Another very informative newsletter from The Vitamin D Council
New study concludes the need for vitamin D repletion in systemic lupus erythematosis patients
Several studies have documented that patients with systemic lupus erythematosis (SLE) have low vitamin D levels and that those with the lowest levels progress to the most serious cases. Furthermore, animal studies have consistently shown that treatment with vitamin D helps the disease, but positive controlled human trials are lacking (one such human trial used meaningless doses of vitamin D). As usual, to some, this means that vitamin D deficiency in SLE should not be treated until such trials show effectiveness, a conclusion I just don’t understand.
Finally, a paper was publsihed from a group of physicians from the University of Oklahoma Health Sciences Center who reached a conclusion that both lupus experts and I understand. The study, led by Dr. Lauren Ritterhouse, concluded that their data “strongly suggests that repletion with vitamin D should be considered” for patients with SLE.
What did they discover that led them to break with the pack and recommend treatment of SLE with vitamin D in spite of the lack of controlled trials indicating effectiveness?
They discovered two things. First, they found evidence of early lupus in healthy controls that were vitamin D deficient but no such evidence in healthy controls with higher vitamin D levels. This makes it unlikely that well patients are more active, thereby explaining their higher vitamin D levels. Second, they found that a marker of destructive inflammation was much higher in vitamin D deficient SLE patients comapred to vitamin D sufficient SLE patients. In fact, their figure 2 on page 1571 shows that inflammatory marker was at its lowest in the few patients with the highest vitamin D levels (around 30 ng/ml).
More than 150,000 Americans suffer from SLE. Modern medical treatment has led to increased life expectancy for SLE patients, although their pain and suffering is another story. So hats off to these Oklahoma physicians. Using common sense and uncommonly good science, they showed SLE patients may well be wise to treat their vitamin D deficiency.
John J. Cannell, M.D.
Vitamin D Council
Tags: SLE, systemic lupus erythematosis, vitamin D
This rule would help by creating a uniform and enforceable definition of “Gluten-free”.
The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.
One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.
People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, oats and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the United States population is estimated to have the disease.
“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.
The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov1. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.
To submit your comments electronically to the docket go to www.regulations.gov2
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.
For more information:
Federal Register Notice (scroll to FDA–temporary link will update when document publishes on Aug. 3):
http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=13
Gluten-Free Portal (scroll to Gluten-Free):
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/default.htm#gluten4
FDA’s Proposed Rule on the Gluten-Free Labeling of Foods:
http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm5
Questions and Answers on the Gluten-Free Labeling Proposed Rule:
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-SpecificLabelingInformation/ucm265309.htm6
Consumer Update on the Gluten-Free Labeling Proposed Rule:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm7
The FDA, an agency within the U.S. Department of Health and Human Services, is supposed to protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Tags: CD, Celiac disease, FDA, GF, gluten, Gluten-Free
An update newsletter from the Vitamin D Council
This weekend, scientists from an American medical institution published a study that has practical implications for patients undergoing ACL (Anterior Cruciate Ligament) surgery.
The study, by a group in Utah, may have answered in part the long sought question of why some patients do well after knee surgery (quickly regain strength in their quadriceps) and some do not. Dr. Tyler Barker, of the Orthopedic Specialty Hospital in Murray, Utah, and his colleagues at the University of Utah (where I did a surgical internship back in 1976) discovered that vitamin D levels are associated with muscle strength recovery after knee surgery (anterior cruciate repair). Those with levels above 30 ng/ml recovered much better than those with levels below 30 ng/ml.
I found it somewhat disappointing that the authors refused to say that vitamin D deficiency should be treated before knee surgery. All they would say was that Americans should fund more studies before any action is taken. Of course this is neither practical or ethical, as physicians are (and always have been) obligated to act on what is known now — not on what may or may not be discovered in the future. Randomized trials of vitamin D supplemention need to be undertaken to discover what the optimum vitamin D level for knee surgery is. But such trials will take years, while orthopedists need to act, or not, now.
John J. Cannell, M.D.
The August 2011 ezine edition of The Health Gazette has been published as scheduled today.
This month we have a break from our ongoing series on The Dimensions of Health. The August edition is a special “Your Say” edition that features reader’s questions and Dr Peter Tylee’s answers.
The Your Say section of the monthly Ezine Edition provides details of questions and answers relevant to the day-to-day health concerns of our readers and visitors to our network of sites. We consider this an important section of our publication because it directly relates to the real concerns of individuals. However ordinary or obscure the questions may seem one can rest assured that other readers will find relevance for them too, not in every case of course, but frequently enough.
Why not come and join us? You can read a few years worth of Your Say sections in monthly editions held in the Subscriber Archive.
Tags: Health Gazette Ezine
The US FDA in a Drug Safety Communication notified healthcare professionals and patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. The notification includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate). FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.
BACKGROUND: Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget’s disease. There have been conflicting findings from studies evaluating the risk of esophageal cancer. Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates. See the Data Summary in the Drug Safety Communication for additional details.
RECOMMENDATION: Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
While osteoporosis remains a condition best avoided, there are safer ways to treat the condition than using the dangerous drugs listed above. Consult a naturopathic physician for best health care and management of osteoporosis.