At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.

Reporter Alicia Ault has this video report:

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

Hospitals are a place where people go to get healthy, but the same can't be said about all hospital cafeterias, according to a recent study by the Physicians Committee for Responsible Medicine (PCRM).

The study analyzed food served to patients, staff, and visitors at U.S. hospitals in all 50 states and the District of Columbia and found that some hospitals housed as many as five fast-food outlets and featured menus that were dominated by foods high in fat, cholesterol, sugar, and sodium. For hospitalists, many of whom spend 50, 70, and even 90 hours per week in the hospital, the lack of healthy eating options can be especially problematic.

"We relied on menus that were provided, and while we don't have the recipes in hand, we can tell a lot just by the fundamental ingredients," says Susan Levin, RD, PCRM's director of nutrition education and lead author of the study.

Levin says the presence of these kinds of foods in hospitals is "irresponsible," and suggests hospitals ban fast-food outlets and fill menus with low-fat, plant-based options as a way to "reverse and prevent disease."

Many hospital cafeterias around the country are doing just that. MetroWest Medical Center, just outside of Boston, has formed a "Go Green" committee that plans to group and label healthy versus nonhealthy drinks and snacks, and will reward patients and hospital staff for choosing water and other healthy options. Benioff Children's Hospital at the University of California at San Francisco (UCSF) Medical Center now offers nutritional information for entrees, and food-purchase receipts note calories and fat content.

PCRM hopes the study will encourage hospitals to lead the way in promoting healthful eating habits. "I hope that something is changing and people are thinking bigger picture and better care," Levin says.

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

An emerging category of hospital quality initiatives, comparable to preventing medical errors and improving quality and patient safety, could be labeled “waste management” or “waste reduction.” "Waste" in this sense refers not to biohazardous substances in need of disposal, but to the overuse of medical resources—such as lab tests and pharmaceuticals—when they are not helpful to a patient's medical management.

This will be a growing focus for hospitalists, says Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California at San Francisco (UCSF) Medical Center, and author of the HM-focused blog, Wachter's World.

"If patients are getting CAT scans they don't really need or an extra day of telemetry because we don't have criteria for who should be on telemetry, that's wasteful, it's costly, and it could be dangerous,” Dr. Wachter explained at the UCSF Management of the Hospitalized Patient meeting last October. "The data are clear that 30% of what we do in American medicine is of no value to patients—and some substantial portion of that is harmful as well. I think we as hospitalists should be identifying what these wasteful things are—and making the hard decisions to stop them."

In an academic setting such as UCSF, many of the hospitalists lead quality, safety, and "waste reduction" projects, which often use similar tools and methods but have a different focus. Dr. Wachter's colleague Niraj Sehgal, MD, MPH, the department of medicine's associate chair for quality improvement (QI) and patient safety, says that process-improvement tools such as Six Sigma and Lean methodologies can put unnecessary variation and waste under the microscope. But at UCSF, these efforts start with just looking at the data, then sharing the data with trainees and faculty.

"Clearly, attention is growing to this issue," Dr. Sehgal says. "We often talk about generating value in healthcare where value equals quality divided by cost, but we need to include the concept of appropriateness in that equation as well."

A radiology utilization awareness project at UCSF is looking at whether cost and radiation exposure information might influence the ordering of five common radiologic tests that together generate annual charges of nearly $10 million at UCSF's Moffitt-Long Medical Service. The project uses a number of educational strategies to encourage providers to think about whether the tests will change their clinical management.

"The preliminary data suggest that simply providing the cost and utilization data decreased utilization for three of the five tests evaluated," Dr. Sehgal says.

Physicians didn't necessarily ignore inefficiency and overuse in the past, he adds, but healthcare reform offers new opportunities to leverage greater cost consciousness in medical education and practice. "We're not having to convince our trainees and faculty that cost is important," he says. "They just don't always see the costs involved."

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.

MIAMI BEACH – Patients with head and neck cancers who develop alcohol withdrawal syndrome perioperatively experience significantly more complications after undergoing surgery, a large database analysis indicates.

The presence of withdrawal symptoms was associated with a 25% incidence of postoperative complications, compared with 14% among patients who abused alcohol and 7% among those without alcohol abuse, Dr. Dane J. Genther said at the Triological Society’s Combined Sections Meeting. The risk for wound complications was nearly double in this population (odds ratio, 1.9).

Dr. Genther, a resident in otolaryngologyhead and neck surgery at Johns Hopkins Hospital in Baltimore, and his associates used ICD-9 codes in the Nationwide Inpatient Sample discharge database to identify more than 92,000 patients who underwent an ablative procedure for head and neck cancer in 2003-2008. The retrospective, cross-sectional study included patients with malignant oral cavity, laryngeal, hypopharyngeal, and oropharyngeal neoplasms.

In a multivariate analysis, alcohol withdrawal syndrome was significantly more likely for patients undergoing a major procedure (OR, 2.0) and was significantly associated with Medicare payer status and a need for additional health care following discharge, Dr. Genther said.

The researchers found no significant association between alcohol withdrawal syndrome and increased risk for postoperative infections or in-hospital mortality, but there was a significant increase in hospital stay and related costs associated with the syndrome.

Having a major procedure and experiencing alcohol withdrawal contributed approximately $15,000 per admission in 2011 U.S. dollars, Dr. Genther said.

The findings point to a need for alternatives to current alcohol withdrawal prevention therapies, Dr. Genther said. "Despite prophylaxis, which is our current treatment to attempt to stem the onset of alcohol withdrawal syndrome, complications do occur and they are no less severe or frequent than in the absence of prophylaxis."

Abstinence from alcohol for at least 4 weeks is another strategy proposed to minimize risk of alcohol withdrawal syndrome for any at-risk surgical patient, said Dr. Genther. However, he added, "for many cancer patients, especially those with more advanced disease, waiting a prolonged period of time to possibly gain that benefit from abstinence is not necessarily a viable option."

Another aim of the study was to assess factors contributing to alcohol abuse. Patients aged 40-64 years had the highest proportion of alcohol abuse, and this age range was a significant factor (OR, 2.37). Those who abused alcohol were more often male and more often underwent major procedures, Dr. Genther said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. In addition, alcohol abuse was significantly associated with pneumonia and need for additional postdischarge health care.

Dr. Genther received a G. Slaughter Fitz-Hugh Resident Research Award for this study from the Triological Society. He reported having no financial disclosures.

SNOWMASS, COLO. – A disturbing proportion of gout cases are mismanaged by primary care physicians, and the blame falls squarely upon rheumatologists, according to one prominent gout expert.

"As rheumatologists, gout is our disease. The cause and pathophysiology are well understood, we can make the diagnosis with absolute certainty, and we’ve got great medicines. Yet today we all see people with tophi. That’s tragic. It shouldn’t exist. One of our biggest mistakes has been not being able to educate primary care physicians that having a tophus is bad, that it’s eroding cartilage and bone, and that it’s something we can prevent if we start urate-lowering therapy soon enough," Dr. Robert L. Wortmann said at the conference.

An estimated 8.3 million Americans have gout. Yet, the pharmaceutical industry says only 3.1 million of them are prescribed urate-lowering drugs. Five different studies show that a mere 40% of those on allopurinol are prescribed a dose sufficient to drive serum uric acid below 6 mg/dL, a key tenet of gout management, noted Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

Moreover, poor treatment adherence is a huge problem in gout. A study of close to 4,200 gout patients started on urate-lowering drug therapy found that 56% of them were nonadherent (Arthritis Res. Ther. 2009;11(2):R46).

"I charge you all to go back from this meeting and try to communicate with all the primary care physicians you can about the principles of managing gout. People shouldn’t suffer from this," the rheumatologist declared.

He offered these major take home points:

Don’t prescribe urate-lowering drugs for asymptomatic hyperuricemia: This practice hasn’t been shown to prevent the future development of gout, yet it exposes patients to the risk of drug toxicities.

But don’t ignore asymptomatic hyperuricemia, either: Epidemiologic studies have linked asymptomatic hyperuricemia, defined by a serum urate in excess of 6.8 mg/dL, to increased risks of hypertension, cardiovascular disease, diabetes, chronic kidney disease, and all-cause mortality. The big unanswered question is whether using medications to lower serum urate in individuals with asymptomatic hyperuricemia reduces the risk of any of these conditions. That’s the subject of ongoing large clinical trials in high-risk patients. If those studies prove positive, clinical practice will change.

While awaiting the outcome of the prevention trials, it’s worth bearing in mind that Framingham Heart Study data indicate that individuals with a serum uric acid level above 9 mg/dL have a 22% chance of developing gout within the next 5 years. The major contributors to asymptomatic hyperuricemia include obesity, metabolic syndrome, and heavy consumption of fructose-containing beverages or alcohol. Those issues should be addressed.

Losartan is the only antihypertensive agent that’s uricosuric. Fenofibrate is the sole uricosuric drug indicated for dyslipidemia. Preferential consideration could be given to the use of these drugs in hypertensive and/or hyperlipidemic patients with asymptomatic hyperuricemia.

The important thing is not which oral agent you use for treatment of acute gout, it’s to initiate therapy as early as possible, at the first hint of an attack. Colchicine, maximum-dose NSAIDs, and oral prednisone dosed at 20 mg BID until symptoms have been gone for 1 week followed by another week at 20 mg/day – they’re all effective. And since they work by different mechanisms, they can beneficially be combined in refractory patients.

The old-school colchicine dosing regimen most physicians were taught has been cast aside of late. It had a high rate of diarrhea, an inhumane side effect in gout patients hobbled by a foot too sore to walk on. The former regimen has been replaced by 1.2 mg, given in a single dose, followed by 0.6 mg 1 hour later.

"This lower dose is just as effective as the old high-dose regimen of two 0.6-mg pills given at once and then one per hour for the next 5 hours. And the lower-dose program has the same side effect profile as placebo," Dr. Wortmann said.

Get the gout patient’s serum urate below 6 mg/dL using the lowest effective dose of the urate-lowering drug you’ve selected. Physicians have traditionally started gout patients on allopurinol at the standard dose of 300 mg/day. Recently, it has been demonstrated that the risk of developing allopurinol hypersensitivity syndrome is greatly reduced by starting off at 150 mg/day, checking the urate level 2 weeks later, then increasing to 300 mg/day if the serum urate isn’t below 6 mg/dL. After 2 weeks at 300 mg/day, check the urate again, and if it still isn’t below 6 mg/dL then bump the dose to 400 mg/day. Continue testing and titrating every 2 weeks until the serum urate is less than 6 mg/dL – and preferably less than 4 mg/dL if the patient has tophi – or until the maximum approved dose of 800 mg/day is reached.

The same start-low-and-titrate strategy applies to febuxostat, with a maximum approved dose of 80 mg/day.

"We have to educate primary care physicians to check the serum urate after starting therapy, and that, if it’s not below 6 mg/dL, they need to increase the dose. And if they don’t feel comfortable with that, they need to send the patient to us," the rheumatologist said.

Fortunately, patients who have a hypersensitivity reaction to allopurinol are very unlikely to experience one with febuxostat, and vice versa.

For patients who can’t reach the target serum urate with maximum-dose therapy, take heart: Second-line agents with impressive potency are well-along in the developmental pipeline.

Many labs now list the upper limit of normal for serum urate as 8 mg/dL or 8.5 mg/dL. Ignore that. This raised ceiling is simply the result of the changing demographics among the increasingly obese U.S. population in the last several decades. The definition of asymptomatic hyperuricemia remains unchanged: a serum urate greater than 6.8 mg/dL. And the target in patients with gout is still a serum urate less than 6 mg/dL. Merely dropping a gout patient’s urate from 10 to 8 or even 6.6 mg/dL isn’t doing any favors; the disease will continue to progress if the urate is above 6 mg/dL.

All gout is tophaceous. Even if tophi aren’t apparent on clinical examination, often they are radiographically. "This is a message that has to get out," Dr. Wortmann insisted.

Proposed American College of Rheumatology gout management guidelines call for starting urate-lowering drug therapy when a patient is experiencing three attacks per year. Dr. Wortmann takes issue with that.

"I would argue that once you’ve had a third attack of gout, period, you should be treated. Maybe even sooner. We need to prevent the erosion and bony destruction that occur with tophi," he said.

One audience member complained that his gout patients with comorbid renal insufficiency and/or cardiovascular disease often get caught in a revolving door. He titrates their allopurinol to an effective dose, but when they are later admitted to the hospital because of their comorbid condition the hospitalists, nephrologists, and/or cardiologists are shocked at the allopurinol dose and either reduce it or stop it altogether. The first that the rheumatologist learns of it is when patients reappear in his office with active gout. He then resumes their allopurinol at the previous dose, and they remain well controlled until the next hospitalization, when the same thing happens.

Dr. Wortmann responded that the solution requires convincing the nonrheumatologists in one-on-one conversation that urate-lowering therapy is not a one-size-fits-all matter. They need to understand that to get rid of gout, it’s necessary to drive the serum urate to the target of less than 6 mg/dL, and it helps to reassure them that that this will be accomplished using the lowest effective dose.

He reported serving as a consultant to Savient, Takeda, URL Pharmaceuticals, Novartis, and Ardea Biosciences.

SNOWMASS, COLO. – A disturbing proportion of gout cases are mismanaged by primary care physicians, and the blame falls squarely upon rheumatologists, according to one prominent gout expert.

"As rheumatologists, gout is our disease. The cause and pathophysiology are well understood, we can make the diagnosis with absolute certainty, and we’ve got great medicines. Yet today we all see people with tophi. That’s tragic. It shouldn’t exist. One of our biggest mistakes has been not being able to educate primary care physicians that having a tophus is bad, that it’s eroding cartilage and bone, and that it’s something we can prevent if we start urate-lowering therapy soon enough," Dr. Robert L. Wortmann said at the conference.

An estimated 8.3 million Americans have gout. Yet, the pharmaceutical industry says only 3.1 million of them are prescribed urate-lowering drugs. Five different studies show that a mere 40% of those on allopurinol are prescribed a dose sufficient to drive serum uric acid below 6 mg/dL, a key tenet of gout management, noted Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

Moreover, poor treatment adherence is a huge problem in gout. A study of close to 4,200 gout patients started on urate-lowering drug therapy found that 56% of them were nonadherent (Arthritis Res. Ther. 2009;11(2):R46).

"I charge you all to go back from this meeting and try to communicate with all the primary care physicians you can about the principles of managing gout. People shouldn’t suffer from this," the rheumatologist declared.

He offered these major take home points:

Don’t prescribe urate-lowering drugs for asymptomatic hyperuricemia: This practice hasn’t been shown to prevent the future development of gout, yet it exposes patients to the risk of drug toxicities.

But don’t ignore asymptomatic hyperuricemia, either: Epidemiologic studies have linked asymptomatic hyperuricemia, defined by a serum urate in excess of 6.8 mg/dL, to increased risks of hypertension, cardiovascular disease, diabetes, chronic kidney disease, and all-cause mortality. The big unanswered question is whether using medications to lower serum urate in individuals with asymptomatic hyperuricemia reduces the risk of any of these conditions. That’s the subject of ongoing large clinical trials in high-risk patients. If those studies prove positive, clinical practice will change.

While awaiting the outcome of the prevention trials, it’s worth bearing in mind that Framingham Heart Study data indicate that individuals with a serum uric acid level above 9 mg/dL have a 22% chance of developing gout within the next 5 years. The major contributors to asymptomatic hyperuricemia include obesity, metabolic syndrome, and heavy consumption of fructose-containing beverages or alcohol. Those issues should be addressed.

Losartan is the only antihypertensive agent that’s uricosuric. Fenofibrate is the sole uricosuric drug indicated for dyslipidemia. Preferential consideration could be given to the use of these drugs in hypertensive and/or hyperlipidemic patients with asymptomatic hyperuricemia.

The important thing is not which oral agent you use for treatment of acute gout, it’s to initiate therapy as early as possible, at the first hint of an attack. Colchicine, maximum-dose NSAIDs, and oral prednisone dosed at 20 mg BID until symptoms have been gone for 1 week followed by another week at 20 mg/day – they’re all effective. And since they work by different mechanisms, they can beneficially be combined in refractory patients.

The old-school colchicine dosing regimen most physicians were taught has been cast aside of late. It had a high rate of diarrhea, an inhumane side effect in gout patients hobbled by a foot too sore to walk on. The former regimen has been replaced by 1.2 mg, given in a single dose, followed by 0.6 mg 1 hour later.

"This lower dose is just as effective as the old high-dose regimen of two 0.6-mg pills given at once and then one per hour for the next 5 hours. And the lower-dose program has the same side effect profile as placebo," Dr. Wortmann said.

Get the gout patient’s serum urate below 6 mg/dL using the lowest effective dose of the urate-lowering drug you’ve selected. Physicians have traditionally started gout patients on allopurinol at the standard dose of 300 mg/day. Recently, it has been demonstrated that the risk of developing allopurinol hypersensitivity syndrome is greatly reduced by starting off at 150 mg/day, checking the urate level 2 weeks later, then increasing to 300 mg/day if the serum urate isn’t below 6 mg/dL. After 2 weeks at 300 mg/day, check the urate again, and if it still isn’t below 6 mg/dL then bump the dose to 400 mg/day. Continue testing and titrating every 2 weeks until the serum urate is less than 6 mg/dL – and preferably less than 4 mg/dL if the patient has tophi – or until the maximum approved dose of 800 mg/day is reached.

The same start-low-and-titrate strategy applies to febuxostat, with a maximum approved dose of 80 mg/day.

"We have to educate primary care physicians to check the serum urate after starting therapy, and that, if it’s not below 6 mg/dL, they need to increase the dose. And if they don’t feel comfortable with that, they need to send the patient to us," the rheumatologist said.

Fortunately, patients who have a hypersensitivity reaction to allopurinol are very unlikely to experience one with febuxostat, and vice versa.

For patients who can’t reach the target serum urate with maximum-dose therapy, take heart: Second-line agents with impressive potency are well-along in the developmental pipeline.

Many labs now list the upper limit of normal for serum urate as 8 mg/dL or 8.5 mg/dL. Ignore that. This raised ceiling is simply the result of the changing demographics among the increasingly obese U.S. population in the last several decades. The definition of asymptomatic hyperuricemia remains unchanged: a serum urate greater than 6.8 mg/dL. And the target in patients with gout is still a serum urate less than 6 mg/dL. Merely dropping a gout patient’s urate from 10 to 8 or even 6.6 mg/dL isn’t doing any favors; the disease will continue to progress if the urate is above 6 mg/dL.

All gout is tophaceous. Even if tophi aren’t apparent on clinical examination, often they are radiographically. "This is a message that has to get out," Dr. Wortmann insisted.

Proposed American College of Rheumatology gout management guidelines call for starting urate-lowering drug therapy when a patient is experiencing three attacks per year. Dr. Wortmann takes issue with that.

"I would argue that once you’ve had a third attack of gout, period, you should be treated. Maybe even sooner. We need to prevent the erosion and bony destruction that occur with tophi," he said.

One audience member complained that his gout patients with comorbid renal insufficiency and/or cardiovascular disease often get caught in a revolving door. He titrates their allopurinol to an effective dose, but when they are later admitted to the hospital because of their comorbid condition the hospitalists, nephrologists, and/or cardiologists are shocked at the allopurinol dose and either reduce it or stop it altogether. The first that the rheumatologist learns of it is when patients reappear in his office with active gout. He then resumes their allopurinol at the previous dose, and they remain well controlled until the next hospitalization, when the same thing happens.

Dr. Wortmann responded that the solution requires convincing the nonrheumatologists in one-on-one conversation that urate-lowering therapy is not a one-size-fits-all matter. They need to understand that to get rid of gout, it’s necessary to drive the serum urate to the target of less than 6 mg/dL, and it helps to reassure them that that this will be accomplished using the lowest effective dose.

He reported serving as a consultant to Savient, Takeda, URL Pharmaceuticals, Novartis, and Ardea Biosciences.

SNOWMASS, COLO. – A disturbing proportion of gout cases are mismanaged by primary care physicians, and the blame falls squarely upon rheumatologists, according to one prominent gout expert.

"As rheumatologists, gout is our disease. The cause and pathophysiology are well understood, we can make the diagnosis with absolute certainty, and we’ve got great medicines. Yet today we all see people with tophi. That’s tragic. It shouldn’t exist. One of our biggest mistakes has been not being able to educate primary care physicians that having a tophus is bad, that it’s eroding cartilage and bone, and that it’s something we can prevent if we start urate-lowering therapy soon enough," Dr. Robert L. Wortmann said at the conference.

An estimated 8.3 million Americans have gout. Yet, the pharmaceutical industry says only 3.1 million of them are prescribed urate-lowering drugs. Five different studies show that a mere 40% of those on allopurinol are prescribed a dose sufficient to drive serum uric acid below 6 mg/dL, a key tenet of gout management, noted Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

Moreover, poor treatment adherence is a huge problem in gout. A study of close to 4,200 gout patients started on urate-lowering drug therapy found that 56% of them were nonadherent (Arthritis Res. Ther. 2009;11(2):R46).

"I charge you all to go back from this meeting and try to communicate with all the primary care physicians you can about the principles of managing gout. People shouldn’t suffer from this," the rheumatologist declared.

He offered these major take home points:

Don’t prescribe urate-lowering drugs for asymptomatic hyperuricemia: This practice hasn’t been shown to prevent the future development of gout, yet it exposes patients to the risk of drug toxicities.

But don’t ignore asymptomatic hyperuricemia, either: Epidemiologic studies have linked asymptomatic hyperuricemia, defined by a serum urate in excess of 6.8 mg/dL, to increased risks of hypertension, cardiovascular disease, diabetes, chronic kidney disease, and all-cause mortality. The big unanswered question is whether using medications to lower serum urate in individuals with asymptomatic hyperuricemia reduces the risk of any of these conditions. That’s the subject of ongoing large clinical trials in high-risk patients. If those studies prove positive, clinical practice will change.

While awaiting the outcome of the prevention trials, it’s worth bearing in mind that Framingham Heart Study data indicate that individuals with a serum uric acid level above 9 mg/dL have a 22% chance of developing gout within the next 5 years. The major contributors to asymptomatic hyperuricemia include obesity, metabolic syndrome, and heavy consumption of fructose-containing beverages or alcohol. Those issues should be addressed.

Losartan is the only antihypertensive agent that’s uricosuric. Fenofibrate is the sole uricosuric drug indicated for dyslipidemia. Preferential consideration could be given to the use of these drugs in hypertensive and/or hyperlipidemic patients with asymptomatic hyperuricemia.

The important thing is not which oral agent you use for treatment of acute gout, it’s to initiate therapy as early as possible, at the first hint of an attack. Colchicine, maximum-dose NSAIDs, and oral prednisone dosed at 20 mg BID until symptoms have been gone for 1 week followed by another week at 20 mg/day – they’re all effective. And since they work by different mechanisms, they can beneficially be combined in refractory patients.

The old-school colchicine dosing regimen most physicians were taught has been cast aside of late. It had a high rate of diarrhea, an inhumane side effect in gout patients hobbled by a foot too sore to walk on. The former regimen has been replaced by 1.2 mg, given in a single dose, followed by 0.6 mg 1 hour later.

"This lower dose is just as effective as the old high-dose regimen of two 0.6-mg pills given at once and then one per hour for the next 5 hours. And the lower-dose program has the same side effect profile as placebo," Dr. Wortmann said.

Get the gout patient’s serum urate below 6 mg/dL using the lowest effective dose of the urate-lowering drug you’ve selected. Physicians have traditionally started gout patients on allopurinol at the standard dose of 300 mg/day. Recently, it has been demonstrated that the risk of developing allopurinol hypersensitivity syndrome is greatly reduced by starting off at 150 mg/day, checking the urate level 2 weeks later, then increasing to 300 mg/day if the serum urate isn’t below 6 mg/dL. After 2 weeks at 300 mg/day, check the urate again, and if it still isn’t below 6 mg/dL then bump the dose to 400 mg/day. Continue testing and titrating every 2 weeks until the serum urate is less than 6 mg/dL – and preferably less than 4 mg/dL if the patient has tophi – or until the maximum approved dose of 800 mg/day is reached.

The same start-low-and-titrate strategy applies to febuxostat, with a maximum approved dose of 80 mg/day.

"We have to educate primary care physicians to check the serum urate after starting therapy, and that, if it’s not below 6 mg/dL, they need to increase the dose. And if they don’t feel comfortable with that, they need to send the patient to us," the rheumatologist said.

Fortunately, patients who have a hypersensitivity reaction to allopurinol are very unlikely to experience one with febuxostat, and vice versa.

For patients who can’t reach the target serum urate with maximum-dose therapy, take heart: Second-line agents with impressive potency are well-along in the developmental pipeline.

Many labs now list the upper limit of normal for serum urate as 8 mg/dL or 8.5 mg/dL. Ignore that. This raised ceiling is simply the result of the changing demographics among the increasingly obese U.S. population in the last several decades. The definition of asymptomatic hyperuricemia remains unchanged: a serum urate greater than 6.8 mg/dL. And the target in patients with gout is still a serum urate less than 6 mg/dL. Merely dropping a gout patient’s urate from 10 to 8 or even 6.6 mg/dL isn’t doing any favors; the disease will continue to progress if the urate is above 6 mg/dL.

All gout is tophaceous. Even if tophi aren’t apparent on clinical examination, often they are radiographically. "This is a message that has to get out," Dr. Wortmann insisted.

Proposed American College of Rheumatology gout management guidelines call for starting urate-lowering drug therapy when a patient is experiencing three attacks per year. Dr. Wortmann takes issue with that.

"I would argue that once you’ve had a third attack of gout, period, you should be treated. Maybe even sooner. We need to prevent the erosion and bony destruction that occur with tophi," he said.

One audience member complained that his gout patients with comorbid renal insufficiency and/or cardiovascular disease often get caught in a revolving door. He titrates their allopurinol to an effective dose, but when they are later admitted to the hospital because of their comorbid condition the hospitalists, nephrologists, and/or cardiologists are shocked at the allopurinol dose and either reduce it or stop it altogether. The first that the rheumatologist learns of it is when patients reappear in his office with active gout. He then resumes their allopurinol at the previous dose, and they remain well controlled until the next hospitalization, when the same thing happens.

Dr. Wortmann responded that the solution requires convincing the nonrheumatologists in one-on-one conversation that urate-lowering therapy is not a one-size-fits-all matter. They need to understand that to get rid of gout, it’s necessary to drive the serum urate to the target of less than 6 mg/dL, and it helps to reassure them that that this will be accomplished using the lowest effective dose.

He reported serving as a consultant to Savient, Takeda, URL Pharmaceuticals, Novartis, and Ardea Biosciences.

SNOWMASS, COLO. – The epidemiology of gout has changed considerably in the past several decades, rendering treatment more challenging.

For example, today fully 21.4% of all U.S. adults are hyperuricemic as defined by a serum uric acid in excess of 6.8 mg/dL.

"When I was a fellow it was 5%. There’s a lot more uric acid in the world today," Dr. Robert L. Wortmann observed at the symposium.

Major contributing factors include metabolic syndrome, the obesity epidemic, increased consumption of high-fructose drinks and processed foods, and alcohol. Liquor has a twofold stronger urate-boosting effect than does wine, and beer’s impact is fourfold greater than wine, according to Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

"When I was in training uric acids above 9 mg/dL weren’t common; now, when I see a newly diagnosed gout patient with a uric acid level below 9, it’s exceptional. Gout patients today have uric acids of 10, 11, and 12 mg/dL as opposed to 7.5, 8, and 9 in decades past," he said.

Since 1964 the standard dose of allopurinol has been 300 mg/day. Back then, that was sufficient to reach the serum uric acid target of less than 6.0 mg/dL in about 90% of gout patients. Today, 300 mg/day gets only about 40% of patients to target, as has been shown in numerous studies.

Dr. Wortmann reported serving as a consultant to Ardea Biosciences, Novartis, Savient, Takeda, and URL Pharmaceuticals.

SNOWMASS, COLO. – The epidemiology of gout has changed considerably in the past several decades, rendering treatment more challenging.

For example, today fully 21.4% of all U.S. adults are hyperuricemic as defined by a serum uric acid in excess of 6.8 mg/dL.

"When I was a fellow it was 5%. There’s a lot more uric acid in the world today," Dr. Robert L. Wortmann observed at the symposium.

Major contributing factors include metabolic syndrome, the obesity epidemic, increased consumption of high-fructose drinks and processed foods, and alcohol. Liquor has a twofold stronger urate-boosting effect than does wine, and beer’s impact is fourfold greater than wine, according to Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

"When I was in training uric acids above 9 mg/dL weren’t common; now, when I see a newly diagnosed gout patient with a uric acid level below 9, it’s exceptional. Gout patients today have uric acids of 10, 11, and 12 mg/dL as opposed to 7.5, 8, and 9 in decades past," he said.

Since 1964 the standard dose of allopurinol has been 300 mg/day. Back then, that was sufficient to reach the serum uric acid target of less than 6.0 mg/dL in about 90% of gout patients. Today, 300 mg/day gets only about 40% of patients to target, as has been shown in numerous studies.

Dr. Wortmann reported serving as a consultant to Ardea Biosciences, Novartis, Savient, Takeda, and URL Pharmaceuticals.

SNOWMASS, COLO. – The epidemiology of gout has changed considerably in the past several decades, rendering treatment more challenging.

For example, today fully 21.4% of all U.S. adults are hyperuricemic as defined by a serum uric acid in excess of 6.8 mg/dL.

"When I was a fellow it was 5%. There’s a lot more uric acid in the world today," Dr. Robert L. Wortmann observed at the symposium.

Major contributing factors include metabolic syndrome, the obesity epidemic, increased consumption of high-fructose drinks and processed foods, and alcohol. Liquor has a twofold stronger urate-boosting effect than does wine, and beer’s impact is fourfold greater than wine, according to Dr. Wortmann, professor of medicine at Dartmouth Medical School in Hanover, N.H.

"When I was in training uric acids above 9 mg/dL weren’t common; now, when I see a newly diagnosed gout patient with a uric acid level below 9, it’s exceptional. Gout patients today have uric acids of 10, 11, and 12 mg/dL as opposed to 7.5, 8, and 9 in decades past," he said.

Since 1964 the standard dose of allopurinol has been 300 mg/day. Back then, that was sufficient to reach the serum uric acid target of less than 6.0 mg/dL in about 90% of gout patients. Today, 300 mg/day gets only about 40% of patients to target, as has been shown in numerous studies.

Dr. Wortmann reported serving as a consultant to Ardea Biosciences, Novartis, Savient, Takeda, and URL Pharmaceuticals.

According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

According to a survey released last fall by the Health Forum, a subsidiary of the American Hospital Association, and the Samueli Institute of Alexandria, Va., complementary and alternative medicine (CAM) services in responding hospitals increased to 42% in 2010 from 37% in 2007.

The fourth Complementary and Alternative Medicine Survey of Hospitals is a follow-up report to the 2007 survey, which The Hospitalist featured in January 2010.

Twelve percent of 5,858 hospitals answered a 42-question instrument in 2010, according to Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author. The results, Ananth says, showed that the hospitals most likely to offer CAM were urban and tended to be either medium-size (50-299 beds) or large (500+ beds) institutions.

What’s driving the increase? She believes that hospitals are simply responding to patients’ desire to have “the best that both conventional and alternative medicine can offer.”

[Hospitals undertaking complementary services should] start small and not have high expectations of breaking even for several years.

—Sita Ananth, MHA, director of knowledge services at the Samueli Institute and study report author

Sixty-five percent of hospitals responding to the survey offer CAM therapies for pain management. That figure is echoed in a 2008 National Health Statistics report (PDF) published by the Centers for Disease Control and Prevention. Back pain, neck pain, and joint pain were the three top reasons for using CAM, according to the CDC report.

“Adjacent” Treatment

Hospitalist Sanjay Reddy, MD, assistant clinical professor of medicine in the Department of Medicine at the University of California at San Francisco (UCSF), says acupuncture can be a valuable adjunct when treating patients for pain, chemotherapy-induced nausea, and insomnia. He is a trained acupuncturist and has studied complementary therapies extensively. He also is interested in exploring ways to incorporate acupuncture into the UCSF’s Osher Center for Integrative Medicine program.

David H. Gorski, MD, PhD, FACS, associate professor of surgery and director of the Breast Cancer Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute at Wayne State University School of Medicine in Detroit, strenuously objects to the incorporation of alternative therapies (often under the moniker of “integrative medicine”) in the hospital setting.

“If you accept the premise that medicine should be based in sound science and evidence, then we have an obligation not to be offering treatments that are not based in science,” he asserts. Dr. Gorski, who also blogs on such topics, finds that many of those who endorse integrative medicine have become “true believers,” and that some are mixing pseudo-science with science.

In an August 2011 post regarding the College of Physicians and Surgeons of Ontario’s draft policy on alternative treatments, Dr. Gorski wrote: “Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.”

Dr. Reddy notes that with appropriate disclosure, offering a modality such as acupuncture can be appropriate. For example, in the setting of pain relief, acupuncture offers a less sedative approach. He explains that Chinese diagnostics and treatment approaches are slightly different, so it’s difficult to study them in the context of randomized trials. (Click here to listen to more of Dr. Reddy’s discussion of appropriate indications for acupuncture.)

In the Health Forum/Samueli Institute survey, 57% of hospitals reported that their programs were not yet breaking even and only 16% said they'd be breaking even in three years (see Figure 1). In light of these results, Ananth says, hospitals undertaking complementary services should “start small and not have high expectations of breaking even for several years.”

Gretchen Henkel is a freelance writer in California. 

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

SILVER SPRING, MD. – The leukemia drug decitabine didn’t show robust-enough results to convince the majority of an advisory panel to support its approval by the U.S. Food and Drug Administration as a new treatment for elderly patients with acute myeloid leukemia.

Ten members of the independent Oncologic Drugs Advisory Committee (ODAC) voted no, three voted yes, and one member abstained on a question related to the proposed indication. They were asked whether decitabine (Dacogen) demonstrated a favorable risk-benefit profile for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years and older who are not candidates for induction chemotherapy.

Those who voted no said they didn't find the results of a key study convincing and were not comfortable drawing any solid conclusions. The yea-sayers said they looked beyond the fact that the study didn’t meet its end point and instead erred on the side of adding another treatment choice for doctors and their patients.

The FDA considers the panel’s recommendations, but doesn’t necessarily follow them.

Drugmaker Eisai sought the drug’s approval by filing an application to the FDA in May 2011, with the goal of meeting the "unmet medical need" of older adults with AML who are not candidates for induction therapy.

Although the company’s trials didn’t reach a statistically significant result, its officials made the argument that aggregate clinical data from a randomized trial and a single-arm study showed that the drug was well tolerated, had good efficacy and safety profiles, and would provide a clinically meaningful benefit to older patients with AML who are not candidates for induction chemotherapy.

But FDA officials made the case that the "primary end point of overall survival was not met and any further analyses are expiatory and inflate the false-positive rate." They also pointed out that they defined efficacy as a statistically significant survival rate or a rigorous analysis that shows noninferiority.

AML is mainly a disease of the elderly, with an onset at the median age of 69 years. Because of poorer outcomes among this age group, one-third of patients don’t receive chemotherapy.

Decitabine, a hypomethylating agent, was FDA approved in 2006 for the treatment of myelodysplastic syndromes.

A 2009 randomized, open-label, multinational phase III trial, conducted by Eisai, enrolled 485 patients, with a median age of 73. Patients were randomized to decitabine (242) or treatment of choice (low-dose cytarabine or supportive care) (243), with the primary end point of overall survival, prespecified as a 25% reduction in mortality risk.

Patients in the decitabine arm had a median overall survival of 7.7 months, compared with 5 months in the treatment of choice group, (hazard ratio, 0.85; P = .11). A 2010 post hoc analysis showed the median overall survival was unchanged, but the difference became statistically significant (HR, 0.82; P = .037).

FDA officials argued that, "given the final analysis results, post hoc analysis results could be due to chance," adding that the false-positive rate is greater than 5%.

Eisai also conducted a phase II supportive study, which was a single-arm trial that enrolled 55 patients with a median age of 60 years or older. The efficacy and safety results were similar to those of the randomized trial. The safety profile of decitabine was comparable to that in the label for myelodysplastic syndrome, Eisai officials reported.

"Elderly patients [with AML] are desperate for new treatments," said Dr. Mikkael Sekeres, an ODAC member from the department of hematologic oncology and blood disorders at the Cleveland Clinic Taussig Cancer Institute who voted no. "Unfortunately this drug didn’t do the job."

Dr. Wyndham Wilson, ODAC chair and chief of the lymphoma therapeutics section at the National Institutes of Health, voted yes and said he looked at the totality of the data and thought that they favored its approval.

"I see it as a rare setting, where we really have no good drugs. I couldn’t get stuck on that the primary end point wasn’t met. I feel that I wanted to err on the side of choice," he said. "For me the data was sufficiently robust to approve the drug and have the choice available for physicians and patients."

Dr. Ralph Freedman of the University of Texas M.D. Anderson Cancer Center in Houston – the only ODAC member who abstained from voting – said it was his first time doing so, and he expressed his ambivalence on the risks and benefits of the drug based on the study’s results.

Meanwhile, the issue at hand highlights the fact that the standard of care for treating older adults with AML is not clearly defined, said Dr. Sekeres. Their treatment options currently range from induction chemotherapy to aggressive supportive care, with low-dose cytarabine therapy as a middle-of-the-road therapy.

There are currently four FDA-approved first-line drugs for AML. The last drug was idarubicin, approved in 1990.

Another issue highlighted during the discussions was the available treatments for the growing aging population. The medical community is entering somewhat of an uncharted territory and such trials are important, said Dr. William Kevin Kelly, a voting member of ODAC and professor of medical oncology and urology at Thomas Jefferson University, Philadelphia who voted no.

Panelists were cleared of potential conflicts before voting on decitabine.

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."

A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.

"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."

Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.

A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.

Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.

Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.

"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."