Subclinical Hypothyroidism Common with Chronic Kidney Disease

By Charles Bankhead
DENVER, 12 june 2008-- Almost 20% of patients with chronic kidney disease have subclinical primary hypothyroidism, according to data from a large cohort of outpatients.
About 10% of unselected patients had subclinical primary hypothyroidism, Michel Chonchol, M.D., of the University of Colorado Health Sciences Center, and colleagues reported online in the Clinical Journal of the American Society of Nephrology.
However, patients with an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 had a prevalence of 18%.
"Future clinical and experimental studies should explore potential causal mechanisms linking subclinical primary hypothyroidism and chronic kidney disease," the authors concluded.
"The possible adverse effects of subclinical hypothyroidism on cardiovascular risk associated with chronic kidney disease are presently unknown. Whether adult patients with chronic kidney disease should be routinely screened for subclinical hypothyroidism requires further investigation."
An improved capability to detect subtle changes in thyroid function has led to the emergence of the concept of subclinical primary hypothyroidism, defined as elevated serum thyrotropin levels but normal free thyroxine levels.
Subclinical primary hypothyroidism has been associated with markers of cardiovascular risk and impaired cardiac function, the authors said. Moreover, subclinical primary hypothyroidism is an independent predictor of all-cause mortality in dialysis patients and is a risk factor for nephropathy and cardiovascular events in patients with type 2 diabetes.
The prevalence of subclinical primary hypothyroidism in the general population and by different levels of estimated GFR has not been studied extensively. Dr. Chonchol and colleagues performed a cross-sectional analysis of a large database from a clinical chemistry laboratory in Verona, Italy.
The study involved 3,089 adults, 293 (9.5%) of them meeting the laboratory definition for subclinical primary hypothyroidism and 277 (9%) who had an estimated GFR of lower than 60 mL/min/1.73 m2.
The prevalence of subclinical primary hypothyroidism increased from 7% in patients with an estimated GFR ≥90 mL/min/1.73 m2 to 17.9% in patients with an estimated GFR <60 mL/min/1.73 m2 (P<0.0001 for trend).
After adjustment for age, sex, fasting glucose, total cholesterol, and triglycerides, an estimated GFR of lower than 60 mL/min/1.73 m2 increased the likelihood of subclinical hypothyroidism by almost 75% compared with patients who had higher estimated GFR values (OR 1.73, 95% CI 1.20 to 2.48, P=0.003).
"With progressively lower estimated GFR, there was graded increased likelihood of subclinical primary hypothyroidism," the authors said.
The authors noted several limitations of the study. "Because this study is cross-sectional, the present analysis is limited in its ability to establish causal or temporal relationships between subclinical primary hypothyroidism and kidney disease."
"Nonthyroidal (e.g., low T3 syndrome, which is typically seen in some ill patients, including those with end-stage renal disease) and thyroidal causes of subclinical hypothyroidism were not identified."
Dr. Chonchol and colleagues reported no disclosures.

Primary source: Clinical Journal of the American Society of NephrologySource reference:Chonchol M, et al "Prevalence of subclinical hypothyroidism in patients with chronic kidney disease" Clin J Am Soc Nephrol 2008; DOI: 10.2215/cjn.00800208.

ADA: Intensive Diabetes Treatment to Blame for Excess Mortality Risk

By Crystal Phend
SAN FRANCISCO, 12 june 2008-- The elevated mortality seen among patients with type 2 diabetes in a major trial of intensive glucose management cannot be pegged to either rosiglitazone (Avandia) or hypoglycemia, researchers said here.
Rather, they suggested, it was the multiple-agent treatment and rapid decrease in glycosylated hemoglobin levels to a target 6.5% that increased mortality 22% (1.41% versus 1.14% per year, P=0.04) compared with a standard approach targeting 7% in the ACCORD trial.
The results of ACCORD and two other large, randomized trials of tight glucose control made waves at the American Diabetes Association meeting. Subgroup analyses of ACCORD found no single factor that could account for the higher death rate, said Robert P. Byington, Ph.D., of Wake Forest University in Winston-Salem, N.C., and colleagues in an extensive panel discussion of the results.
"I think this is the price one pays for more intensive control," he said.
Notably, rosiglitazone tended to be protective against mortality, reported Michael E. Miller, Ph.D., also of Wake Forest University.
The only agents associated with significantly higher mortality were bolus and premixed insulin with a strong trend for basal insulin as well. All three increased risk about 25%, but an analysis did not find significant interactions with rosiglitazone for any of the three (P=0.53).
Dr. Miller noted, though, that premixed insulin was used more frequently in the standard glycemia treatment group and bolus insulin showed no difference between treatment groups.
A similar analysis of the Veterans Affairs Diabetes Trial, also reported here, showed that, if anything, there was a trend toward lower event rates with rosiglitazone. However, some researchers were skeptical of these post-hoc subgroup analyses, including Steven Nissen, M.D., of the Cleveland Clinic, who first brought to light the increased MI and other cardiovascular risks associated with the drug.
Not only were the trials not designed to answer questions about rosiglitazone, Dr. Nissen commented, but also the drug was used frequently across treatment groups and patients who took the drug were less likely to have pre-existing heart disease.
The ACCORD researchers likewise were circumspect about the significance of their subgroup findings, suggesting only hypotheses for further study.
The VA trial researchers identified severe hypoglycemia as one of the strongest predictors of cardiovascular events (HR 2.062, 95% CI 1.132 to 3.756, P=0.018).
But the ACCORD analysis did not confirm this as a factor in the increased mortality risk with intensive glycemic control, Dr. Byington reported.
Severe hypoglycemia more than doubled the risk of mortality but was linked to a higher rate of mortality in the standard treatment arm than in the intensive therapy arm (2.8% versus 4.9% per year, adjusted hazard ratio 0.52).
In patients who had never had a severe hypoglycemic event in the trial, the trend was the same as in overall mortality (1.3% versus 1.1% per year, adjusted HR 1.22).
"People keep asking us what was the cause of the higher mortality," said Denise G. Simons-Morton, M.D., Ph.D., of the National Heart, Lung, and Blood Institute in Bethesda, Md., another ACCORD investigator. "It's the strategy."
The reason for the significant increase in mortality in ACCORD but not the VA trial or the third trial reported here -- ADVANCE -- was likely the more rapid drop in glycosylated hemoglobin, she said."The biggest problem from my perspective is the fact that you're dealing with a regimen that's extremely intense in patients who had atherosclerosis for a long time," agreed Robert Sherwin, M.D., of Yale, who commented on the findings in a separate panel discussion of results from all three trials.
He noted that the regimens used in ACCORD typically included three to five oral agents and at least one insulin, which is rare in clinical practice and has never been tested in trials in such extensive combinations. "With ACCORD they just went too far, I think."
Clinical practice will likely continue as is but "maybe not push as hard" for the near normal glycosylated hemoglobin levels, commented Sue Kirkman, M.D., of the ADA in New York, who spoke at the same session. "It probably matters how you get there."
ACCORD was funded by the National Institutes of Health, the CDC, and General Clinical Research Centers. Medications, equipment, and supplies were provided by Abbott, Amylin, AstraZeneca, Bayer, Closer Healthcare, GlaxoSmithKline, King, Merck, Novartis, Novo Nordisk, Omron, sanofi-aventis, and Schering-Plough.
The ACCORD researchers who were presenting reported no potential conflicts of interest.
Dr. Kirkman reported no conflicts of interest. Dr. Sherwin reported conflicts of interest for Amylin, Merck, Lilly, Boehringer Ingelheim, and Bristol-Myers Squibb with a possible future role with Pfizer as well. Dr. Nissen reported no conflicts of interest.

Primary source: American Diabetes Association meetingSource reference:Kirkman S, et al "ACCORD trial -- study results" ADA Meeting 2008. Additional source: American Diabetes Association meetingSource reference: Lebovitz H, et al "Panel discussion -- glycemic control and heart disease -- implications for clinical practice" ADA Meeting 2008.

Benefit small from lung cancer screening method

11 june 2008--A high-tech X-ray called a spiral CT scan may help reduce lung cancer deaths in smokers and former smokers, but only reduces their overall risk of premature death by 4 percent, researchers reported on Tuesday.
Heart disease, respiratory disease and other types of cancer are still highly likely to kill smokers and former smokers early, the team at Harvard Medical School and the Mayo Clinic in Rochester, Minnesota, found.
Their study, published in the journal Radiology, will likely add to a debate on the value of screening smokers for lung cancer.
"Our study suggests that screening may be one way to reduce risk of death from lung cancer," Dr. Pamela McMahon of Massachusetts General Hospital and Harvard said in a statement.
"However, the number-one goal should still be to quit smoking, because it will reduce risk of death from many causes, including lung cancer."
Lung cancer is the leading cause of cancer death in the United States -- the American Cancer Society estimates it will kill 168,840 people in 2008. About 87 percent of lung cancer cases are caused by smoking.
It is so deadly in part because it causes few symptoms in early stages -- only 15 percent of lung tumors are found before they have spread. If diagnosed in the earliest stages, half of lung cancer patients live five years or more, but that survival rate drops to 2 percent for people diagnosed in later stages.
Some experts have proposed spiral computed tomography, or spiral CT scans, as a way to screen smokers and other high-risk people.
McMahon's team looked at a study done at the Mayo Clinic of 1,520 current and former smokers who got helical, or spiral, CT scans. They entered data into a computer model of lung cancer development.
The computer projection showed that patients who had five annual screenings had an estimated 37 percent relative increase in lung cancer detection, compared with those who had not been screened. The relative reduction in lung cancer-specific death was 28 percent.
But they said those who were screened would be only 4 percent less likely to die of all causes, compared with people not screened.
After 15 years, those who got screened annually would be 15 percent less likely to have died of lung cancer and 2 percent less likely to have died of anything.
"Our study fills in a piece of the puzzle but does not solve it," McMahon said in a statement. "We are hopeful that randomized trials conducted by the National Cancer Institute will show a benefit from screening. Until then, patients should think carefully about undergoing a test that has no direct evidence of benefit."
Some experts worry that screening can lead to detection of tumors that would never have grown into something serious for the patient.
X-rays can also find lesions that must be tested with a biopsy -- a small piece of tissue -- taken from the lung. Taking a biopsy carries a small risk of collapsing a lung.

Bright Lighting May Alleviate Some Symptoms of Dementia

By Todd Neale
AMSTERDAM, 11 june 2008--For older patients who have dementia, bright lighting may help correct circadian rhythms and improve cognitive and physical functioning, researchers found.
Compared with patients in assisted living facilities who were exposed to lower levels of light in the dayroom, those exposed to bright lighting had less cognitive deterioration, fewer depressive symptoms, and a slower decline in functional limitations, Eus Van Someren, Ph.D., of the Netherlands Institute for Neuroscience here, and colleagues reported in the June 11 issue of the Journal of the American Medical Association.
A daily dose of melatonin had mixed effects, they said, improving sleep quality but worsening mood and increasing withdrawn behavior.
Therefore, the researchers said, melatonin's "long-term use by elderly individuals can only be recommended in combination with light to suppress adverse effects on mood."
In older patients with dementia, cognitive decline is frequently accompanied by changes in mood, behavior, sleep, and activities in daily living, which may be influenced by changes in the circadian pacemaker in the brain, the researchers said.
Because circadian rhythms may be subject to the effects of environmental light and melatonin, the researchers evaluated 189 older patients (mean age 85.8; 90% female) living in 12 group care facilities in the Netherlands. Most of the participants (87%) were diagnosed with some form of dementia.
Half of the facilities were assigned to bright lighting (±1000 lux) in the common living room and half to dim, or placebo, lighting (±300 lux) from 9 a.m. to 6 p.m. daily. At each facility, participants were randomized to 2.5 mg of melatonin an hour before bedtime each night or to placebo, creating four study groups:
Bright lights only (49)
Melatonin only (46)
Both bright lights and melatonin (49)
Neither bright lights nor melatonin (45)
The mean duration of the study was 15 months (maximum 3.5 years).
Bright lighting alone was associated with a relative 5% attenuation of cognitive decline, as measured on the Mini-Mental State Examination (P=0.04).
Bright lights also reduced depressive symptoms by a relative 19% (P=0.02), slowed the increase in functional limitations by a relative 53% (P=0.003), and increased total sleep duration by 2% (P=0.04).
Treatment with melatonin alone shortened sleep onset latency by 19% (P=0.02), increased sleep duration by 6% (P=0.004), and lengthened the average duration of uninterrupted periods of sleep by 25% (P=0.02).
However, the hormone was associated with worse scores on the positive scale of a mood assessment (P=0.02) and higher scores on the negative scale (P=0.01), as well as an increase in withdrawn behavior (P=0.02).
All three of these negative effects were diminished when melatonin was combined with exposure to bright lights, the researchers said.
The combined treatment also reduced agitated behavior by 9%, increased sleep efficiency by 3.5%, improved nocturnal restlessness by 9%, and reduced the average duration of individual awakenings at night by 12% (P=0.01 for all).
None of the treatments increased the occurrence of adverse events and the bright lights reduced dizziness, headache, inability to sleep, irritability, and constipation, which was also reduced by melatonin.
The researchers hypothesized that the benefits resulted from the synchronization of the circadian timing system, and that light acting on the suprachiasmatic nucleus "may have improved its abilities to synchronize rhythms in, for example, hormones, metabolism, and peripheral oscillators."
In terms of whether the effects were clinically significant, the researchers concluded, "On the whole, light treatment could have clinically beneficial effects."
For instance, they said, the combined effects of melatonin and bright light on sleep, if sustained over time, "could help maintain sleep efficiency above 85%, which has been regarded as a cutoff for clinically relevant disturbed sleep."
Most of the other effects have no accepted cutoff values for clinical relevancy, they said, but the improvements in depressive symptoms could possibly change major depression to minor depression or minor depression to no symptoms.
The authors acknowledged some limitations, including the fact that the trial was conducted in a "somewhat homogenous" population, a high dropout rate, and the fact that the results might not be applicable to men because of the small percentage of them in the study population.
Also, interpretation of the results should be done with caution, they said, because of the multiplicity of analyses and outcomes in the study.
The study was supported by the Netherlands Organization for Health Research, the Netherlands Organization for Scientific Research, the Stichting De Drie Lichten, Stichting RVVZ, Zeist, the Japan Foundation for Aging and Health, Hersenstichting Nederland, and Internationale Stichting Alzheimer Onderzoek. Philips Lighting BV, Braun, and Cambridge Neurotechnology supplied material at reduced cost.The authors made no financial disclosures.

Primary source: Journal of the American Medical AssociationSource reference:Riemersma-van dek Lek R, et al "Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial" JAMA 2008; 299: 2642-2655.

Bone drug prevents one type of breast cancer, study says

11 june 2008--The osteoporosis drug Evista can help prevent breast cancer -- but only the type fueled by the hormone estrogen, researchers reported on Tuesday.
So-called estrogen-receptor-positive breast cancer is the most common type and women who took Eli Lilly and Co's Evista were 55 percent less likely to develop this type of cancer than women taking a placebo, the researchers reported in the Journal of the National Cancer Institute.
Evista, known generically as raloxifene, is already approved for reducing the risk of breast cancer in women past menopause who have osteoporosis.
Because it acts on estrogen, scientists had assumed it would be more effective against estrogen-receptor-positive breast cancer but no one had demonstrated this.
Dr. Deborah Grady of the University of California, San Francisco and colleagues tested this, using a group of 10,000 women who originally volunteered for a study to see if the drug can lower the risk of heart disease.
The Raloxifene Use for the Heart (RUTH) trial showed that the drug did not protect against heart disease. But it did reduce the risk of invasive breast cancer by 44 percent over 5.6 years, compared with women not taking the drug.
Half the women got Evista and half got a placebo. Those who took raloxifene had a 55 percent reduction in the risk of developing invasive ER-positive breast cancer.
There was no reduction in the risk of other types of breast cancer, including noninvasive breast cancer, often called carcinoma in situ.
Raloxifene is a selective estrogen receptor modulator, or SERM, and prevents osteoporosis in a different way than other types of drugs known as bisphosphonates.
"Overall, clinical evidence is accumulating that the SERMs hold great promise in being able to control multiple diseases," Craig Jordan of the Fox Chase Cancer Research Center in Philadelphia wrote in a commentary.
"This is the good news because, until recently, it was generally believed that hormone replacement therapy was the answer to controlling the development of coronary heart disease and osteoporosis but at the price of an enhanced risk of invasive breast cancer," Jordan said.

ADA: Metabolic Monitoring Guidelines for Antipsychotics Largely Unheeded

By Crystal Phend
SAN FRANCISCO, 11 june 2008-- Recommendations for lipid and glucose monitoring for patients on atypical antipsychotic drugs have made scarcely a dent on clinical practice, researchers found.Metabolic screening and monitoring rates rose by 5% or less since 2004, when the FDA warned of increased diabetes and cardiovascular risk with antipsychotic medications, according to two separate analyses of large insurance claim databases reported here at the American Diabetes Association meeting.Only about 20% of patients on second-generation antipsychotics received recommended glucose monitoring and just 10% had lipids monitored, reported Dan W. Haupt, M.D., of Washington University in St. Louis, and colleagues in one of the studies.
Changes in screening rates were no better than, and in some cases worse, for patients starting antipsychotics than for other commercially-insured patients, found Elaine Morrato, Dr.P.H., M.P.H., of the University of Colorado in Denver, and colleagues in the other study.
In 2004, the FDA asked manufacturers of atypical antipsychotics to add a warning of the risk of hyperglycemia and diabetes with these medications.
Around the same time, the ADA, American Psychiatric Association, and other groups issued a joint consensus statement recommending that doctors screen and monitor patients on second-generation antipsychotics for signs of rapid weight gain or other problems that could lead to diabetes, obesity, and heart disease.
Surveys have found relatively high awareness of risk, intentions to screen, and self-reported screening rates, Dr. Morrato said. "So there's a disconnect between what's happening and what they say is happening."
Her study included 18,176 adults initiating aripiprazole (Abilify), clozapine (Clozaril, FazaClo), olanzapine (Zyprexa, Zydis), quetiapine (Seroquel), risperidone (Risperdal), or ziprasidone (Geodon) from 2001 through 2006 compared with 56,522 adults likewise at high risk because of diabetes.
For patients on antipsychotics, blood sugar screening rates in 2006 in the month prior to or after initiation was 25.6% and 45.5% within 61 days. Lipid screening rates were 8.9% and 26.9%, respectively.
Glucose screening rose 0.8% per quarter among antipsychotic-treated patients before the guidelines compared with a decrease of 0.6% per quarter afterward (P=0.07 for trend).
Among diabetic control group patients, laboratory glucose screening rates rose 1.2% per quarter before the statement and decreased 1.3% per quarter afterward (P<0.01 for trend).
Likewise, lipid screening decreased 0.6% per quarter after the consensus statement among antipsychotic-treated patients (P<0.001 for trend) compared with a decrease of 1.3% per quarter (P=0.37 for trend) among control group patients.
"Whatever we're observing is just sort of background rates happening," Dr. Morrato said.
Dr. Haupt's retrospective cohort study similarly used a large national insurance database. It included 5,787 patients pre-guideline (2000 to 2003) and 17,832 post-guideline (2004 to 2006) followed from 40 days prior to and 130 days after atypical antipsychotic prescription.
Monitoring rates were:
For lipid screening, 8.25% before guidelines and 10.08% afterward (P<0.01).
For lipid monitoring, 6.78% before guidelines and 8.63% after (P<0.05).
For glucose screening, 17.23% before guidelines and 21.37% after (P<0.01).
For glucose monitoring, 14.03% before guidelines and 17.61% afterward (P<0.01).
Part of the reason for low screening and monitoring rates may be that patients don't follow up on doctor's orders, particularly because many psychiatrists offices are not set up to do onsite blood draws, Dr. Morrato said.
Adding to this challenge is an "identity crisis" in psychiatry, Dr. Haupt said. "Historically these are people who have gone to medical school but have not viewed themselves as physicians in the same way as an internist would."
After the de-institutionalization of psychiatry in the late '60s and '70s, he said, "psychiatrists have been practicing really kind of separated from the rest of the medical field."
Even when screening is done, interpreting the findings of lab results and treating based on them has been problematic, as well, Dr. Morrato noted.
"Many psychiatrists don't necessarily consider these kinds of metabolic complications associated with mental illness and its treatment to be their responsibility," Dr. Haupt said.
The APA is completing a report on these issues that should be similar to existing ADA recommendations, said Dr. Haupt, who was a member of the work group for the report.
Changing clinical behavior for any guideline is not easy, Dr. Morrato said. A disease management approach may help, she said, but Dr. Haupt saw the real shift in the future as reimbursement linked to this kind of quality of care measures comes down the pipeline.
Dr. Morrato's study was supported by Pfizer. Dr. Haupt's study was supported by funding by Bristol-Myers Squibb and Otsuka Pharmaceutical.
Dr. Morrato reported no conflicts of interest. Dr. Haupt reported receiving research support from Abbott and the National Institutes of Health; consulting for Abbott, Bristol-Myers Squibb, Pfizer, Organon, and Wyeth; and receiving royalties from Compact Clinicals for a metabolic reporting form.
Primary source: American Diabetes Association meetingSource reference:Morrato EH, et al "Metabolic screening before and after the ADA consensus statement on antipsychotic drugs and risk of diabetes and dyslipidemia" ADA Meeting 2008; Abstract 967-P. Additional source: American Diabetes Association meetingSource reference: Haupt DW, et al "Prevalence and predictors of lipid and glucose monitoring among commercially insured patients treated with atypical antipsychotic agents" ADA Meeting 2008; Abstract 1216-P.

ADA: Glycemic Control Markedly Improved with Duodenal-Jejunal Sleeve

By John Geve
SAN FRANCISCO, 11 june 2008-- For obese patients with diabetes, a Teflon-like sleeve placed inside the small intestine just beyond the stomach seems to improve glycemic control quickly and markedly, a researcher said here In a small study, the investigational two-foot-long bypass prevented food from coming into contact with the duodenum and upper jejunum, reported Christopher H. Sorli, M.D., of the Billings Clinic in Billings, Mont., at the American Diabetes Association meeting. The impermeable fluoropolymer sleeve is placed via an endoscope and fastened with a barbed metal anchor at the duodenal entrance. The 16 patients in the study had a mean baseline BMI of 38 and a hemoglobin A1c of 9%.
After only one week, the daily average glucose level declined 58.4 mg/dL (SD 54.5 mg/dL) among 11 patients receiving the bypass sleeve, compared with an increase of 1.1 mg/dL (SD 45.7 mg/dL) in five sham-treated patients (P<0.05), according to interim results.
There were similar changes in average fasting plasma glucose levels in the two groups one week after placement, but the difference did not reach statistical significance.
Among eight patients receiving the sleeve for whom follow-up data were available at 31 weeks, glycosylated hemoglobin levels fell by 2.9 percentage points, from a baseline level of 8.9%, Dr. Sorli reported. For three sham-treated patients with 31-week data, hemoglobin A1c levels fell 0.76 percentage points (P=0.04).
"[The sleeve] rapidly improves glycemic control in type 2 diabetes as early as one week, independent of weight loss," he said.
The sham treatment involved sedation and endoscopy, but no sleeve was placed. In both groups, patients were on a liquid pureed-food diet for the first two weeks, advancing to solid food as tolerated.
All patients also were counseled to keep daily food intake to 1,200 calories for women and 1,500 calories for men.
Most patients receiving the sleeve were able to stop their previous diabetes medication, he added.
At baseline, seven of the patients were taking metformin alone and another four were on metformin and a sulfonylurea drug.
After 12 weeks, just one patient remained on metformin and none were taking sulfonylureas.
In the sham group, three of five patients evaluable at week 12 were still on oral medication.
Dr. Sorli said the sleeve is designed to mimic the effects on glycemia seen with Roux-en-y gastric bypass surgery, but less invasively.
Exactly how the sleeve affects glycemia is unclear, as the case for bypass surgery. "There's something happening in the small bowel that if you interact with it correctly, it has potential benefits, particularly for blood sugar control," Dr. Sorli said.
A number of studies in bypass patients have suggested that it involves the so-called incretin pathway that is now the target for several new diabetes drugs.
Patients lost weight with the sleeve, but a difference from sham treatment did not appear until several months into the study.
At week 12, mean weight loss relative to baseline was 7.76 kg in the sham-treated group and 8.55 kg with the sleeve.
But there was no further weight loss in the sham arm, whereas patients receiving the sleeve lost a total of 11.44 kg from baseline at week 20, Dr. Sorli said.
Dr. Sorli said the sleeve came loose and began migrating in three patients. In all cases, it was successfully retrieved through endoscopy.
Other adverse events included 8 cases of abdominal pain, three cases each of diarrhea and vomiting, two incidents of hypoglycemia, and one of nausea.
Dr. Sorli said the sleeve's design has not been finally established. "This is a pilot study, and there are so many variables we need to explore," he said. "Would longer be better? Would shorter be better? We don't know the answer to that. We also don't know the answer to how long we can leave it in."
He said leaving them in place for six months is now being studied, and even longer trials will probably be undertaken, he said.
Richard Pratley, M.D., a diabetologist at the University of Vermont in Burlington, said the concept seemed promising.
The prospect of a shorter and easily reversible procedure without general anesthesia would be an advantage over gastric bypass, he said. "Bypass surgery is big surgery," he said.
He said additional data on the safety and tolerability would be important.
Dr. Pratley also questioned whether the efficacy stemmed more from changes in patients' diet than from the device itself.
"Anything where you stop eating will lower your glucose. There may not be anything magical behind it," he said.
However, Dr. Sorli said that patients could eat as much as they did previously, and many probably did. Unlike gastric bypass or banding procedures, the sleeve does not physically restrict how much patients can eat, he said.
The study was supported by GI Dynamics, developer of the bypass sleeve.
Dr. Sorli reported relationships with GI Dynamics, GlaxoSmithKline, Eli Lilly, Novo Nordisk, Takeda, Merck, sanofi-aventis, and Covidian.
Dr. Pratley reported relationships with GlaxoSmithKline, Eli Lilly, Novo Nordisk, Takeda, Merck, sanofi-aventis, Novartis, and Roche Diagnostics.
Primary source: American Diabetes Association meetingSource reference:Tarnoff M, et al "Interim report on a prospective, randomized sham controlled trial investigating a completely endoscopic duodenal-jejunal bypass sleeve for the treatment of type 2 diabetes" ADA Meeting 2008; Abstract 32.

Expand TB Prevention and Care, U.N. Forum Urges

By Michael Smith
NEW YORK, 10 june 2008-- Tuberculosis treatment, prevention, and research needs to be scaled up drastically in conjunction with the battle against HIV/AIDS, speakers at a United Nations forum said today.
In a call to action by the inaugural HIV/TB Global Leaders Forum, participants said the combination of the two diseases means that one person with HIV dies of TB every three minutes, even though TB is both preventable and treatable.
One estimate puts the number of HIV-associated TB deaths at 700,000 annually, according to Kevin De Cock, M.D., director of the World Health Organization's HIV department.
"It's the cause of death of about half the patients dying from AIDS," Dr. De Cock said in a telephone press conference.
Even to cut that in half will need an estimated $19 billion in new money between now and 2015, the forum was told, including about $5 billion for research into new drugs and vaccines.
The forum called on the international community to:
Implement good infection controls to ensure that those with HIV are able to attend health services without fear of contracting TB.
Make sure regular TB screening and preventive treatment is available in all HIV care settings.
Ensure that all TB patients can get HIV counseling and testing and appropriate HIV prevention, treatment, and care.
The call to action came on the eve of a high-level meeting of the U.N. General Assembly called to review progress in the battle against AIDS.
It also came as the U.S. Congress debated re-authorization of the President's Emergency Plan for AIDS Relief, which would contain up to $4 billion for TB.
Dr. De Cock said the U.N. is committed to a goal of universal access to HIV treatment, but that must be coupled with universal access to TB testing and treatment.
"There can be no universal access without universal access to TB prevention, treatment, and care," he said.
Kenyan HIV activist Lucy Cheshire -- herself co-infected at one time with both diseases -- said 205 civil groups from 67 countries are presenting a call to the global leaders to expand TB prevention and treatment.
"That means we ensure every person with TB is offered HIV testing," she said, as well as "ensuring that every person living with HIV is screened for TB."
Experience in several countries in Africa shows better TB care is possible, according to Mario Raviglione, M.D., director of the WHO's Stop TB Department.
In Kenya, for instance, 70% of TB patients were tested for HIV in 2007, up from 19% in 2004. In Rwanda, the proportions went from 0% in 2004 to 80% in 2004, he said.
The issue is especially critical with the advent of new strains of TB that are highly resistant to current medications. So-called extensively drug resistant TB (XDR TB) hits as many 40,000 people a year, according to Dr. Raviglione.
Most of that is in the former Soviet Union and China, he said, but it is also spreading in southern Africa. The most dramatic evidence of the risk came during the 2006 AIDS meeting, when South African researchers reported an outbreak that killed 52 of 53 victims, many within days of infection. Dr. Raviglione said cases of XDR TB are now being reported in Botswana, Namibia, and Lesotho, among other countries. "We believe that XDR is spreading in that part of the continent," he said.
While new molecular methods of testing are under development, they are not likely to be available at the point of care for at least a few years, Dr. Raviglione said. In the meantime, clinicians still rely on the microscope to diagnose TB -- exactly as they have done for more than a century.
He added that about a dozen new drugs are in the pipeline, but new multi-drug regimens are unlikely to be available before about 2015.
Dr. De Cock added that even the current techniques for TB testing are beyond the capabilities of many developing nations. "We need infrastructure as well," he said.

Racial Disparities in Diabetes Care Rooted in Physician Performance

By Todd Neale
BOSTON, 10 june 2008 -- Black patients treated for diabetes had worse outcomes than whites seen by the same clinicians at a large group practice in Massachusetts, researchers here found. The black patients were significantly less likely than whites to achieve control of hemoglobin A1c, LDL cholesterol, and blood pressure (P<0.001 for all), Thomas Sequist, M.D., M.P.H., of Brigham and Women's Hospital and Harvard, and colleagues reported in the June 9 issue of Archives of Internal Medicine. Controlling for sociodemographic factors attenuated some of the differences, but the bulk of the disparity was strongly driven by individual physician activity, the researchers concluded.
"In addition, the substantial physician-level variation in [diabetes] care was not related to overall performance or volume of black patients treated," the researchers said, "suggesting that system-wide interventions will be needed to improve care for minority patients across all physicians."
These interventions might include cultural competency training and the creation of race-stratified performance reports to raise awareness of disparities, Dr. Sequist said.
Racial disparities in diabetes care -- including poor attainment of intermediate treatment goals and worse long-term outcomes for blacks compared with whites -- have been well studied, the researchers said, but few studies have examined the role that factors at the physician level might play.
To help fill the gap, Dr. Sequist and colleagues evaluated care given to adults with diabetes at an integrated multispecialty group practice. They looked at records from 90 primary care physicians practicing in 13 ambulatory health centers who cared for at least five white patients and five black patients.
Of 6,814 patients, 4,556 were white and 2,258 were black. The black patients were significantly younger, less likely to be male, and more likely to live in communities with lower median household incomes than the whites (P<0.001 for all).
Patients of both races were equally likely to receive annual testing for hemoglobin A1c and LDL cholesterol, but blacks were less likely to have received a statin prescription in the previous year (54% versus 65%, P<0.001).
Blacks were significantly less likely to achieve ideal targets -- a hemoglobin A1c level of less than 7% (39% versus 47%), an LDL cholesterol level of less than 100 mg/dL (45% versus 57%), and a blood pressure of less than 130/80 mm Hg (24% versus 30%) (P<0.001 for all).
Blacks were also significantly less likely than whites to achieve even adequate control for these three measures (P<0.001 for all), the researchers said.
Controlling for clinical factors and between-physician effects had little impact on the disparities in care.
Sociodemographic factors, including age, sex, income, and insurance status, explained 13% to 38% of the observed differences, the researchers said.
Effects at the individual physician level, however, had a substantial influence on the differences, from 66% and 68% of the differences in hemoglobin A1c and LDL cholesterol control, respectively, to 75% of the disparity in blood pressure control.
There were no significant associations between the magnitude of the racial disparities and the number of black patients treated or the overall quality of diabetes care by individual physicians.
"Our data suggest that the problem of racial disparities is not characterized by only a few physicians providing markedly unequal care," the researchers said, "but that such differences in care are spread across the entire system, requiring the implementation of system-wide solutions."
The authors acknowledged several limitations, including the fact that studying just one practice might have reduced the ability to find between-physician effects on disparities in care.
The study was also limited by the inability to analyze differences in physician practice patterns, the use of zip code estimates of median income, the lack of information on outside social factors, and the exclusion of other racial or ethnic groups.
Despite these limitations, Carolyn Clancy, M.D., director of the Agency for Healthcare Research and Quality in Rockville, Md., called the findings "important and provocative."
In an accompanying editorial, she proposed two explanations for the poorer outcomes in black patients in the study: First, aspects of care besides testing, such as teaching about medications and overall communication, might have been inferior. Second, she said, the disparities might have resulted from differences in the patients' level of engagement and support for long-term behavioral changes.
The findings illustrate the need to close the gap between ideal and actual care in diabetes, she said, noting that even in whites the level of control for intermediate outcomes fell short.
She said that public reporting of individual physicians' clinical performance might be one solution to eliminating disparities in care, although this remains controversial.
"Eliminating disparities in healthcare will require that all patients have access to care, as well as physician leadership to assure that the care provided is evidence-based, patient-centered, effective, consistent, and equitable," she concluded.
The study was funded by the Robert Wood Johnson Foundation Finding Answers: Disparities Research for Change national program.
Dr. Sequist serves as a consultant on the Aetna External Advisory Committee for Racial and Ethnic Equality. One of his co-authors serves as a consultant to RTI International and DxCG Inc. Dr. Clancy made no financial disclosures.

Primary source: Archives of Internal MedicineSource reference:Sequist T, et al "Physician performance and racial disparities in diabetes mellitus care" Arch Intern Med 2008; 168: 1145-1151. Additional source: Archives of Internal MedicineSource reference: Clancy C "Improving care quality and reducing disparities" Arch Intern Med 2008; 168: 1135-1136.

Low Vitamin D Levels in Men Linked to Heart Attack Risk

By Judith Groch
BOSTON, 10 june 2008 -- A vitamin D deficiency has been associated with twice the risk of a myocardial infarction over a decade for men with undiagnosed coronary disease at baseline, a nested case-control study found.
Men with intermediate levels of the vitamin had a 60% increased MI risk, epidemiologist Edward Giovannucci, M.D., Sc.D., of the Harvard School of Public Health, and colleagues reported in the June 9 issue of the Archives of Internal Medicine.
Studies have shown that deaths from cardiovascular disease rise at higher latitudes, increase during the winter months, and are lower at high altitudes, the investigators wrote.
This pattern is consistent with an adverse effect of low vitamin D which is more prevalent at higher latitudes, during the winter, and at lower altitudes, said Dr. Giovannucci and colleagues.
To determine whether plasma 25-hydroxyvitamin D concentrations are associated with risk of coronary heart disease, the researchers undertook the nested case-control study of 18,225 men in the Health Professionals Follow-up Study.
Only 23% of the men in this study had vitamin D levels considered normal (at least 30 ng/mL). This percentage is typical of many populations, and deficiency is even higher in dark-skinned individuals and elderly persons.
The men (ages 40 to 75) were free of diagnosed cardiovascular disease at blood collection. The blood samples were returned
from April 1, 1993 to Nov. 30, 1999 with 99% received by Nov. 30, 1995.
During 10 years of follow-up, 454 men developed nonfatal myocardial infarction or fatal coronary heart disease.
These men were matched (2:1 ratio) with records and blood samples from 900 living men with no history of cardiovascular disease. Age, smoking status, diet, and lifestyle factors were recorded from self-administered questionnaires.
After adjustment for matched variables, men deficient in vitamin D (15 ng/mL or less) had 2.42 times the risk for MI compared with those with ≥30 ng/mL (relative risk 2.42, 95% confidence 1.53 to 3.84, P< 0.001 for trend).
This relationship remained significant (RR, 2.09, 95% CI 1.24 to 3.54, P=0.02 for trend), even after additional adjustment for family MI history, BMI, alcohol consumption, physical activity, history of diabetes and hypertension, ethnicity, region, marine omega-3 intake, low and high-density lipoprotein cholesterol levels, and triglyceride levels.
Even men with intermediate vitamin D levels of 22.6 to 29.9
ng/mL) had a greater risk compared with those with sufficient levels: RR 1.60, 95% CI 1.10 to 2.32.
The association was suggestively stronger for fatal coronary heart disease, but the number of cases was too small for definitive conclusions, the researchers said.
Individuals in sun-rich environments, where clothing or cultural practices do not appreciably limit vitamin D production, often reach vitamin D levels of 54 to 90 ng/mL.
Because vitamin D levels are largely affected by sun exposure, it is possible that some other consequences of sun exposure other than vitamin D production are responsible for the observed association with MI, the researchers said.
Although alternative explanations are possible, a variety of plausible biological mechanisms support a role for vitamin D.
The vitamin affects vascular smooth-muscle cell proliferation,
inflammation, a cytokine profile that favors inflammation, vascular calcification, and blood pressure through the renin-angiotensin system, all of which affect the risk for cardiovascular disease and MI, the researchers wrote.
Other possible mechanisms include vitamin D deficiency possibly combined with low calcium intake, which has been associated with impaired fasting glucose and possibly a risk of diabetes, all risks associated with cardiovascular disease.
Vitamin D deficiency has been related to an increasing number of conditions and to total mortality. These results further support an important role for vitamin D in MI risk, the investigators said.
If the association between vitamin D deficiency and MI risk is causal, which remains to be established, the amount of vitamin D required for optimal benefit may be much higher than would be provided by current recommendations (200-600 IU/d), especially
for those with minimal sun exposure, they said.
To increase circulating levels of vitamin D from 12 to 35.5 ng/mL would require approximately 3,000 IU of vitamin D daily. A glass of milk has approximately 100 IU, so that those who achieve 35 ng/mL do so largely through sun exposure.
Thus, the present findings "add further support to the belief that the current dietary requirements of vitamin D need to be increased to have an effect on circulating vitamin D levels substantially large enough for potential health benefits," the investigators said.
Dr. Giovannucci reported no financial conflicts. This study was supported by grants from the National Cancer Institute and the National Heart, Lung, and Blood Institute.
Primary source: Archives of Internal MedicineSource reference:Giovannucci E, et al "25-hydroxyvitamin D and risk of myocardial infarction in men: A prospective study" Arch Intern Med 2008; 168: 1174-1180.

ADA: Gum Disease Raises Diabetes Risk

By Crystal Phend
SAN FRANCISCO, 10 june 2008-- Periodontal disease and tooth loss may moderately increase the risk of developing type 2 diabetes, according to two longitudinal studies.
Tooth loss was associated with a 14% to 29% elevated risk of incident diabetes among both men and women, according to Kaumudi J. Joshipura, Sc.D., D.P.H., of the Harvard Schools of Public Health and Dental Medicine in Boston, and colleagues.
In their combined analysis of the Nurses' Health Study and the Health Professionals' Follow-Up Study, periodontitis was also associated with a 32% increased risk of incident diabetes among men with a trend for a 20% increased risk among women, they reported at the American Diabetes Association meeting here.
Inflammation is probably to blame for the link found in the study, though "it is a two-way relationship," Dr. Joshipura said.
"It's one more reason periodontal disease should be kept in control," she said. "Dentistry does need to be a part of the diabetic regimen."
Periodontal disease is considered one of the complications of diabetes, although most of the studies to look for a relationship have been cross-sectional. Dr. Joshipura's analysis is among the first prospective studies.
The two prospective cohort studies included 51,529 male health professionals ages 40 to 75 followed for 18 years and 104,064 female health professionals ages 34 to 59 followed for 12 years.
Both groups self-reported periodontal disease in periodic mailed questionnaires.
Among participants without type 2 diabetes at baseline, 3,646 men and 2,343 women developed incident diabetes verified by medical records.
After adjustment for adjusted for number of teeth, age, gender, smoking, family history of diabetes, exercise, obesity, diet, and other factors, the associations with incident diabetes included:
A history of periodontal disease at baseline showed only a weak increased relative risk of 1.08 among men (95% CI 0.96 to 1.21).
More recent periodontal disease during follow-up significantly increased risk among men (RR 1.32, 95% CI 1.15 to 1.51).
Moderate to severe periodontal disease was associated with a nonsignificant 17% increased risk among men (RR 1.17, 95% CI 0.97 to 1.42) and 20% increased risk among women (RR 1.20, 95% CI 0.96 to 1.50).
Periodontal surgery was associated with only a small trend for increased risk among women (RR 1.05, 95% CI 0.93 to 1.19).
Loss of at least one tooth during follow-up increased risk for both women (RR 1.14, 95% CI 1.06 to 1.22) and men (RR 1.25, 95% CI 1.12 to 1.40). The link was even stronger for more recent tooth loss in the two years prior to diabetes incidence (RR 1.18 and 1.29, respectively).
Fewer teeth at baseline also increased the relative risk significantly for all measures among women from 1.15 for 17 to 24 teeth (95% CI 1.05 to 1.24) to 1.34 for 10 or fewer teeth (95% CI 1.21 to 1.48). Likewise, the risk increased from 4% to 12% among men, although the risk was only significant for 10 or fewer teeth.
These associations are what would have been expected from prior studies, Dr. Joshipura said. But she cautioned that the study used self-reported periodontal disease, which may have underestimated the risk.
Notably, though, both periodontal disease and tooth loss were significantly associated with diabetes independent of smoking status (P<0.05), which was reassuring that confounding was not a problem in the study, Dr. Joshipura said.
"We're still at the age where more studies are needed to confirm these relationships," she concluded.
Dr. Joshipura reported no conflicts of interest.
Primary source: American Diabetes Association meetingSource reference:Joshipura KJ, et al "Periodontal disease and incidence of type 2 diabetes mellitus" ADA Meeting 2008; Abstract 889-P.

Can exercise help prevent addiction to drugs or alcohol?

By LAURAN NEERGAARD
10 june 2008--Sure, exercise is good for your waistline, your heart, your bones — but might it also help prevent addiction to drugs or alcohol?
There are some tantalizing clues that physical activity might spur changes in the brain to do just that. Now the government is beginning a push for hard research to prove it.
This is not about getting average people to achieve the so-called runner's high, a feat of pretty intense athletics.
Instead, the question is just how regular physical activity of varying intensity — dancing, bicycling, swimming, tae kwan do — might affect mood, academic performance, even the very reward systems in the brain that can get hijacked by substance abuse.
What first caught the attention of National Institute on Drug Abuse chief Dr. Nora Volkow: A study found tweens and teens who reported exercising daily were half as likely to smoke as their sedentary counterparts, and 40 percent less likely to experiment with marijuana.
Volkow knows — from her own 6-mile daily runs and from her scientific experiments — that the brain literally likes physical activity. Exercise seems to invigorate neurochemicals that sense and reinforce pleasure.
"In children, it's innate," she notes. "Children want to move."
But the nation's children are becoming more sedentary, as illustrated by the obesity epidemic, "screen time" replacing outdoor play and a drop in school P.E. And as youngsters approach adolescence, the run around the yard that used to be fun too often becomes a chore — the dreaded jog around the school track or the nagging to get off the couch. The sedentary teen turns into the sedentary adult.
"Why do we lose the ability to experience pleasure from physical activity?" asks Volkow.
Last week she brought more than 100 specialists in exercise and neurobiology to a two-day conference to explore physical activity's potential in fighting substance abuse, and announced $4 million in new research grants to help.
Drug treatment programs often include exercise, partly to keep people distracted from their cravings, but there's been little formal research on the effects.
The best evidence: Brown University took smokers to the gym three times a week and found adding the exercise to a smoking-cessation program doubled women's chances of successfully kicking the habit. The quitters who worked out got an extra benefit: They gained half as much weight as women who managed to quit without exercising, says lead researcher Dr. Bess Marcus.
She now is working with the YMCA on a larger, NIDA-funded study to prove the benefit.
Marcus cautions that people trying to kick an addiction have a powerful incentive to exercise. Could that possibly translate into prevention? Among the clues:
_Rats were less likely to ingest amphetamines if their cages had running wheels, suggesting exercise stimulated a reward pathway in the brain to leave them less vulnerable to the drug's rush.
_In people, exercise acts as a mild antidepressant and relieves stress. Depression, anxiety and stress increase risk of alcoholism, smoking or drug abuse.
_Volkow is intrigued that attention deficit disorder and obesity both involve problems with the brain chemical dopamine, one system that drugs hijack to create addiction.
_Baby monkeys who don't play enough in childhood have problems controlling aggression when they're older. The most aggressive tend to have defects involving the feel-good brain chemical serotonin — and binge-drink when researchers offer them alcohol.
_Back to rats, physical activity increases production of growth factors and stem cells in key brain regions important for learning and mood; increases formation of blood vessels; and strengthens communication networks between brain cells.
Together, that's far too little research to know if exercise really matters for substance abuse, scientists at the National Institutes of Health meeting cautioned.
But, a few studies of school-age children suggest physical activity predicts better performance on math, verbal and other tests — and better school performance in turn is linked to lower risk for substance abuse.
And getting sedentary seniors moving improves brain function — research aimed at preventing dementia, not drug abuse, although the improvement is in an area that in younger people is linked to risky decision-making.
A caveat: If your own youth includes memories of parties with beer-guzzling athletes, well, the research concurs. A major study that tracks adolescent risk behaviors found that by 12th grade, exercise offers no protection against binge-drinking.
"Now the kids who exercise the most actually drink the most," says Dr. Lloyd Johnston of the University of Michigan. It may have to do with the celebratory nature of team sports, or getting revved for college — or, other researchers suggested, even that competition is to blame.

Drawing a Map for the Later Years

By CHRISTINE LARSON
09 june 2008--LAURA MORGAN’S father, in his final years, had lost much of his short-term memory to Alzheimer’s disease. But Ms. Morgan was moved by what remained. On one visit, he didn’t seem to know her until she spoke her name: Then, “he put his arms together like he was holding a baby,” she recalls.
Years later, her insight into dementia and her empathy for patients and families led her to a new career. After two decades in communications, she began training to work in elder care. She took courses on aging issues and became certified to operate an assisted-living facility, then took a job in a hospital’s geriatric psychiatry unit. This year Ms. Morgan, 59, started her own geriatric care management practice in Los Angeles, helping families coordinate care.
The number of Americans over 65 is expected to exceed 71 million by 2030, and demand is growing for aging experts in every field, from law to fitness training to relocation. Revenue for elder care services should grow 6.6 percent annually through 2011, according to the Freedonia Group, a research firm.
But many family members don’t know how, or live too far away, to find and manage help for aging parents. That’s where geriatric care managers come in. They serve as guides through the fragmented care landscape, connecting clients with local services, assisted-living facilities and a wide network of paid caregivers, elder law attorneys and financial advisers. They help families find living options, assess the abilities of older people, write care plans and sometimes hire and supervise home help.
Some geriatric care managers specialize in problems of dementia, while others may focus on aging issues like depression or relocation.
Although geriatric care management has existed in the United States for about 20 years, with roughly 7,000 practitioners today, experts on aging say the profession is poised for rapid growth.
“I believe in the next 10 years, geriatric care managers will be one of the most important professional roles in the whole health services delivery system,” says Larry Minnix, C.E.O. of the American Association of Homes and Services for the Aging, a group of nonprofit retirement homes and service providers.
According to a 2008 survey by the National Association of Professional Geriatric Care Managers, 32 percent are solo practitioners, Many others work for social services agencies or small practices.
“This work satisfies two parts of myself: the part that loves to take care of people and the part that wants to be a businesswoman,” says Beverly Bernstein Joie, a co-founder of Elder Connections, a care management and home help practice outside Philadelphia.
A care manager working for an agency or small practice may earn $50,000 to $80,000 a year, says Cathy Cress, author of “Handbook of Geriatric Care Management.” Practice owners may make as much as $250,000 to $500,000. Solo practitioners often charge hourly fees of $80 to $200 and may earn more than $100,000 a year. Because geriatric care management is rarely covered by insurance, most clients pay out of pocket.
The payoff can be more than financial. Ms. Morgan worked with the family of one woman in her 80s who had suddenly become depressed. Ms. Morgan says she discovered that the new owner of the woman’s retirement community had discontinued all social activities. She recommended another community, known for its busy social calendar. Today, the woman has a boyfriend, roughly her age, who takes her dancing. Seeing this woman blossom was “immensely rewarding,” Ms. Morgan says.
Technically, anyone can call himself a geriatric care manager. But the association requires new members to hold one of four certifications. (Members who joined before 2008 will need to be certified by 2010.) Among them is “care manager certified,” issued by the National Academy of Certified Care Managers. It requires several years of supervised experience and a four-hour exam. Ms. Joie holds this certification.
Another is “certified case manager,” from the Commission for Certified Case Manager Certification; it requires a license in a caregiving field like nursing or social work, as well as certain types of experience and an exam.
MANY care managers start as nurses or social workers. All need to be familiar with the physical, emotional and social issues of aging, as well as with local resources.
To provide that background, more colleges are offering programs in geriatric care management. Hunter College in New York has offered a certificate in the subject since 2002, and the master’s program in gerontology at San Francisco State University added a formal emphasis in care management last year. The care managers association offers many resources for would-be care managers at http://www.caremanager.org/.
The profession has its drawbacks. Care managers sometimes mediate bitter family conflicts, and most are on call round the clock. Those starting practices may earn nothing or very little the first year, as they build networks.
But most managers find that the rewards outweigh the disadvantages. “"It’s an honor to be allowed into people’s lives at a very vulnerable moment,” Ms. Joie says. “It teaches you a lot about how to live your own life.”

Patient Web sites used for news, support in crisis

By STEPHANIE NANO
09 june 2008--When he was diagnosed with kidney cancer last year, Dave deBronkart needed an easy way to keep his far-flung friends and family updated. So did the president of the American Medical Association when he fell ill months ago. And so did the mother of a soldier wounded in Iraq who later suffered brain damage.
They all turned to the Internet, setting up individual Web sites to give progress reports. In return, they get posted notes of encouragement and support — all without having to repeat the details in emotional and exhausting phone calls.
"I had already been burning myself out with phone calls" telling people, said deBronkart, of Nashua, N.H.
DeBronkart, like others, used free online services like CaringBridge and CarePages and their user-friendly formats to quickly set up a Web site to share the news — good and bad. Patients themselves or family members write about treatment and recovery from illnesses, accidents or other medical crises, such as a premature births.
Sarah Doyle first used CarePages to prepare her for the arrival of her now year-old son Aidan. She learned during her pregnancy that Aidan would be born with his liver and intestines exposed. She read about the experiences of other families who had dealt with similar birth defects.
"I got a good idea what to expect. It wasn't such a shock," said Doyle, of Bellingham, Mass.
She has used her own page to chronicle Aidan's 11 months in a Boston hospital, his multiple surgeries and his arrival home in March. She recently reported that Aidan said his first word: mama.
"We really use it as a tool to say: We've been through some of the worst and now we're doing fine," said Doyle, who's expecting a second child in September.
Both online services were born out of medical emergencies, and have been used by tens of thousands since.
Sharon and Eric Langshur used a Web site created by a relative when their first child, Matthew, was born with a heart defect in 1998 and needed surgery. From their experience, they created the Chicago-based CarePages.
"The emotional support really took us by surprise," said Sharon Langshur, who was in training to become a pediatrician when her son was born.
Sona Mehring was involved in Web site design in 1997 when friends were faced with a difficult pregnancy. When she offered help, they asked her to just "let everyone know what's going on." She set up a Web site that was the beginning of CaringBridge, based in Minneapolis.
Both services are similar, with different features. To set up a Web site, all that is needed is an e-mail address and access to the Internet. There are different levels of privacy — ranging from those open to anyone who knows the page name, to those that are restricted to approved visitors. Individual pages can't be found through search engines.
Once an update is posted, visitors can be notified through an e-mail alert system.
"These stories are very personal, very unique and very powerful," said Mehring.
For visitors, CarePages provides a list of do's and don'ts when dealing with someone with a serious illness.
"Illness and hospitalization are incredibly isolating, and then to have people back away, can be very hurtful," said Langshur.
CaringBridge is supported primarily by donations from users, as well as sponsor fees from hospitals. CarePages also has arrangements with hospitals and sells advertisements.
Children's Hospitals and Clinics of Minnesota has been using CaringBridge since its beginning and helps families do updates by providing computers and digital cameras. President and CEO Alan Goldbloom said the hospital draws patients from around the Midwest, so some families are hundreds of miles from home when their child is in the hospital.
"We just think it's made a huge difference for families," said Goldbloom.
People learn about the Web services from hospital workers, or just through word of mouth, according to the founders.
Dr. Ron Davis knew of two people who used them during illnesses. So when he was diagnosed with pancreatic cancer this year, the preventive medicine specialist decided to share his story.
As AMA president, Davis, 51, figured others would want to know what was going on. And he's using it as an educational tool, providing the details of his treatment, with lab results, and to spread the word about the value of the Internet services.
"We need as physicians to focus more on the patient's emotional needs," said Davis, of East Lansing, Mich.
DeBronkart had heard about CaringBridge from a colleague when he was working in Minnesota.
"When my time came, I said, 'I know what I'm doing," deBronkart said.
A self-described e-mail maniac who works in computer software marketing, the 58-year-old deBronkart was soon doing frequent, chatty entries, sometimes from the hospital in the middle of the night.
"It lets you stay in touch with people even if you literally can't get out of your bed and they're thousands of miles away," he said.
He's racked up more than 16,000 visits to his Web page, some from old friends and classmates that he'd lost touch with over the years. "It really went viral," he said.
Anne deBronkart used it to keep tabs on her son between visits from her Maryland home. She said it was better than group e-mails because she drew support from all the posted messages, particularly the humorous tales some contributed.
"We all need that when we're going through something like this," she said.
The mother of Marine Lance Cpl. John Doody uses CaringBridge to keep in touch with his Marine buddies, friends and relatives in the Denver area, where he grew up, and her new husband and friends in Idaho.
Chris Ott has been at her son's side since January when he collapsed while recovering from gunshot wounds from Iraq and suffered brain damage. For a time, she stopped answering her phone because "it was too painful to talk about it."
Her sister set up the Web page and soon Ott was posting updates, writing about each step in her son's recovery, the move from San Diego to a Veterans Affairs rehabilitation center in Tampa, Fla., and outings to the mall and beach. News that her 25-year-old son had begun to talk again brought a flurry of excited replies.
"It helps lift your spirits when you know people are thinking about you and praying for you," said Ott, who was married at her son's bedside in February.

Cancer drug Velcade might work in lupus: study

09 june 2008--Velcade, a drug used to treat cancer, might also work against the chronic autoimmune disease lupus, German researchers said on Sunday.
Velcade was developed by Millennium Pharmaceuticals, a U.S. biotech company that was bought two months ago by Takeda Pharmaceutical Co Ltd for $8.8 billion in the biggest overseas acquisition by a Japanese drugmaker.
The injected medicine is currently given to patients with multiple myeloma, a cancer of the white blood cells. But tests on mice suggest it may also fight systemic lupus erythematosus, the research team reported in the journal Nature Medicine.
Using two mouse strains with lupus-like disease, Reinhard Voll and colleagues at the University of Erlangen-Nuremberg showed that Velcade blocked autoantibody production and prolonged survival of the mice.
As a result, Velcade -- known generically as bortezomib -- could represent a new and highly efficient treatment strategy for antibody-mediated diseases like lupus, they said.
"Careful clinical studies should be initiated," they concluded.
Lupus is an autoimmune disease characterized by inflammation of the joints, skin, major organs and central nervous system as the immune system attacks healthy tissues and cells. The disease tends to flare up and wane, making it difficult to assess the effectiveness of any treatment.
It has been more than 30 years since a new drug has been approved for lupus and many drug companies have failed in attempts to develop a successful treatment.
Existing therapy, involving a variety of immunosuppressive and cytotoxic drugs, is generally considered inadequate.
Velcade had global sales of $800 million last year. It is jointly marketed in the United States and other countries with Johnson & Johnson.

Intense diabetes therapy didn't cut heart problems

By STEPHANIE NANO
09 june 2008--Aggressively treating diabetes doesn't prevent heart problems and deaths any better than standard treatment for lowering blood sugar, Australian researchers reported Friday.
It's the second large study, involving thousands of patients, to show no heart benefit from drastically lowering diabetics' blood sugar levels. Experts said doctors should stick to the recommended target levels.
Heart disease is the cause of death for two-thirds of diabetics. Researchers tried pushing blood sugar down to near-normal levels to see if that would protect the hearts of high-risk patients with Type 2 diabetes.
But the Australian study showed no difference in the number of heart attacks, strokes and heart-related deaths between groups who got intensive or standard care. A U.S. study that was stopped earlier this year also showed no benefit and in addition reported an unexplained higher number of deaths among those who were aggressively treated.
The Australian study showed one positive result — a one-fifth reduction in kidney problems, a common complication of diabetes, compared to normal care.
"Both studies are important contributions to the field but do not provide a definitive answer," Dr. William T. Cefalu, of Louisiana State University, wrote in an editorial in the New England Journal of Medicine. He said other ongoing studies should provide clarification.
Both studies were released Friday in the journal and are being presented at an American Diabetes Association meeting in San Francisco. Partial results of the U.S. research were released in February when it was halted.
An estimated 21 million Americans and 250 million people worldwide have diabetes, meaning their bodies can't properly regulate their blood sugar, or glucose. Most have Type 2 diabetes. High levels of blood sugar can cause damage to the heart, blood vessels, kidneys and eyes.
Instead of trying aggressive measures, experts say there should be more focus on other strategies known to lower heart risks — diet, exercise and medications such as aspirin, cholesterol-lowering statins and blood pressure drugs.
In the two studies, researchers used a test that tracks average glucose levels over two to three months. For diabetics in the U.S., the recommended level is below 7. People without diabetes have levels around 5.
Both studies targeted diabetes patients middle-aged or older who had a heart problem or other heart risk factors. Doctors used a variety of diabetes drugs and insulin to try to get blood sugar levels down — to less than 6 in the U.S. study and 6.5 or lower in the international study.
The Australian study had more than 11,000 participants from Asia, Australia, Europe and Canada; the U.S. study had 10,000.
The U.S study was stopped after 3 1/2 years because of more deaths in the aggressively treated group: 257 deaths compared to 203 for standard care. The researchers said they haven't found a reason for the difference. Everyone was switched to standard treatment, and the researchers are continuing to follow them.
In a statement, Dr. Elizabeth G. Nabel, director of the National Heart, Lung, and Blood Institute, said that severely lowering blood sugar appears to be too risky for diabetes patients at higher risk for heart problems. Her institute helped pay for the study.
Dr. Alvin Powers of Vanderbilt University said the Australian study was reassuring because it showed blood sugar levels could be safely lowered below the current targets, in contrast to the U.S. results. He said reducing kidney complications is significant because it would might mean fewer people needing dialysis or a kidney transplant.
"I think this affirms that 7 (blood sugar level) should remain our goal — but most people don't reach that goal," he said.
The Australian study was funded by the government and diabetes drugmaker Servier. The U.S. study was paid for by National Institutes of Health, and various companies provided diabetes drugs. A number of researchers in both studies report receiving grant support or frees from drugmakers.

Bird flu detected in Hong Kong market

By DIKKY SINN
09 june 2008--Hong Kong health workers slaughtered 2,700 poultry in a market Saturday after chickens were found to be carrying the dangerous H5N1 bird flu virus, officials said.
The slaughter may be extended to all live poultry in the territory if the virus is detected in any other locations, Secretary for Food and Health York Chow said.
"Since we have detected the virus in the market, we will cull all the chickens in this market," Chow told reporters. "If we find another positive detection in another market, then we will assume that the risk is much higher and we need to cull all the chickens in all the markets."
Hong Kong TV Cable showed health workers wearing protective gear placing live poultry from nine stalls into bags to prepare for the slaughter.
Routine bird flu checks detected the H5N1 virus in five samples of chicken waste. The samples were collected June 3 from three vendors in the market in the Sham Shui Po residential district, Chow said.
Health officials declared the market an infected area and suspended all sales of live poultry there, a government statement said.
Chow said authorities were tracing the origin of the infected chickens.
Chow also ordered a 21-day ban on the supply of live poultry from mainland China and from local farms.
Occasional H5N1 infections in wild birds are common in Hong Kong but the territory has not suffered a major outbreak of the disease since the virus killed six people in 1997.
That prompted the government to slaughter the territory's entire poultry population of about 1.5 million birds.
At least 241 people have died of bird flu worldwide since 2003, according to the World Health Organization.
Most human cases have been linked to contact with infected birds, but health experts worry the virus could mutate into a form that passes easily among humans, sparking a pandemic that might kill millions of people.

Redefining Quality — Implications of Recent Clinical Trials

Harlan M. Krumholz, M.D., and Thomas H. Lee, M.D.
08 june 2008--Simple approaches to patient care are better — except when they are not. Recent clinical studies are leading to a reexamination of the paradigm whereby efforts to prevent vascular disease focus on the achievement of particular levels of risk factors such as low-density lipoprotein (LDL) cholesterol, systolic blood pressure, and glycated hemoglobin. Although these factors and their levels are important determinants of the development and progression of vascular disease, it is increasingly apparent that the specific strategies used to modify them make a critical difference in patient outcomes. This insight has implications for clinical practice, performance measurement, and regulatory requirements.
The conventional wisdom, which emerged from epidemiologic studies of risk factors and the subsequent successful trials of certain strategies for risk-factor modification, has been that the clinician's key focus ought to be on reducing risk factors below specific levels. This approach, however, neglects the importance of which specific strategies are used to modify these factors. A clinical trial is ultimately a test of a strategy, and we should not be surprised that different strategies may have different effects on patients beyond their effect on risk-factor levels.
Awareness of this issue was boosted on December 2, 2006, the day Pfizer stopped the study named ILLUMINATE (Investigation of Lipid Level Management to Understand Its Impact in Atherosclerotic Events) and all other trials involving torcetrapib, which until then had been seen as a promising agent that lowered LDL cholesterol levels and raised high-density lipoprotein (HDL) cholesterol levels. ILLUMINATE was halted because patients receiving torcetrapib plus atorvastatin had a higher mortality rate than those receiving atorvastatin alone — despite 72% increases in HDL levels and 25% decreases in LDL levels.1
ILLUMINATE is not alone in raising questions about the wisdom of patient care that prioritizes target levels of some risk factors over attention to the way in which those levels are achieved. The Women's Health Initiative revealed that hormone-replacement therapy, which reduces LDL cholesterol levels, increased the risk of cardiovascular disease.2 Another study, called ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin versus Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia), showed that ezetimibe did not reduce the progression of arteriosclerosis when combined with simvastatin, as compared with simvastatin alone, even though the combination did result in a greater reduction of LDL cholesterol. Rosiglitazone improves glucose control, but it may also be associated with increased cardiovascular risk.3 Adding an angiotensin-receptor blocker to an angiotensin-converting–enzyme inhibitor may produce a greater reduction in blood pressure, but it may not reduce cardiovascular risk and it increases the risk of other adverse events.4
The importance of understanding clinical trials as tests of strategies has assumed even greater prominence because of two studies being reported on in this issue of the Journal — ACCORD (Action to Control Cardiovascular Risk in Diabetes) and ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation). These two studies (pages 2545–2559 and 2560–2572, respectively) tested the hypothesis that specific strategies involving the use of multiple medications to achieve tight glucose control would improve outcomes in patients with type 2 diabetes mellitus. The studies, which used different pharmacologic strategies, found that the tight control achieved did not reduce the risk of macrovascular complications. The ACCORD study's intensive control strategy was associated with a higher risk of death, which led to early discontinuation of this part of the study. The ADVANCE study's findings indicate that its strategy may reduce the risk of worsening renal function at the cost of an excess risk of hypoglycemic events.
Thus, the risk–benefit ratio of interventions designed to modify risk factors can vary depending on the type and number of medications and other approaches that are concurrently incorporated. In particular, some medications may have beneficial or harmful effects beyond their effect on a risk factor. Moreover, the strength of the evidence supporting particular strategies varies. Some strategies are known to improve patient outcomes, whereas others are known to affect only risk-factor levels or other intermediate outcomes. We are now beginning to appreciate that a strategy's effect on a risk factor may not predict its effect on patient outcomes.
Clearly, the way in which risk factors are modified really does matter. Lifestyle interventions may have few risks, but we cannot assume the same for drugs — and drug-related risks are not always known or appreciated. For example, the tendency of torcetrapib to cause blood pressure to rise and potassium levels to fall attracted much more attention after December 2006 than it had previously. In addition, medications may have interactions with other drugs, either directly or through their effect on patient adherence to treatment regimens.
As a result of these research advances, clinicians are now in a quandary. We prefer our clinical practice to be based on strong evidence. In the interest of promoting good care, we have constructed guidelines and performance measures that encourage treatment geared toward achieving ambitious goals for levels of glycated hemoglobin, lipids, and blood pressure. These treatment goals generally do not specify the strategy that should be used to reach the target. Statins are preferred in the reduction of LDL cholesterol, but guidance on their use is not strict.5 If strategy matters, then guidelines should reflect this fact — and performance measures should be changed as well. After all, these measures are intended to hold clinicians accountable for practices whose benefits are widely recognized as far outweighing their risks.
How, then, should guidelines and performance measures change? First, we should no longer support the use of targets without reference to the strategies used to achieve them. Guidelines and performance measures should reflect the evidence about interventions that are known to be beneficial. For example, guidelines for lowering lipid levels should be based on tested strategies and should make it clear that the strategies with the strongest evidence are preferred. A quality measure that incorporated the use of statins into an assessment of lipid-level control would be more scientifically sound than the simple assessment of the proportion of a physician's or practice's patients in whom a specific LDL cholesterol level was reached by any strategy. A quality measure for tight glucose control should require evidence that a proven strategy provides a strong net benefit for patients. We know that we are setting a high standard for developers of performance measures, but advances in our knowledge demand nothing less.
Second, guidelines and performance measures should incorporate more sophisticated and explicit considerations of the risks of disease and adverse consequences posed by the intervention. In patients with a low likelihood of a particular poor outcome, an intervention designed to protect against that outcome is unlikely to provide substantial benefit — so if the intervention carries even a small risk, this risk can offset or even outweigh the benefit. In sicker patients and those with more complex conditions, certain interventions (such as maintenance of tight glucose control) may be more likely to produce adverse effects than they would in healthier patients, either directly or through their effect on adherence. For these patients, we need evidence that the strategy is safe and has a substantial net clinical benefit despite the greater risks of treatment.
The assessment of net clinical benefit should be based on events averted or lives improved. The promulgation of those strategies that are shown to be effective will serve as an incentive for drug and device developers to provide evidence about patient outcomes, not just about how a drug or device affects intermediate outcomes. Moving practice toward evidence-based strategies and becoming more accountable for what we do for patients represent important advances in our delivery of health care, but we must ensure that in implementing quality measures we are always acting in the patient's best interests. ACCORD, ADVANCE, and other recent studies remind us that practice is complex and that ultimately we need to understand a strategy's effects on people, not just on surrogate end points.
No potential conflict of interest relevant to this article was reported.
Source Information
Dr. Krumholz is a professor of medicine at Yale University School of Medicine and director of the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital — both in New Haven, CT. Dr. Lee is network president of Partners HealthCare System in Boston and an associate editor of the Journal. This article (10.1056/NEJMp0803740) was published at www.nejm.org on June 6, 2008. It will appear in the June 12 issue of the Journal.

References

Nissen SE, Tardif JC, Nicholls SJ, et al. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med 2007;356:1304-1316. [Free Full Text]
Anderson GI, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative Randomized Controlled Trial. JAMA 2004;291:1701-1712. [Free Full Text]
Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-2471. [Erratum, N Engl J Med 2007;357:100.] [Free Full Text]
The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008;358:1547-1559. [Free Full Text]
Smith SC Jr, Allen J, Blair SN, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation 2006;113:2363-2372. [Erratum, Circulation 2006;113(22)e847.] [Free Full Text]

Low-Energy Femoral Shaft Fractures Associated With Alendronate Use.

Andrew S MD
08 june 2008--Abstract: Objective: Increasing evidence suggests long-term alendronate use may overly suppress bone metabolism, limiting repair of microdamage and creating risk for insufficiency fractures. The purpose of this study is to demonstrate an association between alendronate use and a specific pattern of low-energy femoral shaft fracture.
Design, Setting, and Patients: A retrospective review was performed of patients with femoral shaft fractures admitted to a Level 1 trauma center between January 2002 and March 2007. Seventy low-energy fractures were identified.
Main Outcome Measure: The medical records were reviewed, and the incidence and duration of alendronate use were recorded. The incidence of a specific femoral shaft fracture in those patients taking alendronate compared with those not being treated was determined.
Results: There were 59 females and 11 males. The average age was 74.7 years. Twenty-five (36%) were being treated with alendronate. None of the patients had used or were using other bisphosphonates. Nineteen (76%) of these 25 patients demonstrated a simple, transverse fracture with a unicortical beak in an area of cortical hypertrophy. This fracture pattern was seen in only 1 patient (2%) not being treated with alendronate. Alendronate use was a significant risk factor for the fracture pattern (odds ratio [OR]) 139.33, 95% CI [19.0-939.4], P < 0.0001). This pattern was 98% specific to alendronate users. The average duration of alendronate use in those with the pattern was significantly longer than those who did not exhibit the pattern but were taking alendronate, 6.9 years versus 2.5 years of use, respectively (P = 0.002). Only 1 patient with the fracture pattern had been taking alendronate for less than 4 years.
Conclusions: Low-energy fractures of the femoral shaft with a simple, transverse pattern and hypertrophy of the diaphyseal cortex are associated with alendronate use. This may result from propagation of a stress fracture whose repair is retarded by diminished osteoclast activity and impaired microdamage repair resulting from its prolonged use.

Surgeon's trial study on cancer is hailedBrain tumor took his life, but his pioneering therapy now may give others hope

By TODD ACKERMAN
08 june 2008--The death of Houston neurosurgeon Samuel Hassenbusch from the brain cancer he treated has been one of 2008's sadder stories. But there's good news about the experimental treatment that he pioneered.
In study results to be presented next week at an annual meeting of cancer doctors, Hassenbusch's treatment — chemotherapy and a new vaccine — significantly prolonged survival of patients with glioblastoma, the most common and aggressive brain cancer.
Sen. Edward Kennedy was diagnosed with the disease last week.
"I'm biased, but this is some of the best data we've ever seen," said Dr. John Sampson, a Duke University neurosurgeon and the principal investigator of the study, conducted at the University of Texas M.D. Anderson Cancer Center and Duke. "It appears very promising for a cancer where there's been little hope."
The trial's big surprise was that the chemotherapy didn't stop the vaccine from prompting a strong immune response and instead enhanced it. Because chemotherapy kills patients' white blood cells, it is usually considered incompatible with vaccines or, as they're also known, immunotherapy.
Glioblastoma kills nearly 10,000 Americans annually, a majority within the first 15 months after diagnosis, largely because of tentacle-like cells that creep into the brain from the main mass.
Hassenbusch, an M.D. Anderson professor of neurosurgery and a pain control expert who treated more than 500 brain cancer patients, was diagnosed with the disease in 2005. After surgery and follow-up radiation, he and his doctors decided to combine Temodar, the now-standard chemotherapy, and the vaccine, until then only used alone.
Hassenbusch became the first patient in the M.D. Anderson-Duke trial.
In all, the study enrolled 23 patients between 2005 and 2007. It was only open to those with a particular protein — present in one-third to two-thirds of glioblastomas — and those who were tumor free after surgery and radiation.
Kennedy's tumor is thought to be inoperable.
The study found the average time for recurrence of the tumor was 16.6 months, up from the previous six months. The time of survival was also up significantly from the previous average of 14 months, said Sampson, who declined to reveal the exact number until he presents the data June 2 at the American Society of Clinical Oncology meeting in Chicago.
Immune responseUnder the trial protocol, some patients received Temodar for the first five days of the month, and some received it for the first 21 days. On the 21st, all received the vaccine, which signals the immune system to destroy the cancer. Without the vaccine, the immune system doesn't recognize glioblastoma.
Almost all the patients mounted an immune response. The response was better with the highest dose of Temodar.
"I think Sam would be pretty excited about these results," said Dr. Mark Gilbert, an M.D. Anderson professor of neuro-oncology whose study of Temodar enrolled some 1,150 patients, the most ever in a brain cancer trial.
Gilbert cautioned that the study results are preliminary. He noted the impressive results could be the result of cherry-picking patients, accepting only those whose tumors had been excised by surgery and radiation.
To resolve that possibility, a new trial is under way at 20 cancer centers, including M.D. Anderson, dividing such patients into a group that gets just Temodor and a group that gets the combination therapy.
Also on tap is a trial adding a third drug — Avastin, a targeted therapy that starves tumors by stopping them from building blood vessels that supply them with nutrients — to the regimen.
For one patient in the study, the Temodar-vaccine combination by itself has worked fine.
"Doctors originally gave me six to eight months to live when I was diagnosed with glioblastoma," said Barbara Derenowski, 69, of Surprise, Ariz., a retirement community northwest of Phoenix. "But two years later, I'm in good shape, living a normal life and still returning cancer-free scans every month, thanks to this trial. I hope it becomes available to more people."
Hassenbusch lived almost three years after his diagnosis. He appeared to be beating the cancer with the combination therapy. But in May 2007, the cancer returned and this February claimed his life.