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Not all methods for counting platelets are created equal, according to a recent study. The study found that a commonly used method, called the impedance method, produces platelet counts lower than the immunoflourescence method at low platelet levels. Because therapy choices are based on platelet counts, the authors suggest the use of the immunoflourescence method to obtain accurate results.
In the study, both methods produced similar platelet counts for healthy individuals, but they differed widely for thrombocytopenic patients. Of the 35 people in the study, nine patients had platelet counts 50 percent greater from the immunoflourescence assays than the impedance method, and four patients had counts that were 100 percent greater.
Source: Bowles, Kristian M., David M. Bloxham, David J. Perry and Trevor P. Baglin. "Discrepancy between impedance and immunofluorescence platelet counting has implications for clinical decision making in patients with idiopathic thromocytopenia purpura." British Journal of Haematology. Vo134: 320-322
Platelets do more than patch up a wound; they also deliver important molecules to a damaged tissue, according to a recent study.
Within the platelet are tiny sacs called granules, which carry a variety of important molecules including serotonin. In the brain, an imbalance of serotonin results in sleep and mood disorders, and for years, doctors have prescribed serotonin to treat depression. But scientists have not been able to prove that serotonin in the brain is affected by the serotonin in platelets.
Scientists have shown that platelets not only patch damaged tissue, but are also needed to secrete high concentrations of serotonin and other molecules, which allow for better healing.
Source: "Blood platelets: Nature's own targeted therapeutic delivery system." The Hematologist. July/August 2006. Vol 3 (4): 6
Based on: Lesurtel M, Graf R, Aleil B, et al. Platelet-derived serotonin mediates liver regeneration. Science 2006;312:104-7
The Benaroya Research Institute in Seattle has created a four-armed molecule, called a tetramer, that may help diagnose and treat immune disorders. Artificially-produced tetramers attach to targets in the blood, which allows scientists to identify what antigen caused an immune response.
Most immune-response tests examine the blood stream for antibodies, immune particles that mark unwanted objects for destruction. But antibodies are only part of the immune system’s response; immune cells also recognize and initiate immune responses. Tetramers allow scientists to locate these rare immune cells and learn what makes them attack.
The Benaroya Research Institute is supported, in part, by Pat's Fund (www.patsfund.org), a non-profit organization created in memory of Pat Rising. In the early 1990s, Pat was diagnosed with ITP and died less than two months later, at age 33. In his honor, Pat’s family created Pat's Fund and the DAISY Foundation. The latter supports PDSA’s annual conference.
Paulson, Tom. "Seattle in demand on even a molecular level widely-wrought tetramers help diagnose disease." The Seattle Post-Intelligencer. July 5, 2006.
"Research team at Benaroya Research Institute discovers new means of targeted regulation of the immune system." Pat's Fund. March 14, 2005.
It seems like nearly everyone with high cholesterol is taking baby aspirin every day. But most people don’t know that almost no research supports long-term aspirin therapy.
In fact, several studies showed long-term aspirin therapy doesn’t prevent strokes and heart attacks, but it may also damage the blood vessels and platelets, according to John Cleland, a professor of cardiology at the University of Hull in the National Clinical Practice of Cardiovascular Medicine.
A short course of aspirin (usually five weeks) after a heart attack or stroke does reduce a patient’s risk of another dangerous clot, but no studies conclusively show that long-term aspirin therapy is safe or effective for patients at risk for heart disease and blood clots.
Instead, Cleland suggests, long-term doses of aspirin may damage the body by permanently preventing platelets from sticking together and by weakening the blood vessel walls. “On existing evidence,” he said, “aspirin should only be given to carefully selected patients, for a few weeks after a vascular event.”
Cleland called for more long-term studies of aspirin to support its popularity.
Cleland, John GF. “Chronic aspirin therapy for the prevention of cardiovascular events: A waste of time, or worse?” Nat Clin Pract Cardiovasc Med. 2006. 3(5):234-235.
More Americans know about “American Idol” than obesity, said a recent poll by the American Cancer Society (ACS). The poll showed 65 percent of Americans understood how to play the popular television show “American Idol,” but only 8 percent knew the risks associated with obesity.
Obesity, or being 30 pounds overweight, is second only to smoking as the leading cause of preventable death in the United States. It interferes with the body’s use of insulin and is a risk factor for several cancers including: breast, prostate, colorectal, endometrial, kidney, pancreas, esophagus and some lymphomas.
ACS's survey suggested that Americans have a skewed perception of their own weight. Only 45 percent of the respondents said that they are overweight, but, according the ACS, 65 percent of Americans are overweight and 30 percent of these are obese.
Over half of the respondents found some food “irresistible.” The most craved foods were chocolate (20 percent), Italian food (14 percent), cookies, cakes and doughnuts (10 percent), hamburgers and meat (9 percent) and seafood (9 percent).
The survey was part of the ACS “Great American Eat Right Challenge,” which can be found on their Web site: http://www.cancer.org/docroot/PED/PED_9_Great_American_Eat_Right_Challenge.asp
Hematology & Oncology News & Issues. June 2006.
Several large clinical trials this year have revealed that popular vitamins and dietary supplements offer fewer benefits that expected.
Instead the studies highlighted the importance of a healthy diet. In foods, vitamins and minerals interact with other components and produce optimal results, but supplements offer one isolated dietary component and not the whole package. A diet consisting of a variety of fruits and vegetables provides the optimal amount of vitamins and minerals.
Vitamins and supplements shown to be less effective than believed are:
Payne, January W. "A bad year for favorites." The Washington Post. June 20, 2006.
(Note: You can view PDSA’s diet and lifestyle suggestions at http://www.pdsa.org/articles.htm
The Food and Drug Administration and the pharmaceutical industry are considering using adaptive trials, which allow studies to change procedures based on early results. Traditionally, trials for prospective drugs are “double-blinded, placebo-controlled” meaning that neither physician nor patient knows if the patient is given the trial drug or a placebo.
The new trials would be run based on complex plans developed by computers before the study begins. If early in the trial, one dosage or treatment appears to be more effective than others, patients would be switched into that treatment. Adaptive trials would be more efficient than current trials and could save millions of dollars.
Proponents of the adaptive trials believe they will reduce the number of patients needed in a trial by as much as 30 percent, and they claim that patients will benefit from an increased chance of receiving more effective treatment. Those opposing adaptive trials claim they are vulnerable to bias and abuse.
The FDA plans to create a “concept paper” describing guidelines for adaptive trials.
Mathews, Anna Wilde. “FDA signals it’s open to drug trials tat shift midcourse.” The Wall Street Journal Online. July 10, 2006.
Paying for it: Americans, British seek better health care for citizens
When British family physicians were paid according to their performance, patient care exceeded expectations, according to a study published in the New England Journal of Medicine.
Unlike the United States' insurance-based health care, the United Kingdom's government provides its citizens with health care, and doctors receive their paycheck from the state.
This payment system gives little motivation for physicians to provide better health care for their patients. So, in 2004, the National Health Service of the United Kingdom created a performance-based payment program to reward physicians who provided better care for their patients.
Each condition was assigned a number and a list of good treatment practices. Physicians who completed these treatments were awarded points.
Those creating the program expected family practices to achieve 75 percent of their available points, but instead practices earned almost 97 percent of the available points. These high performances increased the cost of health care to tax payers and required extra funding.
Performance-based payments are becoming more popular on both sides of the Atlantic as more American insurers are experimenting with the new system. In December 2005, only two communities, Orange County Calif. and Boston, implemented large-scale pay-for-performance programs, but most health care plans and Medicare are developing these programs, according to the Center for Studying Health System Change.
Doran, Tim, Catherin Fullwood, Hugh Gravelle, David Reeves, Evangelos Kontopantelis, Urara Hiroeh and Martin Roland. "Pay-for performance programs in family practices in the United Kingdom." The New England Journal of Medicine. July, 2006.
Bodenheimer, Thomas, Jessica H. May, Robert A.Berenson and Jennifer Coughlan. “Can money buy quality? Physician response to pay for performance.” Center for Studying Health System Change. Dec. 2005. 102. www.hschange.org
Insurance policies provide health care for most Americans, but approximately 15 percent of the population -- 41 to 45 million people -- do not have health insurance, according to the 2002 US Census Bureau, as reported by The Journal of Infusion Nursing.
Income was the most influential factor determining whether a person had health insurance. Over 30 percent of Americans at or below the poverty level did not have insurance, and for those only slightly above poverty, 28 percent were not insured.
Personal characteristics also affected a person’s chances of being uninsured. More women had health insurance than men. Adults between the ages of 18 to 64 years were less likely to be insured than both the young and the elderly.
African and Hispanic Americans were more likely to not have insurance than either Caucasian or Asian Americans, and those who were foreign-born were twice as likely to not have insurance compared to people born in America.
Education and employment also directly affected who had insurance. Not surprisingly, those with more education also were more likely to have health insurance and vice versa. In the general population, only 18 percent of full-time employees lacked health insurance, but 26 percent of the unemployed went without insurance. But these numbers switched among the poor; 38 percent of the unemployed and 49 percent of full-time employees did not have insurance.
Those with health insurance are more likely to receive better health care than those without. For example, an uninsured woman’s risk of death from breast cancer was 30 to 50 percent greater than a woman with insurance. Even if the uninsured are treated, the government and the health care providers must bear the cost and, therefore, may reduce treatment options available to consumers without health insurance.
Trotochaud, Karen. "Ethical issues and access to health care." Journal of Infusion Nursing. May/June 2006; 29(3) : 165-170.
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Pediatric Blood & Cancer is a monthly, international medical journal that covers research on blood disorders and cancers. A special issue (Volume 47, Issue S5, October 15, 2006) reports on the 2nd Intercontinental Childhood ITP Study Group (ICIS) Expert Meeting. Studies cover a broad spectrum, including diagnosis, treatment, epidemiology, etiology, biology, and molecular and clinical genetics of these diseases.
The table of contents and subscription information is available at: http://www3.interscience.wiley.com/cgi-bin/jtoc/106561790/
Individuals can order a copy for $27 by contacting the subscription department of John Wiley and Sons at 1-800-825-7550.
Articles in the Special Issue Pediatric Blood & Cancer include:
In a discussion of critical and unsolved issues in splenectomy in children with chronic ITP, researchers from Austria note that, while chronic ITP accounts for 20-30% of all pediatric cases, spontaneous remission occurs in about one-third of the children. Severe chronic ITP (persistent platelet count <30 x109/L and clinically significant hemorrhage), which could justify splenectomy, accounts for just 2-3% of all ITP cases. Yet, the frequency of splenectomy for chronic ITP, depending on the study, varies between 10% and 40%. They note that existing recommendations are based on expert opinion rather than clinical trials, and suggest a well-designed prospective trial, perhaps through the Intercontinental Childhood ITP Study Group, to address existing controversies and “better define the value of splenectomy in the management of chronic ITP in children.”
Minkov M. Critical issues concerning splenectomy for chronic idiopathic thrombocytopenic purpura in childhood. Pediatric Blood Cancer 2006;47:734-736
The Danish authors reviewed 25 papers on anti-D (Win Rho SDF® in the U.S.) treatment in childhood ITP published between 1986 and 2006 and found that intravenous anti-D seems safe in classic childhood ITP with fewer side effects than IVIG. However, hemolysis, or a breaking apart of red blood cells, is a concern. Subcutaneous anti-D may be better tolerated, but must be studied first.
Kjaersgaard M, Hasle H. A review of anti-D treatment of childhood idiopathic thrombocytopenic purpura. Pediatric Blood Cancer 2006;47:717-720.
Rituximab is a monoclonal antibody that results in depletion of B-cells, which may stifle the autoimmune response that occurs in ITP. Researchers from The Netherlands review treatment options for children with ITP that is chronic and symptomatic. Most treatments aim to reduce platelet destruction. Steroids and IVIG are most often used, yet their effects are temporary and side effects from long-term use can be serious. Anti-D (Win Rho SDF® in the U.S.) is an alternative to IVIG, but causes hemolysis in some patients. Splenectomy is often considered in children with ITP for 12-24 months who are refractory to the above-mentioned treatments. However, the risks from splenectomy are greater for children than adults, and more than half of children spontaneously recover after a period of years. They note, “ways to prevent or postpone splenectomy should be considered.” They found only three studies published on rituximab treatment, and each showed a similar efficacy—one third of children had a continuous response to treatment, though important side effects were possible. They conclude that in the small percentage of children whose ITP becomes chronic and symptomatic, intermittent treatment with steroids or IVIG is first choice. However, in non-responding disease or when side effects influence quality of life, treatment with rituximab is second-line treatment. Finally, they state, only those who fail rituximab treatment should proceed to splenectomy.”
Tamminga RYJ, Bruin MCA. Rituximab treatment for symptomatic chronic ITP. Pediatric Blood Cancer 2006;47:714-716.
The Public Hospital Pharmacy Coalition (PHPC) released a September 2006 survey stating that, along with a supply shortage of IVIG products, hospitals that serve many low-income patients face a widespread problem of accessing IVIG at discounted prices, which drug companies are required to provide under the federal “340B” program. Half of survey respondents stated they are unable to obtain sufficient IVIG to fulfill the needs of their patients. And close to 80% stated they are unable to purchase any IVIG at the discounted 340B prices.
A copy of the full report is at: http://www.phpcrx.org/documents/IVIG_report.pdf
The Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation held a town hall meeting on Patient and Physician Concerns in Access to Intravenous Immunoglobulin (IVIG) in Arlington, VA, on September 28, 2006. Along with the Public Hospital Pharmacy Coalition, the Plasma Protein Therapeutics Association commented regarding efforts to assure access to IVIG in Medicare. A final report is expected to be released in early 2007. From the meeting website:
“Written comments are welcome from the public regardless of whether you attended the Town Hall Meeting or whether you made an oral presentation at the Town Hall Meeting. Written comments can be submitted either via e-mail to meetings@erg.com (subject: IVIG Meeting Comments) or via regular mail to ATTN: IVIG Meeting, ERG, 110 Hartwell Avenue, Lexington, MA 02421. Please note that electronic submissions are preferred due to delays in receiving U.S. Postal Mail. We are able to consider only those comments received in writing and/or via email by 5 p.m. EST on October 15, 2006.”
A survey by the International Alliance of Patients’ Organizations (IAPO) randomly polled 1,200 members of patients’ organizations in 12 countries*and found three themes shared consistently regarding the accessibility of individualized treatment and healthcare information. Timely access to the best medicines and information is one of the primary concerns of those surveyed. Ninety five percent of members of patient organizations demand a right to participate as partners in making healthcare decisions that affect their lives. Finally, they indicated a strong belief that patients should shape healthcare policy decisions that affect their lives.
The study was supported by Pfizer.
* UK, Germany, France, Hungary, Austria, Czech Republic, Italy, Spain, Belgium, Sweden, Canada, Nigeria.
A summary of the study can be found on the IAPO website: www.patientsorganizations.org
The October 2006 issue of National Geographic contains an article, “The Pollution Within.” Author David Ewing Duncan writes about his “journey of chemical self-discovery.” He was tested for 320 chemicals that any of us can pick up from food, drink, the air we breathe, or the products that touch our skin. He was screened for older chemicals such as DDT and PCBs, pollutants like lead, mercury, and dioxins; newer pesticides and plastic ingredients; and the compounds that make pans nonstick and fabrics water-resistant and fire-safe. The article details how he thinks he was exposed to each and explores the known effects of some of these chemicals.
The article is online: http://www3.nationalgeographic.com/ngm/0610/feature4/index.html
The mechanism by which IVIG can improve the condition of patients with ITP is unclear. Using a mouse model with ITP, the researchers probe the efficacy of IVIG and offer a model for refining therapy in ITP. They demonstrated that cells in the innate immune system, but not lymphocytes, are central for the success of IVIG in ITP.
Siragam V, Crow AR, Brinc D, et al. Intravenous immunoglobulin ameliorates ITP via activating Fcgamma receptors on dendritic cells. Nat Med 2006;12;688-692.
This research team is exploring ways to improve upon IVIG’s impact using monoclonal antibodies. They generated highly stable immune complexes by mixing IVIG with monoclonal anti-human IgG (immunoglobulin G). The complexes were more potent than IVIG in preventing or reversing antibody-induced platelet reduction in mice. Also, adding the antibody directly to human serum, they were able to generate the immune complex that exhibited the same activity as that prepared in the laboratory. They suggest that it may be possible to develop a substitute for IVIG by forming immune complexes using IgG from ITP patients and the anti-human IgG monoclonal antibody.
Bazin R, Lemieux R, Tremblay T. Reversal of immune thrombocytopenia in mice by cross-linking human immunoglobulin G with a high-affinity monoclonal antibody. British J Haematology 2006;135:97-100.
This paper points to a surprising role for platelets in liver regeneration. They carry biologically active molecules in their granules that they deposit at sites of vascular injury. These molecules include peptide growth factors, enzymes, and enzyme inhibitors. In the case of liver regeneration, serotonin appears to be the important molecule carried by platelets. In a mouse model in which 70% of the liver is removed, mice with low platelet counts or nonfunctioning platelets could not regenerate their livers. They showed that platelets aid in regeneration by bringing serotonin to serotonin receptors on the liver, which increase three-fold or more after part of the liver is removed.
Lesurtel M, Graf R, Aleil B, et al. Platelet-derived serotonin mediates liver regeneration. Science 2006;312:104-7.
Researchers have found in studies in mice that the brain somehow senses the presence of potentially lethal sepsis and sends a signal via the efferent vagus nerve to the spleen to shut down production of inflammatory cytokines. When a spleen does not exist, the body’s response to the sepsis is ineffectual. Researchers are exploring other means of activating the anti-inflammatory pathway, using drugs or electrical stimulation of the vagus nerve. In the September – October 2006 issue of The Hematologist, Dr. Roy Silverstein reviewed the work and wrote, “These studies may explain in part why patients without spleens are more likely to develop sepsis syndromes in the setting of certain bacterial infections.”
Huston JM, Ochani M, Rosas-Ballina M. et al. Splenectomy inactivates the cholinergic anti-inflammatory pathway during lethal endotoxemia and polymicrobial sepsis. J Exp Med 2006;203:1623-1628.
Contents:
Two teams of researchers conducted phase 1-2 studies of a protein to stimulate platelet development in patients with ITP [Existing treatments work to reduce platelet destruction or stop production of antibodies against platelets]. The protein, dubbed AMG 531 by its maker, Amgen, Inc., is given by injection. One trial included 16 patients treated at several centers in Europe, the other enrolled 24 (in phase 1) and 21 (in phase 2) in 9 U.S. centers. AMG 531 caused some adverse events, but none were considered major and platelet counts increased in some patients. Both studies were funded by Amgen. The main aim of these early phase studies is to assess safety and begin exploring efficacy. Further studies will examine dosing questions and evaluate the durability of the platelet response.
Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen C-F, Nichols JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic immune thrombocytopenia purpura. N Engl J Med 355:1672-1681.
Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, Christal J, Chen C-F, Nichol JL. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. British Journal of Haematology, 135,547-553.
Cranberries, which are high in antioxidants, are credited with reducing bladder infections because they prevent the bacteria, E. coli, from adhering to the bladder wall and multiplying to cause bladder infections. Now cranberries are getting credit for thwarting another bacteria, H. pylori. H. pylori is the bacteria responsible for most stomach ulcers, and cranberries may help protect the body by stopping H. Pylori from adhering to the stomach lining. [From PDSA: This is worth noting for patients with ITP because several published studies have associated eradicating H. Pylori with ITP going into remission.]
Environmental Nutrition, November 2006, pg. 8.
A new device using infrared light is helping nurses and phlebotomists locate veins to draw blood. The device is making venipuncture less painful and less stressful for patients with veins that are difficult to see. The VeinViewer, from Luminetx, Corp., Memphis Tenn, is available in about 100 hospitals nationwide. It uses infrared light and contrasting green light to make veins look dark gray—easier to see—against a green background. No published clinical trials discuss its effectiveness, but clinicians who have used it appear impressed.
Wall Street Journal, October 17, 2006, pg. D2.
A study of turmeric extract in rats with artificially induced rheumatoid arthritis found that injections of the extract reduced joint swelling and tissue destruction by blocking a specific inflammatory pathway, the NF-Kappa B pathway. The researcher, from the University of Arizona, warns that turmeric-based supplements found in health food stores do not often contain the amount of turmeric shown on the label, and much research still needs to be done. The study was published in the November issue of Arthritis & Rheumatism.
Washington Post, October 30, 2006, page A6.
Eating two or more servings of vegetables a day may slow a person’s mental decline by about 40 percent compared with people who eat fewer vegetables, according to a study published in the October 24 issue of Neurology. And it may never be too late to reap the benefit of vegetables. Older people who started eating more vegetables each day showed a significant delay in mental decline.
Washington Post, October 24, 2006, pg. A3
Antioxidants help deactivate the free radicals that damage cells and promote chronic disease. A new analysis of total antioxidant activity in foods yielded a list of the top 300 antioxidant foods. The top 14 foods/beverages are: blackberries, walnuts, strawberries, artichokes, cranberries, brewed coffee, raspberries, pecans, blueberries, cloves, grape juice, unsweetened baking chocolate, sour cherries, and red wine. The report, in the American Journal of Clinical Nutrition, notes that antioxidants are pretty well preserved during processing or cooking. Removing the peel from some produce, such as apples and cucumbers, cuts the antioxidant content in about half.
UC Berkeley Wellness Letter, November 2006, pg. 5.
To cut toxins and improve their patient environments, some cutting-edge hospitals are going with “green” construction. They are building or renovating to standards set by the Green Guide for Health Care (GGHC.org), by the U.S. Green Building Council. Not a moment too soon, say environmental health experts, who warn that materials that cover floors, walls and ceilings release hundreds of chemicals into hospital air. Even IV and blood bags, plastic tubing, and other hospitals products, including carpets, contain polyvinyl chloride (PVC), which releases the carcinogen dioxin. Poor ventilation and high energy consumption also contribute to pollution and poor air quality. Pressure from local and state governments and environmentally conscious donors is moving hospitals to build more efficient, eco-friendly facilities that conserve energy and reduce potentially dangerous emissions.
Wall Street Journal, October 4, 2006, page D1.
Trace amounts of antibiotics, acetaminophen, tranquilizers, and other common drugs have been found in rivers, streams, and treated water, according to the UC Berkeley Wellness Letter. The long-term impact is unknown, but it is best to ask your doctor or pharmacy if they will take medicines for disposal, or bring them to a local household hazardous waste facility. As a last resort, throw unwanted or expired medications in the trash, closed in their original containers or otherwise securely wrapped.
UC Berkeley Wellness Letter, November 2006, pg. 8.
A new website has been launched to collect data on the side effects of statin drugs, which are used for lowering cholesterol and reducing the risk of heart attack. Statins are sold under the brand names Lipitor, Zocor and others. University of California-San Diego researchers created the Statin Effects Survey site www.statineffects.com because of flaws they see in the current system for reporting adverse events with the Food and Drug Administration. The aim is to help doctors get a clearer understanding of statin side effects, such as muscle aches and memory loss. Patients interested in describing their experiences with statin drugs must first register with the web site. All patient information is confidential. (Note: Some people have told us that statins reduced their platelet count)
Parker-Pope T. Researchers ask patients to help fill gap in data on side effects of statins. Wall Street Journal, October 3, 2006, page D1.
The October 2006 AARP Bulletin reported a study from Rensselaer Polytechnic Institute that blue light might be the answer to restless nights. Doses of blue light, as little as 30 minutes, work better than full-spectrum light, which has been used for years to fight off sleep disorders and winter depression. Older people exposed to blue light early in the evening are much more likely to sleep through the night, as are Alzheimer’s patients who get two hours of exposure of blue light. Blue light boxes are available commercially, but vary considerably in quality. Get a recommendation from a health professional.
The 48th Annual Meeting and Exposition the American Society of Hematology was held in Orlando, Florida from December 8 through December 13, 2006. Over 20,000 hematologists from around the world gathered to learn the latest about the diagnosis and treatment of hematologic disorders. Thrombocytopenia, low platelets, and ITP were center stage. Data about the new treatments that Amgen (AMG 531) and GSK (eltrombopag) have in clinical trials was presented in a number of sessions during the meetings. You can search and read the abstracts at: http://meeting.bloodjournal.org/content/vol108/issue11/. You can read the papers included in the ASH Education Program Book at: http://www.asheducationbook.org/current.shtml
GlaxoSmithKline has announced the initiation of a Phase III clinical trial that will assess the safety, efficacy, and tolerability of eltrombopag in a long-term treatment setting in previously treated patients with chronic idiopathic thrombocytopenia purpura (ITP). Eltrombopag is a novel oral platelet growth factor. The trial, called RAISE, will involve 189 patients who will be treated at 135 centers in 26 countries. The announcement of this trial follows completion of earlier trials of eltrombopag in which the treatment was well tolerated with a dose dependant increase in the platelet count. For more information, go to www.itpstudy.com or www.clinicaltrials.gov
The National Women’s Health Report published a special issue in September on women and autoimmune diseases. It contains articles on common autoimmune diseases, a resources list, and a feature on the need for a low-stress lifestyle when an autoimmune disease is part of life. Practical tips include taking a walk, resting an hour every day, learning techniques to reduce stress hormone levels, and finding a support system.
www.healthywomen.org/Documents/NationalWomensHealthReport.September2006.pdf
Sixteen people in Brownsville, Texas, have contracted Dengue hemorrhagic fever, according to the Centers for Disease Control and Prevention. The disease causes high fever, headache, vomiting, muscle and joint aches, and rashes. It also causes small blood vessel leakage, which can lead to shock, internal bleeding, and death; however, none of the U.S. patients died. Dengue, common in tropical regions, is caused by a virus that is carried by mosquitoes. The mosquitoes breed in open water containers and pools.
Science News, October 28, 2006, page 286.
British authors published a review of research looking at the antioxidant role of grapeseed extract, a dietary supplement rich in flavonoids. Oxidative stress and inflammation have both been implicated in recent years in atherosclerosis and cardiovascular disease. Flavonoids have been found to reduce oxidative stress and inhibit platelet aggregation. Grape seed extracts may be source.
Kar P, Laight D, Shaw KM, Cummings MH. Flavonoid-Rich Grapeseed Extracts: A New Approach in High Cardiovascular Risk Patients? Int J Clin Pract. 2006;60(11):1484-1492. The article was reprinted on Medscape www.medscape.com/viewarticle/546099.
The National Institutes of Health (NIH) has launched a patient friendly website called Genetics Home Reference. It provides helpful information on topics such as newborn screening, plus consumer-friendly descriptions of genetic disorders, including definitions of terms.
Brisk walking may be more important than crossword puzzles for boosting brain power in older adults, according to a study from the University of Illinois, Urbana. Three hours a week of brisk walking (about 3 miles an hour) increases blood flow to the brain and increases production of new brain neurons. Fifty nine adults ages 60 to 79 got either aerobic training, stretching-and-toning training, or nothing. Only the group that did aerobic exercise for one hour three times a week showed an increase in brain volume. Earlier studies had shown that people who do aerobic exercise have a better working memory and are nimbler at switching between mental tasks, but this new study suggests what changes in the brain enable this improved mental capacity. The findings were published in the November 2006 issue of the Journal of Gerontology: Medical Sciences.
Sharon Begley, How to Keep Your Aging Brain Fit. Wall Street Journal, November 16, 2006, page D1.
The Wall Street Journal carried tips from an environmental engineer for reducing mold at home:
In the November 2006 issue of Self Healing, Dr. Andrew Weil’s newsletter, honey is endorsed for its wound healing properties when applied topically to a wound. One review of 22 clinical trials concluded that honey shortens healing time on wounds and provided better pain relief than antifungal creams or antibiotics (International Journal of Lower Extremity Wounds, March 2006). In a separate study, one specific honey product, called Medihoney, healed wounds faster than most antibiotics (Supportive Care in Cancer, January 2006). Medihoney is awaiting FDA approval in the United States. The article notes that there is no evidence that honey helps heal wounds when eaten as a sweetener.
Celery is rich in vitamin K and phytonutrients, such as phthalides, quercetin, apigenin, and luteolin. It’s high in water, but not the high-sodium food that some may call it. Taiwanese researchers found that liver cells treated with celery extract produced more of a liver enzyme that helps remove toxins and drugs from the body.
Environmental Nutrition, December 2006, page 8.
Warfarin is the most commonly used anticoagulant drug, or “blood thinner”. It is prescribed to treat or prevent clots associated with heart attacks, atrial fibrillation, prosthetic valve replacement, deep vein thrombosis, and pulmonary embolism. Cranberry juice has gained popularity as a beverage that can prevent urinary tract infections. A literature review indicates that drinking large amounts of cranberry juice can destabilize warfarin therapy. Although the authors note that small amounts of cranberry juice are not likely to cause problems, they suggest that doctors warn their patients of the potential interactions.
Aston JL, Lodolce AE, Shapiro NL. Interaction between warfarin and cranberry juice. Pharmacotherapy. 2006;26(9):1314-1319. Medscape reprinted the article (www.medscape.com/viewarticle/545631).
Dark chocolate may delay blood clotting, which may be helpful for patients with blood vessels narrowed by cardiovascular disease, according to a recent study by scientists at Johns Hopkins. The study, however, wasn’t designed to evaluate chocolate’s effect. It was designed to look for genetic factors that identify which patients respond best to aspirin therapy to reduce blood clotting. All 1,200 volunteers had slightly elevated risk of heart disease. Two weeks before the study, they were asked to avoid foods rich in flavonols, including chocolate, coffee, red wine, and strawberries. When some participants confessed to eating chocolate anyway, the Hopkins researchers decided to study its effect on platelet activity. They found slower clotting time and actual platelet suppression in the people who admitted to eating chocolate. The study was presented at a meeting of the American Heart Association. Other researchers are calling for larger, randomized trials to see if the effect is real, and warn about overindulging in chocolate, especially higher fat milk chocolate.
Low levels of vitamin D are being linked to muscle pain and weakness, to infection, and to disability in the elderly
Researchers at the University of Minnesota decided to test the vitamin D levels in 150 patients ages 10 to 65 who complained of nonspecific muscle pain and weakness. They were stunned to find that nearly everyone—93 percent—had too low levels. Vitamin D is made by the body when sunlight hits the skin, but many people are minimizing sun exposure to avoid skin cancer. Salmon is a good dietary source of vitamin D, as are fortified milk products.
Self Healing, December 2006, page 2.
Vitamin D boosts production in white blood cells of one of the antimicrobial compounds that defends the body against germs. A review of 100 articles has led a California researcher to propose that vitamin D deficiency may underlie a vulnerability to infections caused by a wide range of bacteria, viruses, and fungi. Vitamin D may do so by boosting an antimicrobial called cathelicidin.
Science News, November 11, 2006, page 312.
Finally, a Dutch study found that people over age 65 with low blood levels of vitamin D were three times more likely to end up in a nursing home than those with high levels. The difference appeared to be due to bone and muscle strength related to falls in older people. The government recommendation for people ages 50 to 70 is 400 IU a day; for those over 70, it is 600 IU a day.
Berkeley Wellness Letter, December 2006, page 1.
Contents:
Thrombocytopenia Drug-Induced Thrombocytopenia: Heparin and Quinine
Drug-induced thrombocytopenia is common but well documented only for a small number of specific compounds. Two drugs known to induce thrombocytopenia are heparin and quinine. A recent article in the New England Journal of Medicine presents a case vignette of heparin induced thrombocytopenia, examines evidence supporting various treatment strategies, and reviews the formal guidelines http://www.chestjournal.org/cgi/content/full/126/3_suppl/311
In studying quinine-induced thrombocytopenia, researchers unexpectedly found quinine-dependant antibodies in addition to the platelet-reactive antibodies they expected. This may help them design a simpler test to confirm the diagnosis of drug-induced thrombocytopenia.
Note: Quinine is used to treat the common symptom of nocturnal leg cramps. It is an ingredient in tonic water and is present in bitter melons.
Arepally, G.M., et al, “Heparin Induced Thrombocytopenia”, The New England Journal of Medicine, 355:809-817, August 24, 2006.
George, J.N., “Quinine: Common Remedy, Serious Reactions, New Insights”, Blood, vol. 108, no. 3, pp. 782-783, August 1, 2006.
Bougie, D.W., et al, “Patients with Quinine-Induced Immune Thrombocytopenia Have Both ‘Drug-Dependent’ and ‘Drug-Specific’ Antibodies”, Blood, vol. 108, no. 3, pp. 922-927, August 1, 2006. http://www.bloodjournal.or
ITP: No Race Disparities in Prevalence Among Males
The authors of a recent letter to the editor of Blood point out that “ethnic, racial, and geographic differences influence virtually all human disease, and certain conditions exhibit well-established differences between Africans and Europeans.” Awareness and careful study of these differences can have important consequences for health care delivery. The authors in their letter report the results of their study of veteran’s health records. This review did not reveal a significant disparity in the prevalence of ITP among Whites and African Americans. An acknowledged limitation of the study is that the database was all male. Also these results are not consistent with the findings of six other studies that addressed the same question and which were summarized in Blood in 2005 (reference below).
Landgren, O., et al, “Immune Thrombocytopenia Purpura Does Not Exhibit a Disparity in Prevalence between African American and White Veterans” (To the Editor), Blood, vol. 108, no. 3, pp. 1111-1112.
Terrell, D.R., et al, “Is Immune Thrombocytopenia Less Common Among Black Americans?”, Blood, vol. 105, no. 3, February 1, 2005 pp. 1368-1369.
IVIG Supply Problems
Some patients are experiencing problems obtaining IVIg. The FDA is investigating the situation and is requesting input from patients and physicians. If your physician feels IVIg is a good treatment for you but it is not available, please call 800-835-4709 or email CBERProductShortages@cber.fda.gov. These are provided to report availability issues only. They are not for reimbursement problems, issues or complaints. For Medicare reimbursement issues call 800-633-4227 (800-MEDICARE)
The HHS is also seeking information on the IVIg access. The are hosting a public meeting on September 28, 2006 from 10 a.m. to 5 p.m at the Sheraton Crystal City Hotel in Arlington, VA
To register go to https://www2.ergweb.com/projects/conferences/hhs/ or call the ERG conference registration line, 781-674-7374 Restoring Bone Density in Patients Taking Glucocorticoids: Fosamax vs. Vitamin D A randomized, double-placebo, double-blind clinical trial lasting 18 months involved 201 patients who were starting glucocorticoids (ex. Prednisone) as treatment for a rheumatic disease. The patients were given either Fosamax and a vitamin-D placebo or vitamin-D and a Fosamax placebo. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months. The researchers report that bone mineral density of the lumbar spine increased by 2.1 percent (1.1% to 3.1%) in the Fosamax group and decreased 1.9 percent (-3.1% to -0.7%) in the vitamin-D group. www.clinicaltrials.gov (ClinicalTrials.gov number, NCT00138983)
De Nijs, et al, “Alendronate [Fosamax] or Alfacalcidol [Vitamin-D] in Glucocorticoid-Induced Osteoporosis”, New England Journal of Medicine, vol. 355, no. 7, August 17, 2006, pp.675-684.
Gender and Genetics: Illness, Treatment and the Gender Divide
Most autoimmune diseases affect women in far greater numbers than they affect men. ITP for instance affects about three times (3:1) as many women as men. The ratio for other autoimmune disease is as high as 10:1. Researchers are looking at genetics to understand this disease disparity. A recent study by a group at the University of California at Los Angeles found that in “liver, fat, and muscle tissue males and females differently expressed 55 to 72 percent” of the 23,000 genes studied. Follow-up studies hint that “sex hormones such as estrogen and testosterone control the expression of many of the genes.” This work with mice (mice and people share about 99% of their genes) “could guide researchers in figuring out why men and women have different risks for different diseases. Further studies might also pinpoint the optimal doses of prescription drugs for men or women or assist researchers in crafting new, gender-specific medicines.”
Brownlee, C., “Gender Divide”, Science News, vol. 170, July 22, 2006, p. 52.
Yang, X., et al, “Tissue Specific Expression and Regulation of Sexually Dimorphic Genes in Mice”, Genome Research, vol. 16, July 6, 2006, pp. 995-1004.
Eat Your Veggies, You Won’t be Sorry
The benefits of vegetables in our diet are becoming much better understood. In response the government has revamped the effort to boost their consumption. New recommendations were published jointly by the Department of Health and Human Services and the Department of Agriculture. They consist of specific amounts of produce, measured in cups rather that the vague “servings” and they vary by age and sex, and level of activity. We have a long way to go. According to the Centers for Disease Control, about 90% of the U.S. population does not meet the government’s recommendations. The USDA recommendations can be found at: https://health.gov/dietaryguidelines/
For fruits and vegetables they read;
Wang, S., McKay, B., “More Reasons to Eat Your Veggies”, Wall Street Journal, July 25, 2006, p. D1.
Alzheimer’s Onset: Impact of Fruit and Vegetable Juices
A new study links the delayed onset of Alzheimer’s to a diet generous with fruit and vegetable juices. See http://www.medscape.com/viewarticle/544012 Diabetes and a Vegan Diet
A recent study compared the vegan diet to the ADA diet for diabetes in 99 patients. Forty-three percent of those on the vegan diet reduced their need to take drugs to manage their diabetes compared to 26 percent of the ADA diet group.
http://www.cbsnews.com/stories/2006/07/26/health/webmd/printable1837927.shtml
Contents:
RITUXAN
Rituxan (rituximab) is approved by the Food and Drug Administration (FDA) for treatment of certain types of lymphoma and for rheumatoid arthritis that has not responded to other therapies. However, the drug is also prescribed in what is called off-label indications for patients with lupus and patients with ITP.
After two patients taking Rituxan for lupus died from a rare brain infection, the Food and Drug Administration and the drug’s makers, Genentech and Biogen Idec, released a “preliminary public safety alert”. It warned doctors to carefully monitor patients taking Rituxan for any reason. The link between Rituxan and the viral brain infection, called progressive multifocal leukoencephalopathy, or PML, is unclear. The drug’s label already includes a warning about PML. And also states that patients who are carriers of the Hepatitis B virus (which means persistently having the virus, not just having a past infection), are at risk of reactivating the hepatitis B with Rituxan treatment. However, when given on its own as a treatment for ITP, Rituxan has not been associated with infections.
The FDA is not suggesting that Rituxan be pulled from the market. The side effect is rare and appears to occur only in people who have received multiple immunosuppressive treatments in addition to Rituxan. Dr. James Bussel, a PDSA medical advisor, states: “We do not believe that this should alter clinical practice unless the patient is receiving multiple immunosuppressive treatments in addition to Rituxan.”
PAINKILLERS
The FDA would like to see stronger labeling rules on over-the-counter painkillers to warn consumers of the risks of stomach bleeding or liver injury. Nonprescription drugs such as ibuprofen (Advil, Motrin), acetaminophen (Tylenol), and aspirin, can cause serious health problems, especially if consumers take too much of a given product, which can occur when people take a combination of over-the-counter cold medicine and another pain reliever. The drugs are safe, but consumers need to be aware of possible side effects and to avoid accidentally overdosing when taking multiple products. The FDA proposal would require all manufacturers to use the same language and make current warnings more prominent.
Wall Street Journal, December 20, 2006, pg D4
UNAPPROVED QUININE PRODUCTS
The FDA has ordered the removal of unapproved drug products containing quinine. The only quinine product currently approved by the FDA is called Qualaquin, by Mutual Pharmaceutical Company. It is indicated for the treatment of a specific type of malaria. But it is often prescribed to treat leg cramps and similar conditions, despite drug labeling that the risks associated with its use in this setting outweigh the potential benefits.
Close monitoring may be required for patients with liver or kidney problems. Serious adverse events include cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs are also possible.
Medscape Medical News, December 13, 2006.
ANIMAL STUDY SUGGESTS ROLE FOR ARSENIC COMPOUND TO TREAT SYSTEMIC B-CELL AUTOIMMUNITY
Arsenic trioxide is a poison that is used to treat acute promyelocytic leukemia. In a mouse model of lupus, the drug halted disease progression through various mechanisms. In a commentary, Pistoia writes that the latest study supports the feasibility of a clinical trial in treatment-resistant patients with lupus or possibly autoimmune lymphoproliferative syndrome.
Pistoia V. Poisoning Autoimmunity. Blood, December 15, 2006, 108(13):3964.
EVIDENCE BUILDING FOR VITAMIN D’S BENEFITS
Scientists now think that vitamin D, which many people do not get enough of, has many more benefits than reducing the risk for rickets. Studies link low blood levels of vitamin D to type 1 diabetes, multiple sclerosis, tuberculosis, colon cancer and flu. High levels prevent against fractures. Our bodies make vitamin D when we get exposure to the sun, but most people spend a lot more time indoors than outdoors, or avoid sun exposure to reduce the risk of skin cancer. Food sources are limited to fortified milk products and new research suggests that the recommended dietary allowance, or RDA, is not sufficient. Meir J. Stampfer, professor of medicine at Harvard Medical School, writes that there is growing agreement among experts that a daily vitamin D supplement makes good sense.
Newsweek, December 11, 2006, pg. 85-86.
MEDICAL OFFICES COULD USE A SAFETY CHECK
Many doctor’s offices fall short when it comes to keeping track of patients, their appointments, and their test results. According to one non-profit group, too many errors occur because of poor communication with referring physicians, inadequate communication with the patient, or inadequate follow-up. Three organizations are offering a new, Web-based “Physician Practice Patient Safety Assessment” to help doctors evaluate how well they run their offices, with a focus on tracking medication use and safety, transferring information to other doctors, and communicating to patients. The tool was developed by the nonprofit Medical Group Management Association, the Institute for Safe Medication Practices, and Health Research and Educational Trust, under a grant from the Commonwealth Fund. Any doctor can download the self-assessment program free at www.physiciansafetytool.org. For a fee, the group will analyze the data and provide a report. Patients can also download materials to get a sense of what their doctors’ offices should be doing.
To help patients do their part, HMO giant Kaiser Permanente is including “after visit summaries” that recount the salient points of a doctor visit, describe prescription medications and doses, and lay out instructions for self-care and follow-up visits.
Landro, L. The Informed Patient. Booking Your Medical Office for a Safety Checkup. Wall Street Journal, November 15, 2006, page D3.
CURRY MAY HELP BRAIN POWER
Diets High in curry may prevent cognitive impairment, according to a study in the Nov. 1 American Journal of Epidemiology. A chemical found in turmeric, an ingredient in curry, had earlier shown anti-inflammatory and anti-cancer properties in animal studies. For this study, medical researchers in Singapore evaluated a database of about 1,000 elderly, mentally sound adults, and found that those who stated they ate curry often or occasionally had slightly higher scores on cognitive-function tests than those who reported rare or no curry consumption.
Science News, November 11, 2006, Pg. 316.
DO GUT BACTERIA PLAY ROLE IN OBESITY?
Obese mice—and people—have more of one type of bacteria and less of another kind, according to two studies published in the journal Nature in January. A family of bacteria called Firmicutes was high among the obese and a type of bacteria called Bacteroidetes were low. The researchers aren’t sure if more Firmicutes makes people fat or if people who are obese grow more of that type of bacteria. Could changing the bacteria in the intestines and stomach make a difference?
In one study, lean mice with no germs in their guts were given larger ratios of Firmicutes. Subsequently, they got twice as fat and took in more calories from the same amount of food than mice with the more normal bacteria ratio. In a second study of obese people, 3 percent of their gut bacteria was Bacteroidetes before dieting. After successful dieting, their levels of Bacteroidetes were much higher.
The studies were done at Washington University in St. Louis.
UNINSURED AND LOW-INCOME PATIENTS CAN GET HELP PAYING FOR MEDICATIONS
Many patient advocacy organizations, pharmaceutical companies, foundations, and other charitable organizations have programs to help patients pay for prescription therapies. To qualify for PAPs and cost-sharing assistance programs, patients must meet income guidelines and other eligibility criteria. The Patient Advocate Foundation ( www.copays.org or 1-866-512-3861) is one of many good resources.
Thomas
http://thomas.loc.gov
“Thomas” is the Federal government’s Website for tracking any piece of pending legislation, including bills related to healthcare or medical research. The site is sponsored by the Library of Congress. National Institute of Child Health & Human Development.
www.nichd.nih.gov
This Website has been redesigned for easier access to a wealth of information for patients and the public. NICHD is the component of the National Institutes of Health that supports research on human development, medical rehabilitation, and the health of children, adults, families, and communities.
Plasma Protein Therapeutics Association
www.pptaglobal.org
Policy issues, standards, newsroom, donor and consumer information and more from the Plasma Protein Therapeutics Association (PPTA), the primary advocate for the world's leading producers of plasma-based and recombinant biological therapeutics. Patient Notification System
www.patientnotificationsystem.org
is a free, confidential, 24-hour communication system of the Plasma Protein Therapeutics Association that provides information on plasma-derived and recombinant analog therapy withdrawals and recalls.
Note: This includes various IVIg products and WinRho® SDF
Contents:
Because rituximab has become a common treatment for patients with idiopathic thrombocytopenic purpura (ITP), researchers at McMasters University in Ontario, Canada, reviewed the medical literature to determine how much evidence exists to support the use of the drug in ITP. They found 19 reports on efficacy (313 patients) and 29 reports on safety (306 patients). More than 60 percent of adults experienced an increase in overall platelet counts and one study found that a shorter period between diagnosis and rituximab administration resulted in better relapse-free survival. However, sixty-six of 306 patients experienced mild or moderate adverse events and 9 patients across the studies died. Importantly, none of the studies were “controlled studies”, comparing patients taking the drug with similar patients not taking the drug. Overall, the authors determined that “the quality of the evidence in support of rituximab for the treatment of adult ITP is poor.” They go on to caution against indiscriminate use of this treatment, stating that randomized, controlled trials of rituximab in patients with ITP are “urgently needed.”
Arnold DM, Dentali F, Crowther MA, Meyer RM, Cook RJ, Sigouin C, Fraser GA, Lim W, Kelton JG. Systematic review: Efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Annals of Internal Medicine. 2007;146:25-33.
IVIG DISTRIBUTION UP IN 2006
Data from the Plasma Protein Therapeutics Association (PPTA) indicate that, during the first 11 months of 2006, IVIG distribution in the U.S. market exceeded the total amount distributed in 2005. More than 29,500 kg of IVIG were distributed between January and November 2006. PPTA has developed a Stakeholder Toolkit with information on plasma protein therapy manufacturing process and available resources (http://pptaglobal.org/en/stakeholder.cfm). Comments and recommendations on the toolkit should be sent to Diana Krueger at dkrueger@pptaglobal.org.
ITP patients may soon be able to boost their platelet production with fewer side effects, thanks to two oral drugs that are nearing the end of clinical trials. Two other drugs in earlier trials are also showing promise. The new drug, a non-peptide oral platelet growth factor is called Promacta (eltrombopag), and in a trial of 231 ITP patients at Weill Cornell Medical Center in New York City, three-fourths of patients getting the drug experienced a rise in platelets sufficient to restore healthy clotting. The maker of eltrombopag, GlaxoSmithKline, also announced results from a phase 2 international trial in 117 adults with chronic ITP, randomized to placebo or 3 different doses of eltrombopag. At all 3 doses, platelet counts rose compared with placebo.
During a presentation at the American Society of Hematology Meeting, Dr. David Kuter presented results from a clinical trial of AMG531. In that trial the compound boosted platelet counts in 31 of 36 ITP patients.
The other drugs that show promise are AKR-501, and SB559448.
Science News, January 13, 2007, pg. 29. Hematology & Oncology News & Issues, January 2007, pg. 21.
People who eat more slowly and deliberately consume fewer calories at a meal than those who speed through the meal, according to research at the University of Rhode Island. Tips in a new book, “Mindless Eating,” by researcher Brian Wansink, of Cornell University, include try to be the last person to start eating, decide how much to eat before sitting down, use smaller dishes so portions look larger, and don’t eat in front of the TV or in the car.
Parker-Pope, T. Latest Weight-Loss Advice: Slow Down and Pay Attention. Wall Street Journal, January 16, 2007, pg. D1.
Bulgur is made from wheat kernels that are first boiled or steamed, then dried and cracked into pieces. It is a good source of complex carbohydrates, contains 6 grams of fiber per cup (twice the amount found in brown rice!), and it offers a healthy dose of minerals and antioxidants. Bulgur can substitute for rice in any dish.
One more tip: exercising for 45 minutes, five days a week, may help prevent you from catching a cold.
Environmental Nutrition, January 2007, pg. 8.
POSITIVE MOOD MAY WARD OFF COLDS
Another way to ward off a cold is to keep a positive mood, according to research from Carnegie Mellon University in Pittsburgh. The researchers suspect that positive emotions stimulate symptom-fighting substances. They exposed more than 300 volunteers to cold viruses via nasal drops. Those who displayed generally positive outlooks, including feelings of liveliness, cheerfulness, and being at ease, were least likely to develop cold symptoms.
Science News, December 16, 2006, pg. 387.
The Dalai Lama has been encouraging brain researchers to study whether thoughts could cause physical changes in the brain. Neuroscientists already knew that the adult brain can change—its structure and activity can morph in response to experience. Experiments had shown that intensely practiced movements can alter the motor cortex of stroke patients and allow them to move once paralyzed arms or legs. But the Dalai Lama was interested in whether thought could rewire the brain. Experiments by scientists at University of Toronto found that, in depressed adults, the antidepressant paroxetine yielded the same outward effect as cognitive-behavior therapy. All of the patients came out of their depression. However, the impacts on the brain were different. Cognitive therapy rewired the brain in different areas than the drug. Additional studies found that meditation can change the function of the brain as well, making it easier for the brain to turn on circuits that underlie compassion and empathy.
How Thinking Can Change the Brain. Wall Street Journal, January 19, 2007, Pg. B1. [Book excerpt from “Train Your Mind, Change Your Brain” by Sharon Begley]
Two Websites vie for consumer audience
Steve Case, founder of American Online, is launching a new Website that will “put health care back into the hands of the consumer.” RevolutionHealth.com will start off free, but eventually charge about $100/year for premium services. It will digitally store medical records and provide telephone services that coach patients about their health, match them with doctors, and help unsnarl insurance claims. The existing leader in the market, WebMD.com, is competing by offering more of its services for consumers free. WebMD.com already maintains health records and enables users to personalize its site.
Tesoriero HW. The Doctor’s Office Gets Crowded on the Web, Wall Street Journal, January 22, 2007, pg. B1.
Adults age 50-plus face a sizable list of health screening tests. Some people don’t get tested when they need to. Others get screened too frequently. The U.S. Preventive Services Task Force suggests that early detection tests should be targeted based on an individual’s age, gender, underlying health conditions and family history. Low-cost and free services can be found through several sources:
Fleck C. How’s Your Health? AARP Bulletin, December 2006, g. 20.
Remodeling? Tips for a Healthier Home
“It’s gotten much easier to avoid troublesome products and to incorporate cleaner materials and techniques into your remodeling job,” according to the Website, www.alternativemedicine.com. Nontoxic materials have come down in price, and many more contractors are accustomed to using them.
For details, go to www.alternativemedicine.com. In the search box, type in “healthy home” to find the full article, “Blueprint for a Healthy Home”, by Sally Lehrman.
Contents:
Because prednisone and prednisolone are widely used first-line therapies for ITP, but long-term responses after therapy stops are very low (10%-25%), researchers in Italy tested high-dose dexamethasone (HD-DXM), another steroid, for untreated patients. In two studies, they found promising results. One study of adults showed an initial response rate of 90% and long-term response rate of 68%. A second, multicenter study in adults and children also found a high long-term response rate. They contend that their results confirm that HD-DXM can be a first-line therapy for adults and children with ITP. For both groups, 6 cycles appeared to be unnecessary. They have proposed a new randomized trial comparing 3 cycles of HD-DXM with conventional prednisone treatment for this population.
Mazzucconi MG, Fazi P, Bernasconi S, Derossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, rodeghiero F, Amendola A, Baronci C, Carbone C, Quatrin S, Fioritoni G, D’Alfonso G, Mandelli F. Therapy with high-dose dexamethsaone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood, 15 Feb, 2007; 109(4):1401-07.
The antibiotic vancomycin can cause antiplatelet antibodies that lead to ITP, according to scientists at the Medical College of Wisconsin and Baylor College of Medicine. Platelet levels returned to normal in every patient after vancomycin was stopped. They suggest that testing for drug-dependent antibodies can be helpful to identify the cause of thrombocytopenia, or low platelet count, in patients receiving vancomycin.
In a Perpective in the same issue of New England Journal of Medicine, Theodore E. Warkentin of McMaster University in Ontario, Canada, describes the impact and mechanism of other drugs implicated in immune-mediated thrombocytopenia, such as quinine and heparin.
Von Drygalski A, Curtis Br, Bougie DW, McFarland JG, Ahl S, Limbu I, Baker KR, Aster H. Vancomycin-induced immune thrombocytopenia. N Engl J Med. 1 March, 2007; 356(9):904-10.
Warkentin TE. Drug-induced immune-mediated thrombocytopenia—from purpura to thrombosis. N Engl J Med. 1 March, 2007; 356(9):891-3.
The American Society of Hematology is offering a new Web-based practice aid to help physicians provide the best care to patients with ITP. PIMs guide practice-based learning and improvement and include links to educational materials and other resources. Physicians who complete a PIM can earn CME credits.
http://www.hematology.org/education/recertification/itp/add_or_viewresults.cfm
Talecris, the maker of Gamunex® an IGIV therapy that requires cold-storage shipping, has made its insulated shipping containers more environmentally friendly by using a fully degradable Control Tem Blue™ container.
The American College of Critical Care Medicine (ACCM) task force issued clinical practice guidelines for support of patients and their families in adult, pediatric, or neonatal intensive care units. The guidelines define standards for incorporating families into decision making and care for ICU patients.
Critical Care Medicine, February 2007;35:605-622.
Medscape produced a CME activity around the new guidelines at: www.medscape.com/viewarticle/551738
Abuse of prescription drugs has surpassed elicit drug use in some places, according to the United Nations. In the U.S., prescription drug abuse is second only to marijuana abuse. The World Health Organization estimates that 10% of drugs on the global market are counterfeit. In developing countries, that number rises to 25% to 50%. The rise in counterfeit drugs is due to unregulated global markets selling through the Internet and mail order.
The Wall street Journal, March 1, 2007, pg. A4.
(Dangerous Doses, a book by Katherine Eban, is an exciting read that describes the problem. See: http://www.dangerousdoses.com/)
An analysis of 111 studies of soft drinks, juice and milk published in Public Library of Science, found that studies funded entirely by the beverage industry were four to eight times more likely to be favorable to those beverages than other research. Of 22 studies funded by the beverage industry, only 14% had unfavorable findings; more than 38% of independently funded research, however, was unfavorable. The researchers would like to see more government funding for nutrition research.
Tufts University Health & Nutrition Letter, March 2007, pg. 3.
The U.S. Food and Drug Administration is attempting to expand its program that enables people with life-threatening or serious illnesses to gain access to drugs that are still in testing and have not yet been approved by the FDA. For decades the FDA has allowed certain patients with AIDS and cancer to access experimental therapies on the grounds of “compassionate use” after all other avenues have been explored. The new rules spell out a broadening of who is eligible for unapproved drugs, how to request them, and how much companies can charge for them. Opponents of the expansion say that expanded access to these drugs will harm clinical trial enrollment, and may provide access to drugs that have not been well enough tested in humans and may cause more harm than good.
The comment period on the proposed rules was set to close in March. http://www.fda.gov/cder/regulatory/applications/IND_PR.ht
Nature Medicine February 2007, 13(2):111.
The mere belief that you are getting a workout may provide similar benefits to actual exercise. Researchers at Harvard University enrolled two groups of hotel housekeepers in the study. One group was told that their regular work was good exercise and met the guidelines for a healthy, active lifestyle. The other group was told nothing. Although the amount of activity done by the women did not change during the 4 weeks of the study, the “informed” group commented that their lives were healthier, and they lost an average of 2 pounds, their blood pressure dropped, and they lost body fat. The women who were told nothing experienced no changes.
The Wall Street Journal, February 2, 2007, pg. B1.
Heart disease is not gender-neutral, according to new research from Cedars-Sinai Medical Center in Los Angeles. Many women have a form of heart disease called coronary microvascular dysfunction that isn’t detected by standard diagnostic procedures, according to the NIH-funded Women’s Ischemia Syndrome Evaluation (WISE) study. This means that, instead of plaque causing obstructions in a large coronary artery, women are more likely to experience narrowing of the tiny vessels of the heart. This may help explain why so few women have the crushing chest pain that men experience. More often, they feel less dramatic symptoms, such as diffuse discomfort, exhaustion, or shortness of breath. The researchers found high levels of certain inflammatory substances in women at higher risk for heart disease. The inflammatory substances course through the blood stream, stripping away cells that line the blood vessels, allowing cholesterol to form plaques and stiffen the vessel walls. Inflammation persists as the vessels try to repair themselves and risk for clots increases. Bottom line: Risk is higher for African American women and premenopausal women with inflammatory disorders, autoimmune diseases, or low estrogen levels. Live heart-healthfully by getting regular exercise, maintaining a healthy weight, not smoking, and controlling levels of cholesterol, glucose, and blood pressure. See a doctor if you experience unexplained fatigue or shortness of breath.
Harvard Women’s Health Watch, February 2007, pg. 1.
Contents:
In April, the Food and Drug Administration approved a new use for Rhophylac, an anti-D Rh immunoglobulin. The intravenous compound is now approved as a means of raising platelet counts in Rh0(D) positive adult patients with chronic ITP who have not had their spleen removed. Rhophylac is a product of CSL Behring. For more information visit www.rhophylac.com
A new study sponsored by GlaxoSmithKline will evaluate repeated dosing of eltrombopag in patients who have been previously treated for chronic ITP. Previous treatments could include splenectomy, corticosteroids, immunoglobulins, cyclophosphamide, and rituximab. Eltrombopag is an experimental drug that is being tested as a platelet growth factor because it stimulates the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. It is given as a pill once-a-day. In this new study, called REPEAT (Repeat ExPosure to Eltrombopag in Adults with ITP), 50 patients will be recruited at several centers around the world. The drug will be given in three six-week cycles. Eltrombopag is not approved for marketing for any indication at this time.
For further information on the REPEAT trial, visit www.itpstudy.com or www.clinicaltrials.gov
The National Heart Lung and Blood Institute’s new strategic plan, Shaping the Future of Research: A Strategic Plan for The National Heart Lung and Blood Institute, can be downloaded from: www.nhlbi.nih.gov/strategicplan
The United Kingdom’s adult ITP registry has been sitting dormant since 2004 for lack of funding. But now, with support from GlaxoSmithKline and the UK’s ITP Support Association (http://www.itpsupport.org.uk/), data analysis will begin and new patients will be added to the existing database. Between 2001 and 2004, 609 ITP patients were enrolled, “making the study the largest of its kind in the world,” according to the ITP-UK newsletter. The aim of the registry is to learn more about ITP, its prevalence, clinical behavior, and responses to treatment. Progress reports for the study will be published in a bi-monthly newsletter, at www.ukitpregistry.com. The study coordinator is Ameet Sarpatwari (avs31@medschl.cam.ac.uk)
In a report last updated August 2005, the Food and Drug Administration stated that it found no evidence of an overall shortage of Immune Globulin Intravenous (IGIV) a.k.a. IVIG products. But is encourages health care providers and patients who experience difficulty obtaining IVIG products to send an email to CBERPRoductshortages@cber.fda.gov or call 1-800-835-4709.
www.hhs.gov/bloodsafety.igiv.html
In response to concerns about the potential risk of a rare fatal brain infection called variant Creutzfeldt-Jakob Disease for recipients of plasma-derived clotting factors and other plasma products (such as immune globulins), the FDA did a risk assessment and determined that the risks are extremely small, though somewhat uncertain. They devised a Website with several factsheets and Q&As: www.fda.gov/cber/blood/vcjdrisk.htm.
The Illusion of Coverage: How Health Insurance Fails People When They Get Sick, by The Access Project, recounts the personal, emotional, and physical hardships of the millions of hard working, insured Americans who are struggling with medical debt. The report demonstrates the specific ways in which health insurance products fail to protect people financially and fail to guarantee their access to needed care when ill or injured. 70 pp. (2007)
http://www.accessproject.org/adobe/the_illusion_of_coverage.pdf
Three other reports come from Families USA:
A Pound of Flesh: Hospital Billing, Debt Collection, and Patients' Rights provides an overview of some of the progressive reform measures that state policymakers have implemented to help families struggling with medical debt. 8 pp. (March 2007)
www.familiesusa.org/assets/pdfs/medical-debt.PDF
No Bargain: Medicare Drug Plans Deliver High Prices shows the huge differences between prices secured by the Department of Veterans Affairs (VA) — which bargains for cheaper drug prices — and the much higher prices charged by all the private drug plans in Medicare Part D, which cannot bargain for cheaper prices. 23 pp. (January 2007)
http://www.familiesusa.org/assets/pdfs/no-bargain-medicare-drug.pdf
Understanding How Health Insurance Premiums are Regulated provides a comprehensive overview on the different ways states can regulate health insurance premiums. 21 pp. (September 2006)
www.familiesusa.org/assets/pdfs/rate-regulation.pdf
The National Children’s Study will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The goal of the study is to improve the health and well-being of children. With a hefty appropriation of $69 million from Congress, the study is moving forward to expand into additional communities and begin recruitment. A Request for Proposals went out to fund 15-20 new study centers nationwide. The study is a huge undertaking. For example, it faces big obstacles in finding study participants within rural communities. The four South Dakota and Minnesota counties cover more than 2,500 square miles and the researchers are expected to recruit 75% to 80% of the counties’ newborns.
http://www.nationalchildrensstudy.gov/
In a survey of more than 1500 people ages 50 and older, only 3 in 10 told their doctors that they were using a complementary or alternative medicine (CAM). That means 7 of 10 were trying a CAM therapy without discussing it with their regular doctor. Many (42%) said the doctor never asked, 30% did realize they should tell their doctor, and 12% feared the doctor would have a negative reaction. The CAM therapies most often used were massage, chiropractic or some other form of body work, followed by herbal or dietary supplements.
www.aarp.org/research/health/prevention/cam_2007.html
Note: These findings are consistent with our survey (http://www.itppeople.com/surveyres/ ) PDSA recommends telling your doctor about any complementary or alternative therapies you are using.
Because proving that low-calorie diets can increase longevity would take decades, a group of scientists in Baton Rouge, LA, looked for more fast-responding changes in the cells of people put on calorie-restricted, yet nutritionally complete diets. Thirty six overweight people were assigned to one of three groups. The first group ate a diet with 25% fewer calories than their initial energy expenditure. The second group ate 12.5% fewer calories, then exercise to burn another 12.5%. The third group ate a weight-maintenance diet. During the 6-month study, both calorie-restricted groups showed an increase in mitochondria in their muscle cells and a 60% decrease in DNA damage. The mitochondria appeared to be more youthful and efficient. Both of these findings indicate a shift toward longer living. The group now plans to test people of normal body weight for 2 years.
Barry P. Living Long on Less? Science News, March 10, 2007, pg. 147.
Foods rich in folic acid may boost brain power and protect against Alzheimer’s disease, according to studies from the Netherlands and Columbia University Medical Center. The Netherlands study tested 800 microgram supplements of the vitamin in volunteers ages 50 to 70. In three years’ time, those taking the supplement had improved memory and information processing speed. The New York study showed people with the highest intake of folic acid over a 6-year period had the lowest risk for Alzheimer’s. Folic acid is found in green leafy vegetables, citrus fruit, beans, and fortified breads and cereals.
AARP Bulletin, March 2007, pg. 9.
Adults age 50 and older are at increased risk for vitamin B12 deficiency because their ability to absorb B12 from food declines. When B12 levels are low, and folic acid levels are high, older adults run a higher risk of anemia and cognitive impairment. For adults with normal B12 levels, however, folic acid seemed to be beneficial for cognitive function. The authors, from Tufts University, suggest improved efforts to detect and treat low vitamin B12 in seniors, especially in this age in which many foods are fortified with folic acid.
Folic-Acid Effects Depend on B12 Levels, Tufts University Health & Nutrition Letter, 25(2), April 2007, pg. 1-2.
Contents:
AMG 531 (Amgen) binds to and activates the receptor for thrombopoietin, a growth factor that induces bone marrow to make more platelets. The drug is being tested for its ability to increase platelet production. A phase 3b, open-label trial in which patients are randomized to either AMG 531 or standard of care for ITP is enrolling patients who are 18 or older with ITP who have not had their spleen removed and have received at least 1 prior therapy for ITP. Treatment period is 52 weeks. The study began enrolling in November 2006, in 21 states, Canada, and Europe. www.clinicaltrials.gov
AKR-501 - This Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study will assess the efficacy, safety and tolerability, of AKR-501 tablets, as compared to placebo, in the treatment of patients with ITP. Approximately 65 eligible patients will be randomized for 28 days. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose. You can find out more information about the study at www.PlateletStudies.com/pdsa.
A recombinant, antibody product that is comprised of 25 different anti-Rhesus D antibodies is moving into a phase 1 trial in healthy volunteers. It is being developed for treatment of ITP and for prevention of hemolytic disease of the newborn. Up to 39 RhD positive and 19 RhD negative healthy volunteers will be enrolled in the double-blind, randomized, placebo-controlled trial to assess safety and tolerability following a single intravenous infusion. The trial is being conducted at a clinic in the U.S.
According to the company news release, “Sym001 is the first ever recombinant polyclonal antibody to enter human clinical trials.” The drug is being developed by Symphogen, a pharmaceutical company in Denmark, and Biovitrum, a biopharma company in Sweden and the U.K.
TPO-mimetics are drugs that bind to the thrombopoietin (TPO) receptor, but bear no structural resemblance to TPO. The hypothesis is that these TPO-mimetics might treat ITP without causing production of anti-TPO antibodies. Examples of TPO-mimetics are AMG 531, Eltrombopag, and AKR-501. Researchers from New York Presbyterian Hospital reported on a phase 1/2 trial of AMG 531 in ITP. After testing various doses in phase 1, phase 2 included 16 patients with long-term ITP in a double-blind, placebo controlled trial. The compound produced a dose-dependent increase in platelet counts in ITP patients. A reviewer writes, “Although the data on TPO-mimetics are currently tantalizing, the long-term effects of these compounds remain to be established.”
Abrams C. Are TPO-Mimetics Better Than the Real Thing? The Hematologist, March/April 2007, Vol 4(2), pg. 7.
Rituximab, a monoclonal antibody against CD20-positive B cells, is increasingly used to treat ITP, but data to support its use are limited. A review of the literature between 1997 and 2004 found just 19 reports that described five or more patients; nine of those were abstracts only. None of the studies were randomized trials. The drug can induce remissions in ITP, but it is difficult to estimate its true efficacy since the literature is biased by small case reports touting high response rates. The reviewer concludes that it would be “worthwhile and beneficial for both patients and physicians to study rituximab in a larger cohort.”
Abrams, C. Rituximab in ITP – When and Why Does it Work? The Hematologist. May/June 2007, Vol 4(3), pg. 8
Researchers at the Blood Center of Wisconsin reported that a 4-year-old girl experienced several episodes of acute thrombocytopenia (low platelet count) after taking acetaminophen (Tylenol). Years earlier they had found a similar reaction to acetaminophen and naproxen (Aleve), and determined that the triggers for platelet destruction were acetaminophen sulfate and naproxen glucuronide. For the more recent patient, the metabolite trigger was different: acetaminophen glucuronide.
Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH. Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen. Blood, 15 April 2007, pg. 3608-9.
The Centers for Medicare and Medicaid has established new, brand-specific codes for 4 intravenous immune globulin (IVIG) products and one Rho(D) immune globulin product. This enables brand-specific reimbursement for Medicare beneficiaries. The IVIG products with their own codes are Octagam, Gammagard, Flebogamma, and Gamunex. The Rho(D) receiving its own code is Rhophylac.
Immunoglobulin is included in the 15th edition of the World Health Organization (WHO) list of Essential Medicines. From the WHO website: “The WHO List of Essential Medicines provides a model for countries to select medicines addressing public health priorities according to quality, safety and efficacy standards.”
The Food and Drug Administration (FDA) warned U.S. consumers that Web sites may be distributing counterfeit prescription drugs, after reports of 24 Web sites distributing fake Xenical, a drug prescribed for weight loss. FDA advice: Be wary if 1) there is no way to contact the Web site pharmacy by phone, 2) if prices are dramatically lower than the competition, or 3) if no prescription from your doctor is required. FDA’s Web site contains tips for consumers as well as the list of 24 questionable Web sites.
The Centers for Disease Control and Prevention’s (CDC) Division of Hereditary Blood Disorders has been officially renamed the Division of Blood Disorders. The Division works with multiple partners to implement specialized prevention programs for persons with blood disorders and their families.
A study in The New England Journal of Medicine tested whether aggressive treatment of gum disease can decrease chronic inflammation and thereby reduce risk for atherosclerosis. The authors demonstrated that a single intensive treatment of severe periodontal disease was associated with a sustained improvement in dental health, endothelial function, and markers of chronic inflammation. Endpoints, however, were surrogate markers for inflammation and blood vessel health. Larger studies are needed.
Silverstein R. Flossing May Prevent Plaque (of a Different Sort)! The Hematologist. May/June 2007, Vol 4(3), pg. 6.
The New York Times and other media outlets reported that arsenic, a recognized cancer-causing agents that may also contribute to heart disease and diabetes, is deliberately given to chicken in the U.S. Arsenic is a government-approved additive in poultry feed because it kills parasites and promotes growth in chickens.
Organic chicken and those labeled “antibiotic-free” do not contain arsenic. Tyson Foods, the nation’s largest chicken producer, has stopped using arsenic in chicken feed; but “there are many more arsenic-fed than arsenic-free chickens for sale in the U.S.”
Burros M. Chicken with Arsenic? Is that O.K.? The New York Times, April 5, 2006.
(Note: Arsenic can reduce platelet counts)
The federal government is warning consumers to stop flushing old drugs down the toilet. Pharmacy groups used to recommend flushing unused drugs to prevent pets and curious children from retrieving them from wastebaskets. But now prescription drugs are found flowing down the nation’s rivers and have been linked with reproductive problems in fish and drug-resistant germs spread by waterfowl. The new campaign, called SMARxT, recommends unused drugs be disposed through municipal hazardous-waste-collection programs. The next best choice is putting them in the trash. But first, individuals are asked to crush pills or dissolve them in water; add them to sawdust, kitty little or some other inedible material; and seal them in a plastic bag.
Science News, April 7, 2007, vol 171, pg. 222.
In our April e-news we reported that the United Kingdom’s adult ITP registry has been sitting dormant since 2004 for lack of funding. This was incorrect. The ITP registry was put on hold because of a change in staffing. Dr. Provan has returned to the project which is now very active and accumulating data. The aim of the registry is to learn more about ITP, its prevalence, clinical behavior, and responses to treatment. Progress reports for the study will be published in a bi-monthly newsletter, at www.ukitpregistry.com. The study coordinator is Ameet Sarpatwari (avs31@medschl.cam.ac.uk)
Platelet Disorder Support Association
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IMPORTANT!
The Platelet Disorder Support Association does not provide medical advice or endorse any medication, vitamins or herbs. The information contained herein is not intended nor implied to be a substitute for professional medical advice and is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider before starting any new treatment, discontinuing an existing treatment and to discuss any questions you may have regarding your unique medical condition.