination products include: Advicor (lovastatin/niacin extended-release , Simcor (simvastatin/niacin extended-release , and Vytorin (simvastatin/ezetimibe , the FDA said in a statement reprinted by Tuesday. When asked about the changes, Cleveland Clinic Cardiology Chairman Steven Nissen told Forbes reporter Matthew Herper that the blood sugar warning is the result of "a very small uptick in blood sugar that makes a few more people cross the threshold we call diabetes." “This small increased risk of higher blood-sugar levels needs to be taken in the context of the very strong evidence of beneficial things that are provided by statins,” added Matthew Price, director of the cardiac catheterization laboratory at Scripps Clinic in La Jolla, California, in a telephone interview with Bloomberg's Anna Edney and Michelle Fay Cortez. “This doesn’t affect my prescribing of statins where it’s clinically indicated, though I will make sure I closely follow patients at risk for diabetes.” In terms of the cognitive issues, the FDA said that reports of memory loss and/or confusion were not series, and in most cases the symptoms were reversed after the patient stopped using the statin. The agency also noted that they would be removing a requirement for regular monitoring of liver enzymes for those using the cholesterol medication, after concluding that serious liver injury was "rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect." They did, however, warn patients to contact their doctors if they experienced any symptoms of liver-related ailments, including weakness or fatigue, loss of appetite, dark-hued urine, yellowing of the skin or the whites of the eyes, or upper abdominal pain. “We want health-care professionals and patients to have the most-current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, director of FDA’s division of metabolism and endocrinology products, told Edney and Cortez. --- On the Net:



01.03.2012 0:02:51
WAYNE, N.J, Feb. 29, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA has approved a lower dose formulation of Angeliq (drospirenone and estradiol tablets to...



29.02.2012 23:00:00
Federal health officials have added new safety alerts to statins, a class of drugs used to lower cholesterol levels. The Food and Drug Administration cited rare side effects, including memory loss, diabetes and muscle pain. Robert Siegel talks to Rob Stein about the news.



29.02.2012 4:00:00
A recent announcement released by the Food and Drug Administration (FDA , claims that statins, drugs taken to lower cholesterol, may cause various health problems. According to IMS Health, over 20 million Americans were taking some type of statins last year...

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