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GE3LS Digest - January 16, 2009

Collins Dominates Rumor Mill for NIH Director – January 2, 2009
http://blogs.sciencemag.org/scienceinsider/2009/01/collins-dominat.html
Francis Collins, former director of the National Human Genome Research Institute in Bethesda, Maryland, appears to be the top contender for the post as President-elect Barack Obama's director of the National Institutes of Health (NIH). Collins, buttonholed today at a meeting of one of the Obama transition teams, answered "no comment" when asked if he aspired to the post. But Alan Trounson, head of the California Institute for Regenerative Medicine in San Francisco, admitted to Science: "That's the name I've heard most often." Collins and Trounson were among the scientists and disease advocates at the meeting of Obama's agency review team for the Department of Health and Human Services.

What’s Race Got to Do With It? Nine clinical trials around the world are studying treatments in groups defined by race, gender or both:  – January 3, 2009
http://www.newsweek.com/id/177737
It is the question that almost never gets raised in polite company, although almost everyone has an opinion about it. Often, in fact, two opinions, one public and one private. There are many ways of asking it, but perhaps the most neutral way is: what, if any, are the significant genetic differences between racial groups, besides the obvious superficial ones, such as skin color, that we use to define "race" in the first place? That sentence took me a half hour to compose, and I hope I got it right, because this is as touchy a subject as there is in America, or most other countries with populations of mixed ancestry. For decades, it was virtually a closed question in academia, where the reigning scientific paradigm, expressed by Harvard geneticist Richard Lewontin in 1972, held that almost all the variation in the human genome represented differences between individuals. This notion fit well with the social consensus that the question was better not asked, because it could lead toward racial comparisons that almost invariably end badly for one group or another. And there the matter might have rested, but for the march of medical progress, which has been accumulating data on the differential health risks and drug responses of population groups.

Danforth Plant Science Center Receives Grant From The Gates Foundation
- To Establish New Program To Ensure The Safety Of Nutritionally Enhanced Crops – January 5, 2009
http://www.agbioworld.org/newsletter_wm/index.php?caseid=archive&newsid=2843
The Donald Danforth Plant Science Center was recently awarded a $5.4 million grant from the Bill & Melinda Gates Foundation as part of the Grand Challenges in Global Health initiative which seeks to identify and direct funds to the most critical scientific challenges in global health. Funds will be used to create and manage a BioSafety Resource Network (BRN) to support four project teams conducting research under Grand Challenge #9 (GC9) which focuses on the use of appropriate technologies to increase nutrients in local crops in a socially and culturally acceptable way. Results of this research will ultimately be shared with developing countries throughout the world where malnutrition is prevalent. The BioSafety Resource Network will be managed by Dr. Paul Anderson, executive director of International Programs at the Danforth Center. He will be assisted by Dr. Hector Quemada, (Calvin College, MI) who will serve as project director and Dr. Mark Halsey - formerly research Director at the United Soybean Board - who will serve as assistant director. Drs. Quemada and Halsey have many years of experience in biosafety and regulatory science related to genetically modified crops. Reducing death and disease related to malnutrition and infection caused by nutrient poor diets depends on giving farmers access to more nutritious crops so they can build healthier lives for themselves and their families. The GC9 projects work to provide combinations of micronutrients, vitamins and essential amino acids in a bioavailable form in local crops such as rice, sorghum, cassava and bananas, or to enhance energy density and improve protein quality in such foods. Farmers would only have the opportunity to grow GC9 biofortified crops to feed their families or sell in markets after a rigorous process of research, testing, product development and regulatory approval. Efficacy, safety and regulatory concerns must be thoroughly and systematically addressed for each crop. The goal of the BRN is to ensure that research projects address quality assurance, biosafety science and regulatory science requirements.

My Genome, My Self – January 7, 2009
http://www.nytimes.com/2009/01/11/magazine/11Genome-t.html?_r=1&ref=health
One of the perks of being a psychologist is access to tools that allow you to carry out the injunction to know thyself. I have been tested for vocational interest (closest match: psychologist), intelligence (above average), personality (open, conscientious, agreeable, average in extraversion, not too neurotic) and political orientation (neither leftist nor rightist, more libertarian than authoritarian). I have M.R.I. pictures of my brain (no obvious holes or bulges) and soon will undergo the ultimate test of marital love: my brain will be scanned while my wife’s name is subliminally flashed before my eyes.
Skip to next paragraph Last fall I submitted to the latest high-tech way to bare your soul. I had my genome sequenced and am allowing it to be posted on the Internet, along with my medical history. The opportunity arose when the biologist George Church sought 10 volunteers to kick off his audacious Personal Genome Project. The P.G.P. has created a public database that will contain the genomes and traits of 100,000 people. Tapping the magic of crowd sourcing that gave us Wikipedia and Google rankings, the project seeks to engage geneticists in a worldwide effort to sift through the genetic and environmental predictors of medical, physical and behavioral traits.

FDA Mulls OK for Blood Thinner From Genetically Engineered Goats – January 9, 2009
http://health.usnews.com/articles/health/healthday/2009/01/09/health-highlights-jan-9--2009.html?PageNr=2
The U.S. Food and Drug Administration is moving closer to approval for an anti-clotting drug made from the milk of genetically engineered goats, the Associated Press reported Wednesday. Called ATryn, the drug was developed by GTC Biotherapeutics, a Massachusetts biotech company, by altering goat genes to produce milk rich in antithrombin, a protein that acts as a natural blood thinner in humans. ATryn has already been approved in Europe, and FDA advisers are expected to meet Friday to make a recommendation on approval. The FDA will then make the final decision, the news service said. "It's the first time we've held an advisory committee meeting on any product from a genetically engineered animal," FDA spokeswoman Siobhan DeLancey told AP. If the drug is approved, DeLancey added, the agency may require follow-up monitoring to insure patients' immune systems don't make antibodies to the medication.
About 1 in 5,000 people don't produce enough antithrombin, putting them at risk of developing painful blood clots that can break loose and travel through the bloodstream to the lungs or the brain, AP reported. Pregnant women with the disorder are at high risk of miscarriage or stillbirth because of blood clots in the placenta.

Revolutionary stem cell therapy boosts body's ability to heal itself – January 8, 2009
http://www.guardian.co.uk/science/2009/jan/08/stem-cells-bone-marrow-heart-attack
A groundbreaking medical treatment that could dramatically enhance the body's ability to repair itself has been developed by a team of British researchers. The therapy, which makes the body release a flood of stem cells into the bloodstream, is designed to heal serious tissue damage caused by heart attacks and even repair broken bones. It is expected to enter animal trials later this year and if successful will mark a major step towards the ultimate goal of using patients' own stem cells to regenerate damaged and diseased organs. When the body is injured, bone marrow releases stem cells that home in on the damaged area. When they arrive, they start to grow into new tissues, such as heart cells, blood vessels, bone and cartilage. Scientists already know how to make bone marrow release a type of stem cell that can only make fresh blood cells. The technique is used to collect cells from bone marrow donors to treat people with the blood cancer leukaemia.

Health Canada yet to respond to expert calls for better nanotechnology regulations – January 9, 2009
http://www.cbc.ca/cp/health/090109/x010904A.html
 Scientists and academics say Canada urgently needs to assess the potential health and environmental risks of tiny particles being used in a growing number of consumer products, but lacks the research funding and regulatory tools to do the job.
The good: If developed safely, nanomaterials and nanotechnologies - the almost mythical science involving the manipulation of atomic and molecular-sized matter - could someday revolutionize the economy and improve our quality of life.  The bad: Canada doesn't have a single regulation on nanomaterials on the books. It doesn't have a nanotechnology strategy or a list of the nanomaterials that have been developed. Scientists don't even have a standard system of measuring these materials which can be 100,000 times smaller than the diameter of a human hair.  What's happening now: A panel of nanotechnology experts has recommended that Canada should create a special regulatory classification for nanomaterials and standards of measuring these effects and properties should also be developed.

She may never get breast cancer - but girl's birth raises new doubts over designer babies – January 10, 2009
http://www.guardian.co.uk/science/2009/jan/10/pgd-baby-debate-breast-cancer
The birth of the first British baby genetically screened before conception to be free of a breast cancer gene was hailed yesterday as a breakthrough by doctors but raised fresh questions about the ethics of creating so-called designer babies. The baby girl grew from an embryo screened to ensure that it did not contain the faulty BRCA1 gene, which would have meant she had a 50%-85% of developing breast cancer. While mother and daughter were said by a spokesman at University College hospital, London, to be doing "very well" following the birth at this week, medical experts and those involved in cancer research were considering the implications.

Biotech Bash Opens Under Cloud – January 12, 2009
http://blogs.wsj.com/health/2009/01/12/biotech-bash-opens-under-cloud/
The invitation-only shindig that Hambrecht & Quist made into an annual must-attend biotech money hunt gets rolling today. H&Q and the meeting have been under J.P. Morgan’s growing umbrella for a decade now. And it would be hard to imagine gloomier times for the get-together in that period, or, for that matter, since Genentech and the biotech industry took root more than 30 years ago, the WSJ reports. About 300 companies, most of them small and many closely held, will be making their pitches for money. There’s a whiff of desperation in the air, as “an atypically large number of the companies are down to their last few months of cash,” the WSJ reports. Some 120, or almost one-third of publicly traded biotech companies, have less than six months’ cash on hand, according to the trade group BIO. Financing is going to be a tough sell. Randy Scott, chairman of Genomic Health, a maker of cancer tests that, happily, isn’t looking for cash, told the Journal: “If people don’t want to buy bonds in General Electric, what’s going to make them want to invest in an early-stage biotech company?”

NHGRI to Fund Genomics ELSI Centers – January 12, 2009
http://www.genomeweb.com/nhgri-fund-genomics-elsi-centers
The National Human Genome Research Institute has set aside $3.9 million in funding for 2010 to create several cross-disciplinary centers that will study the ethical, legal, and social implications of genomics technologies. To that end, the agency said it plans to launch a new funding program to support the effort, and will give grants of up to $750,000 per year for five years to fund as many as three specialized centers and exploratory centers and up to $150,000 per year for three years for three exploratory research projects. NHGRI wants these Centers for Excellence in Ethical, Legal and Social Implications Research, to be called CEERs, to fund research teams trying to integrate basic genomics, clinical and health policy research, ethics, law, the humanities, and other areas. The teams will be able to research and respond to "a range of ELSI issues related to emerging genome technologies and the growing proliferation of genomic information," according to the National Institutes of Health's funding announcement.

Public consultation launched on draft fertility regulations – January 12, 2009
http://www.ivf.net/ivf/public_consultation_launched_on_draft_fertility_regulations-o3932.html
Following the granting of Royal Assent to the UK's Human Fertilisation and Embryology Act in November 2008, the Department of Health has launched a public consultation on draft regulations to implement the Act. While certain aspects of the Act's provisions will come into force as early as April 2009, other provisions may not come into force until sometime in 2010, and the majority of provisions will come into force in October 2009.
The consultation document (available from the Department of Health website) solicits feedback on 10 specific proposals embodied in 85 draft regulations. These proposals and regulations fall into four broad categories - 'storage period for embryos and gametes'; 'procedure for revocation, variation or refusal of licences'; 'appeals'; and 'disclosure of information for research purposes'.The first category, 'storage period for embryos and gametes', concerns circumstances in which embryos and gametes might be frozen for longer than has previously been permitted. Respondents are asked whether the same criteria should apply to embryos as to gametes; whether extended freezing should be permitted in cases of premature infertility (for example in children) and in cases involving embryo or gamete donation or surrogacy; and whether the extended period should be for a set time period rather than an age limit.

Single gene fuels overeating risk – January 12, 2009
http://news.bbc.co.uk/2/hi/health/7820042.stm
Scientists have produced more evidence that carrying the wrong variant of a single gene can raise the risk of overeating and obesity. Several studies have suggested that carrying one of two variants of the FTO gene make overeating more likely.  A University College London team found children carrying one or two of these variants were more likely to binge on biscuits after eating a meal.  The study appears in the International Journal of Obesity. The researchers hope their work will shed more light on why some children become overweight or obese. They believe a greater understanding of the impact of specific genes paves the way for new therapies to minimise their effect. It is thought that more than half the European population carries at least one of the two key FTO variants.

Largest-ever study of U.S. child health begins: Hope is to see how environment interacts with genetics to impact health – January 13, 2009
http://www.msnbc.msn.com/id/28640577/
Scientists begin recruiting mothers-to-be in North Carolina and New York this week for the largest study of U.S. children ever performed — aiming eventually to track 100,000 around the country from conception to age 21. "We are embarking on the road to discovering the preventable causes of the major chronic diseases that plague American children today," Dr. Philip Landrigan of the Mount Sinai School of Medicine, one of the lead researchers, declared Tuesday. Nearly a decade in the planning, the ambitious National Children's Study tackles a major mystery: How the environment — everything from a pregnant woman's diet to a child's exposure to various chemicals — interacts with genetics to affect youngsters' health and development.

Uncertain future for hybrid research – January 13, 2009
http://news.bbc.co.uk/2/hi/health/7826331.stm
It sparked impassioned debate, but less than a year after parliament refused to ban hybrid human animal embryos scientists say a lack of funding means their research has been put on ice.  Condemned as "Frankenstein" science by at least one religious leader, and rejected by the majority of the Tory shadow cabinet, hybrids proved one of the most controversial aspects of the Human Fertilisation and Embryology Bill. But since the bid to outlaw the research was defeated in May last year, two of the three groups which hold a license to create hybrid embryos have been unable to find funding, while the third has yet to try.  Human animal hybrid embryos - in which the nuclei of human cells are inserted into animal eggs - have been seen as one of the most promising ways of overcoming the dramatic shortage of good quality human eggs.

Nanotech in your vitamins – January 14, 2009
http://www.physorg.com/news151160447.html
The ability of the Food and Drug Administration (FDA) to regulate the safety of dietary supplements using nanomaterials is severely limited by lack of information, lack of resources and the agency's lack of statutory authority in certain critical areas, according to a new expert report released by the Project on Emerging Nanotechnologies (PEN).
The report, A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, details the main problems at FDA in regulating nano-enabled dietary supplements and offers a host of recommendations for improving oversight of such products. "Historically, the regulation of dietary supplements has been a significant challenge for FDA, and the fact that some of those products are now being manufactured using nanotechnology creates an additional layer of complexity," says William B. Schultz, a co-author of the report and a former FDA official.

KDEL-tagged scFv antibody expression in tobacco roots – January 14, 2009
http://greenbio.checkbiotech.org/news/kdel_tagged_scfv_antibody_expression_tobacco_roots
Plant molecular farming: Genetically engineered crops have been one of the most rapidly adopted technologies in the history of agriculture, and recently transgenic crops have been successfully exploited for the expression of pharmaceuticals, industrial enzymes, functional proteins, fine chemicals, and other important metabolites, representing the growing business of plant molecular farming. In the past 30 years it has been possible to transform plants to improve their agronomic qualities and enhance their nutritional value. More recently it has also been possible to use plants as innovative factories for the production of biopharmaceuticals such as drugs, antibodies, hormones, enzymes, blood proteins, and vaccines. The number of small companies, universities, and research centers that are at present investing in this field is in fact increasing rapidly worldwide, as it is recognized that plant made-pharmaceuticals, PMPs, can offer numerous benefits, including inexpensive production and biological safety. A wide range of host systems has been examined for large-scale production of recombinant proteins. Compared to the traditional bacterial and yeast cell-cultures, plants, seeds, and cultured plant cells represent one of the most economical and promising systems for the biochemical, veterinary, and pharmaceutical industries. In fact, several plant systems have already been tested, including aquatic plants, food and non-food crops, leafy crops, fruits, vegetables, and seeds, mostly from legumes and cereals, revealing important benefits in rapid growth, high yields, and ease of transformation1. Nonetheless, some concerns have been raised over the potential impacts of these so-called “pharma crops” upon the environment and human health. Of particular concern has been the accidental dispersal of their bioactive products, especially when food and feed crops such as maize, potato, rice, and safflower are used for PMP production.

FDA Issues Final Regulations for Genetically Engineered Animals – January 15, 2009
http://health.msn.com/medications/articlepage.aspx?cp-documentid=100231390
The U.S. Food and Drug Administration on Thursday issued its final regulations governing the approval of genetically engineered animals. The rules do not require consumer labeling for foods from these animals. Genetic engineering involves using recombinant DNA (rDNA) to introduce new characteristics or traits into an animal. The new FDA guidance tells producers of these animals what they need to do to get the newly engineered animal approved by the agency. "It serves to reassure stakeholders that FDA has clear standards for regulatory decisions on these animals allowing us, when appropriate, to bring safe, effective products to market in a timely manner," Randall Lutter, deputy commissioner for policy in the FDA's Center for Veterinary Medicine, said during a morning teleconference.
Genetically engineered animals will require FDA approval before they can enter the marketplace, Lutter said. In addition, producers of these animals will also have to comply with the law and regulations of the National Environmental Policy Act, he said.