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Implementation of the health care privacy law widely known as HIPAA, or the U.S. Health Insurance Portability and Accountability Act, has severely eroded the process of scientific research, delaying some clinical studies and curtailing others before they even begin, according to a study published in JAMA. The findings are part of the first national survey of epidemiologists commissioned by the Institute of Medicine, National Academies of Science. The privacy rule has made research more costly and time-consuming, the researchers said. As a result, they add, some possibly important studies are not being done. Survey responses from 1,527 epidemiology practitioners employed in academia, government, industry, and other sectors, revealed that two-thirds believed that HIPAA had made research “a great deal” more difficult to accomplish. All respondents are part of the Joint Policy Committee, Societies of Epidemiology, which co-sponsored the study.

DEMENTIA: LONG-TERM BETA CAROTENE SUPPLEMENTATION MAY HELP PREVENT COGNITIVE DECLINE

Men who take beta carotene supplements for 15 years or longer may have less cognitive decline, according to a report in the Archives of Internal Medicine. Decreases in cognitive ability—thinking, learning, and memory skills—strongly predict dementia. Long-term cellular damage from “oxidative stress” may be a major factor in cognitive decline. Some evidence suggests that antioxidant supplements may help preserve cognition, although previous studies have been inconclusive. Researchers at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues studied the antioxidant beta carotene and its effect on cognitive ability in two groups of men. The long-term participants were treated for an average of 18 years and the short-term participants for an average of one year. Men in the short-term group displayed no differences in cognition regardless of whether they took beta carotene or a placebo, but men in the long-term group who took beta carotene had significantly higher scores on several of the cognitive tests compared with men who took placebo.

 

REGENERATIVE MEDICINE: MENSTRUATION PROVIDES NEW SOURCE OF STEM CELLS
The cells that thicken the womb wall during a woman's menstrual cycle contain a newly discovered type of stem cell, and could be used in the treatment of damaged or old tissue, according to research published today in the online open access publication, Journal of Translational Medicine. Researchers at the Bio-Communications Research Institute in Wichita, Kansas led the research team consisting of scientists from the University of Alberta, University of Western Ontario, and Tempe, Arizona-based Medistem Laboratories, which funded the research. The team identified a new type of stem cell that can be isolated and reproduced from menstrual blood collected from healthy female subjects. Just 5 ml of menstrual blood collected from a healthy woman provided enough cells, which after two weeks of culture provided beating heart cells. The researchers said their work indicates that these cells could be cultured at a large scale to provide an alternative to using cells derived from bone and umbilical cord blood, which poses threats of rejection.

 

FLU: ANTIVIRALS REDUCE DEATHS IN HOSPITALIZED PATIENTS
Adults with influenza infections serious enough to require hospitalization are much less likely to die from the disease if they are given antiviral medications, according to a study published in the journal Clinical Infectious Diseases. While previous clinical trials have shown the antiviral benefit in a relatively young, healthy adult population if they were treated within 48 hours of the onset of flu symptoms, this study showed a significant benefit to an older population even when given antivirals three or four days after the appearance of flu symptoms. Influenza is a disease contracted by between 5 percent and 20 percent of the U.S. population each year. Annually, more than 200,000 Americans are hospitalized with the flu and about 36,000 die from the disease. Older people and young children are at higher risk for serious flu complications. Researchers from Mount Sinai Hospital, the University of Toronto, and the Toronto Invasive Bacterial Diseases Network found that treatment with antivirals reduced the risk of death by nearly 80 percent.

 

The risk of a major stroke occurring within a week after a minor stroke, or transient ischemic attack, is substantial, according to an article published online in The Lancet Neurology. Furthermore, the lowest risk of a second stroke was reported among patients treated as emergency cases in specialist stroke units. Although many studies have looked at the risk of stroke after a minor stroke or TIA, results have been inconsistent, with seven-day stroke risk ranging from 0 percent to 12.8 percent. This has led to problems with their interpretation. Researchers at the Stroke Prevention Research Unit, University of Oxford, U.K. reviewed studies of the risk of stroke within seven days after a TIA to estimate overall stroke risk, and also look at the influence of study method, setting, population, treatment, and case mix. They found the risk of stroke among patients treated urgently in specialist units was substantially lower than for patients treated in alternative settings. These results, they said, support the argument that a TIA is a medical emergency and that urgent treatment in specialist units may reduce the risk of subsequent stroke.

 

An immune system messenger molecule that normally helps reduce inflammation could be an effective tool against multiple sclerosis. Researchers at the Jefferson Medical College of Thomas Jefferson University and the Jefferson Hospital for Neuroscience in Philadelphia have found that the protein interkeukin-27 (IL-27) helped block the onset or reverse symptoms in animals with an MS-like disease. The results suggest that IL-27 may someday be part of a therapy to temper over-active immune responses, which are thought to be at the heart of MS, an autoimmune disease in which the body attacks its own tissue, affecting the central nervous system. The findings were published in the journal Nature Immunology.

 

Chemotherapy given at the same time as radiation therapy can help boost the number of patients that survive at least five years with a certain type of lung cancer by nearly 50 percent compared to patients given the same treatment differently, according to an international team’s analysis of several trial results. Researchers at the Jefferson Medical College of Thomas Jefferson University and Jefferson’s Kimmel Cancer Center in Philadelphia, led one of six trials comparing the effectiveness of giving chemotherapy at the same time as radiation therapy versus giving radiation first, followed later by chemotherapy, to treat locally advanced non-small cell lung cancer. There had been some controversy over whether simultaneous administration of chemotherapy and radiation for such cases was better than sequential delivery. In the United States, chemotherapy and radiation together have become the standard, whereas in other areas, such as Europe, for example, this has not been the case. To try to resolve the matter, the International NSCLC Collaborative Group examined the results of more than 1,200 patients from six trials. The researchers found that the five-year survival rate was 10.6 percent with sequential therapy, while 15.1 percent with concurrent treatment, a relative increase of nearly 50 percent.

 

Eating too much fructose and glucose can turn off the gene that regulates the levels of active testosterone and estrogen in the body, according to a study in mice and human cell cultures published in the Journal of Clinical Investigation. The researchers from the University of British Columbia who conducted the study said the discovery reinforces public health advice to eat complex carbohydrates and avoid sugar. Using a mouse model and human liver cell cultures, the scientists discovered that the increased production of lipid shut down a gene called SHBG (sex hormone binding globulin), reducing the amount of SHBG protein in the blood. SHBG protein plays a key role in controlling the amount of testosterone and estrogen that’s available throughout the body. If there’s less SHBG protein, then more testosterone and estrogen will be released throughout the body, which is associated with an increased risk of acne, infertility, polycystic ovaries, and uterine cancer in overweight women. The researchers said the findings point to using SHBG as a biomarker for monitoring liver function well before symptoms arise.

 

Research from the University of Alabama at Birmingham finds that adding a single dose of two common anti-HIV drugs can prevent HIV-positive pregnant women from developing resistance to an entire class of drugs, potentially improving future treatment options. The research, published in an online edition of The Lancet, found that providing tenofovir and emtricitabine with nevirapine during labor greatly reduces the extent of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI), such as nevirapine, which HIV-positive women take to lower the risk of mother-to-child transmission during childbirth. The combination of drugs reduced the development of resistance to NNRTIs by more than half at six weeks after delivery. The researchers said that’s significant because anywhere from 20 to 69 percent of women given nevirapine develop resistance to the NNRTIs after taking a single dose. Although resistance becomes undetectable one to two years after ingestion, there are concerns that it could still compromise a woman’s future treatment options.

 

VASCULAR SURGERY: STUDY QUESTIONS DISPARITIES AMONG HISPANICS
Hispanics in the United States receive fewer vascular surgeries than the general population and have worse outcomes in some cases, according to new research, which also finds that Hispanics often seek treatment only after developing more advanced vascular diseases. Reasons for the disparities are not fully understood, but may include a combination of socioeconomic factors and genetic variations. Published in the November Journal of Vascular Surgery, the study was led by a vascular surgery team from NewYork-Presbyterian Hospital, Columbia University Medical Center, and Weill Cornell Medical College. They found that Hispanic patients, compared to non-Hispanic whites, had higher rates of amputation following lower extremity revascularization (a surgical procedure to restore blood supply to a body part or organ) (6.2 percent vs. 3.4 percent) and greater risk for death following elective abdominal aortic aneurysm repair (5.0 percent vs. 3.4 percent). Additionally, Hispanic patients were as much as two times more likely than whites to seek treatment only after developing more advanced disease. They also spend more time in the hospital recovering.

 

The only realistic way of preventing deaths and severe complications arising from chicken pox is to routinely vaccinate children against the disease, concludes research published online in the Archives of Disease in Childhood. At present, only healthcare workers and others likely to be at risk of contracting or passing on the infection are routinely immunized in the U.K. But vaccination programs for children have been introduced in several other countries, including the United States, Canada, Australia, and Finland. The authors base their conclusions on active monitoring by pediatricians in the U.K. and Ireland of children up to the age of 16 admitted to hospital with severe complications resulting from chicken pox infection. The complications included septic shock, pneumonia, and encephalitis, as well as uncoordinated movement (ataxia), toxic shock syndrome, and "flesh eating" bacterial infection (necrotizing fasciitis).

 

Nursing home residents who received eyeglasses for uncorrected refractive error were found to have improved quality of life and decreased symptoms of depression when compared to those with refractive error who had not received eyeglasses, according to a report in the Archives of Ophthalmology. Nursing home residents in the United States and other industrialized countries have high rates of vision impairment, with estimates ranging from three to 15 times higher than corresponding rates for community-dwelling older adults. Researchers at the University of Alabama at Birmingham conducted a trial in which 142 nursing home residents age 55 or older were assigned to a group that would receive eyeglasses one week after check-up (78 residents) or a group that would receive eyeglasses at a follow-up two months after check-up (64 residents). Vision-related quality-of-life and depressive symptoms were measured at baseline and at two months. At baseline, both groups had similar demographic and medical characteristics and had similar visual acuity and refractive error uncorrected by eyeglasses. After two months, distance and near visual acuity for the right and left eye improved in the group that received eyeglasses, while the group that had not received eyeglasses had no change in visual acuity. Also at the two-month follow-up, the group that received eyeglasses reported higher scores for reading, activities, and hobbies and social interaction as well as fewer depressive symptoms.

 

In youth with attention deficit hyperactivity disorder (ADHD), the brain matures in a normal pattern, except that it is delayed three years in some regions, on average, compared to youth without the disorder, according to researchers at the National Institutes of Health’s National Institute of Mental Health. The delay in ADHD was most prominent in regions at the front of the brain’s outer mantle (cortex), important for the ability to control thinking, attention, and planning. Otherwise, both groups showed a similar back-to-front wave of brain maturation with different areas peaking in thickness at different times. The motor cortex emerged as the only area that matured faster than normal in the youth with ADHD, in contrast to the late-maturing frontal cortex areas that direct it. This mismatch might account for the restlessness and fidgety symptoms common among those with the disorder, the researchers suggested. The findings support the theory that ADHD results from a delay in cortex maturation. In future studies, the researchers hope to find genetic underpinnings of the delay and ways of boosting processes of recovery from the disorder.

 

ACNE: DRUG’S MECHANISM TIED TO DEPRESSION
Researchers at the University of Bath in the U.K. have found that a drug used to treat severe forms of acne reduces the availability of the chemical serotonin, low levels of which have been linked to aggression and clinical depression. In a study published in the journal Experimental Biology and Medicine, scientists reveal a potential mechanism that might link the drug Roaccutane (Accutane in the United States) to reported cases of depression in some patients taking the medication. The researchers had previously reported that the drug caused depressive behavior in mice but, until now, the mechanism by which this might happen was unknown.

 

Research out of the Neurological Institute at University Hospitals Case Medical Center in Cleveland finds that deep brain stimulation helps patients who suffer from Tourette syndrome, a neurobehavioral disorder characterized by sudden, repetitive muscle movements and vocal tics. Deep brain stimulation is approved by the Food and Drug Administration for treatment of Parkinson’s disease, essential tremor, and dystonia. The stimulation involves the surgical implantation of electrodes in the brain and pulse generators in the upper chest just beneath the collarbones. The implanted pulse generator is connected to the electrode in the brain by a thin cable that is placed under the skin. The pulse generator is then programmed to deliver a high-frequency electrical stimulation to the targeted area of the brain. This first-of-its-kind study of five adults with Tourette syndrome determined that deep brain stimulation can reduce tic frequency and severity in some people who have exhausted other medical treatments. The researchers plan to conduct a larger clinical trial to further determine its efficacy in helping patients who have failed traditional medical therapy for Tourette syndrome.

 

Researchers from Wake Forest University Baptist Medical Center suggests that age alone shouldn’t be a barrier to receiving a kidney transplant—and that using donated kidneys that would once have been discarded may help alleviate the burgeoning organ shortage among older adults. In a study published in the journal Surgery, the researchers note that there is an increasing need for kidney transplants among older adults. While the number of patients younger than 50 added to the waiting list for kidney transplants has remained constant during the last decade, the number of patients who are 65 or older has tripled. In 2002, the United Network for Organ Sharing instituted a new policy to make better use of higher-risk organs that were once considered unsuitable for transplantation. These organs from “expanded criteria” donors include kidneys from deceased donors over age 60 years or those over age 50 with health conditions such as high blood pressure, stroke, or elevated levels of a protein called creatinine. Creatinine levels are used to determine kidney function. The researchers found patient and organ survival rates were similar regardless of patient age—and whether they received a kidney from expanded-criteria donor or a standard-criteria donor organ.

 

A survey conducted by researchers at the University of Toronto reveals that Americans living in states with high rates of income inequality are significantly more likely to have a disability that limits the completion of daily tasks such as dressing, bathing, and mobility at home. The study, published in the British journal Public Health, looked at information collected from 645,000 Americans through the 2003 American Community Survey of the U.S. Census Bureau. In states with greater inequality, the rich were also at a health disadvantage. Both rich and poor people living in states with unequal wealth distribution were 11 percent more likely to have high-level disabilities than their counterparts living in states where income is distributed more equally. New York, Arizona, and the District of Columbia were the three regions with the highest levels of income inequality. The researchers could not say whether there was a causal relationship between income disparity and disability levels in states.

 

The Juvenile Diabetes Research Foundation and Eli Lilly said that they are joining together to create a $3-million research effort to accelerate the pace of research into drugs and therapies to cure diabetes and its complications by developing biomarkers—indicators that can measure the progress of disease and the effectiveness of therapeutics.

The project—called the JDRF-Lilly Innovative and Academic Research and Development Grants in Diabetes Biomarkers—will be funded by a $3-million grant from the Lilly Foundation to JDRF over three years. The new JDRF-Lilly project will support cutting-edge research on biomarkers for pancreatic beta cell mass and function.

Grants by the JDRF-Lilly project will be available to both academic and commercial investigators.

 

A study by researchers at Brandeis University and the State University of New York at Buffalo published in the journal Pediatric Hematology and Oncology reports that while most pediatric oncologists say they are spiritual, and many are open to connecting with the families of very sick children through religion or spirituality, they typically lack the formal healthcare training that could help them build such bridges. More than half of the respondents said their spiritual or religious beliefs influence to some extent their interactions with families, patients, and colleagues, while almost 40 percent believed they did not. The researchers said their study suggests that we should consider training to help physicians relate spiritually to families confronting life-threatening illness such as cancer.

 

AIDS: BRAZIL SAVES $1 BILLION IN DRUG COST THROUGH NEGOTIATIONS, LOCALLY MADE GENERICS
Brazil’s strategy of negotiating AIDS drug prices with multinational pharmaceutical companies and producing generic AIDS drugs locally saved that country’s AIDS program approximately $1 billion between 2001 and 2005, according to research published in PLoS Medicine. In a study from the Harvard School of Public Health, researchers analyzed the costs of individual AIDS drugs in Brazil. They found that even though the generic drugs produced in Brazil were generally more expensive than similar drugs made elsewhere, by negotiating patented drug prices, Brazil has enjoyed lower prices for patented AIDS drugs than many other developing countries. The study concludes that although the Brazilian model initially saved $1 billion, drug costs rose rapidly as Brazil provided treatment to increasing numbers of patients and people with HIV/AIDS lived longer. In 1996, Brazil became the first developing country to commit to providing free and universal access to AIDS drugs. Since then, Brazil’s successful AIDS treatment program has become a model for the developing world, with 180,000 Brazilians receiving treatment at the end of 2006.

 

In a petition filed today with the U.S. Food and Drug Administration, an international coalition of scientists and doctors seeks to compel the agency to stem the flood of dangerous drugs reaching American consumers by mandating the use of scientifically superior non-animal testing methods when those alternatives exist. The coalition calls on the FDA to emulate a European Union regulation that requires the use of human-centered testing methods, when available. The Mandatory Alternatives Petition, or MAP, lays the groundwork for legal action. If the FDA does not act within six months, the petitioners will consider further action. The MAP coalition urges wider use of human-centered research methods such as microdosing, tissue studies, and virtual drug trials. Greater use of alternatives would also have a humane benefit because it would reduce the use of monkeys, dogs, cats, mice, and other animals, the group said. 

 

The world community quickly needs to reach a compromise that outlaws reproductive cloning or prepare to protect the rights of cloned individuals from potential abuse, prejudice, and discrimination, according to authors of a new policy analysis by the United Nations University’s Institute of Advanced Studies. A legally-binding global ban on work to create a human clone, coupled with freedom for nations to permit strictly controlled therapeutic research would be the most politically viable to the international community, according to the report “Is Human Reproductive Cloning Inevitable: Future Options for UN Governance” by the Yokohama, Japan-based institute. Virtually every nation opposes human cloning and more than 50 have legislated bans on such efforts. Efforts in 2005 to negotiate an international convention fell through over so-called research or therapeutic cloning. Whereas reproductive cloning is meant to duplicate a person or animal, research cloning is meant to produce tissues that genetically match those of the person or animal whose cells are cloned.