Science Weekly: Are Britain’s libel laws stifling science worldwide?

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Simon Singh on how our libel laws suppress academic debate; music of the telescopes; and the importance of being vague

Translational Medicine at Target Health

 

Target Health is pleased to announce active involvement in four academic programs in translational medicine where we are providing regulatory, toxicology and data management support services. All of these programs are NIH-funded. One program with SUNY Stony Brook is in 3rd degree burns and another is with Rutgers in the area of Countermeasures. A 3rd is with the University of Washington in the area of arthritis and the 4th program is with the Cleveland Clinical also in the area of arthritis. It is the opinion of Target Health that academia will be the next source of major products to the pharmaceutical industry, but the key is for our friends in academia to bring their products through Phase 2A to confirm efficacy and preliminary safety prior to licensing.

We also recommend that a successful way to fund healthcare in the US, would be for the US Government to get a 1% royalty from any marketed drug or device which was developed with any NIH funding, and that patent life of a drug start when a product is approved as long as a company is actively developing the drug.

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 at www.targethealth.com

Fat May Serve a Purpose in Stem Cell Research
 

Fat cells could play an important role in stem cell research and 1) ___ medicine. Researchers may have found an important purpose for fat cells, turning them into stem cells that can be used to treat injuries and repair damaged 2) ___. Scientists at the Stanford University School of Medicine have found a new and improved way to transform 3) ___ cells taken from fat into pluripotent stem cells that can be used in regenerative medicine. Pluripotent cells are important in modern medicine, because they can be induced to become different types of specialized 4) ___, which can be used to treat injuries and other health issues. Stanford researchers plan to first use these cells to better understand human heart disease and eventually develop new treatment options. The new technique is both safer and simpler than current commonly used techniques, which use viruses to introduce 5) ___ into the cells or permanently alter a cell’s genome. Instead, the Stanford researchers used microscopic rings of DNA to induce pluripotency in stem cells from human 6) ___. The ramifications are far-reaching, notes cardiologist Dr. Joseph Wu. For example, in a patient with heart 7) ___, scientists could simply do a fat or skin biopsy and reprogram the cells to pluripotency so they can become 8) ___ cells that they can study in the lab, rather than having to take cells directly from a patient’s heart. The scientists hope that the ease and safety of the new technique will smooth the way through the necessary FDA approval process.

ANSWERS

1)  regenerative;  2)  organs;  3)  stem;  4)  cells;  5)  genes;  6)  fat;  7)  disease;  8)  cardiac

Darwin‘s Lifelong Illness Gets a Diagnosis (1809-1882)

A chronic condition more frequently seen in children plagued the “father of evolution” during much of his life, according to a new study.  That Charles Darwin was incapacitated by seasickness for much of his historic voyage on the HMS Beagle may not be surprising. But the author of The Origin of Species experienced disabling nausea and vomiting for most of his life, and a researcher has now put a name to that illness — cyclical vomiting syndrome (CVS).  Symptoms of the syndrome are an “extraordinary” match with Darwin’s description of the illness that often incapacitated him into adulthood, said Dr. John Hayman, associate professor of anatomy and developmental biology at Monash University in Melbourne, Australia. He offered his diagnosis in a report posted online in December.  “My original thought was that he may have had abdominal migraine, but his symptoms did not match exactly,” Dr. Hayman wrote in an e-mail. “Abdominal migraine led me to CVS, and here the symptoms seem to match.”  Darwin’s illness has been attributed over time to hypochondria, panic disorder, middle ear damage, arsenic poisoning from prescribed drugs and Chagas’ disease from an insect bite. Dr. Hayman points out that those theories have been disallowed.  But a diagnosis of CVS fits, due to its episodic nature and association with motion sickness and atopic dermatitis, which is also among Darwin’s symptoms. And the syndrome is brought on by stress — even pleasurable stress, Dr. Hayman said.  Although CVS is primarily a disease of children, it may persist into adulthood or appear for the first time in adulthood. “This disease is neither well-known nor well-recognized, particularly in adults, although it was first described in the English literature in 1882,” Dr. Hayman said.  The chronic, intermittent condition also has been linked to genetic abnormalities, and Darwin’s mother and uncle had symptoms of the illness, Dr. Hayman wrote.  Darwin experienced the disorder before he boarded the Beagle and was aware he could feel worse at sea. While aboard on Dec. 30, 1831, he wrote in his diary: “Wretchedly out of spirits and very sick. I often said before starting that I had no doubt I should frequently repent of the whole undertaking, little did I think with what fervour I should do so.”  Darwin also seemed to recognize that the syndrome could be triggered by pleasurable events. After his voyage, he told a former shipmate that he could not bear a visit from him. “Twice lately I could not resist seeing old friends … and the excitement made me so ill afterwards that I have been advised not to do so again,” Darwin wrote.  He underwent many medical treatments without lasting improvement, Dr. Hayman said. The most famous was cold water therapy at a British clinic.  Dr. Hayman was surprised that Darwin accomplished so much in his life, considering his struggles with CVS. “He was fortunate in having a very supportive wife, devoted servants and loyal colleagues. And, of course, he was wealthy — he did not have to work for a living. But above all, it was his great intellect and powers of observation and deduction that drove him even when sick.”  Darwin likely was affected by CVS for at least 50 years, although the syndrome became less severe in his later life, Dr. Hayman said. Darwin died in 1882 at 73 with symptoms of heart failure and cardiac ischemia. Source: ama-assn.org/amednews/2010, by Susan J. Landers

Glycated Hemoglobin, Diabetes, and Cardiovascular Risk in Nondiabetic Adults

 

Fasting glucose is the standard measure used to diagnose diabetes in the United States. Recently, glycated hemoglobin was also recommended for this purpose. As a result, a study published in the New England Journal of Medicine (2010;362:800-811), compared the prognostic value of glycated hemoglobin and fasting glucose for identifying adults at risk for diabetes or cardiovascular disease. The study measured glycated hemoglobin in whole-blood samples from 11,092 black or white adults who did not have a history of diabetes or cardiovascular disease and who attended the second visit of the Atherosclerosis Risk in Communities (ARIC) study. Results showed that the glycated hemoglobin value at baseline was associated with newly diagnosed diabetes and cardiovascular outcomes. For glycated hemoglobin values of less than 5.0%, 5.0 to less than 5.5%, 5.5 to less than 6.0%, 6.0 to less than 6.5%, and 6.5% or greater, the hazard ratios for diagnosed diabetes were 0.52, 1.00 (reference), 1.86, 4.48, and 16.47, respectively. For coronary heart disease, the hazard ratios were 0.96, 1.00 (reference), 1.23, 1.78, and 1.95, respectively. The hazard ratios for stroke were similar. In contrast, glycated hemoglobin and death from any cause were found to have a J-shaped association curve. All these associations remained significant after adjustment for the baseline fasting glucose level. The association between the fasting glucose levels and the risk of cardiovascular disease or death from any cause was not significant in models with adjustment for all covariates as well as glycated hemoglobin. For coronary heart disease, measures of risk discrimination showed significant improvement when glycated hemoglobin was added to models including fasting glucose. According to the authors, in this community-based population of nondiabetic adults, glycated hemoglobin was similarly associated with a risk of diabetes and more strongly associated with risks of cardiovascular disease and death from any cause as compared with fasting glucose. These data add to the evidence supporting the use of glycated hemoglobin as a diagnostic test for diabetes.

Cardiovascular Disease in Patients with Inflammatory Rheumatic Disease is Associated with Up-Regulation of Markers of Inflammation

 

Various inflammatory rheumatic diseases (IRDs) are associated with increased mortality due to cardiovascular disease. As a result, a study published in Arthritis and Rheumatism (2010;62:667-673), was performed to examine heart biopsy specimens obtained from patients undergoing coronary artery bypass grafting. For each specimen, markers of inflammation and endothelial cell activation were compared in the cardiac and skeletal muscle of patients with and those without IRD. For the study, paired biopsy specimens of cardiac and skeletal muscle were obtained from 22 consecutive patients with IRD and 8 patients without IRD, all of whom were undergoing coronary artery bypass grafting. The biopsy specimens were evaluated in a blinded manner by conventional microscopy and digital image analysis for cell markers (CD3, CD4, CD8, CD68, CD163, and CD31), HLA (HLA-ABC, HLA-DR, and HLA-DQ), adhesion molecules (intercellular adhesion molecule 1 and vascular cell adhesion molecule 1), and proinflammatory cytokines (interleukin-1, interleukin-1, and tumor necrosis factor). Results showed that patients with IRD had significantly higher expression of adhesion molecules, proinflammatory cytokines, and all classes of HLA on cardiomyocytes and endothelial cells but no increase on mononuclear cells in the myocardium compared with patients without IRD. Furthermore, cardiac muscle from patients with IRD displayed significantly higher local expression of inflammation and activation of cardiac microvessels compared with skeletal muscle from the same patients. According to the authors, patients with cardiovascular disease had increased expression of adhesion molecules, HLA, and proinflammatory cytokines in heart tissue, indicating local inflammation involving microvessels and cardiomyocytes that could play a role in the pathogenesis of cardiovascular disease. The authors added that the more pronounced changes in patients with IRD compared with those without IRD might contribute to the increased risk of cardiovascular disease and premature death in patients with IRD.

Vitamin D and Calcium May Affect the Cardiovascular System Independently and Interactively

 

A study, published in the Annals of Internal Medicine (2010;152:315-323), was performed to assess whether vitamin D and calcium supplements reduce the risk for cardiovascular events in adults. For the study, a meta analysis was performed based on studies published in English from 1966 to July 2009 in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. In order to select the studies, two investigators independently selected 17 prospective and randomized studies that examined vitamin D supplementation, calcium supplementation, or both and subsequent cardiovascular events. Results showed that five prospective studies of patients receiving dialysis and 1 study involving a general population showed consistent reductions in cardiovascular disease (CVD) mortality among adults who received vitamin D supplements. Four prospective studies of initially healthy persons found no differences in incidence of CVD between calcium supplement recipients and nonrecipients. Results of secondary analyses in eight randomized trials showed a slight but statistically nonsignificant reduction in CVD risk (pooled relative risk, 0.90) with vitamin D supplementation at moderate to high doses (approximately 1000 IU/d) but not with calcium supplementation (pooled relative risk, 1.14), or a combination of vitamin D and calcium supplementation (pooled relative risk, 1.04) compared with placebo. According to the authors, evidence from limited data suggests that vitamin D supplements at moderate to high doses may reduce CVD risk, whereas calcium supplements seem to have minimal cardiovascular effects, and that further research is needed to elucidate the role of these supplements in CVD prevention.

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.

 

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public

The FDA and NIH unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people. As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process. In addition, the NIH and the FDA will jointly issue a Request for Applications, making $6.75 million dollars available over three years for work in regulatory science. The research supported through this initiative should add to the scientific knowledge base by providing new methods, models or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development. The effort will rely on the NIH’s vast experience supporting and facilitating new discoveries in the laboratory and clinic and the FDA’s more than 100 years of experience and knowledge in the regulation and approval of drugs, biologics and medical devices. The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.

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

Target Health (www.targethealth.com) is a full service eCRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, EDC utilizing Target e*CRF®, and Medical Writing. Target Health has developed a full suite of eClinical Trial software including 1) Target e*CRF® (EDC plus randomization and batch edit checks), 2) Target e*CTMS™, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTR™ (electronic medical record for clinical trials). Target Health ‘s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.  

 

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