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Oct 14, 2011
How Vitamin D Defeats Diabetes
Many studies link vitamin D deficiency with an increased risk of type 2 diabetes. An exciting new study shows how vitamin D protects against the disease.
in the Division of Endocrinology, Diabetes and Metabolism at Tufts
Medical Center in Boston studied 92 people at risk for diabetes. Their
average age was 57 (growing older is a risk factor); they were obese
(extra pounds is a risk factor); and...
Clinical evidence for rapid transmission of Lyme disease following a tick bite. Lyme disease transmission...is thought to require at least 36-48 h of tick attachment. We describe 3 cases in which transmission of Borrelia burgdorferi, ..appears to have occurred in less than 24 hours...Health care providers and individuals exposed to ticks should be aware that transmission of Lyme disease may occur more rapidly than animal models suggest. A diagnosis of Lyme disease should not be ruled out based on a short tick attachment time... http://www.ncbi.nlm.nih.gov/pubmed/22104184
www.townsendletter.comLetter from the Publisher: FDA Guidance Statement Threatens Supplement Industry by Jonathan Collin, MD **Townsend Letter for Doctors & Patients' alternative medicine articles are written by researchers, health practitioners and patients.
In July, the US Food and Drug Administration (FDA) drafted a guidance document for industry on dietary supplements. Although the document is a draft with "non-binding" recommendations, the wording is very formal and appears ready to be implemented. The "guidance" calls for manufacturers of food supplements to report to the FDA the ingredients of all supplements marketed after 1994. The purpose of the report is to notify the FDA that food supplement ingredients are being manufactured by a specific company and to provide data to the FDA that the "new dietary ingredients" (NDIs) are safe. The guidance draft differentiates between a dietary ingredient that is wholly derived from a food and an ingredient that has undergone chemical processing. In the event that there has been enzymatic or chemical manipulation of the food or botanical ingredient, a statement is required explaining the exact manufacturing process. As a whole, the reporting process appears to be more than onerous and time-consuming – for those "new dietary ingredients" that lack safety documentation based on historical use, the FDA is requiring expensive, multistep, multiorganism, lengthy safety studies.
The US Congress enacted the Dietary Supplement Health and Education Act (DSHEA) on October 25, 1994. The legislation defined dietary supplements to distinguish them from drug agents. The purpose of the legislation was to protect dietary supplements from needing to undergo the rigorous testing required of pharmaceuticals. However, DSHEA apparently also defined a new term, "new dietary ingredient." An NDI is simply a dietary ingredient, a food supplement ingredient, that was not marketed in the U.S. before October 15, 1994. Hence all supplements marketed prior to this date are considered "grandfathered" from this FDA regulatory guidance NDI reporting. No reporting is required for these supplements. Unfortunately all supplement ingredients marketed after this date are subject to the NDI notification requirements. The FDA is proposing that an NDI notification for each ingredient in a supplement must be made 75 days before the marketing of that product. In the event that no NDI notification is made the supplement is considered to be "adulterated."
The FDA defines a food supplement ingredient that has not been chemically altered as one which has only been dehydrated, milled, lyophilized, or made into a tincture. However, if the food or botanical ingredient has been subject to a process of hydrolysis or esterification, mixed in solvents other than water or ethanol, subject to high-temperature baking, nanotechnology, or fermented to a different chemical composition, it would be considered a new NDI requiring notification. The notification process, once approved, would be published for public information. However, one manufacturer may not use the NDI notification of a second manufacturer for an identical dietary ingredient.
The FDA also defines a new dietary ingredient based on its derivation from a food or botanical source that has undergone chemical alteration. In the event that the food supplement contains a chemical or a synthetic copy of a botanical or food constituent, it would not be considered a dietary ingredient – instead, it would be considered "adulterated" as a food supplement. If a drug company has applied to the FDA to use a dietary ingredient as a drug agent, the FDA will disallow a food supplement manufacturer from using that ingredient as an NDI in a food supplement. Hence, drug applications will supersede NDI notifications.
The most onerous part of the NDI reporting process is establishing the safety of the dietary ingredient. In providing documentation for an NDI, the FDA recommends including "published data such as peer-reviewed scientific literature, reports from authoritative bodies, survey data on food or nutrient composition and consumption, advertisements or other published promotional material describing the composition of products and published agricultural or food production data." However, when the "use of the NDI differs substantially" from historical use of the ingredient "additional supportive data" would be required to prove the safety of the NDI. The major difficulty occurs when there is no historical information to substantiate the safety of an NDI. Then the FDA requires scientific testing to prove that the NDI is safe.
The FDA draft guidance proposes the following scientific studies to assess the safety of a dietary supplement's NDI(s):
1. A three-study genetic toxicity (genetox) battery (bacterial mutagenesis, in vitro cytogenetics, and in-vivo mammalian test) that includes a test for gene mutations in bacteria, either an in vitro mouse lymphoma thymidine kinase+/- gene mutation assay (preferred) or another suitable in vitro test with cytogenetic evaluation of chromosomal damage using mammalian cells, and an in vivo test of chromosomal damage using mammalian hematopoietic cells; 2. a 14-day range-finding oral study to establish a maximum tolerated dose (MTD) in at least two appropriate species, at least one of which is non-rodent; 3. two 90-day sub-chronic oral studies (one for each species for which there is a range-finding study) to establish an MTD and a NOAEL (no observable adverse effect level) for use in calculating the margin of safety; 4. a one-year chronic toxicity study in an appropriate animal model or a two year carcinogenesis study in rodents; 5. a repeat-dose tolerability study in humans (30-90 days duration); 6. a multi-generation rodent reproductive study (minimum of two generations); and 7. a teratology study (rodent or non-rodent)1
It is hard to imagine that food supplement manufacturers and/or distributors would be capable of organizing, financing, and carrying out the aforementioned safety studies. It is evident that the FDA's intent is to set up egregiously overwhelming NDI safety requirements. While these requirements may make sense for a new drug or biologic agent, clearly they make little sense for food supplements. The Centers for Disease Control's reporting of poisoning from the use of food supplementation has consistently shown that extremely few incidents have occurred. Toxicity data from use of food supplementation has historically shown minimal incidents of adverse effects. To apply the same standards to food supplements as to drug agents is ridiculous. If drug companies were obliged to sell new drugs in the $20 to $60 range with competition from a myriad of other manufacturers, there would be no business of new drug design. Drug companies manufacture drugs because they receive patent rights to their new drug agents and they can market the drugs for hundreds if not thousands of dollars each month. Such is not the case for food supplement manufacturers. While the intent of the FDA to regulate food supplements deserves some merit, this guidance draft has set the requirements for safety impossibly high to comply with. The FDA should limit safety requirements to documentation from historical use. Once the safety of a dietary ingredient has been established, that information should be sufficient for all supplement manufacturers to use; it is ridiculous that individual companies need to do their own safety studies on the same ingredient. Given that accomplishing these safety studies will require great expense, the FDA should be obligated to set up the testing facilities for these studies and provide financing to do them.
A dramatic tale of microbes, medicine, and money. This eye-opening film investigates the untold story of Lyme disase, am emerging epidemic larger thatn HIV. Each year thousands go undiagnosed or misdignosed, told that their symptoms are "AIYH" or All in your head. Following the stories of patients and physicians as they battle for their lives and livehoods, the film brings into focus a haunting picture of our failed sick care focused big pharma dominated health care system and its inability to cope with the real threats of Lyme. http://www.snagfilms.com/films/title/under_our_skin
Delegate Comstock Resolution Designating May as “Lyme Disease Awareness Month” in Virginia Passes
Richmond, VA – Delegate Barbara Comstock’s House Joint Resolution 643, permanently designating May of 2011, and all succeeding years, as “Lyme Disease Awareness Month” in Virginia, passed this week in the General Assembly.
Delegate Comstock issued the following statement:
"I was proud to introduce this Resolution this year. I am very pleased that it was passed by both the House of Delegates and the Senate unanimously. This will help us raise awareness about this debilitating disease. We will increase our education efforts about the threat of Lyme Disease, and we also have the ongoing efforts with the Governor’s Lyme Disease Commission. I am committed to helping to ensure that people living in high risk areas know how to protect themselves and their children and get the medical treatments they need. I look forward to working on highlighting these needs through focused activities in May 2011 and well beyond."
Delegate Rust also issued the following statement:
“I was pleased to work with Delegate Comstock on the resolution and I will continue to pursue a better understanding and treatment of the disease by the medical profession and the public in general.”
Monte Skall, Executive Director of The National Capital Lyme and Tick-Borne Disease Association issued a statement on the adoption of House Joint Resolution 643:
“The National Capital Lyme Disease Association (NatCapLyme) is grateful to the Virginia General Assembly for adoption of House Joint Resolution No. 643, permanently designating the month of May as “Lyme Disease Awareness Month” in Virginia in every year without need for annual renewal.
On behalf of all Virginians affected by Lyme disease, NatCapLyme and its seven Virginia chapters gratefully acknowledge the leadership of the resolution sponsor, Delegate Barbara Comstock, and those members who joined her as co-patrons. We appreciate their hard work and support.
NatCapLyme represents hundreds of Lyme victims throughout Virginia as well as in Maryland and the District of Columbia. Lyme disease is regarded as the fastest-spreading vector-borne infection in the United States. Virginia has not been spared, experiencing a 169% increase in CDC-reportable Lyme cases. Many authorities, including the U.S. Centers for Disease Control, have called for greater public awareness of this disease to foster better prevention and early detection. With this Resolution, organizations can reliably plan to make May a focal point of public education and awareness.
Joint Resolution No. 643 achieves that noble purpose of encouraging public education on Lyme and how to prevent its further spread in the Commonwealth. Resolution No. 643 will be an important benefit to our citizens. This measure extends official recognition of the problem, encourages Virginians to learn about these diseases, treat them seriously, take aggressive prevention measures and seek early treatment. It will encourage physicians to seek medical education about Lyme and tick-borne infections in Virginia.”
About Delegate Barbara Comstock Barbara Comstock was elected in November 2009, to represent the 34th District (Great Falls, parts of McLean, Vienna and Herndon) in the Virginia House of Delegates. She serves on the Transportation Committee, the Science and Technology Committee and the General Laws Committee, where she serves as Chairman of the Housing Subcommittee. Barbara was appointed by the Governor to serve on the Governor's Economic Development and Job Creation Commission and, also, was appointed by the Speaker to serve on the Northern Virginia Transportation Commission. Barbara also serves on The National Capital Region Transportation Planning Board.
Barbara Comstock is a 28 year resident of McLean, Virginia. She and her husband, Chip, an assistant principal at Oakton High School, have raised their three children in McLean. Barbara served as a senior aide to Virginia Congressman Frank R. Wolf, Chief Counsel to the House Government Reform and Oversight committee, and the Director of Public Affairs for the U.S. Justice Department. Barbara is on the Board of Friends of Clemyjontri Park in McLean and Childhelp and is a member of the Fairfax Chamber of Commerce, the Greater McLean Chamber of Commerce and the Northern Virginia Technology Council. Barbara is a small businesswoman and attorney. For more information, please visit http://www.delegatecomstock.com or call 703-209-3787. You can also follow on Twitter at http://twitter.com/BarbaraComstock or at Facebook on http://www.facebook.com/ComstockforDelegate.
Richmond, VA- Friday January 7, 2011. Virginia Governor Bob McDonnell’s appointed Lyme Disease Task Force will conduct its second expert testimony hearing on Friday, January 21, 2011 in the Perimeter Center outside Richmond. The hearing is designed to gather important information about methods of prevention of this rapidly spreading vector borne illness. A similar hearing held in November focused on improving diagnostic tests and increasing awareness among patients and medical practitioners. Expert witnesses for this month’s session will include representatives from academia, public health and government agencies (see below for speaker affiliations).
More than nine hundred new cases of Lyme in Virginia were reported in 2009, and the CDC indicates ten times as many residents, particularly children, may be afflicted with this insidious disease. According to the Virginia Department of Health (VDH), in addition to the Eastern Shore and Northern Virginia, areas of high incidence now include counties to the south and west. “Whole families are ill and are being harmed,” says Michael Farris, chairman of the Task Force.
Mr. Farris is a United States constitutional lawyer and the Chancellor of Patrick Henry College. Members of the task force include physicians, patient representatives, state health and wildlife officials, a veterinarian and other key professionals.
In addition to further expert testimony hearings, the task force will hold five geographically-organized forums to gather the testimonies of patients and caregivers. These forums will be held over the course of 2011 in Northern Virginia, Norfolk, Richmond, Roanoke and Harrisonburg. The output of the expert hearings and patient forums will be developed into recommendations for Governor McDonnell’s consideration.
All hearings are free and open to the public. The January 21 hearing will be held from 1:00PM until 4:00PM at the Perimeter Center in the Commonwealth Conference Center on the second floor. The Perimeter Center is easily accessible off 1-64 at 9960 Mayland Drive, Henrico, Virginia 23233. Ample free parking is available.
Dr. David N. Gaines Public Health Entomologist VA Department of Health, Office of Epidemiology
Nelson Lafon Assistant Deer Project Leader VA Department of Game and Inland Fisheries
J. Mathews (Mat) Pound, PhD Research Entomologist USDA-ARS Knipling-Bushland U.S. Livestock Insects Research Service
Dr. Charles Apperson Public Health Entomologist North Carolina State University
Kerry Clark, M.P.H., PhD. Professor of Epidemiology and Environmental Health University of North Florida