Thursday, June 28, 2007
Veggie Booty Recall
All lots and sizes of Veggie Booty Snack Food are being recalled, the company said, following a report of 51 cases of salmonella poisoning that may be associated with the product. Georgine Hertzwig of Robert's American Gourmet in Sea Cliff, N.Y., said the company acted after the Food and Drug Administration contacted them about the illnesses in 17 states. Salmonella can cause serious and sometimes fatal infections, especially in young children, frail or elderly people and others with weakened immune systems. Symptoms include fever, diarrhea, nausea, vomiting and abdominal pain. Hertzwig said none of the products has tested positive for salmonella, but the company acted as a precaution after the FDA and the Centers for Disease Control and Prevention reported that many of the infected people has eaten the product. The brand name is Robert's American Gourmet, and all codes and expiration dates of Veggie Booty are being recalled. The company said consumers who purchased Veggie Booty and still have the product in their homes should discard the contents and contact the company at 1-800-626-7557 for reimbursement.
Wednesday, June 27, 2007
American Journal of Clinical Nutrition - June Highlights
- Reducing dietary energy density, particularly by combining increased fruit and vegetable intakes with decreased saturated fat intake, is an effective strategy for managing body weight while controlling hunger. Fruits and vegetables are water-rich foods that adds weight from water without adding energy and holding satiety.
- Snack chips fried with corn oil alleviate cardiovascular risk factors when substituted for low-fat or high fat snacks. We mentioned this study because even the most inane, skewed studies can appear in prestigious journals. This study was, of course, funded by Frito-Lay!
- Healthy men either consumed a high-fat, low carbohydrate diet (40% and 45%) or a low-fat, high carbohydrate diet (20% and 65%) to see how it would effect Lp(a) and triglycerides, both crucial cardiovascular risk markers. Only the low-fat, high carbohydrate diet increased these markers, showing that excess carbohydrate consumption (especially grains), exacerbates cardiac inflammation.
- Cinnamon reduces blood glucose and delays gastric emptying without affecting satiety.
- In two studies, a high intake of fresh fruit, root vegetables, and fruiting vegetables was associated with reduced mortality and lower blood pressure while aging, most likely as a result of antioxidants such as vitamin's C & A.
Tuesday, June 26, 2007
FDA says unmoved by aspartame/cancer report
Italian researchers published a new study last week that showed aspartame -- widely used in soft drinks -- might cause leukemia, lymphoma and breast cancer in rats, but the FDA said there was no immediate need to take action.
"This is the second study by the same lab showing that aspartame causes cancer in rats," Center for Science in the Public Interest executive director Michael Jacobson said in a telephone interview.
"On the basis of the present findings, we believe that a review of the current regulations governing the use of aspartame cannot be delayed," researchers wrote in the journal Environmental Health Perspectives, which is published by the U.S. National Institute of Environmental Health Sciences.
"This review is particularly urgent with regard to aspartame-containing beverages, heavily consumed by children."
FDA spokesman Michael Herndon said the agency had not yet reviewed the study.
"However, the conclusions from this second European Ramazzini Foundation are not consistent with those from the large number of studies on aspartame that have been evaluated by FDA, including five previously conducted negative chronic carcinogenicity studies," Herndon said in an e-mail.
"Therefore, at this time, FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food."
Jacobson said people should avoid the product for now.
"People shouldn't panic, but they should stop buying beverages and foods containing aspartame," he advised.
Bonnie - we are not surprised by the FDA's response. They are in hot water with this.The previous studies the FDA refers to were all done by the manufacturer of aspartame and severely flawed. This is the first legitimate study executed on rats or humans. For further info, click on last week's blog entry on the issue.
As of 6/28/07, the FDA altered its response slightly: "FDA is interested in reviewing the recently published study; however, to date FDA has not been provided the data from this new study. Until FDA conducts an evaluation of the study, it cannot comment on the findings."
Distress-Prone People More Likely to Develop Memory Problems
People who are easily distressed and have more negative emotions are more likely to develop memory problems than more easygoing people, according to a study published in the June 12, 2007, issue of Neurology.
In the study, those who most often experience negative emotions such as depression and anxiety were 40 percent more likely to develop mild cognitive impairment than those who were least prone to negative emotions. Mild cognitive impairment is a transitional stage between normal aging and dementia. People with mild cognitive impairment have mild memory or cognitive problems, but have no significant disability. Researchers analyzed the results from two larger studies, the Religious Orders Study and the Memory and Aging Project. The studies involved 1,256 people with no cognitive impairment. During up to 12 years of follow-up, 482 people developed mild cognitive impairment.
Participants were evaluated on their level of proneness to distress and negative emotions by rating their level of agreement with statements such as "I am not a worrier," "I often feel tense and jittery," and "I often get angry at the way people treat me." "People differ in how they tend to experience and deal with negative emotions and psychological distress, and the way people respond tends to stay the same throughout their adult lives," said study author Robert S. Wilson, PhD, of Rush University Medical Center in Chicago, IL. "These findings suggest that, over a lifetime, chronic experience of stress affects the area of the brain that governs stress response. Unfortunately, that part of the brain also regulates memory."
An earlier study by Wilson and his colleagues showed that people who are easily distressed are more likely to develop Alzheimer's disease than more easygoing people. Wilson said several factors lead researchers to believe that proneness to stress is a risk factor for memory problems and not an early sign of disease. The study was supported by grants from the National Institute on Aging and the Illinois Department of Public Health.
Bonnie - this data further heeds the call for taking stress management seriously and creating an environment of positive thinking!
In the study, those who most often experience negative emotions such as depression and anxiety were 40 percent more likely to develop mild cognitive impairment than those who were least prone to negative emotions. Mild cognitive impairment is a transitional stage between normal aging and dementia. People with mild cognitive impairment have mild memory or cognitive problems, but have no significant disability. Researchers analyzed the results from two larger studies, the Religious Orders Study and the Memory and Aging Project. The studies involved 1,256 people with no cognitive impairment. During up to 12 years of follow-up, 482 people developed mild cognitive impairment.
Participants were evaluated on their level of proneness to distress and negative emotions by rating their level of agreement with statements such as "I am not a worrier," "I often feel tense and jittery," and "I often get angry at the way people treat me." "People differ in how they tend to experience and deal with negative emotions and psychological distress, and the way people respond tends to stay the same throughout their adult lives," said study author Robert S. Wilson, PhD, of Rush University Medical Center in Chicago, IL. "These findings suggest that, over a lifetime, chronic experience of stress affects the area of the brain that governs stress response. Unfortunately, that part of the brain also regulates memory."
An earlier study by Wilson and his colleagues showed that people who are easily distressed are more likely to develop Alzheimer's disease than more easygoing people. Wilson said several factors lead researchers to believe that proneness to stress is a risk factor for memory problems and not an early sign of disease. The study was supported by grants from the National Institute on Aging and the Illinois Department of Public Health.
Bonnie - this data further heeds the call for taking stress management seriously and creating an environment of positive thinking!
Do you know the nutrient content of your greens?
Greens pack a powerful nutrient punch. Here are several examples that may surpise you:
Belgian Endive - one head provides 222% of daily vitamin A requirement, 56% vitamin C, 27% calcium, and 24% iron;
Butterhead - one head provides 108% of daily vitamin A requirement and 11% iron;
Cabbage - one head provides 761% of daily vitamin C requirement, 50% calcium, and 33% iron;
Iceberg - one head provides 76% daily vitamin A requirement, 35% vitamin C, 14% calcium, and 17% iron;
Spinach - one head provides 638% of daily vitamin A requirement, 159% vitamin C, 51% iron, and 34% calcium;
Romaine - one head provides 727% of daily vitamin A requirement, 250% vitamin C, 34% iron, and 21% calcium;
Belgian Endive - one head provides 222% of daily vitamin A requirement, 56% vitamin C, 27% calcium, and 24% iron;
Butterhead - one head provides 108% of daily vitamin A requirement and 11% iron;
Cabbage - one head provides 761% of daily vitamin C requirement, 50% calcium, and 33% iron;
Iceberg - one head provides 76% daily vitamin A requirement, 35% vitamin C, 14% calcium, and 17% iron;
Spinach - one head provides 638% of daily vitamin A requirement, 159% vitamin C, 51% iron, and 34% calcium;
Romaine - one head provides 727% of daily vitamin A requirement, 250% vitamin C, 34% iron, and 21% calcium;
Complementary techinques for breast cancer becoming more common
To reduce side effects of breast cancer treatment and improve outcomes, the following therapies are becoming an integral part of the regimen:
- Massage - helps with pain
- Acupuncture - helps reduce nausea
- Yoga - helps with fatigue
- Diet & Nutrients - helps with all of the above
Monday, June 25, 2007
Our take on the cGMPs for dietary supplements
The U.S. Food and Drug Administration (FDA) has posted its final rule on current good manufacturing practice (cGMP) for dietary supplements.
Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, companies that manufacture, pack, label or hold dietary supplements have been required to conform to conventional food cGMP. Dietary Supplements now have their own set of standards.
We found several specifics in this ruling that warrant discussion:
-The final rule goes into effect one year from publication date for large companies (defined as 500 or more employees) and two years from publication for small companies (defined as less than 500 employees) and very small companies (defined as less than 20 employees) will have three years.
NCI: we are disappointed with the length of time the smaller companies have to conform. In our view, they should have been adhering closely to the standards for medications already, which are even more stringent than these cGMPs.
-The rule is relevant to all dietary supplements sold or offered for sale in the United States, so that even foreign firms will be required to meet the new manufacturing identification standards.
NCI: this is fine. Manufacturers must identify every ingredient with 100% certainty. However, this still leaves it up to the manufacturer to create its own quality control measures to ensure the safety of raw materials. Raw material suppliers are exempt from these cGMPs. There is a lot left to be desired from raw materials coming from abroad. The adverse reaction reporting system that was passed earlier this year will help with safety, but a set of ironclad safety guidelines for all to follow could have been placed in this ruling. Now, instead of acting as a preventive, safety will still be reactive.
-FDA will "exercise enforcement discretion" with regard to products made by practitioners, such as acupuncturists and herbalists who use the products that they make in a "one-on-one consultation."
NCI: we are very encouraged by this development. There is very little attention paid to supplements manufactured by practitioners, pharmacies, and custom vitamin formulators. However, oversight of this regulation will take a "Herculean" effort.
-Requires a qualified person to investigate any ''product complaint'' that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.
NCI: Once again, noble, but impossible to enforce in the FDA's current state. Look at the deplorable track record they have had with addressing food and drug infractions/safety.
Additional FYI:
A colleague was on the FDA press conference call the day the cGMPs were released, and he asked if the agency currently has the resources and personnel to effectively enforce the GMP requirements.
The answer was that this will become a part of the agencies overall enforcement strategy which bases resource allocation on potential risk.
When he asked what level of risk the agency believes exists in the dietary supplement sector, the response was that the agency does not really know yet.
We've been saying it all along, but will say it again. If the agency does not enforce the cGMPs, then this will only make the playing field even more unlevel. And we have serious doubts that this will be accomplished.
Another crucial issue that was not addressed in this ruling: there are still no regulations that require supplements to carry adequate directions for use and appropriate warnings.
If you read this newsletter, most likely you have put your nutritional care in the hands of Nutritional Concepts. Why should this put you at ease?
Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, companies that manufacture, pack, label or hold dietary supplements have been required to conform to conventional food cGMP. Dietary Supplements now have their own set of standards.
We found several specifics in this ruling that warrant discussion:
-The final rule goes into effect one year from publication date for large companies (defined as 500 or more employees) and two years from publication for small companies (defined as less than 500 employees) and very small companies (defined as less than 20 employees) will have three years.
NCI: we are disappointed with the length of time the smaller companies have to conform. In our view, they should have been adhering closely to the standards for medications already, which are even more stringent than these cGMPs.
-The rule is relevant to all dietary supplements sold or offered for sale in the United States, so that even foreign firms will be required to meet the new manufacturing identification standards.
NCI: this is fine. Manufacturers must identify every ingredient with 100% certainty. However, this still leaves it up to the manufacturer to create its own quality control measures to ensure the safety of raw materials. Raw material suppliers are exempt from these cGMPs. There is a lot left to be desired from raw materials coming from abroad. The adverse reaction reporting system that was passed earlier this year will help with safety, but a set of ironclad safety guidelines for all to follow could have been placed in this ruling. Now, instead of acting as a preventive, safety will still be reactive.
-FDA will "exercise enforcement discretion" with regard to products made by practitioners, such as acupuncturists and herbalists who use the products that they make in a "one-on-one consultation."
NCI: we are very encouraged by this development. There is very little attention paid to supplements manufactured by practitioners, pharmacies, and custom vitamin formulators. However, oversight of this regulation will take a "Herculean" effort.
-Requires a qualified person to investigate any ''product complaint'' that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.
NCI: Once again, noble, but impossible to enforce in the FDA's current state. Look at the deplorable track record they have had with addressing food and drug infractions/safety.
Additional FYI:
A colleague was on the FDA press conference call the day the cGMPs were released, and he asked if the agency currently has the resources and personnel to effectively enforce the GMP requirements.
The answer was that this will become a part of the agencies overall enforcement strategy which bases resource allocation on potential risk.
When he asked what level of risk the agency believes exists in the dietary supplement sector, the response was that the agency does not really know yet.
We've been saying it all along, but will say it again. If the agency does not enforce the cGMPs, then this will only make the playing field even more unlevel. And we have serious doubts that this will be accomplished.
Another crucial issue that was not addressed in this ruling: there are still no regulations that require supplements to carry adequate directions for use and appropriate warnings.
If you read this newsletter, most likely you have put your nutritional care in the hands of Nutritional Concepts. Why should this put you at ease?
- 25 years of clinical and public health experience with nutritional supplements.
- Many manufacturers that we work with adhere to the cGMPs required of drug manufacturers, which exceeds the new cGMPs set for the dietary supplement industry.
- Having prescribed the same dietary supplements for 10 to 20 years, a track record of safety and reliability has been established.
- We go beyond the cGMPs and ask our manufacturers to provide us with data on their raw material suppliers. We do this to confirm that our manufacturers are consistently checking their raw materials for impurities, toxins, and place of origin.
- Your nutrient needs have been individualized to your unique needs, going far beyond any recommendations that could be made on a label or by a store employee.
Dinner plate helps diabetics shed pounds
Overweight people with diabetes have as much success dropping pounds using a colorful dinner plate that measures food portions as they do on many weight-loss drugs, Canadian researchers said on Monday. In addition, diabetics who stick to using the tool to control their diet can sometimes even reduce their insulin intake over time, said Sue Pedersen, an endocrinologist at the University of Calgary Faculty of Medicine, who led a six-month study. "People using the plate were over three times more likely to lose a clinically significant amount of weight than non-plate users," Pedersen said. "And that weight loss is similar to the weight loss seen in studies of weight-loss drugs, but without the potential for side-effects." Findings of the team, which studied 130 people with type 2 diabetes, were published in the Archives of Internal Medicine. Half the subjects used the so-called Diet Plate, a British-made tool that allows people to measure out portions of carbohydrates, proteins, sauces and fruits and vegetables.
No one was told to make big lifestyle changes, such as exercising more or less. Of those who used the plate for six months, 17 percent lost 5 percent or more of their weight, an amount considered clinically important because it cuts risks of obesity-related conditions like heart disease and cancer, Pedersen said. In the group that didn't use the plate, fewer than one person in 20 lost a clinically important amount. More than a quarter of the plate users could reduce their diabetic medication, versus 11 percent in the other group, according to the study. In addition, 34 percent of those who did not use the Diet Plate had to increase their drug intake. "That's important, because if we can, with better diet control, get someone down on their medication, that means there is less potential for side-effects related to medication and the cost of medication," she said.
Steve - this is encouraging while not surprising. Our version of the Diet Plate, The Circle of Health, mirrors the size of a dinner plate and exhibits ideal dietary balance. Many of our clients lose more weight in six months than what is shown in this study and our plate is even more colorful.
No one was told to make big lifestyle changes, such as exercising more or less. Of those who used the plate for six months, 17 percent lost 5 percent or more of their weight, an amount considered clinically important because it cuts risks of obesity-related conditions like heart disease and cancer, Pedersen said. In the group that didn't use the plate, fewer than one person in 20 lost a clinically important amount. More than a quarter of the plate users could reduce their diabetic medication, versus 11 percent in the other group, according to the study. In addition, 34 percent of those who did not use the Diet Plate had to increase their drug intake. "That's important, because if we can, with better diet control, get someone down on their medication, that means there is less potential for side-effects related to medication and the cost of medication," she said.
Steve - this is encouraging while not surprising. Our version of the Diet Plate, The Circle of Health, mirrors the size of a dinner plate and exhibits ideal dietary balance. Many of our clients lose more weight in six months than what is shown in this study and our plate is even more colorful.
Echinacea might reduce chances of becoming ill, researcher says
According to a meta-analysis, Eginacea might reduce the chances of catching a cold by 58 percent, according to the latest in a long line of confusing and contradictory studies.
Better yet, echinacea might reduce the length of a cold by an average of 1.4 days -- a substantial savings, because colds cause 40 percent of the nation's lost work time, the authors of a recent study say.
The study, conducted by scientists from the University of Connecticut, is published online today in The Lancet Infectious Diseases, a British medical journal.
Over the years, studies of echinacea have shown "a trend of improving colds," but none involved enough patients to be statistically significant, said the author of today's article, Dr. Craig Coleman of the University of Connecticut's School of Pharmacy.
Other studies have shown just the opposite. In 2000, German scientists reported that echinacea could help treat colds but not necessarily prevent them. In 2005, a study of more than 400 patients published in the New England Journal of Medicine indicated that echinacea had no effect on colds at all.
Coleman's team performed a meta-analysis, combining the results of 14 independent studies involving more than 1,600 patients.
Some experts say that's still not good enough. They argue that Coleman's meta-analysis combines too many studies with different combinations of drugs.
"Some of the patients were also taking Vitamin C, rosemary, thyme ... you really don't know what's going on," said Dr. Adriane Fugh-Berman, associate professor of complementary and alternative medicine at Georgetown University.
To compensate for this problem, Coleman said, his team did a "sensitivity analysis" to determine whether echinacea worked on its own.
"There was still reduction in cold duration," Coleman said, but not enough to be statistically significant.
Steve - we treat meta-analysis of dietary supplements exactly as we do medications...very cautiously. This means that we are not going to blanketly start recommending echinacea just because of this review study. Echinacea has and always will be a mixed bag. It is low on the totem pole of our recommendations for immune boosters.
While some benefit from its positive effect on immune function, others do not. How one responds to echinacea, we believe, is due to one's genetic makeup. In addition, echinacea contraindicates with other herbs and some medications. We also never recommend taking it for more than two weeks at a time.
Better yet, echinacea might reduce the length of a cold by an average of 1.4 days -- a substantial savings, because colds cause 40 percent of the nation's lost work time, the authors of a recent study say.
The study, conducted by scientists from the University of Connecticut, is published online today in The Lancet Infectious Diseases, a British medical journal.
Over the years, studies of echinacea have shown "a trend of improving colds," but none involved enough patients to be statistically significant, said the author of today's article, Dr. Craig Coleman of the University of Connecticut's School of Pharmacy.
Other studies have shown just the opposite. In 2000, German scientists reported that echinacea could help treat colds but not necessarily prevent them. In 2005, a study of more than 400 patients published in the New England Journal of Medicine indicated that echinacea had no effect on colds at all.
Coleman's team performed a meta-analysis, combining the results of 14 independent studies involving more than 1,600 patients.
Some experts say that's still not good enough. They argue that Coleman's meta-analysis combines too many studies with different combinations of drugs.
"Some of the patients were also taking Vitamin C, rosemary, thyme ... you really don't know what's going on," said Dr. Adriane Fugh-Berman, associate professor of complementary and alternative medicine at Georgetown University.
To compensate for this problem, Coleman said, his team did a "sensitivity analysis" to determine whether echinacea worked on its own.
"There was still reduction in cold duration," Coleman said, but not enough to be statistically significant.
Steve - we treat meta-analysis of dietary supplements exactly as we do medications...very cautiously. This means that we are not going to blanketly start recommending echinacea just because of this review study. Echinacea has and always will be a mixed bag. It is low on the totem pole of our recommendations for immune boosters.
While some benefit from its positive effect on immune function, others do not. How one responds to echinacea, we believe, is due to one's genetic makeup. In addition, echinacea contraindicates with other herbs and some medications. We also never recommend taking it for more than two weeks at a time.
Monsanto slapped on wrist for false ad claim
Biotech crops giant Monsanto has been ordered to withdraw an advertising claim that no negative reactions have ever been reported to genetically modified foods.
The Advertising Standards Authority of South Africa made the ruling this week in response to a consumer complaint lodged against a Monsanto South Africa print ad referring to GM grain products.
The ad, which ran in the February edition of You magazine, carried the heading: "Is your food SAFE?" and contained an image of a woman with two children in a kitchen looking at a cake.
Below the sub-heading: "Biotechnology - the true facts" it said: "This is one of the most extensively tested and controlled types of food, and no negative reactions have ever been reported."
The ASA said that the onus was now on Monsanto to provide independent verification of the "no negative reactions" claim.
Steve - I am looking forward to seeing this independent verification :)
The Advertising Standards Authority of South Africa made the ruling this week in response to a consumer complaint lodged against a Monsanto South Africa print ad referring to GM grain products.
The ad, which ran in the February edition of You magazine, carried the heading: "Is your food SAFE?" and contained an image of a woman with two children in a kitchen looking at a cake.
Below the sub-heading: "Biotechnology - the true facts" it said: "This is one of the most extensively tested and controlled types of food, and no negative reactions have ever been reported."
The ASA said that the onus was now on Monsanto to provide independent verification of the "no negative reactions" claim.
Steve - I am looking forward to seeing this independent verification :)
Friday, June 22, 2007
FDA issues final ruling on Good Manufacturing Practices for Dietary Supplements
It only took them ten years to do it! The ruling is 815 pages long and just released today. We need some time to review the information before we can make an educated response.
What we can say is this is a great step in the right direction. However, tracking those unsavory manufactureres who do not comply will be a tall order as we have seen so many times with their handling of medication safety and GMPs.
What we can say is this is a great step in the right direction. However, tracking those unsavory manufactureres who do not comply will be a tall order as we have seen so many times with their handling of medication safety and GMPs.
1st U.S. Drug Approved for Fibromyalgia
Lyrica (pregabalin) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia. It's the first drug approved in the United States to treat the condition that affects up to 6 million Americans, the agency said Thursday. People with fibromyalgia usually have chronic pain, muscle stiffness, fatigue, and sleep problems. The disorder affects more women than men, and commonly develops in early-to-middle adulthood.
Lyrica was approved for fibromyalgia following clinical trials involving about 1,800 people, although not all participants were helped by the drug, the agency said. Lyrica, manufactured by Pfizer, Inc., is already approved to treat partial seizures, and pain from shingles and diabetic neuropathy. Lyrica's main action affects the central nervous system.
What are the possible side effects of LYRICA?
• dizziness and sleepiness.
• eyesight problems.
• weight gain and swelling of the hands and feet (edema).
Weight gain may affect the management of diabetes. Weight
gain and swelling can also be a serious problem for people with
heart problems.
• unexplained muscle problems, such as muscle pain,
soreness, or weakness. If you develop these symptoms,
especially if you also feel sick and have a fever, tell your
doctor right away.
The most common side effects of LYRICA are:
• dizziness
• blurry vision
• weight gain
• sleepiness
• trouble concentrating
• swelling of hands and feet
• dry mouth
LYRICA caused skin sores in animals. Although skin sores were not seen in studies in people, if you have diabetes, you should pay extra attention to your skin while taking LYRICA and tell your doctor of any sores or skin problems.
LYRICA may cause some people to feel “high.” Tell your doctor, if you have abused prescription medicines, street drugs, or alcohol in the past.
These are not all the side effects of LYRICA. For more information, ask your doctor or pharmacist.
What are the ingredients In LYRICA?
Active ingredient: pregabalin
Inactive ingredients: lactose monohydrate, cornstarch, talc;
Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.
Lyrica was approved for fibromyalgia following clinical trials involving about 1,800 people, although not all participants were helped by the drug, the agency said. Lyrica, manufactured by Pfizer, Inc., is already approved to treat partial seizures, and pain from shingles and diabetic neuropathy. Lyrica's main action affects the central nervous system.
What are the possible side effects of LYRICA?
• dizziness and sleepiness.
• eyesight problems.
• weight gain and swelling of the hands and feet (edema).
Weight gain may affect the management of diabetes. Weight
gain and swelling can also be a serious problem for people with
heart problems.
• unexplained muscle problems, such as muscle pain,
soreness, or weakness. If you develop these symptoms,
especially if you also feel sick and have a fever, tell your
doctor right away.
The most common side effects of LYRICA are:
• dizziness
• blurry vision
• weight gain
• sleepiness
• trouble concentrating
• swelling of hands and feet
• dry mouth
LYRICA caused skin sores in animals. Although skin sores were not seen in studies in people, if you have diabetes, you should pay extra attention to your skin while taking LYRICA and tell your doctor of any sores or skin problems.
LYRICA may cause some people to feel “high.” Tell your doctor, if you have abused prescription medicines, street drugs, or alcohol in the past.
These are not all the side effects of LYRICA. For more information, ask your doctor or pharmacist.
What are the ingredients In LYRICA?
Active ingredient: pregabalin
Inactive ingredients: lactose monohydrate, cornstarch, talc;
Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.
Thursday, June 21, 2007
Locally grown, fresh market booms on green culture, report
Sales of fresh and locally grown foods have shot up in recent years, driven by factors such as food safety fears and America's growing 'green' culture, claims a new report by Packaged Facts.
And based on the "exponential growth" of farmers' markets, as well as retail and foodservice initiatives to add more local products to their merchandise mix and menus, Packaged Facts estimates that locally grown foods could turn into a $7bn business by 2011.
The report defines 'fresh foods' as anything that requires refrigeration or has a short shelf life. 'Locally grown foods' are those that need to travel no more that one day from their point of production to their point of purchase.
According to Packaged Facts, consumers equate locally grown food with freshness, and freshness with higher quality. As a result, they are increasingly looking toward the perimeter departments of supermarkets for fresh foods that include locally grown and organic fruits and vegetables, fresh meats, seafood, dairy and baked goods.
Consumers are also turning to these products as they are increasingly concerned about the impact of businesses on the environment, which prompts a desire for 'greener' purchases. Another concern is a loss of confidence in the conventional food safety systems, which turns some people away from a reliance on a heavily industrialized food chain.
"New trends, including 'food miles', 'the Slow Food movement', and even 'locavores' who eat only locally grown foods, are just beginning to take root in the US and we anticipate these and other trends will swiftly drive growth of local and fresh market foods," said Don Montuori, the publisher of Packaged Facts.
Steve - all we can say is...YEAH!
And based on the "exponential growth" of farmers' markets, as well as retail and foodservice initiatives to add more local products to their merchandise mix and menus, Packaged Facts estimates that locally grown foods could turn into a $7bn business by 2011.
The report defines 'fresh foods' as anything that requires refrigeration or has a short shelf life. 'Locally grown foods' are those that need to travel no more that one day from their point of production to their point of purchase.
According to Packaged Facts, consumers equate locally grown food with freshness, and freshness with higher quality. As a result, they are increasingly looking toward the perimeter departments of supermarkets for fresh foods that include locally grown and organic fruits and vegetables, fresh meats, seafood, dairy and baked goods.
Consumers are also turning to these products as they are increasingly concerned about the impact of businesses on the environment, which prompts a desire for 'greener' purchases. Another concern is a loss of confidence in the conventional food safety systems, which turns some people away from a reliance on a heavily industrialized food chain.
"New trends, including 'food miles', 'the Slow Food movement', and even 'locavores' who eat only locally grown foods, are just beginning to take root in the US and we anticipate these and other trends will swiftly drive growth of local and fresh market foods," said Don Montuori, the publisher of Packaged Facts.
Steve - all we can say is...YEAH!
Stevia product appears in mainstream grocer aisles
Stevia, derived from the South American plant stevia rebaudiana, is said to have up to 300 times the sweetness of sugar. As a sweetener, stevia's taste has a slower onset and longer duration than that of sugar, although some of its extracts may have a bitter or liquorice-like aftertaste at high concentrations.
It has made it onto the sweetener aisle shelves of Kroger, Schnucks, Brookshire and Albertsons, sitting right next to the top three artificial sweetener products in the world.
There have been rumors that the US Food and Drug Administration (FDA) could be petitioned to approve stevia as a food additive.
Public awareness of the ingredient shot up earlier this month, after the Wall Street Journal revealed that big players Coca-Cola and Cargill were teaming up to market a stevia sweetener product. Coca-Cola has filed 24 patent applications for the ingredient in the US.
According to the article, the two firms are gathering data on the ingredient in order to apply for FDA approval.
It has made it onto the sweetener aisle shelves of Kroger, Schnucks, Brookshire and Albertsons, sitting right next to the top three artificial sweetener products in the world.
There have been rumors that the US Food and Drug Administration (FDA) could be petitioned to approve stevia as a food additive.
Public awareness of the ingredient shot up earlier this month, after the Wall Street Journal revealed that big players Coca-Cola and Cargill were teaming up to market a stevia sweetener product. Coca-Cola has filed 24 patent applications for the ingredient in the US.
According to the article, the two firms are gathering data on the ingredient in order to apply for FDA approval.
Second Ramazzini aspartame study published in Environmental Health Perspectives
A second ERF study on the artificial sweetener aspartame, entitled "Lifespan Exposure to Low Doses of Aspartame Beginning During Prenatal Life Increases Cancer Effects in Rats" has been accepted for publication in Environmental Health Perspectives.
The full text of the article is available online at: http://www.ehponline.org/docs/2007/10271/abstract.html
Environmental Health Perspectives (EHP), the peer-reviewed journal of the United States' National Institute of Environmental Health Sciences, is an important vehicle for the dissemination of environmental health information and research findings. EHP's mission is to serve as a forum for the discussion of the interrelationships between the environment and human health by publishing in a balanced and objective manner the best peer-reviewed research and most current and credible news of the field. With an impact factor of 5.34, EHP ranks first among 132 environmental sciences journals and first among 90 public, environmental, and occupational health journals. EHP is read in over 190 countries.
Study Abstract
Background. In a previous study conducted at the Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation (CMCRC/ERF), we demonstrated for the first time that aspartame (APM), administered with feed at various doses to 8 week-old Sprague Dawley rats for the lifespan, is a multipotent carcinogenic agent.
Objective. The aim of this second study is to better quantify the carcinogenic risk of APM, beginning treatment during fetal life.
Methods. The study was conducted on groups of 70-95 male and female Sprague Dawley rats, administered APM with feed at concentrations of 2000, 400, or 0 ppm from the 12th day of fetal life until natural death.
Results. The results of the study show: a) a significant dose-related increase of malignant tumor-bearing animals in males, in particular in the group treated at 2000 ppm; b) a significant increase of the incidence in lymphomas/leukemias in males treated at 2000 ppm and a significant dose-related increase of the incidence of lymphomas/leukemias in females, in particular in the group treated at 2000 ppm; c) a significant dose-related increase of the incidence of mammary cancer in females, in particular in the group treated at 2000 ppm.
Conclusions. The results of this carcinogenicity bioassay not only confirm, but also reinforce the first experimental demonstration of APM’s multipotential carcinogenicity at a dose level close to the acceptable daily intake (ADI) for humans. Furthermore, the study demonstrates that when lifespan exposure to APM begins during fetal life, its carcinogenic effects are increased.
Link to first Ramazzini APM study (Environ Health Perspect 114:379-385, 2006): First Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats
Steve - we have followed this very closely over the years. The fact that Cargill and Coca Cola are venturing into the world of stevia says a lot about where aspartame is headed. As we have said forever, aspartame is poison. The public at large will be privy to this soon enough.
Wednesday, June 20, 2007
Tyson to Sell Chicken Free of Antibiotics
Tyson Foods, one of the nation’s largest poultry producers, said yesterday that it would no longer use antibiotics to raise chicken sold fresh in stores and would start a $70 million advertising campaign to promote the shift. The company said that fresh chicken raised without antibiotics was shipped to stores Monday and would be sold beginning later this week in packaging that emphasizes there are no artificial ingredients. “We’re providing mainstream consumers with products they want,” Tyson’s chief executive, Richard L. Bond, said at a news conference.
Consumers will have to pay slightly more for the privilege though. Dave Hogberg, a senior vice president at Tyson, declined to specify how much of an increase shoppers would see at stores, but he said it would be “below the cost consumers say they’re willing to pay.” He said that Tyson was converting 20 — not quite half — of its production facilities to produce the products. Mr. Bond said the switch would not affect the company’s earnings in the short term and could increase demand for chicken.
Courtesy of Associated Press
Steve - in 2002, it was reported in the NY Times that Tyson only used antibiotics when a flock was at risk for a disease. Further study will have to be made to see if they were using antibiotics more widely than believed.
Consumers will have to pay slightly more for the privilege though. Dave Hogberg, a senior vice president at Tyson, declined to specify how much of an increase shoppers would see at stores, but he said it would be “below the cost consumers say they’re willing to pay.” He said that Tyson was converting 20 — not quite half — of its production facilities to produce the products. Mr. Bond said the switch would not affect the company’s earnings in the short term and could increase demand for chicken.
Courtesy of Associated Press
Steve - in 2002, it was reported in the NY Times that Tyson only used antibiotics when a flock was at risk for a disease. Further study will have to be made to see if they were using antibiotics more widely than believed.
Food allergies rise 12-fold in Australian children
Food allergies in Australian children have risen 12-fold since 1995 and there is an "urgent need" for further research into the trend, according to a new study.
The study provides processors with a view of the dietary requirements of consumers of the future and the potential scale that a contamination problem involving allergy-triggering ingredients could have.
A "dramatic increase" in the number of children hospitalized as a result of anaphylaxis - the most severe and potentially deadly type of food allergy, was also found during the study, published this month.
Over a twelve year period, 1489 children aged between 0 and five years-old were referred to a specialist allergy practice in the Australian Capital Territory, of which found 697, or 47 per cent, suffered from a food allergy.
The specialist allergy practice in the Australian Capital Territory that conducted the study found the most common reactions were involved peanuts, eggs, cows milk and cashews.
During the study, the number of children tested at the clinic with suspected allergies rose four-fold from 55 in 1955 to 240 in 2006.
While the prevalence of non-food allergies, such as hay fever and asthma, experienced little change during the study, food allergies rose from 20 per cent of children tested in 1995 to 57.5 per cent by 2006.
While part of this increase could be attributed to an increasing understanding of the symptoms of allergies, improving parents' ability to spot what is a likely reaction to food, the marked increase demonstrates a trend towards intolerance towards certain foods.
Bonnie - as we know full well, this dramatic rise is not limited to Australia. However, Australian's dietary habits are similar to ours. As long as wheat, milk, corn, and soy are in everything we eat, food intolerance/allergy will continue to rise.
The study provides processors with a view of the dietary requirements of consumers of the future and the potential scale that a contamination problem involving allergy-triggering ingredients could have.
A "dramatic increase" in the number of children hospitalized as a result of anaphylaxis - the most severe and potentially deadly type of food allergy, was also found during the study, published this month.
Over a twelve year period, 1489 children aged between 0 and five years-old were referred to a specialist allergy practice in the Australian Capital Territory, of which found 697, or 47 per cent, suffered from a food allergy.
The specialist allergy practice in the Australian Capital Territory that conducted the study found the most common reactions were involved peanuts, eggs, cows milk and cashews.
During the study, the number of children tested at the clinic with suspected allergies rose four-fold from 55 in 1955 to 240 in 2006.
While the prevalence of non-food allergies, such as hay fever and asthma, experienced little change during the study, food allergies rose from 20 per cent of children tested in 1995 to 57.5 per cent by 2006.
While part of this increase could be attributed to an increasing understanding of the symptoms of allergies, improving parents' ability to spot what is a likely reaction to food, the marked increase demonstrates a trend towards intolerance towards certain foods.
Bonnie - as we know full well, this dramatic rise is not limited to Australia. However, Australian's dietary habits are similar to ours. As long as wheat, milk, corn, and soy are in everything we eat, food intolerance/allergy will continue to rise.
Tuesday, June 19, 2007
Favorable Impact of Meditation on Memory Impairment and Brain Function
Practiced by millions of individuals to reduce stress and anxiety, improve concentration, and even lower blood pressure, meditation is among the most commonly used alternative therapies in the world. At the Alzheimer’s Association International Conference on the Prevention of Dementia in Washington, D.C., results from a University of Pennsylvania study were unveiled confirming for the first time that daily practice of meditation can improve cognitive function among individuals with memory complaints.
Researchers began their investigation by conducting a series of neurological and memory tests on each subject, who ranged in age from 52-70, with either a history of memory complaints or a diagnosis of mild cognitive impairment. Single Photon Emission Computed Tomography (SPECT) scans, a brain imaging technique which measures cerebral blood flow, were also conducted on each subject. Following the initial tests, subjects were taught the techniques of Kirtan Kriya, the most widely practiced meditation in the Kundalini Yoga tradition, and instructed to practice a 12-minute meditation each day for eight weeks.
While follow up testing confirmed statistically significant improvements in memory among all of the study's subjects, the most significant outcome of the study was the stark contrast between the pre and post-training SPECT scans. Follow up scans showed dramatic increases in blood flow to the posterior cingulate gyrus, the region of the brain associated with learning and memory. It is the first region of the brain to decline in individuals diagnosed with Alzheimer’s disease, which helps to explain why the blood flow-producing meditation has such a profound impact on cognitive functioning.
Researchers began their investigation by conducting a series of neurological and memory tests on each subject, who ranged in age from 52-70, with either a history of memory complaints or a diagnosis of mild cognitive impairment. Single Photon Emission Computed Tomography (SPECT) scans, a brain imaging technique which measures cerebral blood flow, were also conducted on each subject. Following the initial tests, subjects were taught the techniques of Kirtan Kriya, the most widely practiced meditation in the Kundalini Yoga tradition, and instructed to practice a 12-minute meditation each day for eight weeks.
While follow up testing confirmed statistically significant improvements in memory among all of the study's subjects, the most significant outcome of the study was the stark contrast between the pre and post-training SPECT scans. Follow up scans showed dramatic increases in blood flow to the posterior cingulate gyrus, the region of the brain associated with learning and memory. It is the first region of the brain to decline in individuals diagnosed with Alzheimer’s disease, which helps to explain why the blood flow-producing meditation has such a profound impact on cognitive functioning.
Friday, June 15, 2007
Food makers in limbo over 'organic' labeling
Anheuser-Busch's organic beers have become fully organic — at least for now.
The nation's largest brewer said Wednesday that because of inaction on proposed regulations by the U.S. Department of Agriculture, it had started using 100% organic hops in its two beers that carry the "USDA Organic" seal. Previously, less than 10% of the beers' hops were organic.
"We have now begun brewing our nationally available organic beers with 100% organic hops, although at this time we have a limited amount of organic hops available," Doug Muhleman, vice president of brewing operations for Anheuser-Busch, said.
Food makers have been awaiting USDA approval of a list of 38 nonorganic ingredients, including hops, that could be allowed in organic products. Permission to use some nonorganic ingredients in organic foods expired Saturday, leaving many organic food makers uncertain on what to do.
"Since the deadline passed, Anheuser-Busch has not received any communications from the USDA regarding the reason for the delay," Muhleman said.
George Siemon, chief executive of Organic Valley Family of Farms in LaFarge, Wis., said Tuesday that he had organic sausage and bacon that could spoil unless the USDA acts soon.
"It's so grossly unfair, and it's just like we got dropped off a cliff," Siemon said. "We don't know what's going on."
The USDA's National Organic Program sent an e-mail to its certifying agents Friday, emphasizing that organic foods produced after that day could not use nonorganic ingredients that had previously been allowed under a misinterpretation of federal law.
"There is no provision for a grace period for this requirement; all products must be in compliance," said the e-mail from Mark A. Bradley, associate deputy administrator.
Regarding the ingredients under review, Bradley said, "We are doing our best to work these materials through the regulatory process as quickly as possible."
Although most organic food manufacturers have supported the move to allow use of the 38 ingredients, many consumers have protested what they perceive as a watering down of the organic label. The National Organic Program received more than 1,000 complaints about the proposed rule during a one-week public comment period in May.
For food to be called organic, it must be grown without chemical fertilizers and pesticides. Animals must be raised without antibiotics and growth hormones and given some access to the outdoors.
Federal law requires products carrying the "USDA Organic" label to contain at least 95% organic ingredients. The other 5% can be nonorganic ingredients that have been placed on the USDA National List, provided that organic equivalents are not commercially available or available in sufficient quantity.
Courtesy of LA Times
Steve - this is one example of the USDA's ineptness helping our cause!
The nation's largest brewer said Wednesday that because of inaction on proposed regulations by the U.S. Department of Agriculture, it had started using 100% organic hops in its two beers that carry the "USDA Organic" seal. Previously, less than 10% of the beers' hops were organic.
"We have now begun brewing our nationally available organic beers with 100% organic hops, although at this time we have a limited amount of organic hops available," Doug Muhleman, vice president of brewing operations for Anheuser-Busch, said.
Food makers have been awaiting USDA approval of a list of 38 nonorganic ingredients, including hops, that could be allowed in organic products. Permission to use some nonorganic ingredients in organic foods expired Saturday, leaving many organic food makers uncertain on what to do.
"Since the deadline passed, Anheuser-Busch has not received any communications from the USDA regarding the reason for the delay," Muhleman said.
George Siemon, chief executive of Organic Valley Family of Farms in LaFarge, Wis., said Tuesday that he had organic sausage and bacon that could spoil unless the USDA acts soon.
"It's so grossly unfair, and it's just like we got dropped off a cliff," Siemon said. "We don't know what's going on."
The USDA's National Organic Program sent an e-mail to its certifying agents Friday, emphasizing that organic foods produced after that day could not use nonorganic ingredients that had previously been allowed under a misinterpretation of federal law.
"There is no provision for a grace period for this requirement; all products must be in compliance," said the e-mail from Mark A. Bradley, associate deputy administrator.
Regarding the ingredients under review, Bradley said, "We are doing our best to work these materials through the regulatory process as quickly as possible."
Although most organic food manufacturers have supported the move to allow use of the 38 ingredients, many consumers have protested what they perceive as a watering down of the organic label. The National Organic Program received more than 1,000 complaints about the proposed rule during a one-week public comment period in May.
For food to be called organic, it must be grown without chemical fertilizers and pesticides. Animals must be raised without antibiotics and growth hormones and given some access to the outdoors.
Federal law requires products carrying the "USDA Organic" label to contain at least 95% organic ingredients. The other 5% can be nonorganic ingredients that have been placed on the USDA National List, provided that organic equivalents are not commercially available or available in sufficient quantity.
Courtesy of LA Times
Steve - this is one example of the USDA's ineptness helping our cause!
Thursday, June 14, 2007
Cod liver oil linked to less depression
Regular and long-term intake of omega-3 fatty acid-rich cod liver oil may protect people from symptoms of depression, says a large study published in the Journal of Affective Disorders. In 21,835 Norwegian subjects aged between 40 and 49 and 70 and 74 years, the prevalence of depressive symptoms was 29 per cent lower in regular cod liver oil users than the rest of the population.
"In this large population based cross-sectional study we found that daily use of cod liver oil was negatively associated with high levels of depressive symptoms and that the prevalence of such depressive symptoms decreased with the duration of cod liver oil use," wrote lead author Maria Baroy Raeder from Haukeland University Hospital
Baroy Raeder and co-workers used data from the population based cross-sectional health survey "The Hordaland Health Study '97-'99" (HUSK), and report that 8.9 per cent of subjects used cod liver oil daily.
"The users of cod liver oil were significantly less likely to have depressive symptoms than non-users after adjusting for multiple possible confounding factors (29 per cent reduction)," wrote the researchers.
They also report that length of regular cod liver oil supplementation was found to influence the prevalence of high levels of depressive symptoms - the longer the duration of supplementation, the lower the prevalence of symptoms of depression.
The study does have several limitations, most notably the lack of dietary data that could have affected the results. In addition, socio-economic factors were not accounted for in the study, which also may affect the overall health and mental state of the subjects. The researchers, therefore, stressed that the results should be interpreted with care.
"To confirm such a possible protective effect, randomized controlled trials are needed," concluded the researchers.
Bonnie - limitations on this study, yes. However, it was such a large population study and was done in a country with very little yearly sun exposure. It confirms what we have been saying: the combination of omega-3's and vitamin D for mood is dynamite!
"In this large population based cross-sectional study we found that daily use of cod liver oil was negatively associated with high levels of depressive symptoms and that the prevalence of such depressive symptoms decreased with the duration of cod liver oil use," wrote lead author Maria Baroy Raeder from Haukeland University Hospital
Baroy Raeder and co-workers used data from the population based cross-sectional health survey "The Hordaland Health Study '97-'99" (HUSK), and report that 8.9 per cent of subjects used cod liver oil daily.
"The users of cod liver oil were significantly less likely to have depressive symptoms than non-users after adjusting for multiple possible confounding factors (29 per cent reduction)," wrote the researchers.
They also report that length of regular cod liver oil supplementation was found to influence the prevalence of high levels of depressive symptoms - the longer the duration of supplementation, the lower the prevalence of symptoms of depression.
The study does have several limitations, most notably the lack of dietary data that could have affected the results. In addition, socio-economic factors were not accounted for in the study, which also may affect the overall health and mental state of the subjects. The researchers, therefore, stressed that the results should be interpreted with care.
"To confirm such a possible protective effect, randomized controlled trials are needed," concluded the researchers.
Bonnie - limitations on this study, yes. However, it was such a large population study and was done in a country with very little yearly sun exposure. It confirms what we have been saying: the combination of omega-3's and vitamin D for mood is dynamite!
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