The Food and Drug Administration (FDA), the National Cancer Institute (NCI), part of the National Institutes of Health, and the Centers for Medicare & Medicaid Services (CMS) today announced the Oncology Biomarker Qualification Initiative (OBQI) — an agreement to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, as well as tests on blood, tissue and other biologic samples. This initiative is the first time these three Department of Health and Human Services (HHS) agencies have focused together on biomarkers as a way of speeding the development and evaluation of cancer therapies.

“We are excited about this effort to speed the development and delivery of new cancer treatments for patients,” said Secretary of Health and Human Services Mike Leavitt. “By bringing together the scientific, regulatory and delivery expertise of these three agencies, we can bring targeted, more personalized cancer diagnostics, treatments and preventions to patients more rapidly.”

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to:

– Assess after one or two treatments if a patient’;s tumor is responding to treatment

– Determine more definitively if a tumor is dying, even if it is not shrinking

– Identify which cancer patients are at high risk of their tumor coming back after therapy

– Determine if a patient’;s tumor is likely to respond at all to a specific treatment

– Efficiently evaluate whether an investigational therapy is effective for tumor treatment.

The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.

“Almost four years ago, NIH set out to create a “roadmap” for 21st century medical research. Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration,” said NIH Director Elias A. Zerhouni, M.D.

“An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA’;s program to modernize the medical product development process,” said FDA Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process, so we can bring personalized medicines to patients more quickly and ultimately improve outcomes.”

Under the OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to utilize biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.

“By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection,” said NCI Deputy Director Anna D. Barker, Ph.D. “Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses.”

The first OBQI project to be implemented will serve to validate and standardize the use of Fluorodeoxyglucose – Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin’;s lymphoma, to determine if FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both FDA and CMS work with drug developers based on a common understanding of the roles of these types of assessments.

“There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients.”

Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and address agency priorities identified through FDA’;s Critical Path and NIH’;s Roadmap Initiatives. The OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between NCI and FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments. The two agencies, along with CMS, share knowledge and resources to facilitate the development of new cancer drugs and diagnostics and speed their delivery to patients as safely and as cost-effectively as possible.

FDA Critical Path

Critical Path is the FDA’;s premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools to find answers about how the safety and effectiveness of new medical products can be demonstrated in faster timeframes with more certainty and at lower costs.

The NIH Roadmap

The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address to make the biggest impact possible on the progress of medical research, and to catalyze changes that will serve to transform new scientific knowledge into tangible benefits for public health. Additional information about the NIH Roadmap can be found at its Web site, nihroadmap.nih.

For information about the Food and Drug Administration, please visit fda.

For additional information about the National Cancer Institute, please visit cancer.

For information about the Centers for Medicare & Medicaid Services, please visit cms.hhs.

FDA/NCI/CMS Memorandum of Understanding Continue reading →

Radiation Exposure In Utero and in Young Children Increases Adult Cancer Risk

Radiation exposure before birth or during early childhood increased the risk of adult solid cancers, according to a study of survivors of the Hiroshima and Nagasaki bombings.

It is known that radiation exposure during fetal development increases the risk of childhood cancers and that exposure during early childhood increases the risk of adult-onset cancers. However it was not known if radiation exposure to the fetus increases the risk of adult cancers.

To find out, Dale Preston, Ph.D., of the Hirosoft International Corporation in Eureka, Calif., and colleagues at the Radiation Effects Research Foundation in Hiroshima, Japan, calculated the excess risk of solid cancers in adult survivors of the Hiroshima and Nagasaki bombings, relative to non-exposed populations.

Of the 2,452 study participants who were exposed to radiation before birth, 94 have developed adult cancers, as did 649 of the 15,388 individuals who were exposed between birth and six years of age. By age 50, the excess relative risk for those exposed before birth was 1.0 per Sv (a unit for measuring radiation exposure), and for those exposed as young children, it was 1.7 Sv at age 50.

The researchers note that the overall risk of solid cancers increases with age, and so continuing to follow the study participants as they age will be important. Also, the investigators only considered solid cancers, and did not examine the rate of blood cancers, such as leukemia.

“The present data suggested that increases in risks of adult-onset cancer among those exposed to radiation in utero may be smaller than for those exposed in early childhood,” the authors write. That said, these data may be important when considering the public health risks of medical and occupational radiation exposure for pregnant women.

Contact: Dale Preston or Roy Shore, chief of research, Radiation Effects Research Foundation

Anchoring Protein Variant Associated with Increased Breast Cancer Risk

Individuals who carry a rare genetic variant have an increased risk of developing breast cancer over their lifetimes, compared with those who do not have the variant.

Few genes have been found to have a large impact on the risk of familial breast cancer, and researchers expect that most breast cancers are influenced by the combined effects of multiple genes, each of which has a small impact on its own. One of those genes may be AKAP9.

To determine whether a rare sequence variant of the AKAP9 gene increases the risk of breast cancer, Barbara Burwinkel, Ph.D., of the German Cancer Research Center in Heidelberg and colleagues compared the frequency of the variant in 9,523 breast cancer patients with its frequency in 13,770 healthy control subjects from a large international collaboration project.

The team found that individuals who carry two copies of the rare variant have a 17 percent increased relative risk of developing breast cancer compared with those who carry two copies of the normal sequence. For those individuals who carry one copy of the rare variant and one copy of the normal sequence, their relative risk increased 10 percent over their lifetime.

“It is also of interest that this variant has previously been found to be associated with colorectal and lung cancer risk,” the authors write.

Contact: Stefanie Seltmann

Sexual Activity and Marijuana Use Associated with HPV-Positive Head and Neck Cancer

The risk factors for human papillomavirus (HPV) type 16-associated head and neck cancer are different from those associated with head and neck cancers that do not express HPV. The two types of cancers should be considered distinct malignancies.

Scientists have recently discovered that HPV-16, which is known to cause cervical cancer, can also lead to head and neck cancers. It was not clear, however, whether previously identified risk factors for head and neck cancer, such as tobacco smoking and alcohol consumption, apply to the malignancies caused by the virus.

To find out, Maura Gillison, M.D., Ph.D., of the Johns Hopkins Kimmel Comprehensive Cancer Center in Baltimore and colleagues conducted a case-control study with 240 head and neck cancer patients and 322 matched control subjects. The team collected behavioral information using a computer-assisted self-interview technique. They also examined tumor samples from each patient to determine whether the cancer expressed HPV-16.

A total of 92 cancers (38 percent) were HPV-16 positive. HPV-positive cancers were associated with increasing numbers of oral sexual partners and with increased marijuana use. Smoking, alcohol consumption, and poor oral hygiene were not associated with HPV-positive cancers, but were associated with HPV-negative head and neck cancers.

“Our data support the existence of at least two etiologically distinct pathways for [head and neck cancer] pathogenesis, one mediated by tobacco and alcohol and the other by HPV,” the authors write.

Contact: Vanessa Wasta, media relations, Sidney Kimmel Comprehensive Cancer Center

Overexpression of an Inflammatory Marker May Be Associated with an Increased Risk of Breast Cancer

Expression of the inflammatory protein, cyclooxygenase-2 (COX-2), in benign breast biopsy samples may be associated with an increased risk of a breast cancer diagnosis in the future.

Many breast biopsies uncover non-cancerous but abnormal tissue growth patterns, including atypical hyperplasia. Although women with such a diagnosis are at a higher risk of developing breast cancer in the future, not all of them will do so. Identifying ways to distinguish precancerous lesions from ones that will remain benign is important. One marker that has been associated with cancer development in animal models and some human cancers is COX-2.

Lynn Hartmann, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues tested archival biopsy samples for expression of COX-2 and collected information on subsequent breast cancer diagnoses from medical records and a study questionnaire. The risk of developing breast cancer was compared with that of the general population.

A total of 235 women participated in the study, each of whom had been diagnosed with atypical hyperplasia between 1967 and 1991. After a median follow-up of 15 years, 41 women had developed breast cancer. The risk of a breast cancer diagnosis increased with the intensity of COX-2 expression in the initial biopsy sample. The trend of increasing risk with increasing expression intensity was of borderline statistical significance. For those with the highest level of expression, the risk rose 5.66-fold, from an expected 1.6 cases of breast cancer to nine observed cases.

These data, together with other studies in breast cancer, suggest COX-2 “may be a relevant target for chemoprevention strategies,” the authors write.

Also in the March 11 JNCI:

* Survival In Gastric Cancer Patients Not Improved By Postoperative Chemotherapy

* Better Survival In Dutch Ovarian Cancer Patients When Treated At Specialized Hospitals

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ExonHit Therapeutics (Paris:ALEHT)(Alternext: ALEHT) announced that the Company was awarded two grants to support two of its Research & Development projects under the Qualifying Therapeutic Discovery Project Program: AclarusDx™ in Alzheimer’s disease and the EHT 107 program in oncology.

“We are excited to benefit from these grants as they are a recognition of the potential medical benefit of AclarusDx™ and the EHT 107 program,” said Matthew Pando, PhD, Executive Vice President, Therapeutics of ExonHit Therapeutics. “These awards also further highlight the ability of our Genome-Wide SpliceArray™ discovery platform to generate both innovative diagnostic and therapeutic products. These grants will contribute to support the ongoing development of two programs targeting areas of high medical need.”

These two grants totaling USD 0.3 million were awarded to ExonHit by the U.S. Secretary of Health and Human Services to support its Alzheimer’s disease and oncology research and development projects. Among the determining criteria used by the Secretary in allocating funds were those projects that show potential to result in new therapies to treat areas of unmet medical need.

About the Qualifying Therapeutic Discovery Project Program

The Qualifying Therapeutic Discovery Project Program (QTDP) was created by the U.S. Congress as part of the recent health legislation reform (Patient Protection and Affordable Care Act of 2010) and is designed to foster biotechnology growth and innovation. The program also seeks to create and sustain biotechnology jobs in the US. QTDP grants are awarded to companies with fewer than 250 employees for projects related to the treatment or prevention of diseases through the conduct of preclinical or clinical studies.

The project recipients, jointly selected by the Treasury Department and the Department of Health and Human Services (HHS), were required to demonstrate preclinical or clinical research costs incurred in 2009 or 2010 expended on projects fulfilling specific criteria. More precisely, the grant targets therapeutic discovery projects that show a reasonable potential to:

– Result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions,

– Reduce the long-term growth of health care costs in the United States, or

– Significantly advance the goal of curing cancer within 30 years.

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As physicians and scientists at St. Jude Children’s Research Hospital work to find new insights into pediatric cancer and other catastrophic diseases, a central tenant of any treatment plan is to keep families at the center of children’s care.

The philosophy of family-centered care strives to give parents and their children a voice as well as a sense of control during this arduous time. The family-centered care approach seeks answers to the direct needs of patients and their parents by seeking their input and responding in kind.

“It is about respecting the unique relationship that the family has with the health care team and validating the strengths that each family brings to the hospital when their child is ill,” said Alicia Huettel, RN, St. Jude family-centered care coordinator. “In a traditional health care delivery model, the system-whether it is the physicians, nurses or other staff-has been what dictates care. Family-centered care is different in that it puts the family at the center of decision-making, empowers them and honors their preferences.”

This philosophy has always existed at the heart of St. Jude, Huettel said, but now health care workers nationwide are putting a name to it and finding new ways to evolve and advance this mission.

To help nurture this approach to care, the hospital established the Family Advisory Council. Family members of patients hold two-thirds of the seats on the committee, and faculty and staff from hospital departments make up the remaining spots.

Through the council, hospital employees meet with patients and parents to discuss an array of topics that affect patient care from campus construction projects to the way the pharmacy provides medicines to patients after hospital discharge. “The process creates pathways of information and communication,” Huettel said. “We’re getting their input on the front end, discussing options and making decisions together.”

Huettel and her team employ several tactics for sparking dialogue between families and health care workers. Parents serve as active members of various hospital committees. Focus groups are held to obtain the input and opinions of parents and patients. An informational newsletter is also published each month to address topics most pressing to St. Jude parents.

In addition to reaching out to parents and patients for feedback, Huettel and her team look for ways to strengthen the initiative by inviting evaluators to assess the program as well as by holding advanced training and seminars for hospital staff.

“The idea of putting the family at the heart of care is not new to St. Jude, but now we’re putting actions to the philosophy and finding ways to move it forward,” Huettel said. “There is a business case for it, because including parents in the decision-making on the front end increases satisfaction as well as improves quality and safety. But more than anything, we’ve embraced the family-centered care approach because it’s the right thing to do.”

Expert available:

Alicia Huettel, RN, is a family-centered care coordinator at St. Jude. Huettel works with families and hospital staff to enhance communication as well as develop avenues that empower parents and patients in the hospital setting. Huettel can address topics such as strengthening the role and voice of parents; developing programs and committees that encourage and support family-center care; and promoting communication among hospital staff, families and patients during treatment.

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The US Surgeon General, Richard Carmona, made a strong condemnation of secondhand smoke, saying a non-smoker’s health is harmed when he/she breathes in smoke from other people’s tobacco. He said that secondhand smoke is not just a nuisance, science has clearly shown it is a serious health hazard.

According to the Surgeon General’s 670-page report, The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General, tens of thousands of Americans die each year as a result of involuntary smoking. Over 126 million people in the USA are regularly exposed to passive smoke. He said passive smoking causes lung cancer, cardiovascular disease and a host of other illnesses. 20% of American children regularly breathe in secondhand smoke at home. The report says such children are at a greater risk of suffering from Sudden Infant Death Syndrome, bronchitis, asthma, pneumonia, ear infections and other illnesses.

According to Carmona, a non-smoker who is regularly exposed to secondhand smoke is 30% more likely to develop heart disease or lung cancer than a non-smoker who is not exposed.

(Involuntary smoking = breathing secondhand smoke = passive smoking)

According to the report, having separate areas for smokers, as well as special ventilations systems, do not completely protect non-smokers from the effects of secondhand smoke. It urges authorities to ban smoking in buildings and public places.

In fact, in America today many state and local authorities have some of the strictest laws in the world.

Carmona says his duty is to publicize the report. The power to bring in new laws rests in the hands of legislators, he said.

The last time a Surgeon General issued a report on passive smoking was in 1986, when smoking rates in the USA were much higher. Then, it said that secondhand smoke was responsible for 3,000 deaths a hear. Now, with much lower smoking rates, secondhand smoke is blamed for over 35,000 deaths each year.

Some bars, restaurants and advocates claiming to represent the rights of smokers, say that banning smoking in all public areas, which would include all bars and restaurants, would be bad for business as smokers would not longer come to them. Others say that They don’t go to them because of the smoke, and would probably start patronising them if they were smoke-free.

Copies of The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General are available on the Surgeon General’s Web site at:
surgeongeneral/library/secondhandsmoke.

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The established antidepressant sertraline does not improve symptoms, wellbeing or survival in patients with advanced cancer who do not have major depression. The findings are reported early Online – timed to coincide with presentation of the paper at the American Society of Clinical Oncology meeting in Chicago – and in the July edition of The Lancet Oncology.

Self-ratings of depression, mood, fatigue, and quality of life are significant predictors of survival in patients with advanced cancer. Although the simple explanation for this is that people close to death get very depressed, two previous small randomised trials showed substantial survival benefits with psychological treatments aimed to improve wellbeing. Therefore Dr Martin Stockler, National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Australia, and colleagues assessed the benefit on symptoms and survival of sertraline in patients with advanced cancer but no major depression.

The authors say: “We postulated that sertraline might improve these features of health-related quality of life and increase overall survival by helping patients to cope better with their illness and treatment.”

Between 2001 and 2006, the researchers treated 189 patients with advanced cancer with 50mg sertraline each day, or placebo. They found that patients receiving sertraline experienced no significant effect on depression, anxiety, fatigue, wellbeing or quality of life. Their findings suggest the overmedicalisation (giving drugs to patients where the benefit is unclear or unproven) of patients with advanced cancer should be avoided.

However, the authors stress that sertraline use should continue in situations where it is of proven benefit – such as patients with advanced cancer who have major depression.

They conclude: “Treatment with a selective serotonin reuptake inhibitor [antidepressant] should be reserved for those with a proven indication.”

Contact: Dr. Martin Stockler

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Antimicrobial treatments for bacterial vaginosis (BV) are effective, but taking lactobacillus tablets alongside metronidazole antibiotic therapy increases effectiveness over taking this antibiotic alone, according to a Cochrane Systematic Review. The researchers also concluded that intravaginal lactobacillus was as effective as oral metronidazole, although they did note unexplained drop-outs from the trials.

BV is a very common vaginal infection. Traditionally, antibiotics in tablet or gel form have been given to treat the disease, but some have unpleasant side effects. BV is usually a mild disease and can pass unnoticed but is associated with an increased risk of HIV transmission.

“Treating BV could help reduce susceptibility of women to HIV. Therefore it is important, particularly in the developing world, to establish the most effective and appropriate forms of treatment,” says lead researcher Oyinlola Oduyebo, of the Department of Medical Microbiology and Parasitology at the University of Lagos in Lagos Nigeria.

The researchers reviewed 24 trials involving 4,422 people. The antibiotics clindamycin and metronidazole both cured BV in over 90% of cases within two to three weeks, although there was a high rate of relapse. Side effects of metronidazole included nausea and a metallic taste in the mouth. However, it is the cheaper option and therefore likely to remain the most widely used in developing countries. Lactobacillus probiotic taken alongside metronidazole and taken intravaginally both showed significant effectiveness. Hydrogen peroxide and triple sulphonamide cream were not effective.

“There are a range of good treatments for BV, but the high relapse rates require more attention and indicate that we need more research into other agents that can increase their effectiveness,” said Oduyebo. “We also need to understand why so many people dropped out of the Lactobacillus trials as this suggests there are unreported adverse effects.”

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Individuals admitted for heart attack to a hospital ranked as one of “America’s Best” by U.S. News & World Report are less likely to die within 30 days than those admitted to a non-ranked hospital, according to a report in the July 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Using a methodology that is similar to the recently released mortality measures that are publicly reported by the Centers for Medicare and Medicaid Services (CMS), the study found that ranked hospitals were also more likely to have lower-than-expected death rates however, many unranked hospitals did as well.

“Among the increasing number of academic, industry and governmental profiling systems that evaluate and compare hospitals, U.S. News & World Report’s annual issue of ‘America’s Best Hospitals’ for specialty and overall care is one of the most well known,” the authors write as background information in the article. “Despite their prominent role in the public arena, the ability of the U.S. News & World Report rankings to identify hospitals with excellent survival rates for common cardiovascular conditions is not known.”

Oliver J. Wang, M.D., of Yale University School of Medicine, New Haven, Conn., and colleagues assessed 30-day death rates among 13,662 patients admitted to 50 hospitals ranked on the U.S. News list as the best in “Heart and Heart Surgery” and among 254,907 patients admitted to 3,813 unranked hospitals in 2003. The researchers also compared the hospitals’ standardized mortality ratios, where a ratio of greater than one indicates that the hospital had more deaths than expected and a ratio of less than one means there were fewer deaths than expected.

After the researchers factored in patient characteristics, the 30-day death rates were, on average, lower in ranked hospitals vs. non-ranked hospitals (16 percent vs. 17.9 percent). When the hospitals were divided into four groups based on these rates, 35 ranked hospitals (70 percent) were in the group with the fewest deaths, 11 (22 percent) were in the middle two groups and four (8 percent) were in the worst-performing group.

Eleven ranked hospitals (22 percent) and 28 non-ranked hospitals (0.73 percent) had standardized mortality ratios significantly less than one, meaning that although ranked hospitals were more likely to have lower-than-expected death rates, non-ranked hospitals with favorable ratios outnumbered ranked hospitals with similar performance by nearly three to one. “As a result, the U.S. News & World Report ranking list does not include many hospitals that have outstanding performances for the care of patients with acute myocardial infarction,” or heart attack, the authors write.

One reason for this may be the reputation component of the rankings, which accounts for one-third of the overall ranking score and is based on cardiologists’ opinions of hospitals that provide the best treatment, the authors speculate. “Citations by cardiologists likely favor tertiary centers with strong subspecialty care for the most critically ill patients while not necessarily reflecting the perceived care for the overwhelming majority of admissions for more common diagnoses, which in turn have a more substantial impact on overall hospital outcomes,” they continue.

“The U.S. News & World Report ranking, which includes many of the nation’s most prestigious hospitals, did identify a group of hospitals that was much more likely than non-ranked hospitals to have superb performance on 30-day mortality after acute myocardial infarction,” the authors conclude. “However, our study also revealed that not all ranked hospitals had outstanding performance and that many non-ranked hospitals performed well. Consequently, although the U.S. News & World Report rankings provide some guidance about the performance on outcomes, they fall short of identifying all the top hospitals with respect to 30-day survival after admission for acute myocardial infarction and include a few hospitals that are actually in the lowest quartile of performance.”

Although hospital rankings are now published by a wide variety of governmental and non-governmental organizations, it is unclear how useful they are to patients, write Sean Michael O’Brien, Ph.D., and Eric D. Peterson, M.D., of Duke University, Durham, N.C, in an accompanying editorial.

“A growing literature of methodological studies presents a sobering picture for patients who would like to use available quality information to identify hospitals with the best outcomes for a particular condition,” they write. “Most systems seem to do a reasonable job at identifying groups of hospitals that perform well on average, yet there is considerable uncertainty regarding the true performance of a particular hospital. As noted, some truly exceptional hospitals will be improperly rated as poor whereas some mediocre hospitals will be rated as excellent.”

However, that does not mean that assessing hospital quality has no role in medicine, they write. Hospitals ranked poorly should take action, and those ranked highly should not boast or become complacent. “They need to understand the potential inconsistency and fallibility of quality-ranking systems. And they need to realize that regardless of their true rank, their goal should not be to merely beat their peers in the ratings but to strive for optimum performance. In this type of quality competition, the real winners are the patients,” Drs. O’Brien and Peterson conclude.

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Ikonisys, a leading provider of non-invasive, cell-based diagnostic solutions, announced at the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting that it has begun a clinical trial evaluating its breakthrough test for early detection of chromosomal abnormality trisomy 21. Early, non-invasive detection of genetic disorders, including Down syndrome, provides pregnant women with fast and accurate solutions that eliminate the need for repeat testing. Led by renowned physician Professor Kypros Nicolaides of King’s College Hospital in London, the trial aims to validate the use of circulating fetal cells in early prenatal detection of Down syndrome within the first trimester of pregnancy.

The trial is intended to establish accuracy and efficacy in the detection of trisomy 21 in circulating fetal cells. Ikonisys expects this solution to be the first in a suite of non-invasive cell-based fetal tests.

“Although medical research and new technologies have enabled some genetic disorders to be detected throughout the first and second trimesters, there is still a false positive rate of three to five percent. Unfortunately, this often translates to a need for several more invasive procedures,” said Professor Nicolaides, the director of the Harris Birthright Research Centre for Fetal Medicine at King’s College. “Through non-invasive testing of maternal fetal cells, we hope to replace a large portion of invasive testing, while simultaneously improving upon the detection rate and safety for detecting Down syndrome and other genetic disorders.”

Ikonisys’ innovative test is supported by its CellOptics® platform, a unique integration of intelligent imaging, microscopy, biology and informatics. The company’s proprietary technology, the Ikoniscope®, is a robotic, optical microscope that offers labs high operational throughput, remote access and increased accuracy.

“We are very excited to begin this clinical trial,” said Ikonisys CEO and Chairman Dr. Petros Tsipouras. “Prenatal procedures that detect genetic disorders can be expensive and labor intensive and are typically associated with an increased risk of miscarriage. With this clinical trial, we seek to prove a novel test for early non-invasive, detection of Down syndrome that eliminates the need for repeat testing and offers women the reassurance, certainty and accuracy that they need to make better, more informed decisions.”

About Ikonisys

Ikonisys is changing the practice of diagnostic medicine through its unique CellOptics platform. Through an innovative combination of intelligent imaging, microscopy, biology and informatics, Ikonisys enables physicians and researchers to deliver accurate, fast and personalized results for early cancer diagnosis, genetic disorder screening and fertility testing.

Ikonisys’ solutions enable its customers to launch novel, new tests designed to achieve rare cell detection. Ikonisys offers both large and regional reference labs, hospitals, research institutions and practice groups the ability to expand test volume capacity during an industry-wide shortage of trained technical personnel.

In 2006, Ikonisys obtained FDA clearance for fastFISH amnio, an imaging application for the Ikoniscope® that provides automated identification of numerical aberrations of chromosomes associated with common birth defects. Additionally, in early 2007, the company received FDA clearance for oncoFISH bladder, an Ikoniscope® application that helps in the initial diagnosis of bladder cancer.

About the Society for Maternal-Fetal Medicine (SMFM)

The Society for Maternal-Fetal Medicine was established in 1977 and is the membership organization for obstetricians/gynecologists who have additional formal education and training in Maternal-Fetal medicine. There are currently about two thousand active members of the Society. The Society hosts an annual scientific meeting in which new ideas and research in the area of Maternal-Fetal Medicine are discussed and there are additional frequent Continuing Medical Education courses provided by our members throughout the world. The Society is also an advocate for improving public policy and expanding research funding and opportunities in the area maternal-fetal medicine.

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Before a new treatment for a disease like cancer becomes available, physician-researchers must recruit hundreds or thousands of patients to participate in clinical research trials. Yet, too often, finding these patients is difficult, as individuals may be unaware of clinical studies, or logistical barriers may preclude participation. The result is that many patients miss out on opportunities for novel treatment approaches, and the development of new and improved therapies is delayed.

Addressing this vital issue is a unique and innovative collaborative study, known as IMPACT, for “Improving Methods for Patient Accrual to Clinical Trials.” Two institutions — Weill Cornell Medical College in New York City and the Cornell University College of Agriculture and Life Sciences in Ithaca, NY — have teamed to develop strategies to better understand and enhance such patient participation in clinical trials.

“Low patient accrual in clinical trials poses a serious problem for the advancement of medical science,” observes Dr. John Leonard, a co-leader of the IMPACT study, who is also professor of medicine at Weill Cornell Medical College and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “The time required to conduct clinical trials is widely recognized as a rate-limiting step in moving novel treatments forward. As one example, less than 2 percent of patients choose to participate in clinical trials for cancer therapies across the United States. Even a modest increase of 2 to 3 percentage points would make a major impact, meaning the difference between completing a study in two years instead of three years — and potentially resulting in thousands of lives saved if the standard of care is improved more rapidly. To this end, this unique collaborative study will seek to uncover new means for improving recruitment and better serving patients,” he says.

“We’re excited to strengthen the alliances between our two campuses while bringing together expertise in both medical and communication science to address important social issues. The IMPACT project is the start of what we envision as a long-term collaboration between our two groups. We envision that together we will use established communication research methods to promote health-related activities in numerous areas,” says Dr. Geri Gay, another co-leader of the effort as well as professor and chairman of the Department of Communication in the College of Agriculture and Life Sciences at Cornell University.

IMPACT investigators will also collaborate with The Leukemia & Lymphoma Society, which has helped finance the first phase of the project, including a national survey on attitudes toward participation in clinical trials. The funding will also support a doctoral student in the Communication Department focusing in this area.

“Cancer clinical trials have brought enormous advances in the areas of cancer prevention, treatment and diagnosis. By encouraging broader and more rapid enrollment, the benefits of clinical research, including prevention and treatment, will be more quickly available to a greater number of patients,” says Dr. Dwayne Howell, president and CEO of The Leukemia & Lymphoma Society.

“Hundreds of studies have sought to identify and overcome barriers to enrollment. This project is the first to assess the problem from a socio-psychological perspective, using the specialized methods of risk communication,” says Dr. Katherine McComas, principal leader of the IMPACT study and assistant professor in the Department of Communication at the College of Agriculture and Life Sciences at Cornell. “We will be using two proven approaches — the model of Risk Information Seeking and Processing (RISP) and Theory of Planned Behavior. These will allow us to examine specific factors that influence how patients inform themselves about a clinical trial and decide whether to participate.”

Previous research has identified several barriers to enrollment, including patients’ fears of randomization and risk of side effects; distrust of physicians and researchers; time commitment and other logistical concerns; and lack of familiarity with clinical trials. On the flip side, patients may choose to participate in clinical trials because they perceive potential for a better treatment (or for refractory cases, any treatment where no good alternative is available), reduced treatment cost and feelings of altruism.

The IMPACT project is one of several recent efforts at Weill Cornell Medical College to foster clinical research programs across the medical spectrum, including the development of the Institute for Clinical Research under the direction of Dr. Ralph Nachman, Associate Dean for Clinical Research at Weill Cornell.

“Our aim is to provide data-supported recommendations for strategies to improve the accrual of patients in clinical trials,” adds Dr. Andrew Dannenberg, also a co-leader of the IMPACT project, professor of medicine at Weill Cornell Medical College and attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “Future phases of the study will develop specific tools to better inform patients, educate them as to the pros and cons of enrolling in clinical trials, as well as create strategies to facilitate participation so that new therapies for many disorders can be more rapidly designed and evaluated in order to deliver their maximal benefit.”

Weill Cornell Medical College

Weill Cornell Medical College — Cornell University’s Medical School located in New York City — is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Weill Cornell, which is a principal academic affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum that integrates the teaching of basic and clinical sciences, problem-based learning, office-based preceptorships, and primary care and doctoring courses. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research in such areas as stem cells, genetics and gene therapy, geriatrics, neuroscience, structural biology, cardiovascular medicine, AIDS, obesity, cancer, psychiatry and public health — and continue to delve ever deeper into the molecular basis of disease in an effort to unlock the mysteries behind the human body and the malfunctions that result in serious medical disorders. The Medical College — in its commitment to global health and education — has a strong presence in such places as Qatar, Tanzania, Haiti, Brazil, Salzburg, and Turkey. With the historic Weill Cornell Medical College in Qatar, the Medical School is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient.

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College of Agriculture and Life Sciences at Cornell University

The College of Agriculture and Life Sciences at Cornell University is committed to developing leaders to address the global challenges of the 21st century. With more than 3,000 students and 400 faculty, the preeminent college for research, teaching and extension of agriculture and the life sciences is the second largest undergraduate college at Cornell and the third largest college of its kind in the United States. A commitment to four priorities — the land-grant mission, the applied social sciences, the environmental sciences and the new life sciences — allows faculty and students to examine the world from multiple perspectives, and ensures that every student’s education is geared to contemporary, real-world issues. Diverse strengths across the biological sciences, a commitment to biodiversity, a strong undergraduate business program, a long tradition of international work and the translation of groundbreaking discoveries into commercial practice and educational outreach ensures that faculty, staff and students make an important difference in the lives of stakeholders in New York state, the nation and the world.

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The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society, headquartered in White Plains, N.Y., with 68 chapters in the United States and Canada, is the world’s largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The Society’s mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, the Society has invested more than $550 million in research — specifically targeting leukemia, lymphoma and myeloma. Last year alone, the Society made 5.1 million contacts with patients, caregivers and health-care professionals.

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