Each year the American Society of Hematology (ASH) meeting attracts thousands of clinicians and scientists, worldwide, to learn about and report on the latest research. This year’s meeting, December 7 to 10 in New Orleans, featured more than 10 hours of presentations and 90 pages of abstracts about ITP and related diseases. Below are some trends.
(The ASH abstract numbers are in parentheses. You can search on the number and read the complete abstract at https://ash.confex.com/ash/2013/webprogram/start.html, after you agree with the terms.)
Dr. Howard Liebman: "By using a combination of agents it may be possible to achieve a greater efficacy with acceptable toxicity."
Treating with a single therapy targets only one of the three possible cell types involved in lowering platelets in ITP so researchers experimented with treatment combinations that addressed all three. They treated 26 patients with various doses of rituximab (B-cells), prednisone or dexamethasone (T-cells) and cyclosporine or mycophenolate mofetil (antigen-presenting cells). After a year, half of the patients were still in remission.
Only 20% of people taking rituximab (Rituxan®) achieve a long-term remission. However, when newly diagnosed (less than 2 years) patients were treated with a combination of rituximab and 3 cycles of dexamethasone, about 75% had a positive response. After five years, 59% maintained a complete response.
Understanding More about TPO TreatmentsWhen the TPO treatments (romiplostim/Nplate®, eltrombopag/Promacta®) were approved, some doctors and regulators had concerns about patients developing problematic changes in their bone marrow. In a study of the bone marrow of patients taking eltrombopag (Promacta®) for up to 5 years, independent experts found that bone marrow reticulin (scarring) was either absent or only mildly increased in 98% of the patients tested. No patients developed lasting bone marrow problems due to the treatments.
In one study, 15% of the patients who received TPO treatments remained in remission after treatments were discontinued. In a second study of patients who participated in TPO clinical trials, those who had ITP fewer than 5 years were more likely to sustain a remission after discontinuation. A third study mirrored the positive results and showed that patients who were treated about a month could achieve a lasting remission.
Making a Correct DiagnosisH.pylori bacteria have been associated with ITP and past research has shown that eradication of the bacteria can improve platelet counts. However, the results were not consistent. At ASH, three studies addressed the connection between H.pylori and ITP. All three reported some positive platelet response after eradicating H.pylori. One study was from Iran, another from Korea, and a third from an ethnically diverse patient population in Los Angeles. This confirms earlier findings that patient ethnicity can be a factor in the success of this treatment.
ITP is a diagnosis of exclusion, when all other causes of low platelets are ruled out. However more causes of low platelets are being discovered each year. Researchers did genetic studies on several members of a family in Michigan who were diagnosed with ITP as children. They discovered that a mutation to a gene producing nitrous oxide (NOS3) was the cause of low platelets in this family, not ITP. For more information on low platelets and families see:
http://www.pdsa.org/about-itp/and-families.html
Improving the Treatment of ChildrenThe 2011 updated ASH Guidelines for ITP recommend that children be managed with observation alone if they have only mild or no bleeding symptoms, regardless of platelet count. To determine if these guidelines were changing practice, a large hospital in Pennsylvania looked at how they managed newly-diagnosed children with ITP. They did find a marked decrease in treatment over the years. The percent of children observed and not treated increased from 34% in 2007-2010 to 72% in 2012.
In one study, children treated with romiplostim (Nplate®), some more than three years, continued to maintain a platelet count greater than 50,000. In another report, 82% of the 33 children treated with either romiplostim or eltrombopag (Promacta®) responded to the treatments. Some of the children had additional therapies and a few were able to stay in remission after therapy was discontinued. No severe side effects were reported.
Long-term Nplate® side effects talliedResearchers summarized the side effects for 653 patients with ITP enrolled in 13 romiplostim (Nplate®) clinical trials. The patients were treated for up to 5 years, 921.5 patient-years total. Results: 6% had thrombotic, blood clotting, events (some linked to a larger than recommended dose or count); 8% had serious bleeding; 1.8% developed bone marrow reticulum; 3.8% died. The authors conclude: “Our data demonstrate that long-term romiplostim treatment is well tolerated, with no new safety signals, even in patients treated for up to 5 yr.”
Rodeghiero F et al. “Long-term safety and tolerability of romiplostim in patients with primary immune thrombocytopenia: a pooled analysis of 13 clinical trials.” European Journal of Hematology. 91.5: 423–436, Nov 2013.
http://onlinelibrary.wiley.com/doi/10.1111/ejh.12181/abstract
Hydroxychloroquine (Plaquenil, Axemal, Dolquine, Quensyl) is sometimes used to treat lupus, rheumatoid arthritis, and other diseases. However, it is not a treatment used for ITP. In this new report doctors gave hydroxychloroquine to12 patients diagnosed with both ITP and lupus and another 28 patients diagnosed with ITP who also had a high ANA test result (one marker for lupus). Overall, 60% of people in the study responded to the treatment. Those who were officially diagnosed with both diseases had a higher response rate.
Khellaf M et al. “Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies.” Am. J. Hematol. Oct 28 2013.
http://onlinelibrary.wiley.com/doi/10.1002/ajh.23609/abstract
Another genetic disease has been confused with ITP, sitosterolemia (phytosterolemia). All 13 patients with this disease in the study had been misdiagnosed as having ITP, one person for 28 years. Patients with sitosterolemia can have low red cells, abnormally large platelets, premature arteriosclerosis, red or orange fatty bumps on the skin, and more. This article reminds us that ITP is a diagnosis of exclusion and sometimes other causes of low platelets are missed. It is important to tell your doctor about all medical problems to help get an accurate diagnosis.
Note: For more information on genetic causes of low platelets see:
http://www.pdsa.org/about-itp/and-families.html
Wang Z et al. “Specific macrothrombocytopenia/hemolytic anemia associated with sitosterolemia.” Am. J. Hematol. Oct 26 2013.
http://onlinelibrary.wiley.com/doi/10.1002/ajh.23619/abstract
Wouldn’t it be wonderful if there was a test to determine if you are going to respond or not to a treatment, rather than the current trial-and-error treatment model? Researchers are making some progress toward this goal. A group of scientists in France and the US found a difference in the spleen cells between those who responded to rituximab (Rituxan®) and those who didn’t. Those who didn’t respond had an increase in CD8+ T-cells and these CD8+ T-cells were in a specific pattern.
Audia S et al. “Preferential splenic CD8+ T-cell activation in rituximab-nonresponder patients with immune thrombocytopenia.” Blood. Oct 3 2013.
http://bloodjournal.hematologylibrary.org/content/122/14/2477.abstract
Many more people are dying in US hospitals from medical mistakes than previously reported, perhaps more than four times more. This makes medical errors the third leading cause of death behind heart disease and cancer. Since no one counts all medical errors and sometimes these are not reported, all numbers are estimates. However, no matter what the number, the research shows a problem that needs to be addressed. Patients can help by reporting harmful events and participating in follow-up investigations.
Allen M, ProPublica. “How Many Die from Medical Mistakes in U.S. Hospitals?” Scientific American. Sep 20 2013
http://www.scientificamerican.com/article.cfm?id=how-many-die-from-medical-mistakes-in-us-hospitals
Rodak S. “Study: Medical Error Deaths 4.5 Times More Likely Than IOM Estimate.” Becker’s Clinical Quality and Infection Control. Sep 20 2013.
http://www.beckershospitalreview.com/quality/study-medical-error-deaths-4-5-times-more-likely-than-iom-estimate.html
James JT. “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care.” Journal of Patient Safety. Sep 2013 9.13:122–8.
http://journals.lww.com/journalpatientsafety/Fulltext/2013/09000/A_New,_Evidence_based_Estimate_of_Patient_Harms.2.aspx
Prescription-Drug Imports Approved in MaineIt is no secret that people outside of the US pay less for their pharmaceuticals. Saving money by using foreign pharmacies is nothing new to those near the Canadian border. The city of Portland, Maine, saved more than $3.2 M by using a Canadian drug service between 2004 and 2012. Recently, the state of Maine has passed a law, the first of its kind, sanctioning the use of foreign pharmacies for the purchase of drugs. The drug makers are suing the state citing safety concerns.
Levitz J, Martin TW. “Maine to Allow Prescription-Drug Imports.” Wall Street Journal. Oct. 11 2013.
http://online.wsj.com/news/articles/SB10001424052702303442004579123613325473946
Many people with ITP are depressed from the disease and the treatments, but their depression can be difficult to manage since drugs like Prozac can impact platelets. Diet changes could help. In one study, more than 43,000 women who were not depressed were followed for 12 years. Those who consumed soft drinks, fatty red meat, and refined grains (ex. pasta, white bread, crackers) consistently were about 40% more likely to be diagnosed or treated for depression over time than the healthier eaters. The depressed women also had elevated markers for inflammation. A Mediterranean diet high in vegetables, olive oil, and fish was linked to a lower rate of depression in prior studies. Diet choices can also reduce inflammation.
Note: Inflammation has been linked to ITP. For information on diet and ITP see:
http://www.pdsa.org/treatments/complementary/food-as-a-cure.html
Heid M. “Pass the pasta -- and the Prozac?” Prevention News. Oct 2013.
http://www.prevention.com/mind-body/emotional-health/certain-foods-linked-inflammation-and-depression
Acupuncture Comes to the RescueAcupuncture and counseling may also improve depression according to a new study. In this study 755 people with long-standing, moderately-severe depression were divided into three groups. One group received the standard treatment for depression; a second group got the standard treatment plus acupuncture, and the third group had the standard treatment plus humanistic counseling. Both the acupuncture and counseling groups fared better than the standard treatment group. “Acupuncture seems like an excellent second-line, and perhaps even first-line, treatment for primary-care patients preferring an alternative therapy.”
Note: People with low platelets can safely get acupuncture treatments according to experts. See:
http://www.pdsa.org/treatments/complementary/energy-therapy.html
Roy-Bryne P. “Acupuncture for Depression Really Works!” NEJM Journal Watch. Oct 11 2013.
http://www.jwatch.org/na32441/2013/10/11/acupuncture-depression-really-works
MacPherson H. “Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial.” PLOS Medicine. Sep 24,2013.
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001518
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a healthcare professional.
Rituximab (Rituxan®) can reactivate hepatitis B in those who have had the disease. Because of this potential health problem, the package insert now includes a new boxed warning for the treatment. The new package information includes a recommendation for screening all patients for hepatitis B before receiving rituximab as well as suggestions for treating hepatitis B should it occur.
“Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation.” FDA. Sep 25 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369846.htm
Low platelets can be caused by a genetic anomaly, not just antibodies. While each of the individual inherited (genetic) bleeding disorders is rare, in total, they are not. Some of these inherited bleeding disorders, such as Bernard-Soulier Syndrome, have been known for 20 years, but others have been more recently characterized. “[Most] can be diagnosed by a combination of clinic history, physical examination, and standard laboratory studies, including an assortment of platelet morphologic and functional studies. Confirmatory, targeted-gene analyses are often done.”
Lambert MP, Poncz, M. “They're not your Daddy's Inherited Platelet Disorders anymore.” J Thromb Haemost. Sep 14 2013, pp:1538-7836.
http://onlinelibrary.wiley.com/doi/10.1111/jth.12405/abstract
Note: Some people with an inherited bleeding disorder are misdiagnosed as having ITP. PDSA has more information at:
http://www.pdsa.org/about-itp/and-families.html
and
http://www.pdsa.org/resources/other-platelet-disorders.html
SSRIs (selective serotonin reuptake inhibitors) are a popular class of drugs used to treat depression. Think Prozac®, Paxil ® and Zoloft ®. In the past, a number of studies have associated the use of these drugs with upper gastrointestinal bleeding after several months use. This new study shows that bleeding can occur much earlier. The study measured bleeding at 7, 14, and 28 days and found bleeding at each timeframe.
Wang YP et al. “Short-Term Use of Serotonin Reuptake Inhibitors and Risk of Upper Gastrointestinal Bleeding.” Am J Psychiatry. Sep 13 2013.
http://ajp.psychiatryonline.org/article.aspx?articleid=1738031
Your gut plays a big part in maintaining a healthy immune system, so an unhealthy gut could cause problems. Now scientists figured out a way to regulate gut immune functions. They manipulated gut bacteria in mice to enhance the activity of specific T-regulatory cells (Tregs), cells that play an important role in the development of autoimmune diseases such as ITP. They conclude: using targeted bacteria to change the gut has potential for treating immune disorders.
Atarashi R. “Treg induction by a rationally selected mixture of Clostridia strains from the human microbiota.” Nature 500. 232–236. Aug 8 2013.
http://www.nature.com/nature/journal/v500/n7461/full/nature12331.html
Physicians often rely on medical practice guidelines for treatment recommendations. However, a close review of two groups of practice guidelines, one for endocrine problems and another for cancer treatment, shows that these guidelines can be flawed. In the endocrine guidelines 34% of the strong recommendations were based on weak evidence. In a review of 169 guidelines on various types of cancer, researchers found they met only 2.75 of the 8 guideline criteria established by the National Institute of Medicine.
Brett AS. “Clinical Practice Guidelines Require Scrutiny for Quality.” Journal Watch. Sep 26 2013.
http://www.jwatch.org/na32275/2013/09/26/clinical-practice-guidelines-require-scrutiny-quality
Note: PDSA has links to various ITP guidelines and other expert commentary at
http://www.pdsa.org/treatments/treatment-resources/treatmentguidelines.html.
PDSA staff participated in the development of the International Consensus Report and witnessed the rigorous development of that document.
Google is experimenting with driverless cars, Internet by balloon, and now…ways to keep us young and healthy for a very long time. The search giant has made a major investment in the California Life Co., or Calico. Calico will be headed by Arthur Levinson, chairman of the boards of Apple and Genentech (maker of Rituxan ®). “For Google, nothing is off limits. Even death is on the firing line.”
Guynn J. “Google launches healthcare company Calico to extend life.” LA Times. Sep 18, 2013.
http://www.latimes.com/business/la-fi-google-aging-20130919,0,3691955,full.story
Many people with ITP rely on Tylenol or other products containing the main ingredient, acetaminophen, because aspirin or NSAIDs can promote bleeding. For millions of users Tylenol and like products have been safe and effective; but for 1,500 people in the last decade the drugs were instrumental in their death. Acetaminophen In large amounts, especially if combined with alcohol, can damage or even destroy the liver. It is important to use the medication as directed and read the labels of other drugs to be sure they do not contain acetaminophen and, unwittingly, add to the amount taken.
Gerth J, Miller TC. “Use only as Directed.” ProPublica. Sep 20, 2013:
http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed.
You can find more articles in the series at:
http://www.propublica.org/series/overdose
Scientists found ten toxic metals in 32 drugstore lipsticks and lip balms and 75% of the lipsticks tested contained lead. European brands may be safer since the European Union bans more than 10,000 potentially toxic ingredients from make-up while the US bans only nine. The Environmental Working Group (http://www.ewg.org/skindeep/) and The Campaign for Safe Cosmetics (http://safecosmetics.org/article.php?list=type&type=33) have much information to help you choose less toxic products.
Snowder T. “4 easy swaps to make your makeup less toxic.” Happy Living. Sep 12 2013.
http://www.ksl.com/index.php?fm=home_page&nid=1010&s_cid=featured-5&title=4-easy-swaps-to-make-your-makeup-less-toxic&sid=26829198
Note: Low platelets have been linked to toxin exposure. See:
http://www.pdsa.org/about-itp/warnings.html
Long-term corticosteroids, like prednisone, significantly diminished adrenal function in almost half of the 60 patients tested in a recent study. After the prednisone was stopped, the adrenal function in the test population returned to normal, when it was measured some months later. People who took the prednisone for a longer time, at a higher cumulative dose, had more adrenal problems.
Sacre et al. “Pituitary-Adrenal Function After Prolonged Glucocorticoid Therapy for Systemic Inflammatory Disorders: An Observational Study.” JCEM. August 2013.
http://jcem.endojournals.org/content/98/8/3199.abstract
Rigel Pharmaceuticals announced that it is planning a Phase III clinical study of fostamatinib in ITP, pending discussions with regulatory agencies. Fostamatinib is a pill that stops macrophages, a kind of white blood cell, from destroying antibody-coated platelets. The Phase III trial would enroll about 150 patients and be completed in 2015. In a Phase II trial of the drug, 75% of the people responded. The most frequent side effect was nausea. You can watch a YouTube clip that illustrates how the drug works at:
http://www.youtube.com/watch?v=ov2JUHDpt58.
“Rigel To Focus On ITP, DLE And Dry Eye:Strategy Provides Multiple Paths to Phase 3/NDA in Next 2-3 Years.” Digital Journal. Sept. 5, 2013
http://www.digitaljournal.com/pr/1451169#ixzz2eoMbP4Dr
“Fostamatinib (R788) – ITP.” Rigel Pharmaceuticals.
http://www.rigel.com/rigel/ITP
The quality-of-life of children with ITP who were treated for the disease was worse than children with ITP who were not treated, according to a survey of 217 parents of children in six countries. To reach this conclusion the researchers examined factors that could account for the variation. They found no significant differences in the initial platelet count, symptoms, or age of the children in the treatment and non-treatment groups that would explain the results. The largest decrease in quality-of-life was for newly diagnosed children treated with prednisone.
Grainger JD,et al. “Quality of life in immune thrombocytopenia following treatment.” Arch Dis Child. 2013 Aug 16.
http://www.ncbi.nlm.nih.gov/pubmed/23956257
Low platelets and the diagnosis of ITP can be associated with many infectious diseases such as HIV, H. pylori, hepatitis C and B, cytomegalovirus, Epstein–Barr virus, varicella zoster virus, and parvovirus B19. While corticosteroids (ex. Prednisone) are usually the first treatment given for low platelets, in the case of secondary ITP related to infections, IVIg may be a better choice. Corticosteroids suppress the immune system, just when the immune system is trying to fight off an infection.
Smíšková D et al. “Immune thrombocytopenia as a complication of acute infectious diseases - case reports”. Klin Mikrobiol Infekc Lek. 2013 Mar;19(1):15-8.
http://www.ncbi.nlm.nih.gov/pubmed/23945832
Some doctors in the US are paid by insurance companies more than twice what other doctors are paid for routine visits and maintenance procedures. The reimbursements were different for the same procedures, the same kind of visits, the same types of patients, and the same places of service. Geographic location explained only about one-third of the variation. To reach these conclusions, researchers looked at 40 million physician insurance claims from 2007, about 75% of them for office visits. While what a doctor is paid may not matter to patients, the resulting left-over costs can add to personal expenses.
Baker L et al. “Private insurers' payments for routine physician office visits vary substantially across the United States.” Health Aff (Millwood). 2013 Sep;32(9):1583-90.
http://www.ncbi.nlm.nih.gov/pubmed/24019363
Kelly JC. “Private Insurer Physician Payment Differences Unexplained.” Medscape Medical News. Sep 11, 2013.
http://www.medscape.com/viewarticle/810862 (free sign-on required)
Major provisions of the Affordable Care Act (Obamacare) are scheduled to begin this October. That’s when individuals can have a closer look at the new healthcare choices for the coming year. The healthcare options vary by state, since states have flexibility in how they implement the healthcare insurance exchanges and how they deal with Medicaid. Here are three websites that can help you understand how the new law will affect you and perhaps save you money.
http://healthlawanswers.aarp.org/ - creates unique suggestions based on your location, gender, age, number of people in your household, income, and current health-insurance status.
http://rarediseases.org/patients-and-families/state-by-state-insurance-information - click on your state for a contact list and state-specific regulations
https://www.healthcare.gov/ - the official US healthcare site. “Answer a few questions to see if you qualify for lower costs.”
SSRIs (selective serotonin reuptake inhibitors), a common type of anti-depressant (think Prozac), can affect platelet function and promote blood loss. Multiple studies have shown that this type of drug can increase the chance of brain hemorrhage and stomach bleeding. Serotonin, a mood-elevating protein, is attached and carried by platelets. Serotonin on platelets is also involved in the clotting process. SSRIs block the serotonin from attaching to platelets, interfering with the ability of blood to clot.
Hulisz D. “Do SSRIs Cause Bleeding?” Medscape. Aug 20, 2013
http://www.medscape.com/viewarticle/809492 (free sign-on required)
At any one time, 70% of the immune cells in the body can be found in the intestine. The bacteria and viruses in the gut (microbiota) can educate these immune cells and determine how they will behave in other parts of the body when they circulate throughout the system. This gut education process includes t-cells, the cells linked to ITP. Diet, hormones, and the environment, among other things, can affect the gut microbiota which, in turn, can impact your mood, your behavior, and your health.
Konkel. L. “The Environment Within: Exploring the Role of the Gut Microbiome in Health and Disease.” Environ Health Perspect. Sept. 2013.
http://ehp.niehs.nih.gov/121-A276/
Thrombopoietin stimulates the bone marrow to produce more platelets. However, people with ITP often fail to produce higher thrombopoietin levels to compensate, as seen in those with other low platelet diseases. In a new study, researchers looked at the TPO levels of people with various reasons for low platelets, including 21 with ITP who were treated with the TPO receptor agonists, romiplostim or eltrombopag. The study participants with ITP who had TPO levels greater than 95pg/mL did not respond well to the TPO agents. The authors conclude: “Elevated TPO levels in ITP patients may predict a poor clinical response to treatment with TPO receptor agonists.”
Note: A test to measure TPO levels is available through Quest Diagnostics (test no. 16336).
Makar RS et al. “Thrombopoietin (TPO) levels in patients with disorders of platelet production: Diagnostic potential and utility in predicting response to TPO Receptor agonists.” Am J Hematol. 2013 Aug 1.
http://www.ncbi.nlm.nih.gov/pubmed/23913253
If you received vaccinations within six months of receiving rituximab (Rituxan®), they were probably ineffective. In a new study, people who received pneumonia and flu vaccines six months after their rituximab treatments had a significantly lower response to these vaccines than the placebo group. Nearly 20% did not respond to the vaccines at all. Rituximab depletes B-cells (cells that make antibodies) and also reduces cellular immunity (the part of the immune system that doesn’t include antibodies), both needed for a healthy immune system. This cellular depletion lasts at least six months and has implications for the lack of response to vaccinations and the increased risk of infection seen in rituximab patients.
Nazi I et al. “The effect of rituximab on vaccine responses in patients with immune thrombocytopenia.” Blood. 2013 Jul 12.
http://www.ncbi.nlm.nih.gov/pubmed/23851398
In the past, many doctors did not order antiplatelet antibody tests for people with suspected ITP since these tests could not accurately diagnose the disease. Now researchers have found another potential use for the tests: helping to predict treatment response and the general course of ITP.
In one study, researchers measured antiplatelet antibodies attached to three different regions on the platelets of people with ITP: GPIIb/IIIa, GPIb/IX, and GPIa/II. Those with antibodies to GPIIb/IIIa had a much higher response to IVIg and prednisone than people with the other antibody types or those diagnosed with ITP who had no measurable antibodies.
In another study, scientists tested the antiplatelet antibody levels of those newly diagnosed with ITP using the MAIPA diagnostic test, then followed these patients to see if there was a correlation between antibody levels and their disease prognosis. The scientists concluded: “…indirect MAIPA positivity at disease onset is associated with more severe hemorrhage and predicts a chronic course in adult ITP patients.”
Liu XF et al. “Relationship between the expression of autoantibodies against platelet membrane glycoprotein and therapeutic effect in primary immune thrombocytopenia.” Zhonghua Xue Ye Xue Za Zhi.(Chinese Journal of Hematology) 2013 Jul;34(7):610-3.
http://www.ncbi.nlm.nih.gov/pubmed/23906456
Grimaldi D et al. “Antiplatelet antibodies detected by the MAIPA assay in newly diagnosed immune thrombocytopenia are associated with chronic outcome and higher risk of bleeding.” Ann Hematol. 2013 Aug 4.
http://www.ncbi.nlm.nih.gov/pubmed/23912633
Most children with ITP improve within a year, regardless of treatment, but some go on to have a much longer struggle with low platelets. Knowing whether a child will recover soon could influence treatment choices. The results of two new studies could help.
Study 1: Researchers found two factors in children who recovered more quickly from the disease: age less than 10 and a sudden onset of low platelets.
Study 2: The T-cell profile, some cytokines (cell-signaling molecules), and several blood proteins were not the same in children who had a short course of ITP and those who developed the chronic form. Because of these physical variations, the study authors concluded that chronic ITP in children is a different disease than the acute version.
Revel-Vilk S et al. “Age and Duration of Bleeding Symptoms at Diagnosis Best Predict Resolution of Childhood Immune Thrombocytopenia at 3, 6, and 12 Months.” J Pediatr. 2013 Jul 24.
http://www.ncbi.nlm.nih.gov/pubmed/23891349
Jernås M et al. “Differences in gene expression and cytokine levels between newly diagnosed and chronic pediatric ITP.” Blood. 2013 Jul 18.
http://www.ncbi.nlm.nih.gov/pubmed/23869085
US News and World Report staff analyzed data for 5,000 hospitals to determine the best and published their results for all to see. You can search their ratings for adult and children’s hospitals in total, by 16 specialty areas (alas, no hematology) and by region. See: Best Hospitals
http://health.usnews.com/best-hospitals
Is newer better? Not always, according to a new study. Of the 343 established medical practices listed in the New England Journal of Medicine from 2001 to 2010, 146 of the recommended drugs or procedures were found to be no better and sometimes worse than the previous practices. More than 40% of the usual practices studied were found to be either harmful or ineffective. Dr. Prasad, lead author of the report has this to say to patients when their doctor recommends a medical procedure: “…the real question is: Does it work? What evidence is there that it does what you say it does? What trials show that it actually works? You shouldn’t ask how does it work, but whether it works at all.”
Bakalar N. “Medical Procedures May Be Useless, or Worse.” New York Times. 2013 July 26
http://well.blogs.nytimes.com/2013/07/26/medical-procedures-may-be-useless-or-worse/
Vinay Prasad, MD et al. “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices.” Mayo Clin Proc. 2013 August;88(8):790-798.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619613004059.pdf
You are born with a set of genes, but some things within your own control can determine whether these genes and the proteins they signal get turned on or off. Exercise is one of them. In a Swedish study, scientists measured physical changes in a group of previously sedentary men after they completed a six-month exercise program. In addition to the weight loss, lower blood pressure, and lower cholesterol they expected, the researchers found changes in more than 17,900 individual locations on 7,663 separate genes in fat cells that could affect their functioning.
Reynolds G. “How Exercise Changes Fat and Muscle Cells.” New York Times. 2013 July 31.
http://well.blogs.nytimes.com/2013/07/31/how-exercise-changes-fat-and-muscle-cells/
Volkov RT et al. “A six months exercise intervention influences the genome-wide DNA methylation pattern in human adipose tissue.” PLoS Genet. 2013 Jun;9(6).
http://www.ncbi.nlm.nih.gov/pubmed/23825961
A group of students were given almonds and asked to chew them 10, 25, or 40 times. When the amount of fecal fat and energy was calculated, those who chewed the almonds the longest gained the most value and energy from the food. Vegetables, fruits, and whole grains are the best source of energy and when they are chewed well the body will absorb the smaller particles more easily. These high-fiber foods will also result in a greater loss of fat since fiber binds to fatty acids to produce energy.
“The benefit of chewing your food more.” Medical News Today. 2013 Jul 18.
http://www.medicalnewstoday.com/articles/263541.php
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
Low Vitamin D Levels Linked to ITPIn a study of vitamin D status in ITP, the 45 participants with ITP had lower levels of two types of vitamin D in their blood and an increased expression of the vitamin D gene than the 30 healthy controls. The researchers concluded: “…Vitamin D level and its receptor expression may play an important role in ITP, and vitamin D and its similarities may be a new agent to treat patients with ITP.”
Mu W, et al. “Expression and significance of vitamin d and its receptor mRNA in the peripheral blood of initial immune thrombocytopenic patients.” Chinese Journal of Hematology.2013 Jun;21(3):684-7.
http://www.ncbi.nlm.nih.gov/pubmed/23815922
Veltuzumab is an anti-CD20 monoclonal antibody that depletes B-cells, similar to rituximab (Rituxan®). It produced a meaningful response in 55% of the 41 people with ITP tested in a phase 1 study. The treatment can be given by IV or under the skin (sub-cutaneous). People responded to both infusion methods at all dose levels, with those diagnosed less than a year having a better response rate and longer time to relapse. The positive response and low rate of severe adverse reactions lead to a positive conclusion: ”Sub-cutaneous veltuzumab appears convenient, well-tolerated, and with promising clinical activity in relapsed ITP.”
Liebman HA et al. “Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study.” Br J Haematol. 2013 Jul 6.
http://www.ncbi.nlm.nih.gov/pubmed/23829485
People with ITP were separated into groups to test three different treatments and to compare their levels of T-regulatory (Tregs) cells with healthy controls. One ITP group was treated with prednisone, another with dexamethasone, and the third with rituximab plus dexamethasone. The rituximab plus dexamethasone group fared best with 67% maintaining a sustained response. When the researchers compared the Tregs of the sustained responders to those who relapsed, they found the responders had an increase in their Tregs. Tregs are important in ITP and other diseases because they play a role in balancing the immune system and preventing autoimmune disease.
Note: Prior ITP research has shown that people with ITP have a different T-cell profile compared to those in good health and that effective treatments alter their T-cells.
Li ZY et al. “Effect of different therapeutic regimens on regulatory T cells in patients of primary immune thrombocytopenia.” Chinese Journal of Hematology. 2013 Jun 14;34(6):478-81.
http://www.ncbi.nlm.nih.gov/pubmed/23827100
Platelet transfusions can be a problem. Platelets are difficult to obtain, don’t last long in storage, and are prone to contamination. So it is not surprising that scientists are looking for other ways to help people who can benefit from receiving someone else’s platelets. In one option, researchers reprogramed active stem cells to produce blood cells, including platelets, outside of the body. A company in Scotland is gearing up to mass produce these new cells and test them in humans. In a second option, scientists manufactured two chains of molecules that, when put together, act like platelets to form blood clots. They are looking at using these artificial platelets in wounded soldiers for emergency situations since these artificial platelets could cause too many blood clots in people who aren’t already in a life-threatening situation.
Press Release. “Researchers identify novel approach to create red blood cells, platelets in vitro.” Boston University. 2013 May 30.
http://www.bumc.bu.edu/2013/05/30/researchers-identify-novel-approach-to-create-red-blood-cells-platelets-in-vitro/
“World's first human trials of synthetic blood could take place in Scotland.” MRC Centre for Regenerative Medicine. 2013 May 30.
https://www.univercellmarket.com/@offers/news/view/3484/
Minor S. “A biomedical breakthrough could quicken the clotting process.” Atlanta. June 10, 2013.
http://www.atlantamagazine.com/agenda/2013/06/10/battlefront-biomedicine-georgia-tech
Medicare Enhances Doctor WebsiteMedicare staff, as part of the new healthcare law, are beginning to collect and preparing to publish physician performance data, including patient ratings and treatment success. As a first step, the Doctor Compare website was updated to include an enhanced search, more accurate contact information, and data on physician specialties. Group practice information will be added in 2014. The goal is help patients make better choices and to help reduce the more than $2.5 trillion the US spends for healthcare each year.
Rau J. “Medicare Enhances Doctor-Rating Website.” Kaiser Health News. 2013 Jun 27.
http://capsules.kaiserhealthnews.org/index.php/2013/06/medicare-enhances-doctor-rating-website/
The US lags behind most other industrialized countries in every major health measure from deaths to diminished quality-of-life. The rankings and individual quality-of-life can be improved by more people embracing a healthy diet, losing weight, exercising, and stopping smoking. But other factors responsible for the dismal ratings are less straight forward. The county level statistics varied considerably indicating that someone’s place of residence is a strong predictor or health and longevity.
Christopher J et al. “The State of US Health, 1990-2010 Burden of Diseases, Injuries, and Risk Factors.” JAMA. 2013 July 10.
http://jama.jamanetwork.com/article.aspx?articleid=1710486
Fineberg HV. “The State of Health in the United States.” JAMA. 2013 July 10.
http://jama.jamanetwork.com/article.aspx?articleid=1710485
Fox M. “Americans live a little longer, still lag other rich countries.” NBC News. 2013 July 10.
http://www.nbcnews.com/health/americans-live-little-longer-still-lag-other-rich-countries-6C10588107
Tick Diseases Can Drop Platelets: Protect YourselfThe best way to prevent illnesses caused by ticks is prevention. Here are some suggestions: If you walk in the woods, wear long pants and long sleeves. When you leave a tick-prone area, check for ticks immediately and shower within two hours. If you find a tick, remove it with a tweezers, grabbing close to where it is attached to the skin. Ticks must stay in place for 36 hours to infect someone, so immediate attention is important.
Note: Ticks can transmit Lyme disease, Rocky Mountain spotted fever, babesiosis, and ehrlichiosis, all of which can cause low platelets.
“Protect Yourself Against Tick-Borne Disease.” US Food and Drug Administration. 2013 June 26.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm358486.htm
The U.S. Preventive Services Task Force recommends screening all adults born between 1945 and 1965 for hepatitis C, even if they have no symptoms of liver problems. People born between those dates have a greater risk of having hepatitis C than others because infusion-related infection was more likely during that timeframe. Treating the disease, if found, can prevent serious liver complications. Repeat testing is not necessary.
Note: A healthy liver is very important for people with ITP since the liver makes thrombopoietin and clotting factors.
Moyer VA. “Screening for Hepatitis C Virus Infection in Adults: U.S. Preventive Services Task Force Recommendation Statement.” Ann Intern Med. 25 June 2013
http://annals.org/article.aspx?articleid=1700383
This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
People receiving IVIg, an infusion of immune globulin, have an increased chance of developing a blood clot (thrombosis) which can give them a heart attack, stroke, or other blood clotting problem, according to the Food and Drug Administration (FDA). The FDA came to this conclusion after reviewing a large medical claims database and their adverse event reports. Because of this finding, the FDA is requiring all manufacturers of IVIg to change the boxed warnings on the product labels to highlight the risk of thrombosis plus add instructions on what to do if a clot develops.
Note: Low platelets do not protect someone from developing unwanted blood clots.
“FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.” June 10, 2013
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm355986.htm
People with ITP who were older than 65 years when they had a splenectomy had three times more bleeding problems, stayed in the hospital twice as long, and had less favorable responses than those who were younger than 65 when they had the operation, according to recent research tracking 218 patients. Patients between 65 and 70 in good health had fewer problems than others in the ‘elderly’ category. The rate of laproscopic and open surgeries was about the same in the two groups.
Gonzalez-Porras JR et al. “Safety and efficacy of splenectomy in over-65 year old patients with immune thrombocytopenia.” Eur J Haematol. 2013 May 17.
http://www.ncbi.nlm.nih.gov/pubmed/23679653
Despite low platelets, many people with ITP are prone to get blood clots. Of the 165 people with ITP followed in a recent study, almost 13% developed a clotting problem. The major risk factor was the presence of antiphospholipid antibodies, antibodies against phospholipids in the blood, a protein needed for the blood to clot. Other risk factors were high blood pressure and lupus anticoagulant (antibodies that bind to phospholipids and proteins associated with the cell membrane).
Kim KJ et al. “Thrombotic risk in patients with immune thrombocytopenia and its association with antiphospholipid antibodies.” Br J Haematol. 2013 Jun;161(5):706-14.
http://www.ncbi.nlm.nih.gov/pubmed/23530551
A recent case report reminds us that the thrombopoietin (TPO) agents, romiplostim (Nplate®) and eltrombopag (Promacta®/Revolade®) work slightly differently. If one fails, switching to the other one can be effective. In this particular report a patient failed steroids, splenectomy, IVIg, rituximab, and finally, eltrombopag. Romiplostim was successful in raising the platelet count.
Piccin A et al, “Idiopathic thrombocytopenic purpura resistant to eltrombopag, but cured with romiplostim.” Blood Transfusion. 2013 Apr 17.
http://www.bloodtransfusion.it/articolosing.aspx?id=000433
The Food and Drug Administration (FDA) encourages consumers to report problems with the products they regulate (drugs, medical devices, biologics, food, cosmetics, and supplements) through their MedWatch system. To make the process easier and encourage more public input, the organization has released a simplified form. Anyone can complete the form and notify the FDA of side effects, quality problems, or other serious issues. When the FDA sees a pattern in these reports they can require a label change, take a product off the market, and more. You can access the new form at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf or https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
“WANTED: Consumers to Report Problems.” FDA Consumer Updates. 2013 Jun 3.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm
The US Government funds many clinical research studies; but some of them do not have a sufficient ethical review and problems in the studies may be discovered too late, according to experts. Some factors contributing to these issues are inexperienced Institutional Review Board members, increased numbers of clinical trial participants, international recruitment, financial conflicts of interests, and lack of attention to lay input. While there are many areas that could be improved, the safety and transparency of clinical studies is much better than in the past.
Ammann AJ. “US clinical-research system in need of review.” Nature. 05 June 2013.
http://www.nature.com/news/us-clinical-research-system-in-need-of-review-1.13126?WT.ec_id=NATURE-20130606
“President’s Bioethics Commission Releases Report on Human Subjects Protection.” 2011Dec 15
http://bioethics.gov/node/559
Note: PDSA has information for people who are considering participation in a clinical trial at
http://www.pdsa.org/about-itp/clinical-trials.html
Residues of glyphosate, the active ingredient in Roundup, are found in many foods containing wheat, soy, corn, and sugar. This herbicide inhibits the cytochrome P450 (CYP) enzyme in people, the enzyme that plays an important role in detoxifying harmful chemicals we breathe and eat. This impaired detox process, over time, disrupts gut bacteria and increases inflammation, promoting the many diseases associated with the Western diet such as obesity, diabetes, heart disease, and more.
Samsel A, Seneff, S. “Glyphosate’s Suppression of Cytochrome P450 Enzymes and Amino Acid Biosynthesis by the Gut Microbiome: Pathways to Modern Diseases.” Entropy 2013, 15(4), 1416-1463.
http://www.mdpi.com/1099-4300/15/4/1416
Note: Exposure to toxic substances can reduce the platelet count. See:
http://www.pdsa.org/about-itp/warnings.html
People in all vegetarian categories, including some who occasionally eat fish and a little meat, had a lower mortality rate than the national average, concluded researchers in a study of 73,308 Seventh-day Adventist men and women. Those who considered themselves vegan fared the best. Men’s disease and mortality rate showed more improvement over the national average than women with this diet regimen.
Orlich MJ et al. “Vegetarian Dietary Patterns and Mortality in Adventist Health Study 2.” JAMA Intern Med. 2013;():1-8.
http://archinte.jamanetwork.com/article.aspx?articleid=1691919
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a healthcare professional.
People with ITP who had a splenectomy were about three times more likely to develop a blood clot in their veins, almost twice as likely to develop a blood clot in their abdomen soon after surgery, and had a slightly higher risk of developing sepsis, a severe blood infection. To reach these conclusions researchers examined the medical records of 1,762 splenectomized patients with ITP and compared them to 8214 people with ITP who did not have the surgery.
Boyle S et al. “Splenectomy and the incidence of venous thromboembolism and sepsis in patients with immune thrombocytopenia.” Blood. 2013 May 1.
http://www.ncbi.nlm.nih.gov/pubmed/23637127
Parents with children diagnosed with ITP know those bruises are not the result of some angry assault, just low platelets. However, others have a more nuanced task since there are many bleeding disorders that can result in a bruised child and people who are not familiar with these causes can jump to the wrong conclusion. To address this situation the AmericanAcademy of Pediatrics published a clinical report and journal article that reminds those who suspect child abuse to look for bleeding disorders and provides a step-by-step guide to accomplish the task. These resources can also come in handy for parents of children with bleeding disorders. The clinical report and journal article are available to all at no cost.
Anderst JD et al. “Clinical Report:Evaluation of Bleeding Disorders in Suspected Child Abuse.” Pediatrics. 2013 April 131(4):e1314-22.
http://pediatrics.aappublications.org/content/early/2013/03/18/peds.2013-0195.full.pdf
Carpenter SL et al. “Evaluating for Suspected Child Abuse: Conditions That Predispose to Bleeding.” Pediatrics. 2013 April 131(4):1357-1373.
http://pediatrics.aappublications.org/content/early/2013/03/18/peds.2013-0196.full.pdf
H. pylori, a bacteria found in the stomach, has been associated with many diseases, including ITP. Researchers in China found that children with ITP had twice the rate of H. pylori infection than those without the disease. They divided the children with ITP and H.pylori into two groups and assigned them to two treatment protocols: steroids and steroids plus antibiotics. The children treated with antibiotics to eradicate the H.pylori had a better response to the treatments and were less apt to relapse. This confirms earlier research and indicates the potential benefit of identifying and eradicating H.pylori in children with ITP.
Tang Y et al. [Clinical significance of helicobacter pylori in children with idiopathic thrombocytopenic purpura].Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2013 Mar 21(2):419-21.
http://www.ncbi.nlm.nih.gov/pubmed/23628045
Russo G et al, “Effect of eradication of Helicobacter pylori in children with chronic immune thrombocytopenia: a prospective, controlled, multicenter study.” Pediatr Blood Cancer. 2011 Feb;56(2):273-8.
http://www.ncbi.nlm.nih.gov/pubmed/20830773
ITP experts from London have done all of us a favor by creating a single journal article that explains why a treatment that stimulates platelet production is successful in raising the platelet count of people with ITP. The article describes romiplostim (Nplate®), how it works, why it works, and how successful it has been in clinical trials, along with the usual side effects and its effect on the quality of life of patients. The entire journal article is available FREE.
Cooper N et al. “The efficacy and safety of romiplostim in adult patients with chronic immune thrombocytopenia.” Ther Adv Hematol. 2012 October; 3(5): 291–298.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627322/
The costs to treat a condition in one hospital can be as much as 50 times greater than treating the same condition in another hospital, according to data gathered by the Centers for Medicare and Medicaid Services (CMS). CMS assembled and analyzed detailed charges for the most common discharge codes from more than 3,000 hospitals. The detail data is available to the public. To see the costs for hospitals near you, download the data to a spreadsheet (http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/index.html) or select and sort the data online (https://data.cms.gov/Medicare/Inpatient-Prospective-Payment-System-IPPS-Provider/97k6-zzx3). This is just the beginning. The US government and other organizations are funding more ways to make medical costs transparent and available to everyone.
“Report outlines ‘vast variations’ in hospital costs.” Hem/Onc Today. May 9, 2013.
http://www.healio.com/hematology-oncology/practice-management/news/online/%7B3506C9E5-5F3E-47BB-9946-950A6BC7BD91%7D/Report-outlines-vast-variations-in-hospital-costs
For several years the US Food and Drug Administration (FDA) has increased their outreach to consumers through meetings and newsletters. They recently completed the most ambitious part of their public communication efforts: the FDA Patient Network website (http://www.patientnetwork.fda.gov/). This comprehensive source gives everyone easy access to information about the regulatory process, diseases, clinical trials, medications, treatment options, and more.
“FDA Wants YOU (to Get Involved).” FDA Consumer Updates. April 23, 2013.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm348661.htm
People with compromised immune systems (for example, those without a spleen or taking immune-suppressing drugs like prednisone) are at a greater risk of becoming very sick when exposed to listeria, a bacteria found in some food. Listeria is most prevalent in deli meats, hot dogs, smoked seafood, and store-prepared deli salads. But that is not an inclusive list since a few years ago it was found in cantaloupes. To prevent illness caused by listeria (listeriosis) keep refrigerated foods cold, clean your refrigerator regularly, and clean hands and kitchen surfaces often. The FDA web site has details and more tips on avoiding listeriosis.
“Keep Listeria Out of the Kitchen.” FDA Consumer Updates. May 10, 2013.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm274114.htm
Not everyone has access to or can afford to buy only organic produce, so the folks at the Environmental Working Group have done us all a favor by measuring the amount of pesticide residue in fruits and vegetables. They separated their findings into the fruits and vegetables with the most pesticide residue and those with the least. This helps us understand the food items that are most important to buy organic and the items that are less risky, from a pesticide residue viewpoint. See EWG's 2013 Shopper's Guide to Pesticides in Produce™
http://www.ewg.org/foodnews/summary.php
“Apples Top EWG's Dirty Dozen.” Environmental Working Group Press Release. April 22, 2013.
http://www.ewg.org/foodnews/press.php
Note: Pesticides have been linked to increased destruction of platelets in the spleen. For this reference and more information on the effects of environmental compounds on platelets see the ‘Warnings’ page:
http://www.pdsa.org/about-itp/warnings.html
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
Oxidative stress, the over-production of free radicals, is associated with many disease states, including ITP. In one study, newly diagnosed people with ITP had ten times the amount of vanin-1 protein (an indicator of oxidative stress), and those with chronic, non-responsive disease had three times the amount, compared to healthy controls. In another study, people with ITP had an increase in the blood proteins that signal oxidative stress and a decrease in the proteins that mitigate oxidative stress. In both studies, the authors conclude that oxidative stress may play a role in ITP and dealing with it may have therapeutic benefits.
Note: Diet, exercise, and relaxation techniques can reduce oxidative stress. See:
http://www.pdsa.org/treatments/complementary.html
Elsalakawy WA et al. “Value of vanin-1 assessment in adult patients with primary immune thrombocytopenia.” Platelets. 2013 Mar 27.
http://www.ncbi.nlm.nih.gov/pubmed/23534352
Jin CQ et al. “Antioxidant status and oxidative stress in patients with chronic ITP.” Scand J Immunol. 2013 Mar 30.
http://www.ncbi.nlm.nih.gov/pubmed/23551069
Epstein-Barr virus (EBV, a type of herpes virus linked to mononucleosis) and cytomegalovirus (CMV, another type of herpes virus) have been associated with the development of ITP. These viruses were evident in about 20% of the spleens of the 40 people with ITP studied, versus only one of 20 in the control group. Those with ITP whose spleens contained the Epstein-Barr virus had a reduced platelet count compared to those with ITP who were not exposed to this virus. There was no difference in the platelet counts for the ITP patients if they did or didn’t have CMV antibodies.
Note: The “International consensus report on the investigation and management of primary immune thrombocytopenia.” suggests that testing ITP patients for the presence of CMV can have some benefit.
http://bloodjournal.hematologylibrary.org/content/115/2/168.full
For information on how viruses can cause ITP see:
http://www.pdsa.org/about-itp/causes.html
Wu Z et al. “The role of Epstein-Barr virus (EBV) and cytomegalovirus (CMV) in immune thrombocytopenia.” Hematology. 2013 Mar 22.
http://www.ncbi.nlm.nih.gov/pubmed/23540727
Pediatric hematologists from around the world have submitted data on their treatment of children with ITP to the Intercontinental Cooperative ITP Study Group (ICIS). With disease history for 1,345 children, it is the largest database of its kind in existence. A recent summary of the data states: “Remission was observed in 37% of patients between 28 days and 6 months, 16% between 6 and 12 months, and 24% between 12 and 24 months. There were no reports of intracranial hemorrhage, and the most common site of bleeding was skin.” Increased drug treatment was associated with an increased number of bleeding sites.
In a study of hospital records in the US from 2008 to 2010, researchers found 2,314 children (age 1 – 18) admitted with a new diagnosis of ITP. Although guidelines recommend a conservative and mostly watchful waiting approach to children with ITP, 90% of the children in this hospital study received a treatment, usually IVIg. There was considerable geographic variation in treatment strategies, length of stay, charges, and readmission rates.
Neunert CE et al. “Bleeding manifestations and management of children with persistent and chronic immune thrombocytopenia: data from the Intercontinental Cooperative ITP Study Group (ICIS).” Blood. 2013 Apr 2.
http://bloodjournal.hematologylibrary.org/content/early/2013/04/02/blood-2012-12-466375.abstract
Kime C et al. “Patterns of Inpatient Care for Newly Diagnosed Immune Thrombocytopenia in US Children's Hospitals.” Pediatrics. 2013 Apr 8.
http://pediatrics.aappublications.org/content/early/2013/04/03/peds.2012-2021.abstract
We first mentioned the success of this combination in our January 2013 e-news when the study results were available on-line. Since the paper has been in print, this therapeutic approach has gained traction with articles in other venues and with more published research. In short, it has people talking. In this study published in Blood, the rituximab (Rituxan®) plus dexamethasone group had a better response (and a greater number of side effects) than the dexamethasone-only group. But what sets this study of newly diagnosed ITP patients apart is that it was a randomized controlled trial comparing two treatments for ITP with a relatively long follow-up period.
The Blood study used the lymphoma dose of rituximab. Another study, looking at prior patient experience, showed that using a lower dose of rituximab plus dexamethasone was more effective than prednisone for newly diagnosed patients.
Rao VK. “ITP: hematology's Cosette from Les Miserables.” Blood. 2013 Mar 14;121(11):1928-30
http://bloodjournal.hematologylibrary.org/content/121/11/1928.long
”Rituximab improved dexamethasone response rates in immune thrombocytopenia.” Healio Hematology/Oncology April 4, 2013.
http://www.healio.com/hematology-oncology/hematology/news/online/%7Bd1c2680d-b565-45f3-b173-0d40fd8be316%7D/rituximab-improved-dexamethasone-response-rates-in-immune-thrombocytopenia
Gudbrandsdottir S et al. “Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia.” Blood. 2013 Mar 14;121(11):1976-81.
http://www.ncbi.nlm.nih.gov/pubmed/23293082
Gómez-Almaguer D et al. “High response rate to low-dose rituximab plus high-dose dexamethasone as frontline therapy in adult patients with primary immune thrombocytopenia.” Eur J Haematol. 2013 Mar 7.
http://www.ncbi.nlm.nih.gov/pubmed/23470153
Selected physicians in Canada, France, and the US participated in a survey to assess the quality of information they received from consecutive visits by pharmaceutical sales representatives. The pharmaceutical reps mentioned adverse events in about 5% of drug promotions, although 45% of these drugs had black box warnings, a sign that the FDA considered them to have significant potential problems. More harm information was mentioned in France, a country that has stricter laws regarding pharmaceutical promotion. Despite the lack of information, doctors said they were ready to prescribe the treatments 64% of the time. This research questions “whether current approaches to regulation of sales representatives adequately protect patient health.”
Mintzes B et al. “Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States.” J Gen Intern Med. 2013 Apr 5.
http://www.ncbi.nlm.nih.gov/pubmed/23558775, http://link.springer.com/article/10.1007/s11606-013-2411-7
The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996, is sometimes used to prevent family members from receiving the information they seek and are entitled to, according to Carol Levine of the United Hospital Fund. Healthcare professionals can share relevant information with family members unless the patient specifically objects. HIPAA is there to protect patients, and patients can share their health information with anyone they choose. To clarify patient rights under HIPAA, The United Hospital Fund has published easy-to-understand information on their Next Step in Care Web site.
(http://www.nextstepincare.org/next_step_in_care_guides/4/HIPAA/english)
Span P. “A Privacy Law Often Misinterpreted.” New York Times. March 7, 2013.
http://newoldage.blogs.nytimes.com/2013/03/27/a-privacy-law-often-misinterpreted/
Our long-time readers know that PDSA has always advocated eating leafy greens, especially kale and collards, for many reasons. Now there is another one. New research shows that leafy greens can switch on the genes that create innate lymphoid cells (ILCs), a type of immune cell that lives in our digestive system. “ILCs are essential for maintaining the delicate balance between tolerance, immunity and inflammation,” the very factors that play a part in developing ITP and maintaining low counts. The researchers, surprised that food could control gene expression, are exploring this further.
Press release. “Gene discovery reveals importance of eating your greens.” Walter+Elisa Hall Institute of Medical Research. April 3, 2013.
http://www.wehi.edu.au/site/latest_news/gene_discovery_reveals_importance_of_eating_your_greens
Rankin LC. “The transcription factor T-bet is essential for the development of NKp46+ innate lymphocytes via the Notch pathway.” Nature Immunology 14, 389–395 (2013).
http://www.nature.com/ni/journal/v14/n4/abs/ni.2545.html
Researchers looked at the urine levels of bisphenol A (BPA, found in many plastics) and triclosan (found in some hand sanitizers, toothpaste, and other products), both endocrine disrupters, in adults and children. They then compared the BPA and triclosan levels with the presence of cytomegalovirus (CMV) antibodies and the diagnosis of allergies and hay fever. In adults, BPA was associated with higher levels of CMV antibodies. Tricolsan was associated with a diagnosis of hay fever and allergies.
Note: CMV infections have been associated with the diagnosis of ITP (see “More Viruses Found in ITP Patients” above) and hay fever and allergies are a sign of an over-active immune system.
Clayton EM et al. “The impact of bisphenol A and triclosan on immune parameters in the U.S. population, NHANES 2003-2006.” Environ Health Perspect. 2011 Mar;119(3):390-6.
http://www.ncbi.nlm.nih.gov/pubmed/21062687
This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
For almost everyone who takes them, the thrombopoietin agents (romiplostim and eltrombopag) promote a safe platelet count as long as they are given. However, for some, the platelet count can remain at a safe level when the treatments are discontinued. In a study of 31 chronic ITP patients taking TPO agents in a single practice, nine were able to discontinue the treatments and retain their elevated platelet count. In three of these patients, the platelets remained above 100,000/µl and didn't return to baseline. This study supports the practice of gradually lowering the dose of these treatments.
Ghadaki B et al. "Sustained remissions of immune thrombocytopenia associated with the use of thrombopoietin receptor agonists." Transfusion. 2013 Mar 3.
http://www.ncbi.nlm.nih.gov/pubmed/23451917
Surgical guidelines suggest platelet counts of at least 50 000/µl before minor surgery and 80 000/µl before major surgery. Of the 494 participants in the eltrombopag (Promacta®/Revolad®) studies, 87 had either a major or minor non-dental surgery. Prior to their surgery the majority of these people had platelet counts within the guidelines and only two experienced a bleeding event. These findings show that eltrombopag can raise the platelet count to meet surgical guidelines for most patients.
Tarantino MD et al. "Hemostatic challenges in patients with chronic immune thrombocytopenia treated with eltrombopag." Platelets. 2013 Feb 12.
http://www.ncbi.nlm.nih.gov/pubmed/23402314
Patients taking romiplostim (Nplate®) for up to five years (recorded in a single-arm, open-labeled study) were generally able to maintain a platelet count of 50 000/µl. on stable doses of the treatment. No new side effects were noticed in the group and very few people required rescue therapies. There were few serious adverse events and these didn't increase with the length of time someone was treated
Kuter DJ et al. "Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy." Br J Haematol. 2013 Feb 22.
http://www.ncbi.nlm.nih.gov/pubmed/23432528
Researchers looked at the humoral immunity of people with ITP, the part of the immune system present in body fluids, not regulated by cells such as white blood cells. To study humoral immunity they gave volunteers a dose of pneumonia vaccine and measured the antibodies people developed as a result of the shot. Normally, someone would develop antibodies against the types of pneumonia in the vaccine and therefore be less prone to get pneumonia. Of the people in the study, 39% showed signs of some immune deficiency. A specific antibody deficiency was the most common. The authors recommend that people with ITP get an evaluation of their immune function. This is especially important for people who have had a splenectomy since the spleen plays a role in antibody production.
Rahiminejad MS. "Evaluation of humoral immune function in patients with chronic idiopathic thrombocytopenic purpura." Iran J Allergy Asthma Immunol. 2013 Mar;12(1):50-6.
http://www.ncbi.nlm.nih.gov/pubmed/23454778
Hospitals, Insurance, and Medical Care Clinical trials in children are usually very small so it is important to report serious adverse events for drugs and devices used by children to the FDA. When reporting be sure to include the product name, type, dose, how it was used, age of the child, other medications or medical conditions, outcome, contact information for the person submitting the report, and the child's doctor. The FDA places these reports in a database that is monitored by staff to determine if additional follow-up is needed. You can report adverse event problems for children and adults on-line through MedWatch, http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
FDA Consumer Update. Report Kids' Problems With Medical Products. Feb. 19, 2013.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm339672.htm
In February, 17 medical societies added 90 more tests and procedures that are often unnecessary and could be harmful to the Choosing Wisely Web site. Choosing Wisely®, a campaign of the American Board of Internal Medicine Foundation, seeks to reduce treatment costs, reduce the risks associated with additional procedures, and change the medical culture of 'more is better." The group hopes information on the Web site will help patients engage in a conversation with their doctors when their situation matches those on the list.
Choosing Wisely: http://www.choosingwisely.org/
Salt, sodium chloride, found in processed foods and many home salt shakers, can alter CD4+ helper T-cells (TH17 cells), cells that help regulate the immune system. Researchers in Germany and the US found these altered TH17 cells caused additional inflammation which can lead to autoimmune disease. More salt led to more inflammation and more problems. Some salt is necessary for the body to function. However, pure sodium chloride, salt without accompanying minerals present in sea salt, may be causing more problems because minerals are absent from many people's diets.
Kleinewietfeld M et al. "Sodium chloride drives autoimmune disease by the induction of pathogenic TH17 cells." Nature. 06 March 2013.
http://www.ncbi.nlm.nih.gov/pubmed/23467095
McCarthy A. "Scientists Officially Link Processed Foods To Autoimmune Disease." PreventDisease.com. 07 March 2013.
http://preventdisease.com/news/13/030713_Scientists-Officially-Link-Processed-Foods-To-Autoimmune-Disease.shtml
Millions of people take drugs to lower their blood pressure and cholesterol. These drugs, taken individually or in combination, may trigger low platelets for someone susceptible to drug-induced thrombocytopenia. In a case report, doctors found that a low blood pressure medication, amlodipine (a calcium channel blocker with many different names) definitely caused their patient's low platelets and the cholesterol-lowering drug, simvastatin (Zocor) probably contributed to the low platelets as well. This case reminds us that some of the most popular drugs can cause low platelets and it is difficult to determine the specific drug culprit when someone is taking more than one drug.
For more information on drug-induced thrombocytopenia and a list of drugs that are known to cause low platelets see:
http://www.ouhsc.edu/platelets/ditp.html
Cvetković Z, et al. "Simvastatin and amlodipine induced thrombocytopenia in the same patient: double trouble and a literature review."J Clin Pharm Ther. 2013 Feb 26
http://www.ncbi.nlm.nih.gov/pubmed/23442182
This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
Sometimes people with ITP do not require constant therapy. In a trial of short-term administration of eltrombopag (Promacta®/Revolade®) participants were given three short-term courses of the drug. Of those that responded to the first cycle, 87% responded to the second and 71% responded to both the second and third cycle. Adverse events did not increase with subsequent cycles. The authors conclude that eltrombopag is likely to be safe and effective for those people with ITP who need only intermittent treatment.
Bussel JB. “Repeated short-term use of eltrombopag in patients with chronic immune thrombocytopenia (ITP).” Br J Haematol. 2013. v160, pp.538–546.
http://onlinelibrary.wiley.com/doi/10.1111/bjh.12169/abstract
Scientists found that romiplostim (Nplate®) increased the number of megakaryocytes, the cells in the bone marrow that produce platelets, but decreased the ability of these megakaryocytes to spin off platelets. Increasing the dose of romiplostim increased these effects. Because this research was done in a test tube the scientists could explore some of the reactions in more detail. They found the platelet response correlated with the AKT protein involved in regulating cell survival.
Currao M et al. “High doses of romiplostim induce proliferation and reduce proplatelet formation by human megakaryocytes.” PLoS One. 2013;8(1):e54723. 2013 Jan 24.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3554640/
Doctors in Switzerland report three patients who had severe skin reactions to eltrombopag (Promacta®/Revolade®). In all three cases the skin problems cleared after eltrombopag was discontinued. Patient 1 was diagnosed with erythroderma, a scaly skin reaction. Patient 2 had exanthema, a wide-spread rash. Patient 3 had erythema, general redness. It is important to note that one of these patients had many other diseases and the other two had a history of allergic reactions.
Meyer SC et al. “Severe cutaneous toxicity related to Eltrombopag.” Br J Haematol. 2013. v160, pp.404–418.
http://onlinelibrary.wiley.com/doi/10.1111/bjh.12126/full
People with ITP Have More Surgical Complications
Surgical patients with ITP had more fatalities, more complications after surgery, longer hospital stays, a greater chance of going to the intensive care unit, and higher medical costs than those without ITP. This was particularly true if the person required red blood cell or platelet transfusions or was admitted during an emergency. To reach these conclusions researchers matched the medical records of people with ITP with those without the disease trying to isolate only those factors due to ITP.
Chang CC et al. “Adverse postoperative outcomes in surgical patients with immune thrombocytopenia.” Br J Surg. 2013 Jan 25.
http://www.ncbi.nlm.nih.gov/pubmed/23355086
The Affordable Care Act has many provisions. Some have been implemented; others will begin this year or later. For 2013: Insurance for small businesses and individuals must include essential health benefits in ten areas; Insurance, in most cases, must offer contraceptive coverage; States must plan for affordable insurance exchanges to be available January 1, 2014; Beginning January 1, 2014 insurers may not deny people coverage based on pre-existing conditions and must set insurance premiums evenly.
Haughton-Denniston P. “What’s New What's Next With the Affordable Care Act in 2013.” Dorland Health. January 7, 2013
http://www.dorlandhealth.com/case_management/trends/Whats-Next-With-the-Affordable-Care-Act-in-2013_2621.html
For additional information on the Affordable Care Act see:
http://www.healthcare.gov/
A new rule will require companies making drugs, biologics, devices, and supplies and receiving funds from federal healthcare programs (ex: Medicare, Medicaid) to report how much money they give to doctors and teaching hospitals. The Centers for Medicare and Medicaid Services (CMS) will begin collecting this data August 1, 2013 and will make it available on a public Web site by Sept. 30, 2014. According to Dr. Peter Budetti of the CMS, “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”
“Affordable Care Act ‘Sunshine Rule’ Increases Transparency in Health Care.” CMS Press Release. February 1, 2013.
http://www.cms.gov/apps/media/press_releases.asp
Corticosteroids (ex. prednisone) can cause osteoporosis with even a small dose. However, deciding when and how to treat bone loss involves many factors: availability and affordability of conventional treatments, likely implementation of lifestyle changes, age, and fracture risk. The World Health Organization has developed a tool to help determine the potential for fracture risk to aid the decision process (http://www.shef.ac.uk/FRAX/). Whatever the risk, it is important for the physician and the patient taking corticosteroids to discuss this complication early in the treatment cycle.
Deal CL, “Recent recommendations on steroid-induced osteoporosis: More targeted, but more complicated.” Cleveland Clinic Journal of Medicine. February 2013. v80:2. pp.117-125.
http://www.ccjm.org/content/80/2/117.full.pdf+html
Quiet the mind, quiet the body. In a study comparing people who completed and practiced mindfulness-based stress reduction, a type of meditation, with those who didn’t, the meditators had an easier time handling stress and healed more quickly from induced inflammation. The author conclude: “These results suggest behavioral interventions designed to reduce emotional reactivity may be of therapeutic benefit in chronic inflammatory conditions.”
Rosenkranz MA et al. “A comparison of mindfulness-based stress reduction and an active control in modulation of neurogenic inflammation.” Brain, Behavior, and Immunity. January 2013. v 27.pp.174–184.
http://www.sciencedirect.com/science/article/pii/S0889159112004758
Note: ITP has been associated with increased inflammation.
This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
This e-newsletter is a monthly publication of the Platelet Disorder Support Association. The information in this newsletter is for educational purposes only. For advice on your unique medical condition, please consult a health care professional.
Contents:
Eltrombopag (Promacta®/Revolade®) and romiplostim (Nplate®) are similar to naturally occurring thrombopoietin (TPO) in that they stimulate the bone marrow to produce more platelets. While they are very effective, they don't work for everyone. Two patients were featured in a report demonstrating that switching from one agent to another may be beneficial. In one case the patient was given eltrombopag, then switched to romiplostim. In another patient, the switch was from romiplostim to eltrombopag. In both cases the patients improved with the second TPO option. Romiplostim and eltrombopag attach to a different position in the thrombopoietin receptor and that, along with subtle differences in the patients' genes, may explain these results.
Polverelli N et al. "Absence of bi-directional cross-resistance of thrombopoietin receptor agonists in chronic refractory immune thrombocytopenia: possible role of MPL polymorphisms." Br J Haematol. Dec. 29, 2012.
http://onlinelibrary.wiley.com/doi/10.1111/bjh.12186/full
The National Institute for Health and Clinical Excellence (NICE) in the UK issued draft guidance approving the use of eltrombopag (Revolade®) for qualified UK patients. The treatment is recommended for those people who have had a splenectomy and failed corticosteroids and IVIg or as a second- line treatment in cases where a splenectomy could cause problems. The final guidance is scheduled for May, 2013, and is dependent upon the manufacturer supplying the drug at a discount. Romiplostim was approved by NICE in 2011 with similar terms.
NICE Press Release. "NICE says yes in draft guidance to eltrombopag for the treatment of chronic immune (idiopathic) thrombocytopenic purpura." Dec. 18, 2012.
http://www.nice.org.uk/newsroom/pressreleases/NICESaysYesInDraftGuidanceToEltrombopagForTheTreatmentOfChronicImmuneIdiopathicThrombocytopenicPurpura.jsp
Painengda® is a new treatment being tested in China for the treatment of ITP as well as diseases with low amounts of white and red blood cells. The drug, a patented compound isolated from ginseng (a plant used to treat various ailments for centuries) stimulates the bone marrow to produce more blood cells and regulates the immune system. Based on successful animal testing, it was approved for clinical trials in 2010. Production of the compound is moving forward.
Note: Ginseng can interfere with the ability of blood to clot. However Painengda contains just one of the many compounds in ginseng and has different properties.
Gao RL,Chong BH. "Research and development of the effective components of panaxdiol saponin as new chinese patent medicine for treating hemocytopenia." Chin J Integr Med. 2012 Dec;18(12):897-902.
http://www.ncbi.nlm.nih.gov/pubmed/23238997
Dexamethasone (a corticosteroid similar to prednisone) and rituximab (Rituxan®) are both used to treat ITP soon after diagnosis. Perhaps a combination of the two would lead to a better recovery rate. To investigate that possibility researchers randomized 133 newly diagnosed patients into two groups, one group taking dexamethasone alone and the other trying the duo. The combo group did have a better response rate with 58% achieving a platelet count greater than 50,000/uL at six months versus 37% for the dexamethasone group. The combo group also had a longer-lasting response and more adverse events.
Gudbrandsdottir S, "Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia." Blood. 2013 Jan 4.
http://www.ncbi.nlm.nih.gov/pubmed/23293082
Insurance companies in the US are sometimes asking for and getting double-digit rate increases (some more than 20%) in healthcare premiums, mostly for small businesses and individuals with their own health insurance. The rate hikes for employee-based plans are about 4%. Some states regulate insurance rates and others so not which leads to a big difference in the rates by state. Medical costs are expected to increase an average of about 7.5% next year.
Between 2003 and 2011 premiums for employee-based health insurance plans increased 62%, employee contributions increased 74%, and the cost of deductibles has risen 177%, indicating that everyone is paying more for insurance and getting fewer protective benefits.
Abelson R. "Health Insurers Raise Some Rates by Double Digits." New York Times. Jan. 5, 2013.
http://www.nytimes.com/2013/01/06/business/despite-new-health-law-some-see-sharp-rise-in-premiums.html
Schoen C. "State Trends in Premiums and Deductibles, 2003–2011: Eroding Protection and Rising Costs Underscore Need for Action." The Commonweath Fund Issue Brief. Dec. 12, 2012 | Volume 31.
http://www.commonwealthfund.org/Publications/Issue-Briefs/2012/Dec/State-Trends-in-Premiums-and-Deductibles.aspx (includes state-by-state variations).
Of the $2.2 trillion spent on healthcare in the United States, $1.2 trillion is wasted, according to a Price Waterhouse Coopers report. The wasteful practices fall into three categories: behavioral (where lifestyle changes can prevent or help the problem); clinical (overuse, misuse, underuse, missed opportunities or errors in medical care); and operational (administrative and other business costs that do not benefit the patient.)
"The price of excess: Identifying waste in healthcare spending." Price Waterhouse Cooper (complete report - free .pdf)
http://www.pwc.com/us/en/healthcare/publications/the-price-of-excess.jhtml
Americans die sooner and have more illnesses and accidents than those in 16 other affluent countries according to a report by the National Research Council and the Institute of Medicine. This was true for everyone including those with higher incomes, a college education, and health insurance. The average life expectancy for men, 75.6 years, was the lowest of all countries included in the report. The average life expectancy for women, 80.8 years, was the second lowest. A national conversation on the importance of public health could help mitigate the many factors that contribute to these disparities and close the wellness gap.
Radnofsky L. "U.S. Lags Peers in Life Expectancy." The Wall Street Journal. Jan. 10, 2013 page A2.
U.S. Health in International Perspective: Shorter Lives, Poorer Health. National Academies Press. 2013. (complete report - free .pdf)
http://www.nap.edu/catalog.php?record_id=13497
Note: PDSA encourages everyone to adopt healthy lifestyle practices.
See http://www.pdsa.org/products-a-publications/diet-a-lifestyle-info.html
Americans could theoretically gain up to two years in life expectancy if they reduced their sitting time to less than three hours per day, according to an analysis of available data. If TV watching was reduced to less than 2 hours per day, that act alone could increase life expectancy by 1.38 years. These research findings suggest that a sedentary life is a comparable health risk to smoking and obesity.
Katzmarzyk PT, Lee I-M. "Sedentary behaviour and life expectancy in the USA: a cause-deleted life table analysis." 2012. British Medical Journal Open.
http://bmjopen.bmj.com/content/2/4/e000828.full.pdf+html
This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org