Science Weekly: Top 10 myths of ecological living

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The truth about eco-friendly living; the role of religion in climate change; and regrowing breasts after mastectomy

Target eClinical Trial Record (Target e*CTRTM

Target eClinical Trial Record (Target e*CTR®; patent pending) software, which allows for direct data entry of EDC data and the generation of the eSource document, is being released at the end of the month. It is estimated that adoption of the software will reduce monitoring-related travel expenses by 75%. There have already been 3 meetings with regulatory agencies and they will review one of the validation protocols. Target Health will implement Target e*CTR in clinical trials in January. With a recent approval in Canada, there are now 18 unique EDC approvals worldwide that used Target e*CRF® for the pivotal trials. Target Health is currently preparing an eCTD submission and is doing eCTD IND submissions for many of its clients (we have the software in-house).  

Current software products include:

§        Target e*CRF® (EDC; patent pending)

§        Target Encoder® (developed with Regeneron and Ferring Pharmaceuticals)

§        Target Document® (paperless TMF; patent pending)

§        Target e*CTMSTM

§        Target e*PharmacovigilanceTM (generates Form 3500A and CIOMS forms)

§        Target Newsletter®

§        Target Batch Edit ChecksTM (works within the EDC query system for data management)

§        Target e*CTRTM (generates eSource; patent pending)

For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel ( 212-681-2100  212-681-2100 ext 0) 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

Statins May Reduce Cancer Deaths in COPD Patients 

Treatment with statins in patients with chronic obstructive pulmonary disease (COPD) was associated with a reduced risk of 1) ___ from extrapulmonary cancer in a Dutch study. Although COPD has a well-known association with 2) ___ cancer, its relationship with extrapulmonary cancers is less well defined, and furthermore, “it is not known whether the risk of COPD and cancer mortality can be modulated by pharmacologic treatment,” said, Dr. Don Poldermans, from Erasmus Medical Center in Rotterdam. “Several studies suggest that 3) ___ may reduce the risk of cancer while others have suggested that statins may promote the development of new carcinomas,” Dr. Poldermans added. To investigate this, he and his colleagues studied 3,371 patients with peripheral arterial disease who underwent elective vascular surgery between 1990 and 2006. According to their report in the November issue of Thorax, the largely male cohort (73%) included 1,310 patients with COPD. COPD was characterized as mild in 578, moderate in 579, and severe in 153. At baseline, 810 subjects were using statins, including 26% of the current smokers and 23% of the never/ex-smokers. The average age of study participants was 66 years. During a median follow-up of 5 years, 316 patients (9%) died from cancer. The risk of cancer mortality in patients with no, mild, moderate and severe COPD was 8%, 10%, 14%, and 12%, respectively (p<0.001). One hundred two patients died from lung cancer. The risk of lung cancer mortality with no, mild, moderate and severe COPD was 2%, 3%, 5%, and 6%, respectively (p < 0.001). COPD was independently associated with total 4) ___ mortality, with a hazard ratio of 1.61, and the hazard ratio between COPD and lung cancer mortality was even higher (HR, 2.06). This association was largely driven by the group of patients with moderate and severe COPD (FEV1 < 80% predicted), which were both strongly related to lung cancer mortality (HR, 2.51 and 3.38, respectively). “As the risk increases with disease severity, it is important to prevent deterioration of pulmonary function by reducing risk factors associated with COPD,” Dr. Poldermans said. COPD was also associated with an increased risk of death from extrapulmonary cancer, with a hazard ratio of 1.43. The relationship was significant for moderate COPD (HR, 1.70), but not for severe COPD (HR, 1.38), “probably due to competing risks for mortality,” nor for patients with mild COPD (HR, 1.22). Dr. Poldermans and his colleagues also report a trend toward a lower 5) ___ of cancer mortality among patients with COPD who used statins compared with patients with COPD who did not (HR, 0.57). “Interestingly,” Dr. Poldermans said, “statins were even related to reduced risk for extrapulmonary cancer mortality” in COPD patients (HR, 0.49). Overall, according to the report, 6% of statin-treated patients and 11% of no-statin patients died from cancer during the follow-up period. After excluding patients with lung cancer, 4% of statin users and 7% of non-statin-users died from extrapulmonary cancers. The findings suggest that statins may be effective in 6) ___ deaths, especially from extrapulmonary cancers, in COPD patients. Source: Thorax. 2009;64:963-967.  

ANSWERS: 1) death; 2) lung; 3) statins; 4) cancer; 5) risk; 6) reducing

Evolution of the Human Appendix: A Biological ‘Remnant’ No More

Darwin theorized that the appendix in humans and other primates was the evolutionary remains of a larger structure, called a cecum, which was used by now-extinct ancestors for digesting food. The latest study demonstrates two major problems with that idea. First, several living species, including certain lemurs, several rodents and a type of flying squirrel, still have an appendix attached to a large cecum which is used in digestion. Second, Professor William Parker, of Duke University, says the appendix is actually quite widespread in nature. “For example, when species are divided into groups called ‘families’, we find that more than 70% of all primate and rodent groups contain species with an appendix.” Darwin had thought that appendices appeared in only a small handful of animals. Using a modern approach to evolutionary biology called cladistics, which utilizes genetic information in combination with a variety of other data to evaluate biological relationships that emerge over the ages, Parker and colleagues found that the appendix has evolved at least twice, once among Australian marsupials and another time among rats, lemmings and other rodents, selected primates and humans. “We also figure that the appendix has been around for at least 80 million years, much longer than we would estimate if Darwin’s ideas about the appendix were correct.” “Darwin simply didn’t have access to the information we have,” explains Parker. “If Darwin had been aware of the species that have an appendix attached to a large cecum, and if he had known about the widespread nature of the appendix, he probably would not have thought of the appendix as a vestige of evolution.” He also was not aware that appendicitis, or inflammation of the appendix, is not due to a faulty appendix, but rather due to cultural changes associated with industrialized society and improved sanitation. Those changes left our immune systems with too little work and too much time their hands – a recipe for trouble. That notion wasn’t proposed until the early 1900’s, and “we didn’t really have a good understanding of that principle until the mid 1980’s,” Parker said. “Even more importantly, Darwin had no way of knowing that the function of the appendix could be rendered obsolete by cultural changes that included widespread use of sewer systems and clean drinking water.” The lowly appendix, long-regarded as a useless evolutionary artifact, won newfound respect two years ago when researchers at Duke University Medical Center proposed that it actually serves a critical function. The appendix, they said, is a safe haven where good bacteria could hang out until they were needed to repopulate the gut after a nasty case of diarrhea, for example. Now, some of those same researchers are back, reporting on the first-ever study of the appendix through the ages. Writing in the Journal of Evolutionary Biology, Duke scientists and collaborators from the University of Arizona and Arizona State University conclude that Charles Darwin was wrong: The appendix is a whole lot more than an evolutionary remnant. Not only does it appear in nature much more frequently than previously acknowledged, but it has been around much longer than anyone had suspected. Parker says now that we understand the normal function of the appendix, a critical question to ask is whether we can do anything to prevent appendicitis. He thinks the answer may lie in devising ways to challenge our immune systems today in much the same manner that they were challenged back in the Stone Age. “If modern medicine could figure out a way to do that, we would see far fewer cases of allergies, autoimmune disease, and appendicitis.”

Pregnant Women Mount Strong Immune Response to One Dose of 2009 H1N1 Vaccine

According to the Centers for Disease Control and Prevention (CDC), since the H1N1 outbreak began last spring, at least 100 pregnant women have been hospitalized in intensive care units in the US and at the last official count, 28 pregnant women have died. According to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH, pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine. A preliminary analysis of blood samples taken 21 days post-vaccination from a subgroup of 50 pregnant women participating in the trial shows the following:  

§        In 25 women who received a single 15-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 92%, or 23 of 25, of these women

§        In 25 women who received a single 30-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 96%, or 24 of 25, of these women.

The trial began on Sept. 9 and reached its target enrollment of 120 volunteers in mid-October. All participants are between 18 to 39 years old and began the study in their second or third trimester (14 to 34 weeks) of pregnancy. At entry into the study, the participants were divided at random into two groups: half are receiving two doses of a 15-microgram vaccine and the other half are receiving two doses of a 30-microgram vaccine. The two injections of vaccine are spaced three weeks apart. Safety is being monitored closely in the trial, by the study investigators and by an independent panel of experts known as a safety monitoring committee. To date, the vaccine appears to be well-tolerated, and no safety concerns related to the vaccine have arisen. The vaccine used in this clinical trial was manufactured by Sanofi Pasteur in its plant in Swiftwater, Pa., in the same manner as the company’s injectable seasonal influenza vaccine. Like the seasonal flu vaccine, the 2009 H1N1 flu vaccine contains a purified portion of the killed virus and therefore cannot cause infection. The vaccine does not contain the preservative thimerosal or an immune boosting substance known as an adjuvant.

Increased Frequency of Extremely Skewed X Chromosome Inactivation In Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is a childhood rheumatic disease of unknown etiology. Two subgroups of JIA, i.e., oligoarticular and polyarticular, are thought to have an autoimmune component, and show a higher female:male ratio. Skewed X chromosome inactivation (XCI) has previously been shown to be associated with scleroderma and autoimmune thyroiditis, 2 autoimmune disorders occurring predominantly in females. As a result, a study published in Arthritis & Rheumatism (2009;60:3410-3412), was performed to extend the analysis to the pediatric age group and to determine the XCI profiles of patients with JIA. For the study, a polymorphic repeat in the androgen receptor gene was genotyped to determine XCI status in 81 female patients with JIA (21 with polyarticular disease and 60 with oligoarticular disease), and 211 healthy female controls. DNA obtained from venous blood samples was used for this analysis. Informative data were obtained on 62 JIA patients and 155 controls. Skewed XCI was observed in 14 patients (22.6%) and 11 controls (7.1%) (P = 0.0036), and extreme skewing was apparent in 8 patients (12.9%) and 2 controls (1.3%) (P = 0.0008). According to the authors, the findings indicate that skewed XCI may be a risk factor for the occurrence of autoimmune disorders, including JIA.

VIROLOGY

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Hospitalized Patients with 2009 H1N1 Influenza in the US, April-June 2009

During the spring of 2009, a pandemic influenza A (H1N1) virus emerged and spread globally. A study, published in the New England Journal of Medicine (2009; 361:1935-1944), describes the clinical characteristics of patients who were hospitalized with 2009 H1N1 influenza in the US from April 2009 to mid-June 2009. The study used medical chart data on 272 patients who were hospitalized for at least 24 hours for influenza-like illness and who tested positive for the 2009 H1N1 virus with the use of a real-time reverse-transcriptase-polymerase-chain-reaction assay. Results showed that of the 272 patients studied, 25% were admitted to an intensive care unit and 7% died. Forty-five percent of the patients were children under the age of 18 years, and 5% were 65 years of age or older. Seventy-three percent of the patients had at least one underlying medical condition; these conditions included asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. Of the 249 patients who underwent chest radiography on admission, 100 (40%) had findings consistent with pneumonia. Of the 268 patients for whom data were available regarding the use of antiviral drugs, such therapy was initiated in 200 patients (75%) at a median of 3 days after the onset of illness. Data suggest that the use of antiviral drugs was beneficial in hospitalized patients, especially when such therapy was initiated early. According to the authors, during the evaluation period, 2009 H1N1 influenza caused severe illness requiring hospitalization, including pneumonia and death. Nearly three quarters of the patients had one or more underlying medical conditions and few severe illnesses were reported among persons 65 years of age or older. Patients seemed to benefit from antiviral therapy.

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 Clears First Rapid Test for Bacterial Contamination in Pooled Platelets

Platelets are used to prevent or treat bleeding in individuals with dangerously low platelet counts, including those undergoing chemotherapy for cancer, following major trauma, during or after surgery, and in individuals who do not produce adequate numbers of platelets. Platelets have the potential to be contaminated with bacteria and it is important to detect and interdict such contamination before transfusion. Patients who are transfused with contaminated platelets are at risk of developing serious and potentially life-threatening infections. The FDA has cleared for marketing the Platelet PGD Test System. This is the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood. The Platelet PGD Test System consists of a single-use test strip that, in fewer than 60 minutes, produces a signal that indicates the presence of bacteria. The test is intended for use mainly by hospital transfusion services as a quality control test for the detection of bacteria after platelets derived from whole blood have been pooled, just prior to a patient blood transfusion. Clinical studies showed that the Platelet PGD Test System improved the sensitivity for detecting bacterial levels by 100 to 1000-fold over existing methods used to test pooled platelets prior to transfusion. The Platelet PGD Test System is manufactured by Verax Biomedical, in Worcester, MA

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