20090715-3

United States President Barack Obama has named genome project leader Dr Francis S Collins as head of the US National Institutes of Health (NIH).

The National Institutes of Health, which is a part of the US Department of Health and Human Services, is the primary federal agency responsible for conducting and supporting medical research.  It was Dr Collins, 59, the geneticist, who discovered the causes of half a dozen diseases and supervised the US government’s efforts to map the human genome.

As the chief of the NIH, Dr Collins will oversee 27 institutes and an annual budget of about $30 billion for biological and medical research.

In 2006, Dr Collins published the famous book titled The Language of God: A Scientist Presents Evidence for Belief, in which he presented scientific evidence for a belief in God.

The appointment of Dr Francis Collins as head of the NIH, which has been widely welcomed, will make him one of the most powerful and influential scientists not only in the United States but also worldwide.

It was in 1989 that Dr Collins first attained fame when he and his colleagues at the University of Michigan announced that they had found the defective gene that causes cystic fibrosis. The team developed a technique – known as ‘positional cloning’ – that allowed researchers to scan large segments of the human genome in order to look for disease-causing genes even when they did not know the function of the genes in question.

Using that technique, Dr Collins and team identified the genes responsible for Huntington’s disease, neurofibromatosis, multiple endocrine neoplasia type 1 (a tumor of the parathyroid and pituitary glands), and the M4 type of adult acute leukemia.

In 1993, Dr Collins took over as the head of the National Human Genome Research Institute, and supervised the effort to sequence the human genome – a collection of over 3 billion bases of DNA that comprise the human blueprint.

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GoogleNews.com, WSJ.com, July 14, 2009  —  Far-left liberals are unlikely to be thrilled by President Obama’s new pick to head the National Institutes of Health. Francis Collins, leader of the Human Genome Project, is an outspoken Christian and has written a book about his faith and about reconciling science and religion.

While not part of the Intelligent Design camp (he has called the theory “interesting, but ultimately flawed”), Dr. Collins has repeatedly taken issue with the renowned atheist and biologist Richard Dawkins over the limits of naturalism and science. In his view, God created the universe 13.7 billion years ago with its “parameters tuned to allow the development of complexity over time.”

Dr. Collins’s selection certainly won’t do anything to hurt Mr. Obama’s effort to improve his rapport with Christian conservatives. Allaying liberals’ fears, however, the new appointee also will have no impact on the issue of human embryonic stem cell research since the administration lifted President Bush’s limits on stem cell research in March.

All this is in keeping with other relatively cost-free Obama gestures, like recruiting Reverend Rick Warren for his inauguration and speaking to the graduates at Notre Dame. Adored by both the scientific and Christian communities, Dr. Collins epitomizes the ideological centrism that Obama officially extols but has been hard to find in his policies. Best of all from the liberal perspective, Dr. Collins will have virtually no political clout.

Allysia Finley

GoogleNews.com, July 14, 2009  —  President Obama’s nomination of Francis Collins to be director of the National Institutes of Health has resulted in pro-life advocates expressing concerns about the views regarding unborn life held by the world-renowned scientist and evangelical Christian.

Collins, 59, is probably best known for his leadership of the Human Genome Project, the 13-year program that identified all of the roughly 20,000 to 25,000 genes in human DNA.

In announcing his intention to nominate Collins, the president described him as “one of the top scientists in the world,” adding “his groundbreaking work has changed the very ways we consider our health and examine disease.”

In recent years, Collins has spoken and written about the relationship between Christianity and science, including in the best-selling book “The Language of God: A Scientist Presents Evidence for Belief.” He has sought to harmonize science and Christian faith and has endorsed a version of theistic evolution he calls BioLogos rather than a six-day creation or intelligent design.

Since Obama announced Collins’ nomination July 8, some evangelical and pro-life spokesmen have taken issue with the nominee’s comments about embryonic stem cell research and cloning.

A Southern Baptist philosophy professor at Union University said Collins needs to make his views clear before he takes over as director of the National Institutes of Health (NIH), which oversees federal funding of embryonic stem cell research (ESCR). Extraction of stem

cells from an embryo requires the destruction of a tiny human being less than a week old.

Collins was mistaken or misleading in comments about Obama’s position on federally funded embryonic stem cell research, said Justin Barnard, associate professor of philosophy and director of the Carl F.H. Henry Institute for Intellectual Discipleship at Union University in Jackson, Tenn.

At Obama’s direction, NIH issued final regulations July 6 governing federal funding of stem cell research. In a May interview Collins said Obama’s position “is not very radical” because Obama basically said “what Bush said in August of 2001” when the former president announced his policy. But that is not the case, Barnard says. The new NIH guidelines allow research not only on lines that were in existence when Obama made his announcement but new stem cell lines, Barnard wrote in a July 13 commentary for Public Discourse (www.thepublicdiscourse.com). Obama’s position in fact is a “dramatic shift” from Bush’s, Barnard said.

In these and other comments, Collins “is less than clear” regarding “the metaphysics and moral value of human life,” Barnard wrote.

Meanwhile, Collins appears to support therapeutic cloning for research purposes while opposing reproductive cloning with the intent of producing a born child.

In “The Language of God,” Collins says the “immediate product” of cloning, or somatic cell nuclear transfer, falls “short of the moral status of the union of sperm and egg,” Barnard wrote. The problem with this comment, Barnard said, is a “cloned human embryo, no less than a human embryo produced by the union of , is an embryonic human. That is a matter of biological fact that Collins conveniently shuffles off stage,” Barnard said.

The NIH guidelines prohibit federal grants for research on stem cell lines produced by cloning.

David Prentice, senior fellow for life sciences at the Family Research Council, expressed more certainty about Collins’ stem cell views, telling Religion News Service, “Francis is a great person, a good scientist, but we disagree with his positions on human embryonic stem cell research and on cloning human embryos for experimentation.”

Barnard wrote, “Collins needs to come clean. Either he upholds the dignity of human life or he doesn’t. If he does, and he accepts the nomination to lead the NIH, then it seems that he is deeply compromised as a professing evangelical Christian. If he does not, then the evangelical community needs to know. For his appointment to this position has the potential to cause great harm in the way of moral confusion to many unsuspecting evangelicals as long as his views on nascent human life remain veiled behind a cloud of sophistical rhetoric.”

Because of their ability to develop into other cells and tissues, stem cells provide hope for producing cures for a variety of diseases.

Many scientists have promoted embryonic stem cell research because stem cells from embryos are pluripotent, meaning they can transform into any cell or tissue in the body. But the research has yet to provide treatments for human beings and has been plagued by the development of tumors in lab animals.

Human trials using stem cells from non-embryonic sources, however, have produced therapies for at least 73 ailments in human beings, despite the fact such cells are not considered pluripotent, according to Do No Harm, a coalition promoting ethics in research. Among the afflictions treated by non-embryonic cells are cancer, juvenile diabetes, multiple sclerosis, heart damage, Parkinson’s, sickle cell anemia and spinal cord injuries, according to Do No Harm.

Extracting non-embryonic stem cells does not harm the donor.

Collins served as director of the National Human Genome Research Institute at NIH from 1993 to 2008.

HHS:  For Immediate Release

HHS Purchases Additional H1N1 Vaccine Ingredients

HHS Secretary Kathleen Sebelius announced today that the department will commit $884 million to purchase additional supplies of two key ingredients for potential H1N1 vaccine to further prepare the nation for a potential resurgence of the 2009 H1N1 virus.  

“We recognize that preparedness is shared responsibility between federal, tribal, state, local governments, private organizations and individuals. We are doing our part to be as prepared as possible for the impact that this infectious disease could have on our country,” Secretary Sebelius said. “Vaccines may serve an important role in that preparedness. The action we are taking today will provide flexibility in a future immunization program, if a program is recommended.”

The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts with Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. The vaccine ingredients will become a part of the pandemic stockpile, for use if a vaccination campaign is necessary.

Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvant could be added to a vaccine to boost the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

In May, Secretary Sebelius directed approximately $1 billion to be used for the development of a vaccine and for clinical studies to determine dose level and assess the safety and effectiveness of potential vaccines. 

The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response established the existing contracts with these companies in 2004 as part of the National Strategy for Pandemic Influenza.

 

Fact Sheet

 

Overview

The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines.

A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

HHS Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of 2009 H1N1 Influenza Vaccine Antigen and Adjuvant

Manufacturer

Bulk Vaccine Antigen

Oil-In-Water Bulk Adjuvant

Novartis $150 million $139 million
GlaxoSmithKline $ 38 million $144 million
Sanofi Pasteur $191 million  
CSL Biotherapies $180 million  
MedImmune $ 90 million  
Total $649 million $283 million

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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Center for Research Resources (NCRR) 

For Immediate Release: Tuesday, July 14, 2009

Seven Institutions to Receive $171 Million Over 5 Years to Help Researchers Turn Laboratory Discoveries into Treatments for Patients 

Clinical and Translational Science Awards (CTSAs) will be made to seven more academic health centers, bringing the consortium to 46 member institutions, the National Center for Research Resources (NCRR), part of the National Institutes of Health, announced today. This national network of medical research institutions is working to accelerate the process that develops laboratory discoveries into treatments for patients, to engage communities in clinical research and to train a new generation of clinical and translational researchers. 

The NCRR also released the first progress report outlining the impact of the CTSA program in its first two years.

Launched in 2006, this network now includes awardees in 26 states. When the program is fully implemented, it will support approximately 60 CTSAs across the nation.

 “As the world’s largest public funding agency for clinical research, it is imperative that the NIH promote scientific innovation and collaboration,” said NIH Acting Director Raynard Kington, M.D., Ph.D. “The CTSA consortium exemplifies this approach by bringing together resources and expertise to translate new research discoveries into tangible benefits for the American people.”

The first CTSA progress report released today highlights the innovations, collaborations and partnerships that emerged from the CTSA consortium from 2006 through 2008. Included are summaries of how CTSAs are enabling researchers to work in unprecedented ways to advance medical research across many disease areas and conditions, including cancer, neurological diseases, cardiovascular disease, diabetes and obesity. To view the full report, visit <www.ncrr.nih.gov/ctsa/progress_report_2009>.

The institutions receiving new CTSA funding include:

— Medical University of South Carolina (Charleston)
— Mount Sinai School of Medicine (New York City)
— New York University School of Medicine (New York City)
— University of Arkansas for Medical Sciences (Little Rock)
— University of Florida (Gainesville)
— University of Illinois at Chicago
— University of Texas Medical Branch (Galveston)

View descriptions of the CTSA awardees at <www.ncrr.nih.gov/ctsa2009>.

These seven institutions join the University of Cincinnati, announced earlier this year, as the 2009 CTSA recipients. The 2009 CTSA grants expand state representation in the consortium to Arkansas, Florida and South Carolina.

“Now in its third year, the momentum behind the CTSA consortium continues to build as membership expands across the nation,” said NCRR Director Barbara Alving, M.D. “The CTSA institutions provide opportunities for clinical and basic researchers to train and work as interdisciplinary teams which are now essential for developing and delivering new treatments and prevention strategies.”

Since its launch in 2006, the consortium is:
— training researchers to master the complexities of clinical and translational research through nationally recognized degree-granting programs;
— leveraging CTSA resources to expand research and training opportunities in underserved states and communities;
— assembling interdisciplinary teams that include but are not limited to basic scientists, biologists, clinical researchers, dentists, veterinarians, nurses, pharmacists, biomedical engineers and geneticists;
— partnering with researchers at minority institutions to enhance outreach to underserved populations, local community and advocacy organizations, and health care providers;
— identifying best practices to improve clinical research informatics tools to analyze research data and manage clinical trials;
— designating technologies for marketing and licensing purposes that will increase global access to research tools; and
— forging new partnerships with private and public health care organizations, including pharmaceutical companies, Departments of Veterans Affairs hospitals, and health maintenance organizations, as well as state health agencies.

A fifth funding opportunity announcement for CTSAs is available, calling for the next round of applications to be submitted by Oct. 14, 2009, with the awards expected in July 2010. For more information about this funding announcement, see <www.ncrr.nih.gov/crfunding>.

For more information about the CTSA program, visit www.ncrr.nih.gov/ctsa. The CTSA consortium Web site, which provides information on the consortium, current members and new grantees, can be accessed at CTSAweb.org.

The National Center for Research Resources, part of NIH, provides laboratory scientists and clinical researchers with the resources and training they need to understand, detect, treat and prevent a wide range of diseases. NCRR supports all aspects of translational and clinical research, connecting researchers, patients and communities across the nation. For more information, visit <www.ncrr.nih.gov>.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH and Wikimedia Foundation Collaborate to Improve Online Health Information                              

U.S Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News

For Immediate Release: Tuesday, July 14, 2009

The National Institutes of Health and the Wikimedia Foundation, the nonprofit organization that operates the Wikipedia(r) online encyclopedia, are joining forces to make health and science information more accessible and reliable. This collaboration is the first of its kind for both organizations.

 

“NIH works to ensure that the information it provides on science and health is of the highest quality and reaches the widest audience,” said John Burklow, NIH associate director for communications and public liaison. “We look forward to this opportunity to collaborate with the Wikimedia Foundation and participate in a resource that is used by millions of people around the world.”

 

On July 16, NIH will host Wikimedia staff and volunteers working in the sciences for an all-day event on its Bethesda campus. Participants will learn about the philosophy and mechanics of Wikipedia and will begin what is hoped to be a long-term dialogue aimed at improving public knowledge about health, science, and medicine. The international foundation has never before worked with a federal agency or a health sciences institution.

 

“Wikipedia Academies are public outreach events, usually lasting one or two days, aimed at engaging academics and other subject-matter experts who are not familiar with wiki culture or online communities,” said Frank Schulenburg, head of public outreach for the Wikimedia Foundation. “In presentations and workshops, experienced Wikipedia authors teach the participants how to contribute to Wikipedia and orient the audience to Wikipedia’s structures and community policies.”

 

“We’re incredibly excited about our first official Wikipedia Academy in the United States,” said Sue Gardner, executive director of the Wikimedia Foundation. “With the broad range of experts from the National Institutes of Health, we see a great opportunity for increasing the quality of all health-related information on Wikipedia, benefitting users of Wikipedia from all over the world.” Wikipedia contains nearly 13.5 million articles written in over 250 languages. In May, it served over 315 million unique visitors. The site manages, on average, more than 14 million page views per hour.

 

To satisfy the public’s growing need for reliable health information, NIH and the Wikimedia Foundation want to increase the availability of accurate medical and health information available to the public. At the same time, they hope to establish strategies to interlace the distinct cultures of Wikipedia and the research community.

 

After the Wikipedia Academy, NIH subject matter experts will be able to contribute to Wikipedia and also help develop best practices for future sessions. Instructions about how to contribute, including video of the Wikipedia Academy at NIH, will be available on the NIH and the Wikipedia websites for scientists across the country.

 

Wikipedia is an international online encyclopedia written collaboratively by volunteers. For more information about Wikipedia, visit <www.wikipedia.org>.

 

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <www.nih.gov>.

By Patrick Yoest

Of DOW JONES NEWSWIRES

 

GoogleNews.com. WSJ.com, July 14, 2009  —  WASHINGTON (Dow Jones)–The Senate Health, Education, Labor and Pensions Committee approved an amendment late Monday that would protect makers of biologic drugs from competition from generic drug manufacturers for 12 years.

The drugs — which are manufactured by living cells — represent a growing segment of the pharmaceuticals industry. The committee vote on the amendment, sponsored by Sens. Orrin Hatch, R-Utah, and Mike Enzi, R-Wyo., gives the biotechnology industry a major victory.

The amendment was approved by a 16-7 vote. It is now part of a larger health-care overhaul measure expected to be approved by the committee as soon as Tuesday.

Consumer groups and AARP, the largest lobbying group for older Americans, campaigned hard for a shorter exclusivity period for the drugs. The Biotechnology Industry Organization sought at least 12 years of exclusivity.

Sen. Sherrod Brown, D-Ohio, introduced an amendment that would grant the drugs five years of exclusivity, with the possibility for an extension. Brown pointed to a Federal Trade Commission report that said that a 12- to 14-year period of exclusivity was not necessary.

But Hatch and other supporters of the 12-year amendment said a shorter exclusivity period would stifle innovation and put U.S. companies at a disadvantage to international competitors, especially those in the European Union.

The amendment passed in the committee faces an uncertain future as Congress moves forward on health-care legislation. The White House has stated that it supports seven years of exclusivity for the drugs, while House Energy and Commerce Chairman Henry Waxman, D-Calif., has proposed five years of exclusivity.

Major manufacturers of biologic drugs include Amgen, Inc. (AMGN) and Johnson & Johnson (JNJ).

-By Patrick Yoest, Dow Jones Newswires;                202-862-3554        ; patrick.yoest@dowjones.com

Serious HealthCare Issues – Part One

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Serious HealthCare Issues – Part Two

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