- Treatments to Stimulate Platelet Production: Testing Continues
- False Blood Glucose Measurement May Follow Use of Some IgG Products
- Reporting Adverse Drug/Device Interaction
- Treatment of ITP in Children
- Vegetables: New Health Risks from Imports and Pre-chopped Products
- Social Drinking and Bleeding
- Graphic Surgery Videos: Educate and Discourage
- Whole Grains: Is It or Isn’t It?
- Natural Herbal Treatment Developed by MDs (advertisement)
TREATMENTS TO STIMULATE PLATELET PRODUCTION: TESTING CONTINUES
This month encouraging reports were presented at the American Society of Hematology (ASH) Conference in Atlanta, Georgia on the new ITP treatments in development that stimulate platelet production. Reports from clinical trials of both Amgen’s AMG 531 and GlaxoSmithKline’s Eltrombopag indicate treatments that increase platelet counts to safe levels at doses that are well tolerated.
One group of researchers at ASH reported that “AMG 531 has been generally well tolerated and able to stimulate platelet production in a dose-response manner in healthy volunteers and ITP patients. Results suggest that both unit dosing and weight based dosing provide a predictable platelet response. AMG 531 may represent a new treatment option for thrombocytopenic patients with ITP.” Another group of researchers reporting results from a clinical trial involving 21 patients state that “AMG 531 was well tolerated and both doses (two dose levels were tested) were able to increase platelet counts within the targeted range.”
Results of clinical trials were announced for GSK’s Eltrombopag. Researchers reported that a phase 1 study resulted in a dose-dependent increase in platelet count without safety or tolerability issues. They reported no effects on other blood cell lineages or priming of platelets for activation or aggregation. The report from a phase 2 study demonstrated that patients with ITP for at least 6 months and having failed at least one prior therapy with a platelet count less that 30,000 achieved platelet counts greater that 50,000 after 6 weeks without safety or tolerability issues.
Clinical trials for both compounds are on-going. See http://www.itppeople.com/clinical.htm for information on these and other clinical trials for ITP.
See http://www.hematology.org/meetings/2005/abstracts.cfm to view the abstracts. The next issue of our newsletter, The Platelet News, sent to our members (see http://www.pdsa.org/joinus.htm) will contain a synopsis of all the relevant ITP abstracts as well as summaries of the special ITP sessions.
Stepan, D.E., et. al., “Safety Profile of AMG 531 in Healthy Volunteers and in Thrombocytopenic Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
Kuter, D., et. al., “A Placebo Controlled tudy Evaluating the Platelet Response and Safety of Weekly Dosing with a Novel Thrombopoietic Protein (AMG 531) in Thrombocytopenic Adult Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
FALSE BLOOD GLUCOSE MEASUREMENT MAY FOLLOW USE OF SOME IgG PRODUCTS
The Food and Drug Administration (FDA) has issued a safety alert indicating that some IgG products may cause false elevated blood glucose measurements. These false measurements have resulted in inappropriate administration of insulin, resulting in life-threatening hypoglycemia according to the FDA. The products involved are Octagam 5%, Gamimune N 5%, and WinRho SDF Liquid (No interference expected at labeled doses).
See: http://www.fda.gov/ohrms/dockets/ac/05/slides/1 for more information.
IgG Today: News and Information for Clinicians, IgG America, December 2005.
REPORTING ADVERSE DRUG/DEVICE INTERACTION
Adverse drug and device events affect hundreds of thousands of patients annually. Many are or become life-threatening. New medications and devices are tested very carefully before being approved for use by the medical community to treat patients. However, these trials are conducted with relatively small numbers of patients. This means that adverse events that will affect a small percentage of patients are less likely to be detected. It is important that post approval adverse events be reported and evaluated. The FDA has established an on-line system that enables patients to report adverse events directly. You can report an adverse event at the MedWatch section of the FDA website. The form is available at: http://www.fda.gov/medwatch/SAFETY/3500.pdf. Instructions to complete the form can be found at: http://www.fda.gov/medwatch/REPORT/CONSUMER/INSTRUCT.HTM.
TREATMENT OF ITP IN CHILDREN
ITP is one of the most common bleeding disorders in children. However, there have been relatively few clinical trials with ITP children leaving diagnosis and treatment to expert opinion not clinical trial evidence. As a result, treatment varies widely. Drs. A.T. Shad, C.E. Gonzalez and S.G. Sandler (a member of the PDSA Board of Medical Advisors) all at Georgetown University Medical Center have reviewed the diagnosis and treatment of ITP in children in the current issue of Pediatric Drugs. The abstract is available at:http://pt.wkhealth.com/pt/re/pdd/currenttoc.htm;jsessionid=DnLAOpOPaJ8l05yMxI1AzP3PH7BuZQc56t5SQnDfJ2Mwo32cJl16!-85436088!-949856145!9001!-1 and a sample issue of the journal is available at the same site after registration.
Shad, A.T., et. al., “Treatment of Immune Thrombocytopenic Purpura in Children”, Pediatric Drugs, 2005: 7 (5):325-336.
VEGETABLES: NEW HEALTH RISKS FROM IMPORTS AND PRE-CHOPPED PRODUCTS
The good news is more Americans are eating vegetables. The bad news is illnesses traced to fresh vegetables are on the rise. Government and the produce industry have identified five products that are particularly problematic: tomatoes, melons, lettuce, sprouts, and green onions. The FDA is pushing to extend food-safety practices to include those who harvest, store, and distribute raw agricultural products. The industry is also developing detailed guidelines covering each step of the journey to market. The Partnership for Food Safety Education recommends a six step approach to handling fruits and vegetables. One, check for bruises and reject bruised fruits and vegetables; two, clean hands and utensils with hot soapy water before washing fruits and vegetables; three, separate fresh fruits and vegetables from household cleaning chemicals as well as meat, poultry, and sea food from shopping cart to table; four, cook or throw away fresh items that touch meat, poultry, or sea food; five; chill by refrigerating all cut, peeled, or cooked fresh fruits and vegetables within 2 hours; six, throw away all fresh fruits and vegetables not refrigerated within two hours. To get the details on the six step procedure go to: http://portal.fightbac.org/pfse/toolsyoucanuse/phec.
Zhang, J, “When Eating Your Vegetables Makes You Sick”, The Wall Street Journal, November 30, 2005, p D1.
SOCIAL DRINKING AND BLEEDING
A study conducted by Kenneth Mukamal and colleagues at Beth Israel Deaconess Medical Center in Boston suggests that moderate drinking may lower the risk of heart attacks. They studied the blood of 3,789 men and women over several decades investigating risk factors for cardiovascular disease. They found that “the blood of people who consume 3 to 6 [alcoholic] drinks weekly was less likely to clot in a test tube than was blood from nondrinkers, Platelets from the moderate drinkers were also less likely than those from nondrinkers to display a surface protein that makes them sticky.” The study seems to confirm other work showing that people who drink regularly have a lower risk of heart attacks but a higher risk of bleeding strokes than do teetotalers.
Science News, November 12, 2005, vol 168, p 317
GRAPHIC SURGERY VIDEOS: EDUCATE AND DISCOURAGE
Health insurance companies are using graphic videos to educate patients about their health and help them go into surgery with realistic expectations. Some of the videos available show very graphic detail of surgical procedures such as a needle being inserted into the eye as part of cataract surgery or blood dripping from a foot from which skin is being peeled away as part of a surgical procedure. This objective for the videos of building realistic expectations for patients is claimed by the companies that create them and the insurers and employers who are making them available to workers. Surgery videos join preventive-care guides and online drug cost software that insurers and health-plan administrators are using to educate patients as part of a movement that is referred to as consumer driven health care. Some claim that watching these videos can empower patients to question their physicians instead of just accepting their recommendations as if no alternative is available or worthy of consideration. Others see these tools as discouraging procedures that patients can benefit from. The Ottawa Health Research Institute recently chaired an international group to develop standards for effective standards for effective “decision aids” for patients.
Rubenstein, S, “Health Insurers Show Employees Graphic Surgery Videos”, The Wall Street Journal, November 30, 2005, p B1.
WHOLE GRAINS: IS IT OR ISN’T IT?
Food marketers want to use terms such as “good source” and “excellent source” of whole gains to promote the sale of a wide range of grain-based food products. According to the Wall Street Journal 432 whole grain products have been launched this year. The FDA has entered the fray by rejecting General Mills Inc.’s request for permission to label cereal, bread and other products as “good source” or “excellent source” of whole gains. Presently it is difficult for shoppers to know how much whole grain is in a product. While some manufacturers are using the phrase “all our products are made with whole grain” the FDA has not ordered them to pull this wording. The FDA has not decided what “whole grains” includes or whether it should be considered a food category, ingredient, nutrient, or something else. It will be some time before this is resolved. In the mean time buyer beware.
Zhang, J., Adamy, J., “FDA Limits Claims About Whole Grains”, The Wall Street Journal, December 6, 2005, p D1.