Science Weekly: Testing fear, panic and arousal in cinemagoers

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The physiology of panic, fear and arousal in cinema-goers; the evolutionary psychology of leadership; plus, robonauts and holographic communications

eClinical Forum and CTTI

Target Health is pleased to announce Target Health is a member of the eClinical Forum and Dr. Mitchel is on the Steering Committee of the Clinical Trials Transformation Initiative (CTTI). The meeting of the eClinical Forum was held in Fort Lauderdale this past week and addressed issues such as Investigator Portals, eSource, the EMA Reflection Paper on eSource, Electronic Health Records and many more topics. The CTTI meeting is being held in Washington on November 8 and we will report on this next week.

For more information about Target Health contact Warren Pearlson (212-681-2100 ext 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

Improve Your Math Skills with an Electric Jolt to Your Brain

Electricity Helps Neurons Fire Faster – Credit: Patrick Hoesly on Flickr


With just 15 minutes of a barely perceptible 1) ___ current passed through the brain, scientists at the University of Oxford have succeeded in improving a person’s math abilities with an effect lasting as long as six months. Using a non-invasive method known as 2) ___ direct current stimulation (TDCS), the scientists passed a mild electric current through the skull into the brain’s parietal lobe, where numbers are processed.

Patients were asked to learn new symbols to represent numbers, then, while they were on TDCS, they attempted to organize the numbers. Participants whose 3) ___ were being stimulated demonstrated an improved ability to perform the task. The amazing part is that, when tested again six months later, they retained their higher performance level. The current helps the affected 4) ___ to fire more quickly, making it easier to learn information.

The next trials will involve patients who have lower-than-average number processing 5) ___, and Oxford scientists hope to one day develop a device to deliver TDCS. While it may be some time before such brain-zapping is widely administered, this 6) ___ could help the significant portion of the population (nearly 20 percent) with moderate to severe math disability, and possibly those with difficulty in other subjects as well. Do not zap your brain with 7) ___ except under professional supervision. Source: Oxford University,


ANSWERS: 1) electric; 2) transcranial; 3) brains; 4) nerves; 5) skills; 6) treatment; 7) electricity

Genome Study Provides a Census of Early Humans

One current view of the temporal and geographical distribution of hominid populations. Other interpretations differ mainly in the taxonomy and geographical distribution of hominid species.

Homo Erectus

Did everyone alive today descend from just 18,500 people? From the composition of just two human genomes, geneticists have computed the size of the human population 1.2 million years ago from which everyone in the world is descended. They put the number at 18,500 people, but this refers only to breeding individuals, the “effective” population. The actual population would have been about three times as large, or 55,500.

Comparable estimates for other primates then are 21,000 for chimpanzees and 25,000 for gorillas. In biological terms, it seems, humans were not a very successful species, and the strategy of investing in larger brains than those of their fellow apes had not yet produced any big payoff. Human population numbers did not reach high levels until after the advent of agriculture. Geneticists have long known that the ancestors of modern humans numbered as few as 10,000 at some time in the last 100,000 years.

The critically low number suggested that some catastrophe, like disease or climate change induced by a volcano, had brought humans close to the brink of extinction. If the new estimate is correct, however, human population size has been small and fairly constant throughout most of the last million years, ruling out the need to look for a catastrophe. The estimate, reported in 2010, in The Proceedings of the National Academy of Sciences, was made by a team of population geneticists at the University of Utah led by Chad D. Huff and Lynn B. Jorde. The human population a million years ago was represented by archaic species like Homo ergaster in Africa and Homo erectus in East Asia.

The Utah team says its estimate of 18,500 implies “an unusually small population for a species spread across the entire Old World.” But that estimate would apply to the worldwide population only if there were inbreeding between the humans on the different continents. If not, and if modern humans are descended from just one of these populations, like Homo ergaster in Africa, then the estimate would apply only to that.

Richard G. Klein, a paleoanthropologist at Stanford, said it was hard to believe the population from which modern humans are descended was as small as 18,500 “unless they were geographically restricted to Africa or a small part of it.” There is no independent way of assessing a genetics-based estimate of population size at this period, Dr. Klein said, although archaeologists have developed ways of assessing ancient populations of more recent times. The Utah team based its estimate on the genetic variation present in two complete human genomes, one prepared by the government’s human genome project and the other by J. Craig Venter, the genome sequencing pioneer.

The government decoded a single copy of a mosaic genome derived from a medley of people, apparently of European and Asian origin. Dr. Venter decoded both copies of his own genome, the one inherited from his father and the one from his mother. The Utah team thus had three genomes to work with and looked at ancient elements known as Alu insertions, the youngest class of which appeared in the human genome around a million years ago. The amount of variation seen in the DNA immediately surrounding the Alu insertions gave a measure of the size of human population at that time. Their estimate agrees almost exactly with an earlier one, also based on Alu insertions but with sparser data. The insertions tag ancient regions of the genome that are unaffected by the recent growth in population, Dr. Huff said. Source: The New York Times, 2010, by Nicholas Wade

Fall Prevention in Acute Care Hospitals

Falls cause injury and death for persons of all ages, but risk of falls increases markedly with age. Hospitalization further increases risk, yet no evidence exists to support short-stay hospital-based fall prevention strategies to reduce patient falls. As a result, a study published in the Journal of the American Medical Association (2010;304:1912-1918) was performed to investigate whether a fall prevention tool kit (FPTK) using health information technology (HIT) decreases patient falls in hospitals.

The investigation was a cluster randomized study conducted January 1, 2009, through June 30, 2009, comparing patient fall rates in 4 urban US hospitals in units that received usual care (4 units and 5104 patients) or the intervention (4 units and 5160 patients). Based on a valid fall risk assessment scale completed by a nurse, the FPTK software tailored fall prevention interventions to address patients’ specific determinants of fall risk. The FPTK produced bed posters composed of brief text with an accompanying icon, patient education handouts, and plans of care, all communicating patient-specific alerts to key stakeholders.

The primary outcome was patient falls per 1000 patient-days adjusted for site and patient care unit. A secondary outcome was fall-related injuries.

During the 6-month intervention period, the number of patients with falls differed between control (n = 87) and intervention (n = 67) units (P=.02). Site-adjusted fall rates were significantly higher in control units (4.18) than in intervention units (3.15) per 1000 patient-days (P = .04). The FPTK was found to be particularly effective with patients aged 65 years or older (adjusted rate difference, 2.08 per 1000 patient-days; P = .003). No significant effect was noted in fall-related injuries.

According to the authors, the use of a fall prevention tool kit in hospital units compared with usual care significantly reduced rate of falls.

Safety of Recombinant Activated Factor VII in Randomized Clinical Trials

The use of recombinant activated factor VII (rFVIIa) on an off-label basis to treat life-threatening bleeding has been associated with a perceived increased risk of thromboembolic complications. However, data from placebo-controlled trials are needed to properly assess the thromboembolic risk. To address this issue, a study published in the New England Journal of Medicine (2010; 363:1791-1800) evaluated the rate of thromboembolic events in all published randomized, placebo-controlled trials of rFVIIa used on an off-label basis.


Data were analyzed from 35 randomized clinical trials (26 studies involving patients and 9 studies involving healthy volunteers) to determine the frequency of thromboembolic events. The data were pooled with the use of random-effects models to calculate the odds ratios and 95% confidence intervals.


Among 4,468 subjects (4,119 patients and 349 healthy volunteers), 498 had thromboembolic events (11.1%). Rates of arterial thromboembolic events among all 4,468 subjects were higher among those who received rFVIIa than among those who received placebo (5.5% vs. 3.2%, P=0.003). Rates of venous thromboembolic events were similar among subjects who received rFVIIa and those who received placebo (5.3% vs. 5.7%). Among subjects who received rFVIIa, 2.9% had coronary arterial thromboembolic events, as compared with 1.1% of those who received placebo (P=0.002). Rates of arterial thromboembolic events were higher among subjects who received rFVIIa than among subjects who received placebo, particularly among those who were 65 years of age or older (9.0% vs. 3.8%, P=0.003); the rates were especially high among subjects 75 years of age or older (10.8% vs. 4.1%, P=0.02).


According to the authors, in a large and comprehensive cohort of persons in placebo-controlled trials of rFVIIa, treatment with high doses of rFVIIa on an off-label basis significantly increased the risk of arterial but not venous thromboembolic events, especially among the elderly.


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Long-term Effect of Aspirin on Colorectal Cancer Incidence and Mortality

High-dose aspirin (>500 mg daily) reduces long-term incidence of colorectal cancer, but adverse effects might limit its potential for long-term prevention. The long-term effectiveness of lower doses (75-300 mg daily) is unknown. As a result, a study published online in The Lancet, Early Online Publication (22 October 2010), assessed the effects of aspirin on incidence and mortality due to colorectal cancer in relation to dose, duration of treatment, and site of tumor.

The study followed four randomized trials of aspirin versus control in primary (Thrombosis Prevention Trial, British Doctors Aspirin Trial) and secondary (Swedish Aspirin Low Dose Trial, UK-TIA Aspirin Trial) prevention of vascular events, and one trial of different doses of aspirin (Dutch TIA Aspirin Trial).

In the four trials of aspirin versus control (mean duration of scheduled treatment 6·0 years), 391 (2·8%) of 14,033 patients had colorectal cancer during a median follow-up of 18·3 years. Allocation to aspirin reduced the 20-year risk of colon cancer (hazard ratio [HR] 0·76, p=0·02; mortality HR 0·65, p=0·005), but not rectal cancer. Where subsite data were available, aspirin reduced risk of cancer of the proximal colon (0·45, p=0·001), but not the distal colon. However, benefit increased with scheduled duration of treatment, such that allocation to aspirin of 5 years or longer reduced risk of proximal colon cancer by about 70% p<0·0001) and also reduced risk of rectal cancer (0·58,  p=0·02). There was no increase in benefit at doses of aspirin greater than 75 mg daily, with an absolute reduction of 1.76% in 20-year risk of any fatal colorectal cancer after 5-years scheduled treatment with 75-300 mg daily. However, risk of fatal colorectal cancer was higher on 30 mg versus 283 mg daily on long-term follow-up of the Dutch TIA trial (odds ratio 2·02, p=0·15).


According to the authors, aspirin taken for several years at doses of at least 75 mg daily reduced long-term incidence and mortality due to colorectal cancer. Benefit was greatest for cancers of the proximal colon, which are not otherwise prevented effectively by screening with sigmoidoscopy or colonoscopy.

TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.

FDA Clears Cymbalta To Treat Chronic Musculoskeletal Pain

The FDA has approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004. 

Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective. 

The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

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