- WinRho® News from Baxter
- Best Practice for Asplenic Patients Not Being Followed
- Beans May Be Overtaking Berries in the Antioxidant Sweepstakes
- Data Suggests a High Percentage Diagnosed With Evans Syndrome May Have ALPS
- Clinical Trial Reminder
- Hospital Data To Help Patients Make Decisions
WinRho® NEWS FROM BAXTER
March 28th - Baxter Healthcare and Cangene announced that Baxter is assuming exclusive rights to market and distribute Cangene’s WinRho® SDF in the United States. WinRho® SDF is used to elevate the platelet level in patients with ITP. The Food and Drug Administration approved WinRho® SDF in 1995 for the treatment of chronic ITP in Rh-positive non-splenectomized adults and acute and chronic ITP in Rh-positive children who have not had a splenectomy. Cangene Corporation is one of Canada’s largest biotechnology companies headquartered in Winnipeg, Manitoba.
April 11th - “Baxter Healthcare Corporation and Cangene Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the liquid formulation of Cangene’s WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)].” The liquid product provides an alternative therapeutic in treating the same indications as the lyophilized (freeze-dried) product but without the need to reconstitute prior to infusion.
From Baxter/Cangene Press Releases.
To view complete press releases go to http://www.itppeople.com/winrho.htm
BEST PRACTICE FOR ASPLENIC PATIENTS NOT BEING FOLLOWED
Patients without spleens are at increased risk of overwhelming post-splenectomy infection (OPSI) since the spleen is responsible for filtering encapsulated bacteria such as Streptococcus pneumoniae from the blood stream. “The overall incidence of OPSI remains low but death rates from OPSI have been reported to be up to 600 times greater than in the general population, with an estimated lifetime risk for OPSI of approximately 5%.” While in theory the risks of serious sepsis “can be reduced with good advice, immunization, and antibiotic prophylaxis, in practice, such preventive measures may not be followed or may fail.” This study, which came to our attention recently, examined specific associated factors to determine whether currently recommended preventive measures are being followed. The study reports that “few patients had been adequately advised on antibiotic prophylaxis or other measures.” The author concludes that “currently accepted best practice for managing asplenic patients is not being followed.
D.J. Waghorn, “Overwhelming Infection in Asplenic Patients: Current Best Practice Preventive Measures are Not Being Followed”, Journal of Clinical Pathology, 2001, 54:214-218.
BEANS MAY BE OVERTAKING BERRIES IN THE ANTIOXIDANT SWEEPSTAKES
Antioxidents are believed to help prevent and repair oxidative stress, a process that damages cells within the body and has been linked to the development of cancer, Alzheimer’s disease, heart disease, and Parkinson’s disease. In the past, blueberries have gotten a big share of the attention when the antioxidant content of foods has been reported. They may have to move aside. A recent analysis of the antioxidant content of common foods shows that disease-fighting antioxidants may be found in unexpected fruits and vegetables, such as beans, artichokes, and even the much-maligned Russet potato. Researchers found that small red beans, red kidney beans and pinto beans are all in the same league with wild blueberries and have more antioxidant capacity that cultivated blueberries.
J. Warner, (reviewed by B. Nazario, MD), “Antioxident Riches Found in Unexpected Foods”, http://my.webmd.com/content/Article/89/100138.htm
DATA SUGGESTS A HIGH PERCENTAGE DIAGNOSED WITH EVANS SYNDROME MAY HAVE ALPS
Diagnosing autoimmune diseases can be difficult; more so in some cases than others. Misdiagnosis is a problem because in most cases it means mistreatment, not good for the patient or physician. This paper reports a study of 12 children diagnosed with Evans syndrome (ES) a disorder defined by autoimmune destruction of at least two of the three hematologic cell types (red cells, white cells, platelets). ES presents with symptoms similar to another disease, autoimmune lymphoproliferative syndrome (ALPS) a disease that typically includes autoimmune cytopenias, increased risk of malignancies, and other pathology. The 12 ES patients were studied for the laboratory characteristics of ALPS. On the basis of the testing, the researchers found an unexpectedly high (7 of the 12 patients) prevalence of abnormal laboratory findings highly suggestive of ALPS among patients diagnosed with ES. “Our data further suggest that a number of patients with ES may have ALPS, a novel finding with important therapeutic implications.”
D.T. Teachey, et. al., “Unmasking Evans Syndrtome: T-Cell Phenotype and Apoptotic Response Reveal Autoimmune Lymphoproliferative Syndrome (ALPS)”, Blood, 15March2005, 105:2443-2448.
CLINICAL TRIAL REMINDER
There are three clinical trials and a clinical research study underway of interest to ITP patients. This is exciting news.
Amgen is recruiting patients for two clinical trials for AMG531. This novel thrombopoietic agent is a protein molecule used to stimulate platelet production. For information about these trials and registration information, go to http://www.amgentrials.com and use the search engine window in the upper left hand corner of the screen, search on “ITP”. You can also call 1- 866- 57AMGEN (1-866-572-6436) for more information.
Thrombopoietin Receptor Agonist
A clinical research study for adults with chronic (ITP) is recruiting patients to study the safety and effectiveness of an investigational oral drug compared to placebo for the treatment of ITP in adults. This investigational drug is a TPO (thrombopoietin) receptor agonist. For more information including eligibility criteria go to: http://www.itpstudy.com or call 1-877-587-4257
Gray Platelet Syndrome
The National Human Genome Research Institute of NIH is currently recruiting patients for a genetic analysis of Gray Platelet Syndrome. This study (as described on http://www.clinicaltrials.gov/ct/show/NCT00069680 ) will identify and characterize the gene or genes responsible for Gray Platelet syndrome (GPS). This study is of interest to ITP patients because some GPS patients carry a diagnosis of ITP or thrombocytopenia of unknown origin for many years before being diagnosed with GPS. For more information you can also call the National Human Genome Project Patient Recruitment and Public Liaison Office 1-800-411-1222 or e-mail firstname.lastname@example.org
We update our clinical trials page with new information as we receive it. See: http://www.itppeople.com/clinical.htm
Transportation to Clinical Trials
Clinical trials are not always conducted in locations convenient to the patients who may contribute and/or benefit the most. That’s a problem. One solution is Angel Flight of America. This organization provides air transportation for people to obtain a medical procedure or to participate in a clinical trial. For more information go to http://www.angelflightamerica.org/ or call 800-446-1231.
HOSPITAL DATA TO HELP PATIENTS MAKE DECISIONS
There is mounting pressure to provide health-care consumers with “report cards” and other information to assist them in making decisions. In the face of this pressure, most hospitals are reluctant to publicly report any statistics that might make them look bad. The Dartmouth-Hitchcock Medical Center (DHMC) is rolling out a radical new concept of full disclosure. At DHMC, patients are being provided with the institutions’ success rates, even when they don’t measure up. Other leading institutions are expanding the data made available to patients. But everywhere doctors and hospital executives are questioning how far to go. User surveys of the Dartmouth site have found a common theme among users to be trust. Melanie P. Mastanduno, a Dartmouth-Hitchcock clinical measurement analyst said, “Just the fact that we gave all the information to the public and were not ashamed or embarrassed gave confidence.”
More detailed data on hospital performance can be found at:
The Cleveland Clinic www.clevelandclinic.org
Colorado Hospital Quality www.hospitalquality.org
NY State Hospital Report Card www.myhealthfinder.com
L. Landro, “Hospitals Give Patients More Data”, Wall Street Journal, April 6, 2005, p.D4.