Fishy diet comes with lower risk of stroke

(Reuters Health) - Women who eat more than three servings of fish per week are less likely to experience a stroke, a new study suggests.

Specifically, fish-lovers in Sweden were 16 percent less likely to experience a stroke over a 10-year-period, relative to women who ate fish less than once a week.

"Fish consumption in many countries, including the U.S., is far too low, and increased fish consumption would likely result in substantial benefits in the population," said Dr. Dariush Mozaffarian of the Harvard School of Public Health, who reviewed the findings for Reuters Health.

When choosing fish to eat, it's best to opt for fish that are rich in omega-3 fatty acids, found most abundantly in fatty fish like salmon, mackerel and albacore tuna. "But any fish is better than none," Mozaffarian noted.

Indeed, these fatty acids likely underlie the benefits of fish on stroke risk, study author Dr. Susanna Larsson of the Karolinska Institute in Stockholm told Reuters Health. "These fatty acids may reduce the risk of stroke by reducing blood pressure and blood (fat) concentrations."

This is not the first study to suggest that people who eat more fish have a lower risk of stroke, and experts already recommend a fishy diet to reduce the risk of cardiovascular problems, Mozaffarian added. "This study supports current recommendations."

Earlier this year, for instance, a study showed that middle-aged and older men who eat fish every day are less likely than infrequent fish eaters to develop a suite of risk factors for heart disease, diabetes and stroke.

In the current study, published in the American Journal of Clinical Nutrition, Larsson and her colleagues looked at 34,670 women 49 to 83 years old. All were free of cardiovascular disease and cancer at the beginning of the study, in 1997.

During 10 years of follow-up, 1,680 of the women (4 percent) had a stroke.

Stroke caused by blockage of an artery that supplies blood to the brain -- also known as a "cerebral infarction" or "ischemic stroke" -- was the most common event, representing 78 percent of all strokes in the study. Other types of strokes were due to bleeding in the brain, or unspecified causes.

Women who ate more than three servings of fish per week had a 16 percent lower risk of stroke than women who ate less than one serving a week. "Not a small effect," Mozaffarian said in an e-mail, noting that it was roughly equivalent to the effect of statin drugs on stroke risk. Furthermore, the researchers asked women about their diets only once, using a questionnaire, which might have caused errors that would underestimate the link between a fishy diet and stroke risk, he explained. "So, the true risk reduction may be larger."

Interestingly, women appeared to benefit most from eating lean fish, when other research shows fatty fish is better for health. This finding may stem from the fact that most fatty fish, such as herring and salmon, is eaten salted in Sweden, Larsson explained. "A high intake of salt increases blood pressure and thus may increase the risk of stroke," she said in an e-mail. "So the protective effects of fatty acids in fatty fish may be attenuated because of the salt."

Indeed, when it comes to fish, not all have equal benefits, Mozaffarian noted - for instance, he said, research has not shown any cardiovascular benefits from eating fast food fish burgers or fish sticks.

In addition, women of childbearing age should avoid certain types of fish known to carry relatively high levels of pollutants, such as shark and swordfish, Mozaffarian cautioned. "This is a very, very short list of fish to avoid or minimize -- there are many, many other types of fish to consume," he said. "Women at risk of stroke are generally beyond their child-bearing years, and so for these women, all types of fish can be consumed."

Larsson and her team speculate that certain nutrients in fish, such as fatty acids and vitamin D, might explain its apparent benefits. The Swedish study cannot prove cause and effect for high fish consumption and lowered stroke risk, however. For instance, fish consumption could be a sign of a generally healthier lifestyle or some other mechanism at work.

Last December, Larsson and colleagues published data from the same group of women in the journal Stroke showing that those who eat a lot of red meat may also be putting themselves at increased risk of stroke.

(Reuters Health) - Women who eat more than three servings of fish per week are less likely to experience a stroke, a new study suggests.

Specifically, fish-lovers in Sweden were 16 percent less likely to experience a stroke over a 10-year-period, relative to women who ate fish less than once a week.

"Fish consumption in many countries, including the U.S., is far too low, and increased fish consumption would likely result in substantial benefits in the population," said Dr. Dariush Mozaffarian of the Harvard School of Public Health, who reviewed the findings for Reuters Health.

When choosing fish to eat, it's best to opt for fish that are rich in omega-3 fatty acids, found most abundantly in fatty fish like salmon, mackerel and albacore tuna. "But any fish is better than none," Mozaffarian noted.

Indeed, these fatty acids likely underlie the benefits of fish on stroke risk, study author Dr. Susanna Larsson of the Karolinska Institute in Stockholm told Reuters Health. "These fatty acids may reduce the risk of stroke by reducing blood pressure and blood (fat) concentrations."

This is not the first study to suggest that people who eat more fish have a lower risk of stroke, and experts already recommend a fishy diet to reduce the risk of cardiovascular problems, Mozaffarian added. "This study supports current recommendations."

Earlier this year, for instance, a study showed that middle-aged and older men who eat fish every day are less likely than infrequent fish eaters to develop a suite of risk factors for heart disease, diabetes and stroke.

In the current study, published in the American Journal of Clinical Nutrition, Larsson and her colleagues looked at 34,670 women 49 to 83 years old. All were free of cardiovascular disease and cancer at the beginning of the study, in 1997.

During 10 years of follow-up, 1,680 of the women (4 percent) had a stroke.

Stroke caused by blockage of an artery that supplies blood to the brain -- also known as a "cerebral infarction" or "ischemic stroke" -- was the most common event, representing 78 percent of all strokes in the study. Other types of strokes were due to bleeding in the brain, or unspecified causes.

Women who ate more than three servings of fish per week had a 16 percent lower risk of stroke than women who ate less than one serving a week. "Not a small effect," Mozaffarian said in an e-mail, noting that it was roughly equivalent to the effect of statin drugs on stroke risk. Furthermore, the researchers asked women about their diets only once, using a questionnaire, which might have caused errors that would underestimate the link between a fishy diet and stroke risk, he explained. "So, the true risk reduction may be larger."

Interestingly, women appeared to benefit most from eating lean fish, when other research shows fatty fish is better for health. This finding may stem from the fact that most fatty fish, such as herring and salmon, is eaten salted in Sweden, Larsson explained. "A high intake of salt increases blood pressure and thus may increase the risk of stroke," she said in an e-mail. "So the protective effects of fatty acids in fatty fish may be attenuated because of the salt."

Indeed, when it comes to fish, not all have equal benefits, Mozaffarian noted - for instance, he said, research has not shown any cardiovascular benefits from eating fast food fish burgers or fish sticks.

In addition, women of childbearing age should avoid certain types of fish known to carry relatively high levels of pollutants, such as shark and swordfish, Mozaffarian cautioned. "This is a very, very short list of fish to avoid or minimize -- there are many, many other types of fish to consume," he said. "Women at risk of stroke are generally beyond their child-bearing years, and so for these women, all types of fish can be consumed."

Larsson and her team speculate that certain nutrients in fish, such as fatty acids and vitamin D, might explain its apparent benefits. The Swedish study cannot prove cause and effect for high fish consumption and lowered stroke risk, however. For instance, fish consumption could be a sign of a generally healthier lifestyle or some other mechanism at work.

Last December, Larsson and colleagues published data from the same group of women in the journal Stroke showing that those who eat a lot of red meat may also be putting themselves at increased risk of stroke.

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Vitamins C and E linked to metabolic syndrome in low-income Ecuadorians

BOSTON – (January 4, 2011) With life expectancy increasing in Latin America, age-related disease has become a pressing public health concern. Results of an epidemiological study conducted by researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging (USDA HNRCA) at Tufts University and the Corporacion Ecuatoriana de Biotecnologia showed that the metabolic syndrome, a condition that increases a person's risk of developing cardiovascular disease and type 2 diabetes, was prevalent in a low-income urban community in Ecuador and that a poor diet low in micronutrients appeared to contribute.

The study enrolled 225 women and 127 men age 65 and older, living in three low-income neighborhoods on the outskirts of Quito, the capital of Ecuador. The authors examined the relationship between the metabolic syndrome and micronutrients such as folate, zinc and vitamins C, B12 and E. The participants reported their food intake in biweekly interviews and provided blood samples.

Using the International Diabetes Foundation (IDF) definition, the authors determined that 40 % of the population had the metabolic syndrome, with a disproportionate number of women affected: 81 % compared to 19% of the men, which the authors attribute to more of the women being overweight. According to the IDF, the metabolic syndrome is present in centrally obese men and women, as defined by hip and waist measurements, with at least two of the four following metabolic risk factors: raised triglycerides, reduced high-density lipoprotein (HDL) cholesterol, raised blood pressure, and raised fasting plasma glucose (blood sugar).

"In this population of low-income Ecuadorians, we observed a pattern of high carbohydrate, high sodium diets lacking in healthy fats and good sources of protein. Our blood analyses indicates a significant number of participants weren't consuming enough of a range of micronutrients," says senior author Simin Nikbin Meydani, PhD, DVM, director of the USDA HNRCA and the Nutritional Immunology Laboratory at the USDA HNRCA. "After adjusting for age and sex, we observed significant relationships between the metabolic syndrome and two of the micronutrients, vitamins C and E."

"As a group, the participants did not exhibit low blood levels of vitamin E," Meydani continues. "The association suggests that having higher blood levels of vitamin E may protect against the metabolic syndrome." However, low blood levels of vitamin C were seen in 82% of the participants, which the authors suspect was due to limited intake of fresh fruits and vegetables. The bulk of the participants' calories came from white rice, potatoes, sugar and white bread. The authors noted 55% of the women and 33% of the men were overweight.

"With high-calorie foods lacking essential nutrients serving as pillars of the diet, it is possible to be both overweight and malnourished," Meydani says. "Our data suggests that limited consumption of nutrient dense foods such as chicken, vegetables and legumes makes this small population of Ecuadorian elders even more susceptible to the metabolic syndrome."

Additionally, Meydani and colleagues observed a significant relationship between the metabolic syndrome and C-reactive protein (CRP), a marker of low-grade inflammation that has been associated with cardiovascular disease risk. High CRP blood concentrations were seen in almost half of the population.

The results, published online ahead of print in the journal Public Health Nutrition, build on the authors' previous observational study which noted a high prevalence of two metabolic risk factors -elevated waist circumference and low HDL cholesterol levels- in a population of low income, older Ecuadorian adults.

Meydani, who is also a professor at the Friedman School of Nutrition Science and Policy and the Sackler School of Graduate Biomedical Sciences at Tufts, says the results of the present study are a preliminary step toward understanding metabolic disease risk in older adults living in impoverished areas of Latin America. "To our knowledge, there are few studies of the metabolic syndrome in Latin America. Additional research is needed to affirm that there is a relationship between vitamins C and E intake and the metabolic syndrome and CRP and the metabolic syndrome," she says. "This requires interventional studies in larger, more economically diverse populations of older, Latin American men and women."

Meydani and colleagues view nutrition intervention as a potential strategy for curbing metabolic risk in Latin America. "Presently, there are about 59 million Latin American and Caribbean men and women over the age of 60 and the United Nations predicts the population will reach 101 billion by 2025," Meydani says. "Medical resources are minimal in developing countries and those that are in place are usually not directed toward older adults. Nutrition interventions, such as encouraging older adults to consume more nutrient dense foods, for example, locally grown produce, could reduce the strain on the health care system."

BOSTON – (January 4, 2011) With life expectancy increasing in Latin America, age-related disease has become a pressing public health concern. Results of an epidemiological study conducted by researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging (USDA HNRCA) at Tufts University and the Corporacion Ecuatoriana de Biotecnologia showed that the metabolic syndrome, a condition that increases a person's risk of developing cardiovascular disease and type 2 diabetes, was prevalent in a low-income urban community in Ecuador and that a poor diet low in micronutrients appeared to contribute.

The study enrolled 225 women and 127 men age 65 and older, living in three low-income neighborhoods on the outskirts of Quito, the capital of Ecuador. The authors examined the relationship between the metabolic syndrome and micronutrients such as folate, zinc and vitamins C, B12 and E. The participants reported their food intake in biweekly interviews and provided blood samples.

Using the International Diabetes Foundation (IDF) definition, the authors determined that 40 % of the population had the metabolic syndrome, with a disproportionate number of women affected: 81 % compared to 19% of the men, which the authors attribute to more of the women being overweight. According to the IDF, the metabolic syndrome is present in centrally obese men and women, as defined by hip and waist measurements, with at least two of the four following metabolic risk factors: raised triglycerides, reduced high-density lipoprotein (HDL) cholesterol, raised blood pressure, and raised fasting plasma glucose (blood sugar).

"In this population of low-income Ecuadorians, we observed a pattern of high carbohydrate, high sodium diets lacking in healthy fats and good sources of protein. Our blood analyses indicates a significant number of participants weren't consuming enough of a range of micronutrients," says senior author Simin Nikbin Meydani, PhD, DVM, director of the USDA HNRCA and the Nutritional Immunology Laboratory at the USDA HNRCA. "After adjusting for age and sex, we observed significant relationships between the metabolic syndrome and two of the micronutrients, vitamins C and E."

"As a group, the participants did not exhibit low blood levels of vitamin E," Meydani continues. "The association suggests that having higher blood levels of vitamin E may protect against the metabolic syndrome." However, low blood levels of vitamin C were seen in 82% of the participants, which the authors suspect was due to limited intake of fresh fruits and vegetables. The bulk of the participants' calories came from white rice, potatoes, sugar and white bread. The authors noted 55% of the women and 33% of the men were overweight.

"With high-calorie foods lacking essential nutrients serving as pillars of the diet, it is possible to be both overweight and malnourished," Meydani says. "Our data suggests that limited consumption of nutrient dense foods such as chicken, vegetables and legumes makes this small population of Ecuadorian elders even more susceptible to the metabolic syndrome."

Additionally, Meydani and colleagues observed a significant relationship between the metabolic syndrome and C-reactive protein (CRP), a marker of low-grade inflammation that has been associated with cardiovascular disease risk. High CRP blood concentrations were seen in almost half of the population.

The results, published online ahead of print in the journal Public Health Nutrition, build on the authors' previous observational study which noted a high prevalence of two metabolic risk factors -elevated waist circumference and low HDL cholesterol levels- in a population of low income, older Ecuadorian adults.

Meydani, who is also a professor at the Friedman School of Nutrition Science and Policy and the Sackler School of Graduate Biomedical Sciences at Tufts, says the results of the present study are a preliminary step toward understanding metabolic disease risk in older adults living in impoverished areas of Latin America. "To our knowledge, there are few studies of the metabolic syndrome in Latin America. Additional research is needed to affirm that there is a relationship between vitamins C and E intake and the metabolic syndrome and CRP and the metabolic syndrome," she says. "This requires interventional studies in larger, more economically diverse populations of older, Latin American men and women."

Meydani and colleagues view nutrition intervention as a potential strategy for curbing metabolic risk in Latin America. "Presently, there are about 59 million Latin American and Caribbean men and women over the age of 60 and the United Nations predicts the population will reach 101 billion by 2025," Meydani says. "Medical resources are minimal in developing countries and those that are in place are usually not directed toward older adults. Nutrition interventions, such as encouraging older adults to consume more nutrient dense foods, for example, locally grown produce, could reduce the strain on the health care system."

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Study shows vitamin D deficiencies may impact onset of autoimmune lung disease

CINCINNATI—A new study shows that vitamin D deficiency could be linked to the development and severity of certain autoimmune lung diseases.

These findings are being reported in the Jan. 4 edition of the journal Chest.

Brent Kinder, MD, UC Health pulmonologist, director of the Interstitial Lung Disease Center at the University of Cincinnati and lead investigator on the study, says vitamin D deficiencies have been found to affect the development of other autoimmune diseases, like lupus and type 1 diabetes.

"We wanted to see if lack of sufficient vitamin D would also be seen in patients who are diagnosed with an autoimmune interstitial lung disease (ILD) and whether it was associated with reduced lung function," he says.

Some ILD patients first discover they have an undifferentiated connective tissue disease, a chronic inflammatory autoimmune disease that affects multiple organ systems but is not developed enough for physicians to easily recognize and categorize.

Autoimmune diseases occur when the body produces abnormal cells that turn on the body and attack major organs and tissues. Connective tissue diseases include lupus, scleroderma, polymyositis, vasculitis, rheumatoid arthritis and Sjogren's syndrome.

"ILD is a group of diseases that mainly affect the tissues of the lungs instead of the airways, like asthma and emphysema do," says Kinder. "It causes scarring of the lungs, is more difficult to diagnosis and treat than other kinds of lung diseases and is often fatal.

"Since vitamin D deficiency has implications for other manifestations of autoimmune illnesses, we wanted to see it had an effect on the lungs of this patient population."

Researchers evaluated 118 patients from the UC ILD Center database—67 with connective tissue disease-related ILD and 51 with other causes of lung fibrosis—for serum 25-hydroxyvitamin D levels, which indicate levels of vitamin D in the body. Then, they evaluated associations between these serum levels and the patients' conditions.

Overall, those with connective tissue disease-related ILD were more likely to have vitamin D deficiency—52 percent versus 20 percent—and insufficiency—79 percent versus 31 percent—than other forms of ILD.

Among this same group of patients, reduced serum 25-hydroxyvitamin D levels were strongly associated with reduced lung function.

"These findings suggest that there is a high prevalence of vitamin D deficiency in patients with ILD, particularly those with connective tissue disease," Kinder says. "Therefore, vitamin D may have a role in the development of connective tissue disease-related ILD and patients' worsening lung function.

"One of the next steps is to see if supplementation will improve lung function for these patients."

He adds that if these findings are confirmed and vitamin D supplementation is shown to be effective in clinical trials, this may also provide a more natural, inexpensive treatment for the illness.

"Vitamin D is known to be a critical dietary factor for bone and skin health," he says. "Now, we're learning that it could potentially be modified as a treatment to improve ILD as opposed to other, more toxic therapies."

CINCINNATI—A new study shows that vitamin D deficiency could be linked to the development and severity of certain autoimmune lung diseases.

These findings are being reported in the Jan. 4 edition of the journal Chest.

Brent Kinder, MD, UC Health pulmonologist, director of the Interstitial Lung Disease Center at the University of Cincinnati and lead investigator on the study, says vitamin D deficiencies have been found to affect the development of other autoimmune diseases, like lupus and type 1 diabetes.

"We wanted to see if lack of sufficient vitamin D would also be seen in patients who are diagnosed with an autoimmune interstitial lung disease (ILD) and whether it was associated with reduced lung function," he says.

Some ILD patients first discover they have an undifferentiated connective tissue disease, a chronic inflammatory autoimmune disease that affects multiple organ systems but is not developed enough for physicians to easily recognize and categorize.

Autoimmune diseases occur when the body produces abnormal cells that turn on the body and attack major organs and tissues. Connective tissue diseases include lupus, scleroderma, polymyositis, vasculitis, rheumatoid arthritis and Sjogren's syndrome.

"ILD is a group of diseases that mainly affect the tissues of the lungs instead of the airways, like asthma and emphysema do," says Kinder. "It causes scarring of the lungs, is more difficult to diagnosis and treat than other kinds of lung diseases and is often fatal.

"Since vitamin D deficiency has implications for other manifestations of autoimmune illnesses, we wanted to see it had an effect on the lungs of this patient population."

Researchers evaluated 118 patients from the UC ILD Center database—67 with connective tissue disease-related ILD and 51 with other causes of lung fibrosis—for serum 25-hydroxyvitamin D levels, which indicate levels of vitamin D in the body. Then, they evaluated associations between these serum levels and the patients' conditions.

Overall, those with connective tissue disease-related ILD were more likely to have vitamin D deficiency—52 percent versus 20 percent—and insufficiency—79 percent versus 31 percent—than other forms of ILD.

Among this same group of patients, reduced serum 25-hydroxyvitamin D levels were strongly associated with reduced lung function.

"These findings suggest that there is a high prevalence of vitamin D deficiency in patients with ILD, particularly those with connective tissue disease," Kinder says. "Therefore, vitamin D may have a role in the development of connective tissue disease-related ILD and patients' worsening lung function.

"One of the next steps is to see if supplementation will improve lung function for these patients."

He adds that if these findings are confirmed and vitamin D supplementation is shown to be effective in clinical trials, this may also provide a more natural, inexpensive treatment for the illness.

"Vitamin D is known to be a critical dietary factor for bone and skin health," he says. "Now, we're learning that it could potentially be modified as a treatment to improve ILD as opposed to other, more toxic therapies."

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Treatment of Lymphoma in Cats

Stein TJ, Pellin M, Steinberg H et al: Treatment of feline gastrointestinal small-cell lymphoma with chlorambucil and glucocorticoids, J Am Anim Hosp Assoc 46:413, 2010. 

Gastrointestinal lymphoma is the most commonly diagnosed form of lymphoma in cats. There are two distinct forms based on size of the neoplastic lymphocytes, large- and small-cell lymphoma. This was a retrospective study of 28 cats diagnosed in large part via full-thickness intestinal biopsies with small-cell lymphoma. The majority of cases were CD3+ (T cell marker) and many exhibited epithelioltropism. In this study, all cats were started on chlorambucil at a dose of 20 mg/m² every 2 weeks. Additionally, 17 of the 28 cats (60%) received prednisone or prednisolone at 2 mg/kg once daily for one week. All cats had their prednisone/prednisolone dosages tapered to 1 mg/kg orally every other day until disease relapse or progression of disease. Treatment with chlorambucil and a glucocorticoid resulted in clinical remission in 96% of cats, with a median duration of 786 days for the first clinical response. Seven cats relapsed from remission and were treated with a rescue protocol of cyclophosphamide and glucocorticoids. The response rate was 100% for the rescue protocol. The authors did find it striking that four (14%) of the 28 cats developed a second malignancy during their course of treatment. [VT]

Related articles:

Lingard AE, Briscoe K, Beatty JA et al: Low-grade alimentary lymphoma: clinicopathological findings and response to treatment in 17 cases, J Feline Med Surg 11:692, 2009.

More on cat health: Winn Feline Foundation Library

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Stein TJ, Pellin M, Steinberg H et al: Treatment of feline gastrointestinal small-cell lymphoma with chlorambucil and glucocorticoids, J Am Anim Hosp Assoc 46:413, 2010. 

Gastrointestinal lymphoma is the most commonly diagnosed form of lymphoma in cats. There are two distinct forms based on size of the neoplastic lymphocytes, large- and small-cell lymphoma. This was a retrospective study of 28 cats diagnosed in large part via full-thickness intestinal biopsies with small-cell lymphoma. The majority of cases were CD3+ (T cell marker) and many exhibited epithelioltropism. In this study, all cats were started on chlorambucil at a dose of 20 mg/m² every 2 weeks. Additionally, 17 of the 28 cats (60%) received prednisone or prednisolone at 2 mg/kg once daily for one week. All cats had their prednisone/prednisolone dosages tapered to 1 mg/kg orally every other day until disease relapse or progression of disease. Treatment with chlorambucil and a glucocorticoid resulted in clinical remission in 96% of cats, with a median duration of 786 days for the first clinical response. Seven cats relapsed from remission and were treated with a rescue protocol of cyclophosphamide and glucocorticoids. The response rate was 100% for the rescue protocol. The authors did find it striking that four (14%) of the 28 cats developed a second malignancy during their course of treatment. [VT]

Related articles:

Lingard AE, Briscoe K, Beatty JA et al: Low-grade alimentary lymphoma: clinicopathological findings and response to treatment in 17 cases, J Feline Med Surg 11:692, 2009.

More on cat health: Winn Feline Foundation Library

Join us on Facebook

Follow us on Twitter

Read More

Dairy fat may cut Type 2 diabetes risk: study

A natural fatty acid found in whole-fat dairy products may lower the risk of Type 2 diabetes, U.S. scientists have found.

Studies on populations show that diets rich in dairy foods such as milk, cheese, yogurt and butter are linked to lower risk of Type 2 diabetes. Animal studies also suggest naturally occurring palmitoleic acid helps protect against insulin resistance and diabetes.

The reasons for the effect are unknown. To find out more about the fatty acid and its potential health benefits, researchers at the Harvard School of Public Health analyzed data from more than 3,736 American seniors who have been followed for 20 years as part of a study on risk factors for cardiovascular diseases.

Unlike industrially produced trans fats found in partially hydrogenated vegetable oils, which have been linked to higher risk of heart disease, trans-palmitoleic acid is found mainly in naturally-occurring dairy and meat. Previous studies have not linked this type of trans fat to higher risk of heart disease.

In the study, participants who said they consumed more whole-fat dairy products had higher levels of trans-palmitoleate in their blood three years later, the study's lead investigator, Dariush Mozaffarian, an epidemiology professor at Harvard and his co-authors report in the December issue of the Annals of Internal Medicine.

People with the highest levels of the fatty acid circulating in their blood had about two-thirds the risk of developing Type 2 diabetes than those with the lowest levels, the researchers found.

A natural fatty acid found in whole-fat dairy products may lower the risk of Type 2 diabetes, U.S. scientists have found.

Studies on populations show that diets rich in dairy foods such as milk, cheese, yogurt and butter are linked to lower risk of Type 2 diabetes. Animal studies also suggest naturally occurring palmitoleic acid helps protect against insulin resistance and diabetes.

The reasons for the effect are unknown. To find out more about the fatty acid and its potential health benefits, researchers at the Harvard School of Public Health analyzed data from more than 3,736 American seniors who have been followed for 20 years as part of a study on risk factors for cardiovascular diseases.

Unlike industrially produced trans fats found in partially hydrogenated vegetable oils, which have been linked to higher risk of heart disease, trans-palmitoleic acid is found mainly in naturally-occurring dairy and meat. Previous studies have not linked this type of trans fat to higher risk of heart disease.

In the study, participants who said they consumed more whole-fat dairy products had higher levels of trans-palmitoleate in their blood three years later, the study's lead investigator, Dariush Mozaffarian, an epidemiology professor at Harvard and his co-authors report in the December issue of the Annals of Internal Medicine.

People with the highest levels of the fatty acid circulating in their blood had about two-thirds the risk of developing Type 2 diabetes than those with the lowest levels, the researchers found.

Read More

How exercise grows a healthy heart

Everyone knows that exercise comes with metabolic and cardiovascular benefits, but scientists understand surprisingly little about how physical activity influences the heart itself. Now, a new study in the December 23rd issue of Cell, a Cell Press publication, offers some of the first molecular-level insights.

The studies in mice suggest that exercise turns on a genetic program that leads the heart to grow as heart muscle cells divide. It appears that shift in activity is driven in part by a single transcription factor (a gene that controls other genes). That gene, known as C/EBPb, was known to play important roles in other parts of the body, but this is the first evidence for its influence in the heart.

"We've identified a pathway involved in beneficial cardiac hypertrophy – the good kind of heart growth," said Bruce Spiegelman of Harvard Medical School.

The findings may have clinical implications, particularly for those with heart failure or other conditions that make exercise difficult to impossible, the researchers say.

"This is yet another reason to keep on exercising," said Anthony Rosenzweig of Harvard Medical School. "In the longer term, by understanding the pathways that benefit the heart with exercise, we may be able to exploit those for patients who aren't able to exercise. If there were a way to modulate the same pathway in a beneficial way, it would open up new avenues for treatment."

There may also be ways to optimize training regimens such that they tap into this natural mechanism more efficiently, Spiegelman added.

Researchers had known that heart muscle adapts to increased pressure and volume by increasing in size. That's true in the case of exercise as it is in pathological conditions including high blood pressure. In disease states as opposed to exercise, those changes to the heart can ultimately lead to heart failure and arrhythmias.

In the new study, the researchers sought to better understand those differences using methods developed in the Spiegelman lab that allowed them to quantify changes in the expression of transcription factors in the heart at the genome-wide level in both exercised mice and those who had their aortas surgically constricted, a treatment that leads to a pathological increase in heart size.

The researchers found changes in 175 transcription factors in exercised mice and 96 in mice whose aortas were constricted. Importantly, the changes showed little overlap between the two animal models. For instance, the researchers said, 13 percent of the genes with differential expression following exercise have known or suggested roles in cell proliferation compared to less than one percent of those that changed with the surgery.

The researchers then zeroed in on one transcription factor, C/EBPb, which goes down about two-fold with exercise and a second that rises in turn. Studies in animals and cell culture showed that the decline in C/EPBb leads to changes that appear to be consistent with those that follow endurance exercise, including an increase in heart muscle size and proliferation. Those mice with lower C/EPBb levels also were resistant to heart failure.

That finding is key given that there is little prior evidence showing that the increase in heart size with exercise has direct benefits, the researchers say. The new evidence also gives important biological insights into the heart's potential for regeneration of muscle.

Rosenzweig said it will be important in future studies to explore all of the players in the pathway and to provide even more definitive evidence that exercise leads to an increased rate of cell proliferation in heart muscle.

Everyone knows that exercise comes with metabolic and cardiovascular benefits, but scientists understand surprisingly little about how physical activity influences the heart itself. Now, a new study in the December 23rd issue of Cell, a Cell Press publication, offers some of the first molecular-level insights.

The studies in mice suggest that exercise turns on a genetic program that leads the heart to grow as heart muscle cells divide. It appears that shift in activity is driven in part by a single transcription factor (a gene that controls other genes). That gene, known as C/EBPb, was known to play important roles in other parts of the body, but this is the first evidence for its influence in the heart.

"We've identified a pathway involved in beneficial cardiac hypertrophy – the good kind of heart growth," said Bruce Spiegelman of Harvard Medical School.

The findings may have clinical implications, particularly for those with heart failure or other conditions that make exercise difficult to impossible, the researchers say.

"This is yet another reason to keep on exercising," said Anthony Rosenzweig of Harvard Medical School. "In the longer term, by understanding the pathways that benefit the heart with exercise, we may be able to exploit those for patients who aren't able to exercise. If there were a way to modulate the same pathway in a beneficial way, it would open up new avenues for treatment."

There may also be ways to optimize training regimens such that they tap into this natural mechanism more efficiently, Spiegelman added.

Researchers had known that heart muscle adapts to increased pressure and volume by increasing in size. That's true in the case of exercise as it is in pathological conditions including high blood pressure. In disease states as opposed to exercise, those changes to the heart can ultimately lead to heart failure and arrhythmias.

In the new study, the researchers sought to better understand those differences using methods developed in the Spiegelman lab that allowed them to quantify changes in the expression of transcription factors in the heart at the genome-wide level in both exercised mice and those who had their aortas surgically constricted, a treatment that leads to a pathological increase in heart size.

The researchers found changes in 175 transcription factors in exercised mice and 96 in mice whose aortas were constricted. Importantly, the changes showed little overlap between the two animal models. For instance, the researchers said, 13 percent of the genes with differential expression following exercise have known or suggested roles in cell proliferation compared to less than one percent of those that changed with the surgery.

The researchers then zeroed in on one transcription factor, C/EBPb, which goes down about two-fold with exercise and a second that rises in turn. Studies in animals and cell culture showed that the decline in C/EPBb leads to changes that appear to be consistent with those that follow endurance exercise, including an increase in heart muscle size and proliferation. Those mice with lower C/EPBb levels also were resistant to heart failure.

That finding is key given that there is little prior evidence showing that the increase in heart size with exercise has direct benefits, the researchers say. The new evidence also gives important biological insights into the heart's potential for regeneration of muscle.

Rosenzweig said it will be important in future studies to explore all of the players in the pathway and to provide even more definitive evidence that exercise leads to an increased rate of cell proliferation in heart muscle.

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Highest-Paid U.S. Doctors Get Rich With Fusion Surgery Debunked by Studies

Mikel Hehn poses in St. Cloud, Minnesota, with the daily medications he takes to combat pain and depression as a result of his spinal surgery. Photographer: Andy King/Bloomberg

Suffering from an aching back, truck driver Mikel Hehn went to see surgeon Jeffrey Gerdes in 2008. The St. Cloud, Minnesota, doctor diagnosed spinal disc degeneration, commonly treated with physical therapy, and said surgery wasn’t called for.
Unhappy with the answer, Hehn turned to Ensor Transfeldt, a surgeon at Twin Cities Spine Center in Minneapolis. Transfeldt performed fusion surgery on Hehn, screwing together three vertebrae in his lower spine.

Fusion aims to limit painful spine movements. This one didn’t work out. Two years later, the pain in Hehn’s neck, lower back, buttocks and thighs is so bad that he can’t hold a job and seldom leaves home, he said in an interview.

“There’s days when I just can’t take it and the tears run,” said Hehn, 52, who lives in Sartell, Minnesota. He said he takes oxycodone for pain, Soma to sleep, Lexapro for depression and Imitrex for headaches.
Hehn’s surgery generated a $135,786 bill from Abbott Northwestern Hospital in Minneapolis, feeding a national boom in costly fusion surgeries. It also illustrates how spine surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is -- and a lot more dangerous.

The number of fusions at U.S. hospitals doubled to 413,000 between 2002 and 2008, generating $34 billion in bills, data from the federal Healthcare Cost and Utilization Project show. The number of the surgeries will rise to 453,300 this year, according to Millennium Research Group of Toronto.

Unnecessary Surgeries

The possibility that many of these and other surgeries are needless has gotten little attention in the debate over U.S. health care costs, which rose 6 percent last year to $2.47 trillion. Unnecessary surgeries cost at least $150 billion a year, according to John Birkmeyer, director of the Center for Healthcare Outcomes & Policy at the University of Michigan.

“It’s amazing how much evidence there is that fusions don’t work, yet surgeons do them anyway,” said Sohail Mirza, a spine surgeon who chairs the Department of Orthopaedics at Dartmouth Medical School in Hanover, New Hampshire. “The only one who isn’t benefitting from the equation is the patient.”
The Twin Cities Spine bill for Hehn’s surgery was $19,292, his medical records show. The firm received $8,978 after an insurance discount, $7,742 of it for Transfeldt’s services. Hehn’s insurer paid after his bid for workers’ compensation coverage was denied on grounds he wasn’t injured on the job.

Royalties, Consulting Fees


Another beneficiary was Medtronic Inc., which makes products for spinal surgery, including Infuse, a bone-growing material widely used in fusions. Infuse accounted for $17,575 of Abbott Northwestern’s charges, Hehn’s medical bills and insurance records show.

Infuse, approved by the U.S. Food and Drug Administration in 2002, had sales of $840 million last year.
Medtronic paid six of the 10 Twin Cities Spine surgeons -- including Transfeldt -- $1.75 million in royalties and consulting fees in the first nine months of this year. It also makes other financial contributions to the firm.
“Product usage is not a part of any development or consulting relationship” between Medtronic and doctors, said Brian Henry, a company spokesman.

Eleven Twin Cities Spine fusion patients, most of whom tried to get or hold onto coverage benefits through the Minnesota Workers’ Compensation Court of Appeals, said in interviews that the surgery did nothing to relieve their back pain, and in several cases left them worse off than before.

Hooked on Morphine

The patients illustrate the costs and risks of fusion surgery. They are not a scientifically representative sample of Twin Cities Spine patients, the majority of whom the firm says are happy with the treatment they receive.
One of the 11 died of a methadone overdose when his pain worsened after surgery and he couldn’t afford prescription painkillers, his mother said. Another patient said he is hooked on morphine to ease the burning sensation in his back where screws and rods were implanted in an operation that cost his insurer $60,000.
Twin Cities Spine performs fusions on patients with conditions the surgery doesn’t treat effectively, said Brian Nelson, an orthopedic surgeon and medical director of a Minneapolis clinic that stresses exercise for back pain. Nelson said he used to perform fusions and has been in the operating room with at least three of the 10 Twin Cities Spine surgeons.

“I have a lot of respect” for the practice and its surgical skills, Nelson said. “But we have a fundamental disagreement. I think there are too many people being fused.”

Risk Warnings

Payments by medical-device makers pose an “irresistible” temptation to tailor treatment to more-lucrative procedures, said Eugene Carragee, chief of spine surgery at Stanford University in Palo Alto, California. “There is precious little in human nature to suggest this proposition is unlikely.”

Twin Cities Spine believes in a “conservative course of treatment in the vast majority of cases,” according to an e- mailed statement from Lisa Arrington, the practice’s marketing director. There are some people for whom surgery is appropriate, she wrote, and numerous patients “have experienced successful outcomes from spinal fusion procedures,” regaining functionality. The operations “reduced pain and improved their quality of life,” she said.


Degenerative Disc Disease

Financial relationships with medical companies are disclosed to patients and do not influence whether surgery is performed, according to the statement from Arrington. Royalties are not received by Twin Cities Spine doctors on devices they use in surgery, the e-mail said.

Fusion has helped spine surgeons become the best paid doctors in the U.S. Their average annual salary is $806,000, more than three times the earnings of a pediatrician, according to the American Medical Group Association, a trade organization for doctor practices.

One of the most common causes of back pain is degenerative disc disease, or the breakdown in the soft, puck-shaped cushions between the vertebrae. Pain also comes from a condition called stenosis, or the narrowing of the spinal canal, which can be caused by bulging discs or arthritis.

Narcotics For Pain

British and Norwegian researchers found fusion no better than physical therapy for disc-related pain in three studies, totaling 473 patients, published in the journals Spine, Pain and the British Medical Journal between 2003 and 2006. A 2001 Swedish study of 294 patients in Spine found fusion better than physical therapy that was less structured than the kinds used in the other studies.

Rates of complications from surgery in three of the European studies -- including bleeding, blood clots, and infections -- were as high as 18 percent. None reported complications from physical therapy. The four studies are cited in journals as the only head-to-head, randomized comparisons between the two treatments.
In a U.S. study in Spine in 2007, surgeons reported fusion was successful in only 41 percent of 75 patients suffering from lower-back disc degeneration. Success measures included pain reduction. Two years earlier in the same journal, surgeons found a 47 percent success rate among 99 patients, 80 percent of which were taking narcotics for pain two years later. Both studies compared fusion to artificial disc replacement in trials submitted to the FDA.

Evidence ‘Lacking’

Evidence that fusion is better than a simpler procedure called decompression for stenosis is “lacking,” a study in the Journal of the American Medical Association found earlier this year. The study also found that fast-growing complex fusions -- those joining more than three vertebrae -- carried a 5.6 percent risk of life threatening complications, more than double the 2.3 percent rate for decompression, which usually involves cutting away damaged discs or bone pressing on spinal nerves.

Twin Cities Spine performs 3,000 spine surgeries a year, 1,300 of them fusions, and accounts for 75 percent of the spine operations at Abbott Northwestern, according to Daryll Dykes, a surgeon in the practice. More than 4,000 spine procedures a year are performed at Abbott Northwestern, the most of any U.S. hospital, according to its website.

The practice generates big bills. Medica Health Plans, one of Minnesota’s largest insurers, says it pays a median of $26,021 for back surgeries performed by Twin Cities Spine, including hospital and doctor fees. The medians range between $12,814 an
d $23,546 for all other spine and orthopedic practices in the area, Medica says.

Porsches, Ferrari, Mercedes

One Twin Cities Spine surgeon, Manuel Pinto, 56, earned $1.85 million from the practice in 2007, according to filings in his divorce proceedings that year. He told state superior court in Minneapolis that he and his wife’s assets included two Porsches; a Ferrari 430 coupe; a Mercedes Benz; two other cars; three boats and proceeds from the $1 million sale of a farm where the Pintos bred Lusitano horses.
Pinto’s 7,185-square-foot house presides over a wooded promontory on Lake Minnetonka. Valued at $4 million in 2007, the house has a swimming pool and 50 yards of beach.

In addition to Transfeldt, Pinto is one of the six surgeons who receive payments from Medtronic. The others are Francis Denis, Timothy Garvey, Joseph Perra and James Schwender.
Schwender, 44, earned $1.2 million from the practice and $440,000 from royalties and consulting in 2008, divorce filings show. Schwender bought his lakefront home outside Minneapolis for $2.6 million in 2005, according to real estate records.

‘90 Percent Success’

Twin Cities Spine performed 1,100 lumbar, or lower-back, fusion surgeries in 2009, Dykes said. Of those, he added, 380 patients had degenerative disc disease and another problem such as stenosis, and 282 had degenerative disc disease alone.

Twin Cities Spine doesn’t have any scientifically validated studies on the success of fusion for those in the latter group, Dykes said. He called them “the controversial patients.”
Spinal fusion on back-pain patients is performed as a last resort after less invasive treatments fail, he said. Measuring outcomes has been difficult because researchers, doctors and payers can’t agree on criteria for success, he said.

“Living Well With Back Pain,” a 2006 consumer guide produced by Twin Cities Spine and published by HarperCollins, states that, “With proper patient selection and optimal surgical techniques, the success rate for spinal fusion surgery for back pain is now about 90 percent.”

Two-Level Surgery
A letter from Pinto to patient Robin Washburn in 2005 said surgery offered “a very good chance” of success, adding that a “good to excellent outcome” would mean at least a 70 percent reduction in pain.
Two spinal fusion surgeries later, her back is worse than ever, said Washburn, who is 40 and a 911 dispatcher in Grand Rapids, Minnesota. Washburn’s insurer, Blue Cross Blue Shield of Minnesota, paid $80,000 for the two procedures.

“Before it was annoying. Now, it’s pain every day, all day, worse when it’s cold,” she said in an interview.
Ninety-eight percent of Twin Cities Spine’s post-operative patients who responded to a 2009 survey would choose or recommend the group for surgical care, according to Arrington’s e-mailed statement. She said about a third of patients responded to the survey.
Patients that the practice recommended to Bloomberg News for interviews reported being happy with their surgeries. One of them, Jody Rasmusson, 48, of Minneapolis, underwent her second spinal surgery in three years by Dykes in October 2009. One year after the two-level fusion and decompression, the shooting pain in her back and legs was gone, said Rasmusson, a bank customer- service agent. A level is the space between two vertebrae; a two-level surgery means three vertebrae were fused.

Playing Football

Before Robert Gumatz, 60, had a five-level spinal fusion by Dykes in November 2009, the grain-company manager had so much back and hip pain he was losing the use of his legs, he said. He had stopped playing soccer with his kids and taking nightly walks with his wife. A year later, “I can play tackle football if I want to,” said Gumatz, of Oakdale, Minnesota. “I know I’m an exception. I have no pain.”
For 50 years, surgery was a calling at Twin Cities Spine. Led by surgeon John H. Moe, a pioneer in correcting scoliosis, or abnormally curved spines, the group’s doctors rebuilt the twisted backs of children with polio and other malformations -- vertebra by vertebra.

They traveled at least 90 days a year, often paying their own way, to show doctors around the world how to mend childhood spinal deformities, said David Bradford, who spent 20 years at the practice before becoming chair of orthopedics at the University of California at San Francisco in 1991.

Adapting Fusion

At home, Bradford said surgeons operated weekly at Gillette Children’s Hospital in St. Paul, Minnesota, usually for free. “‘It was just what you did; that’s why we became doctors,” said Bradford, now a professor and chair emeritus at UCSF’s spine center. “We weren’t in medicine to make gazillions.”
While senior surgeons continue to research and treat crippling disease, Pinto and other protégés have also adapted the fusion techniques Moe pioneered to surgery for common back pain, said Robert Winter, the firm’s research director.

Twin Cities Spine surgeons published articles on fusion techniques for back pain and presented results at professional meetings. Its financial relationship with Medtronic, the largest maker of spinal implants in the U.S., began as early as 2002, when, according to a deposition by Pinto, he began receiving money from the company, which is based in Fridley, Minnesota.

Medtronic Money

In addition to the $1.75 million it paid the six Twin Cities Spine surgeons this year, Medtronic and three other device companies give the practice a total of $100,000 to $500,000 for a fellowship program, Arrington said. Twin Cities Spine calls it the largest such program in the country and says it has trained 140 spine surgeons.
Medtronic also has disclosed contributing $150,000 in 2008 to a non-profit that Schwender heads to spread the use of minimally invasive surgical devices. The contribution represented 95 percent of the non-profit’s expenses that year, according to the organization’s latest-available tax filings.
In 2004, Pinto was seeing Jean Kingsley, 57, a patient who had had two previous fusion surgeries and was still suffering back pain. Pinto told her, according to a hospital report he wrote, that more “surgical treatment could provide her with some relief of her pain” if her symptoms “were extremely severe, unrelenting” and had “failed extensive conservative care,” which “appeared to be the case.”

Not Negligent

Her third operation, a daylong procedure by Pinto in September of that year, fused 13 vertebrae along her entire spine and was a disaster. Kingsley, of Milaca, Minnesota, returned home paralyzed from the waist down, according to hospital records in a lawsuit she brought against Pinto. A jury in Minnesota state court found earlier this year that Pinto was not negligent in the case.

The judge awarded $46,616 in attorney’s fees to Pinto, which Kingsley said she can’t pay. She has appealed the decision. Her case is a “unique set of events for which even in retrospect there is no obvious explanation that one can prove,” Pinto said in his 2008 deposition, in which he estimated he performed 400 to 500 back surgeries a year.

Abbott and Twin Cities Spine billed a combined $239,000 for the surgery, Kingsley’s records show. Insurer Medica says it paid about a third of that amount after a discount.
Kingsley arrived home in a wheelchair, wore a diaper for two and a half years and had a home health aide visiting to bathe her in bed, she said in a deposition in the case. As her condition improved, she said she was able to move short distances with the aid of leg braces and a walker.

‘I’m Paralyzed’

Today, Kingsley lives alone after the 2008 death of her husband. She said she takes medication for depression and doesn’t do “much of anything,” usually watching television and reading, and lives off Social Security benefits from her husband’s death. “Now I don’t feel any pain,” Kingsley said in an interview. “I’m paralyzed.”

Pinto co-authored a study in Spine in 2009 on 125 of his patients who had, like Kingsley, undergone fusions of four or more vertebrae. The study, which a Twin Cities Spine fellow presented at six surgical conferences around the globe, concluded that patients with extensive degenerative pain “can be successfully treated with surgical intervention.”

The Pinto study showed why back-pain patients should avoid spinal fusions, said Stanford University’s Carragee. The paper tracked progress in only 80 of the 125 surgical patients; “what happened to the other 45 patients?” Carragee asked.

Lifting a Keg

Twenty-seven of the 80 patients needed a second surgery, while about 40 percent of the patients had complications, including 5 percent of the men who suffered permanently diminished sexual function, Carragee said.

“This should make you pretty cautious about doing this kind of stuff,” he said.
Twin Cities Spine, in its statement, said Pinto’s study was the first to report on such extensive fusion surgery for degenerative back pain, an operation it said “is in no way comparable” to less complicated procedures.
Schwender first performed fusion surgery on Catherine Engels in May 2001, after finding she had a herniated disc. She came to see him again on June 4, 2003, complaining of sharp back pain, her medical records show.
Engels, now 50, received Schwender’s support for a workers’ compensation claim, in which she said she injured her back lifting a keg at a liquor store where she worked in July 2000. Schwender said in a deposition that the incident was “a significant contributing factor” to Engels’s back problems.
‘Constant, Sharp Pain’

The workers’ compensation judge rejected her claim, finding “multiple significant inconsistencies” between her and Schwender’s testimony, on one side, and the medical records submitted by six doctors Engels saw before Schwender, on the other. Two of those doctors said Engels hadn’t attributed her back pain to any specific injury, and others said Engels attributed the pain to lifting patio brick, the judge found.
Schwender operated a second time on Engels in January 2004, removing the screws and rods he’d put in her spine and decompressing the spinal canal. It didn’t help. By then, Schwender told Engels, the rods and screws had shifted and caused permanent nerve damage, she said in an interview. Now she has “constant, sharp pain” down her left leg, treated with drugs and a neurostimulator in her back designed to send out current that interferes with pain signals.

“I went through with fusion thinking it would be the cure- all,” Engels said. “It wasn’t.”
OxyContin, Hydrocodone, Elavil Dan Bebault was suffering from lower back and leg pain when he visited Twin Cities Spine’s Garvey in May 2006. Garvey discussed surgery with him and told him he’d “likely” be able to return to light work three to six months afterwards, according to Bebault and notes Garvey made on the case. “He pretty much talked me into it,” Bebault said.

The fusion took place in August that year. When Bebault returned to see Garvey five months later, he said, his life was falling apart. The pain had spread to his neck and arms, and OxyContin, hydrocodone and Elavil weren’t helping much. Bebault’s wife had left him after the surgery; he hadn’t worked in four years.
Garvey wasn’t sympathetic, said Bebault, a 53-year-old former machinist who lives in Brooklyn Park, Minnesota. “He said my life was like an old country-western song and he didn’t want to hear about it,” Bebault said in an interview at his home. “He said come back if I want more surgery.”
Methadone Overdose

Additional fusion surgery for Bebault’s neck “would be an option,” Garvey’s chart notes from this time say. Bebault, now reunited with his wife and on Social Security disability, decided against more surgery and quells the pain in his back and neck with 120 milligrams a day of morphine, plus occasional vicodin, valium and amitriptyline, an anti-depressant.

He said he feels “withdrawals” when his morphine wears off, shaking and sweating. His surgery cost his former employer’s workers’ compensation insurer $48,633; Garvey’s fee was $5,870.
“The patient is like a piece of meat; everybody’s making money off the guy,” Bebault said.
Garvey did a three-level spinal fusion on Ross Tamminen in April 2006. Six months later, Tamminen, a heavy-equipment operator, reported severe pain again in his back and legs, according to documents from a case in state workers’ comp court.

As a treatment option, Garvey proposed more surgery to examine the fusion site, remove the implants in Tamminen’s spine, and perform decompression. His employer’s insurer denied a coverage request, saying surgery wasn’t warranted, according to court filings.

The rest of the story comes from Tamminen’s mother, Barbara Grove. Denied federal disability benefits and in intractable pain, Tamminen ran out of money for painkillers, she said, and began taking methadone obtained through friends.

He died of an overdose on June 20, 2008, 26 months after spinal fusion. He was 41.
To contact the reporters responsible for this story: Peter Waldman in San Francisco at pwaldman@bloomberg.net; David Armstrong in Boston at darmstrong16@bloomberg.net
To contact the editor responsible for this story: Gary Putka at gputka@bloomberg.net

Mikel Hehn poses in St. Cloud, Minnesota, with the daily medications he takes to combat pain and depression as a result of his spinal surgery. Photographer: Andy King/Bloomberg

Suffering from an aching back, truck driver Mikel Hehn went to see surgeon Jeffrey Gerdes in 2008. The St. Cloud, Minnesota, doctor diagnosed spinal disc degeneration, commonly treated with physical therapy, and said surgery wasn’t called for.
Unhappy with the answer, Hehn turned to Ensor Transfeldt, a surgeon at Twin Cities Spine Center in Minneapolis. Transfeldt performed fusion surgery on Hehn, screwing together three vertebrae in his lower spine.

Fusion aims to limit painful spine movements. This one didn’t work out. Two years later, the pain in Hehn’s neck, lower back, buttocks and thighs is so bad that he can’t hold a job and seldom leaves home, he said in an interview.

“There’s days when I just can’t take it and the tears run,” said Hehn, 52, who lives in Sartell, Minnesota. He said he takes oxycodone for pain, Soma to sleep, Lexapro for depression and Imitrex for headaches.
Hehn’s surgery generated a $135,786 bill from Abbott Northwestern Hospital in Minneapolis, feeding a national boom in costly fusion surgeries. It also illustrates how spine surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is -- and a lot more dangerous.

The number of fusions at U.S. hospitals doubled to 413,000 between 2002 and 2008, generating $34 billion in bills, data from the federal Healthcare Cost and Utilization Project show. The number of the surgeries will rise to 453,300 this year, according to Millennium Research Group of Toronto.

Unnecessary Surgeries

The possibility that many of these and other surgeries are needless has gotten little attention in the debate over U.S. health care costs, which rose 6 percent last year to $2.47 trillion. Unnecessary surgeries cost at least $150 billion a year, according to John Birkmeyer, director of the Center for Healthcare Outcomes & Policy at the University of Michigan.

“It’s amazing how much evidence there is that fusions don’t work, yet surgeons do them anyway,” said Sohail Mirza, a spine surgeon who chairs the Department of Orthopaedics at Dartmouth Medical School in Hanover, New Hampshire. “The only one who isn’t benefitting from the equation is the patient.”
The Twin Cities Spine bill for Hehn’s surgery was $19,292, his medical records show. The firm received $8,978 after an insurance discount, $7,742 of it for Transfeldt’s services. Hehn’s insurer paid after his bid for workers’ compensation coverage was denied on grounds he wasn’t injured on the job.

Royalties, Consulting Fees


Another beneficiary was Medtronic Inc., which makes products for spinal surgery, including Infuse, a bone-growing material widely used in fusions. Infuse accounted for $17,575 of Abbott Northwestern’s charges, Hehn’s medical bills and insurance records show.

Infuse, approved by the U.S. Food and Drug Administration in 2002, had sales of $840 million last year.
Medtronic paid six of the 10 Twin Cities Spine surgeons -- including Transfeldt -- $1.75 million in royalties and consulting fees in the first nine months of this year. It also makes other financial contributions to the firm.
“Product usage is not a part of any development or consulting relationship” between Medtronic and doctors, said Brian Henry, a company spokesman.

Eleven Twin Cities Spine fusion patients, most of whom tried to get or hold onto coverage benefits through the Minnesota Workers’ Compensation Court of Appeals, said in interviews that the surgery did nothing to relieve their back pain, and in several cases left them worse off than before.

Hooked on Morphine

The patients illustrate the costs and risks of fusion surgery. They are not a scientifically representative sample of Twin Cities Spine patients, the majority of whom the firm says are happy with the treatment they receive.
One of the 11 died of a methadone overdose when his pain worsened after surgery and he couldn’t afford prescription painkillers, his mother said. Another patient said he is hooked on morphine to ease the burning sensation in his back where screws and rods were implanted in an operation that cost his insurer $60,000.
Twin Cities Spine performs fusions on patients with conditions the surgery doesn’t treat effectively, said Brian Nelson, an orthopedic surgeon and medical director of a Minneapolis clinic that stresses exercise for back pain. Nelson said he used to perform fusions and has been in the operating room with at least three of the 10 Twin Cities Spine surgeons.

“I have a lot of respect” for the practice and its surgical skills, Nelson said. “But we have a fundamental disagreement. I think there are too many people being fused.”

Risk Warnings

Payments by medical-device makers pose an “irresistible” temptation to tailor treatment to more-lucrative procedures, said Eugene Carragee, chief of spine surgery at Stanford University in Palo Alto, California. “There is precious little in human nature to suggest this proposition is unlikely.”

Twin Cities Spine believes in a “conservative course of treatment in the vast majority of cases,” according to an e- mailed statement from Lisa Arrington, the practice’s marketing director. There are some people for whom surgery is appropriate, she wrote, and numerous patients “have experienced successful outcomes from spinal fusion procedures,” regaining functionality. The operations “reduced pain and improved their quality of life,” she said.


Degenerative Disc Disease

Financial relationships with medical companies are disclosed to patients and do not influence whether surgery is performed, according to the statement from Arrington. Royalties are not received by Twin Cities Spine doctors on devices they use in surgery, the e-mail said.

Fusion has helped spine surgeons become the best paid doctors in the U.S. Their average annual salary is $806,000, more than three times the earnings of a pediatrician, according to the American Medical Group Association, a trade organization for doctor practices.

One of the most common causes of back pain is degenerative disc disease, or the breakdown in the soft, puck-shaped cushions between the vertebrae. Pain also comes from a condition called stenosis, or the narrowing of the spinal canal, which can be caused by bulging discs or arthritis.

Narcotics For Pain

British and Norwegian researchers found fusion no better than physical therapy for disc-related pain in three studies, totaling 473 patients, published in the journals Spine, Pain and the British Medical Journal between 2003 and 2006. A 2001 Swedish study of 294 patients in Spine found fusion better than physical therapy that was less structured than the kinds used in the other studies.

Rates of complications from surgery in three of the European studies -- including bleeding, blood clots, and infections -- were as high as 18 percent. None reported complications from physical therapy. The four studies are cited in journals as the only head-to-head, randomized comparisons between the two treatments.
In a U.S. study in Spine in 2007, surgeons reported fusion was successful in only 41 percent of 75 patients suffering from lower-back disc degeneration. Success measures included pain reduction. Two years earlier in the same journal, surgeons found a 47 percent success rate among 99 patients, 80 percent of which were taking narcotics for pain two years later. Both studies compared fusion to artificial disc replacement in trials submitted to the FDA.

Evidence ‘Lacking’

Evidence that fusion is better than a simpler procedure called decompression for stenosis is “lacking,” a study in the Journal of the American Medical Association found earlier this year. The study also found that fast-growing complex fusions -- those joining more than three vertebrae -- carried a 5.6 percent risk of life threatening complications, more than double the 2.3 percent rate for decompression, which usually involves cutting away damaged discs or bone pressing on spinal nerves.

Twin Cities Spine performs 3,000 spine surgeries a year, 1,300 of them fusions, and accounts for 75 percent of the spine operations at Abbott Northwestern, according to Daryll Dykes, a surgeon in the practice. More than 4,000 spine procedures a year are performed at Abbott Northwestern, the most of any U.S. hospital, according to its website.

The practice generates big bills. Medica Health Plans, one of Minnesota’s largest insurers, says it pays a median of $26,021 for back surgeries performed by Twin Cities Spine, including hospital and doctor fees. The medians range between $12,814 an
d $23,546 for all other spine and orthopedic practices in the area, Medica says.

Porsches, Ferrari, Mercedes

One Twin Cities Spine surgeon, Manuel Pinto, 56, earned $1.85 million from the practice in 2007, according to filings in his divorce proceedings that year. He told state superior court in Minneapolis that he and his wife’s assets included two Porsches; a Ferrari 430 coupe; a Mercedes Benz; two other cars; three boats and proceeds from the $1 million sale of a farm where the Pintos bred Lusitano horses.
Pinto’s 7,185-square-foot house presides over a wooded promontory on Lake Minnetonka. Valued at $4 million in 2007, the house has a swimming pool and 50 yards of beach.

In addition to Transfeldt, Pinto is one of the six surgeons who receive payments from Medtronic. The others are Francis Denis, Timothy Garvey, Joseph Perra and James Schwender.
Schwender, 44, earned $1.2 million from the practice and $440,000 from royalties and consulting in 2008, divorce filings show. Schwender bought his lakefront home outside Minneapolis for $2.6 million in 2005, according to real estate records.

‘90 Percent Success’

Twin Cities Spine performed 1,100 lumbar, or lower-back, fusion surgeries in 2009, Dykes said. Of those, he added, 380 patients had degenerative disc disease and another problem such as stenosis, and 282 had degenerative disc disease alone.

Twin Cities Spine doesn’t have any scientifically validated studies on the success of fusion for those in the latter group, Dykes said. He called them “the controversial patients.”
Spinal fusion on back-pain patients is performed as a last resort after less invasive treatments fail, he said. Measuring outcomes has been difficult because researchers, doctors and payers can’t agree on criteria for success, he said.

“Living Well With Back Pain,” a 2006 consumer guide produced by Twin Cities Spine and published by HarperCollins, states that, “With proper patient selection and optimal surgical techniques, the success rate for spinal fusion surgery for back pain is now about 90 percent.”

Two-Level Surgery
A letter from Pinto to patient Robin Washburn in 2005 said surgery offered “a very good chance” of success, adding that a “good to excellent outcome” would mean at least a 70 percent reduction in pain.
Two spinal fusion surgeries later, her back is worse than ever, said Washburn, who is 40 and a 911 dispatcher in Grand Rapids, Minnesota. Washburn’s insurer, Blue Cross Blue Shield of Minnesota, paid $80,000 for the two procedures.

“Before it was annoying. Now, it’s pain every day, all day, worse when it’s cold,” she said in an interview.
Ninety-eight percent of Twin Cities Spine’s post-operative patients who responded to a 2009 survey would choose or recommend the group for surgical care, according to Arrington’s e-mailed statement. She said about a third of patients responded to the survey.
Patients that the practice recommended to Bloomberg News for interviews reported being happy with their surgeries. One of them, Jody Rasmusson, 48, of Minneapolis, underwent her second spinal surgery in three years by Dykes in October 2009. One year after the two-level fusion and decompression, the shooting pain in her back and legs was gone, said Rasmusson, a bank customer- service agent. A level is the space between two vertebrae; a two-level surgery means three vertebrae were fused.

Playing Football

Before Robert Gumatz, 60, had a five-level spinal fusion by Dykes in November 2009, the grain-company manager had so much back and hip pain he was losing the use of his legs, he said. He had stopped playing soccer with his kids and taking nightly walks with his wife. A year later, “I can play tackle football if I want to,” said Gumatz, of Oakdale, Minnesota. “I know I’m an exception. I have no pain.”
For 50 years, surgery was a calling at Twin Cities Spine. Led by surgeon John H. Moe, a pioneer in correcting scoliosis, or abnormally curved spines, the group’s doctors rebuilt the twisted backs of children with polio and other malformations -- vertebra by vertebra.

They traveled at least 90 days a year, often paying their own way, to show doctors around the world how to mend childhood spinal deformities, said David Bradford, who spent 20 years at the practice before becoming chair of orthopedics at the University of California at San Francisco in 1991.

Adapting Fusion

At home, Bradford said surgeons operated weekly at Gillette Children’s Hospital in St. Paul, Minnesota, usually for free. “‘It was just what you did; that’s why we became doctors,” said Bradford, now a professor and chair emeritus at UCSF’s spine center. “We weren’t in medicine to make gazillions.”
While senior surgeons continue to research and treat crippling disease, Pinto and other protégés have also adapted the fusion techniques Moe pioneered to surgery for common back pain, said Robert Winter, the firm’s research director.

Twin Cities Spine surgeons published articles on fusion techniques for back pain and presented results at professional meetings. Its financial relationship with Medtronic, the largest maker of spinal implants in the U.S., began as early as 2002, when, according to a deposition by Pinto, he began receiving money from the company, which is based in Fridley, Minnesota.

Medtronic Money

In addition to the $1.75 million it paid the six Twin Cities Spine surgeons this year, Medtronic and three other device companies give the practice a total of $100,000 to $500,000 for a fellowship program, Arrington said. Twin Cities Spine calls it the largest such program in the country and says it has trained 140 spine surgeons.
Medtronic also has disclosed contributing $150,000 in 2008 to a non-profit that Schwender heads to spread the use of minimally invasive surgical devices. The contribution represented 95 percent of the non-profit’s expenses that year, according to the organization’s latest-available tax filings.
In 2004, Pinto was seeing Jean Kingsley, 57, a patient who had had two previous fusion surgeries and was still suffering back pain. Pinto told her, according to a hospital report he wrote, that more “surgical treatment could provide her with some relief of her pain” if her symptoms “were extremely severe, unrelenting” and had “failed extensive conservative care,” which “appeared to be the case.”

Not Negligent

Her third operation, a daylong procedure by Pinto in September of that year, fused 13 vertebrae along her entire spine and was a disaster. Kingsley, of Milaca, Minnesota, returned home paralyzed from the waist down, according to hospital records in a lawsuit she brought against Pinto. A jury in Minnesota state court found earlier this year that Pinto was not negligent in the case.

The judge awarded $46,616 in attorney’s fees to Pinto, which Kingsley said she can’t pay. She has appealed the decision. Her case is a “unique set of events for which even in retrospect there is no obvious explanation that one can prove,” Pinto said in his 2008 deposition, in which he estimated he performed 400 to 500 back surgeries a year.

Abbott and Twin Cities Spine billed a combined $239,000 for the surgery, Kingsley’s records show. Insurer Medica says it paid about a third of that amount after a discount.
Kingsley arrived home in a wheelchair, wore a diaper for two and a half years and had a home health aide visiting to bathe her in bed, she said in a deposition in the case. As her condition improved, she said she was able to move short distances with the aid of leg braces and a walker.

‘I’m Paralyzed’

Today, Kingsley lives alone after the 2008 death of her husband. She said she takes medication for depression and doesn’t do “much of anything,” usually watching television and reading, and lives off Social Security benefits from her husband’s death. “Now I don’t feel any pain,” Kingsley said in an interview. “I’m paralyzed.”

Pinto co-authored a study in Spine in 2009 on 125 of his patients who had, like Kingsley, undergone fusions of four or more vertebrae. The study, which a Twin Cities Spine fellow presented at six surgical conferences around the globe, concluded that patients with extensive degenerative pain “can be successfully treated with surgical intervention.”

The Pinto study showed why back-pain patients should avoid spinal fusions, said Stanford University’s Carragee. The paper tracked progress in only 80 of the 125 surgical patients; “what happened to the other 45 patients?” Carragee asked.

Lifting a Keg

Twenty-seven of the 80 patients needed a second surgery, while about 40 percent of the patients had complications, including 5 percent of the men who suffered permanently diminished sexual function, Carragee said.

“This should make you pretty cautious about doing this kind of stuff,” he said.
Twin Cities Spine, in its statement, said Pinto’s study was the first to report on such extensive fusion surgery for degenerative back pain, an operation it said “is in no way comparable” to less complicated procedures.
Schwender first performed fusion surgery on Catherine Engels in May 2001, after finding she had a herniated disc. She came to see him again on June 4, 2003, complaining of sharp back pain, her medical records show.
Engels, now 50, received Schwender’s support for a workers’ compensation claim, in which she said she injured her back lifting a keg at a liquor store where she worked in July 2000. Schwender said in a deposition that the incident was “a significant contributing factor” to Engels’s back problems.
‘Constant, Sharp Pain’

The workers’ compensation judge rejected her claim, finding “multiple significant inconsistencies” between her and Schwender’s testimony, on one side, and the medical records submitted by six doctors Engels saw before Schwender, on the other. Two of those doctors said Engels hadn’t attributed her back pain to any specific injury, and others said Engels attributed the pain to lifting patio brick, the judge found.
Schwender operated a second time on Engels in January 2004, removing the screws and rods he’d put in her spine and decompressing the spinal canal. It didn’t help. By then, Schwender told Engels, the rods and screws had shifted and caused permanent nerve damage, she said in an interview. Now she has “constant, sharp pain” down her left leg, treated with drugs and a neurostimulator in her back designed to send out current that interferes with pain signals.

“I went through with fusion thinking it would be the cure- all,” Engels said. “It wasn’t.”
OxyContin, Hydrocodone, Elavil Dan Bebault was suffering from lower back and leg pain when he visited Twin Cities Spine’s Garvey in May 2006. Garvey discussed surgery with him and told him he’d “likely” be able to return to light work three to six months afterwards, according to Bebault and notes Garvey made on the case. “He pretty much talked me into it,” Bebault said.

The fusion took place in August that year. When Bebault returned to see Garvey five months later, he said, his life was falling apart. The pain had spread to his neck and arms, and OxyContin, hydrocodone and Elavil weren’t helping much. Bebault’s wife had left him after the surgery; he hadn’t worked in four years.
Garvey wasn’t sympathetic, said Bebault, a 53-year-old former machinist who lives in Brooklyn Park, Minnesota. “He said my life was like an old country-western song and he didn’t want to hear about it,” Bebault said in an interview at his home. “He said come back if I want more surgery.”
Methadone Overdose

Additional fusion surgery for Bebault’s neck “would be an option,” Garvey’s chart notes from this time say. Bebault, now reunited with his wife and on Social Security disability, decided against more surgery and quells the pain in his back and neck with 120 milligrams a day of morphine, plus occasional vicodin, valium and amitriptyline, an anti-depressant.

He said he feels “withdrawals” when his morphine wears off, shaking and sweating. His surgery cost his former employer’s workers’ compensation insurer $48,633; Garvey’s fee was $5,870.
“The patient is like a piece of meat; everybody’s making money off the guy,” Bebault said.
Garvey did a three-level spinal fusion on Ross Tamminen in April 2006. Six months later, Tamminen, a heavy-equipment operator, reported severe pain again in his back and legs, according to documents from a case in state workers’ comp court.

As a treatment option, Garvey proposed more surgery to examine the fusion site, remove the implants in Tamminen’s spine, and perform decompression. His employer’s insurer denied a coverage request, saying surgery wasn’t warranted, according to court filings.

The rest of the story comes from Tamminen’s mother, Barbara Grove. Denied federal disability benefits and in intractable pain, Tamminen ran out of money for painkillers, she said, and began taking methadone obtained through friends.

He died of an overdose on June 20, 2008, 26 months after spinal fusion. He was 41.
To contact the reporters responsible for this story: Peter Waldman in San Francisco at pwaldman@bloomberg.net; David Armstrong in Boston at darmstrong16@bloomberg.net
To contact the editor responsible for this story: Gary Putka at gputka@bloomberg.net

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