www.criteriuminc.comMAY 2010

 This Month's Clinical Focus:

 Many Kids With Hepatitis C Are Missed
Researchers from the University of Miami Miller School of Medicine noted that national data shows that between 0.2 percent and 0.4 percent of children in the United States are infected with hepatitis C. Based on that data, they thought they would find about 12,155 cases of pediatric infection in Florida, yet only 1,755 cases were identified, a mere 14.4 percent of the expected number of cases.

"Our study showed a lack of adequate identification of hepatitis C virus infection in children that could be widespread throughout the nation," said lead researcher Dr. Aymin Delgado-Borrego, a pediatric gastroenterologist and assistant professor of pediatrics.

Hepatitis C is like a "ticking bomb," she said. "It seems harmless until it explodes." Most children and adults infected with hepatitis C do not have symptoms or only nonspecific symptoms, such as fatigue or abdominal pain, Delgado-Borrego said. She planned to present the findings at the Digestive Disease Week conference in New Orleans.

Delgado-Borrego chose Florida for the study because it is one of the few states that requires all cases of the infection to be reported to the local health department. "Not only was there a lack of proper identification, but among the children that have been identified the percentage of those receiving medical care is extremely and unacceptably low," she said.

Based on these data, Delgado-Borrego's group found only about 1.2 percent of children with hepatitis C were receiving treatment by a pediatric hepatologist. Most young children get the infection from their mothers while in the womb. That accounts for about 60 percent of the infections in young children, Delgado-Borrego said. Teenagers can get it through IV drug use and other substance abuse, she added.

So why are so many kids missed? According to Delgado-Borrego, there's a widespread lack of awareness of the condition and adequate screening is not often done. Moreover, children are too often not referred to treatment.
"Primary care doctors should screen all children who are at risk for hepatitis C infection, such as those whose mothers are infected," Delgado-Borrego said. In addition, infected children should be referred to specialists, she added.

"Early identification of pediatric hepatitis C infection would likely help us cure the infection in over 50 percent of children that currently have it," Delgado-Borrego pointed out. "This would save children from liver damage as well as possible liver failure, liver cancer and even early death," she added.

Dr. Marc Siegel, an associate professor of medicine at New York University, said that, "this is a pretty shocking study." Siegel said early diagnosis of hepatitis C is very important, especially in children. "Because if kids have it they have a lifetime of exposure to it, so the chances of damage to the liver is very high," he explained.

SOURCES: Aymin Delgado-Borrego, M.D., MPH, pediatric gastroenterologist and assistant professor, pediatrics, University of Miami Miller School of Medicine; Marc Siegel, M.D., associate professor, medicine, New York University, New York City; May 2, 2010, presentation, Digestive Disease Week, New Orleans


 Parents of Autistic Children Turning to Alternative Treatments
Little research supports most options, but families driven by need for help, experts say   

About one in 110 U.S. children has autism, which is characterized by difficulties with social, language and communications skills and restricted or repetitive behaviors or interests. About one in five children with autism uses alternative treatments to help with the neurodevelopmental disorder, most often a special diet, a new study finds.

Of 1,212 children with an autism spectrum disorder included in the study, about 17 percent were on special diets. More than half of those were on a gluten-free, casein-free diet, which eliminates wheat and dairy products. Other common dietary changes included avoiding processed sugars and taking probiotics, microorganisms found in foods such as yogurt and supplements that may help maintain gut bacterial flora.

"People turn to complementary and alternative treatments anytime they perceive conventional medical treatments as either not doing the job or being too expensive, or that the complementary and alternative treatments are more natural," said Dr. Daniel Coury, medical director of the Autism Treatment Network and a professor of pediatrics and psychiatry at Ohio State University. "We see the same sorts of reasons among children on the spectrum."

The study was to be presented at the Pediatric Academic Societies' annual meeting in Vancouver, British Columbia, Canada.

Other alternative treatments parents reported trying for their kids ran the gamut from hyperbaric oxygen, which involves pressurized chambers with oxygen-rich air that usually are used to treat divers with the bends, to chelation therapy, a treatment that removes heavy metals from the body. That treatment stemmed from fears that mercury causes autism, Coury said.

Despite significant publicity about the methods, less than 1 percent of parents had tried them, the study found. And that's a good thing, Coury said, because there's no evidence that either works and some evidence that they might be dangerous.

Parents might be turning to special diets because of reports that autistic children are more prone to gastrointestinal (GI) problems. Though earlier studies have had mixed results about the prevalence of GI issues, a second study also slated for presentation at the meeting found that parents reported GI symptoms in nearly half of the children.

Autism is a complex disorder, and parents are driven by the desire to help their children, said Dr. Paul Law, director of the Interactive Autism Network at the Kennedy Krieger Institute in Baltimore. He said he's seen hundreds of alternative treatments tried by parents: supplements and vitamins, acupuncture, acupressure, bathing in distilled water and various types of animal therapy, among them. One mother, Law said, had tried 68 different methods.

Though it's not hard to find testimonials about the effectiveness of one treatment or another, medical evidence that they work is scanty, and the placebo effect can be powerful, Law said.

"There is an adage in medicine that the more you don't know about how to treat something, the more treatments there are," Law said, noting that medications can treat some of the symptoms of autism, but no medication treats the autism itself. Coury agreed. "For the majority of these treatments, there is no good research to support their effectiveness," he said.

Treatments that have been shown to work include behavioral interventions and medications that can help curb aggressive and other behavioral issues, Law said.

About 27 percent of children with an autism spectrum disorder are taking at least one medication to manage their behavior, according to a fourth study from the meeting. It found that the most common reasons for medication use were hyperactivity, repetitive behaviors, irritability and problems with attention. Of the children taking medications, nearly half were taking two or more medications.

Medication use became more common as children got older, the study found. About 60 percent of children aged 11 and older took medication, compared with 44 percent of children aged 6 to 10, 11 percent of children aged 3 to 5 and 4 percent of kids younger than 3.

The most common medications were stimulants to treat attention-deficit/hyperactivity disorder (ADHD) and risperidone (Risperdal), approved by the U.S. Food and Drug Administration to treat irritability, aggression, temper tantrums and self-injurious behavior.

SOURCES: Daniel Coury, M.D., medical director, Autism Treatment Network, and professor, pediatrics and psychiatry, Ohio State University College of Medicine, Columbus, Ohio; Paul Law, M.D., director, Interactive Autism Network, Kennedy Krieger Institute, Baltimore; May 2, 2010, presentations, Pediatric Academic Societies annual meeting, Vancouver, British Columbia, Canada


 If you want to accelerate your clinical trials,
 you need to change the workflow paradigm.

Criterium knows resources are precious, time is the enemy, and results are paramount. Information Management done right is the key to successful trials. Our user-friendly technologies are integrated into all aspects of our clinical development services for improved efficiencies. And a talented in-house staff that is committed to the professional support of our clients' individual and particular needs is the backbone of our processes for maximum client outcomes.

 We have managed successful clinical trials for 
 over 19 years.

Of particular interest to you would be our experience with PEDIATRICS TRIALS, including:  Pain, ADHD, Depression, Anxiety, Auto-Immune & AIDS, Vaccines, Dyslexia, OCD, Autism, and Allergy & Asthma studies.

 We have several propriety technology solutions 
 that are proven to improve your clinical trial results.
Contact: John Hudak, President at
jmhudak@criteriuminc.com

WHAT'S NEW AT CRITERIUM:
 CRITERIUM, Inc. Global CRO Releases New Whitepaper
June 15, 2009

 
CRITERIUM, Inc. Global CRO Offers "A La Carte" Service Structure
April 15, 2009
   CRITERIUM, Inc. Global CRO Expands Services to Canada
February 2, 2009

WHITE PAPERS
   NEW!! Critical Clinical Research Factors in the Down Economy
By Lawrence Reiter, Ph.D.
   The Evolution of the Data Management Role: The Clinical Data Liaison
By Mary Stefanzick
   India: A Target-Rich Environment
By Ronny Schnel

VIDEOS
   NEW!!  The DIA Interview
Featuring Lawrence Reiter, Ph.D.

 
Addressing the Challenge of Finding Investigators for Clinical Trials
Featuring Kabelo Pududu
   The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

PODCASTS
 

 NEW!!  Science is Greater than the Economy   
Featuring Lawrence Reiter, Ph.D.

 The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Featuring John M. Hudak

   Agile Clinical Trials and the Use of Real-Time Data
Featuring John M. Hudak

PUBLICATIONS
 

 NEW!! Predictions for the 2010 Pharma Market
- Lawrence Reiter, Ph.D.

Journal for Clinical Studies


 NEW!! Maintaining Clinical Operations: It's Just Good Business 
- Lawrence Reiter, Ph.D.

PharmaVoice View on Clinical Operations

   EDC Implementation 
- Greg Bailey

PharmaVOICE, View on
E-Solutions
   Going Global 
- John M. Hudak

Future Pharmaceuticals
   Trials Limber Up 
- John M. Hudak

International Clinical Trials Magazine

PRESENTATION
   Criterium Capabilities Presentation

OUR BROCHURE
 

 Criterium -
Connect - Communicate - Control


 LINKS FOR YOUR INFO:
 

 Pediatric News Online

 American Academy of Pediatrics

 

About Criterium Inc.  Criterium Inc. www.criteriuminc.com is a global, full-service, technology-driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, pharmaceutical, medical device, and CRO industries.  

 CALL US FOR COMPETITIVE BIDS ON YOUR NEXT PROJECT:   
FULL-SERVICE RESEARCH - TRIAL RESCUE SERVICES - PRO
JECT & DATA MANAGEMENT - BIOSTATISTICS - SITE SELECTION & MANAGEMENT - PROTOCOL DESIGN & CONSULTING - CLINICAL & MEDICAL MONITORING - CRF DESIGN   IVR / IWR - FAX & ELECTRONIC DATA CAPTURE - MEDICAL WRITING - SAFETY - REGULATORY CONSULTING -- MORE!

GET TO KNOW US!
This email was sent by Criterium Inc.com. You are receiving this email because of your affiliation with Criterium Inc. If you do not wish to receive Criterium Inc. announcements and updates, please unsubscribe here. If the link is not working, please send an e-mail to releases@criteriuminc.com and type "UNSUBSCRIBE" in the subject line or please send a letter including your name, request for removal, and e-mail address to: Criterium Inc., 358 Broadway, Suite 201, Saratoga Springs, NY 12866.