Erik L. Goldman

NEW YORK – Moderate exercise can confer a measurable survival advantage in patients who have undergone treatment for colorectal cancer, said Dr. Jeffrey Meyerhardt at an international conference sponsored by the Society for Integrative Oncology.

"Published data are showing a major decrease in morbidity and mortality in patients who exercise. These are changes in actual cancer outcomes, not just quality of life measures," said Dr. Meyerhardt of the department of medical oncology, Dana-Farber Cancer Institute, Boston.

"My research really came out of patients’ questions. They wanted to know, ‘What should I be eating? Should I exercise? What else can I do to improve my chances?’ We wanted to help them live longer and live better."

Emerging data indicate that physical activity, avoidance of the typical meat-heavy Western diet patterns, maintenance of body mass index under 35 kg/m2, higher levels of vitamin D, and regular use of aspirin or other anti-inflammatory compounds reduces the risk of recurrence in colorectal cancer (CRC), Dr. Meyerhardt said during his keynote presentation.

An Australian cohort study of 526 colorectal cancer patients showed that the probability of surviving for 10 years post-diagnosis was 73% for the patients who exercised regularly prior to the cancer diagnosis, versus 54% among those who did not exercise (Gut 2006;55:62-7). The investigators noted that percent of body fat and the waist circumference were both inversely correlated with survival.

Dr. Meyerhardt and his group published an analysis of data from a National Cancer Institute–sponsored study called CALGB 89803 that involved 1,264 patients with stage II colon cancer, randomized to treatment with 5-fluorouracil and leucovorin with or without irinotecan following surgical resection.

The study was designed to assess the impact of the drug regimens on overall and disease-free survival, and found no significant differences between the two (J. Clin. Oncol. 2007;25:3456-61). However, there were substantial survival differences based on level of post-diagnosis physical activity, said Dr. Meyerhardt.

He and his colleagues stratified the study participants according to their self-reported activity levels, using the "met-hour" (metabolic equivalent task hour) as a unit of measure. For example, sitting still was defined as 1 met and slow walking was defined as 3 mets. Other activities were assigned met values according to their strenuousness. Met-hours represent the aggregate amount of time per week that a subject spent in metabolically significant activity.

The hazard ratio of recurrence or death was reduced by 49% among people who regularly had between 18 and 26 met-hours of activity per week, compared to those who had fewer than 3 met-hours per week (J. Clin. Oncol. 2006;24:3535-41). Dr. Meyerhardt said that an hour-long walk at a brisk pace of 3-4 miles per hour, three to four times per week, would put someone in the risk-reducing range.

He acknowledged that this analysis has limits in that it was based on self-reporting. Also, people who are able to exercise for 18 or more hours per week after chemotherapy and surgery for colorectal cancer are highly functioning, with good overall health status, which in and of itself would confer a survival advantage.

Data from other studies have also shown that higher activity levels predict better outcomes following colorectal cancer diagnosis. For example, the Nurses’ Health Study showed that post-diagnosis activity levels are predictive of survival. Among the women who had more than 18 met-hours of activity per week, roughly 90% were still alive 10 years after diagnosis, versus 67% of those who had less than 3 met hours per week, and 75% of those who got between 3 and 18 met-hours/week (J. Clin. Oncol. 2006;24:3527-34). In this data set, the prediagnosis activity levels were not predictive of survival, after researchers adjusted for other health status variables.

"It is not simply a matter of more active people getting less aggressive forms of cancer," said Dr. Meyerhardt. "There are statistically significant improvements in survival and reduced morbidity in patients with increased activity post-diagnosis and post-treatment."

The NHS data indicate that women who increased their activity levels post-diagnosis had about 50% reductions in hazard ratios for CRC-specific mortality and overall mortality, while those who decreased their physical activity had increases in their hazard ratios.

A soon-to-be published analysis of data from the Health Professionals Follow-Up Study, involving 51,500 male health care practitioners, showed a similar pattern of reduced overall and CRC-associated mortality among the men with the highest levels of post-diagnosis physical activity, said Dr. Meyerhardt.

He noted that these studies are observational, and a prospective study is needed to confirm their findings. The Colon Health and Life-Long Exercise Change (CHALLENGE) trial is such a study that is expected to be published in several years. An Australian-Canadian collaborative effort, this controlled study will look at the impact of direct, guided exercise training interventions on clinical outcomes in patients with high-risk stage II and III CRC following surgery and adjuvant chemotherapy.

It is not yet known how exercise affects CRC, and cancer in general. Dr. Meyerhardt believes that the potential benefits may be partially attributable to the ability of exercise to modulate insulin metabolism. He noted that elevated insulin and insulin-like growth factors are predictive of increased CRC morbidity and mortality, as is elevation of C-peptide, another marker of insulin resistance.

Insulin resistance and all the metabolic changes that go with it may be a common factor between obesity and colorectal cancer. While not all studies have shown a direct correlation, there are data to suggest that a BMI over 30 kg/m2confers a 25% increase in risk of colorectal cancer recurrence and death.

‘With the rising incidence of obesity in the U.S., we are seeing more obese colorectal cancer patients," said Dr. Meyerhardt. "It used to be that only about 5% of colorectal cancer patients were obese. Now it’s roughly 10%."

He concluded that while there are many unanswered questions, there’s little harm and much potential good in recommending moderate regular physical activity for patients who have undergone surgery and adjuvant chemotherapy for colorectal cancer. Benefits increase if patients can shift toward a low-fat diet rich in vegetables and low in red meat and processed foods, he added.

NEW YORK – Moderate exercise can confer a measurable survival advantage in patients who have undergone treatment for colorectal cancer, said Dr. Jeffrey Meyerhardt at an international conference sponsored by the Society for Integrative Oncology.

"Published data are showing a major decrease in morbidity and mortality in patients who exercise. These are changes in actual cancer outcomes, not just quality of life measures," said Dr. Meyerhardt of the department of medical oncology, Dana-Farber Cancer Institute, Boston.

"My research really came out of patients’ questions. They wanted to know, ‘What should I be eating? Should I exercise? What else can I do to improve my chances?’ We wanted to help them live longer and live better."

Emerging data indicate that physical activity, avoidance of the typical meat-heavy Western diet patterns, maintenance of body mass index under 35 kg/m2, higher levels of vitamin D, and regular use of aspirin or other anti-inflammatory compounds reduces the risk of recurrence in colorectal cancer (CRC), Dr. Meyerhardt said during his keynote presentation.

An Australian cohort study of 526 colorectal cancer patients showed that the probability of surviving for 10 years post-diagnosis was 73% for the patients who exercised regularly prior to the cancer diagnosis, versus 54% among those who did not exercise (Gut 2006;55:62-7). The investigators noted that percent of body fat and the waist circumference were both inversely correlated with survival.

Dr. Meyerhardt and his group published an analysis of data from a National Cancer Institute–sponsored study called CALGB 89803 that involved 1,264 patients with stage II colon cancer, randomized to treatment with 5-fluorouracil and leucovorin with or without irinotecan following surgical resection.

The study was designed to assess the impact of the drug regimens on overall and disease-free survival, and found no significant differences between the two (J. Clin. Oncol. 2007;25:3456-61). However, there were substantial survival differences based on level of post-diagnosis physical activity, said Dr. Meyerhardt.

He and his colleagues stratified the study participants according to their self-reported activity levels, using the "met-hour" (metabolic equivalent task hour) as a unit of measure. For example, sitting still was defined as 1 met and slow walking was defined as 3 mets. Other activities were assigned met values according to their strenuousness. Met-hours represent the aggregate amount of time per week that a subject spent in metabolically significant activity.

The hazard ratio of recurrence or death was reduced by 49% among people who regularly had between 18 and 26 met-hours of activity per week, compared to those who had fewer than 3 met-hours per week (J. Clin. Oncol. 2006;24:3535-41). Dr. Meyerhardt said that an hour-long walk at a brisk pace of 3-4 miles per hour, three to four times per week, would put someone in the risk-reducing range.

He acknowledged that this analysis has limits in that it was based on self-reporting. Also, people who are able to exercise for 18 or more hours per week after chemotherapy and surgery for colorectal cancer are highly functioning, with good overall health status, which in and of itself would confer a survival advantage.

Data from other studies have also shown that higher activity levels predict better outcomes following colorectal cancer diagnosis. For example, the Nurses’ Health Study showed that post-diagnosis activity levels are predictive of survival. Among the women who had more than 18 met-hours of activity per week, roughly 90% were still alive 10 years after diagnosis, versus 67% of those who had less than 3 met hours per week, and 75% of those who got between 3 and 18 met-hours/week (J. Clin. Oncol. 2006;24:3527-34). In this data set, the prediagnosis activity levels were not predictive of survival, after researchers adjusted for other health status variables.

"It is not simply a matter of more active people getting less aggressive forms of cancer," said Dr. Meyerhardt. "There are statistically significant improvements in survival and reduced morbidity in patients with increased activity post-diagnosis and post-treatment."

The NHS data indicate that women who increased their activity levels post-diagnosis had about 50% reductions in hazard ratios for CRC-specific mortality and overall mortality, while those who decreased their physical activity had increases in their hazard ratios.

A soon-to-be published analysis of data from the Health Professionals Follow-Up Study, involving 51,500 male health care practitioners, showed a similar pattern of reduced overall and CRC-associated mortality among the men with the highest levels of post-diagnosis physical activity, said Dr. Meyerhardt.

He noted that these studies are observational, and a prospective study is needed to confirm their findings. The Colon Health and Life-Long Exercise Change (CHALLENGE) trial is such a study that is expected to be published in several years. An Australian-Canadian collaborative effort, this controlled study will look at the impact of direct, guided exercise training interventions on clinical outcomes in patients with high-risk stage II and III CRC following surgery and adjuvant chemotherapy.

It is not yet known how exercise affects CRC, and cancer in general. Dr. Meyerhardt believes that the potential benefits may be partially attributable to the ability of exercise to modulate insulin metabolism. He noted that elevated insulin and insulin-like growth factors are predictive of increased CRC morbidity and mortality, as is elevation of C-peptide, another marker of insulin resistance.

Insulin resistance and all the metabolic changes that go with it may be a common factor between obesity and colorectal cancer. While not all studies have shown a direct correlation, there are data to suggest that a BMI over 30 kg/m2confers a 25% increase in risk of colorectal cancer recurrence and death.

‘With the rising incidence of obesity in the U.S., we are seeing more obese colorectal cancer patients," said Dr. Meyerhardt. "It used to be that only about 5% of colorectal cancer patients were obese. Now it’s roughly 10%."

He concluded that while there are many unanswered questions, there’s little harm and much potential good in recommending moderate regular physical activity for patients who have undergone surgery and adjuvant chemotherapy for colorectal cancer. Benefits increase if patients can shift toward a low-fat diet rich in vegetables and low in red meat and processed foods, he added.

NEW YORK – Moderate exercise can confer a measurable survival advantage in patients who have undergone treatment for colorectal cancer, said Dr. Jeffrey Meyerhardt at an international conference sponsored by the Society for Integrative Oncology.

"Published data are showing a major decrease in morbidity and mortality in patients who exercise. These are changes in actual cancer outcomes, not just quality of life measures," said Dr. Meyerhardt of the department of medical oncology, Dana-Farber Cancer Institute, Boston.

"My research really came out of patients’ questions. They wanted to know, ‘What should I be eating? Should I exercise? What else can I do to improve my chances?’ We wanted to help them live longer and live better."

Emerging data indicate that physical activity, avoidance of the typical meat-heavy Western diet patterns, maintenance of body mass index under 35 kg/m2, higher levels of vitamin D, and regular use of aspirin or other anti-inflammatory compounds reduces the risk of recurrence in colorectal cancer (CRC), Dr. Meyerhardt said during his keynote presentation.

An Australian cohort study of 526 colorectal cancer patients showed that the probability of surviving for 10 years post-diagnosis was 73% for the patients who exercised regularly prior to the cancer diagnosis, versus 54% among those who did not exercise (Gut 2006;55:62-7). The investigators noted that percent of body fat and the waist circumference were both inversely correlated with survival.

Dr. Meyerhardt and his group published an analysis of data from a National Cancer Institute–sponsored study called CALGB 89803 that involved 1,264 patients with stage II colon cancer, randomized to treatment with 5-fluorouracil and leucovorin with or without irinotecan following surgical resection.

The study was designed to assess the impact of the drug regimens on overall and disease-free survival, and found no significant differences between the two (J. Clin. Oncol. 2007;25:3456-61). However, there were substantial survival differences based on level of post-diagnosis physical activity, said Dr. Meyerhardt.

He and his colleagues stratified the study participants according to their self-reported activity levels, using the "met-hour" (metabolic equivalent task hour) as a unit of measure. For example, sitting still was defined as 1 met and slow walking was defined as 3 mets. Other activities were assigned met values according to their strenuousness. Met-hours represent the aggregate amount of time per week that a subject spent in metabolically significant activity.

The hazard ratio of recurrence or death was reduced by 49% among people who regularly had between 18 and 26 met-hours of activity per week, compared to those who had fewer than 3 met-hours per week (J. Clin. Oncol. 2006;24:3535-41). Dr. Meyerhardt said that an hour-long walk at a brisk pace of 3-4 miles per hour, three to four times per week, would put someone in the risk-reducing range.

He acknowledged that this analysis has limits in that it was based on self-reporting. Also, people who are able to exercise for 18 or more hours per week after chemotherapy and surgery for colorectal cancer are highly functioning, with good overall health status, which in and of itself would confer a survival advantage.

Data from other studies have also shown that higher activity levels predict better outcomes following colorectal cancer diagnosis. For example, the Nurses’ Health Study showed that post-diagnosis activity levels are predictive of survival. Among the women who had more than 18 met-hours of activity per week, roughly 90% were still alive 10 years after diagnosis, versus 67% of those who had less than 3 met hours per week, and 75% of those who got between 3 and 18 met-hours/week (J. Clin. Oncol. 2006;24:3527-34). In this data set, the prediagnosis activity levels were not predictive of survival, after researchers adjusted for other health status variables.

"It is not simply a matter of more active people getting less aggressive forms of cancer," said Dr. Meyerhardt. "There are statistically significant improvements in survival and reduced morbidity in patients with increased activity post-diagnosis and post-treatment."

The NHS data indicate that women who increased their activity levels post-diagnosis had about 50% reductions in hazard ratios for CRC-specific mortality and overall mortality, while those who decreased their physical activity had increases in their hazard ratios.

A soon-to-be published analysis of data from the Health Professionals Follow-Up Study, involving 51,500 male health care practitioners, showed a similar pattern of reduced overall and CRC-associated mortality among the men with the highest levels of post-diagnosis physical activity, said Dr. Meyerhardt.

He noted that these studies are observational, and a prospective study is needed to confirm their findings. The Colon Health and Life-Long Exercise Change (CHALLENGE) trial is such a study that is expected to be published in several years. An Australian-Canadian collaborative effort, this controlled study will look at the impact of direct, guided exercise training interventions on clinical outcomes in patients with high-risk stage II and III CRC following surgery and adjuvant chemotherapy.

It is not yet known how exercise affects CRC, and cancer in general. Dr. Meyerhardt believes that the potential benefits may be partially attributable to the ability of exercise to modulate insulin metabolism. He noted that elevated insulin and insulin-like growth factors are predictive of increased CRC morbidity and mortality, as is elevation of C-peptide, another marker of insulin resistance.

Insulin resistance and all the metabolic changes that go with it may be a common factor between obesity and colorectal cancer. While not all studies have shown a direct correlation, there are data to suggest that a BMI over 30 kg/m2confers a 25% increase in risk of colorectal cancer recurrence and death.

‘With the rising incidence of obesity in the U.S., we are seeing more obese colorectal cancer patients," said Dr. Meyerhardt. "It used to be that only about 5% of colorectal cancer patients were obese. Now it’s roughly 10%."

He concluded that while there are many unanswered questions, there’s little harm and much potential good in recommending moderate regular physical activity for patients who have undergone surgery and adjuvant chemotherapy for colorectal cancer. Benefits increase if patients can shift toward a low-fat diet rich in vegetables and low in red meat and processed foods, he added.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

NEW YORK – A standardized extract of American ginseng (Panax quinquefolium) has been shown to be safe and effective in reducing the incidence and severity of acute respiratory infections among both community-dwelling and institutionalized elderly people.

However, the same product was not effective in decreasing respiratory infections among people with chronic lymphocytic leukemia (CLL), a condition that leaves patients particularly vulnerable to influenza and other acute respiratory infections (ARIs), reported Dr. Edward G. Shaw at an international conference sponsored by the Society for Integrative Oncology.

The promising findings from three studies among otherwise healthy elderly individuals led to the hope that this particular extract, known as CVT-E002 and marketed as an over-the-counter product called COLD-FX, might be similarly effective in patients with CLL, said Dr. Shaw of the Comprehensive Cancer Center, Wake Forest University, Winston-Salem, N.C.

CLL is the most common adult form of leukemia, affecting roughly 20/100,000 Americans. Because of the associated anemia, thrombocytopenia, and compromised immune system function, CLL survivors are at substantially increased risk of infections, especially respiratory infections. Common drug therapies like chlorambucil and fluorouracil increase this risk.

"There is a pressing need for effective, relatively low-cost interventions to reduce infection risk in CCL patients," Dr. Shaw said.

Panax ginseng is a reasonable botanical candidate for that job. Although it is indigenous to the United States and Canada, it is commonly used in traditional Chinese medicine and other Asian healing traditions. It is widely promoted as an immune system booster, and a number of preclinical and clinical studies support this claim.

The CVT-E002 extract, marketed by Afexa Life Sciences, is standardized to provide consistent doses of immunologically active compounds poly-furanosyl-pyranosyl-saccharides, which enhance natural killer cell activity, Dr. Shaw said. It is the only American ginseng extract that has been granted investigational new drug clearance by the U.S. Food and Drug Administration.

In 2004, Dr. Janet McElhaney of Eastern Virginia Medical School, Norfolk, published data from two studies of 89 and 109 people (mean age, 81 and 83.5 years, respectively) in nursing home and assisted living settings. The subjects were randomized to the ginseng extract (200 mg twice daily) or to placebo. The first trial lasted 8 weeks, and the second ran for 12. In both study cohorts, upward of 90% of the subjects had been vaccinated against influenza infections.

An episode of ARI was defined as two or more concurrent respiratory symptoms or one respiratory plus one constitutional symptom. Infectious diagnoses were confirmed by culture and serology.

Using an intent-to-treat analysis, Dr. McElhaney and her colleagues pooled the data from the two distinct trials. They found that lab-confirmed influenza was more common among the placebo group (seven cases in 101 subjects), compared with the ginseng-treated group (one case in 97 subjects). Incidence of influenza and respiratory syncytial virus infections combined was also higher in the placebo vs. the ginseng group (nine cases vs. one case). These differences were statistically significant (J. Am. Geriatr. Soc. 2004;52:13-9).

Interestingly, the investigators found no difference between the active treatment and placebo groups in terms of subjective reporting of ARI symptoms; roughly one-third of the people in each group reported ARI episodes, though the incidence of actual lab-confirmed infections was far lower.

Approximately 90% of the subjects in both groups reported adverse effects, the most common being gastrointestinal related. A total of 8% of the placebo group and 4% of the ginseng group required hospitalization, but none of these admissions was related to the study medications.

In 2006, Dr. McElhaney – now at the Center for Immunotherapy of Cancer and Infectious Diseases, University of Connecticut, Farmington – published a trial of the same COLD-FX ginseng formula vs. placebo in a cohort of 43 community-dwelling adults aged 65 years and older. As in the previous trial, the ginseng dose was two 200-mg extract capsules daily, for a period of 4 months. After the first month of the trial, all subjects in both groups were immunized against influenza.

The investigators observed a significant reduction in episodes of ARI during November and December, the closing months of the trial. Of the placebo-treated group, 62% had an ARI episode, compared with 32% among those taking the CV-E002 extract. Duration of symptoms was also considerably longer in the placebo group (12.6 days vs. 5.6 days). Lab confirmation of infection was not done in this study (J. Altern. Complement. Med. 2006;12:153-7).

Adverse effects were few in both groups, and there was no significant difference between them. All of these studies were funded in part by CV Technologies, the company that manufactures the CVT-E002 extract.

These data, along with positive results from a Canadian study (CMAJ 2005;173:1043-8), prompted the Wake Forest group to look at the potential of the ginseng extract to reduce infection risk in CLL patients.

A total of 293 untreated CLL patients were randomized to take COLD-FX, 200 mg twice daily, or matching placebo for 3 months. The patients were instructed to keep a daily record of ARI symptoms in written diaries and to rate their symptoms on a 0-3 scale of severity. Subjects also recorded activity limitations, episodes of fever, and antibiotic use.

The patients had a mean age in the mid-60s; 75% of the active treatment group and 78% of the placebo group had been vaccinated against influenza. The investigators excluded people with HIV, cirrhosis, cardiovascular disease, multiple sclerosis, other malignancies, and liver enzyme abnormalities. They also excluded people on immunomodulatory drugs, hematopoietic stem cell recipients, and those on corticosteroids, antibiotics, or warfarin.

Of all subjects, 53% had an ARI during the study period from January to March. On average, ARI days occurred at a rate of 0.1/patient-day. Put another way, 1 of every 10 days is an ARI day for these patients, Dr. Shaw explained. Since only about half of the subjects actually had ARIs, this means that for them 1 out of every 5 days is an ARI symptom day.

Overall, there were no major differences between the treatment and placebo groups in terms of the primary study end points. In the ginseng-treated group, 50% had at least one ARI episode, compared with 55% in the placebo group, but this difference was not statistically significant.

In terms of symptom duration, the ginseng group had a mean total of 8.9 ARI days vs. 6.9 days, but this difference was also deemed not statistically significant.

There were no differences in use of antibiotics or other secondary end points. While there was a trend toward lower incidence of moderate to severe ARIs in patients taking the ginseng supplement (31% vs. 39%), it did not reach significance.

In terms of adverse events, there were 13 "serious" episodes in the ginseng group versus 27 in the placebo group. Diarrhea, dizziness, hyperglycemia, and joint pain were among the most common reported adverse effects, but these were rare, and only 2 of the 40 episodes were considered "possibly related to the treatment."

Both the ginseng-treated and placebo-treated groups showed a mean increase in total white blood cells, with the increase being slightly higher in the placebo group. However, both groups showed a decrease in absolute neutrophil counts. Peripheral blood CD4 cell counts decreased in the active treatment group but increased in the placebo group. None of these differences were statistically or clinically significant.

The study was funded by the National Cancer Institute and Afexa Life Sciences.

The researchers said they did not know why the ginseng extract failed to produce the expected reductions in ARI among these CLL patients, but suggested that it may be a dosing issue. "We went with the dose used in the previous studies of healthy elderly, noncancer patients. It might not have been enough for CLL patients with impaired immune function." Dr. Shaw added that dose-escalation studies are in the works.

DENVER — Incorrect patient identification information is still the leading reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error.

Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted. The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

American College of Physicians, American College of Surgeons, American Medical Association, and the American Academy of Family Physicians have endorsed Project SwipeIT.

Dr. Lori Heim, AAFP president, attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Creating standards for transfer of ID card data into electronic health records will be critical for general success, she said. “In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Some have suggested implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. Dr. Heim said that she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

DENVER — Incorrect patient identification information is still the leading reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error.

Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted. The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

American College of Physicians, American College of Surgeons, American Medical Association, and the American Academy of Family Physicians have endorsed Project SwipeIT.

Dr. Lori Heim, AAFP president, attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Creating standards for transfer of ID card data into electronic health records will be critical for general success, she said. “In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Some have suggested implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. Dr. Heim said that she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

DENVER — Incorrect patient identification information is still the leading reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error.

Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted. The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

American College of Physicians, American College of Surgeons, American Medical Association, and the American Academy of Family Physicians have endorsed Project SwipeIT.

Dr. Lori Heim, AAFP president, attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Creating standards for transfer of ID card data into electronic health records will be critical for general success, she said. “In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Some have suggested implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. Dr. Heim said that she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at a meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said that one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process—for better or worse—is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D.

Vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II.

Source James E. Reinaker/Elsevier Global Medical News

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at a meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said that one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process—for better or worse—is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D.

Vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II.

Source James E. Reinaker/Elsevier Global Medical News

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at a meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said that one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process—for better or worse—is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D.

Vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II.

Source James E. Reinaker/Elsevier Global Medical News

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles and gift cards at the local coffee emporium. But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play, and the size of the rewards—which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs—underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said that they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country. Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Patti Clavier, manager of Intel Corporation's “Health For Life” program, said her company offers employees a $25 American Express gift card for scheduling a health check—getting a quick blood draw and blood-pressure check—and another $75 for completing a thorough online HRA developed by the Mayo Clinic. She estimated that the program costs Intel roughly $4 million per year, just for its U.S. employees. So far the company has not explored the more costly premium-based incentives.

Some companies find that paid time off is even more of an incentive than premium reductions or cash rewards.

“This is particularly true for higher-ranking employees who are already well compensated,” said Tanya Lewis-Walls, senior director of UnitedHealth Group's Clinical Solutions wellness program.

Cathy Murphy, vice president of human resources for Blue Shield of California, strongly agreed. Under its new WellVolution program, the insurer offers its employees a day off just for completing an HRA and undergoing some basic biometric testing. Ms. Murphy said 52% of all company employees have now taken advantage of this and credited a 200% increase in participation largely to the day-off incentive.

All that paid leave is no small expenditure for a company the size of the California Blue. She estimated that it cost the company $2 million last year. “It's a big commitment, but it is very important,” she said.

Ms. Lewis-Walls of UnitedHealth Group said that employees who achieve healthy weight goals can save their companies as much as $2,500 per year, on average, in reduced medical cost, absences, and lost productivity. Workers who quit smoking can save their bosses up to $3,500.

Still, advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health. But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per-employee, and getting bigger by the year.

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles and gift cards at the local coffee emporium. But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play, and the size of the rewards—which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs—underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said that they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country. Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Patti Clavier, manager of Intel Corporation's “Health For Life” program, said her company offers employees a $25 American Express gift card for scheduling a health check—getting a quick blood draw and blood-pressure check—and another $75 for completing a thorough online HRA developed by the Mayo Clinic. She estimated that the program costs Intel roughly $4 million per year, just for its U.S. employees. So far the company has not explored the more costly premium-based incentives.

Some companies find that paid time off is even more of an incentive than premium reductions or cash rewards.

“This is particularly true for higher-ranking employees who are already well compensated,” said Tanya Lewis-Walls, senior director of UnitedHealth Group's Clinical Solutions wellness program.

Cathy Murphy, vice president of human resources for Blue Shield of California, strongly agreed. Under its new WellVolution program, the insurer offers its employees a day off just for completing an HRA and undergoing some basic biometric testing. Ms. Murphy said 52% of all company employees have now taken advantage of this and credited a 200% increase in participation largely to the day-off incentive.

All that paid leave is no small expenditure for a company the size of the California Blue. She estimated that it cost the company $2 million last year. “It's a big commitment, but it is very important,” she said.

Ms. Lewis-Walls of UnitedHealth Group said that employees who achieve healthy weight goals can save their companies as much as $2,500 per year, on average, in reduced medical cost, absences, and lost productivity. Workers who quit smoking can save their bosses up to $3,500.

Still, advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health. But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per-employee, and getting bigger by the year.

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles and gift cards at the local coffee emporium. But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play, and the size of the rewards—which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs—underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said that they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country. Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Patti Clavier, manager of Intel Corporation's “Health For Life” program, said her company offers employees a $25 American Express gift card for scheduling a health check—getting a quick blood draw and blood-pressure check—and another $75 for completing a thorough online HRA developed by the Mayo Clinic. She estimated that the program costs Intel roughly $4 million per year, just for its U.S. employees. So far the company has not explored the more costly premium-based incentives.

Some companies find that paid time off is even more of an incentive than premium reductions or cash rewards.

“This is particularly true for higher-ranking employees who are already well compensated,” said Tanya Lewis-Walls, senior director of UnitedHealth Group's Clinical Solutions wellness program.

Cathy Murphy, vice president of human resources for Blue Shield of California, strongly agreed. Under its new WellVolution program, the insurer offers its employees a day off just for completing an HRA and undergoing some basic biometric testing. Ms. Murphy said 52% of all company employees have now taken advantage of this and credited a 200% increase in participation largely to the day-off incentive.

All that paid leave is no small expenditure for a company the size of the California Blue. She estimated that it cost the company $2 million last year. “It's a big commitment, but it is very important,” she said.

Ms. Lewis-Walls of UnitedHealth Group said that employees who achieve healthy weight goals can save their companies as much as $2,500 per year, on average, in reduced medical cost, absences, and lost productivity. Workers who quit smoking can save their bosses up to $3,500.

Still, advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health. But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per-employee, and getting bigger by the year.

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, president of the American Academy of Family Physicians. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability. “It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

Implementation costs should be borne by insurers, who have much to gain by digitizing transactions.

Source DR. HEIM

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, president of the American Academy of Family Physicians. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability. “It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

Implementation costs should be borne by insurers, who have much to gain by digitizing transactions.

Source DR. HEIM

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change that. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy. Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, president of the American Academy of Family Physicians. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability. “It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards. And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

Implementation costs should be borne by insurers, who have much to gain by digitizing transactions.

Source DR. HEIM

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles, and gift cards at the local coffee emporium.

But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play and the size of the rewards–which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs–underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for a wide array of goodies–fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country.

Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health.

But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per employee, and getting bigger by the year.

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles, and gift cards at the local coffee emporium.

But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play and the size of the rewards–which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs–underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for a wide array of goodies–fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country.

Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health.

But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per employee, and getting bigger by the year.

If you want to see the impact that health care costs have had on corporate America, just take a look at the measures some companies are taking to encourage employee health.

Paid leave, reduced insurance copayments and premium shares, as well as straight cash rewards are among the inducements corporations now offer employees who participate in company-sponsored wellness programs centered on weight loss, smoking cessation, healthy eating, and ongoing management of chronic diseases.

When corporate wellness programs first emerged 2 decades ago, companies hoped that they would be able to woo participants with the promise of better health, and inexpensive gifts like T-shirts, baseball caps, backpacks, emblazoned water bottles, and gift cards at the local coffee emporium.

But the tchotchke era is over, according to leaders in the field, who spoke at a conference on wellness programs sponsored by the World Research Group.

These days, CEOs who want widespread employee participation in wellness programs are putting real money on the table. The myriad incentive programs now in play and the size of the rewards–which can reach thousands of dollars per employee per year on top of the basic costs of implementing the wellness programs–underscore the lengths some companies are willing to go to get their people healthy.

The first step in most corporate wellness plans is an employee-completed health risk assessment (HRA), a tool used to identify employees' risk for diabetes, heart disease, cancer and other serious diseases, and to guide nutrition and fitness plans aimed at prevention.

Some companies are offering cash incentives just for completing the HRA. For larger companies, that can become a significant line item.

A WebMD survey of more than 20,000 employees participating in corporate wellness plans at eight U.S. companies shows that when it comes to inducements, employee expectations are high, according to Larry Chapman, senior vice president of WebMD Health Services.

Almost half (49%) of respondents said their preferred incentive was a lower monthly health insurance premium, something Mr. Chapman said more companies are beginning to offer. Thirty-three percent said they preferred cash rewards. Gift cards were favored by 9%, and 1% said they would respond to logo-imprinted merchandise.

“Premium reductions are the most highly valued incentives by employees, and these incentives should be linked to the open enrollment process whenever possible,” Mr. Chapman said.

He added that corporate leaders have learned some hard lessons in their 20 years' experience with wellness plans. For one, they have learned what many physicians could have told them: Most people are not intrinsically motivated to improve their health, and it takes a combination of carrots and sticks.

They also are learning how to create meaningful incentives by listening to their employees' wishes, which usually come down to time and money. Lastly, they are learning that healthy behaviors don't occur in a vacuum, and they don't just happen. They're part of a culture of health that involves community and family outreach.

The challenge for employers, according to Stuart Slutsky, chief marketing officer for Vitality Health Engagement Systems, is to right-size the incentives and link them to behaviors that will ultimately lead to net reductions in overall health care spending. Mr. Slutsky's firm provides wellness programs under contract to large corporations and serves over 1.5 million employees across the globe.

The Vitality program offers employees multiple chances to earn employer-subsidized “Vitality Bucks” that can be redeemed for a wide array of goodies–fitness club memberships, hotel accommodations, airfares, movie passes, sporting goods, home entertainment technology, and more. It's akin to a frequent flyer program: The more an employee engages in ongoing health-promoting practices, the more Vitality Bucks he or she earns.

The Kellogg Company, as part of an effort to return to its roots as a health and nutrition company, has one of the most comprehensive and proactive corporate wellness programs in the country.

Employees have opportunities to shave up to $1,100 per year off their health insurance premiums if they complete an HRA, demonstrate that they are non-smokers (or participate in a cessation program), and engage in other healthy lifestyle change, according to David Tanis, one of the company's health promotion specialists.

Kellogg's employees have opportunities to earn additional rewards for getting vaccinated against influenza, meeting weight loss goals, participating in health coaching programs, and taking part in company fitness challenges.

Advocates for corporate wellness programs acknowledge that they can be a tough sell, especially in a down economy. No one would dispute the human benefit of improving worker health.

But the hoped-for cost-savings are realized over the long term, and on an aggregate population, while the actual costs of implementing and incentivizing a wellness program are immediate, per employee, and getting bigger by the year.

Data are lacking on the adverse events that potentially can arise from the millions of people taking nutritional supplements along with pharmaceuticals, but researchers are making some headway in sorting the real causes for concern from the unfounded worries.

Many of the red flags physicians hear about are little more than isolated and unverified case reports that someone has called in to a regulatory agency, according to Philip Gregory, Pharm.D., assistant professor of pharmacy practice at Creighton University's Center for Drug Information and Evidence-Based Practice in Omaha, Neb.

With its limited resources, the Food and Drug Administration investigates a potential adverse event or interaction only if there are multiple reports, clustered in time, that practically scream for attention, he said.

It was only recently that the FDA mandated supplement companies to put adverse event reporting phone numbers on product labels. In reality, most companies have not yet complied, so adverse event and interaction surveillance is spotty, he noted at a meeting sponsored by the Scripps Center for Integrative Medicine.

Nonetheless, Dr. Gregory, editor of the Natural Medicines Comprehensive Database, and his team of researchers there have identified a number of significant concerns, and also exonerated herbs or nutrients that have been unduly vilified. They have screened tens of thousands of published and unpublished research reports, surveys, and regulatory alerts worldwide in an effort to help physicians figure out which potential interactions and adverse events warrant serious attention. Dr. Gregory highlighted a few of their findings:

▸ Bitter orange and cardiovascular effects. Also known as Citrus aurantium and Fructus aurantii, bitter orange has been used in traditional Chinese medicine for hundreds of years in herbal decoctions used to treat digestive problems. More recently, it has become a common ingredient in weight loss and energy supplements, owing to its stimulant and thermogenic properties. The popularity of bitter orange has soared over the past few years, following the FDA's ban on the herb ephedra.

This fruit contains high levels of synephrine, sometimes as much as 30%, and if used in an indiscriminate way can induce the same adverse effects as ephedra, including arrhythmias, ischemic stroke, syncope, QT interval prolongation, myocardial infarction, rhabdomyolysis, and ischemic colitis.

Reports of these problems are exceedingly rare, and in some cases they occurred in people taking bitter orange with other stimulants such as caffeine and the popular South American herb, guarana, Dr. Gregory said.

But given the seriousness of these potential side effects, physicians should discourage patients from using this herb for weight loss. “The risks outweigh the potential benefits, in my mind,” he said.

Be aware that some products containing bitter orange are promoted as “ephedra free,” leading consumers to believe that they're getting a safer alternative. Although these products may technically be free of ephedra, they're not necessarily free of ephedralike risks.

▸ Glucosamine and chondroitin plus warfarin. Several years ago, there was a widely publicized case report of bleeding and bruising in a patient on warfarin who also was taking this popular combination as an arthritis remedy. Since then, there have been 40 reports to the FDA and the World Health Organization of interactions between warfarin and glucosamine alone or between warfarin and the glucosamine/chondroitin combination.

On closer examination of the reports, most involved individuals taking very high doses of the supplement, in some cases up to six times the recommended dose.

“It is probably not a real problem in people who take the recommended doses of glucosamine/chondroitin, but patients taking warfarin should be careful,” he said, adding that this message holds true for almost any drug or supplement added on top of warfarin.

Glucosamine has a “heparinoid” structure, which could explain a plausible mechanism for a mild anticoagulant effect, but data to support this notion are pretty weak, Dr. Gregory noted. Another possible explanation is that the supplement somehow modifies gastrointestinal tract flora, thus altering warfarin pharmacokinetics, but again, this is theoretical.

▸ Calcium and cardiovascular risk. Findings from a large study suggested that older women taking more than 1 g/day of calcium citrate had a twofold increase in myocardial infarctions and significant increases in coronary artery calcification over a 5-year period (BMJ 2008;336:262–6).

These are worrisome findings, given how many postmenopausal women are taking calcium to prevent or attenuate osteoporosis, but this study was riddled with confounding variables and unanswered questions that make it difficult to draw a firm conclusion that calcium is problematic, Dr. Gregory said.

The study gives no data on the patients' magnesium levels, and since calcium and magnesium are antagonistic, the problems observed in the study may reflect the fact that patients were given unopposed calcium without mitigation from magnesium. In those with already low baseline magnesium, that could be dangerous.

The observed increase in heart problems also may be related to low levels of vitamin D and vitamin K, which play a role in calcium metabolism and bone formation, he suggested.

“This study is an alert, not absolute proof, and the finding has not shown up in other calcium studies. So it is not appropriate to conclude that calcium is causing the problem. Do not dissuade patients from taking calcium, but don't overdo it: 1,200 mg/day is fine.” He added that it's a very good idea to make sure patients are also getting enough magnesium.

▸ Selenium and type 2 diabetes. Selenium has been recommended as a possible preventive for several different conditions, including Alzheimer's disease, prostate cancer (though its merits in this context were challenged by the Selenium and Vitamin E Cancer Prevention Trial [SELECT]), and type 2 diabetes. The latter recommendation is based on epidemiologic data showing a strong inverse correlation between incidence of diabetes and selenium intake.

But a secondary analysis of data from the Nutritional Prevention of Cancer Trial indicated that individuals taking 200 mcg of supplemental selenium daily had a significant increase of type 2 diabetes over an 8-year period (Ann. Intern. Med. 2007;147:217–23).

This unexpected finding was corroborated by SELECT, which also showed an increased rate of diabetes in those taking selenium alone, though the difference was not statistically significant.

Complicating matters, there was no diabetes increase in SELECT among patients taking selenium plus vitamin E, compared with those taking placebo. In fact, the incidence actually went down slightly, though, again, the difference was not significant.

“When selenium is taken by itself, it may be oxidative rather than antioxidative. So taking high doses of selenium or any other independent antioxidant may not be so healthy,” Dr. Gregory hypothesized. He added that selenium may also stimulate glucagon release.

Though the picture is hardly clear, he advised against recommending selenium alone, especially for individuals prone to insulin resistance and diabetes. “The diabetes finding is a signal. We can't draw definitive conclusions from it, but we do need to be aware of it,” he concluded.

Dr. Gregory reported having no financial conflicts of interest related to his presentation.

Glucosamine should be used with care by patients also taking warfarin.

Source ©Lamiel/Istockphoto.com

Data are lacking on the adverse events that potentially can arise from the millions of people taking nutritional supplements along with pharmaceuticals, but researchers are making some headway in sorting the real causes for concern from the unfounded worries.

Many of the red flags physicians hear about are little more than isolated and unverified case reports that someone has called in to a regulatory agency, according to Philip Gregory, Pharm.D., assistant professor of pharmacy practice at Creighton University's Center for Drug Information and Evidence-Based Practice in Omaha, Neb.

With its limited resources, the Food and Drug Administration investigates a potential adverse event or interaction only if there are multiple reports, clustered in time, that practically scream for attention, he said.

It was only recently that the FDA mandated supplement companies to put adverse event reporting phone numbers on product labels. In reality, most companies have not yet complied, so adverse event and interaction surveillance is spotty, he noted at a meeting sponsored by the Scripps Center for Integrative Medicine.

Nonetheless, Dr. Gregory, editor of the Natural Medicines Comprehensive Database, and his team of researchers there have identified a number of significant concerns, and also exonerated herbs or nutrients that have been unduly vilified. They have screened tens of thousands of published and unpublished research reports, surveys, and regulatory alerts worldwide in an effort to help physicians figure out which potential interactions and adverse events warrant serious attention. Dr. Gregory highlighted a few of their findings:

▸ Bitter orange and cardiovascular effects. Also known as Citrus aurantium and Fructus aurantii, bitter orange has been used in traditional Chinese medicine for hundreds of years in herbal decoctions used to treat digestive problems. More recently, it has become a common ingredient in weight loss and energy supplements, owing to its stimulant and thermogenic properties. The popularity of bitter orange has soared over the past few years, following the FDA's ban on the herb ephedra.

This fruit contains high levels of synephrine, sometimes as much as 30%, and if used in an indiscriminate way can induce the same adverse effects as ephedra, including arrhythmias, ischemic stroke, syncope, QT interval prolongation, myocardial infarction, rhabdomyolysis, and ischemic colitis.

Reports of these problems are exceedingly rare, and in some cases they occurred in people taking bitter orange with other stimulants such as caffeine and the popular South American herb, guarana, Dr. Gregory said.

But given the seriousness of these potential side effects, physicians should discourage patients from using this herb for weight loss. “The risks outweigh the potential benefits, in my mind,” he said.

Be aware that some products containing bitter orange are promoted as “ephedra free,” leading consumers to believe that they're getting a safer alternative. Although these products may technically be free of ephedra, they're not necessarily free of ephedralike risks.

▸ Glucosamine and chondroitin plus warfarin. Several years ago, there was a widely publicized case report of bleeding and bruising in a patient on warfarin who also was taking this popular combination as an arthritis remedy. Since then, there have been 40 reports to the FDA and the World Health Organization of interactions between warfarin and glucosamine alone or between warfarin and the glucosamine/chondroitin combination.

On closer examination of the reports, most involved individuals taking very high doses of the supplement, in some cases up to six times the recommended dose.

“It is probably not a real problem in people who take the recommended doses of glucosamine/chondroitin, but patients taking warfarin should be careful,” he said, adding that this message holds true for almost any drug or supplement added on top of warfarin.

Glucosamine has a “heparinoid” structure, which could explain a plausible mechanism for a mild anticoagulant effect, but data to support this notion are pretty weak, Dr. Gregory noted. Another possible explanation is that the supplement somehow modifies gastrointestinal tract flora, thus altering warfarin pharmacokinetics, but again, this is theoretical.

▸ Calcium and cardiovascular risk. Findings from a large study suggested that older women taking more than 1 g/day of calcium citrate had a twofold increase in myocardial infarctions and significant increases in coronary artery calcification over a 5-year period (BMJ 2008;336:262–6).

These are worrisome findings, given how many postmenopausal women are taking calcium to prevent or attenuate osteoporosis, but this study was riddled with confounding variables and unanswered questions that make it difficult to draw a firm conclusion that calcium is problematic, Dr. Gregory said.

The study gives no data on the patients' magnesium levels, and since calcium and magnesium are antagonistic, the problems observed in the study may reflect the fact that patients were given unopposed calcium without mitigation from magnesium. In those with already low baseline magnesium, that could be dangerous.

The observed increase in heart problems also may be related to low levels of vitamin D and vitamin K, which play a role in calcium metabolism and bone formation, he suggested.

“This study is an alert, not absolute proof, and the finding has not shown up in other calcium studies. So it is not appropriate to conclude that calcium is causing the problem. Do not dissuade patients from taking calcium, but don't overdo it: 1,200 mg/day is fine.” He added that it's a very good idea to make sure patients are also getting enough magnesium.

▸ Selenium and type 2 diabetes. Selenium has been recommended as a possible preventive for several different conditions, including Alzheimer's disease, prostate cancer (though its merits in this context were challenged by the Selenium and Vitamin E Cancer Prevention Trial [SELECT]), and type 2 diabetes. The latter recommendation is based on epidemiologic data showing a strong inverse correlation between incidence of diabetes and selenium intake.

But a secondary analysis of data from the Nutritional Prevention of Cancer Trial indicated that individuals taking 200 mcg of supplemental selenium daily had a significant increase of type 2 diabetes over an 8-year period (Ann. Intern. Med. 2007;147:217–23).

This unexpected finding was corroborated by SELECT, which also showed an increased rate of diabetes in those taking selenium alone, though the difference was not statistically significant.

Complicating matters, there was no diabetes increase in SELECT among patients taking selenium plus vitamin E, compared with those taking placebo. In fact, the incidence actually went down slightly, though, again, the difference was not significant.

“When selenium is taken by itself, it may be oxidative rather than antioxidative. So taking high doses of selenium or any other independent antioxidant may not be so healthy,” Dr. Gregory hypothesized. He added that selenium may also stimulate glucagon release.

Though the picture is hardly clear, he advised against recommending selenium alone, especially for individuals prone to insulin resistance and diabetes. “The diabetes finding is a signal. We can't draw definitive conclusions from it, but we do need to be aware of it,” he concluded.

Dr. Gregory reported having no financial conflicts of interest related to his presentation.

Glucosamine should be used with care by patients also taking warfarin.

Source ©Lamiel/Istockphoto.com

Data are lacking on the adverse events that potentially can arise from the millions of people taking nutritional supplements along with pharmaceuticals, but researchers are making some headway in sorting the real causes for concern from the unfounded worries.

Many of the red flags physicians hear about are little more than isolated and unverified case reports that someone has called in to a regulatory agency, according to Philip Gregory, Pharm.D., assistant professor of pharmacy practice at Creighton University's Center for Drug Information and Evidence-Based Practice in Omaha, Neb.

With its limited resources, the Food and Drug Administration investigates a potential adverse event or interaction only if there are multiple reports, clustered in time, that practically scream for attention, he said.

It was only recently that the FDA mandated supplement companies to put adverse event reporting phone numbers on product labels. In reality, most companies have not yet complied, so adverse event and interaction surveillance is spotty, he noted at a meeting sponsored by the Scripps Center for Integrative Medicine.

Nonetheless, Dr. Gregory, editor of the Natural Medicines Comprehensive Database, and his team of researchers there have identified a number of significant concerns, and also exonerated herbs or nutrients that have been unduly vilified. They have screened tens of thousands of published and unpublished research reports, surveys, and regulatory alerts worldwide in an effort to help physicians figure out which potential interactions and adverse events warrant serious attention. Dr. Gregory highlighted a few of their findings:

▸ Bitter orange and cardiovascular effects. Also known as Citrus aurantium and Fructus aurantii, bitter orange has been used in traditional Chinese medicine for hundreds of years in herbal decoctions used to treat digestive problems. More recently, it has become a common ingredient in weight loss and energy supplements, owing to its stimulant and thermogenic properties. The popularity of bitter orange has soared over the past few years, following the FDA's ban on the herb ephedra.

This fruit contains high levels of synephrine, sometimes as much as 30%, and if used in an indiscriminate way can induce the same adverse effects as ephedra, including arrhythmias, ischemic stroke, syncope, QT interval prolongation, myocardial infarction, rhabdomyolysis, and ischemic colitis.

Reports of these problems are exceedingly rare, and in some cases they occurred in people taking bitter orange with other stimulants such as caffeine and the popular South American herb, guarana, Dr. Gregory said.

But given the seriousness of these potential side effects, physicians should discourage patients from using this herb for weight loss. “The risks outweigh the potential benefits, in my mind,” he said.

Be aware that some products containing bitter orange are promoted as “ephedra free,” leading consumers to believe that they're getting a safer alternative. Although these products may technically be free of ephedra, they're not necessarily free of ephedralike risks.

▸ Glucosamine and chondroitin plus warfarin. Several years ago, there was a widely publicized case report of bleeding and bruising in a patient on warfarin who also was taking this popular combination as an arthritis remedy. Since then, there have been 40 reports to the FDA and the World Health Organization of interactions between warfarin and glucosamine alone or between warfarin and the glucosamine/chondroitin combination.

On closer examination of the reports, most involved individuals taking very high doses of the supplement, in some cases up to six times the recommended dose.

“It is probably not a real problem in people who take the recommended doses of glucosamine/chondroitin, but patients taking warfarin should be careful,” he said, adding that this message holds true for almost any drug or supplement added on top of warfarin.

Glucosamine has a “heparinoid” structure, which could explain a plausible mechanism for a mild anticoagulant effect, but data to support this notion are pretty weak, Dr. Gregory noted. Another possible explanation is that the supplement somehow modifies gastrointestinal tract flora, thus altering warfarin pharmacokinetics, but again, this is theoretical.

▸ Calcium and cardiovascular risk. Findings from a large study suggested that older women taking more than 1 g/day of calcium citrate had a twofold increase in myocardial infarctions and significant increases in coronary artery calcification over a 5-year period (BMJ 2008;336:262–6).

These are worrisome findings, given how many postmenopausal women are taking calcium to prevent or attenuate osteoporosis, but this study was riddled with confounding variables and unanswered questions that make it difficult to draw a firm conclusion that calcium is problematic, Dr. Gregory said.

The study gives no data on the patients' magnesium levels, and since calcium and magnesium are antagonistic, the problems observed in the study may reflect the fact that patients were given unopposed calcium without mitigation from magnesium. In those with already low baseline magnesium, that could be dangerous.

The observed increase in heart problems also may be related to low levels of vitamin D and vitamin K, which play a role in calcium metabolism and bone formation, he suggested.

“This study is an alert, not absolute proof, and the finding has not shown up in other calcium studies. So it is not appropriate to conclude that calcium is causing the problem. Do not dissuade patients from taking calcium, but don't overdo it: 1,200 mg/day is fine.” He added that it's a very good idea to make sure patients are also getting enough magnesium.

▸ Selenium and type 2 diabetes. Selenium has been recommended as a possible preventive for several different conditions, including Alzheimer's disease, prostate cancer (though its merits in this context were challenged by the Selenium and Vitamin E Cancer Prevention Trial [SELECT]), and type 2 diabetes. The latter recommendation is based on epidemiologic data showing a strong inverse correlation between incidence of diabetes and selenium intake.

But a secondary analysis of data from the Nutritional Prevention of Cancer Trial indicated that individuals taking 200 mcg of supplemental selenium daily had a significant increase of type 2 diabetes over an 8-year period (Ann. Intern. Med. 2007;147:217–23).

This unexpected finding was corroborated by SELECT, which also showed an increased rate of diabetes in those taking selenium alone, though the difference was not statistically significant.

Complicating matters, there was no diabetes increase in SELECT among patients taking selenium plus vitamin E, compared with those taking placebo. In fact, the incidence actually went down slightly, though, again, the difference was not significant.

“When selenium is taken by itself, it may be oxidative rather than antioxidative. So taking high doses of selenium or any other independent antioxidant may not be so healthy,” Dr. Gregory hypothesized. He added that selenium may also stimulate glucagon release.

Though the picture is hardly clear, he advised against recommending selenium alone, especially for individuals prone to insulin resistance and diabetes. “The diabetes finding is a signal. We can't draw definitive conclusions from it, but we do need to be aware of it,” he concluded.

Dr. Gregory reported having no financial conflicts of interest related to his presentation.

Glucosamine should be used with care by patients also taking warfarin.

Source ©Lamiel/Istockphoto.com

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change the situation. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy.

Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

The American College of Physicians is one of many physician groups that have endorsed Project SwipeIT. Others include the American Academy of Family Physicians, American College of Surgeons, and American Medical Association.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, AAFP president. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards.

And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

But she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

'There's no reason we shouldn't have machine-readable cards at this point.'

Source DR. HEIM

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change the situation. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy.

Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

The American College of Physicians is one of many physician groups that have endorsed Project SwipeIT. Others include the American Academy of Family Physicians, American College of Surgeons, and American Medical Association.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, AAFP president. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards.

And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

But she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

'There's no reason we shouldn't have machine-readable cards at this point.'

Source DR. HEIM

DENVER — Incorrect patient identification information is still the No. 1 reason for rejected insurance claims, and the majority of these errors—which cost the nation an estimated $2.2 billion in administrative waste—reflect the failure of the health care industry to embrace standardized, machine-readable magnetic ID cards.

The Medical Group Management Association (MGMA) is hoping to change the situation. Last year, it launched Project SwipeIT, a national, multistakeholder effort to push for full implementation of magnetic insurance ID cards in all public and private health insurance plans.

In its first year, Project SwipeIT garnered pledges of support from more than 1,000 physicians' organizations, insurance companies, and health information technology vendors who vow to issue, support, or accept machine-readable ID cards.

Standards for magnetic insurance ID cards were first developed in 1997. Yet today, health care transactions are still almost entirely dependent on paper or plastic ID cards. Each insurance company has its own card design and format, some of which can be difficult to read or copy.

Stapling a photocopy of a patient's ID card into the medical chart or manually key-stroking information into the patient's record is still the norm in nearly all medical practices.

Reliance on paper-to-paper transfer of identifying information leaves a lot of room for error. Numerals are easily mistaken, names misspelled, benefits changed, and expiration dates unnoted.

The MGMA estimates that 98% of all claims generated by physicians' offices are not electronic, and approximately 5% of those claims are rejected because of incorrect ID information, leading to long and costly delays in physician reimbursement.

On average, it takes roughly 15 minutes of staff time to manually correct and resubmit an erroneous claim once the error has been identified.

The MGMA estimates that outpatient physicians nationwide could save as much as $290 million per year if all insurers used swipe cards in compliance with standards developed by the Workgroup for Electronic Data Interchange.

The American College of Physicians is one of many physician groups that have endorsed Project SwipeIT. Others include the American Academy of Family Physicians, American College of Surgeons, and American Medical Association.

“There's no reason we shouldn't have machine-readable cards at this point,” said Dr. Lori Heim, AAFP president. “We are very supportive of this project.”

Dr. Heim attributed the failure to adopt swipeable ID cards to “procedural inertia.” Though standards for creation of cards have been in place for more than a decade, it has taken more time to develop standards for reader devices, interfaces between card readers and electronic health record systems, and platforms for interoperability.

“It is reflective of the broader problems we've seen regarding the adoption of health care [information technology] in general,” she said in an interview.

Without strong consensus and commitment from all major insurers—or an unequivocal federal mandate—individual plans have been unwilling to take the first steps and implement their own swipe cards.

And if the plans weren't going there, neither would physicians, even though both parties stand to gain.

Dr. Heim said that creating standards for transfer of ID card data into electronic health records will be critical for general success. “It's a complex issue because there are so many different EHR systems, and each has its own setup. In order to realize the savings potential, we need the patient ID information to transfer smoothly from the card reader to the right places in the EHR.”

Like any other technological innovation, implementation of swipe cards will carry some upfront costs for purchase and installation of card readers and production of the cards themselves. The question of who should bear those costs is an open one at this point.

According to the MGMA, card readers cost around $200 per clinic, and the software upgrades needed to interface card readers with electronic practice management systems are minimal.

Dr. Heim said that she believes the implementation costs should be borne by insurers, who have much to gain by digitizing transactions and reducing errors. “It would significantly reduce the amount of money they have to pay to people for spending time on the phone working out disputes with doctors' offices.”

But she will not be surprised if the insurance industry tries to put all or some of that cost on the shoulders of physicians and hospitals. “We will definitely push back on that,” she promised.

In 2010, the MGMA and its partners plan to become more active in pushing the Project SwipeIT agenda. According to the group's Web site, the second phase of the project involves publicly recognizing payers that have met their pledges and issued standardized, machine-readable health ID cards, while publicly identifying those that have not.

'There's no reason we shouldn't have machine-readable cards at this point.'

Source DR. HEIM

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and dietary supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process, for better or worse, is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome. The observation that the mineral might reduce risk was a “by the way” finding that might have been misleading, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years' of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-Based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-Based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D. Some of these reviews were mandated by Congress. Completed reports can be found at www.ahrq.gov/clinic/epcindex.htm

Negative studies are a fact of life in science, he added. Although it may seem like supplements are being treated unfairly, the reality is that a lot of pharmaceutical studies are negative, too.

“Most things don't work all the time. In the case of St. John's wort, there was a study a few years ago showing that it doesn't work well in mild to moderate depression. That simply puts it in the company of most antidepressant drugs, which don't work 50% of the time.”

The recent vitamin E/C combination trial had its roots in population studies.

Source James E. Reinaker/Elsevier Global Medical News

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and dietary supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process, for better or worse, is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome. The observation that the mineral might reduce risk was a “by the way” finding that might have been misleading, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years' of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-Based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-Based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D. Some of these reviews were mandated by Congress. Completed reports can be found at www.ahrq.gov/clinic/epcindex.htm

Negative studies are a fact of life in science, he added. Although it may seem like supplements are being treated unfairly, the reality is that a lot of pharmaceutical studies are negative, too.

“Most things don't work all the time. In the case of St. John's wort, there was a study a few years ago showing that it doesn't work well in mild to moderate depression. That simply puts it in the company of most antidepressant drugs, which don't work 50% of the time.”

The recent vitamin E/C combination trial had its roots in population studies.

Source James E. Reinaker/Elsevier Global Medical News

There seems to be a predictable pattern in nutritional supplement research: Epidemiologic or observational studies suggest that a particular nutrient or botanical might prevent or ameliorate a common chronic disorder, preclinical work describes a plausible physiologic mechanism, and small clinical studies give encouraging findings.

Then the National Institutes of Health or another major research establishment funds a large-scale “definitive trial,” and the data come up equivocal at best, negative at worst.

Over the last year or two, several disappointing nutritional/botanical studies have been reported. For example, vitamins C and E failed to reduce cardiovascular disease risk in the Physicians' Health Study II (JAMA 2008;300:2123–33); selenium and vitamin E did not lower prostate cancer risk in the SELECT trial (JAMA 2009;301:39–51); and ginkgo biloba did not prevent dementia or Alzheimer's disease in the elderly in the GEM trial (JAMA 2008;300:2253–62).

So why do big trials often return negative results when preliminary work looks positive? Is the epidemiology wrong to begin with, or were the trials improperly conducted? Are researchers and trial designs biased against natural products? Are the pilot trials biased in favor?

“Some people in the supplements world take umbrage at randomized, controlled trials. But it is not impossible to do good RCTs with nutrients, and it doesn't mean that negative results are wrong,” Paul M. Coates, Ph.D., director of the Office of Dietary Supplements (ODS) at the National Institutes of Health, said in an interview. “The RCT worked pretty well to document the impact of folic acid in preventing neural tube defects. No one seems to question the study design when the data are positive.”

Still, he acknowledged that the wave of negative studies does raise suspicion that researchers are not asking the right questions, or that epidemiologic signals engender unrealistic expectations.

“Epidemiological and observational studies cannot give cause-and-effect proof. They do provide clues about where to look. If the signals are strong enough, those clues should be followed and tested,” said Dr. Coates, whose job is to set the agenda for NIH-funded nutraceutical research.

Public interest in nutrition, botanicals, and dietary supplements is strong, as is physicians' need for scientific guidance, Dr. Coats said at meeting sponsored by the Scripps Center for Integrative Medicine.

Solid evidence-based recommendations for dietary supplements are rare. Dr. Coates said one of his primary responsibilities is to look closely at those unknowns and establish priorities based on public health needs. This process, for better or worse, is driven by epidemiology.

The recent vitamin E/C combination trial had its roots in population studies looking at heart disease risk in people with high versus low levels of serum markers of various vitamins, he explained. This led to trials designed around two of the possibly relevant nutrients. “We have to recognize that once we move to an intervention design, we cannot include everything that might be relevant,” he said.

In the widely anticipated SELECT trial, the impetus for studying selenium in prostate cancer came from an earlier selenium study that did not have prostate effects as a primary outcome. The observation that the mineral might reduce risk was a “by the way” finding that might have been misleading, according to Dr. Coates.

Part of the problem in designing supplement trials is that researchers and the public often expect nutrients or botanicals to behave like drugs, with big, discrete, and easily detected benefits in a broad range of people. But nutrients and botanicals are not pharmaceuticals, and Dr. Coates said that he thinks expectations may be unrealistic.

Generally speaking, few people in the United States have frank nutrient deficiencies (such as scurvy, rickets, or beriberi), so supplementation seldom results in dramatic effects.

Using vitamin C as an example, he said that although many people fail to get optimal amounts, few have scurvy. “If you give a lot of vitamin C to people who are more or less replete, you may not see much effect. The net effect was basically zero in the Physicians' Health Study II. It's going to be hard to see a strong signal because the effect size [on heart disease] is probably small to begin with, and the level of 'noise' is high.”

Nutrients exert subtle, nonspecific effects on multiple physiologic pathways, rather than strong effects on a relatively small number of pathways, which is how pharmaceuticals work, Jeffrey Bland, Ph.D., said at the conference. But many of the large-scale NIH-funded trials are premised on single-pathway thinking.

Future NIH trials should make greater use of the emerging science of nutrigenomics, which looks at how various nutrients and combinations of nutrients influence gene expression, suggested Dr. Bland, cofounder of the Institute for Functional Medicine, based in Gig Harbor, Wash. The larger trials would also be more clinically applicable if they controlled for or reported on variables like participants' diets, oxidative stress status, and genetic predispositions for various metabolic states.

Beyond the domain of averting frank deficiencies, the effect of any given nutrient is largely determined by individual factors, such as how well someone digests and absorbs the nutrients, what nutrient-depleting or nutrient-blocking drugs are in a person's system, and individual capacities to metabolize particular nutrients, Dr. Bland continued. Nutrition is definitely not a one-size-fits-all proposition, he stressed.

High-profile government-funded studies understandably carry a lot of weight with physicians, said Dr. Mary Hardy, medical director of the Center for Integrative Oncology at the University of California, Los Angeles. But all too often, “we just run with the top-line findings, and miss secondary but important signals.” Although the SELECT study did not show the hoped-for prostate protective benefit, it did show there were no major selenium-associated adverse effects after 6 years' of continuous use, she pointed out, which is reassuring for anyone taking this mineral for other purposes.

Currently, the ODS is working with the federal Agency for Healthcare Research and Quality (AHRQ) and AHRQ's Evidence-Based Practice Centers to conduct a series of meta-analyses and systematic reviews, Dr. Coates said. Of the role of the ODS, Dr. Coates said, “We set the questions, and then we walk away. The Evidence-Based Practice Centers do the actual reviews.”

Future reviews will look at chromium and insulin sensitivity; omega-3s for cardiovascular disease prevention; the effects of soy, B vitamins, and antioxidant phytochemicals on neurodegenerative diseases; and the health effects of vitamin D. Some of these reviews were mandated by Congress. Completed reports can be found at www.ahrq.gov/clinic/epcindex.htm

Negative studies are a fact of life in science, he added. Although it may seem like supplements are being treated unfairly, the reality is that a lot of pharmaceutical studies are negative, too.

“Most things don't work all the time. In the case of St. John's wort, there was a study a few years ago showing that it doesn't work well in mild to moderate depression. That simply puts it in the company of most antidepressant drugs, which don't work 50% of the time.”

The recent vitamin E/C combination trial had its roots in population studies.

Source James E. Reinaker/Elsevier Global Medical News