Science Weekly: The world’s funniest joke

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The science of laughter, the latest Imax film, and what future technology might look like

Preview of Target Document Version 1.5

Target Document® version 1.5 will be released in 2 weeks. In addition to the web-based Trial Master File (standard feature), new features include multiple signoffs at one time (ideal for training records), advanced features for electronic signatures, user management and recovery of deleted documents. Target Document is now a mature software and ready for prime time. It is being used by sponsors and CROs with 100% satisfaction. We are also having discussions to integrate Target Document with other software platforms. As with all Target Health software, the “Price is Right“. Let us know if you are interested in a demo. See our website for a cost analysis

For more information about Target Health and our software tools for paperless clinical trials, please contact Warren Pearlson (212-681-2100 ext 104) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health website at, www.targethealth.com

Cough Medicine Ingredient May Help Prevent Prostate Cancer

 

According to the National Cancer Institute, prostate cancer was diagnosed in more than 192,000 men in the US in 2009, and an estimated 27,360 men died of the disease. Although prostate surgery or 1) ___ is successful in many men, 30 to 40% experience recurrence. A non-addictive derivative of opium that is used in over-the-counter cough medicine may help prevent prostate cancer. Noscapine, which has been on the market since the 2) ___, may soon find its way into a whole new treatment area of medicine. In the 1960s, some experts suggested that noscapine be explored as a 3) ___ fighting agent, but it has taken decades for significant research to occur. Part of that effort has occurred with a research team composed of individuals from the Prostate Cancer Research and Education Foundation (PCREF), the MedInsight Research Institute, and the University of California San Diego, who conducted the new preliminary study. Twenty mice were divided into two groups, with one group receiving 300 mg/kg/day of noscapine for 56 days and the other group receiving a 4) ___. Both groups of mice were injected with prostate cancer cells. Tumor growth in the noscapine-treated mice was two-thirds less than in the placebo group. The rate of cancer 5) ___ to the lungs was 80% less in the noscapine-treated mice than in the control group. Treated mice also did not experience any cancer-related weight loss, while the control mice lost a significant amount of 6) ___. The study’s authors concluded that as a preventive measure, 7) ___ provides significant benefits in cases of prostate cancer. Their next step is to administer noscapine to patients who have undergone surgery or radiation for prostate cancer. Dr. Israel Barken, founder and medical director of the PCREF and one of the study’s investigators, noted that based on their results, “we believe that noscapine could be a very promising treatment to prevent recurrence in such cases due to its excellent safety record and oral bioavailability.“ In the near future, a 8) ___ medicine ingredient may be a new player in the fight against prostate cancer. SOURCES: Barken I et al. Anticancer Research 2010 Mar; 30(2): 399-402, National Cancer Institute http://www.emaxhealth.com/1275/33/36105/cough-medicine-ingredient-may-help-prevent-prostate-cancer.html

ANSWERS: 1) radiation; 2) 1950s; 3) cancer; 4) placebo; 5) metastasis; 6) weight; 7) noscapine; 8) cough

Could Thomas Jefferson’s DNA Trail Reveal Middle-Eastern Origins?

DNA testing carried out by University of Leicester geneticists has thrown new light on the ancestry of one of the USA’s most revered figures, the third President, Thomas Jefferson.  Almost 10 years ago, the University of Leicester team, led by Professor Mark Jobling, together with international collaborators, showed that Thomas Jefferson had fathered at least one of the sons of Sally Hemings, a slave of Jefferson’s. The work was done using the Y chromosome, a male-specific part of our DNA that passes down from father to son. Jefferson carried a very unusual Y chromosome type, which helped to strengthen the evidence in the historical paternity case. Now, new techniques have been brought to bear on Jefferson’s Y chromosome, in a study reported in the American Journal of Physical Anthropology. The presidential chromosome turns out to belong to a rare class called “K2“, which is found at its highest frequency in the Middle East and Eastern Africa, including Oman, Somalia and Iraq. Its closest match was in a man from Egypt. Could this mean that the President had recent ancestry in the Middle East? A careful survey revealed a few K2 chromosomes in France, Spain and England. Together, the K2s form a diverse group that may, in fact, have been in western Europe for many thousands of years. Further evidence for Jefferson’s British origins come from the finding that two out of 85 randomly recruited men named Jefferson share exactly the same Y chromosome as the President. The two men have ancestry in Yorkshire and the West Midlands, and knew of no historical connection to the USA. They were amazed and fascinated by the link, which connects them into Thomas Jefferson’s family tree, probably about 11 generations ago. The ultimate origins of K2 chromosomes remain a mystery, however, and need further investigation. While they may have been present in Europe since the Stone Age, another possibility is that K2s came to Europe with the Phoenicians, an ancient maritime trading culture that spread out across the Mediterranean from their home in what is now Lebanon. The US media has taken up a different theory, leading to the New York Times headline, “Jefferson — the first Jewish president?“ European K2 chromosomes may originate in Sephardic (Spanish) Jewish populations, who have their ultimate origins in the Middle East.  According to the authors, “When we look closely at large collections of British Y chromosomes we find surprises, like this rare K2 lineage, and the African chromosome that we recently found in a Yorkshireman. These exotic chromosomes remind us of the complexity of British history and prehistory.“ The research was funded by the Social Sciences and Humanities Research Council of Canada.  Story adapted from materials provided by McMaster University.

Intensive Blood Pressure Therapy May Not Reduce Combined Cardiovascular Events in Adults with Diabetes

 

An estimated 24 million Americans have diabetes, which is the seventh leading cause of death in the US. Adults with type 2 diabetes are two to four times more likely than adults without diabetes to die from heart disease, and 65% of deaths in people with diabetes are from cardiovascular causes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trial is one of the largest studies ever conducted in adults with type 2 diabetes who were at especially high risk of cardiovascular events, such as heart attacks, stroke, or death from cardiovascular disease. ACCORD tested the effect on cardiovascular disease of systolic blood pressure below 120 mmHg, which is considered normal. Current blood pressure guidelines recommend that adults with type 2 diabetes maintain systolic blood pressure at less than 130 mm Hg. Previous clinical trials have only proven benefits to less than 140 mm Hg; however, observational studies have linked systolic blood pressure levels of 120 mmHg or below to lower cardiovascular disease rates in adults with type 2 diabetes. The multicenter clinical trial tested three potential strategies to lower the risk of major cardiovascular events: intensive control of blood sugar, intensive control of blood pressure, and treatment of multiple blood lipids. The lipids targeted for intensive treatment were high density lipoprotein (HDL) cholesterol and triglycerides, in addition to standard therapy of lowering low density lipoprotein (LDL) cholesterol. According to new results from ACCORD, published on line in the New England Journal of Medicine (March 2010; April 29, 2010 print edition), lowering blood pressure to normal levels – below currently recommended levels – did not significantly reduce the combined risk of fatal or nonfatal cardiovascular disease events in adults with type 2 diabetes who were at especially high risk for cardiovascular disease events. Similarly, treating multiple blood lipids with combination drug therapy of a fibrate and a statin did not reduce the combined risk of cardiovascular disease events more than treatment with statin alone. The study was sponsored by the National Institutes of Health. ACCORD researchers from 77 medical centers in the United States and Canada studied 10,251 participants between the ages of 40 and 79 who had type 2 diabetes for an average of 10 years. When they joined the study, all participants were at especially high risk of cardiovascular events because they had pre-existing cardiovascular disease, evidence of subclinical cardiovascular disease, or at least two cardiovascular disease risk factors in addition to diabetes. All participants were enrolled in the ACCORD blood sugar treatment clinical trial and maintained good control of blood sugar levels during the study. In addition, participants were enrolled in either the blood pressure trial or the lipid trial and were treated and followed for an average of about five years. For the study, 4,733 participants with elevated blood pressure were randomly assigned to a target systolic blood pressure of either less than 120 mmHg (the intensive group) or to less than 140 mmHg (the standard group). A variety of FDA-approved blood pressure medications was used to reach blood pressure goals. After an average follow-up of about five years, no significant differences were found between the intensive group and the standard group in rates of a combined endpoint including nonfatal heart attack, nonfatal stroke, or cardiovascular death. There were 208 cardiovascular events in the intensive group and 237 events in the standard group. Lowering blood pressure to below the standard level significantly cut the risk of stroke by about 40%. The intensive blood pressure group had 36 strokes, compared to 62 strokes in the standard group. The researchers caution, however, that participants in the intensive blood pressure group were more likely to have complications such as abnormally low blood pressure or high levels of blood potassium. They noted 77 events in the intensive groups compared to 30 in the standard group. In addition, some laboratory measures of kidney function were worse in the intensive therapy group, but there was no difference in the rates of kidney failure. According to the authors, the results provide no conclusive evidence that targeting a normal systolic blood pressure compared with targeting a systolic blood pressure of less than 140 mmHg lowers the overall risk of major cardiovascular events in high risk adults with type 2 diabetes. However, the study does suggest that lower blood pressure levels in patients like those in ACCORD may reduce the risk of stroke. This finding is consistent with other blood pressure trials.

Stress, Inflammation, and Yoga Practice

 

According to a study published in Psychosomatic Medicine (2010;72:113-121), a study was performed to address the mechanisms underlying hatha yoga’s potential stress-reduction benefits. For the study, inflammatory and endocrine responses of novice and expert yoga practitioners  were compared before, during, and after a restorative hatha yoga session, as well as in two control conditions. Stressors before each of the three conditions provided data on the extent to which yoga speeded an individual’s physiological recovery. A total of 50 healthy women (mean age, 41 years; range, 30-65 years), 25 novices and 25 experts, were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. Results showed that the yoga session boosted participants’ positive affect compared with the control conditions, but no overall differences in inflammatory or endocrine responses were unique to the yoga session. Importantly, even though novices and experts did not differ on key dimensions, including age, abdominal adiposity, and cardiorespiratory fitness, novices’ serum interleukin (IL)-6 levels were 41% higher than those of experts across sessions, and the odds of a novice having detectable C-reactive protein (CRP) were 4.75 times as high as that of an expert. Differences in stress responses between experts and novices provided one plausible mechanism for their divergent serum IL-6 data; experts produced less lipopolysaccharide-stimulated IL-6 in response to the stressor than novices, and IL-6 promotes CRP production. According to the authors, the ability to minimize inflammatory responses to stressful encounters influences the burden that stressors place on an individual and that if yoga dampens or limits stress-related changes, then regular practice could have substantial health benefits.

Autoimmune Diseases in Women with Turner’s Syndrome

According to an article published in Arthritis & Rheumatism (2010;62:658-666), a study was performed to investigate whether the autoimmune disease profile in women with Turner’s syndrome. Turner syndrome or Ullrich-Turner syndrome (also known as “Gonadal dysgenesis“) encompasses several conditions, of which monosomy X (absence of an entire X chromosome) is most common. It is a chromosomal abnormality in which all or part of one of the X or Y chromosomes is absent. In some cases, the chromosome is missing in some cells but not others, a condition referred to as mosaicism or “Turner mosaicism“. Occurring in 1 out of every 2500 girls, the syndrome manifests itself in a number of ways. There are characteristic physical abnormalities, such as short stature, swelling, broad chest, low hairline, low-set ears, and webbed necks. Girls with Turner syndrome typically experience gonadal dysfunction (non-working ovaries), which results in amenorrhea (absence of menstrual cycle) and sterility. Concurrent health concerns are also frequently present, including congenital heart disease, hypothyroidism (reduced hormone secretion by the thyroid), diabetes, vision problems, hearing concerns, and many autoimmune diseases. Finally, a specific pattern of cognitive deficits is often observed, with particular difficulties in visuospatial, mathematical, and memory areas. For the study, the Danish Cytogenetic Central Register, the Danish National Patient Register, and the Danish Civil Registration System, was used to determine the relative risk of 46 different autoimmune diseases in a cohort of 798 Danish women with Turner’s syndrome followed up for 12,461 person-years between 1980 and 2004. Standardized incidence ratios (SIRs) of first hospitalization for autoimmune disease and 95% confidence intervals (95% CIs) were used as measures of relative risk. Results showed that the overall risk of autoimmune disease among women with Turner’s syndrome was twice that among Danish women in general (SIR 2.1). For autoimmune diseases with a female predominance, the SIR among women with Turner’s syndrome was 1.7, whereas the SIR for autoimmune diseases with a male predominance among these women was 3.9. Associations were strongest for Hashimoto thyroiditis (SIR 14.6), a strongly female-predominant condition, and type 1 diabetes mellitus (SIR 4.1). The authors concluded that women with Turner’s syndrome are at excess risk of autoimmune diseases, notably autoimmune diseases characterized by male predominance.

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.

FDA Approves First Totally Implanted Hearing System

Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech. Sensorineural hearing loss differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum. FDA has now approved Esteem, an implanted hearing system used to treat moderate to severe sensorineural hearing loss. The Esteem system consists of external testing and programming instruments and three implantable components: a sound processor, sensor, and driver. The sensor senses vibrations from the eardrum and middle ear bones and converts these mechanical vibrations into electrical signals, which are then sent to the sound processor, which amplifies and filters the signal to compensate for the individual patient’s hearing loss. The driver converts the enhanced electrical signal back to vibrations, which are then transmitted into the inner ear where they are perceived as sound. The system is designed to alleviate the effects of hearing loss in patients ages 18 years and older. Other criteria for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient’s ability to understand speech using Esteem should be similar to that of conventional hearing aids. In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93% of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56% scored better than with their pre-implant hearing aids. Seven percent of participants experienced facial paralysis, and 42% experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period. As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

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

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