Target Health is pleased to announce that its strategy to collaborate with other CROs/SMOs to provide eClinical software products in order to optimize drug development, is getting good traction. We are collaborating with an international CRO to develop a web-based clinical trial management system (Target e*CTMS). This same CRO is using Target Document for several studies and is also collaborating with Target Health on a global study where they are monitoring the international study sites. Target Health has been contracted by a clinical CRO/SMO to develop 10 EDC studies for their clients. The goal of the CRO is to perform all of their clinical trials with Target e*CRF. This approach will uniquely position them in a very competitive market by providing transparency and speedy clinical trial results. An SMO is piloting Target Document and discussions are taking place with 3 other CROs.

For more information about Target Health or any of its software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors.

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

Acute pain is a symptom of many medical conditions and can significantly interfere with a person’s quality of life and general functioning. Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction. All patients treated with opioids require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when opioid analgesics are no longer needed. Tapentadol hydrochloride (Janssen Ortho, LLC), a centrally-acting synthetic analgesic, has been approved, by FDA for the relief of moderate to severe acute pain. Tapentadol acts in two ways:opioid (narcotic) and non-opioid, and affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect. The most common side effects from Tapentadol are nausea, dizziness, vomiting, and sleepiness. The labeling for Tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

When the enemy of the people, is fast food, is it the 1) __ responsibility to ban or prevent it? A ban on fast food advertisements in the United States could reduce the number of 2) ___ children by as much as 18 percent, according to a new study being published this month in the Journal of Law and Economics. The study also reports that eliminating the tax deductibility associated with television advertising would result in a reduction of childhood 3) ___, though in smaller numbers. The study was conducted by researchers from the National Bureau of Economic Research (NBER) with funding from the National Institutes of Health. NBER economists Shin-Yi Chou of Lehigh University, Inas Rashad of Georgia State University, and Michael Grossman of City University of New York Graduate Center co-authored the paper, which measures the number of hours of fast food television advertising messages viewed by 4) ___ on a weekly basis. The authors found that a ban on fast food television advertisements during children’s programming would reduce the number of overweight children ages 3-11 by 18 percent, while also lowering the number of overweight 5) ___ ages 12-18 by 14 percent. The effect is more pronounced for males than females. Though a ban would be effective, the authors also question whether such a high degree of government involvement—and the costs of implementing such policies—is a practical option. Should the U.S. pursue that path, they would follow Sweden, Norway and Finland as the only countries to have banned commercial sponsorship of children’s programs. “We have known for some time that childhood obesity has gripped our culture, but little empirical research has been done that identifies television advertising as a possible cause,” says Chou, the Frank L. Magee Distinguished Professor at Lehigh’s College of Business and Economics. “Hopefully, this line of research can lead to a serious discussion about the type of policies that can curb America’s obesity 6) ___.” The study also found that the elimination of tax deductibility tied to advertising would similarly produce declines in childhood obesity, albeit at a smaller rate of 5-7 percent. Advertising is considered a business expense and, as such, it can be used to reduce a company’s taxable income. The authors deduce that, since the corporate income tax rate is 35 percent, the elimination of the tax deductibility of food advertising costs would be equivalent to increasing the price of advertising by 54 percent. Such an action would consequently result in the reduction of fast food advertising messages by 40 percent for children, and 33 percent for adolescents. The study—the 7) ___ of its kind to directly tie childhood obesity to fast food advertising on American television—is based on the viewing habits of nearly 13,000 children using data from the 1979 Child-Young Adult National Longitudinal Survey of Youth and the 1997 National Longitudinal Survey of Youth, both issued by the U.S. Department of Labor. A 2006 report issued by the Institute of Medicine indicated there is compelling evidence linking food advertising on television and increased childhood obesity. “Some members of the committee that wrote the report recommended congressional regulation of television food advertisements aimed at children, but the report also said that the final link that would definitively prove that children had become 8) ___ by watching food commercials aimed at them cannot be made,” says Grossman. Finally, two years later, here is that link of proof “Our study provides evidence of that link,” he says. The Centers for Disease Control estimate that, between 1970 and 1999, the percentage of overweight children ages 6-11 more than tripled to 13 percent. Adolescents between the ages of 12 and 19 also saw a significant increase, reaching 14 percent. Research indicates that there is an 80 percent chance an overweight adolescent will be an obese 9) ___ and that over 300,000 deaths can be attributed to obesity and weight in the United States every year.

Adapted from materials provided by Lehigh University.

ANSWERS

1) government’s; 2) overweight; 3) obesity; 4) children; 5) adolescents; 6) epidemic; 7) largest; 8) fatter; 9) adult