Posts Tagged ‘wellness’

Philadelphia Sports Extravaganza & Wellness Expo

Saturday, February 14th, 2009

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The Philadelphia Expo Center is in Oaks, PA. There are plenty of exhibitors and special events. Find health food and drinks, watch karate, strong man competition, arm wrestling, model search, powerlifting and seminars.

Join the Delaware Valley Wellness Network!

Exhibitors and new friends include:

Day 2 - Feb. 15th

Activity is brisk here this morning. The karate events have attracted lots of competitors and their friends and families.

Genetically Engineered Animals

Sunday, February 8th, 2009

FDA approves 1st drug from genetically altered animals

FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder

The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.

The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency. These patients are at high risk of blood clots during medical interventions, such as surgery, and before, during and after childbirth.

ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (called a recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries.

GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.

“This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations,” said Jesse Goodman, M.D., M.P.H., CBER director.

Because hereditary AT deficiency occurs in a small population (approximately 1 in 5,000 people in the United States), the FDA granted ATryn an orphan drug designation. The orphan drug designation system encourages the development of medications for patients with a rare disease or condition.
The agency held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.

Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.

CBER evaluated two studies that included 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which are likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.

As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor’s plan to continue to monitor the construct and its expression for the lifetime of the approved product.

During its review, CVM determined that introduction of the rDNA construct did not cause any adverse outcomes to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products.

As required by the National Environmental Policy Act and its implementing regulations, CVM also determined that the GE goats do not cause any significant impact on the environment.

“We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven’t seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication,” said Bernadette Dunham, D.V.M., Ph.D., CVM director.

A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM’s guidance on the regulation of GE animals containing heritable rDNA constructs are available at .

ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.

ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.

Vitamin D Deficit May Trigger MS

Friday, February 6th, 2009

A service of the U.S. National Library of Medicine and the National Institutes of Health

Department of Biochemistry, University of Wisconsin-Madison 53706, USA.

Recently, it has been clearly demonstrated that exogenous 1,25-dihydroxyvitamin D3, the hormonal form of vitamin D3, can completely prevent experimental autoimmune encephalomyelitis (EAE), a widely accepted mouse model of human multiple sclerosis (MS). This finding has focused attention on the possible relationship of this disease to vitamin D. Although genetic traits certainly contribute to MS susceptibility, an environmental factor is also clearly involved. It is our hypothesis that one crucial environmental factor is the degree of sunlight exposure catalyzing the production of vitamin D3 in skin, and, further, that the hormonal form of vitamin D3 is a selective immune system regulator inhibiting this autoimmune disease. Thus, under low-sunlight conditions, insufficient vitamin D3 is produced, limiting production of 1,25-dihydroxyvitamin D3, providing a risk for MS. Although the evidence that vitamin D3 is a protective environmental factor against MS is circumstantial, it is compelling. This theory can explain the striking geographic distribution of MS, which is nearly zero in equatorial regions and increases dramatically with latitude in both hemispheres. It can also explain two peculiar geographic anomalies, one in Switzerland with high MS rates at low altitudes and low MS rates at high altitudes, and one in Norway with a high MS prevalence inland and a lower MS prevalence along the coast. Ultraviolet (UV) light intensity is higher at high altitudes, resulting in a greater vitamin D3 synthetic rate, thereby accounting for low MS rates at higher altitudes. On the Norwegian coast, fish is consumed at high rates and fish oils are rich in vitamin D3. Further, experimental work on EAE provides strong support for the importance of vitamin D3 in reducing the risk and susceptibility for MS. If this hypothesis is correct, then 1,25-dihydroxyvitamin D3 or its analogs may have great therapeutic potential in patients with MS. More importantly, current research together with data from migration studies opens the possibility that MS may be preventable in genetically susceptible individuals with early intervention strategies that provide adequate levels of hormonally active 1,25-dihydroxyvitamin D3 or its analogs.

Virus Linked To Global Warming

Friday, January 16th, 2009

Belgium — In parts of Europe, a rodent-born viral disease has been linked to climate change. The disease nephropathia epidemica was “scarcely known before 1990,” but is now an epidemic in Belgium, France, Germany, Netherlands and Luxembourg, said viral epidemiologist Dr Jan Clement of the University of Leuven’s Rega Institute

When people contract the disease, they get fevers and can have internal hemorrhaging that can lead to death.

The National Center for Complementary and Alternative Medicine

Wednesday, January 14th, 2009
Delaware Valley Health And Wellness Network

The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government’s lead agency for scientific research on complementary and alternative medicine (CAM). We are 1 of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services.

Our Mission
The mission of NCCAM is to:

Explore complementary and alternative healing practices in the context of rigorous science.
Train complementary and alternative medicine researchers.
Disseminate authoritative information to the public and professionals.
What We Do
NCCAM sponsors and conducts research using scientific methods and advanced technologies to study CAM. CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.

NCCAM has four primary areas of focus:

Advancing scientific research
We have funded more than 1,200 research projects at scientific institutions across the United States and around the world.
Training CAM researchers
We support training for new researchers as well as encourage experienced researchers to study CAM.
Sharing news and information
We provide timely and accurate information about CAM research in many ways, such as through our Web site, our information clearinghouse, fact sheets, Distinguished Lecture Series, continuing medical education programs, and publication databases.
Supporting integration of proven CAM therapies
Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.