- Amgen 531: A New ITP Treatment in Clinical Trial
- Adverse Events with Anti D IGIV
- Hugs: The Universal Medicine
- Handling Health Plan Disputes
- Patient Navigation Bill Signed
- Hold the Fat
- Toxic Ingredients to Avoid
- PDSA Regional Meetings in Seattle, Atlanta, and Miami
AMGEN 531: A NEW ITP TREATMENT IN CLINICAL TRIAL
Dr. David Kuter, of the Massachusetts General Hospital, presented the results of an open-label study evaluating the safety and efficacy of long-term dosing of AMG 531 in subjects with ITP. The presentation was made at the ISTH Congress in Sydney, Australia on August 9, 2005. AMG 531 is a protein molecule that stimulates platelet production. Participants were patients with a platelet count less than 50,000, on long-term corticosteroid use, and over 18 years of age. Dr. Kuter reported 81% of the participating patients achieved the study objective of a platelet count greater than 50,000 and a doubling of their baseline count. This response was durable (greater that 6 months) for 46% of the participating patients. In addition 50% of the participants were able to discontinue all corticosteroid use and 33% of the remaining patients reduced their corticosteroid use by 25%. Half the participants experienced one treatment-related adverse event. The five most frequent adverse events were headache, upper respiratory tract infection, cough, fatigue, and nose bleed.
Amgen is currently enrolling patients for clinical trials of AMG 531. For more information about these clinical trials go to: http://www.amgentrials.com.
Kuter, D.J., “An Open-Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura, ISTH Congress, Sydney, Australia, August 9, 2005.
ADVERSE EVENTS WITH ANTI D IGIV
Successful treatments often have rare but serious side effects or adverse events associated with their use. Rare events typically emerge only after approval and use by large numbers of patients. Ann Reed Gaines, of the Food and Drug Administration, in a recent paper in the journal “Blood” reported on 6 patients with findings suggestive of disseminated intravascular coagulation (DIC) following intravenous administration of anti-D immune globulin. The exact incidence rate of DIC associated with hemoglobinemia or hemoglobinuria following anti-D infusion for ITP and other thrombocytopenias is not known. The author estimated the rate at 0.005% or 1 in 20,232 infusions. The event is rare but serious. Only one of the 6 patients she identified survived. She concludes that her “review reinforces the suggestion that patients should be closely monitored for signs and symptoms of acute hemoglobinemia or hemoglobinuria, clinically compromising anemia, and renal insufficiency following anti-D infusion for ITP.” She also recommends monitoring patients experiencing those events for DIC.
Gaines, A.R., “Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hmoglobinuria Following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura”, Blood, 1 September 2005, vol 106, no 5, pp1532-1537.
Caangene Corporation and Baxter Healthcare, the companies that manufacturer and distribute anti-D, released the following statement in response to the “Blood” article:
Cangene Corporation and Baxter Healthcare Corporation acknowledge that this case series highlights the importance of recognizing that IVH and hemoglobinemia are an etiological factor in the development of DIC. This review article reinforces that patients should be closely monitored for signs and symptoms of IVH, clinically compromising anemia, and renal insufficiency (as outlined in the package insert for WinRho SDF). Early recognition of IVH and DIC may lead to enhanced therapeutic options for clinicians to treat these potentially serious but rare events. The author suggests that DIC following anti-D administration for ITP is at most a rare event. According to FDA the reporting rate of IVH 0.1% (1/1115 doses) (Ann Gaines: Blood, April 2000 vol. 95, #8) and the reporting Rate of DIC with hemoglobinemia 0.005% (1/20,232 doses) (Ann Gaines: Blood Sept, 2005) Cangene and Baxter are working with FDA to promote awareness of this issue by including precautionary information in the package insert of WinRho SDF. If your physician would like to know more information about WinRho or about these cases please contact Baxter medical affairs at 1-800-4winrho (1-800-494-6746).
HUGS: THE UNIVERSAL MEDICINE
Researchers at the University of North Carolina report a study suggesting that hugs may have benefits beyond just comfort and affection. They recruited 59 women who had been living with a spouse or monogamous partner and during a multi-phase set of interactions including a stressor phase they measured blood pressure, heart rate, and oxytocin levels before and after each phase. Women who said they got more hugs from their partners generally had higher oxytocin levels at all phases of testing. They concluded that oxytocin may be a link between hugging and lower blood pressure. Blood pressure is a key risk factor for cardiovascular disease. The findings from this study may explain why individuals with emotional support from a spouse or partner are less likely to die from heart disease.
Harvard Women’s Health Watch, September 2005, p7.
HANDLING HEALTH PLAN DISPUTES
“A Consumer Guide to Handling Disputes with Your Employer or Private Health Plan, 2005 Update” was released recently by the Kaiser Family Foundation and Consumer Union. The publication “includes information about how consumers can take advantage of their health plans’ internal (grievance) processes to resolve disputes, as well a external review processes allowed under state laws.” You can find the guide at: http://www.kff.org/consumerguide/7350.cfm.
PATIENT NAVIGATION BILL SIGNED
Earlier this summer the President signed the Patient Navigator bill into law. The new legislation authorizes $25 million in grants over five years to establish programs that will help patients with chronic illnesses to make medical decisions, especially uninsured and low income patients, and those who live in rural communities. More information can be found at: http://www.medicalnewstoday.com/medicalnews.php?newsid=27221
NORD on-line, September 2005.
HOLD THE FAT
The New York City health department has taken a stand. They have adopted an educational, not a legislative, approach toward the goal of reducing or eliminating trans fats in the preparation of food in New York City restaurants. Most scientists and nutrition experts agree that trans fats are the most dangerous fats in our diet today. The recommendation from these quarters is to use alternatives like olive oil, peanut oil, and sunflower oil. A survey found that 30 to 60 percent of the city’s restaurants use partially hydrogenated oil in food preparation. The city health department and the New York State Restaurant Association which represents 7,000 restaurants across the state have a common goal to reduce the use of trans fat in the preparation of food in New York City restaurants. We can all benefit by eliminating trans fat from our diet by substituting the oils mentioned above in preparing food, by checking labels on the prepared food we buy, and by requesting the restaurants where we dine to join in this campaign.
Santora, M., “Hold That Fat: New York Asks Its Restaurants
TOXIC INGREDIENTS TO AVOID
Many hair dyes, shampoos, and conditioners contain ingredients that are known allergens and worse, some that pose cancer risks. Catching the most troublesome ingredients is not easy because companies get around listing them on the label by claiming they are a trade secret and use terms like “fragrance” on the label. The top four ingredients to watch for and to avoid are phthalates, parabens, coal tar, and two sulfates; sodium lauryl sulfate (SLS), and sodium laureth sulfate (SLES). You can go to http://www.thegreenguide.com/doc.mhtml?i=110&s=hair to find safe alternatives for shampoos, conditioners and dyes.
Ryan, M., Safe, Not Sorry, Hair: The Case for Nontoxic Shampoos, Conditioners and Colors”, The Green Guide, September/October 2005, http://www.thegreenguide.com/.