Press Release Date: April 4, 2011

Some medical and behavioral treatments show promise for reducing certain behaviors in children with autism spectrum disorders (ASDs), but more research is needed to assess the potential benefits and harms, according to a new report funded by HHS’ Agency for Healthcare Research and Quality (AHRQ). The research results were published online in the journal Pediatrics.

The comparative effectiveness report found that two commonly used medications—risperidone and aripiprazole—show benefit in reducing some behaviors, including emotional distress, aggression, hyperactivity and self-injury. However, these medicines are associated with significant side effects, such as rapid weight gain and drowsiness. The review found that no medications used for ASDs improved social behaviors or communication skills. The report also found that several medications show promise and should be studied further, but that secretin, which has been studied extensively, has shown no effectiveness.

Children with ASDs have difficulty in social interaction, behavior, and communication. Some children with ASDs may also have impaired cognitive skills and sensory perception. Based on limited evidence, behavioral interventions also showed promise for improving some symptoms and behaviors, but their effects varied. For example, early intensive behavioral and developmental interventions seemed to improve cognitive performance, language skills, and adaptive behavior in some groups of children, the report found.

Other interventions, which focused on parent training and cognitive behavioral therapy, may be useful for children with ASDs to improve social communication, language use and potentially symptom severity, researchers said.

“Autism spectrum disorders are frustrating and challenging for patients, their families and caregivers,” said AHRQ Director Carolyn M. Clancy, M.D. “This report will help parents and clinicians understand their options and design a course of treatment that is consistent with their goals and values.”

Researchers at the Vanderbilt Evidence-based Practice Center in Nashville, TN, who prepared the report for AHRQ, noted that further research is needed to identify which children are likely to benefit from particular interventions. The authors also were critical of the fact that current studies contain few comparisons of medical interventions with behavioral interventions as well as combinations of the two, despite the fact that most children undergo multiple treatments at the same time.

Because of these limitations in the available evidence, researchers were not able to compare treatments and interventions to each other. In addition, they noted that every case of ASD is different and did not conclude that one type of treatment is superior.

ASDs—which include autistic disorder, Asperger syndrome, and pervasive developmental disorder-not otherwise specified—affect an estimated 1 in every 110 children in the United States. Treatment goals for ASDs often focus on improving social communication and addressing certain behaviors. Other treatments also target anxiety, attention difficulties, and sensory difficulties. Goals for treatment often vary by child.

The report, Comparative Effectiveness of Therapies for Children with Autism Spectrum Disorders, is the latest comparative effectiveness review from AHRQ’s Effective Health Care program is available at http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct”productid=656.

The Effective Health Care program sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act, represents an important Federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, pharmacists and others choose the most effective treatments. Information can be found at http://www.effectivehealthcare.ahrq.gov.

For more information, please contact AHRQ Public Affairs: (301) 427-1892 or (301) 427-1855.

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Internet Citation:

Treatments Show Promise in Reducing Autism-related Behaviors, but Some Have Significant Side Effects. Press Release, April 4, 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2011/autismpr.htm


Novel Vaccine Is Poised to Move Quickly Into Human Trials
In NIH-Funded Study, Researchers Say the Approach Could Also Stop Addiction to Other Drugs, Including Heroin and Nicotine

NEW YORK (Jan. 4, 2011)— Researchers have produced a lasting anti-cocaine immunity in mice by giving them a safe vaccine that combines bits of the common cold virus with a particle that mimics cocaine.

In their study, published Jan. 4 in the online edition of Molecular Therapy and funded by the National Institute on Drug Abuse, the researchers say this novel strategy might be the first to offer cocaine addicts a fairly simple way to break and reverse their habit, and it might also be useful in treating other addictions, such as to nicotine, heroin and other opiates.

“Our very dramatic data shows that we can protect mice against the effects of cocaine, and we think this approach could be very promising in fighting addiction in humans,” says the study’s lead investigator, Dr. Ronald G. Crystal, chairman and professor of genetic medicine at Weill Cornell Medical College.

He says the antibody immune response produced in lab mice by the vaccine binds to, and sequesters, cocaine molecules before the drug reached the brains of these animals — and prevents any cocaine-related hyperactivity. The vaccine effect lasted for at least 13 weeks, the longest time point evaluated.

“While other attempts at producing immunity against cocaine have been tried, this is the first that will likely not require multiple, expensive infusions, and that can move quickly into human trials,” Dr. Crystal says. “There is currently no FDA-approved vaccine for any drug addiction.”

“An approach that works is desperately needed for cocaine addiction, which is an intransigent problem worldwide,” he adds. “There are no therapies now.”

The novelty of this possible treatment is that it hooks a chemical that is very similar in structure to cocaine, onto components of the adenovirus, a common cold virus. In this way, the human immune system is alerted to an infectious agent (the virus) but also learns to “see” the cocaine as an intruder as well, Dr. Crystal says. Once the structure of the new intruder is recognized, natural immunity builds to cocaine particles, so any time cocaine is snorted or used in any way, antibodies to the substance are quickly produced and the cocaine molecules are engulfed by the antibodies and prevented from reaching the brain.

“The human immune system doesn’t naturally tag cocaine as something to be destroyed — just like all small-molecule drugs are not eliminated by antibodies,” he says. “We have engineered this response so that it is against the cocaine mimic.”

In this study, a team of researchers — scientists from Weill Cornell Medical College, Cornell University in Ithaca, and the Scripps Research Institute in La Jolla, Calif. — ripped apart an adenovirus, retrieving only the components that elicit an immune response and discarding those that produce sickness. They then hooked the cocaine analog on to these proteins to make the vaccine. “We used the cocaine analog because it is a little more stable than cocaine, and it also elicits better immunity,” Dr. Crystal says.

The researchers then injected billions of these viral concoctions into “garden variety” laboratory mice (mice that are not genetically engineered). They found a strong immune response was generated against the vaccine, and that these antibodies, when put in test tubes, gobbled up cocaine.

They then tested the vaccine’s effect on behavior, and found that mice that received the vaccine before cocaine were much less hyperactive while on the drug than mice that were not vaccinated. The effect was even seen in mice that received large, repetitive doses of cocaine. Proportionally, the cocaine doses reflected amounts that humans might use.

The vaccine needs to be tested in humans, of course, says Dr. Crystal, but he predicts that if it works, it will function best in people who are already addicted to cocaine and who are trying to stop using the drug. “The vaccine may help them kick the habit because if they use cocaine, an immune response will destroy the drug before it reaches the brain’s pleasure center.”

The study’s authors include Dr. Ronald G. Crystal — who is also chief of the Division of Pulmonary and Critical Care Medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center — and his colleagues Martin J. Hicks, Bishnu P. De, Jonathan B. Rosenberg, Jesse T. Davidson, Neil R. Hackett, Stephen M. Kaminsky, Stefan Worgall and Miklos Toth of Weill Cornell Medical College; Jason G. Mezey of Weill Cornell Medical College and Cornell University in Ithaca, N.Y.; Amira Y. Moreno, Kim D. Janda, Sunmee Wee and George F. Koob of the Scripps Research Institute in La Jolla, Calif.

The study was funded by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health. The NIDA press office can be reached at (301) 443-6245.
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. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson’s disease, and most recently, the world’s first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston, making Weill Cornell one of only two medical colleges in the country affiliated with two U.S.News & World Report Honor Roll hospitals. For more information, visit weill.cornell.edu. Powered by Big Medium™
Contact Info
John Rodgers
jdr2001@med.cornell.edu


Release Date: 01/12/2011
Assessment designed to educate, not diagnose, but could aid in early intervention

A quick online assessment tool developed by Johns Hopkins researchers can help worried seniors find out if they are at risk of developing dementia and determine whether they should seek a comprehensive, face-to-face diagnosis from a physician, according to a new study.

The tool, which is being refined and validated, is not meant to replace a full evaluation from a doctor that includes a physical exam, blood work, imaging studies and more. Instead, this assessment provides a scientific way to help a person educate herself about a disease that doctors now believe is best managed if caught early.

“As the population ages and dementia becomes more prevalent, it’s important to get people diagnosed early,” says Jason Brandt, Ph.D., a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and the leader of the study appearing online in the journal Alzheimer’s & Dementia. “Alzheimer’s disease and other types of dementia don’t just creep up on you. They’re incubating for decades in the brain. This tool is potentially very useful in determining who is at risk.”

Among the questions asked on the Dementia Risk Assessment are about whether a person has a history of high blood pressure, depression, diabetes, high cholesterol or head injury, all of which are considered well-documented risk factors for dementia. The assessment also includes a simple memory test that could point to a subtle cognitive decline, Brandt says.

The study analyzed responses from 357 people over the age of 50 who took the assessment at www.alzcast.org. Those who scored lowest on the memory test were significantly older, and were more likely to be men, have hypertension and report severe memory problems. And while only 9 percent of respondents reported they had severe memory problems, more than one-third said they had a first-degree relative with dementia or severe memory loss — a major risk factor for the condition.

The assessment takes just five to 10 minutes to complete online, and the questions have been borrowed from other scientifically valid assessments.

Brandt says the assessment may be helpful in weeding out those who have signs of dementia from those who are simply experiencing the memory loss that comes with aging or a busy lifestyle. Not being able to find your keys or remembering where you parked is rarely a failsafe sign that a person is suffering from dementia.

“Our goal is really to educate people about what some of the risk factors are and, often, to put people’s minds at ease,” he says. “We somehow expect our memories to be as good at 50 as they were at 30. We can’t run as fast as we could 20 years ago. Why should our memory be as good?”

Alzheimer’s disease still has no cure, but early interventions are being used to slow cognitive decline, Brandt says. Brandt says he hopes this assessment will get patients with several risk factors or symptoms to consult a physician.

Some forms of dementia, he says, may not be permanent, and getting to a doctor could help to restore brain function.

Sometimes, Brandt says, seniors are afraid to mention they are having memory or other cognitive issues. The new tool, he says, lets them learn more about themselves and their individualized risk factors in the privacy of their homes.

The aging population means that many more people will be diagnosed with dementia in the coming decades.

“Screening procedures that have demonstrated validity and predictive value and are noninvasive, brief and do not require any special expertise to administer may have the greatest potential to be accepted and actually used by the greatest number of people,” Brandt says. “This tool, which this study preliminarily validates, is the first step toward developing such a procedure.”

Brandt and colleagues are currently conducting research that compares a patient’s results from the online Dementia Risk Assessment with an in-person, comprehensive evaluation by a physician at one of two Johns Hopkins clinics.

This research was supported by a grant from the Geoffrey Beene Foundation’s GB Gives Back Alzheimer’s Initiative. Mark Rogerson, Ph.D., of Johns Hopkins also worked on this study.

For more information:

http://www.hopkinsmedicine.org/psychiatry/expert_team/faculty/B/Brandt.html

http://www.alzcast.org/

Media Contact: Stephanie Desmon
410-955-8665; sdesmon1@jhmi.edu


For immediate release: Wednesday, January 5, 2011

Boston, MA – A new study of men with prostate cancer finds that physical activity is associated with a lower risk of overall mortality and of death due to prostate cancer. The Harvard School of Public Health and University of California, San Francisco researchers also found that men who did more vigorous activity had the lowest risk of dying from the disease. It is the first study in men with prostate cancer to evaluate physical activity after diagnosis in relation to prostate cancer-specific mortality and overall mortality.

The study appears in an advance online edition of the Journal of Clinical Oncology.

“Our results suggest that men can reduce their risk of prostate cancer progression after a diagnosis of prostate cancer by adding physical activity to their daily routine,” said Stacey Kenfield, lead author of the study and a Harvard School of Public Health researcher. “This is good news for men living with prostate cancer who wonder what lifestyle practices to follow to improve cancer survival.”

Prostate cancer is the most frequently diagnosed form of cancer among men in the United States and affects one in six U.S. men during their lifetime. More than 2 million men in the U.S. and 16 million men worldwide are prostate cancer survivors.

The study was conducted in 2,705 men diagnosed with prostate cancer in the Health Professionals Follow-Up Study over an 18-year period. The participants reported the average time per week they spent doing physical activity, including walking, running, bicycling, swimming and other sports and outdoor work.

The results showed that both non-vigorous and vigorous activity were beneficial for overall survival. Compared with men who walked less than 90 minutes per week at an easy pace, those who walked 90 or more minutes per week at a normal to very brisk pace had a 46% lower risk of dying from any cause.

Only vigorous activity—defined as more than three hours per week—was associated with reduced prostate cancer mortality. Men who did vigorous activity had a 61% lower risk of prostate cancer-specific death compared with men who did less than one hour per week of vigorous activity.

“We observed benefits at very attainable levels of activity and our results suggest that men with prostate cancer should do some physical activity for their overall health, even if it is a small amount, such as 15 minutes of activity per day of walking, jogging, biking or gardening,” said Kenfield. “However, doing vigorous activity for three or more hours per week may be especially beneficial for prostate cancer, as well as overall health,” she said.

This study was funded by the National Institutes of Health, Charles A. King Trust and the Prostate Cancer Foundation.

“Physical Activity and Survival After Prostate Cancer Diagnosis in the Health Professionals Follow-Up Study,” Stacey A. Kenfield, Meir J. Stampfer, Edward Giovannucci, June M. Chan, Journal of Clinical Oncology, online January 4, 2011.

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Todd Datz
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tdatz@hsph.harvard.edu

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