- A Clinical Research Study for Adults with Chronic ITP
- Two People with ITP Respond to “Antifungal” Program
- Four Year Old with Chronic ITP Responds to H Pylori Eradication
- Remissions and Extended Survivors Studied For Clues to Success
- CDC Reports Fatal Bacterial Infections Associated with Platelet Transfusions
- Study Reports on Accuracy of Platelet Counting Hematology Analyzers
- Genetic Test May Reduce Guesswork in Prescribing Medications
- HapMap Project Benefits From Data Donated by California Company
A CLINICAL RESEARCH STUDY FOR ADULTS WITH CHRONIC ITP
This research study is for men and women 18 years of age or older who have been diagnosed with ITP (Immune Thrombocytopenic Purpura) for at least six months. To be eligible for this study, you must have been unsuccessfully treated with either corticosteroids, immunoglobulins, azathrioprin, danazol, immunomodulators and/or splenectomy. Additional criteria will be assessed by the physician at the research site to confirm eligibility.
Qualified study participants will be asked to take the study drug once a day for six weeks. A total of 11 clinic visits will be scheduled during which participants may undergo evaluations including study-related physical examinations, medical history review, and laboratory tests (i.e. platelet counts).
All study-related medical exams, laboratory tests, and study medication will be provided to participants at no cost. Your participation in this study is voluntary, and you can withdraw at any time.
If you are interested in learning more about this study and if you qualify; please visit www.itpstudy/pdsa or http://www.findclinicalstudy.com/index.cfm?cid=185220&did=901&rfr=pdsa
For more information on ITP clinical trials go to: http://www.itppeople.com/clinical.htm
TWO PATIENTS WITH ITP RESPOND TO “ANTIFUNGAL” PROGRAM
A Texas physician reports success with two patients with thrombocytopenia who responded quickly (within 2 to 4 weeks) to an “antifungal” program. This included a Phase I diet, Psyllium husks (powder or capsules), and a natural antifungal. Fungi produce mycotoxins. One family of these, the trichothecenes, can contaminate our food and is associated with hematological disorders including thrombocytopenia and leukopenia.
With appreciation we acknowledge and thank a member of PDSA for bringing the following citations to our attention.
R. Froquet, Y. Sibiril, D. Parent-Massin, “Trichothecene Toxicity on Human Megakaryocyte Progenitors”, Hum Exp Toxicol., February 20, 2001, 20(2), 84-89.
D. Parent-Massin, “Haematotoxicity of Trichothecenes”, Toxicol Lett., October 10, 2004, 153(1), 75-81.
FOUR YEAR OLD WITH CHRONIC ITP RESPONDS TO H Pylori ERADICATION
H Pylori has been associated with ITP for a number of years and studied in the United States, Europe, and Japan. Some researchers have found that H Pylori eradication has restored platelet counts for ITP patients but others have not been able to reproduce these results. Recently, we heard from a member whose 4 year old granddaughter developed chronic ITP about 3 years ago. She reported that all the usual treatments helped for a couple of weeks but then her granddaughter was back in the hospital. After almost a year of this, doctors recommend a splenectomy. Two weeks after the operation she was back in the hospital her platelets had crashed. She was back to treating her ITP every few weeks. Then after reading an article on the PDSA website, www.pdsa.org, about H-pylori eradication they had her checked and sure enough she was positive. She was treated with antibiotics for a week. Her platelet count responded and she hasn’t needed treatment in almost 2 years. Testing for H Pylori is easy and inexpensive. Even though the research results are mixed, if you have been struggling with a chronic case of ITP, testing for H Pylori can’t hurt.
We thank Holly for sending this information to PDSA.
REMISSIONS AND EXTENDED SURVIVORS STUDIED FOR CLUES TO SUCCESS
Researchers at the Institute of Noetic Sciences in Petaluma, California have been studying the lives of individuals experiencing cancer remissions and those described as extended survivors of illness and disease for over twenty years. In the current issue of their magazine, Shift, Marilyn Schlitz reports that “researchers have identified similarities in how survivors account for their hopeful situations.” In summary:
- “Strong sense of self-sufficiency and a feeling of being in charge
- Greater weight to intangible factors, such as attitude changes, .., strong connections to partners and friends
- A strong, supportive, and trusted relationship with one other person, a partner, was considered extremely significant
- Spiritual faith, religious conviction
- Flexibility and a willingness to try anything that makes sense
- No longer feeling it necessary to deny their feelings”
M. Schlitz, “Stories of Hope”, Shift, December 2004 – February 2005, pp 38 – 40.
CDC REPORTS FATAL BACTERIAL INFECTIONS ASSOCIATED WITH PLATELET TRANSFUSIONS
Approximately nine million platelet-unit concentrates are transfused in the United States each year. An estimated one in 1,000 to 3,000 of these units is contaminated with bacteria. Transfusion-associated bacterial sepsis was the second most frequently reported cause of transfusion-related fatalities in the United States during the period 1990 – 1998. Platelets are particularly vulnerable to bacterial growth because they are stored at room temperature for up to 5 days. Other blood components are refrigerated or frozen. To reduce this risk the American Association of Blood Banks (AABB) adopted a new standard on March 1, 2004. This new requirement requires member blood banks and transfusion services to implement measures to detect and limit bacterial contamination in all platelet components. This can protect not only the potential recipient of the platelet unit, but potential recipients of other blood units, by identification and recall of co-components that also might be contaminated.
MMWR, “Fatal Bacterial Infections Associated with Platelet Transfusions --- United States, 2004, CDC Weekly, February 25, 2005, 54(07), 168 – 170.
STUDY REPORTS ON ACCURACY OF PLATELET COUNTING HEMATOLOGY ANALYSERS
Hematology analyzers provide reliable full blood counts but are known to be inaccurate at counting platelets in severe thrombocytopenia. For reasons not associated with the treatment of ITP, a group in the UK compared the platelet counting results of nine different analyzers produced by five different manufacturers. The analyzers studied used optical, impedance, and immunological counting technology. In conducting the study, over 3,000 counts were completed. In the low range, less that 20 X 109/l platelets or what is commonly referred to as 20K, the mean difference (the difference between the average of all counts with a given analyzer and the IRM standard) was small. For all machines the mean difference was less than 5K, for several less than 1K. However the range of readings from each analyzer was much greater. All but one of the analyzers tended to overestimate platelet counts. Eight of the nine analyzers tested overestimated platelet count by 5K or more, even though the mean difference was less. Estimates of two analyzers, on some counts, were as much as 10K over the standard. Four of the nine analyzers also underestimated platelet count by 5K or more for some samples. One underestimated by almost 10K. These results call for ITP patients with low platelet counts to pause before basing treatment exclusively on an analyzer platelet count.
H. C. Segal, et al, “Accuracy of Platelet Counting Haematology Analysers in Severe Thrombocytopenia and Potential Impact on Platelet Transfusion”, British Journal of Haematology, 128, pp520 – 525.
GENETIC TEST MAY REDUCE GUESSWORK IN PRESCRIBING MEDICATIONS
A newly approved genetic test may soon take some of the guesswork out of prescribing certain drugs. Medications do not work the same in everybody and there are many reasons for this. One is that people metabolize drugs at different rates. Two genes, 2D6 and 2C19, regulate the enzymes the liver produces to metabolize a number of drugs. The AmpliChip CYP450 was cleared by the Food and Drug Administration in December of last year and is expected to be available by June. This DNA chip contains millions of DNA molecules which it uses to analyze genetic material from a patient’s blood. Physicians will be able to send a standard blood sample to a laboratory. The DNA will be extracted and applied to the chip and a detailed report generated. This report will describe how the patient’s genetic variability will affect response to a number of medications including: anti-seizure medications, beta blockers, codeine, the breast cancer drug tamoxifen, and several antidepressants. The new test will identify people who clear drugs from their systems at an abnormal rate—fast or slow. This will enable physicians to make dosages more precise and adjust medications. “In the future physicians may be able to predict with pinpoint precision who will do better on a specific drug, and why.”
P. J. Kiger, “The Right Drugs for Your DNA”, AARP Bulletin, March 2005, p 3.
HAPMAP PROJECT BENEFITS FROM DATA DONATED BY CALIFORNIA COMPANY
The HapMap project is an international effort to identify and catalog genetic similarities and differences in human beings. This project will provide information that will help researchers find genes that affect health, disease, and individual responses to environmental factors and medications. The ability to predict individual responses to medications is advancing quickly as reported above. This technology is has been adapted by Perlegen in its genome scanners. These scanners consist of large “gene chips” designed to pick out hundreds of millions of individual segments of DNA simultaneously. This makes it possible to identify millions of single nucleotide polymorphisms (SNPs or single letter differences along a chromosome that vary between individuals) in a matter of days. Perlegen is currently characterizing SNPs in the 270 genomes used as a reference in the HapMap project. Perlegen has announced plans to integrate its own SNPs (a donation of services valued at $1.2 million) into the HapMap and to characterize a total of more than four million SNPs for the project by the end of the year. In addition to contributing to the HapMap project, the company is taking steps to exploit its data in the market place. They “recently licensed a drug that had failed in clinical trials at another company, hoping to figure out what genetic effects contributed to the failure.” If they can, Perlegen could test the drug again in the patients most likely to benefit and if successful rescue a medication the benefits of which otherwise would have been lost.
For information on the HapMap project see: http://www.hapmap.org/
D. Hamilton, “Genetic-Variation Map Gains as Biotech Firm Donates Some Data”, Wall Street Journal, February 25,2005, p B1.