Mount Sinai develops first screening tool for war veterans to assess traumatic brain injury

Mount Sinai develops first screening tool for war veterans to assess traumatic brain injury

From the January 5, 2011 Eureka news alert

A team of researchers at Mount Sinai School of Medicine has developed the first web-based screening tool for Traumatic Brain Injury (TBI). This instrument has recently been used by soldiers returning from the wars in Iraq and Afghanistan who participated in the Sixth Annual Road to Recovery Conference and Tribute in Orlando to determine if they sustained a TBI.

“Traumatic brain injury is underdiagnosed, and left untreated can have long-term cognitive, behavioral and physical effects,” said Wayne Gordon, PhD, the Jack Nash Professor of Rehabilitation Medicine and an Associate Director of the Department of Rehabilitation Medicine at Mount Sinai School of Medicine, who led the project. “If we can intervene and diagnose TBI early, then we can prevent further complications.”

Dr. Gordon and his team began working on this screening tool 20 years ago. Working in local schools, they found a surprising number of students with TBI but never reported it nor received medical attention, often because the injuries were sustained as a result of abuse or assault. Dr. Gordon wanted to develop an anonymous screening tool to help people assess their risk and avoid long-term complications.

The Brain Injury Screening Questionnaire (BISQ) is a web-based tool that allows users to anonymously answer a series of questions about whether they sustained a blow to the head in which they were unconscious or dazed, confused or disoriented. Their symptoms include sleep disturbances, irritability, memory disturbances, difficulties organizing daily tasks, and difficulty concentrating. At the end of the survey, participants receive a computer-generated report. Those who are found to be at risk are advised to seek further evaluation from a qualified health care professional.

According to Mark Wiederhold, MD, who presented at the conference, TBI was diagnosed in 41 percent of patients being treated in the Walter Reed Army Medical Center in Washington, DC. Dr. Gordon hopes that more veterans’ organizations will embrace the tool in this population so that they are treated early.

“I applaud the Coalition to Salute America’s Heroes and The American Legion for taking the first step toward bringing this serious issue to the forefront, and encouraging veterans to get screened,” said Dr. Gordon. “I hope more organizations around the country will follow suit.”

It is estimated that about seven percent of people in the United States have diagnosed or undiagnosed TBI. Dr. Gordon and his team from the Department of Rehabilitation Medicine at Mount Sinai plan to conduct research using the screening tool in other populations as well. The researchers are using BISQ to assess TBI in the prison population in Texas to determine how the condition may contribute to criminality.

The software is $15.00. For more information visit http://www.mssm.edu/research/centers/traumatic-brain-injury-central.

ICU communication study reveals complexities of family decision-making

ICU communication study reveals complexities of family decision-making

From the January 5, 2010 Eureka news alert

While a much hailed communication intervention works for families making decisions for chronically-ill loved ones in medical intensive care units, Case Western Reserve University researchers found the intervention was less effective for surgical and neurological ICU patients.

Barbara Daly and Sara Douglas, the study’s lead researchers from the Frances Payne Bolton School of Nursing at Case Western Reserve, attribute the varied results to different types of patients served by the three types of ICUs and differences among ICU cultures.

“We found the same approach is not going to have the same results for everyone,” Daly said

With the number of ICU patients predicted at more than 600,000 patients annually by 2020, researchers search for ways to help families make critical decisions for their loved ones. This study contributes to those ICU practices involving complex communication issues.

The researchers repeated a study from a Boston hospital that resulted in shorter stays and less unneeded tests and treatments when families were routinely informed through a systemized communications intervention about their family member’s progress in a medical ICU. They compared the effect of the new communication system in 346 patients to usual practice in 135 patients.

The intervention involved a 30-minute communication meeting between the clinical staff and family, beginning five days after a patient requiring a ventilator was admitted to the ICU. The staff and family covered five components: medical update, preferences and goals for the patient, treatment plans, prognosis, and milestones (the markers that can tell whether a person is improving).

The meetings continued weekly until the patient was transferred to a regular hospital ward, to a long-term facility, went home or died.

According to Daly, the discussions are important because up to 40% of these ICU patients do not survive beyond two months if they have spent more than five days on a mechanical ventilator.

For survivors, the most likely outcome is for long-term care, which raises issues about the quality of life that the patient might want to have, she said.

Overall, the researchers found no significant differences between the control and intervention groups in length of stay in the ICU or in limitations of aggressive interventions.

“The Boston study had been the ideal situation where the director of the ICU was conducting the study and the ICU staff accepted the intervention as part of its routine practices, said Daly, professor of nursing and clinical ethics director at University Hospitals Case Medical Center. “We took the study into real-life situations.”

Daly attributes the varying effectiveness of the new communication system to different ages and needs of patients in the medical, compared to surgical units and to differences in clinical staff attitudes towards decisions to limit aggressive interventions, such as feeding tubes and tracheostomy.

In the medical units, the patients generally are older and chronically ill—many suffering several chronic illnesses. The other ICUs generally serve younger patients who are more likely to have suffered a sudden acute health crisis, such as an emergency surgery or trauma from a motor vehicle accident.

Daly said many treatments in the medical ICU will not sustain life, and families face complicated end-of-life decisions to stop or continue ineffective treatments.

The research group also tracked conversational interchanges between family members and doctors.

All families received medical updates. About 86% of the meetings covered treatment plans; 94%, prognosis; 78 percent, preferences and goals; and only 68%, milestones.

Daly said analyses of the types of conversations found that 98% of the time was spent relaying facts about the patient, and only 2% was spent on personal, emotional, or relationship conversation.

The researchers also found that on average, doctors asked families one question, which was: “Do you have any questions?”

The families asked an average of six.

“Better communications is needed. Overall the process is not working as well as we would like and there are missed opportunities to better support families in their decisions,” Daly concluded.

 

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The full results of the National Institute for Nursing Research-funded study were published in the article, “Effectiveness Trial of an Intensive Communication Structure for Families of Long-Stay ICU Patients,” in the journal Chest.

 

 

 

 

Biological joints could replace artificial joints soon

Biological joints could replace artificial joints soon

University of Missouri researchers are part of team that has successfully regenerated complete shoulder joint surfaces using the patient’s own cells

From a January 5, 2011 Eureka news alert

Artificial joint replacements can drastically change a patient’s quality of life. Painful, arthritic knees, shoulders and hips can be replaced with state-of-the-art metal or ceramic implants, eliminating pain and giving a person a new lease on life. But, what if, instead of metal and plastic, doctors were able to take a patient’s cells and grow an entirely new joint, replacing the old one with a fully functional biological joint? A team of University of Missouri and Columbia University researchers have found a way to create these biological joints in animals, and they believe biological joint replacements for humans aren’t far away.

In a study published this fall in The Lancet***, James Cook, a researcher in the MU College of Veterinary Medicine and Dept of Orthopaedic Surgery participated on a research team that created new cartilage in animals using a biological “scaffold” in the animals’ joints. Cook assisted with the implant design and performed the surgeries to implant the biologic joint replacements. The study was led by Jeremy Mao of Columbia University….

 

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How studded winter tires may damage public health, as well as pavement

How studded winter tires may damage public health, as well as pavement

From a January 5, 2011 Eureka news alert

Scientists are reporting new evidence on how studded tires — wintertime fixtures in some areas but banned in others for causing damage to pavement — may also damage the health of motorists and people living near highways. Studded tires have small metal protrusions from the rubber tread that improve traction on icy or snow-covered roads. Their study appears in ACS’ Chemical Research in Toxicology, a monthly journal.

Anders Ljungman and colleagues note that studded tires grind away at the road surface, generating the kind of dust particles believed to contribute to heart and respiratory disease when inhaled into the lungs. Studded tires are winter mainstays in Finland, Norway, Sweden and other northern countries, but have been banned or restricted in others and in some states because they damage pavement. The scientists’ past research found that road dust from studded tires causes biological changes in cells related to inflammation, a process underlying heart and respiratory diseases.

In the new research, the scientists pinpointed specific changes in proteins in cells related to the road dust exposure. Dust exposure resulted in significant increases in three proteins associated with increased inflammation and decreased levels of seven proteins, including some involved in fighting inflammation and maintaining normal metabolism. The results reveal important chemical markers in the body that could help scientists better understand the link between pavement dust and heart disease, the scientists suggest.

Bacteria eyed for possible role in atherosclerosis

Bacteria eyed for possible role in atherosclerosis
Enterobacter hormaechei — normally associated with pneumonia and sepsis — found in excised atherosclerotic plaque tissue

From a January 5, 2011 Eurkea news alert

Dr. Emil Kozarov and a team of researchers at the Columbia University College of Dental Medicine have identified specific bacteria that may have a key role in vascular pathogenesis, specifically atherosclerosis, or what is commonly referred to as “hardening of the arteries” – the number one cause of death in the United States.

Fully understanding the role of infections in cardiovascular diseases has been challenging because researchers have previously been unable to isolate live bacteria from atherosclerotic tissue. Using tissue specimens from the Department of Surgery and the Herbert Irving Comprehensive Cancer Center at Columbia University, Dr. Kozarov and his team, however, were able to isolate plaques from a 78-year-old male who had previously suffered a heart attack. Their findings are explained in the latest Journal of Atherosclerosis and Thrombosis.

In the paper, researchers describe processing the tissue using cell cultures and genomic analysis to look for the presence of culturable bacteria. In addition, they looked at five pairs of diseased and healthy arterial tissue. The use of cell cultures aided in the isolation of the bacillus Enterobacter hormaechei from the patient’s tissue. Implicated in bloodstream infections and other life-threatening conditions, the isolated bacteria were resistant to multiple antibiotics. Surprisingly, using quantitative methods, this microbe was further identified in very high numbers in diseased but not in healthy arterial tissues.

The data suggest that a chronic infection may underlie the process of atherosclerosis, an infection that can be initiated by the systemic dissemination of bacteria though different “gates” in the vascular wall – as in the case of a septic patient, through intestinal infection. The data support Dr. Kozarov’s previous studies, where his team identified periodontal bacteria in carotid artery, thus pointing to tissue-destructing periodontal infections as one possible gate to the circulation.

Bacteria can gain access to the circulation through different avenues, and then penetrate the vascular walls where they can create secondary infections that have been shown to lead to atherosclerotic plaque formation, the researchers continued. “In order to test the idea that bacteria are involved in vascular pathogenesis, we must be able not only to detect bacterial DNA, but first of all to isolate the bacterial strains from the vascular wall from the patient,” Dr. Kozarov said.

One specific avenue of infection the researchers studied involved bacteria getting access to the circulatory system via internalization in white blood cells (phagocytes) designed to ingest harmful foreign particles. The model that Dr. Kozarov’s team was able to demonstrate showed an intermediate step where Enterobacter hormaechei is internalized by the phagocytic cells, but a step wherein bacteria are able to avoid immediate death in phagocytes. Once in circulation, Dr. Kozarov said, bacteria using this “Trojan horse” approach can persist in the organism for extended periods of time while traveling to and colonizing distant sites. This can lead to multitude of problems for the patients and for the clinicians: failure of antibiotic treatment, vascular tissue colonization and initiation of an inflammatory process, or atherosclerosis, which ultimately can lead to heart attack or stroke.

“Our findings warrant further studies of bacterial infections as a contributing factor to cardiovascular disease, and of the concept that ‘bacterial persistence’ in phagocytic cells likely contributes to systemic dissemination,” said Dr. Kozarov, an associate professor of oral biology at the College of Dental Medicine. Dr. Jingyue Ju, co-author and director of the Columbia Center for Genome Technology & Bio-molecular Engineering, also contributed to this research, which was supported in part by a grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health and by the Columbia University Section of Oral and Diagnostic Sciences.

The article appeared in Volume 18 of the Journal of Atherosclerosis and Thrombosis.

How do data exclusivity periods affect pharmaceutical innovation?

How do data exclusivity periods affect pharmaceutical innovation?

Study is first to estimate financial and social impact of extending exclusive access to clinical trial data for conventional drugs

From a January 6, 2011 Eureka news alert

LOS ANGELES, Calif. — January 6, 2011 — Pharmaceutical companies and generic drug manufacturers have long been at odds over regulations about “data exclusivity,” the period of time before generic manufacturers can make use of valuable clinical trial data.

A new study in the January 2011 issue of Health Affairs *** is the first to calculate the financial and social costs of limiting access to trial data — and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

“Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations,” explained Dana Goldman, lead author, director of the Schaeffer Center for Health Policy and Economics at USC and Norman Topping Chair in Medicine and Public Policy at USC.

The pharmaceutical companies that introduce new drugs are currently granted five years of exclusive access to the clinical trial data they submit during the approval process. An extension of three years is available if new applications arise and a six month extension is granted if the drug is approved for use in pediatric populations.

In 2007, the National Academies Committee on Science, Engineering and Public Policy called for extending this “data exclusivity” term to the longer period used in Europe, ten to 11 years. But generic manufacturers have argued for shorter limits so that they can bring less expensive versions of drugs to patients sooner.

“Unfortunately, the health policy literature contains no information about the effects such a policy would have on innovation, population longevity and social welfare,” said Darius Lakdawalla, research director at the Schaeffer Center at USC and associate professor in the USC School of Policy, Planning and Development.

In the first study to directly address these issues, the researchers estimate that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent, on average.

With empirical evidence that profits drive drug innovation, this longer term would lead to an additional 228 drug approvals over the next fifty years and an increase of 1.7 months in average life expectancy, according to the study.

John Romley, an economist with the Schaeffer Center at USC and research assistant professor at the USC School of Policy, Planning and Development, acknowledged the trade-off between current and future generations: “Americans in the early 2020’s would bear the cost of increasing drug spending. However, people turning 55 in 2060 could expect increased life expectancy as a result of innovation in the interceding years — that is, new drugs brought to market because of lengthier data exclusivity.”

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Evidence lacking for widespread use of costly antipsychotic drugs, says Stanford researcher

Evidence lacking for widespread use of costly antipsychotic drugs, says Stanford researcher
[This editor blogged a related item on December 6, 2010, Nursing homes are seeking to end the stupor]

From a January 7, 2011 Eureka news alert

STANFORD, Calif. — Many prescriptions for the top-selling class of drugs, known as atypical antipsychotic medications, lack strong evidence that the drugs will actually help, a study by researchers at the Stanford University School of Medicine and University of Chicago has found. Yet, drugs in this class may cause such serious effects as weight gain, diabetes and heart disease, and cost Americans billions of dollars.

“Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is senior author of the study to be published online Jan. 7 in Pharmacoepidemiology and Drug Safety.*** “These are commonly used and very expensive drugs.”

Prescriptions for these drugs have risen steadily since they first came on the U.S. market in 1989, largely replacing the first generation of antipsychotics, which were mainly used to treat schizophrenia. The U.S. government’s original stamp of approval for the new drugs was for treating schizophrenia, but they’re used more today for other conditions, including other psychoses, autism, bipolar disorder, delirium, dementia, depression and personality disorders. And while some of these uses have recently been approved by the U.S. Food and Drug Administration, many have not….

…These new drugs accounted for more than $10 billion in retail pharmacy U.S. prescription drug costs in 2008, representing the largest expenditure for any single drug class — nearly 5 percent of all drug spending, surpassing even blockbusters like statin cholesterol medications. According to a 2004 study, a quarter of all residents of U.S. nursing homes had taken them. Among the drugs are quetiapine, aripoprazole (brand name, Abilify), olanzapine (Zyprexa) and risperidone (Risperdal), each with annual U.S. sales exceeding $1 billion.

Stafford’s new study adds to concerns about the drugs, which have been the focus of thousands of lawsuits, and as a class make up the single largest target of litigation filed under the federal False Claims Act. All major companies selling new-generation antipsychotics have either recently settled cases for hundreds of millions of dollars or are currently under investigation for skewing results or using questionable marketing tactics.

In 2005, the FDA issued its strongest type of caution, the “black box” warning, for use of new-generation antipsychotics, because of increased risk of death for dementia patients.

“Most people think, ‘If my doctor prescribed this, the FDA must have evaluated whether this drug was safe and effective for this use.’ That’s not true,” said Stafford. When doctors prescribe drugs for purposes other than those approved by the FDA, it’s called “off-label” use. Though it’s riskier for patients, there’s nothing illegal about it, and can make sense medically in some instances, Stafford said, especially if there are no approved treatments or if a patient has not responded to approved drugs.

Previous studies had shown that antipsychotic drug use is ballooning. Stafford’s new study not only corroborated and updated these findings but also identified the fraction of off-label use that is based on uncertain evidence.

The researchers’ first step was to analyze the results of a physicians’ survey conducted by health-care information company IMS Health. The IMS Health National Disease and Therapeutic Index survey gives a snapshot of the conditions doctors treated and drugs they prescribed. About 1,800 physicians participate each calendar quarter and each is randomly assigned two days per quarter to provide data.

After identifying which antipsychotics were being used, and for what, the researchers assessed the strength of the evidence supporting those that lacked FDA approval, using efficacy ratings from the widely used drug compendium, Drugdex.

Lead author Caleb Alexander, MD, assistant professor of medicine at the University of Chicago, and colleagues conducted the analysis. Stafford supervised the project and with Alexander interpreted the data. Stanford clinical assistant professor of psychiatry Anthony Mascola, MD, provided expertise on the treatment of psychiatric conditions.

Among their findings:

Antipsychotic treatment prescribed during the surveyed doctors’ visits nearly tripled from 6.2 million in 1995 to 16.7 million in 2008, the most recent year for which they had data. During this period, prescriptions for first-generation antipsychotics decreased from 5.2 million to 1 million.
Antipsychotic use for indications that lacked FDA approval by the end of 2008 increased from 4.4 million prescriptions during surveyed doctors’ visits in 1995 to 9 million in 2008.
In 2008, more than half — 54 percent — of the surveyed prescriptions for the new-generation antipsychotics had uncertain evidence.
An estimated $6 billion was spent in 2008 on off-label use of antipsychotic medication nationwide, of which $5.4 billion was for uses with uncertain evidence.
Prescriptions for antipsychotics began dropping slightly in 2006, shortly after the FDA issued a warning about their safety.
Stafford suggests the upswing in prescriptions for antipsychotics despite the absence of good evidence for their value in many instances is the result of marketing — whether legal or illegal — and ingrained cultural tendencies. “Physicians want to prescribe and use the latest therapies — and even when those latest therapies doesn’t necessarily offer a big advantage, there’s still a tendency to think that the newest drugs must be better,” he said.

Physicians could benefit from more feedback on what percentage of their prescriptions is for off-label uses, said Stafford. “In many cases, physicians don’t realize they’re prescribing off-label,” he said.

In fact, in a previous survey of physicians, Alexander found that the average respondent accurately identified the FDA-approval status of drugs for a given condition just over half the time.

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