Pregnancy weight gain, especially in 1st Trimester, may increase a woman’s risk of gestational diabetes
Women who gain excessive weight during pregnancy, especially in the first trimester, may increase their risk of developing diabetes later in their pregnancy, according to a study by the Kaiser Permanente Division of Research that appears online in the current issue of Obstetrics and Gynecology.
Watch a video of the study author explaining her study: http://bit.ly/clLtlZ
The three-year study of 1,145 pregnant women from an ethnically diverse population found that women who gained more weight than is recommended by the Institute of Medicine had a 50 percent increased risk of developing gestational diabetes mellitus, also known as GDM. The association between pregnancy weight gain and gestational diabetes risk was more pronounced among overweight and non-white women. The study included 345 pregnant women with gestational diabetes and 800 pregnant women without gestational diabetes.
Gestational diabetes is defined as glucose intolerance that typically occurs during the second or third trimester of pregnancy. It causes complications in as much as seven percent of pregnancies in the United States. It can lead to early delivery, C-sections and type 2 diabetes, and can increase the child’s risk of developing diabetes and obesity later in life.
This study is among the first to support a direct link between pregnancy weight gain and gestational diabetes risk. Previous research has shown that weight gain before pregnancy and being overweight or obese at the start of pregnancy are risk factors for gestational diabetes. This study was funded by the American Diabetes Association and the National Institute of Diabetes and Digestive and Kidney Diseases.
The study followed women members of Kaiser Permanente Northern California region and examined their overall rate of pregnancy weight gain up to the time of screening for gestational diabetes (typically between 24-28 gestational weeks), as well as the trimester-specific rates of weight gain compared to the Institute of Medicine’s 2009 guidelines for recommended pregnancy weight gain. Based on a woman’s pre-pregnancy body mass index, the IOM developed the 2009 guidelines for obstetricians to counsel pregnant women on suggested weight gain during pregnancy.
After adjusting for age at delivery, race/ethnicity, previous births, and pre-pregnancy body mass index, the risk of gestational diabetes increased with increasing rates of pregnancy weight gain. Women who exceeded the IOM guidelines for weight gain had a 50 percent increase in the risk of gestational diabetes compared to women who gained within or below the IOM recommendations.
“Health care providers should talk to their patients early in their pregnancy about the appropriate gestational weight gain, especially during the first trimester, and help women monitor their weight gain. Our research shows that weight gain in early pregnancy is a modifiable risk factor for gestational diabetes,” said the study’s lead author Monique Hedderson, PhD, a scientist at the Kaiser Permanente Division of Research. “Randomized studies are needed to determine the feasibility of this early intervention and the best methods to help women meet the IOM recommendations.”
Though the exact mechanism for how excessive weight gain may contribute to gestational diabetes is not known, researchers hypothesize that rapid weight gain early in pregnancy may result in an early increase in insulin resistance that leads to the “exhaustion” of the beta-cells in the pancreas that make and release insulin, which controls the level of glucose in the blood. This could reduce beta-cells’ capacity to secrete adequate levels of insulin to compensate for the insulin resistance induced by the progression of pregnancy and therefore lead to the development of gestational diabetes, researchers said.
A strength of the study is its representative and ethnically diverse population. However, some limitations should be considered. Pre-pregnancy weights were self-reported for most women. However, researchers have no reason to believe that the women who developed gestational diabetes would have misreported their pre-pregnancy weight more than control women and results were similar when looking at the sub-group of women who had a measured pre-pregnancy weight.
This study is part of ongoing research at Kaiser Permanente to understand, prevent and treat gestational diabetes. A recent published Kaiser Permanente study of 16,000 women in Hawaii found that more than 10 percent of women of Chinese and Korean heritage may be at risk for developing gestational diabetes. Another published Kaiser Permanente study of 10,000 mother-child pairs showed that treating gestational diabetes during pregnancy can break the link between gestational diabetes and childhood obesity. That study showed, for the first time, that by treating women with gestational diabetes, the child’s risk of becoming obese years later is significantly reduced.
The study follows other research at Kaiser Permanente regarding healthy weight gain during pregnancy. A recent published Kaiser Permanente study found that obese women who gain more than the recommended amount during pregnancy are much more likely to retain a portion of that weight one year after they give birth. Another published Kaiser Permanente study of 40,000 mother and baby pairs found that women who gained more than 40 pounds during their pregnancies were nearly twice as likely to have a heavy baby.
Assiamira Ferrara, MD, PhD, a research scientist with the Kaiser Permanente Division of Research in Oakland, Calif., is the senior investigator on this study. Erica P. Gunderson, PhD, also with the Kaiser Permanente Division of Research, is an investigator on this study.
Source: Kaiser Permanente
Study: Era of rapid growth in biomedical research over
After a decade of remarkable growth, total annual funding for biomedical research in the U.S. has decelerated and may have even fallen when adjusted for inflation. That is the conclusion of a study today published in the Journal of the American Medical Association.
“The era of rapid expansion in biomedical research funding that began in the 1990’s has ended,” said Ray Dorsey, M.D., a neurologist at the University of Rochester Medical Center and lead author of the study. “Looking back at this period, one of the striking observations is that while research funding increased, the number of novel treatments entering the market remained steady. If research funding levels are to return to a phase of growth, we should examine funding priorities, particularly in health services research, and barriers to the development of new therapies.”
The authors compiled data from government sources, trade organizations, and industry financial reports to create a profile of biomedical research funding from 2003 to 2007. Over the five year period, annual research funding increased from $75.5 to $101.1 billion. Adjusted for inflation, funding grew by an average annual rate of 3.4% over the period. Using incomplete data, the authors estimated research funding from the National Institutes of Health (NIH) and industry for 2008 at $88.8 billion, which, when adjusted for inflation, represents a decrease in funding.
The study is a follow-up to a similar analysis published in 2005 by the same authors that showed that biomedical research funding from all sources had tripled in nominal value and doubled when adjusted for inflation between 1994 and 2003. The annual growth rate in funding over the period was more than twice as fast at 7.8%.
This deceleration in funding, if unchanged, has a significant potential impact for the biotechnology and pharmaceutical industries and academic research institutions that rely on government and private funding. As has been noted in other reports, the flat-lining of federal funding for biomedical research in particular has a cascading effect on the national academic research enterprise, leading to scientists spending more of their time chasing funding, influencing career choices of new graduates, discouraging higher risk research, and curtailing the establishment of new scientific programs and construction of new research facilities.
The growth in research funding that began in the 1990s fueled a significant expansion in academic research and many universities became engines for economic growth in their communities. Consequently, the deceleration in research funding could have a profound effect on communities where academic research, health care, and biotechnology have become major economic players.
Approval of New Drugs and Devices Stagnant
While funding has generally increased over the period examined, this growth has not been accompanied by an increase in the number of new drug and device approvals by the U.S. Food and Drug Administration (FDA). For example, the number of new molecular entities, essentially drugs that have not been marketed in the U.S. previously, approved by the FDA in 2003 was 21 and in 2008 was 17. Similar trends were observed for new biologics, as measured by biologic license applications, and devices, as measured by device pre-market application approvals.
“The relative lack of new therapeutic advances has been a decade-long problem that continues to persist despite previous large investments in research funding,” said Dorsey. “The current model is not working well if the desire is to approve new novel therapies to improve health. We need to modify incentives to reward risk and increase support for companies pursuing early stage and innovative research.”
Increasingly, the model for drug development has the pharmaceutical industry devoting a large portion of its spending for late-stage clinical trials as opposed to drug discovery research. The large pharmaceutical companies have largely abdicated the role of early stage research and development to smaller companies that often serve as the bridge between academic research and the market. These smaller companies, in turn, then develop relationships (either through partnerships or acquisitions) with larger companies once they have proven they have a viable product. However, these smaller firms, with limited resources and capital, face considerable risk and increasing pressures to generate promising results in short time frames from impatient markets. The model currently creates little incentive for investors to put capital into companies who are engaged in research that may be innovative, but has a higher risk of failure.
Biomedical vs. Health Services Research
The analysis also reveals that health services research represents a fraction of the nation’s $2 trillion in annual health care spending. This research – which is funded by foundations and federal agencies such as the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, NIH, and the Center for Medicare and Medicaid Services – is intended to improve health care quality and access and control costs by examining the impact of financial, social, technological, and organizational factors on public health.
The study’s authors contend that, in the context of the ongoing national debate over how to control growth in health expenditures, which now exceed $2.3 trillion in the U.S., and impending legislation in Congress that will dramatically increase the number of people with health insurance, spending on health services research, which was $2.2 billion in 2008, is inadequate.
“We spend almost $5 for every $100 in national health expenditures on biomedical research, but we spend less than a dime on ensuring those treatments reach the right people and the right time,” said Dorsey. “Given the massive changes in health care that may occur in the very near future, we need to dedicate more resources to understanding the most effective and efficient ways of delivering care.”
Industry Funding Up, NIH Funding Shrinks
Industry – pharmaceutical, biotechnology, and medical device firms – supplies the largest proportion of total research spending at 58%, followed by the federal government at 33%. Industry research and development funding increased by 25% between 2003 and 2007 with growth in research activity by medical device (59%) and biotechnology companies (41%) significantly outpacing pharmaceutical companies (14%).
The study found that funding from the National Institutes of Health – which is by far the single largest supporter of biomedical research – decreased by 12% between 2003 and 2008 when adjusted for inflation. Total federal funding for biomedical research increased by 0.7% over the period, that is in contrast to the period between 1994 and 2003 when federal research funding increased by 100%.
Additional authors include: Christopher Beck, Ph.D., Jason Reminick, Benjamin George, Zachary White-Stellato all with the University of Rochester; Jason de Roulet, M.D. with University Hospitals Case Medical Center; Joel Thompson, M.P.H. with the University of Buffalo School of Medicine and Biomedical Sciences; and Hamilton Moses III, M.D. and Ashley Thai with Johns Hopkins University School of Medicine. Moses is also with the Alerion Institute. The study was funded with support from the National Center for Research Resources, part of the National Institutes of Health.
For more information about the initiative, visit: http://www.urmc.rochester.edu/news/story/index.cfm?id=2736
Source: University of Rochester Medical Center
U.S. Government rejoins worldwide consensus on reproductive health
Health and Development Groups Applaud Clinton Speech; Call for Action
A broad coalition of organizations representing millions of Americans applauded statement by Secretary of State Hillary Clinton that the United States unequivocally supports the worldwide consensus that achieving universal access to reproductive health is critical for individual health, family well-being, broader economic development and a healthy planet.
In a speech today at the State Department, Secretary Clinton declared the U.S. government’s renewed support and dedication to reaching the health and development goals laid out in the International Conference on Population Development and other related UN agreements, including the Millennium Development Goals.
The Secretary said that “women’s health is essential to the prosperity and health of all people,” and that the U.S. has rejoined with all governments to “make the access to reproductive healthcare a basic right.”
During the groundbreaking 1994 United Nations International Conference on Population and Development (ICPD) held in Cairo, 179 nations laid out an ambitious plan of action to improve health and achieve sustainable development by focusing on individual health needs and human rights, especially for women and girls.
Countries agreed to achieve universal access to reproductive health services by the year 2015, a target reaffirmed in the Millennium Development Goals. Reproductive health services include voluntary contraception that is affordable and safe, sex education programs to prevent unintended pregnancies and sexually transmitted diseases such as HIV/AIDS, and programs that improve maternal and child health.
“The United States was a major architect of the 1994 Cairo agreement, but U.S. funding for international family planning programs, a major component of reproductive health services, has fallen 23 percent in real dollars since its high in 1995,” said Suzanne Ehlers, Interim President of Population Action International. “Today’s statement by Secretary Clinton marks a return to U.S. leadership on international family planning.”
Investments in reproductive health programs have saved lives and delivered real results. In Mexico, the infant mortality rate fell by 70% between 1970 and 2005, as the use of modern contraceptives nearly doubled. Similar results have been seen in Bangladesh, Egypt, Thailand, and elsewhere.
Conversely, inadequate funding for reproductive health and family planning programs hold grave consequences for women and families. One woman dies needlessly in pregnancy or childbirth every minute of every day, and six million more suffer injury, illness or disability. Each year, between 70 to 80 million unintended pregnancies occur in the developing world.
To meet the unmet need for family planning and achieve the goal of achieving universal access to reproductive health, the coalition of non-profit organizations calls on the Obama Administration to:
– Ensure that the new Global Health Initiative retain a strong focus on interventions to prevent unintended pregnancy, promote women’s health and save women’s lives.
– Ensure that greater access to contraception and reproductive health care remains a high priority within any restructuring of the U.S. government’s foreign assistance program so that women, men and youth can access a comprehensive range of reproductive health services no matter where they are accessing care.
– Work with the U. S. Congress to fund international family planning programs at $1 billion, to reverse a decade of inadequate funding, and eliminate punitive legislative restrictions that continue to tie-up the U.S. contribution to the United Nations Population Fund (UNFPA).
“Poll after poll has shown that a majority of Americans across the ideological divide support family planning programs and proven investments in women’s health,” said Tamara Kreinin, Executive Director of Women and Population at the United Nations Foundation. “I hope that Secretary Clinton’s speech is a signal to everyone that the U.S. government is done with political theater and instead will focus on the important work of saving lives.”
Source: CEDPA
Effort to regenerate injured spinal cords turns to a new model
For more than 400 years, scientists have studied the amazing regenerative power of salamanders, trying to understand how these creatures routinely repair injuries that would usually leave humans and other mammals paralyzed — or worse.
Now, fueled by a highly competitive National Institutes of Health Grand Opportunity grant of $2.4 million, a multi-institutional team of researchers associated with the University of Florida McKnight Brain Institute’s Regeneration Project has begun creating genomic tools necessary to compare the extraordinary regenerative capacity of the Mexican axolotl salamander with established mouse models of human disease and injury.
Researchers want to find ways to tap unused human capacities to treat spinal cord injury, stroke, traumatic brain injury and other neural conditions, according to Edward Scott, Ph.D., principal investigator for the GO grant and director of the McKnight Brain Institute’s Program in Stem Cell Biology and Regenerative Medicine.
“The axolotl is the champion of vertebrate regeneration, with the ability to replace whole limbs and even parts of its central nervous system,” Scott said. “These salamanders use many of the same body systems and genes that we do, but they have superior ability to regenerate after major injuries. We think that studying them will tell us a lot about a patient’s natural regenerative capacities after spinal cord injury and nerve cell damage.”
The issue of what controls organ regeneration was named among the top 25 major questions facing scientists in the next quarter century by Science magazine in 2005, Scott said. With medical science continually adding years to the human lifespan, the importance of “rebuilding and restoring” old tissues and organs is growing. But science had to enter the 21st century to fully explore the use of the highly regenerative axolotl as a model for human disease.
“Only now have new genetic, molecular and cellular technologies as well as scientific knowledge of the salamander, mouse and human genomes and ‘regeneromes’ risen to a level where scientists can compare systemwide responses to injury,” according to Dennis A. Steindler, Ph.D., executive director of UF’s McKnight Brain Institute and a co-investigator on the grant.
“I am extremely hopeful with the discoveries being made in comparative regenerative biology that the questions surrounding cell and tissue regeneration in the human following injury or disease are going to be answered,” Steindler said. “It is going to take broad, multidisciplinary collaborations across a number of scientific fields, but we are making that happen. I think the GO grant shows that these efforts are recognized and valued on a national level.”
GO grants are funded through the American Recovery and Reinvestment Act and are intended to support research with high short-term impact and a high likelihood of enabling growth and investment in biomedical research and health-care delivery.
“NIH Grand Opportunity grants support high-impact projects, which lay the foundation for whole new fields of investigation,” said Naomi Kleitman, Ph.D., repair and plasticity program director at the National Institute of Neurological Disorders and Stroke. “This important model of regeneration is one of several being developed in organisms that can repair themselves, using genetics to find links to mammals. We’ll continue to watch the progress of these exciting studies to ensure that discoveries of genes that promote regeneration are one day applied to improving human health.”
The Regeneration Project is also supported by private foundations such as the Thomas H. Maren Foundation and the Jon L. and Beverly A. Thompson Research Endowment, the UF Office of the Vice President for Research, and an anonymous donor, Steindler said. Enhancing the discovery process are Regeneration Project research fellows — scientists who work across institutes and universities to advance discoveries in tissue and organ regeneration to the clinic.
Even without help, people are capable of a certain degree of regeneration. Humans can regrow fingertips and even more than half of their liver. But they cannot replace whole limbs and restoring parts of their brain and spinal cord is a daunting challenge.
“The axolotl is the highest, most complex organism that can still do this clever trick of completely reconstructing a whole body part in adulthood,” said Arlene Chiu, Ph.D., a scientific adviser for the Regeneration Project and director of New Research Initiatives at Beckman Research Institute of the City of Hope. “I like to think of it in construction terms where we need both the materials such as bricks and beams and the architect’s plans. In regenerative medicine, can we learn where the biological blueprint resides, and understand the basis of restoring and reorganizing many different types of lost cells and tissues? Muscles, bones, nerves and blood vessels all have to be reconstructed at the right time and in the right place, all in perfect coordination with the original biological master plan.
“It may sound like science fiction, but the reality is the salamander is able to do all of these things,” she said. “We are not so far removed that we can’t relate to them, learn from them and try to apply their secrets to improve our capacity to regenerate.”
As discoveries are made, more researchers will begin using the axolotl as a model for exploring regenerative techniques, according to S. Randal Voss, director of the Salamander Genome Project at the University of Kentucky.
“We’ve analyzed genes in common between the axolotl salamander and humans, and found out we share about 90 percent of our genes in a one-to-one sense,” Voss said. “It could be that small but important changes in the way these genes function in an injury environment affect the repair process, but somehow the salamander is able to use these genes for regeneration, while people are not.”
The team has already referenced human and mouse genes with axolotl counterparts.
“We started this with a list of genes in humans and mice that are involved in repair processes and matched them with their counterparts in the axolotl genome,” Scott said. “Ultimately, what makes the axolotl a great model for regeneration is that the model systems we are most familiar with — mice and humans — do not regenerate very well. By comparing how a mammal and a salamander respond to injuries, we can identify genes or proteins that we can now add back to the mammalian system to make it regenerate better.”
Source: University of Florida Health Science Center
Thomson Reuters survey: Most Americans support public option in healthcare reform legislation
but Are Skeptical Healthcare Will Improve in 2010
A majority of Americans support a “public option” in healthcare reform legislation, but most lack confidence that the cost, quality, value or accessibility of medical care will improve in the next year, according to a survey released today by Thomson Reuters.
Sixty percent of survey respondents said they believe a public option should be included in final healthcare reform legislation. Only about one in five, however, believes the cost, quality or value of care will improve in the next 12 months. Twenty-three percent said they expect access to care to improve.
The results are from a telephone survey of 2,999 households conducted from November 9-17 — a segment of the Thomson Reuters PULSE Healthcare Survey, the largest and longest-running survey of its kind. Each year, PULSE polls more than 100,000 U.S. households about healthcare behaviors, attitudes and utilization.
Here are the key findings:
– 18 percent of survey respondents said they expect to spend less on healthcare a year from now.
– 21 percent believe the quality of care will improve in the next 12 months.
– 18 percent believe the value of care delivered will be better in a year.
– 23 percent believe it will be easier for people to receive the care they need a year from now.
– 60 percent of Americans believe a public option should be included in final healthcare legislation. There are sharp divisions, however, along party lines: 86 percent of Democrats support the public option versus 57 percent of Independents and 33 percent of Republicans.
The survey is nationally representative and the margin of error is 1.8 percent.
Source: Thomson Reuters
Rate of confirmed AIDS in prison 2.5 times the rate in the U.S. general population
On December 31, 2008, a reported 20,606 state prisoners and 1,538 federal prisoners were HIV positive or had confirmed AIDS, the Bureau of Justice Statistics (BJS) in the Office of Justice Programs, U.S. Department of Justice, announced.
At yearend 2008, an estimated 5,672 inmates in state and federal prisons had confirmed AIDS, down from 5,762 in 2007. In 2007, about 43 per 10,000 prison inmates were estimated to have confirmed AIDS, compared to 17 per 10,000 persons in the general population.
At yearend 2008, the reported number of state and federal inmates who were HIV positive or had confirmed AIDS totaled 22,144. Among states reporting data in both 2007 and 2008, there was an increase of 145 inmates with HIV/AIDS. Of the state and federal inmates who were HIV positive or had confirmed AIDS, a reported 20,231 were men and 1,913 were women. Between 2007 and 2008, the percentage of male inmates with HIV/AIDS remained stable at 1.5 percent, while the percentage of female inmates with HIV/AIDS decreased slightly from 2.1 percent to 1.9 percent.
Florida (3,626), New York (3,500) and Texas (2,450) reported the largest number of HIV/AIDS cases. While these three states account for 24 percent of the total state custody population, together they account for 46 percent of HIV/AIDS cases in state prison. New York continues to report large decreases (down 450) in the number of HIV/AIDS cases. Notable increases between 2007 and 2008 were in California (up 246), Missouri (up 169) and Florida (up 166).
Between 1995 and 2006 the number of state inmates who died from AIDS-related causes decreased 85 percent from 1,010 to 155. Continuing the downward trend, 120 state inmates died from AIDS-related causes in 2007. Among federal inmates, 13 died from AIDS-related causes in 2008, up from 10 in 2007.
During 2008, a total of 24 states reported testing all inmates for HIV at admission or sometime during custody. Among these 24 states, 23 tested at admission, five tested while in custody, and six tested upon release. Fifty states and the federal system tested inmates if they had HIV-related symptoms or if they requested an HIV test. Forty-two states and the federal system tested inmates after they were involved in an incident in which an inmate was exposed to a possible HIV transmission, and 18 states and the federal system tested inmates who belonged to specific high-risk groups.
The report, HIV in Prisons, 2007-08 (NCJ 228307), was written by BJS statistician Laura M. Maruschak and intern Randy Beavers. Following publication, the report can be found at http://www.ojp.usdoj.gov/bjs/abstract/hivp08.htm.
Source: Office of Justice Programs – U.S. Department of Justice
Biological H1N1 Vaccines: Too little, too late
Lethality of H1N1 Virus Drops to “Non-Epidemic Resting Levels” in Current Cycle – Virus’ Infectivity Remains Increased; New Faster-Developed Synthetic Replikin Vaccines Found Effective, FluForecast(R) Gives Advance Warning of Strain-Specific Outbreaks and Cessation
Biotech firm Replikins Ltd., which has analyzed the H1N1 virus’ genomic data from the 1918 pandemic through the prediction, outbreak, and progress of the current H1N1 pandemic, today issued its latest biochemical analysis of the virus. The new data shows that the lethality of the H1N1 (“Swine Flu”) virus has dropped from its peak of 3.7 (s.d. 4.5) during the virus’s current outbreak in the spring of 2009 to resting non-epidemic levels this week of 2.0 (s.d. 0.1). The H1N1 virus’ infectivity count, however, remains increased.
The new data shows changes in the Replikin Count*, a measure of a virus’s ability to rapidly replicate. A decrease in Replikin Count has signaled the end of each of the three influenza pandemics of the last century (H1N1, H2N2, and H3N2), the end of the SARS outbreak in 2003, and the end of the H5N1 (Avian Flu) outbreak in humans in 2008 (refs).
The company issued an interim advance report of this decrease in lethality on September 30, 2009 (refs). That report has now been confirmed by the current additional Replikins data and by the recent CDC epidemiological reports of declining total hospitalizations and deaths, and declining pediatric deaths from H1N1 (refs). In April 2008, Replikins issued a warning of an impending H1N1 influenza epidemic when the virus’ Replikin Count reached levels not seen since the last H1N1 pandemic in 1918.
Without advance warning, the current biological methods of vaccine production cannot possibly meet the growing needs of a human population that today exceeds 6.7 billion. The current H1N1 Pandemic demonstrates the inherent limitations of biological vaccines, which simply do not permit the timely delivery of vaccine in sufficient quantities before a “hit-and-run” emergent viral disease like H1N1 has come and gone.
The best intentions and efforts of governments, pharmaceutical firms, and public health authorities cannot overcome the absence of advance warning, and the many months required from outbreak to delivery of the vaccine. It is becoming universally acknowledged that new vaccine technologies and methods for providing advance warning of viral outbreaks must be found.
At a meeting of the Influenza Congress USA in Washington, DC on November 19-20, 2009, Replikins chairman Dr. Samuel Bogoch presented new confirmatory evidence of two of its Replikins-based products that offer promise for advance warning of a viral outbreak and for the timely production and delivery of safe and effective vaccines. The first, called FluForecast(R), is software that has correctly provided advance warning of two flu epidemics — H5N1 (Avian Flu) and H1N1 (Swine Flu) — by counting the increase in the number of Replikins in the virus’ genes over time. For the current H1N1 pandemic, the company issued an advisory in April 2008 that forewarned its arrival one year later. With advance warning, scientists, public health officials and the pharmaceutical industry can develop, test and distribute the appropriate vaccine with enough time to avert the worst effects of emerging diseases.
Replikins Ltd. has successfully tested a second promising technology that allows for the faster development and deployment of safe and effective influenza vaccines. The company has now produced completely synthetic vaccines based on both new and conserved Replikin structures, which exclude all biological components and any contact with them. The process eliminates unwanted side effects from contaminants and the need for preservatives such as thimerosol. Synthetic Replikin vaccines made in seven days, given orally or intranasally, recently have been found independently to be effective in blocking emergent viruses including H5N1 in chickens, where it totally blocked virus excretion and thus potentially, virus reservoir formation (refs).
When asked at the Influenza Congress about the goals of Replikins Ltd., Dr. Bogoch replied: “Current biological vaccine technologies for emergent diseases are expected to provide, albeit ‘too little and too late’, approximately 125 million vaccine doses for people worldwide this fall (Klaus Stohr, Influenza Congress USA, Washington, DC, Nov. 19-20, 2009). Replikins synthetic vaccines are targeting emergent diseases in the unserved global population of over six billion people, and selected animal populations, and FluForecast(R) can give advance warning of outbreaks.
“The company has announced the formation of WorldVaccines(TM) Ltd to test and distribute these new Replikins technologies, and invites all interested public health, pharmaceutical, financial, and other institutions to join it in testing and distributing FluForecast(R) and Replikins’ synthetic vaccines against emerging diseases.”
References:
1) US Patent Office publications on Replikins 2002-2009; 2) BogochS, Bogoch,ES. Replikins: the Biochemistry of Rapid Replication, Begell House, New York, 2005; 3) Website <replikins.com> Replikins Press 2006-2009; 4) CDC Weekly Reports website (google “FluView”); 5) Betsy McKay, Wall Street Journal, page A3, November 21-22, 2009; 6) Jackwood, M. et al. Efficacy of a Replikin Peptide Vaccine Against Low Pathogenicity Avian Influenza H5 Virus. Avian Diseases, Publication Online, doi:10.1637/8892-042509-Res. Note.1; Hard copy Article In Press. July 2009.
Source: Replikins Ltd.
Experts examine possible links between climate change and infectious disease transmission
ASTMH Symposium Considers Evidence of Effects of Climate Change on Climate-Sensitive Diseases
An emerging body of evidence suggests that the changing global climate is already affecting infectious disease transmission patterns. As noted in a symposium at the 58th annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), such changes are expected to have a profound impact on global public health.
“There is concrete evidence that the global climate is changing, and these changes are expected to greatly impact human health as surface temperatures rise, agricultural belts shift, and extreme weather events become more commonplace,” observed Mary H. Hayden, Ph.D. of the National Center for Atmospheric Research (NCAR) in Boulder, CO. “Although most scientists agree that climate change is underway, the role it plays in infectious disease transmission is still in contention. The evidence presented today suggests that climate change will exacerbate the challenges of controlling infectious diseases in the developing world.”
The aim of the symposium, “Changing the Climate: A Data-Driven Discussion About Climate,” was to address the use, utility, and limitations of weather and climate models toward a goal of providing data-driven evidence of the links between weather, climate, specific pathogens and ultimately, human health. The symposium included several evidence-based presentations by speakers from the US Centers Disease Control and Prevention (CDC) and Columbia University’s International Research Institute on the established effects of climate variability/change on specific climate-sensitive diseases such as meningitis, malaria, plague and other vector-borne bacterial pathogens.
“Climate change is expected to impact global health through a variety of factors including greater heat stress, air pollution, respiratory disease exacerbation, and changes in the geographic distribution of vector-, food- and water-borne disease,” commented Dr. Hayden, who is one of the three (Dr. Emily Zielinski-Gutierrez (CDC) and Dr. George Luber (CDC)) program coordinators of a joint NCAR/US Centers for Disease Control and Prevention postdoctoral fellowship combining public health applications and climate science. “The complexity of such influences requires that the next generation of climate and health scientists undergo training to ensure that they can address climate-related public health challenges. Such preparation will be critical as the population of at-risk individuals continues to grow.”
“We are moving into the age of ‘decision-making’ with regard to climate change after decades of focusing on reducing uncertainties in attribution and prediction,” added NCAR Director Eric J. Barron, Ph.D., who discussed the potential use of available weather and climate models in health forecasting. “Health has huge potential and should be first in line for greater investment to improve the decision-making process because of its clear ties to weather and climate. Whereas the medical community has tended to respond in a ‘point-of-service’ manner – reacting to incoming cases with almost no discipline of forecasting – health/climate forecasting has real potential if we can design monitoring algorithms or a robust predictive capability.”
“The changing climate will likely bring infectious diseases to the forefront of the public health consciousness in the years and decades to come,” said Thomas Wellems, MD, Ph.D., president of ASTMH. “We salute the NCAR and its research scientists for drawing attention to this growing challenge, which can only be met through concerted effort by the global community.”
Source: The American Society of Tropical Medicine and Hygiene
Military study shows prevention of Novel A/H1N1 virus infection is vaccine-type and age-dependent
Both Live, Attenuated Influenza Vaccine (LAIV) and Trivalent Inactivated Vaccine (TIV) provide Protection against novel A/H1N1, especially against severe disease
Immunization with either live attenuated influenza vaccine (LAIV, also known as FluMist®), or trivalent inactivated influenza vaccine (TIV), appears to offer a protection (~ 45%) against the novel A/H1N1 virus, the cause of the present influenza pandemic. However, the benefit was largely attributed to the youngest age group. The finding emerges from an evaluation of medical encounters and seasonal influenza immunization of U.S. military service members.
As reported today in a Late-Breaker presentation at the 58th annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), seasonal influenza vaccination also appears to offer higher protection against severe disease requiring hospitalization (~ 62%, 95% confidence interval [CI], 14% to 84%) than against milder infections that can be treated on an outpatient basis (~ 42%, 95% CI, 29% to 53%).
“The increasing momentum of the H1N1 pandemic underscores the need for vaccination, yet there is a wide variance in vaccine effectiveness depending on the strain-match for a particular season,” comments Col. (Ret.) Jose L. Sanchez, MD, MPH, of the Armed Forces Health Surveillance Center (AFHSC) in Silver Spring, Maryland.
Dr. Sanchez and colleagues conducted a case control analysis of influenza-related medical encounter data of U.S. military service members, compared to a control group of personnel with acute, non-respiratory illnesses. For the period of April-October 2009, a total of 1,205 cases of pandemic H1N1 2009 infections were reported, of which 966 (80%) were among males and more than one-half (58%) were among those younger than 25 years. The overall vaccine effectiveness (VE) for service members was found to be 45% (95% confidence interval [CI], 33% to 55%). Immunization with prior season’s TIV (VE=37%; 95% CI, 23% to 49%) as well as LAIV (VE=22%; 95% CI, 1% to 38%), were found to be protective.
Interestingly, and unexpectedly, the investigators observed a U-shaped relationship of VE with age stratification. VE was high in the youngest (< 25 yo) and oldest (> 39 yo) service members (50% and 55% respectively), while there was noVE for those 25 to 39 years of age.
“These data highlight the need for concise, timely assessments of influenza vaccine effectiveness against the new A/H1N1 as well as seasonal strains,” notes Thomas Wellems, MD, PhD, president of ASTMH. “Although the United States military constitutes a highly immunized population that may not be generalizable to civilians, it offers unique cohorts of at-risk individuals that can be studied in randomized clinical trials. We look forward to further data from this population.”
“These findings suggest that while prior season’s influenza vaccine may not prevent infection or developing illness once infected, it certainly appears to protect against more severe outcomes. We may also be seeing a cross-protective effect resulting from natural influenza infections and/or prior influenza immunization in the military setting,” says Dr. Sanchez. “This may play a role in conferring a certain degree of ‘immunological priming.”
“Continued timely assessment of influenza vaccine effectiveness among military personnel is a top priority for us at the AFHSC. At the very least, our results will assist health officials in the military and Department of Defense in guiding future policy on seasonal and novel A/H1N1 vaccine use among military service members and dependents,” Dr. Sanchez concludes.
Source: The American Society of Tropical Medicine and Hygiene
Survey shows that Americans lack significant knowledge of age-related vision problems
Macular degeneration and glaucoma among the top areas Americans have the most misunderstanding according to the American Optometric Association
It’s a fact of life that eyes change with age, and baby boomers – Americans born between 1946 and 1964 – are at the stage when many are affected by vision problems. Despite the prevalence of Americans affected by these changes, a new survey from the American Optometric Association (AOA) shows a concerning lack of public knowledge and misunderstanding regarding age-related eye diseases and conditions.
According to the AOA’s American Eye-Q® survey, which assesses public knowledge and understanding of issues related to eye and visual health, only 18 percent of Americans know that macular degeneration is the leading cause of blindness in adults 65 years of age and older, and less than a quarter of all Americans understand the effects of glaucoma. Even more concerning, 89 percent of Americans incorrectly believe that glaucoma is preventable, when in fact it is only treatable if caught early.
Americans who are 40 years of age or older have probably noticed changes in vision. Difficulties seeing clearly for reading and close work are among the most common problems adults develop between the ages of 41 to 60. According to the Eye-Q® survey, top concerns about the effects of vision problems include not being able to live independently, cited by 45 percent; not being able to see loved ones, 21 percent; being unable to read, 20 percent and losing the ability to drive, 11 percent.
“When left undetected and untreated, many age-related eye diseases can damage your vision permanently,” said Mark Wilkinson, O.D., Chair of the AOA’s Vision Rehabilitation Section. “The good news is that most people can preserve their vision with proper treatment, so the key is early detection.”
Age-related vision disorders baby boomers and seniors should be aware of include:
– Age-related macular degeneration (AMD) – an eye disease that causes loss of central vision. Activities like reading, driving, watching TV and recognizing faces all require clear central vision.
– Diabetic retinopathy – a condition occurring in people with diabetes, which causes progressive damage to the retina, the light-sensitive lining at the back of the eye. If left untreated, it can cause blindness.
– Cataracts – a cloudy or opaque area in the clear lens of the eye. Usually cataracts develop in both eyes, but one may be worse than the other. Cataracts can cause a decrease in contrast sensitivity, a dulling of colors and increased sensitivity to glare.
– Glaucoma – a group of eye diseases characterized by damage to the optic nerve resulting in peripheral vision loss. People at higher risk of developing glaucoma include those with a family history of the disease, older adults, African-Americans and Hispanics.
– Dry eye – a condition where there is an insufficient amount of tearsor a poor quality of tears to lubricate and nourish the eye. Tears contribute to clear vision and the health of the front surface of the eye.
– Retinal detachment – tearing or separation of the retina from the underlying tissue. This can be caused by trauma to the eye or head, health problems due to advanced diabetes, and inflammatory disorders of the eye.
The good news is the majority of the American Eye-Q® survey respondents (92 percent) understand that visiting an eye doctor on a regular basis for comprehensive eye exams can help reduce the risk of developing age-related vision problems. The bad news is that respondents were less aware that avoiding smoking (40 percent) and eating a low-fat, low-salt diet (30 percent) can also reduce age-related vision problems.
“Some common warning signs of age-related vision problems include fluctuating vision, seeing floaters or flashes of light, loss of side vision and seeing distorted images,” said Dr. Wilkinson. “However, often patients with eye diseases do not have recognizable symptoms until the conditions are quite advanced, so regular comprehensive eye exams are essential for baby boomers and seniors.”
Addressing Age-Related Vision Problems
The American Eye-Q® survey also revealed that respondents age 55 and older are taking steps to address their age-related vision problems. Thirty three percent said they limit their night driving; 27 percent use brighter lights; 24 percent use wetting eye drops or artificial tears and 18 percent purchase or request items in large print.
Adding certain nutrients to one’s diet every day – either through foods or supplements – can help preserve vision and prevent age-related eye diseases.
The AOA recommends the following eye-healthy nutrients and foods:
– Lutein and zeaxanthin: Colorful fruits and vegetables such as broccoli, spinach, kale, corn, green beans, peas, oranges and tangerines
– Essential fatty acids: Fatty fish like tuna, salmon, or herring;
whole-grain foods; chicken and eggs
– Vitamin C: Fruits and vegetables, including oranges, grapefruit, strawberries, papaya, green peppers and tomatoes
– Vitamin E: Vegetable oils, such as safflower or corn oil; almonds and pecans; sweet potatoes and sunflower seeds
– Zinc: Extra-lean red meat, poultry, liver, shellfish, milk, baked beans and whole grains
Dealing with Vision Loss
Comprehensive eye exams are important for Americans of all ages, but become especially important later in life when more Americans develop age-related conditions and begin taking medications more frequently. The AOA recommends that adults over age 60 have a comprehensive eye examination by an optometrist once a year or more frequently if a doctor recommends it.
For patients with age-related vision loss, a specialized examination by an optometrist who treats vision impairment is a critical first step in the care process that focuses on maintaining and/or regaining independence and maximizing useful remaining vision. Prescribed treatment options commonly include specialized reading spectacles, spectacle-mounted telescopes, hand-held magnifiers and telescopes, therapeutic filters, specialized contact lenses, field enhancement treatments, and video magnification technology that both enlarge and enhance the contrast of reading materials.
There also are numerous other assistive products that can help with daily activities for people who have vision impairment, such as large-type books, magazines, and newspapers, books-on-tape, talking wristwatches, self-threading needles, and more. To learn more about vision rehabilitation and available treatment options, talk to an optometrist.
For additional information about aging eyes or to find a doctor of optometry in your area, please visit www.aoa.org.
About the survey:
The fourth annual American Eye-Q® survey was created and commissioned in conjunction with Penn, Schoen & Berland Associates (PSB). From May 21 – 24, 2009, using an online methodology, PSB interviewed 1,000 Americans 18 years and older who embodied a nationally representative sample of U.S. general population. (Margin of error at 95 percent confidence level.)
Source: American Optometric Association