More Drug Trials Needed for Conditions Affecting Kids: Review

HealthDay – 6 mins ago WEDNESDAY, July 25 (HealthDay News) -- A new review finds that while children account for almost 60 percent of those with five common medical conditions, only 12 percent of clinical trials of drugs for those conditions examined their effects on pediatric patients.

Yet, the review authors noted, previous research has shown that off-label drugs, where the medicine has only been approved for adult use by the U.S. Food and Drug Administration, make up as much as 79 percent of the medications given to children in hospitals and up to 56 percent of drugs prescribed for kids in doctors' offices.

"We think this contrast is striking, and speaks to the under-representation of research on kids," said review author Dr. Florence Bourgeois, an assistant professor of pediatrics at Boston Children's Hospital and Harvard Medical School in Boston. "Understandably, whenever we see an adverse event the concern is, 'Could these drugs really be dangerous?' and we are left wondering."

The results were released online July 23 in advance of publication in the August print issue of the journal Pediatrics.

The FDA requires that clinical trials demonstrate a drug's safety and effectiveness for a condition before it approves the drug to treat that condition, but many drugs are only tested in adults. As a result, physicians are often left to rely on trial-and-error to decide how to use drugs off-label in children, the review noted.

Bourgeois and her team found that, while just over 21 percent of people in high-income countries who are afflicted by conditions such as depression, asthma, migraines, schizophrenia and bipolar disorder are children and adolescents, less than 10 percent of clinical trials studying these conditions included patients under the age of 18.

The gap was even wider for developing countries, where children and adolescents bear nearly 62 percent of the disease burden for conditions such as malaria, diarrhea, HIV and depression, but only about 12 percent of clinical trials of treatments for these diseases include pediatric patients.

A number of professional organizations, including the Institute of Medicine, the American Academy of Pediatrics and the Royal College of Paediatrics and Child Health in England, have all published statements on the importance of evaluating medical treatments for children using randomized, controlled trials. A randomized, controlled trial, in which study participants are randomly chosen to either receive a treatment or not, is the gold standard for medical research.

"In some instances, it may be fine to extrapolate adult

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Bill Gates says much more work needed to turn tide of AIDS

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Many Teens With High Blood Pressure Don't Get Needed Tests

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Physical activity needed to reap benefits of dietary restriction

ScienceDaily (July 2, 2012) — Fruit flies on dietary restriction (DR) need to be physically active in order to get the lifespan extending benefits that come from their Spartan diet. If the same axiom holds true in humans, those practicing caloric restriction in hopes of living longer need to make sure they eat enough to avoid fatigue.

See Also:Health & MedicineFitnessHealthy AgingDietary SupplementPlants & AnimalsBiologyGenetically ModifiedCell BiologyReferenceCalorie restricted dietDetox dietAnaerobic exerciseGlycogen

According to research at the Buck Institute, flies on DR shift their metabolism toward increasing fatty acid synthesis and breakdown, specifically in muscle tissue. "Dietary restriction is known to enhance spontaneous movement in a variety of species including primates, however this is the first examination of whether enhanced physical activity is necessary for its beneficial effects," said Buck faculty Pankaj Kapahi, PhD, who runs the lab where the research took place. "This study establishes a link between DR-mediated metabolic activity in muscle, increased movement and the benefits derived from restricting nutrients," he said, adding that flies on DR who could not move or had inhibited fat metabolism in their muscle did not exhibit an extended lifespan. "Our work argues that simply restricting nutrients without physical activity may not be beneficial in humans," said Kapahi.

The research is published in the July 3, 2012 edition of Cell Metabolism.

The research also points to a potential target that could yield a drug that mimics the beneficial effects of DR. Lead author, Subhash D. Katewa, PhD, Buck Institute staff scientist, said flies genetically engineered to overexpress the circulating peptide AKH (the fly equivalent of glucagon in mammals) showed increased fat metabolism, spontaneous activity and extended lifespan even though their diet was unrestricted. AKH plays a critical role in glucose and lipid metabolism. "Our data suggests that DR may induce changes in muscle similar to those observed under endurance exercise and that molecules like AKH could serve as potential mimetics for DR that enhance activity and healthspan," said Katewa.

"A better understanding of the dynamics of fat metabolism is needed in order to clarify its role in aging and disease," Katewa said. "These current results suggest that enhanced fat metabolism could help slow aging and the onset of age-related disease."

Contributors to the work: Other Buck Institute researchers involved in the study include Marysia Kolipinski, and Simon Melov. Other collaborators include Fabio Demontis and Norbert Perrimon, Department of Genetics, Harvard Medical School, Boston; Allan Hubbard, School of Public Health, Division of Biostatistics, University of California, Berkeley; and Matthew S. Gill, Department of Metabolism and Aging, The Scripps Research Institute, Jupiter, FL. The work was funded by grants from the American Federation of Aging Research, and the National Institutes of Health.

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Lifesaving Defibrillators Often Not Nearby When Needed

HealthDay – Fri, May 11, 2012 FRIDAY, May 11 (HealthDay News) -- Potentially lifesaving automated external defibrillators (AEDs) are not close at hand in most cases of cardiac arrest that occur in public places, according to a new study.

Cardiac arrest occurs when an abnormal heart rhythm causes the heart to stop beating. Automated external defibrillators are devices that use electrical shocks to restore the heart to a normal rhythm.

The findings may help explain why cardiac arrest survival rates remain below 10 percent in most areas of the United States, despite AED and cardiopulmonary resuscitation (CPR) awareness programs, according to the researchers at the University of Pennsylvania School of Medicine.

For the study, the research team examined the locations of nearly 3,500 out-of-hospital cardiac arrests and the locations of more than 2,300 automated external defibrillators throughout Philadelphia County. The devices were most commonly located in schools and on university campuses (30 percent), in office buildings (22 percent) and in residential buildings (4 percent).

The investigators found that just 7 percent of cardiac arrests occurred within a 200-foot radius of an automated external defibrillator, which is about a two-minute round-trip walk from the scene of the emergency. Ten percent of cardiac arrests occurred within 400 feet and 21 percent occurred within 600 feet -- a six-minute walk -- of an automated external defibrillator location.

The study was slated for presentation Friday at the annual meeting of the Society for Academic Emergency Medicine in Chicago.

It's been found that cardiac arrest victims' chances of survival fall by about 10 percent with each minute that passes without CPR and defibrillation. Patients who receive an automated external defibrillator shock six minutes or more after suffering a cardiac arrest have very low survival rates.

"AEDs are an essential part of the 'chain of survival' that's necessary to save cardiac arrest victims," senior author Dr. Raina Merchant, an assistant professor of emergency medicine, said in a Penn Medicine news release. "Despite thousands of them in the community, our results show they are usually not readily available during cardiac arrests. Without an AED, the minutes bystanders spend waiting for paramedics to arrive could mean the difference between life and death."

The researchers said their findings highlight the need to place automated external defibrillators more strategically in communities and to develop new ways to help the public easily find them and use them in emergencies.

Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The American Heart Association has more about automated external defibrillators.

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US health panel: Pap tests needed only every 3 years

Reuters – Thu, Mar 15, 2012 NEW YORK (Reuters Health) - Women only need to get a Pap test once every three years to check for cervical cancer, and don't need to be screened until age 21 - even if they're sexually active earlier, according to new guidelines from a government-backed panel.

The statement from the United States Preventive Services Task Force, released on Wednesday, aligns closely with guidelines from three U.S. cancer groups that were also announced on Wednesday.

Once they hit 30, women also have the option of getting screened once every five years if they choose to do Pap tests together with human papillomavirus (HPV) testing every time, the committees agreed.

"The bottom line is, we strongly recommend screening," said Dr. Virginia Moyer, chair of the USPSTF and a pediatrician at Baylor College of Medicine and Texas Children's Hospital in Houston.

The recommendation to test every three or five years is based on evidence that cervical cancer is relatively slow-growing, she said, so it's very unlikely a woman would develop advanced cancer in the few years after a negative screening.

"The women who get and die of cervical cancer are the women who aren't getting screened," Moyer told Reuters Health. "It's not the woman who hasn't had a screen in a couple years that's the problem."

Moyer's group attracted controversy late last year when it recommended against annual prostate cancer screening in men, after concluding that the possibility the tests could invite unnecessary and potentially harmful follow-up procedures outweighed their benefits.

The USPSTF's latest recommendations are based on a review of evidence on screening's success at detecting pre-cancerous lesions, as well as both physical and psychological side effects of Pap and HPV tests. Its guidelines were published in the Annals of Internal Medicine.

The task force found a benefit for Pap tests every three years in women age 21 to 65, or every five years when Pap tests and HPV tests are done together, starting at 30.

Screen more frequently, and the possibility of women getting complications from any related procedures - such as an exam and biopsy, called a colposcopy, following an abnormal Pap - outweighs any benefit to the extra tests.

Women under 30 shouldn't be tested for HPV because the sexually transmitted infection is common in young people and often goes away on its own, without increasing the cancer risk.

Women who are older than 65 and were screened regularly in the past are also probably in the clear, unless they're at particularly high risk due to a history of precancerous lesions.

Until there's more long-term data on women who've been vaccinated against HPV, they should continue getting normal screening, according to the report.

CANCER GROUPS AGREE

The guidelines broadly agree with others released by the American Cancer Society, the American Society for Colposcopy and Cervical Pathology and the American Society for Clinical Pathology. Those groups favor screening with both Pap and HPV tests every five years once women hit 30, but say every three years with Pap tests alone is also acceptable. Again, they recommend screening from age 21 to 65 in most cases.

In their report, released in CA: A Cancer Journal for Clinicians and other partner journals, the group's report estimates that without screening, 31 to 33 out of every 1,000 U.S. women would be expected to get cervical cancer in their lives. With Pap tests done every three years, that falls to five to eight per 1,000.

The relative benefit is slimmer when the tests are done more frequently, but the chance of having side effects from testing is just as high each time.

"Screening too much and too sensitively finds primarily benign infections that really would be better left unfound," said Philip Castle, head of the American Society for Clinical Pathology Institute, who worked on those guidelines.

"Doing more than what's evidence-based actually has potential harms for patients, and that shouldn't be minimized."

That includes the psychological harms of being told you have an abnormal test, he said. After that, some cervical procedures done as follow-up have been shown to increase women's chances of having a premature baby later in life.

According to the Centers for Disease Control and Prevention, about 12,000 U.S. women get cervical cancer every year - most caused by cancerous strains of HPV.

Castle said the focus needs to be on making sure that everyone gets the basic level of screening, especially poor women who live in isolated areas.

Moyer agreed that targeting those groups is going to make the biggest difference in cutting rates of new cervical cancer cases and deaths.

"We need to get the women who have not had a Pap smear in the past five years in," she said. "The women who aren't getting screened at all, that's the tragedy." SOURCES: http://bit.ly/an7XRm and http://bit.ly/yVwIPk Annals of Internal Medicine and CA: A Cancer Journal for Clinicians, online March 14, 2012.

(Editing by Michele Gershberg; Desking by Eric Walsh)

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