Day: 07/03/2012

FDA panel sees little use for metal-on-metal hips.

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Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.

“I do not use metal-on-metal hips, and I can see no reason to do so,” said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J’s recall of 93,000 metal hips in 2010.

FDA’s experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.

If the FDA ultimately follows the group’s advice, U.S. recommendations would be less involved than those already in place overseas.

Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

“The truth is there are different types of hips and different types of patients,” said Dr. William Maisel, FDA’s chief scientist for devices, in an interview last week. “Understanding the characteristics of patients who experience adverse events is very important.”

Women and overweight people are among the groups that are more likely to have an implant failure.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help “fill in the blanks” on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”

Source: The Associated Press.

 

Nidal embolization of brain arteriovenous malformations: rates of cure, partial embolization, and clinical outcome

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 Nidal embolization of brain arteriovenous malformations (bAVMs) has become an increasingly important component of bAVM treatment. However, controversy exists as to the relative efficacy and safety of single-stage versus multistage approaches to bAVM embolization, with recent literature favoring multistage strategies. The authors present a series of consecutive bAVMs embolized at their institution, demonstrating the safety and efficacy of a predominantly single-stage embolization strategy. The safety and efficacy of embolization are reported in the context of predetermined treatment strategies to provide more generalizable insight into treatment outcome.

Methods

One hundred thirty consecutive patients with 131 bAVMs underwent endovascular embolization at a single center. Diagnostic angiography with superselective microcatheterizations was performed in all patients. Postembolization angiograms were reviewed by 3 neuroradiologists for degree of occlusion and angiographic evidence of procedural complications. Patients were divided into cohorts based on the prospectively determined treatment strategy, which included the following: global devascularization of the bAVM (Devasc); targeting of a focal angioarchitectural weakness (Target), typically as an adjunct to surgery or Gamma Knife treatment; and primary occlusion of the bAVM by embolization alone (Occlude). Safety and efficacy were evaluated in the context of these treatment groups.

Results

The 131 bAVMs were treated over an average of 1.28 embolization sessions per bAVM; 105 bAVMs (80%) were treated in a single stage. The average percentage devascularization in the Devasc arm was 85.3%, which was statistically significantly greater than the 72% aggregate devascularization reported in 8 modern N-butyl cyanoacrylate and Onyx papers based on 1-sample Wilcoxon rank-sum testing (p < 0.001). Focal angioarchitectural weaknesses were successfully embolized for all 24 bAVMs in the Target group, directly with the embolic agent in 23 bAVMs and indirectly in 1 bAVM with a venous aneurysm/pseudoaneurysm by reducing arterial inflow and inducing venous thrombosis. Lesions in all patients in the Occlude arm were 100% occluded with embolization alone. Overall, the bAVMs in the Occlude arm were significantly smaller and required embolization of fewer pedicles than those in the Devasc group. One patient (0.8%) experienced significant morbidity following embolization, and 1 patient in the cohort died (0.8%).

Conclusions

This research communicates the authors’ experience in developing a largely single-stage strategy for embolization of bAVMs. The results suggest that an aggressive, single-stage embolization may be implemented with a margin of safety and effectiveness similar to the multistage approaches more commonly reported in the literature. This work additionally introduces the importance of prospective assignment to a treatment strategy in assessing procedural outcome in bAVM embolization, thereby improving generalizability of the results and allowing for more rigorous interpretation of efficacy and safety.

Source: Journal of Neurosurgery.

 

 

 

 

 

Does Your Supplement Contain this Potentially Hazardous Ingredient?

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It’s common knowledge that drugs, vitamins or supplements contain more than just the active ingredient. Something has to encapsulate them―hold them together―in a form that not only makes them usable, but producible by a manufacturer in massive quantities.

In the U.S. many supplement makers are adding “flow agents” into their capsules. Their only purpose is to keep ingredients from sticking to equipment during mixing and compression. They make manufacturing faster and easier, but it’s not impossible to produce the final product without them. Not using them simply adds to manufacturing costs and final sales price of the product.

Magnesium stearate is a commonly used and potentially harmful additive found in many supplements. This is a substance I have warned about for a long time because of its subtle ability to cause possible harm to your intestine, possibly even preventing the proper absorption of nutrients.

Potentially Harmful Effects of Magnesium Stearate

Magnesium stearate is formed by adding a magnesium ion to stearic acid. The compound has lubricating properties, which is why it’s often used in the making of supplements, as it allows the machinery to run faster and smoother, and prevents the pills or capsules from sticking to each other.

However, previous research has shown that stearic acid suppresses T cells—your natural killer cells—which are a key component of your immune systemi. According to that study, stearic acid causes the collapse of cell membrane integrity—an effect that was found to be time and dose dependent—which, ultimately, can destroy cell function.

Naturally, when you take vitamins and other supplements, you do it with the idea of strengthening your immune system. However, if you take supplements containing magnesium stearate, you could end up doing the exact opposite as you’re actually consuming chalk-like substance with each dose you take.

This filler also stimulates your gut to form a biofilm. You frequently see biofilms when you lift the lid of your toilet reservoir. Biofilms are a sort of sludge lining that acts as an effective barrier to the absorption of not only that particular vitamin but ALL the nutrients you’d normally get from food sources as well.

This is of particular concern for anyone with impaired digestion, which in today’s world includes the vast majority of Americans, due to poor dietary habits.

In my view, this side effect alone is a major reason for focusing on nutritional foods, or, if you’re taking a supplement, making sure it’s a high quality, natural food-based supplement that does not include potentially harmful fillers and additives such as magnesium stearate.

Contamination Issues

Another issue that has been raised in relation to magnesium stearate is the fact that the stearate is commonly sourced from hydrogenated oils such as cottonseed oil. This crop is oftentimes genetically engineered, but even when it’s not, cottonseed oil tends to have very high levels of pesticide residues.

Other contamination can also occur during the manufacturing process of the magnesium stearate. According to a December 2011 report by the World Health Organization (WHO)ii, several batches of magnesium stearate manufactured by Ferro Corporation were found to contain various levels of harmful contaminants such as:

  • Calcium hydroxide: aka “slaked lime,” which is considered toxic, according to the National Institutes of Health
  • Bisphenol-A: a toxic chemical and potent endocrine disrupter
  • Irganox 1010: a “moderately hazardous” chemical with potential developmental toxicity, according to the Environmental Protection Agencyiii

The cross contamination was determined to be due to incomplete cleaning of air milling equipment introduced into the Ohio Ferro plant in February that same year. Granted, this is not a chronic problem, as far as I know, but it just goes to show how easily contamination can occur in general.

Will Magnesium Stearate Get Axed?

As recently explained in the featured article, magnesium stearate might be on the verge of getting axed from supplements altogether, which probably would not be a bad thing; at least from a health perspective.

During the March 2010 session of the Codex Committee on Food Additives (CCFA), it was recommended that “magnesium salts of fatty acids” (ie magnesium stearate) be deleted from the Codex, as it has no known use in food. The following year, at the March 2011 CCFA session, the International Alliance of Dietary Supplement Associations (IADSA) submitted a request to reinstate magnesium stearate as a food additive. It was subsequently reinstated under INS number 470(iii).

However, as explained in the featured article:

“…the Joint Expert Committee on Food Additives (JECFA) now requires toxicity data to substantiate magnesium stearate’s new standing, despite its existing history of use in supplements. According to John Venardos, senior vice president of regulatory affairs for the global network marketing company Herbalife, who presented this issue at the recent NIA West conference in Laguna Beach, the estimated cost of this tox data on magnesium stearate would cost $180,000. No manufacturer has yet volunteered to foot the bill.”

It would appear as though, unless someone accepts the task of doing the research necessary to prove its safety as a food additive, it will likely get eliminated from the market. Considering the fact that a vast majority of supplement makers use magnesium stearate, backlash is to be expected. But for companies that already operate without magnesium stearate, it’s just proof that they’ve been right all along.

Eliminating this component from the product equates to slightly higher manufacturing costs, as the machines cannot run as fast and hence cannot produce as much on any given day. But I believe the increase in cost is well worth it. It’s really important to me to first do no harm, and to take the extra precautions to ensure the products sold on this site are of the highest quality and purity possible.

How to Identify High Quality Multi-Vitamin Supplements

I do believe that dietary supplements — including vitamins and minerals — can help compensate for some of the damage your body incurs through living in a contemporary culture. However, it’s not wise to use supplements to justify a poor diet. In my experience no amount of supplements will ever be able to substitute for healthy food choices.

But there are times when supplements can be quite useful, and I believe that some supplements, such as a high quality animal-based omega-3, for example, are essential for nearly everyone. This is because the main source of animal based omega-3 fats in your diet comes from fish – most of which is now so grossly polluted with heavy metals, PCBs and other environmental toxins I can no longer recommend eating fish for optimal omega 3 levels. Another supplement that many people need is vitamin D3, unless you can get sufficient amounts of safe sun exposure year-round, or use a safe tanning bed.

There are other instances when supplements may be useful as well, such as in the case of CoQ10 if you’re taking a statin drug. You may also want to take one or more food-based supplements to ensure you are getting an adequate variety of nutrients. However, I strongly recommend you make whole food supplements your first choice, and steer clear of synthetic vitamins. How do you tell whether or not a supplement you’re looking at is a good choice? For starters, make sure it has the following characteristics:

  • It is as close as possible to its natural (whole food) form.
  • Use independent third party labs that check the raw materials for contaminants and correct dosage.
  • Follows industry standards for quality assurance including ISO 9001, ISO 17025 and Good Manufacturing Processes (GMP) certifications.
  • The utmost care has been taken in all phases of its production, from growing its ingredients, to manufacturing, testing for potency and quality control.
  • It works! I always try to select from companies that have a long track record of providing high quality products that produce good clinical results.
  • As this article states, avoid any supplement that uses magnesium stearate. Read the labels carefully as companies need to declare it if they use it, but it is in very tiny print and you might need a magnifying lens to read it.

If you are interested in optimizing your health, your BEST solution is to choose the highest quality foods possible, and eat a wide variety of whole organic foods. You can use my free nutrition plan and work your way up to the advanced stage. Once you have addressed your diet and are looking for further improvement, odds are you would likely benefit from some supplements, like an animal-based omega-3 supplement and a probiotic, for example. There are many others you could consider depending on your specific circumstances, but just about everyone would benefit from these two.

Just remember to do your homework first and use only those that come from a reputable manufacturer using whole-food, natural ingredients that are free of harmful additives, fillers and binders, and have gone through a vigorous quality control process.

Source: Mercola.com/dr Mercola.

 

 

How Diet Foods and Drinks Can Actually Cause, NOT Prevent Diabetes.

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Many people equate eating sugar with the development of type 2 diabetes, and in an attempt to be healthier choose sugar-free diet products instead.

Imagine the irony if those diet products actually contained substances that cause an increase in fasting blood glucose levels and contribute to the onset of diabetes. Now stop imagining, because this isn’t just a fantasy … it’s the disturbing result of a newly published study.

Two Toxic Food Additives Common in Diet Foods May Cause Diabetes

A new study using mice as models showed that two additives often put in everyday foods to enhance flavor and reduce calories can actually cause an increase in fasting blood glucose levels, and contribute to the onset of diabetes. The toxins in this startling new study are aspartame and monosodium glutamate (MSG), and the evidence is stacked against them both.

The research showed that aspartame alone can cause an increase in fasting blood glucose levels and reduced insulin sensitivity. But when the two additives get together, they become partners in crime and cause an elevation in both weight and fasting glucose levels.

This is the first study ever to show the hyperglycemic effects of chronic exposure to a combination of these common food additives. Indeed, the consumer must exercise caution, as many mass-market foods contain both aspartame and hidden MSG – the perfect combination for diabetes development.

Researchers noted:

“Aspartame (ASP) and Monosodium Glutamate (MSG) are ubiquitous food additives with a common moiety: both contain acidic amino acids which can act as neurotransmitters, interacting with NMDA receptors concentrated in areas of the Central Nervous System regulating energy expenditure and conservation.”

What You Need to Know About Aspartame and MSG

Many conventional nutritionists will actually recommend artificial sweeteners like aspartame as a smart choice over sugar, especially for people with diabetes, but you should know that, as a result of its unnatural structure, your body processes the amino acids found in aspartame very differently from those in a steak or a piece of fish.

Largely due to the unnaturally high ratio of this amino acid resulting in relatively dangerous levels, the amino acids in aspartame literally attack your cells, even crossing the blood-brain barrier to attack your brain cells, creating a toxic cellular environment of overstimulation called excitotoxicity. MSG is also an excitotoxin, and works synergistically with aspartame to create even more damage to your brain cells.

This is one of the major reasons why I do not recommend taking isolated amino acid supplements.

But the damage does not stay confined to your brain, as food additives like artificial sweeteners, high fructose corn syrup (HFCS), and MSG can lead you down a path of food addiction, obesity, diabetes and metabolic syndrome, while increasing your risk for numerous chronic diseases.

Consider MSG, which is added to 80 percent of all flavored foods. MSG excites the part of your brain that’s in charge of your fat metabolism and storage, and has even been shown to scar the hypothalamus gland, inducing what is known as hypothalamic obesity.i So while MSG is most known for its excitotoxic properties, it’s also used to fatten up mice in scientific studies. Yes, MSG is the perfect obesity drug.

Aspartame and MSG Can Make You Fat

It’s speculated that the hormone leptin may be involved in weight gain, as those who consumed more MSG also produced more leptin.ii Researchers noted that MSG consumption may cause leptin resistance. The way your body stores fat is a highly regulated process that is controlled, primarily, by leptin. If you gain excess weight, the extra fat produces extra leptin that should alert your brain that your body is storing too much fat and needs to burn off the excess.

To do this, signals are sent to your brain to stop being hungry and to stop eating.

It is very important that your brain is able to accurately “hear” the messages leptin sends it, as otherwise you will continue to feel hungry and will likely continue to eat and store more fat. Leptin resistance occurs when your body is unable to properly respond to leptin’s signals, which means your body can no longer hear the messages telling it to stop eating and burn fat — so it remains hungry and stores more fat.

This will not only contribute to your weight gain, but also increase your risk of many chronic illnesses, as leptin resistance plays a significant, if not primary, role in heart disease, obesity, diabetes, osteoporosis, autoimmune diseases, reproductive disorders, and perhaps the rate of aging itself. How does this all happen? By overexposure to high levels of the hormone, which is triggered by the typical American diet full of sugar, refined grains, and processed foods — including those that contain MSG.

Animal studies have also shown that dietary MSG induces markers of insulin resistance,iii a direct cause of type 2 diabetes, while prior research by Ka He and colleagues found the additive may increase your likelihood of being overweight by three-fold.iv

Similarly, one reason for aspartame’s potential to cause weight gain is because phenylalanine and aspartic acid – the two amino acids that make up 90 percent of aspartame — are known to stimulate the rapid release of insulin and leptin, which are both intricately involved with satiety and fat storage. Insulin and leptin are also the primary hormones that regulate your metabolism.  So even though you’re not eating calories in the form of sugar, aspartame can still raise your insulin and leptin levels. Elevated insulin and leptin levels, in turn, are two of the driving forces behind obesity, diabetes, and a number of our current chronic disease epidemics.

Why Our Food is Making Us Fat

It’s likely that the cumulative effects of food additives in a highly processed diet are in large part to blame for the rising rates of obesity in the United States and other developed countries. This includes not only MSG and aspartame, which the featured study showed work synergistically to cause even more health damage, but also other ubiquitous food additives like corn and sugar.

Indeed, corn’s weight-promoting property is highly prized in animal husbandry where it is used to fatten up cattle before slaughter. Corn oil is commonly used in fried foods, which are notorious for their ability to pack on the pounds. But corn’s main deleterious effects come from high fructose corn syrup (HFCS), which is used in so many processed foods that it’s now almost impossible to avoid thanks in large part to the collusion between the food industry and government that serves to provide lavish subsidies to grow corn, which manipulate normal market forces.

Ultimately, sugar in all forms (including fructose, date sugar, molasses, coconut sugar, agave syrup, HFCS, etc.) increases your insulin and leptin levels and decreases receptor sensitivity for both of these vital hormones, and this is another major factor in premature aging and age-related chronic degenerative diseases such as heart disease and diabetes, as well as a leading cause of the climbing rates of overweight and obesity in developed countries. So while MSG and aspartame in diet foods should certainly be avoided, the answer isn’t to simply swap them out for sugar-laden processed alternatives…

Number of Kids Hospitalized With High Blood Pressure Doubles in 10 Years

This startling statistic is another product of our increasingly nutrionally devoid, food-additive-laden processed diets. The number of kids treated in U.S. hopsitals for high blood pressure nearly doubled from over 12,660 in 1997 to more than 24,600 in 2006.v The researchers speculated that the biggest factor behind the massive increase is the corresponding rise in childhood obesity.

Unfortunately, children often mimic their parents, and without a positive role model for healthy diet and exercise, may fall into the same traps that many adults are finding themselves in. But the key to remember is that swapping out your child’s regular soda for diet soda is not the answer… swapping out most processed foods for pure, healthy, whole foods is.

Rising Diabetes Rates Worldwide May Have Unforseen Consequences…

Also an interesting study came out last month that showed rising rates of type 2 diabetes in Africa could actually encourage the spread of malaria. As diabetes rates rise, so do cases of hyperinsulinemia, or high levels of insulin in your blood. Insulin actually suppresses mosquito’s immune systems, which means that as more insulin enters the mosquito, their imune systems become less able to fight off the malaria infection, which means they are much more likely to spread malaria among humans.

Every year, malaria results in about 1 million deaths—which is half as many people as are killed by HIV/AIDS annually. It is such an enormous problem in Africa that each African child has, on average, between 1.6 and 5.4 episodes of malaria fever every year, so the fact that it could get even worse — because of the ill effects of eating a poor diet, which is increasing rates of type 2 diabetes — is an alarming prospect.

Did You Know Type 2 Diabetes is Nearly 100 Percent Preventable… and Reversible Without Drugs?

It’s important to understand that many of the conventional recommendations for treating diabetes are not only flawed but dead wrong, and I discussed the reasons why in this previous article. To reverse the disease, you need to recover your body’s insulin and leptin sensitivities – the ones that are so badly upset by eating a poor diet. So the ONLY way to accomplish this is through proper diet and exercise. There is NO drug that can correct leptin signaling and insulin resistance…

Adhering to the following guidelines can help you do at least three things that are essential for successfully treating, and reversing, diabetes: recover your insulin/leptin sensitivity, help normalize your weight, and normalize your blood pressure:

  • Severely limit or eliminate sugar and grains in your diet, especially fructose, which is far more detrimental than any other type of sugar. Following my Nutrition Plan will help you do this without too much fuss.
  • Exercise regularly. Exercise is an absolutely essential factor, and without it, you’re unlikely to get this devastating disease under control. It is one of the fastest and most powerful ways to lower your insulin and leptin resistance. I recommend reviewing my exercise program for tips and guidelines. It is also critical to work your way up to include some Peak Fitness exercises.
  • Avoid trans fats.
  • Get plenty of omega-3 fats from a high quality, animal-based source, such as krill oil.
  • Optimize your vitamin D levels. Recent studies have revealed that getting enough vitamin D can have a powerful effect on normalizing your blood pressure.
  • Optimize your gut flora. Your gut is a living ecosystem, full of both good bacteria and bad. Multiple studies have shown that obese people have different intestinal bacteria than lean people. The more good bacteria you have, the stronger your immune system will be and the better your body will function overall.

Fortunately, optimizing your gut flora is relatively easy. You can reseed your body with good bacteria by eating fermented foods (like natto, kefir, raw organic cheese, miso, and fermented vegetables) or by taking a high-quality probiotic supplement.

  • Address any underlying emotional issues and/or stress. Non-invasive tools like the Emotional Freedom Technique (EFT) can be extremely helpful and effective.
  • Get enough high-quality sleep every night.
  • Monitor your fasting insulin level. This is every bit as important as your fasting blood sugar. You’ll want your fasting insulin level to be between 2 and 4. The higher your level, the worse your insulin sensitivity is.
  • ·         Source: Mercola.com/dr Mercola.

 

US sees stronger hints of Higgs.

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Hints of the Higgs boson detected last year by a US “atom smasher” have become even stronger, scientists have said.

The news comes amid fevered speculation about an announcement by researchers at the Large Hadron Collider on Wednesday.

Finding the particle would fill a glaring hole in the widely accepted theory of how the Universe works.

This 30-year hunt is reaching an end, with experts confident they will soon be able to make a definitive statement about the particle’s existence.

The latest findings have come from analysis of data gathered by the US Tevatron particle accelerator, which was shut down at the end of last year.

Researchers squeezed the last information out of hundreds of trillions of collisions produced by the Tevatron – which was based at the Fermi National Accelerator Laboratory (Fermilab) in Illinois – since March 2001.

This final analysis of the data does not settle the question of whether the Higgs particle exists, but gets closer to an answer.

The scientists see hints of the boson in roughly the same part of the “search region” as the LHC – between the masses of 115 and 135 Gigaelectronvolts (GeV).

The signal is seen at the 2.9-sigma level of certainty, which means there is roughly a one in 1,000 chance that the result is attributable to some statistical quirk in the data.

In particle physics, three sigma counts as “evidence”. Claiming a discovery requires a statistical certainty of five sigma – which denotes a one in a million chance that any given result is a fluke.

Sniffing success

Fermilab’s Rob Roser, co-spokesperson for the Tevatron’s CDF experiment, said: “Our data strongly point toward the existence of the Higgs boson, but it will take results from the experiments at the Large Hadron Collider in Europe to establish a discovery.”

Stefan Soldner-Rembold, professor of particle physics at the University of Manchester, told BBC News: “The evidence is piling up… everything points in the direction that the Higgs is there.”

 

He added: “At the Tevatron a lot of important work has been done over the last years… it has been essential for arriving at this stage.

“So yes, the Tevatron experiments should get recognition for that, even though the LHC will be the collider to provide the final proof that the Higgs exists.”

The Higgs is the cornerstone of the Standard Model – the most successful theory to explain the workings of the Universe – and explains why all other particles have mass.

But it remains on the run; though it is predicted to exist, the particle has never been detected experimentally.

If the LHC confirms the boson’s existence, physicists will set about the task of working out whether or not it is the version of the Higgs predicted by the Standard Model.

Many researchers will hope it is not, because that would hint at phenomena outside our current understanding of physics.

The Higgs cannot be seen directly; physicists have to infer its existence by looking at the particles it has ultimately decayed – or transformed – into, and work backwards to “reconstruct” it.

The Tevatron and the LHC look for the boson in different ways. The LHC is expected to present evidence for a Higgs transforming into two photons – the rarest decay path predicted by theory.

The Tevatron appears to see hints of a Higgs transforming into particles known as b quarks – the most common type of decay.

Combining information from both accelerators will provide vital clues about the nature of this potential new particle, and whether it is really the Higgs boson scientists expect.

Most researchers now regard the Standard Model as a stepping stone to some other, more complete theory, which can explain phenomena such as dark matter and dark energy.

A non-conformist Higgs could open the door to a theory called supersymmetry – which predicts that each Standard Model particle is accompanied by a heavier partner known as a “sparticle”. Or it could hint at the existence of extra dimensions.

For physicists, these would be more exciting outcomes, and would keep them busy for many years to come.

Source: BBC.

 

 

 

Aspirin’s Mostly Unrecognized Connection to Serious Medical Problems.

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It has been more than a decade since I stopped recommending aspirin for the prevention of heart disease. The evidence in support of aspirin has always been quite weak, and over the last decade it has become even weaker.

In fact, it looks as though aspirin, even “low-dose aspirin” (LDA), may do more harm than good. It is debatable whether or not aspirin may have some beneficial actions in heart disease protection.

However, recent scientific studies have uncovered a number of serious side effects that suggest any benefits of aspirin, just like statins, may be overshadowed by its risks, especially when safe and effective alternative measures of prevention exist.

As is true with nearly all medications, the longer we look at side effects, the more we find—even for drugs like aspirin that have been around for more than 100 years.

Aspirin’s Effectiveness has Been Overvalued

Nearly ten years ago, Dr. John G. F. Cleland, a cardiologist from the University of Hull in the U.K., wrote an excellent article published in the British Journal of Medicinei casting doubt upon the efficacy of aspirin therapy for prevention of heart attacks.

Based on a series of meta-analyses from the Antithrombotic Trialists’ Collaborationii, which is an enormous body of research following more than 100,000 patients at high risk for cardiac events, Dr. Cleland concluded aspirin therapy was NOT shown to save lives.

He made the following main points:

  • Antiplatelet activity of aspirin is not as safe and effective as widely believed.
  • All large, long-term trials involving people treated with aspirin after having a heart attack show no benefit for mortality. In other words, those who take aspirin don’t live any longer than those who don’t.
  • Aspirin seems to change the way vascular events present themselves, rather than preventing them. The number of non-fatal events may be reduced, but there is an INCREASE in sudden deaths. Aspirin may conceal a cardiac event in progress.

He wrote that the studies claiming aspirin is beneficial are seriously flawed, and interpretation of those studies is biased. In the years since Cleland’s original research, there have been numerous studies pointing out aspirin’s questionable benefit, as well as its sizeable risks.

More Science Showing Aspirin’s Dismal Failure

In 2004, Dr. Cleland published the results of a new study (Warfarin/Aspirin Study in Heart Failure, or WASH) in the American Heart Journal in which he investigated antithrombotic strategies in 279 patients with heart failure. He found that the patients who received aspirin treatment actually showed the worst cardiac outcomes, especially worsening heart failure. Dr. Cleland concluded there was “no evidence that aspirin is effective or safe in patients with heart failure.”

Then in 2010, another studyiii looked into whether or not patients taking aspirin before an acute coronary syndrome (ACS) were at higher risk of recurrent problems or mortality. ACS is a term used for any condition brought on by sudden, reduced blood flow to the heart, such as a heart attack or unstable angina. The study found that patients who were taking aspirin showed a higher risk for recurrent heart attack and associated heart problems.

Thus far, aspirin’s performance is quite unimpressive. But what about aspirin’s benefits specifically for women?  As it turns out, aspirin fares no better with women.

In 2005, Harvard conducted a studyiv to investigate whether or not low-dose aspirin offered cardiovascular benefits for women. They followed nearly 40,000 healthy women for a full 10 years. Again, the results did not show any heart benefit from aspirin therapy; researchers concluded aspirin did NOT lower the risk of heart attack or death from cardiovascular causes among women.

Aspirin Never Proven Safe or Effective for Diabetics

Cardiovascular disease is a serious concern if you have diabetes, and a number of studies have set out to determine whether aspirin can offer a degree of protection. Three studies have shown the benefits to be either inconclusive, or nonexistent.

  1. In 2009, a study in the British Medical Journalv found no clear evidence that aspirin is effective in preventing cardiovascular events in people with diabetes. Results differed between men and women, but overall, they found no clear benefit and called for more studies on aspirin’s toxicity.
  2. Also in 2009, a Swedish studyvi examined the effects of aspirin therapy in diabetic patients. Researchers found no clear benefit that aspirin is beneficial for diabetics but did note that it can increase the risk for serious bleeding in some of them. They stated that the current guidelines for aspirin therapy should be revised until further study is done.
  3. In 2010, a meta-analysisvii in the U.K. examined six trials consisting of 7374 diabetic patients, comparing the relative cardiac risks for aspirin users and non-users. They concluded, as did the other researchers, that aspirin did not reduce heart attack risk for diabetic individuals.

It’s pretty clear that aspirin isn’t all that it’s cracked up to be when it comes to preventing you from having a heart attack. But is it doing any harm? Well, as it turns out, the answer is yes—in a number of possible ways.

Aspirin Increases Your Risk of Hemorrhage, GI Damage, and Several Other Problems

Routine use of aspirin has been associated with the following problems:

In fact, there are studies listed on GreenMedInfox showing aspirin’s connection with 51 different diseases! The most well established side effect of aspirin is bleeding, which results from aspirin’s interference with your platelets—the blood cells that allow your blood to clot. According to one scientific articlexi, long-term low-dose aspirin therapy may DOUBLE your risk for gastrointestinal bleeding.

You can certainly understand how a bleed is possible, given what is known about the effects aspirin has on your GI tract.

For example, a studyxii done earlier this year investigated the effects of low-dose aspirin on the gastrointestinal tracts of healthy volunteers. After only two weeks, the group receiving aspirin showed “small bowel injuries” capable of interfering with blood flow (diagnosed upon endoscopic examination). And a 2009 Australian studyxiii showed that aspirin causes gastroduodenal damage even at the low doses used for cardiovascular protection (80mg).

The damage to your duodenum—the highest part of your intestine into which your stomach contents pass—can result in duodenal ulcers, which are prone to bleeding. A Japanese studyxiv found a higher incidence of bleeding at the ulcer sites of patients with duodenal ulcers taking low-dose aspirin therapy, versus those not taking LDA. More than 10 percent of patients taking low-dose aspirin develop peptic ulcers.

The risk of bleeding is particularly pronounced in the elderly, which is very concerning as the elderly are often put on aspirin prophylactically to protect against cardiovascular disease. With all of these adverse effects, why risk it when there are safer and more effective alternatives? One of those alternatives is a relatively new emerging field called Earthing—meaning, grounding your body to the Earth.

How Earthing can Affect Your Blood

Earthing may actually be one of the best-kept secret strategies for preventing blood clots. In its simplest terms, Earthing (or grounding your body) is what occurs when you walk barefoot upon the Earth. There is a transfer of  free electrons from the Earth to your body. And these free electrons are probably some of the most potent antioxidants known to man. These antioxidants are responsible for the clinical observations seen in Earthing experiments, such as:

  • Beneficial changes in heart rate
  • Decreased skin resistance
  • Decreased inflammation

Earthing has been shown to produce a number of health benefits, including decreasing pain and inflammation, improving sleep, and even slowing the aging process. One very important discovery, and one of the most recent, is that Earthing thins your blood, making it less viscous. This discovery could have profound implications for cardiovascular disease.

Virtually every aspect of cardiovascular disease has been correlated with elevated blood viscosity.

Earthing experts Dr. Stephen Sinatra and Dr. James Oschman measure blood viscosity using a method called zeta potential, which is a measure of how quickly your red blood cells migrate in an electrical field. When you ground to the earth, your zeta potential quickly rises, which means your red blood cells have more charge on their surface, forcing them away from each other.

Earthing causes your blood to flow more easily and your blood pressure to drop.

It follows then when your red blood cells become more electro native they are less inclined to stick together and form a clot. They actually repel each other similar to two magnets with the same pole.

Blood clots don’t have to be very big to form a mass that could kill you instantly (such as pulmonary embolus), so this is an important part of lowering your risk for heart attack, stroke, and multi-infarct dementias, where you start losing brain tissue due to micro-clotting in your brain.

This is what many physicians erroneously believe low-dose aspirin is doing for you, and why it’s so widely prescribed. The problem is, as you have seen from the studies summarized above, science just hasn’t been able to prove that aspirin does what it was intended to do. Rather, studies  show that aspirin has several dangerous side effects.

Other Recommendations for a Healthy Heart

The real key to preventing heart disease is to use a combined approach, one that treats all facets of your physical and emotional health. Make sure you are addressing the following lifestyle factors:

  • Restrict your consumption of fructose to less than 25 grams per day. High sugar intake, especially fructose, is directly tied to cardiovascular disease.
  • Avoid processed foods, preservatives, additives, artificial sweeteners and grains as much as possible, and eat a good proportion of your food raw. Make sure your diet contains abundant fresh organic vegetables and high quality protein.
  • Incorporate a high quality animal based omega-3 fats into your diet to optimize your omega 6:3 ratio. An excellent animal source of omega-3 is krill oil.
  • Make sure you are getting adequate vitamin D (ideally from sun exposure) and vitamin K, since both are necessary for good cardiovascular health.
  • Be sure you’re getting enough exercise, and the right kinds of exercise. I highly recommend taking a look at my Peak Fitness program.
  • Optimize your sleep, which is essential for every aspect of your health.
  • Optimize your body weight and composition, and keep an eye on your blood pressure, blood glucose and insulin levels, iron level and lipid profile.

 

Source: Mercola.com

Maintenance treatment with antipsychotic drugs for schizophrenia.

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This Cochrane Review of the use of antipsychotic drugs as maintenance treatment for patients with schizophrenia builds on work that was started nearly four decades ago by one of its authors, John Davis from the University of Illinois in Chicago, USA. At that time, the evidence base showed that continuing with antipsychotic treatment reduced relapse rates but many questions remained. Some of these questions have been answered by subsequent randomised trials and this new Cochrane Review brings the evidence together, to provide information on different types and duration of drug, different types of patients and outcomes additional to relapse.

The review includes 65 randomised trials, with nearly 6500 participants, and uses risk ratios and numbers needed to treat to benefit and to harm to quantify the findings where meta-analyses were possible. The trials span six decades of research, and were published between 1959 and 2011. They also contain considerable heterogeneity in factors such as the antipsychotic drug used, definitions of relapse, study duration, setting, and speed of withdrawal of the antipsychotic in the placebo group. This anticipated heterogeneity led the authors to choose a random-effects meta-analysis as their principle analysis, but they also used the fixed-effect model in a sensitivity analysis for the primary outcome, which was relapse at seven to twelve months after randomization.

The main analysis found that antipsychotic drugs reduced the risk of relapse by nearly two thirds. In 24 randomised trials, with close to 2700 patients, the proportion of patients who relapsed if they were randomised to antipsychotic drugs was 27%, compared to 64% in the placebo group. This absolute reduction in risk corresponds to a number needed to treat to benefit of 3. In the sensitivity analysis, using the fixed effect model for the meta-analysis, the result was very similar, with the same risk ratio 0.40 as in the random-effects meta-analysis but a narrower 95% confidence interval of 0.36 to 0.44, rather than 0.33 to 0.49.

Antipsychotic drugs reduced the need for rehospitalisation and the risk of aggressive behaviour. This latter finding is important because, although aggressive acts of people with schizophrenia are rare, they can have dire consequences for the patients and those around them, as well as contributing detrimentally to the stigma about the disorder. In the three trials (527 patients) that were combined in the review’s analysis of quality of life, this was found to be better in the antipsychotic group. However, the drugs do have side effects, with weight gain, sedation and movement disorders being more common among patients allocated to antipsychotic drugs than those in the placebo group. One of the side effects of interest, mortality, could not be investigated because of a lack of data in the trials. This analysis would have been particularly important because it is possible that antipsychotics might increase mortality due to side effects or might decrease it by, for example, preventing suicides.

The size of this review also allowed the authors to perform a series of pre-specified subgroup analyses. These showed that first-episode patients, patients who had been in remission when randomised, and patients who had been stable for various periods of up to 3-6 years when randomised experienced fewer relapses in the antipsychotic drug group than in the placebo group. This suggests that patients who have been stabilised for 3-6 years cannot be considered to have been cured and that stopping their medication might do more than harm than good. Furthermore, the review does not support the hypothesis that any superiority of antipsychotic drugs over placebo is due to supersensitivity psychosis which would arise after abrupt discontinuation of antipsychotics, because the comparison of abrupt versus gradual withdrawal did not show an important difference in the risk ratio for relapse.

The authors of the review also performed a meta-regression to match the size of the effect on relapse with the duration of the study. This found that the drug-placebo difference got smaller the longer the studies lasted, which is counterintuitive since it implies that the best effects come from stopping the drugs sooner rather than later, but that stopping the drugs is worse than not stopping them. This might mean that antipsychotics lose their efficacy over time, but it could also arise because of confounders in the trials which can impact on any meta-regression. In these trials, for example, decreasing compliance over time could be an alternative explanation for the finding.

Although this Cochrane Review shows that many of the questions that remained unanswered after the 1975 overview have now been answered, important uncertainties remain which require further research. The authors suggest that this research should study patients for longer than two years and that studies in general should make greater efforts to measure outcomes other than relapse, including those related to rehospitalisation, social participation, compliance and death. They include the design of a suitable trial within their implications for research to stimulate those who might undertake such research.

Source: Cochrane Library

Sleep Disordered Breathing (SDB) and Cancer Mortality.

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Sleep disordered breathing (SDB) has been associated with total and cardiovascular mortality, but an association with cancer mortalityhas not been studied. Results from in vitro and animal studies suggest that intermittent hypoxia promotes cancer tumor growth. The goal of the present study was to examine whether SDB is associated with cancer mortality in a community-based sample.

METHODS:

We used 22-year mortality follow-up data from the Wisconsin Sleep Cohort sample (n=1522). SDB was assessed at baseline with full polysomnography. SDB was categorized using the apnea-hypopnea index (AHI) and the hypoxemia index (percent sleep time below 90% oxyhemoglobin saturation). The hazards of cancer mortality across levels of SDB severity were compared using crude and multivariate analyses.

MEASUREMENTS AND MAIN RESULTS:

Adjusting for age, sex, body mass index, and smoking, the SDB was associated with total and cancermortality in a dose-response fashion. Compared to normal subjects, the adjusted relative hazards of cancer mortality were 1.1 [95% confidence interval (CI), 0.5-2.7] for mild SDB (AHI 5-14.9), 2.0 (95% CI, 0.7-5.5) for moderate (AHI 15-29.9), and 4.8 (95% CI, 1.7-13.2) for severe SDB (AHI≥30) (p-trend=0.0052). For categories of increasing severity of the hypoxemia index, the corresponding relative hazards were 1.6 (95% CI, 0.6, 4.4), 2.9 (95% CI, 0.9-9.8), and 8.6 (95% CI, 2.6-28.7).

CONCLUSIONS:

Our study suggests that baseline SDB is associated with increased cancer mortality in a community-based sample. Future studies that replicate our findings and look at the association between sleep apnea and survival after cancer diagnosis are needed.

Source: BMJ

Safety warning over Britain’s most common antidepressant.

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A warning has been sounded over antidepressant drugs taken by more than a million patients in Britain.

A study for medical regulators found that the drugs increase the risk of heart problems which can cause sudden death.

Doctors have been told to lower the maximum dose of the UK’s most widely prescribed antidepressant, Citalopram, for all patients.

However, regulators have admitted that it is not clear whether the lower dose is safe — as this was not tested.

Although GPs were informed of the health risk when it emerged last autumn, and may have explained the matter to patients, no public warning was issued.

Last night, experts criticised the Medicines and Healthcare products Regulatory Agency (MHRA), the prescriptions watchdog, for failing to make a public announcement — as it has done over other alerts, such as the PIP breast implant scandal.

Citalopram is used to treat depression, anxiety and obsessive compulsive disorders. More than 13 million prescriptions were issued in England and Wales last year — more than twice as many as those for Prozac-style antidepressants.

In the study, carried out for the European Medicines Agency (EMA), it was found to be three times more likely to cause cardiac abnormalities than other types of antidepressants.

The study of healthy volunteers found that the likelihood of electrical defects in the heart rose dramatically as the dose was increased. The abnormalities — known as QT prolongation — makes people vulnerable to heart arrhythmias and to Torsade de Pointes, a rare speeding of the heart rhythm which can be fatal.

The research found the risk of Torsade de Pointes also rose threefold with the drug, when compared with the antidepressants fluoxetine (better known as Prozac), paroxetine (Seroxat) and sertraline (Lustral).

A second study found that a variant of Citalopram known as escitalopram, often sold as Cipralex, for which a million prescriptions were issued last year, also increased risks to the heart.

Prescriptions for antidepressants are normally issued for one to two months, meaning that between one million and two million patients are affected by the safety warnings.

Peter Walsh, from Action Against Medical Accidents, a patient safety charity, criticised the failure by regulators to alert the public.

Mr Walsh said: “We need assurances that the necessary steps to protect patients from adverse effects of these drugs have actually been put in place. It is particularly disappointing that there has been so little transparency with patients and the public about this.”

In the study, electrocardiogram measurements showed that when volunteers were given a 60mg dose of Citalopram, it took twice as long for their hearts to recover from each beat, than when they were given a 20mg dose.

As a result, the EMA issued advice that the maximum dose for the drug must be lowered from 60mg to 40mg, and to 20mg for elderly people, who are vulnerable to toxic effects from drugs.

However, in documents seen by this newspaper, regulators admit that it is not clear whether a 40mg dose is safe, as the study did not examine such dosage.

Similar patterns were found with escitalopram, at a dose of 30mg. It already has a maximum dose of 20mg, which remains unchanged, except for patients over 65, where the safe level is 10mg.

Dr Amanda Varnava, a consultant cardiologist from Imperial College Healthcare trust, said: “I don’t think GPs should stop prescribing these drugs, but they do need to be more aware of the risks from upping the dosage.”

Data obtained by this newspaper discloses 6,386 reports of cardiac problems and seizures among patients who took Citalopram.

The reports, which were considered by the EMA, show 569 cardiac arrests and 112 sudden deaths among patients taking the pills. In 124 cases, patients suffered Torsade de Pointes.

Since started being prescribed in the UK in 1995, 8,600 adverse reactions have been reported to the agency, including 155 deaths. In total, 223 cardiac disorders were recorded and 1,703 disorders of the nervous system.

An MHRA spokesman said its enforcement of the EMA’s recommended restrictions enabled health care professionals to give appropriate advice to their patients, and that the agency had ensured information leaflets were updated.

Source: Telegraph

 

Antidepressant Citalopram increases risk of heart problems. What dosage do you prescribe?

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A study for the MHRA (regulators for drugs and devices in the UK) has found that Britain’s most popular antidepressant increases the risk of health problems which can cause sudden death and doctors have been directed to lower the maximum dose for the drug.

“The study of healthy volunteers found that the likelihood of electrical defects in the heart rose dramatically as the dose was increased. The abnormalities — known as QT prolongation — makes people vulnerable to heart arrhythmias and to Torsade de Pointes, a rare speeding of the heart rhythm which can be fatal.”

The study carried out also found that it took patients who had taken a 60mg dose of Citalopram twice as long for their hearts to recover, than compared to a 20mg dose.

13 millon Citalopram prescriptions were made last year in England and Wales (twice as many as Prozac prescriptions)Despite this advice the MHRA do not even know if the lower dose is safe, as tests have not been done on a 40mg dose.

Reports say that GPs were made aware of this risk last autumn but it is only till now that the public have been informed of the potential risks.

It really does make you wonder what sort of tests were carried out before these drugs were put on the market. What are the dosage guidelines? How can we know what is safe?

Source: BMJ