Department of Medicine

Case Western Reserve University School of Medicine & UH Case Medical Center

The Unrealistic Optimism of Cancer Patients

April 12th, 2011 Posted in Breast Cancer, cancer, Case Western Reserve University School of Medicine, Clinical Trial, Colon Cancer, department of medicine, Hematology & Oncology, Hematology & Oncology, medical news, physician, Research, University Hospitals Case Medical Center
Apr, 12 2011
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The New York Times

As a medical student and later during my residency, I trained for some time in a medical center known for its research and clinical trials. Every week, patients with rare diseases and cancers that had not responded to standard therapy arrived from all over the country, eager to try something new, even if the efficacy of the treatments had not yet been proven.

But placed in the context of early-phase clinical cancer trials, unrealistic optimism results in a perfect ethical storm. “You have oncology, a field of medicine that is strongly evidence-based and research-intensive, and you have a population of patients who are experiencing an immediate threat to their lives,” said Dr. Neal J. Meropol, a researcher who has done extensive work on the ethics of early-phase cancer trials and chief of the division of hematology and oncology at University Hospitals Case Medical Center and Case Western Reserve University in Cleveland.

“Patients almost invariably take part in early-phase clinical trials because they believe they will personally benefit.”

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FDA Grants 510(k) Clearance To Life Technologies Stem Cell Growth Medium

April 12th, 2011 Posted in cancer, Case Western Reserve University School of Medicine, department of medicine, Hematology & Oncology, Hematology & Oncology, medical news, Pharmacology, physician, Research, University Hospitals Case Medical Center
Apr, 12 2011
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Life Technologies Corporation (Nasdaq: LIFE) announced it has received FDA 510(k) clearance for StemPro® MSC SFM a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the United States…”

An FDA-cleared, serum-free medium certainly provides a positive step toward moving away from mostly animal-based products for growing mesenchymal stem cells,” said Stanton L. Gerson, MD, Professor, Division of Hematology Oncology in the Department of Medicine, Director, University Hospitals Seidman Cancer Center and the National Center for Regenerative Medicine, at Case Western Reserve University, a pioneer in the use of adult stem cells to treat cancer and heart disease who is also part of a team conducting early phase clinical trials with MSCs to treat graft-versus-host disease and multiple sclerosis. “Growth media that is better defined can facilitate regulatory requirements. Ultimately, clinical trials will determine whether it benefits patients.”

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New England Journal of Medicine editorial :: James Fang, MD

April 8th, 2011 Posted in Cardiovascular Medicine, Cardiovascular Medicine, Case Western Reserve University School of Medicine, cleveland, Clinical Trial, department of medicine, medical news, physician, Research, University Hospitals Case Medical Center
Apr, 08 2011
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A substudy of a randomized comparison of medical therapy with or without bypass surgery for ischemic heart disease in patients with LV systolic dysfunction found that overall, substantial viable myocardium evident at baseline imaging studies had no independent bearing on all-cause mortality over five years; and such viability didn’t influence the relative effectiveness of the two treatment strategies, either for all-cause mortality or the secondary end points of CV mortality and CV hospitalization.

The findings, from the Surgical Treatment for Ischemic Heart Failure trial, based on a selected cohort of about half the total trial population, don’t necessarily mean myocardial viability doesn’t have functional implications, observe the substudy authors…

After pointing out the abundant and longstanding but primarily observational support for revascularization guided by viability testing, Dr James C Fang, University Hospitals and Case Medical Center, Cleveland, OH writes in an accompanying editorial that it was “perhaps surprising” that viability didn’t predict a survival benefit from revascularization. The findings, however, “should be interpreted cautiously,” given the substudy’s limitations; for example, patients were selected for viability testing individually at the physicians’ discretion. “However, the substudy’s findings do raise reasonable questions about the most appropriate method to assess myocardial viability,” Fang writes. “The analysis is a strong reminder that in this era of cost-effectiveness, the role of expensive technologies should be accountable to a rigorous study of incremental benefit.”

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BMJ Editorial :: Cystic fibrosis & survival in patients with advanced lung disease

April 8th, 2011 Posted in Case Western Reserve University School of Medicine, cleveland, department of medicine, Hospital, medical news, physician, Pulmonary, Critical Care & Sleep Medicine, Research, University Hospitals Case Medical Center
Apr, 08 2011
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Elliott Dasenbrook, MD, Assistant Professor of Medicine and Pediatrics, LeRoy W Matthews Cystic Fibrosis Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine wrote the following editorial for BMJ.

“Cystic fibrosis and survival in patients with advanced lung disease ::
rhDNase slows progression, and is strongly recommended in treatment guidelines”

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Novel Clinical Trial Aims to Reduce Recurrence of Aggressive Breast Cancer

April 6th, 2011 Posted in Breast Cancer, cancer, Case Western Reserve University School of Medicine, cleveland, Clinical Trial, department of medicine, Hematology & Oncology, Hematology & Oncology, Hospital, medical news, Research, University Hospitals Case Medical Center
Apr, 06 2011
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Tuesday, March 08

In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center are exploring a new method to potentially prevent recurrence of an early stage, aggressive type of breast cancer.  The pilot study, conducted by Joe Baar, MD, Director of Breast Cancer Research at UH Case Medical Center’s Seidman Cancer Center, is recruiting patients with HER-2 neu+ breast cancer.

Patients with this form of breast cancer typically have a higher recurrence rate of nearly 25% following initial treatment. This novel study aims to improve outcomes through performing bone barrow biopsies to identify if patients’ cancer has spread and adding an additional cancer-targeting drug to standard therapy.

“This study has the potential to change the standard of care for women with this type of breast cancer, which tends to spread very quickly,” says Dr. Baar, who is also Associate Professor of Medicine at Case Western Reserve University School of Medicine. “A small number of HER-2 neu+ breast cancer patients do not do well following standard therapy. We are hoping to identify these high-risk patients and stop the cancer before it progresses to other parts of the body.”

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Study Finds Vitamin D Decreases Swine Flu Death Risk

January 28th, 2011 Posted in Case Western Reserve University School of Medicine, department of medicine, Internal Medicine & Geriatrics, medical news, Research
Jan, 28 2011
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Vitamin D, which plays a key role in healthy bone development, may also decrease the risk of dying from H1N1 swine flu, a study finds.

The vitamin appeared to especially benefit people in high risk groups, including people who are obese. Obesity increases the risk of dying from viral diseases. Last year’s H1N1 pandemic was especially deadly for pregnant women and people who were obese, according to health officials.

But a report, which will be published in the February 1 issue of Clinical Infectious Diseases found that vitamin D can help cut mortality rates.

The study, conducted by Janice Louie of the California Department of Public Health in Richmond, Calif., looked at 500 obese patients with a body mass index of 40 or more. It was found that these patients were three times more likely to die from viruses, like the flu, than people with a healthy BMI.

Dr. Rebecca S. Boxer, a geriatrician at University Hospitals Case Medical Center, says that vitamin D is important to the health of the immune system on a cellular level.

“Vitamin D also has a relationship to inflammation and obese patients may already have a degree of inflammation,” she told AOL Health. “One way to understand this is that the volume of distribution of vitamin D might be greater for obese people. Vitamin D is fat-soluble. So the bigger you are, the more you need for it to show up at adequate levels in your blood. It spreads throughout the fat tissue and less of it is in your blood. So it can be difficult to find obese patients with enough vitamin D because it’s sinking into their fat tissue.”

Boxer says that there has been a lot of interest in vitamin D in relation to general health and well-being but that studies have not yet shown a direct cause and effect when it comes to the swine flu. “People are getting bigger, which can contribute to lower vitamin D levels. Also people do not get enough sun exposure,” she said.

Eating foods high in vitamin D, such as fatty fish, including wild salmon, is a good way to maintain healthy levels of this vitamin, Boxer said.

“Everyone should be getting their levels checked,” said. “If anything, we know that it can help keep bones healthy. We can’t say that it will prevent the swine flu, but it’s important to make sure you’re getting enough.”

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Dr. Gerard Isenberg discusses how antibiotic may become long-awaited treatment for IBS sufferers

January 6th, 2011 Posted in Case Western Reserve University School of Medicine, cleveland, department of medicine, Gastroenterology & Liver Disease, medical news, physician, Research, University Hospitals Case Medical Center
Jan, 06 2011
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cleveland.com
Featured Physician :: Dr. Gerard Isenberg
Division of Gastroenterology and Liver Disease

An antibiotic may become the first new treatment in a decade for an extremely common, and sometimes debilitating, digestive disorder. The treatment provided long-lasting relief to patients with diarrhea-predominant irritable bowel syndrome (IBS) in a large clinical trial completed at Cedars Sinai Medical Center in Los Angeles.

The results, published Wednesday in the New England Journal of Medicine, provide solid support for the theory that the symptoms of this difficult-to-treat illness are sometimes caused by excess bacteria in the small intestine.

CWRUmedicineIBS is a disorder of the lower intestinal tract that causes pain, bloating, nausea, diarrhea and constipation. It affects up to 20 percent of the population, making it one of the most commonly diagnosed disorders, according to the National Institutes of Health.

The treatment, an oral antibiotic called rifaximin, would be the first medication for patients with diarrhea-predominant IBS in more than 10 years if approved by the FDA. The drug is set for review in IBS patients in March.

It may be a boon for a vast number of patients.

Pimentel’s research has shown that between 30 percent and 80 percent of IBS patients, particularly those who suffer primarily from diarrhea, may have bacterial overgrowth and would benefit from rifaximin.

In the current study, a group of more than 1,200 diarrhea-predominant IBS patients gained significant relief from their symptoms — including bloating, pain and diarrhea — from the antibiotic, compared to a placebo.

Rifaximin is different than other antibiotics because it is minimally absorbed and mainly stays in the intestines, reducing side effects, said Pimentel. Symptom relief continued for 10 weeks of follow-up after the initial two-week dose of medication.

IsenbergDr. Gerard Isenberg, associate chief of the Division of Gastroenterology and Liver Disease at University Hospitals Case Medical Center, has used the therapy on his patients for the past two years as an off-label use. The drug is approved for the treatment of traveler’s diarrhea.

Many have shown dramatic improvement and seen few side effects, he says. “What’s hard about IBS is that it’s usually life-long, and you’re confronted with the question of whether you can repeat treatments of an antibiotic.”

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Treatment with Avastin May be Cut Short

December 16th, 2010 Posted in cancer, Case Western Reserve University School of Medicine, department of medicine, Hematology & Oncology, Hematology & Oncology, medical news, physician, Research, University Hospitals Case Medical Center
Dec, 16 2010
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UH Case Medical Center’s Dr. Joseph Baar explains his hopes for the Avastin, which the FDA will rule on for use in late stage breast cancer patients.

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Researcher W. Henry Boom, MD, awarded NIH grant to further study of MTB

December 8th, 2010 Posted in Case Western Reserve University School of Medicine, cleveland, Clinical Trial, department of medicine, Hospital, Infectious Disease & HIV Medicine, medical news, physician, Research, University Hospitals Case Medical Center
Dec, 08 2010
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Case Western Reserve University Department of Medicine  is reaping the rewards of funding from the National Institutes of Health (NIH), in the form of grants and contracts.

Researcher W. Henry Boom, MD, Vice Chair of Research, Professor of Medicine and Director of the Tuberculosis Research Unit, is working to tackle the easily transmissible, and often deadly, Mycobacterium tuberculosis (MTB). He received a grant for more than $750,000 from the NIH, with the potential to receive up to $2.8 million over the next four years.

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Telmisartan improved outcome in patients with hemodialysis, chronic HF

November 19th, 2010 Posted in Cardiovascular Medicine, Cardiovascular Medicine, Case Western Reserve University School of Medicine, department of medicine, Hospital, medical news, physician, Research, University Hospitals Case Medical Center
Nov, 19 2010
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Cardiology Today | November 18 2010

All-cause and CV mortality, as well as HF-associated hospital stays, were significantly lower in patients with hemodialysis and chronic HF who were treated with telmisartan, new data suggested.

“To the best of our knowledge, our results are the first to provide evidence that the addition of an [angiotensin II type 1 receptor blocker], namely telmisartan, to regimens, including various combination of ACE inhibitor, digitalis, and beta-blockers, is feasible and beneficial in end-stage renal disease patients with chronic HF receiving dialysis treatment,” the researchers wrote.

The 3-year, randomized, double blind, placebo-controlled, multicenter trial was performed in 30 Italian clinics featuring hemodialysis patients with chronic HF (NYHA Class II to III; left ventricular ejection fraction ≤40%). Besides ACE inhibitor therapy, patients were randomly assigned telmisartan (Micardis, Boehringer Ingelheim; n=165; target dose, 80 mg) or placebo (n=167).

During a mean follow-up of 35.5 ± 8.5 months, researchers reported a significant reduction for all three primary endpoints in patients taking telmisartan vs. placebo: all-cause mortality (35.1% vs. 54.4%; P<.001), CV death (30.3% vs. 43.7%; P<.001) and hospital admission for chronic HF (33.9% vs. 55.1%; P<.0001).

Additionally, Cox proportional hazards analysis revealed telmisartan to be an independent determinant of all-cause mortality (HR=0.51; 95% CI, 0.32-0.82), CV mortality (HR=0.42; 95% CI, 0.38-0.61) and hospital stay for chronic HF decompensation (HR=0.38; 95% CI, 0.19-0.51).

Such beneficial effects of telmisartan as seen in the trial, the researchers noted, “were evident within 6 months from the beginning of the treatment and persisted for the entire treatment period. … Although further larger trials in hemodialyzed patients with [chronic] HF are desirable, our experience could offer clinicians an opportunity to make additional improvements in the poor prognosis of end-stage renal disease patients with chronic HF.”

“Although the power calculations in the present study showed 90% power, this was to detect a 50% hazard reduction in death, not a commonly seen magnitude of benefit with most agents in any clinical trial setting,” Ilke Sipahi, MD, and James C. Fang, MD, of the Harrington Heart & Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, wrote in an accompanying editorial. “Given this aggressive target of event-reduction benefit and a modest total number of patients (which is comparable to a ‘pilot’ trial), it is not clear whether this trial provides enough power to be definitive.”

Despite this, the findings are important and should lead to further investigation. However, “For now, clinicians should carefully evaluate the choice of agents in the treatment of HF when it complicates dialysis and make sure that drugs that antagonize both the [renin-angiotensin system] and adrenergic axes are considered,” Sipahi and Fang said.

Paper :: Cice G. J Am Coll Cardiol. 2010;56:1701-1708

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