Science Weekly podcast: The next generation supercomputer

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How new technologies will boost your laptop; how Ikea makes you buy stuff you don’t need; plus, new evidence questioning the out of Africa theory

Target e*Studio® – EDC Made Simple

Target Health is pleased to announce that Target e*Studio® Version 1 will be released 21 February 2011. Target e*Studio allows independent programmers and data managers outside of Target Health to configure Target e*CRF® EDC applications. Our estimate is that after the 1-2-week training period, those with the appropriate programming and data management skills will be able to build and release an EDC application in 2-3 weeks or sooner. Most importantly, Target e*Studio will allow programmers to access the forms and database to provide advanced features when necessary. This way, there will be no limit for any EDC application. Target e*Studio Version 1.1 will be released in mid-May and will be showcased at the DIA annual meeting.

Our CRO partner in Korea, LSK Global Pharma Services, led by Dr. Young Jack Lee (formerly of NIH fame), has licensed the software and will be launching their first study in Korea mid-March. Joonhyuk Choi, Director of Application Development at Target Health will be in Korea in February to provide onsite training.

Target e*CRF applications built with Target e*Studio will be fully integrated with Target Encoder®, Target e*CTR® (eClinical Trial Record), Target e*Monitoring and Target e*Pharmacovigilance®.

All Target Health Software Products are reasonably priced and will not “break the bank.” As per Bucky Fuller, you can, “do more with less.”

All Target Health software products Are 21 CFR Part 11 compliant and validated and full documentation is available. There are now 19 approved and marketed products which used Target e*CRF for their pivotal trials including 1 of the 21 drug FDA approvals and 1 PMA diagnostic device approval in 2010. We expect at least 1 drug and 1 PMA approval in 2011.

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 at www.TargetHealth.com

United States Ranks Seventh in Global Cancer Rates

Countries With the Highest Overall Cancer Rates (per 100,000 Population)

Country Overall Males Females
Denmark 326.1 335 325
Ireland 317.0 356 285
Australia 314.1 361 274
New Zealand 309.2 338 287
Belgium 306.8 351 276
France (metropolitan) 300.4 361 255
United States 300.2 335 274
Norway 299.1 338 270
Canada 296.6 326 275
Czech Republic 295.0 349 259

The US has the seventh highest cancer rate in the world, according to new data compiled in January 2011, by the American Institute for Cancer Research (AICR). Of the 50 nations with the highest overall cancer rates in the world, Denmark takes first place and South Africa comes in at number 50.

Overall, the estimates show that high-income countries have significantly higher cancer rates than 1) ___-income ones. The differences in cancer rates among the top 10 nations are relatively small. “But when we look at the top 20 or 25 countries and compare those rates to the lower-income countries, that’s where you really see the differences,” said Alice Bender, of the International Agency for Research on Cancer (AICR), which is part of WHO. “The general idea is that many of these cancers can be prevented by changes in lifestyle and diet,” she said in an interview with Medscape Medical News. “We have very good evidence that a number of our most common cancers can be prevented by being at a healthy weight and being physically 2) ___.”

We can look at these higher rates as being due to some of our 3) ___ issues. For example, people in high-income countries are more likely to be overweight, consume more alcohol, and be inactive. In Denmark, which is at the top of the list, both alcohol and tobacco use are quite 4) ___. Some countries are also better at diagnosing and recording cancer cases; that might play into some of the more subtle differences between the countries on the list. But it is hard to say what exactly is contributing to the subtle differences in ranking.

When broken down by gender, the US comes is ranked 10th for men and 8th women. The 5 most common cancers in the US, are those of the 5) ___, prostate, breast, colorectum, and bladder.

The statistics come from GLOBOCAN, a project from the AICR. Although high-income countries continue to have significantly higher rates of cancer, this disparity is beginning to change. According to 2008 data from GLOBOCAN, more than half of new cancer cases (56%) and deaths (63%) occur in less-developed regions of the world. It takes a few years for these changes to show up, but the pattern is also being seen with other chronic diseases. The increased rates of heart disease and 6) ___ in lower-income countries has some of the same risk factors as other chronic diseases.”

Awareness is an important aspect, and physicians need to realize that, Ms. Bender pointed out. “They do discuss preventing heart disease and diabetes, but they may not spend as much time discussing cancer 7) ___ and what you can do to lower your risk.” Fortunately, many of the recommendations for lowering the risk for other chronic conditions are applicable to reducing the risk for 8) ___. Certainly, there are some cancers that are difficult to prevent, but for many cancers, there are many steps that they can take that will affect their 9) ___.

In the more developed regions, which GLOBOCAN designates as all of Europe plus Northern America, Australia, New Zealand, and Japan, prostate and lung cancer are the most common malignancies found in men. Among women, cancers of the breast and colorectum are the most common. In less developed regions, which include all of Africa, Asia (excluding Japan), Latin America, the Caribbean, Melanesia, Micronesia, and Polynesia, lung and stomach cancer are the most common cancers in men. For women, breast and cervix/uterine cancers are the most common. Source: Medscape.com

ANSWERS: 1) lower; 2) active; 3) lifestyle; 4) high; 5) lung; 6) diabetes; 7) prevention; 8) cancer; 9) risk

Thomas Jefferson Also Supported Government Run Health Care

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FORBES.com, January 30, 2011, by Rick Ungar  —  In response to Forbes’ earlier piece,  “An Act for the Relief of Sick and Disabled Seamen”, the 1798 law revealing that a number of our founders were more supportive of the notion of mandated health coverage and a government run hospital system than some may have imagined, many have noted that it is not surprising that such legislation would have been signed into law by President John Adams, a noted Federalist who serves as a model for much of what today’s Tea Party finds objectionable. Their point is not wholly unreasonable. After all, it was John Adams who brought us the highly objectionable Alien & Sedition Acts.

However, Washington Post blogger, Greg Sargent, today reports that it wasn’t only John Adams who supported the notion of government run health care. According to Georgetown University history professor and noted historian of America’s early days, Adam Rothman, Thomas Jefferson –the iconic hero of the Tea Party – also supported the legislation.

Sargent reprints the following email he received from Prof. Rothan on the subject “Alexander Hamilton supported the establishment of Marine Hospitals in a 1792 Report, and it was a Federalist congress that passed the law in 1798. But Jefferson (Hamilton’s strict constructionist nemesis) also supported federal marine hospitals, and along with his own Treasury Secretary, Albert Gallatin, took steps to improve them during his presidency. So I guess you could say it had bipartisan support.”

Ezra Klein adds to the debate pointing out that “…it was a payroll tax that all sailors on private merchant ships had to pay, and in return, they were basically given access to a small public health-care system. But it was, in essence, a regulation against a form of inactivity: You were not allowed to not do something, in this case, pay for sailor’s health insurance.”

There are those who will continue to argue that these indications of how the founders viewed these issues in their own time do not necessarily resolve the issue as to how we may, Constitutionally speaking, proceed with reforming the health care system of today. They may well be right. But, at the least, can we not agree that the mounting evidence as to how men like Jefferson and Adams perceived the issue should bar the attempt to pin the objections to health care reform on the backs of the nation’s founders? While it may be an effective device to win over the support of a certain segment of American society, throwing the nation’s founders into the stew is really just one more disingenuous and cynical attempt to mislead the debate away from the real issues.  Source: FORBES MAGAZINE @ FORBES.com, The Policy Page by Rick Ungar

GENETICS

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Identification of ADAMTS7 as a Novel Locus for Coronary Atherosclerosis and Association of ABO with Myocardial Infarction in the Presence of Coronary Atherosclerosis

According to an article published in The Lancet (2011;377:83-392), a study was performed to test whether genetic factors distinctly contribute to either development of coronary atherosclerosis or, specifically, to myocardial infarction in existing coronary atherosclerosis.

The investigation included two genome-wide association studies (GWAS) with coronary angiographic phenotyping in participants of European ancestry. To identify loci that predispose to angiographic coronary artery disease (CAD), the study compared individuals who had this disorder (n=12,393) with those who did not (controls, n=7,383). To identify loci that predispose to myocardial infarction, patients who had angiographic CAD and myocardial infarction (n=5,783) were compared with those who had angiographic CAD but no myocardial infarction (n=3,644).

The study identified a novel locus (the specific location of a gene or DNA sequence on a chromosome), ADAMTS7 (p=4 98×10-13) in patients with angiographic CAD compared to the control group. In the comparison of patients with angiographic CAD who had myocardial infarction versus those with angiographic CAD but no myocardial infarction, the study identified a novel association at the ABO locus (p=7 62×10−9). The ABO association was attributable to the glycotransferase-deficient enzyme that encodes the ABO blood group O phenotype previously proposed to protect against myocardial infarction.

According to the authors, the findings indicate that specific genetic predispositions promote the development of coronary atherosclerosis whereas others lead to myocardial infarction in the presence of coronary atherosclerosis. The authors added that the relation to specific CAD phenotypes might modify how novel loci are applied in personalized risk assessment and used in the development of novel therapies for CAD.

Effects of Vitamin D Supplementation on Bone Density in Healthy Children

According to an article published in the British Medical Journal (2011;342:c7254), a study was performed to determine 1) the effectiveness of vitamin D supplementation for improving bone mineral density in children and adolescents and, 2) if effects vary with factors such as vitamin D dose and vitamin D status. The study involved a systematic review of the literature and meta-analysis.

Data sources included: 1) Cochrane Central Register of Controlled Trials, Medline (1966 to present); 2) Embase (1980 to present); 3) CINAHL (1982 to present); 4) AMED (1985 to present); 5) ISI Web of Science (1945 to present), and 5) manual searching of conference abstracts from key journals.

Study selection included placebo controlled, randomized controlled trials of vitamin D supplementation, for at least three months, in healthy children and adolescents (aged 1 month to <20 years) with bone density outcomes.

Data analyses included mean differences of the percentage change from baseline in bone mineral density of the forearm, hip, and lumbar spine and total body bone mineral content in treatment and control groups. Subgroup analyses were carried out by gender, pubertal stage, dose of vitamin D, and baseline serum vitamin D concentration. Compliance and allocation concealment were also considered as possible sources of heterogeneity.

Six studies, totaling 343 participants receiving placebo and 541 receiving vitamin D, contributed data to the meta-analyses. Results showed that vitamin D supplementation had no statistically significant effects on total body bone mineral content or on bone mineral density of the hip or forearm. There was a trend to a small effect on lumbar spine bone mineral density (mean difference 0.15; P=0.07). Effects were similar in studies of participants with high compared with low serum vitamin D levels, although there was a trend towards a larger effect with low vitamin D for total body bone mineral content (P=0.09 for difference). In studies with low serum vitamin D, significant effects on total body bone mineral content and lumbar spine bone mineral density were roughly equivalent to a 2.6% and 1.7% percentage point greater change from baseline in the supplemented group.

According to the authors, it is unlikely that vitamin D supplements are beneficial in children and adolescents with normal vitamin D levels. However, the planned subgroup analyses by baseline serum vitamin D level suggested that vitamin D supplementation of deficient children and adolescents could result in clinically useful improvements, particularly in lumbar spine bone mineral density and total body bone mineral content. However, this observation requires confirmation using prospective studies.

The Risk of Cancer in Patients with Rheumatoid Arthritis: A Nationwide Cohort Study in Taiwan

The association of rheumatoid arthritis (RA) and malignancy has rarely been explored in Asian populations. As a result, a study published in Arthritis & Rheumatism (2011;63:352–358) was performed to investigate the relative risk of cancer in Taiwanese patients with RA and to identify groups of patients with a high risk of cancer.

The investigation was a nationwide cohort study of the risk of cancer among 23,644 patients with RA who had no history of malignancies. For the study, data were obtained from the National Health Insurance database of Taiwan from 1996 to 2007. Standardized incidence ratios (SIRs) for various cancers were analyzed.

During the course of the study, 935 cancers were observed. Results showed that patients with RA had an increased risk of cancer (SIR 1.23, especially hematologic cancers (SIR 2.74). The relative risk of cancer was higher among younger patients. Most cancer cases were detected within the first year following the diagnosis of RA.

The relative risk of cancer decreased as the duration of observation increased. Among hematologic cancers, the risk of non-Hodgkin’s lymphoma was greatest (SIR 3.54). Among solid tumors, the risk of cancers of the kidney and female reproductive organs was highest. A decreased risk of cancers of the cervix and nonmelanoma skin cancer in patients with RA was also observed.

According to the authors, patients with RA have an increased risk of cancer, especially hematologic and kidney cancers and that the relative risk of cancer in patients with RA decreased with long-term followup. The authors recommended cancer screening with continued vigilance for patients with RA.

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

FDA to Improve Most Common Review Path for Medical Devices

The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.

Key actions include:

1.      Streamlining the “de novo” review process for certain innovative, lower-risk medical devices

2.      Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process

3.      Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making

According to FDA, these actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” (Jeffrey Shuren, M.D., J.D., Director of CDRH).

Currently, before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission. These submissions are known as 510(k)s for the section of the Federal Food, Drug, and Cosmetic Act that describes this notification requirement. Generally, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

In September 2009, CDRH set up two internal working groups to address concerns relating to the premarket notification process – industry argued that the 510(k) process was unpredictable, inconsistent and opaque, while consumers and health care professionals argued that the review process wasn’t robust enough. At the same time, CDRH also asked the independent, nonprofit Institute of Medicine to study the program. That review is still underway.

In a transparent effort, CDRH sought public input during both the development and review of the two internal reports. The center held two public meetings in the Washington area and separate “town hall” meetings in Minneapolis, Boston and Los Angeles. The FDA also received 76 written comments to three public dockets from industry members, health care professional organizations, consumer groups, patient groups, third-party payers, venture capital groups, agency staff, trial lawyers, foreign regulatory bodies, law firms, individual members of the public, consulting firms and academic institutions.

The two working groups issued 55 recommendations in August 2010. After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training. CDRH also is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning for a public meeting in April to seek additional feedback on two other recommendations.

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.