- Rhophylac Approved for ITP
- GSK Starts New Trial of eltrombopag for ITP
- NHLBI Releases New Strategic Plan
- ITP Registry Gets Funded in the U.K.
- FDA Still Interested in Experiences of IVIG Shortages
- FDA Assesses Risk for Variant Creutzfeldt-Jakob Disease
- Failure of Health Insurance is Focus of Several Reports
- National Children’s Study Gets Funded to Begin Recruitment
- Patients Don’t Tell Docs About Alternative Therapies
- Early Sign that Humans May Live Longer on Fewer Calories
- Folic Acid Good for the Brain
- In Older Adults, Folic Acid May Be Harmful if B12 Levels Low
RHOPHYLAC APPROVED FOR ITP
In April, the Food and Drug Administration approved a new use for Rhophylac, an anti-D Rh immunoglobulin. The intravenous compound is now approved as a means of raising platelet counts in Rh0(D) positive adult patients with chronic ITP who have not had their spleen removed. Rhophylac is a product of CSL Behring. For more information visit www.rhophylac.com
GSK STARTS NEW TRIAL OF ELTROMBOPAG FOR ITP
A new study sponsored by GlaxoSmithKline will evaluate repeated dosing of eltrombopag in patients who have been previously treated for chronic ITP. Previous treatments could include splenectomy, corticosteroids, immunoglobulins, cyclophosphamide, and rituximab. Eltrombopag is an experimental drug that is being tested as a platelet growth factor because it stimulates the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. It is given as a pill once-a-day. In this new study, called REPEAT (Repeat ExPosure to Eltrombopag in Adults with ITP), 50 patients will be recruited at several centers around the world. The drug will be given in three six-week cycles. Eltrombopag is not approved for marketing for any indication at this time.
For further information on the REPEAT trial, visit www.itpstudy.com or www.clinicaltrials.gov
NHLBI RELEASES NEW STRATEGIC PLAN
The National Heart Lung and Blood Institute’s new strategic plan, Shaping the Future of Research: A Strategic Plan for The National Heart Lung and Blood Institute, can be downloaded from: www.nhlbi.nih.gov/strategicplan
ITP REGISTRY GETS FUNDED IN THE UK
The United Kingdom’s adult ITP registry has been sitting dormant since 2004 for lack of funding. But now, with support from GlaxoSmithKline and the UK’s ITP Support Association (http://www.itpsupport.org.uk/), data analysis will begin and new patients will be added to the existing database. Between 2001 and 2004, 609 ITP patients were enrolled, “making the study the largest of its kind in the world,” according to the ITP-UK newsletter. The aim of the registry is to learn more about ITP, its prevalence, clinical behavior, and responses to treatment. Progress reports for the study will be published in a bi-monthly newsletter, at www.ukitpregistry.com. The study coordinator is Ameet Sarpatwari (email@example.com)
FDA STILL INTERESTED IN EXPERIENCES OF IVIG SHORTAGES
In a report last updated August 2005, the Food and Drug Administration stated that it found no evidence of an overall shortage of Immune Globulin Intravenous (IGIV) a.k.a. IVIG products. But is encourages health care providers and patients who experience difficulty obtaining IVIG products to send an email to CBERPRoductshortages@cber.fda.gov or call 1-800-835-4709.
FDA ASSESSES RISK FOR VARIANT CREUTZFELDT-JAKOB DISEASE
In response to concerns about the potential risk of a rare fatal brain infection called variant Creutzfeldt-Jakob Disease for recipients of plasma-derived clotting factors and other plasma products (such as immune globulins), the FDA did a risk assessment and determined that the risks are extremely small, though somewhat uncertain. They devised a Website with several factsheets and Q&As: www.fda.gov/cber/blood/vcjdrisk.htm.
FAILURE OF HEALTH INSURANCE IS FOCUS OF SEVERAL REPORTS
The Illusion of Coverage: How Health Insurance Fails People When They Get Sick, by The Access Project, recounts the personal, emotional, and physical hardships of the millions of hard working, insured Americans who are struggling with medical debt. The report demonstrates the specific ways in which health insurance products fail to protect people financially and fail to guarantee their access to needed care when ill or injured. 70 pp. (2007)
Three other reports come from Families USA:
A Pound of Flesh: Hospital Billing, Debt Collection, and Patients' Rights provides an overview of some of the progressive reform measures that state policymakers have implemented to help families struggling with medical debt. 8 pp. (March 2007)
No Bargain: Medicare Drug Plans Deliver High Prices shows the huge differences between prices secured by the Department of Veterans Affairs (VA) — which bargains for cheaper drug prices — and the much higher prices charged by all the private drug plans in Medicare Part D, which cannot bargain for cheaper prices. 23 pp. (January 2007)
Understanding How Health Insurance Premiums are Regulated provides a comprehensive overview on the different ways states can regulate health insurance premiums. 21 pp. (September 2006)
NATIONAL CHILDREN’S STUDY GETS FUNDED TO BEGIN RECRUITMENT
The National Children’s Study will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The goal of the study is to improve the health and well-being of children. With a hefty appropriation of $69 million from Congress, the study is moving forward to expand into additional communities and begin recruitment. A Request for Proposals went out to fund 15-20 new study centers nationwide. The study is a huge undertaking. For example, it faces big obstacles in finding study participants within rural communities. The four South Dakota and Minnesota counties cover more than 2,500 square miles and the researchers are expected to recruit 75% to 80% of the counties’ newborns.
PATIENTS DON’T TELL DOCS ABOUT ALTERNATIVE THERAPIES
In a survey of more than 1500 people ages 50 and older, only 3 in 10 told their doctors that they were using a complementary or alternative medicine (CAM). That means 7 of 10 were trying a CAM therapy without discussing it with their regular doctor. Many (42%) said the doctor never asked, 30% did realize they should tell their doctor, and 12% feared the doctor would have a negative reaction. The CAM therapies most often used were massage, chiropractic or some other form of body work, followed by herbal or dietary supplements.
Note: These findings are consistent with our survey (http://www.itppeople.com/surveyres/ ) PDSA recommends telling your doctor about any complementary or alternative therapies you are using.
EARLY SIGN THAT HUMANS MAY LIVE LONGER ON FEWER CALORIES
Because proving that low-calorie diets can increase longevity would take decades, a group of scientists in Baton Rouge, LA, looked for more fast-responding changes in the cells of people put on calorie-restricted, yet nutritionally complete diets. Thirty six overweight people were assigned to one of three groups. The first group ate a diet with 25% fewer calories than their initial energy expenditure. The second group ate 12.5% fewer calories, then exercise to burn another 12.5%. The third group ate a weight-maintenance diet. During the 6-month study, both calorie-restricted groups showed an increase in mitochondria in their muscle cells and a 60% decrease in DNA damage. The mitochondria appeared to be more youthful and efficient. Both of these findings indicate a shift toward longer living. The group now plans to test people of normal body weight for 2 years.
Barry P. Living Long on Less? Science News, March 10, 2007, pg. 147.
FOLIC ACID GOOD FOR THE BRAIN
Foods rich in folic acid may boost brain power and protect against Alzheimer’s disease, according to studies from the Netherlands and Columbia University Medical Center. The Netherlands study tested 800 microgram supplements of the vitamin in volunteers ages 50 to 70. In three years’ time, those taking the supplement had improved memory and information processing speed. The New York study showed people with the highest intake of folic acid over a 6-year period had the lowest risk for Alzheimer’s. Folic acid is found in green leafy vegetables, citrus fruit, beans, and fortified breads and cereals.
AARP Bulletin, March 2007, pg. 9.
IN OLDER ADULTS, FOLIC ACID MAY BE HARMFUL IF B12 LEVELS LOW
Adults age 50 and older are at increased risk for vitamin B12 deficiency because their ability to absorb B12 from food declines. When B12 levels are low, and folic acid levels are high, older adults run a higher risk of anemia and cognitive impairment. For adults with normal B12 levels, however, folic acid seemed to be beneficial for cognitive function. The authors, from Tufts University, suggest improved efforts to detect and treat low vitamin B12 in seniors, especially in this age in which many foods are fortified with folic acid.
Folic-Acid Effects Depend on B12 Levels, Tufts University Health & Nutrition Letter, 25(2), April 2007, pg. 1-2.