Two renowned physicians, Dr. James Bussel and Dr. Douglas Cines, both known for their ITP research and clinical work with ITP patients, explain how they treat ITP in an article in the journal “Blood”. The article is available without charge on an American Society of Hematology website, www.bloodjournal.org. You may have to register before the article is available. Once you have registered, if required, the article is available at the following URL:
http://www.bloodjournal.org/cgi/reprint/106/7/2244
This article, “How I Treat ITP” will be of interest to patients newly diagnosed with ITP as well as patients who have been dealing with the disease for a number of years. In the article Drs. Cines and Bussel set forth their opinion, and they emphasize that it’s their opinion, regarding the best approach to “manage adults with primary idiopathic (autoimmune) thrombocytopenic purpura (ITP).”
The article addresses questions such as: Who gets ITP? How is it diagnosed? Who is treated? Who should be hospitalized? What treatments are the treatments of choice? The article also addresses persistent ITP, splenectomy, approaches to treating chronic ITP, and ITP and pregnancy.
Cines, D.B. and Bussel, J.B., How I Treat Idiopathic Thrombocytopenic Purpura (ITP), Blood (1 October 2005, Vol 106, no 7, pp2244 – 2251).
Gamunex® was introduced in the fall of 2003. It was the first completely new IGIV therapy in more than a decade. Product purity of Gamunex® is enhanced through the use of the Caprylate/Chromatography process that helps to preserve the biologic activity of the product by replacing the solvent-detergent method used in previous generations of IGIV products. Gamunex® is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for ITP.
Talecris Press Release
This study “evaluated whether repeated courses of high-dose methylprednisolone (HDMP) [prednisone] affect the lumbar spine bone mineral density (BMD) in children with chronic ITP.” The study was a retrospective analysis of 24 chronic ITP patients treated between 1992 and 2002. There were 15 male and 9 female patients included. The children were diagnosed and started treatment at a mean age of 6.7 years. They were divided in to three groups with respect to the number of courses of HDMP they received. The authors conclude that HDMP had a significant affect on lumbar BMD. While the affected lumbar BMD was not clinically significant, “some problems related to the decreased BMD might occur in these patients in the future, and we believe that they should be followed-up closely in the adult life.”
Dilber, C, et.al., Reduced Bone Mineral Density in Childhood Chronic Idiopathic thrombocytopenic Purpura treated with High Dose Methylprednisolone, Bone, 35, 2004, pp 306-311.
The Green Guide in a recent issue offered tips for a safer Halloween. Among a much longer list of suggestions were the following: 1. Make sure your kids can both see and be seen. No masks or hats that make it difficult to see. And bright clothing or flashlights that make them visible especially to drivers. Avoid glow sticks as they may pose a health risk if they leak. 2. Avoid polyvinyl chloride masks, costumes, and accessories. They are potential health risks. 3. Decorate pumpkins with non-toxic materials. Turn to the Green Guide for a more comprehensive list of suggestions.
You can find the article at: http://www.thegreenguide.com/doc.mhtml?i=110s=costumes.
A new website (www.ifpma.org/clinicaltrials) has been launched by the International Federation of Pharmaceutical Manufacturers and Associations to report the results of clinical studies. Phase 1 studies on healthy volunteers are exempt and there is no obligation to report results of studies before a drug is approved. There is an obligation to publish results within one year of approval. For drugs already approved, study results are to be published within one year of the completed trial. The hope is that this site will address criticism of the pharmaceutical industry and head off governmental legislation.
http://www.medscape.com/viewarticle/513195
Doctor-patient communication is one of most basic components of the care we receive from our physicians. To facilitate this communication, patients must be clear and as complete as possible regarding the problem or problems for which they seek help. Doctors must use the limited time available carefully, creatively, effectively, and efficiently. Health care provider Kaiser Permanente developed a program a number of years ago to provide interview training to physicians. The Kaiser program is known as the Four Habits model. While it was developed to train physicians, it provides a learning opportunity for patients who want to get the most out of their visits to their doctor. In short, the model focuses on building rapport quickly, prioritizing concerns, and looking at the problem from the patient perspective. The model emphasizes the importance of empathy and emotions in the communication. Finally the model advocates delivering the diagnosis clearly and in terms of the original concern. The end of the visit should provide a rationale for tests and treatments, summarize the visit, and indicate the next steps.
Details of the model can be found at the two sites below:
Landro, L, “Teaching Doctors How to Interview”, Wall Street Journal, September 21, 2005, p D5.
New standards from the Accreditation Council for Graduate Medical Education (ACGME) are proving to be an incentive to medical schools to move more aggressively to train doctors to be more empathetic, considerate, compassionate, in-short…nicer. Medical educators recognize a culture, a “hidden curriculum” in residency training programs that contradicts everything they have been taught about ethical behavior, compassionate care, and professionalism. The behavior that residents observe every day in the medical school environment is more important in forming attitudes and practices than the information taught in the formal course materials. This culture often includes the lessons that lead to behavior that has been described as “cold, intimidating, authoritarian, narrow-minded and disrespectful of subordinates and patients.” Fortunately this problem is being addressed. Leading medical schools are moving to incorporate standards and an evaluative process to assess progress in training “nicer” doctors. For more information see: www.acgme.org.
Landro, L, “Teaching Doctors to Be Nicer”, Wall Street Journal, September 28, 2005, p D1.
We are currently planning our regional meetings for the fall and winter season. We will host a meeting in Seattle November 5, 2005, in Atlanta December 8, 2005, and in Miami on January 21, 2006. You can find the agenda and specific location of the meetings on http://www.itppeople.com/calendar.htm. We update this information as it is finalized.
These meetings are a wonderful way to learn about ITP and meet others.
A message from one of our members in New Orleans
“Have you ever been to New Orleans? Didn't you just LOVE it! Maybe you saw Mardi Gras? Or the Jazz Fest? Came for a vacation, a wedding, enjoying the fabulous food, tapping with the music, tasting and toasting everything... It is our passion and duty on earth to assure that everybody we know "pass a good time". And it was always a good time in New Orleans, regardless.
But there's a HUGE problem. Similar to the ravaging effects ITP, which introduced its horrible self to me with a platelet count of 1000, Katrina is threatening our very ability to survive. Entire families are scattered across the States.
Businesses are disappearing into the bloodstream of their new post-evacuation locations. As a PDSA member for five years, it is immediately obvious no medication, IV drip, or spleen removal will stop the bleeding.
But YOU can stop it, you REALLY can! Please log on to www.desirenola.org. Read what we are doing to increase our count. Desire NOLA (New Orleans, LA) is not-for-profit, led by young professionals like myself, who want to help small businesses to come back, re-open and thrive. Like the place where you tried your first gumbo, or ate your first po-boy, dunking powdered-sugar beignets into freshly-dripped cafe au lait. We know the cure. Money is the cure. Buy a shirt, share the desire, save our City. Our world-famous "joie-de-vivre" is still palpable, but the count must be increased by thousands of thousands if recovery is to be achieved. PLEASE HELP New Orleans once again say, with each one of our hearts, "Ya'll come back, real soon!"
GMA161 – Genzyme Corporation in collaboration with MacroGenics, Inc. is currently conducting a Phase I research study for people over the age of 17 years who have been diagnosed with chronic idiopathic thrombocytopenic purpura (ITP). The study is designed to investigate the safety of a single infusion of GMA161, a monoclonal antibody, as well as the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured.
For more details about eligibility criteria and contact information for participating medical centers, please visit: http://www.clinicaltrials.gov/ct/show/NCT00244257.
You can find a listing of this and other clinical trials at: http://www.itppeople.com/clinical.htm.
Italian investigators demonstrate that slow breathing can reduce blood pressure. They explain that this is accomplished by enhancing baroreflex sensitivity, the sensitivity of nerve cells in the wall of the heart that sense changes in blood pressure and initiate changes in heart function to maintain normal pressure. The study included 46 subjects; 20 patients with essential hypertension and 26 healthy controls. Slow breathing increased baroreflex sensitivity in the hypertensive patients and the control subjects. The authors conclude, "slow breathing had the effect of acutely normalizing the baroreflex sensitivity in these patients," Dr. Bernardi and his group conclude, "It seems that slow breathing induces a generalize decrease in the excitatory pathways regulating respiratory and cardiovascular systems."
Bernardi, L., et.al., Hypertension 2005;46:714-718, http://www.medscape.com/viewarticle/514756
The Institute of Medicine (IOM) notes that “a chasm exists between the kind of care that patients receive and the kind of care they should have, and calls for fundamental change in the system of care. It further argues that these changes would both be better for patients and make the provision of care more satisfying for clinicians.” Dr. Davis proposes seven attributes of patient centered care;
1. Access to care
2. Patient engagement in care
3. Information systems
4. Care coordination
5. Integrated and comprehensive team care
6. Patient-centered care surveys
7. Publicly available information
It has been reported that 25% of primary care physicians currently incorporate these attributes in their practices. Marked improvement will require major changes including a new system of primary care payment. One proposed structural change would ensure that everyone had a “medical home”; everyone regardless of whether insured by public programs or private insurance would have a place to enter the health care system. The task is monumental with rewards to match.
Davis, K., et.al., Journal of General Internal Medicine, 2005;20(10):953-957, http://www.medscape.com/viewarticle/514194.
It is estimated by the World Health Organization (WHO) that 17 million people die prematurely each year from chronic diseases and that international action to prevent chronic disease could save 36 million people world wide over the next decade. The three most important causes of chronic diseases are unhealthy diet, physical inactivity, and tobacco use. The personal, social, and economic impact of these diseases is significant. Families are fractured and the economic losses amount to billions of dollars. It is estimated that in the period 2005 – 2015, China, India, and the Russian Federation will each forgo billions of dollars of national income to premature death due to chronic disease. The WHO report includes inexpensive and cost-effective measures that could produce rapid health gains. These include: salt reduction in processed foods, improved school meals, and taxation of tobacco products. The latter approach is not only cost-effective but would increase revenue as well.
http://www.who.int/mediacentre/news/releases/2005/pr47/en/
Researchers in Toronto report that children treated with steroids for acute ITP are 26% less likely to have a platelet count greater that 20,000 48 hours after therapy than children treated with IVIG. This finding resulted from a meta analysis of data from randomized, controlled trials and was reported originally in the Journal of Pediatrics in October 2005.
Beck, C., Nathan, P., Parkin, P., Blanchette, V., Macarthur, C., “Corticosteroids Versus Intravenous Immune Globulin for the Treatment of Acute Immune Thrombocytopenic Purpura in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials” The Journal of Pediatrics, October 2005 (Vol. 147, Issue 4, Pages 521-527) see also IgG Today, Newsletter of IgG America, November 2005. http://www.jpeds.com/article/PIIS0022347605003422/abstract
The American Society of Hematology (ASH) has made available full-text, searchable PDF versions of all articles dating back to 1946. Access is free to all. Only articles from the last 12 months are under access control. However, even articles published during the last 12 months can be obtained by patients at no cost by emailing a request to the journal. For an explanation of the procedure to obtain articles published during the last 12 months, go to:
http://www.bloodjournal.org/misc/Patient_Request.shtml.
To use the Blood archive, go to: www.bloodjournal.org.
ASH Newslink, November 2005.
Researchers at Boston University reported on data from a nationwide survey examining the teeth and gums of 6,700 nonsmokers. They found that bleeding gums were 20% less likely in those with the highest levels of Vitamin D. The authors suggest that Vitamin D may keep gums healthy by fighting inflammation.
Nutrition Action Healthletter, November 2005, p 10.
The National Institutes of Health (NIH) announced that a 230 page volume, Thrombosis Research, will be available December 10, 2005. This publication represents the work of the NIH Conference on Dietary Supplements, Coagulation, and Antithrombotic Therapies. The volume examines the effects of dietary supplements and various therapies on coagulation.
Representatives from 10 patient care organizations participated including Joan Young, President of PDSA. In addition to the representatives from patient care organizations, more than 35 speakers presented.
http://www.sciencedirect.com/science/journal/00493848
Contents:
This month encouraging reports were presented at the American Society of Hematology (ASH) Conference in Atlanta, Georgia on the new ITP treatments in development that stimulate platelet production. Reports from clinical trials of both Amgen’s AMG 531 and GlaxoSmithKline’s Eltrombopag indicate treatments that increase platelet counts to safe levels at doses that are well tolerated.
One group of researchers at ASH reported that “AMG 531 has been generally well tolerated and able to stimulate platelet production in a dose-response manner in healthy volunteers and ITP patients. Results suggest that both unit dosing and weight based dosing provide a predictable platelet response. AMG 531 may represent a new treatment option for thrombocytopenic patients with ITP.” Another group of researchers reporting results from a clinical trial involving 21 patients state that “AMG 531 was well tolerated and both doses (two dose levels were tested) were able to increase platelet counts within the targeted range.”
Results of clinical trials were announced for GSK’s Eltrombopag. Researchers reported that a phase 1 study resulted in a dose-dependent increase in platelet count without safety or tolerability issues. They reported no effects on other blood cell lineages or priming of platelets for activation or aggregation. The report from a phase 2 study demonstrated that patients with ITP for at least 6 months and having failed at least one prior therapy with a platelet count less that 30,000 achieved platelet counts greater that 50,000 after 6 weeks without safety or tolerability issues.
Clinical trials for both compounds are on-going. See http://www.itppeople.com/clinical.htm for information on these and other clinical trials for ITP.
See http://www.hematology.org/meetings/2005/abstracts.cfm to view the abstracts. The next issue of our newsletter, The Platelet News, sent to our members (see http://www.pdsa.org/joinus.htm) will contain a synopsis of all the relevant ITP abstracts as well as summaries of the special ITP sessions.
Stepan, D.E., et. al., “Safety Profile of AMG 531 in Healthy Volunteers and in Thrombocytopenic Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
Kuter, D., et. al., “A Placebo Controlled tudy Evaluating the Platelet Response and Safety of Weekly Dosing with a Novel Thrombopoietic Protein (AMG 531) in Thrombocytopenic Adult Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
The Food and Drug Administration (FDA) has issued a safety alert indicating that some IgG products may cause false elevated blood glucose measurements. These false measurements have resulted in inappropriate administration of insulin, resulting in life-threatening hypoglycemia according to the FDA. The products involved are Octagam 5%, Gamimune N 5%, and WinRho SDF Liquid (No interference expected at labeled doses).
See: http://www.fda.gov/ohrms/dockets/ac/05/slides/1 for more information.
IgG Today: News and Information for Clinicians, IgG America, December 2005.
Adverse drug and device events affect hundreds of thousands of patients annually. Many are or become life-threatening. New medications and devices are tested very carefully before being approved for use by the medical community to treat patients. However, these trials are conducted with relatively small numbers of patients. This means that adverse events that will affect a small percentage of patients are less likely to be detected. It is important that post approval adverse events be reported and evaluated. The FDA has established an on-line system that enables patients to report adverse events directly. You can report an adverse event at the MedWatch section of the FDA website. The form is available at: http://www.fda.gov/medwatch/SAFETY/3500.pdf. Instructions to complete the form can be found at: http://www.fda.gov/medwatch/REPORT/CONSUMER/INSTRUCT.HTM.
ITP is one of the most common bleeding disorders in children. However, there have been relatively few clinical trials with ITP children leaving diagnosis and treatment to expert opinion not clinical trial evidence. As a result, treatment varies widely. Drs. A.T. Shad, C.E. Gonzalez and S.G. Sandler (a member of the PDSA Board of Medical Advisors) all at Georgetown University Medical Center have reviewed the diagnosis and treatment of ITP in children in the current issue of Pediatric Drugs. The abstract is available at:http://pt.wkhealth.com/pt/re/pdd/currenttoc.htm;jsessionid=DnLAOpOPaJ8l05yMxI1AzP3PH7BuZQc56t5SQnDfJ2Mwo32cJl16!-85436088!-949856145!9001!-1 and a sample issue of the journal is available at the same site after registration.
Shad, A.T., et. al., “Treatment of Immune Thrombocytopenic Purpura in Children”, Pediatric Drugs, 2005: 7 (5):325-336.
The good news is more Americans are eating vegetables. The bad news is illnesses traced to fresh vegetables are on the rise. Government and the produce industry have identified five products that are particularly problematic: tomatoes, melons, lettuce, sprouts, and green onions. The FDA is pushing to extend food-safety practices to include those who harvest, store, and distribute raw agricultural products. The industry is also developing detailed guidelines covering each step of the journey to market. The Partnership for Food Safety Education recommends a six step approach to handling fruits and vegetables. One, check for bruises and reject bruised fruits and vegetables; two, clean hands and utensils with hot soapy water before washing fruits and vegetables; three, separate fresh fruits and vegetables from household cleaning chemicals as well as meat, poultry, and sea food from shopping cart to table; four, cook or throw away fresh items that touch meat, poultry, or sea food; five; chill by refrigerating all cut, peeled, or cooked fresh fruits and vegetables within 2 hours; six, throw away all fresh fruits and vegetables not refrigerated within two hours. To get the details on the six step procedure go to: http://portal.fightbac.org/pfse/toolsyoucanuse/phec.
Zhang, J, “When Eating Your Vegetables Makes You Sick”, The Wall Street Journal, November 30, 2005, p D1.
A study conducted by Kenneth Mukamal and colleagues at Beth Israel Deaconess Medical Center in Boston suggests that moderate drinking may lower the risk of heart attacks. They studied the blood of 3,789 men and women over several decades investigating risk factors for cardiovascular disease. They found that “the blood of people who consume 3 to 6 [alcoholic] drinks weekly was less likely to clot in a test tube than was blood from nondrinkers, Platelets from the moderate drinkers were also less likely than those from nondrinkers to display a surface protein that makes them sticky.” The study seems to confirm other work showing that people who drink regularly have a lower risk of heart attacks but a higher risk of bleeding strokes than do teetotalers.
Science News, November 12, 2005, vol 168, p 317
Health insurance companies are using graphic videos to educate patients about their health and help them go into surgery with realistic expectations. Some of the videos available show very graphic detail of surgical procedures such as a needle being inserted into the eye as part of cataract surgery or blood dripping from a foot from which skin is being peeled away as part of a surgical procedure. This objective for the videos of building realistic expectations for patients is claimed by the companies that create them and the insurers and employers who are making them available to workers. Surgery videos join preventive-care guides and online drug cost software that insurers and health-plan administrators are using to educate patients as part of a movement that is referred to as consumer driven health care. Some claim that watching these videos can empower patients to question their physicians instead of just accepting their recommendations as if no alternative is available or worthy of consideration. Others see these tools as discouraging procedures that patients can benefit from. The Ottawa Health Research Institute recently chaired an international group to develop standards for effective standards for effective “decision aids” for patients.
Rubenstein, S, “Health Insurers Show Employees Graphic Surgery Videos”, The Wall Street Journal, November 30, 2005, p B1.
Food marketers want to use terms such as “good source” and “excellent source” of whole gains to promote the sale of a wide range of grain-based food products. According to the Wall Street Journal 432 whole grain products have been launched this year. The FDA has entered the fray by rejecting General Mills Inc.’s request for permission to label cereal, bread and other products as “good source” or “excellent source” of whole gains. Presently it is difficult for shoppers to know how much whole grain is in a product. While some manufacturers are using the phrase “all our products are made with whole grain” the FDA has not ordered them to pull this wording. The FDA has not decided what “whole grains” includes or whether it should be considered a food category, ingredient, nutrient, or something else. It will be some time before this is resolved. In the mean time buyer beware.
Zhang, J., Adamy, J., “FDA Limits Claims About Whole Grains”, The Wall Street Journal, December 6, 2005, p D1.
PDSA has available a new patient information booklet, “Frequently Asked Questions - ITP and Pregnancy.” This 12 page booklet contains 31 questions and answers of interest to women and their families about thrombocytopenia and pregnancy. You will also find references to other related material.
The content of the booklet is available on the PDSA web site at http://www.itppeople.com/preg/
To obtain a printed copy, send a self-addressed, 6x9 envelope with a 63 cent stamp to PDSA, PO Box 61533, Potomac, MD 20859. If you would like multiple copies, call us at 1-877-528-3538 or send an e-mail to admin@pdsa.org
The annual meeting of the American Society of Hematology was held during the second week of December 2005 and is a showcase for the latest hematology research. The research abstracts are available on line and in print. To view the abstracts go to: http://www.bloodjournal.org and click on ASH Annual Meeting Abstracts. The abstracts are also printed in the journal Blood, Vol. 106, #11, November 16, 2005.
The Food and Drug Administration, Cangene Corporation, and Baxter Healthcare Corporation have sent a letter to healthcare professionals warning them of a rare and potentially fatal risk of intravascular hemolysis in patients with ITP receiving intravenous anti-D (WinRho SDF). [The estimated rate of a very serious reaction is 0.005% or 1 in 20,232 infusions.] “Patients should …be advised to immediately report symptoms of back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath.” The liquid product has been linked to falsely elevated glucose readings on some testing systems because of its maltose content. Patients receiving anti-D are advised to use glucose-specific testing methods.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#WinRho
Note: Physicians and patients are encouraged to report serious side effects from any treatment to the FDA through their MedWatch system. http://www.fda.org/Medwatch/.
According to the New England Journal of Medicine, Americans receive only 55% of recommended health care services. The Commonwealth Fund, a non-profit with a mission to promote a high performing health care system, has reported that nearly one-third of the adult U.S. population (61 million) cannot obtain care because they are uninsured or underinsured. Consistent with this view, Congress gave $29 billion to the National Institutes of Health (NIH) in 2005 and $320 million to the Agency for Healthcare Research and Quality (AHRQ) during the same period. This funding neglect is not only bad for our health but for the economy. The United States spends 15% of its gross domestic product on health care, twice the average per capita spending of all industrialized countries. We may have reached a point where the public would be impressed as much by progress in providing good care as the roll out of a new device or pill.
Woolf, S.H., “Unhealthy Medicine”, The Washington Post, January 8, 2006, p B3.
One avenue to better delivery may come through genetic testing. The FDA is weighing action that could pave the way for widespread use of genetic tests to help set dosing of the blood- thinner warfarin (Coumadin). This medication is used by more than 2 million Americans to prevent blood clots. Serious side effects result from over or under dosing. This is just one example of how genetic testing can improve healthcare by reducing adverse drug reactions which, by some estimates, claim 100,000 deaths and 2 million hospital admissions each year in the US.
Winslow, R., Mathews, A.W., “New Genetic Tests Boost Impact of Drugs”, The Wall Street Journal, December 21, 2005, p D1.
Tryptophan, the substance in turkey that has been linked to Thanksgiving Day afternoon snooze, plays a pivotal role in the immune system according to Lawrence Steinman, MD of Stanford University. Dr. Steinman’s group found when tryptophan breaks down in the body it can alleviate symptoms of multiple sclerosis in mice. Tranilast, a drug that is similar to metabolized tryptophan and suppresses the immune system has been used abroad for other indications.
“The bigger message here is that diet and immunity are inextricably linked.” said Dr. Steinman.
http://news-service.stanford.edu/news/2005/november9/med-turkey-110905.html.
Exercising and reducing marital hostility may speed healing according to two studies by Ohio State University researchers. During one study, researchers compared the length of time it took to heal blister wounds on study participants when they talked normally and when they had disagreements. The couples with a higher level of hostile behavior healed at 60% of the rate of low-hostility couples. In another study of adults aged 55 to 77, those who exercised healed in 29 days compared with 39 in the sedentary group.
January W. Payne, “Get Well Sooner; To Speed Healing, Quit Squabbling and Hit the Gym” The Washington Post, Tuesday, January 10, 2006. F1.
Undisclosed safety problems with approved drugs have prompted calls for more basic information about clinical trial protocols in a publicly accessible registry and the public identification of all trials. Deborah Zarin and colleagues reviewed clinical trials.gov and examined the number of trials registered on May 20, 2005 and October 11, 2005 and the trials registered between these two dates. They report an increase of 73% in the number of registered trials from 13,153 to 22,714. “...Of the 2,670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24% of the records, this field was blank.” They conclude “During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than in May, But there still is room for substantial improvement.”
Zarin, D.A., et. al., “Trial Registration at ClinicalTrilas.gov Between May and October 2005” , New England Journal of Medicine, no 26, December 29, 2005, vol. 353:2779-2787.
Research dating back 40 years ruling out a chill/cold connection is challenged by researchers at Cardiff University, Cardiff, Wales. They randomized 180 healthy participants to dip their feet in ice water for 20 minutes or an empty bowl. There was no difference immediately after the experiment but in a few days 13 of the 90 participants who were chilled reported they were suffering from symptoms of a cold, compared to 5 of the 90 controls. The study does not address infection with a virus but only the development of symptoms after exposure. “The results of the present study demonstrate that chilling is associated with the onset of common cold symptoms but the study does not provide any objective evidence, such as virology, that the subjects were infected with a common cold virus.” The next step is tests to determine which viruses are actually causing the symptoms.
http://www.medpagetoday.com/Pulmonary/URIstheFlu/tb1/2136
Primary Source: Family Practice. 2005;23.
Identifying the gaps between belief (values) and action can kindle an awakening of your inner life. Building or developing your inner life, can help in the control of stress and lead to a fuller more rewarding life. Douglas LaBier, a psychotherapist and business psychologist, finds many people he encounters in his practice and consulting struggle to balance work and home and find this frustrating. He suggests they frame the problem incorrectly. He says, “There is no way to balance work and home, because they exist on the same side of the scale—what I consider the ‘outer’ part. On the other side of the scale is their personal, private life—the ‘inner’ person. I encourage clients not to think about balancing work life and home life, but to balance outer and inner life.” He finds that when people do this they often find that the old conflicts, work vs. life, don’t cause the stress or dominate thoughts anymore.
LaBier, D. “The Inside Out Solution”, Washington Post, February 14, 2006, p. F1.
New research suggests that if you expect more from your medication, you may just get it. Doctors have long assumed the placebo effect was purely psychological. This new work points to physical, not just psychological, effects on your health. At the Society for Neuroscience meeting in Washington, DC, researchers presented evidence of changing levels of brain chemicals and neuron firing patterns associated with placebo “treatment”. Other studies published in the United States and Europe report similar findings.
Washington Post, December 13, 2005, p F3.
It has been known that infectious proteins are harbored in brain and spinal cord tissue of animals infected with mad cow disease. Similarly for chronic wasting disease (CWD) in deer and elk infectious proteins are harbored in brain and spinal cord tissue. New work has demonstrated that in deer and elk, infectious proteins are found in muscle as well. This was determined by injecting a special strain of mice with both brain and muscle tissue of infected deer. Both groups, those receiving injections of brain tissue and those receiving injections of muscle tissue, developed CWD symptoms. It took longer for the mice receiving muscle tissue injections to develop symptoms than those receiving injections of brain tissue. The work demonstrated that exposure to infectious proteins from deer meat can cause disease but it is not known whether humans will be susceptible to CWD.
Brownlee, C., “Hunter Beware”, Science News, January, 28. 20006, vol 169, p52.
GlaxoSmithKline has announced commencement of an Eltrombopag Phase III worldwide clinical trial in adults previously treated for idiopathic thrombocytopenic purpura. The study will be double-blind, randomized, placebo-controlled, parallel group design with sites in 33 countries. Eltrombopag is an investigational small-molecule thrombopoietin receptor agonist that is thought to stimulate the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets, and thus is considered a platelet growth factor. Clinical trial enrollment information can be obtained at: www.itpstudy.com or www.clinicaltrials.gov.
GlaxoSmithKline press release, February 9, 2006.
In January the Food and Drug Administration (FDA) announced significant relaxation of the rules governing at what stage of development experimental drugs can first be tested in people. These changes are intended to expedite drug development. The announced changes will allow scientists to test small doses of experimental drugs for seven days or less in people before full-scale clinical trials begin and before standard in vitro and animal tests are complete. These studies would not test safety or effectiveness, but would assess how the drug acts in the body and is metabolized. This type of testing will enable scientists to quickly identify and discard inappropriate drug candidates. Concerns have been voiced in some circles that these changes will increase the possibility that the drug will not be safe enough when it is tested in people. Others say that patients waiting for a medicine to solve their health problem are willing to take acceptable risks.
Nature Medicine, vol 12, no 2, February 2006.
PDSA has available a new patient information booklet, “Frequently Asked Questions - ITP and Pregnancy.” This 12 page booklet contains 31 questions and answers of interest to women and their families about thrombocytopenia and pregnancy. You will also find references to other related material.
The content of the booklet is available on the PDSA web site at http://www.itppeople.com/preg/
To obtain a printed copy, send a self-addressed, 6x9 envelope with a 63 cent stamp to PDSA, Pregnancy Booklet, PO Box 61533, Potomac, MD 20859. If you would like multiple copies, call us at 1-877-528-3538 or send an e-mail to admin@pdsa.org
Berkeley Wellness Letter, December 2006, page 1.
A federal proposal to limit personal donations of platelets is headed back to the drawing board after government advisers said it would drastically cut the nation's supply. Platelets are chronically scarce, because they last just five days after they're donated. As part of an overhaul of donation guidelines, the Food and Drug Administration had proposed limiting how many platelets someone could donate each year to about 24 pints.
Boston Globe, "Panel rejects plan for platelet donation limits", Saturday, March 13, 2006, page A2.
(Note: Platelet donation changes, if they were approved, would not have a major effect on people with ITP since infused platelets are used infrequently in the treatment of this disease)
The present shortage of IVIG results from many factors including the withdrawal of several well known brands from the market. The Red Cross and ZLB Bioplasma announced earlier last year that they would discontinue production of IVIg products. And in January 2006, after introducing its next generation products last year, Baxter announced that it will discontinue one of its IVIG products by January 2007. IgG America, a home infusion company outside Baltimore reported in its Newsletter that it anticipates more changes in product.
IgG Today, IgG America-Newsletter, March 2006.
The Plasma Protein Therapeutics Association publishes up-to-date information on IVIg availability. See: http://www.pptaglobal.org/
The liquid formulation of WinRho SDF is now available. Previously, it has been available only in a freeze dried formulation. This treatment is licensed in the USA, Canada, and Europe to treat ITP and prevent Rh isoimmunization. Researchers reported that both formulations were well tolerated and the study demonstrated that the liquid formulation was bioequivalent to the freeze-dried formulation in both intravenously (IV) and intramuscular (IM)
Fear of avian or bird flu pandemic has been on the rise in the popular media since the end of last year when the number of deaths from the disease in Europe and Asia approached 100. While a worst case scenario received a great deal of publicity, discussion of more likely scenarios was limited to more technical and less widely read publications. In spite of continuing concerns, nearly all of the 161 human cases of avian flu thus far have resulted from direct exposure to wild or domestic infected birds. While recent studies have identified mutations in the recent samples compared to earlier ones, this is not cause for the heightened alarm seen in some quarters. Robert Webster of St. Jude Children’s Hospital says, “This is an important observation and a worrying one that the virus is more able to associate with human receptors and human cells.” But he adds, “public health officials must adopt a wait and see approach, acting only when human-to-human transmissions start to appear.” Viruses mutate frequently but mutations have to evolve and adapt together, affecting transmissibility and virulence in complex ways. The final answer isn’t in yet but a pandemic is no sure thing.
P. Basu, “Panic Over Bird Flu Pandemic Premature, Experts Say”, Nature Medicine, March 2006, vol 12, no 3, p 258.
“NHLBI (National Heart Lung and Blood Institute) recently released a new initiative: RFA-HL-06-012--Genome-Wide Association Studies to Identify Genetic Components that Relate to Heart, Lung, and Blood Disorders The RFA will support investigators to implement innovative strategies for genome-wide association studies in existing population, cohort, clinical, and family studies. Twenty million dollars will be awarded over three years.”
ASH Newslink March 2006
See: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-06-012.html
Patients taking Tequin, an antibiotic made by Bristol-Myers Squibb, face a sharply higher risk of developing serious blood-sugar problems; this according to two studies that examined the medical histories of 1.4 million elderly Canadians. A company spokesman indicated that the findings were consistent with the company’s own research which prompted the company to warn healthcare providers not to prescribe Tequin for diabetics and to monitor more closely other patients who take the drug.
R. Tomsho, “Antibiotic Linked to Treatments for Blood-Sugar”, WSJ, March 2, 2006, p D2.
(Note: Prednisone can elevate blood sugar levels as well)
In a study of 1740 individuals over 65 over a six year period 158 developed dementia, including 107 cases or Alzheimer’s. The findings: those who exercised at least 15 minutes three or more times a week at the beginning of the study were 32 percent less likely to have any type of dementia and 31 percent less likely to have Alzheimer’s, than those who exercised less often. Exercise data considered the frequency of exercise but not the intensity and came from records kept by the participants.
L. Searing, “Quick Study”, Washington Post, January 31, 2006, p F6.
Find the study at: www.annals.org.
Fresh cut fruits and vegetables are being identified increasingly as the source of outbreaks of illness by the FDA. Processing increases the risk of bacterial contamination and growth because it breaks protective natural barriers. Recent voluntary recommendations call on processors of fresh produce to use safer procedures. The report can be found at:
http://www.foodsafetynetwork.ca/course/videos/fsriskanal/FDA.pdf
J. Zhang, “FDA Issues Guidelines for Prepared Produce”, Wall Street Journal, March 2, 2006, p. D1
Recently, IVIG shortages have been reported by various users. The Plasma Protein Therapeutics Association (PPTA), an organization established and supported by the global suppliers of plasma therapeutics, reports a 2 – 5 weeks supply of IVIG at the manufacturer level. Their supply information is updated frequently and is available on line at www.pptaglobal.org.
In a Phase I/II clinical trial studying the safety and efficacy of rituximab in 36 patients under the age of 18 with severe, chronic ITP, 30% achieved a platelet count greater than 50,000. First-dose infusion related toxicity was common and six percent of subjects developed serum sickness. The study highlights that children are not just small adults and react differently to treatments. Unfortunately there has not been a large scale study to determine the optimal dose, frequency of administration, or duration of treatment.
Cines, D.B., “Putting the ‘Tux’ on ITP”, Blood, vol. 107, no. 7, April 2006, pp. 2590-2591.
http://www.bloodjournal.org/cgi/content/full/107/7/2590
Bennett, C.M.et al, “Prospective phase 1 / 2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura” Blood, vol. 107, no. 7, April 2006, pp. 2639- 2642.
(Patients can receive a complementary copy of this article by sending the article citation including author(s), title of article, issue date & page number and your name and email address to publishing@hematology.org See. www.bloodjournal.org)
In January the FDA said low dose trials in people will eliminate poor drug candidates sooner and result in fewer people being exposed to dangerous or ineffective agents. Last month a low dose trial in the UK of a super-antibody drug (TGN1412 by TeGenero in Germany meant to treat autoimmune diseases) resulted in six of the eight participants being rushed to intensive care. Early reports indicated that the participants were struck by a huge immune reaction called a cytokine storm. In such an event, a flood of inflammatory molecules released by helper T-cells shuts down organs in hours. No deaths have been reported but the trial was halted immediately. Since no impurities have been identified and the antibody had been tested in animals, questions surrounding the protocols followed to permit the trial in the first place are being examined carefully. It remains to be seen what the long-term impact is on practices in the US.
Nature Medicine, vol 12, no 4, April 2006, p 372.
Hopkin, M., “Can Super-Antibody Drugs be Tamed?”, Nature, vol 440, April 2006, pp 855-856.
A recent paper offers a tentative explanation of the mechanism of vitamin D. The authors demonstrate how vitamin D might influence the innate immune response by activating monocytes (a cell involved in the destruction of virus and bacteria, among other things) to kill certain bacteria. Vitamin D also activates two powerful immunosuppressents in the skin that have an anti-inflammatory effect on a wide spectrum of tissues.
Liu, P.T., et.al., “Toll-Like Receptor Triggering of a Vitamin D-Mediated Human Antimicrobial Response”, Sciencexpress, February 23, 2006, www.sciencexpress.org.
Zasloff, M., “Fighting Infections with Vitamin D”, Nature Medicine, vol. 12, no. 4, April 2006, p388-390.
The Office of Dietary Supplements at the NIH provides additional information on Vitamin D
See: http://ods.od.nih.gov/factsheets/vitamind.asp
A toxin produced by a black mold found in water-damaged buildings and already linked to respiratory irritations and asthma in people, was demonstrated in mice to kill specific nasal cells. The cells affected were sensitive to odors and ran from the inside of the nose to the brain’s smell center. The findings raise concerns not only among clean-up crews in New Orleans but for anyone who comes in contact with black mold in basements and damp areas.
J.R., Science News, vol 169, March 25, 2006, p 190.
The full report appears in Environmental Health Perspectives
http://www.ehponline.org/members/2006/8854/8854.pdf
NCI’s Clinical Genetics Branch is undertaking the largest epidemiologic study of its kind in North America to identify adults and children with a diagnosis or suspected diagnosis of an inherited bone marrow failure syndrome in themselves or a family member. Individuals or family members with any of the diagnoses listed below may call the National Cancer Institute at 1-800-518-8474 or visit the Web site at marrowfailure.cancer.gov to find out more details about the protocol and to talk with the research nurse. Diagnosis: Fanconi’s Anemia, Diamond-Blackfan Anemia, Shwachman-Diamond Syndrome, Dyskeratosis Congenita, Severe Congenital Neutropenia, Thrombocytopenia Absent Radii, Pearson’s Syndrome, Amegakaryocytic Thrombocytopenia, Bone Marrow Failure Other Than Acquired.
The Food and Drug Administration’s magazine, FDA Consumer, has developed a special issue (November-December 2005, Vol. 39 No. 6) devoted to educating consumers about new technologies that may lead to new diagnostics and treatments. It includes explanations of genomics, proteomics, nanotechnology, gene expression, and others.
See: http://www.fda.gov/fdac/605_toc.html
To locate other issues of FDA Consumer go to the FDA home page, www.fda.gov and scroll to the bottom right of the page to “FDA Consumer-Current Issue.”
(This information was sent to us from the National Organization of Rare Diseases, www.rarediseases.org)
Women may metabolize a wide variety of drugs differently than men. Some examples: Prednisone is processed more quickly in women because of high levels of progesterone just before menstruation. Coumadin may have a more powerful effect in women when their estrogen levels are highest. Valium is broken down more quickly in women perhaps requiring higher or more frequent doses.
“World News Tonight,” ABC News, John McKenzie (from “Infocus” Autoimmune Diseases Association)
http://abcnews.go.com/WNT/Health/popup?id=1514847
It is known that in malaria infections “the spleen serves the useful function of riding the bloodstream of parasitized (harmed) cells and if it (the spleen) is removed, parasitemia levels (level of malaria parasites in the blood) are apt to rise and symptoms worsen.” But how the spleen accomplishes this is not well understood and direct study of the spleen has been difficult for a number of reasons. Some include the sensitivity of the spleen in vivo (inside the body) to probing and biopsy and the difficulty of demonstrating continued splenic function ex vivo (outside the body). Buffet and colleagues solved this problem. They developed an experimental system to study the spleen ex vivo and track the clearance of parasite-infected red blood cells. The article reminds all without a spleen to avoid exposure to malaria but, equally important, the system developed as part of this research may make possible studies that will detail splenic function and better characterize the risks attendant on splenectomy.
Buffet, P.A., et al, “Ex Vivo Perfusion of Human Spleens Maintains Clearing and Processing Functions”, Blood, vol. 107, no. 9, May 1, 2006, pp. 3745 – 3752.
Mohandas, N., “Of Mice and Men: The Voracious Spleen”, Blood, Vol. 107, no. 9, May 1, 2006, p. 3426.
A life-threatening emergency exists when a 1- to 2-day-old newborn presents with severe thrombocytopenia due to neonatal alloimmune thrombocytopenia (NAIT). Because of the high incidence of an intracranial hemorrhage (ICH 11% - 21%) in this patient population, treatment to rapidly increase the platelet count is imperative. This has been difficult for a number of reasons including the relatively slow rise in platelets after IVIG, the delay in preparing the mother’s platelets (assuming her health permits), and the difficulty of obtaining matched platelets for transfusion. V. Kiefer and colleagues report in a recent issue of Blood “that random donor platelets are often effective (24 of 27 cases) in severely thrombocytopenic neonates unexpectedly affected by alloimmune thrombocytopenia (AIT).” This work confirms a recent study conducted by J. Bussel and his group “which demonstrated that 11 of 18 random donor platelet transfusions in HPA-1a incompatibility increased the platelet count more than 20 X 109 / L.
Bussel, J.B., “Clinical and Diagnostic Comparison of Neonatal Alloimmune Thrombocytopenia to Non-Immune cases of Thrombocytopenia”, Pediatric Blood Cancer, 2005;45:176-183.
Bussel, J.B., “When are Platelets Just Platelets: Comment on Kiefel et al”, Blood, vol. 107, no. 9, May 1, 2006, pp. 3426 – 3427.
Kiefer, V., et.al., “Antigen-Positive Platelet Transfusion in Neonatal Alloimmune Thrombocytopenia (NAIT)”, Blood, vol. 107, no. 9, May 1, 2006, pp. 3761 – 3763.
The question of the role of the conscious versus the unconscious mind in decision making was addressed by researchers at the University of Amsterdam. They report (Science, February 17, 2006) “that conscious thought may be best for simple decisions. But when things get more complex, two minds—conscious and unconscious—could be better than one.” The capacity of the unconscious mind is far greater than the capacity of the conscious mind; it can accommodate much more information. Getting away from a problem, “sleeping on it”, may permit the unconscious to run through all the options and formulate a gut feeling or “hunch” that improves the decision making process in complex situations. They studied both hypothetical and actual consumer purchases and found similar results in each type of situation. The authors suggest that their conclusions may extend “to other types of choices—political, managerial, or otherwise,” but caution that further research would be needed to ensure that there is no fundamental difference between comparison shopping for consumer items and determining one’s political affiliation—or other life choices.
Harvard Women’s Health Watch, May 2006, pp. 6 – 7.
The potential toxicity of PVC (polyvinyl chloride) and DEHP (diethylhexyl phthalate) used in the manufacture of the materials to make intravenous bags and tubes has been a concern for some time. These compounds leach from medical equipment into the blood stream of patients. Studies have shown that DEHP, for instance, can disrupt the body’s hormone system. Recently the two largest manufacturers of this equipment (Baxter Healthcare and Hospira) announced lines of bags and tubes without materials containing PVC or DEHP. These new products are a major equipment improvement and mark the first major overhaul of IV gear in more than 30 years.
Waldman, P., “Intravenous Bags, Tubes Redesigned for Safety”, Wall Street Journal, April 19, 2006, p. D2.
A Boston group identifies a significant role for clinicians in the discovery of off-label drug use. New drug therapies come to market after FDA approval for use in specific treatment situations for which they have been tested in clinical trials. Once approved, clinicians have wide latitude to treat patients with newly approved drugs and biologics in what are referred to as off-label use—situations in which the drug or biologic has not been tested in clinical trials. The clinician must “be well informed about the product, base off-label use on firm scientific rationale and on sound medical evidence, and maintain records of the product’s use and effects.” This study reports on 143 new applications developed for the 29 new drugs considered and approved by the FDA during 1998. Eighty-two of the 143 drug therapy innovations were discovered by practicing clinicians through field discovery.
DeMonaco, H.J., et.al., “The Major Role of Clinicians in the Discovery of Off-Label Drug Therapies”, Pharmacotherapy, 2006;26(3):323-332.
www.medscape.com/viewarticle/529167
Off-label use of drugs and biologics is important in developing new treatment options for many disease conditions. However, publications of the off-label use of recombinant factor VIIa (RFVIIa) raises some concern for the off-label use of this treatment. RFVIIa “is FDA approved for controlling bleeding associated with inhibitors in patients with hemophilia A or B. It is also approved for treatment of patients with congenital factor VII deficiency.” Case reports and several clinical trials have reported the use of RFVIIa to treat a variety of hemostastic abnormalities. “These publications have created an impression that RFVIIa can function as a universal hemostatic agent, and that it is an appropriate supplement for treating the bleeding patient, regardless of the hemorrhagic etiology.” A randomized placebo-control trial of RFVIIa to treat hemorrhagic strokes published in the NEJM last year was followed, on December 5, 2005, by Novo Nordisk, the manufacturer, issuing a safety alert for the use of RFVIIa in non-hemophilia patients. This report noted that clotting events were increased in patients randomized to receive RFVIIa. “Most of these reported events were arterial, and notably, most were observed in patients who received the highest dose of RFVIIa.” The O'Connell study examined a total of 185 thromboembolic events reported to the FDA through the Adverse Event Reporting System (AERS) from March 25, 1999 through December 31, 2004. The vast majority of these events were associated with off-label use.
Abrams, C., “The Dark Side of Recombinant factor VIIIa”, The Hematologist: ASH News and Reports”, vol. 3, issue 3, May/June 2006, p. 8.
Mayer, S.A., et al, Recombinant Activated Factor VII for Acute Intracerebral hemorrhage”, NEJM, 2005;352:777-785.
O’Connell, K.A., Wood, J.J., Wise, R.P., et al, “Thromboembolic Adverse Events After Use of Recombinant Human Coagulation Factor VIIa”, JAMA, 2006;295:293-298.
Recent work strengthens the connection between oxidants and aging by showing that hematopoietic (blood) stem cells (HSCs) respond to oxidants by activating a pathway leading to stem cell exhaustion and bone marrow failure. Liu and Finkel summarize the work of a K. Ito’s group comprised of researchers affiliated with several different centers in Japan. “Whatever the exact sequence of events, it appears that oxidants may contribute to the aging of adult HSCs not as random and nonspecific damaging agents as was originally hypothesized in the free radical theory—but instead, through the redox-dependent activation of a specific MAPK pathway.” The work raises more questions than it answers but just maybe, “the late-night infomercials are on to something.”
Ito, K., et al, “Reactive Oxygen Species Act Through p38 MAPK to Limit the Lifespan of Hematopoietic Stem Cells”, Nature Medicine, vol. 12, no. 4, April 2006, pp. 446-451.
Liu, J, and Finkel, T., “Stem Cell Aging: What Bleach Can Teach”, Nature Medicine, vol. 12, no. 4, April 20206, pp. 383-384.
(Note: We have received letters from people who feel that taking anti-oxidants or reducing oxidative stress in other ways helped increase their platelet count.)
The FDA has a new friend. A newly-created Maryland non-profit corporation has established the FDA Alliance. This alliance will advocate for increased appropriations, more manpower, and enhanced personnel recruitment for the FDA. This organization fills a gap. While many parts of the government “benefit from independent, private organizations that educate and advocate on their behalf” the FDA did not enjoy support from private sector initiatives. You can learn more about this organization at: www.strengthenFDA.org
Three out of 20 promotional brochures developed by pharmaceutical companies to promote their products to physicians were found in a recent study to contain data different from the original study on the effects of the drug. A group at the University of North Texas Health Science Center studied 20 brochures representing 20 different medications. Two reviewers compared the content of each brochure with the data presented in the original study. The group rated 15 of the 20 studies valid. Despite the fact that for the three brochures in which the differences between the data in the brochures and the data in the original study were small, the authors recommended doctors review original studies prior to prescribing new medications.
Hematology and Oncology News and Issues, April 2006, p. 19.
Smile – it’s contagious! Emotions can be shared through facial expressions. When humans interact, they subconsciously mimic gestures, speech inflections, body language and facial expressions – like a smile. Then, the brain interprets these tiny muscle movements as signals and responds with the emotion connected to the expressions. So, seeing someone smile will make you happy.
People synchronize their emotions to those displayed through visual cues and word choices. In studies of conversations, people matched their word choices to the emotions conveyed by the other. By mimicking emotions, people connect and share each other's moods and minds.
People more familiar with each other are more likely to share emotions. A couple who has been happily married for many years will exhibit nearly identical emotional reactions, but two strangers are much less likely to share emotions.
This emotional response occurs in brain cells, called mirror neurons. Mirror neurons internalize outward signals, whether these are emotional of physical signs. For example, the same area of the brain is stimulated for a dancer or other performer and for the person watching the performer, explaining why people enjoy watching sports, seeing movies and listening to musicians.
To find out more about mirror neurons visit: http://www.brainconnection.com/content/181_1
"That look -- it's catching!" Stacy Colino. The Washington Post. Tuesday, May 30, 2006.
Trace your ancestors’ journey around the world through the National Geographic Society’s Genographic Project. The Genographic Project studies human migratory patterns beginning from the earliest humans to modern-day man. The project collects DNA samples from volunteers around the world and then compares the results to other DNA samples to determine family history. To discover your own family's journey, order a kit from www3.nationalgeographic.com/genographic for $99. A few weeks after submitting your DNA, you can view your family's paths across the world through the project’s Web site.
"Way-back gene trace." The Washington Post. Tuesday, May 30, 2006.
Vitamin D may help prevent breast cancer, according to an April study by Harvard Medical School. In the study, women with the most vitamin D were 50 percent less likely to develop cancer than those with the least. Although the study has not been peer-reviewed, the results concur with pervious studies.
The skin produces vitamin D after being exposed to the sun, but too much sunbathing can lead to skin cancer. The study recommended that people receive a little sun exposure, 10 to 15 minutes a few days a week to receive an adequate amount of the vitamin without incurring a great risk of skin cancer.
The report suggested that vitamin D can also be obtained through fatty fish, fortified milk and some cereals. Multivitamins are a good source of vitamin D, but they should be used in moderation. Intake should not exceed 2,000 IU per day, because too much of the vitamin can cause calcium buildup in the body.
"Higher vitamin D may help prevent breast cancer." Harvard Women's Health Watch. June 2006. Vol 13 No. 10.
Safety first is the goal of some medical malpractice reforms proposed by Sen. Hillary Clinton and Sen. Barack Obama, in their article in the New England Journal of Medicine.
They suggested changes to malpractice laws that would reduce the number of preventable patient injuries by enhancing communication between physicians and their patients, and increasing compensation for medical injuries. The proposed bill, called the National Medical Error Disclosure and Compensation (MEDiC) Bill, will also seek to lower physician's liability insurance and create programs improving patient health.
Under the new bill, health care providers will draft safety plans and designate a patient-safety officer. These officers enforce the plan and would notify patients who may have been harmed by any deviances from the safety code. The injured patients then decide if they wish to negotiate for compensation. The bill ensures that patient information and communications between the physician and the patient would be confidential.
This program will reduce administrative and legal costs for insurance companies and health care providers. From these savings, these companies will be required to contribute money toward physicians’ insurance premiums and to programs to improve patient health.
Grants would be given to increase participation in the program and enhance patient-safety efforts. The bill also proposes three studies to ensure patient safety, to monitor the insurance market and to collect a database of poorly-handled cases.
"Making patient safety the centerpiece of medical liability reform." Hillary Rodham clinton and Barack Obama. The New England Journal of Medicine. May 25, 2006. Volume 354 No. 21.
Seven out of 10 physicians are concerned about the safety of prescription drugs after several recent drug-scares, including Vioxx, said a survey by Reuters. To ensure safety, most physicians (68 percent) prefer to prescribe drugs that have been on the market for at least 10 years.
The heightened concern is not limited to doctors. Over 50 percent of patients and 60 percent of pharmacists worry more about drug safety than before the scares.
"Physicians more worried about drug safety: survey." Reuters Health Information. 2006. www.medscape.com/
Since the tragic drug trials in U.K. this March, European scientists are seeking alternatives to the current method of drug testing, according to Nature Medicine.
In the British trial, six men reacted severely to an experimental leukemia drug, although animal tests showed no negative results. Animal trials cannot accurately predict the safety of drugs, especially those targeted to the immune system, because animals have a different set of antibodies than humans.
Instead, scientists suggest that drugs using antibodies be tested on human cells in the laboratory before being used in animal and human trials. Then, the researchers can determine how a human cell will respond to the drug and eliminate any potentially dangerous drugs. Laboratory test cannot determine how the body may digest a drug; therefore animal and human trials are still necessary.
"Cell-based tests tackle predicting safety of antibody drugs." Nature Medicine. May 2006. Vol. 12 No. 5.
Medicine may soon be tailored to the individual patient. Traditionally, prescriptions are based on surveys of the general population. But each patient responds differently to a specific drug, because everyone has a unique combination of genes, environmental exposures and lifestyle.
Researchers seek to identify differences among the population and tailor prescriptions to patients. One area of study is the metabolism, or how the body digests foods and drugs. The study of the metabolism, called metabonomics or metabolomics, may allow doctors to predict how a person will respond to different amounts of medication. Already, researchers can predict how individual rats respond to different drug dosages by identifying their metabolic type. These studies cannot be directly applied to humans, but their results show promise. If successful, metabonomics can provide a simple and cost-effective method of determining drug dosages.
Metabonomics can be combined with current medical approaches that also focus on the individual, like pharmacogenomics, which uses a person's genetic information to diagnosis diseases and prescribe medications. For example, physicians use pharmacogeneomics to predict the survival of breast cancer patients.
Scientists hope that personalized medicine will enhance the speed and accuracy of diagnosis, improve patients' responses to medication and reduce side effects.
"Personalized medicine progresses." John N. Haselden and Andrew W. Nicholls. Nature Medicine. May 2006. Vol. 12 No. 5
ITP patients may have an alternative to expensive intravenous immunoglobulin (IVIg) treatment. While researching how the blood-derived product, IVIg, functions, Alan Lazarus created a synthetic alternative to IVIg, according to Canadian Blood Services. Lazarus, a scientist at the Canadian Blood Services and at St. Michael’ Hospital in Toronto, published his findings in the June edition of Nature Medicine.
In ITP, disease-fighting white blood cells, called lymphocytes, attack the body's platelets, which are blood cells needed for clotting. Many patients with ITP are given IVIg to prevent the lymphocytes from attacking by increasing the number of Fcgamma receptors on the lymphocyte. These receptors act like moderators, preventing lymphocytes from destroying platelets. By increasing the number of Fcgamma receptors, IVIg reduces platelet destruction.
In his research, Lazarus identified other compounds that have the same effect as IVIg by increasing the number of Fcgamma receptors. "IVIg is not the only entity that can induce an IVIg-like ... effect," Lazarus said in his article. These compounds could lead to the creation of a synthetic version of IVIg.
IVIg is expensive and difficult to obtain, and patients must take high doses of it for it to be effective. The new compounds may be less costly and as effective at lower doses than IVIg. If the synthetic version is successful, many more patients would be able to receive the benefits of IVIg through a lower cost substitute.
"Intravenous immunoglobulin ameliorates ITP via activating Fcgamma receptors on dendritic cells." Vinayakumar Siragam, Andrew R.Crow, Davor Brinc, Seng Song, John Freedman and Alan H. Lazarus. Nature Medicine. June 2006.
"Canadian blood services scientist invents poential alternative for high-demand blood product." Canadian Blood Services. May 23, 2006.
Underweight infants are twice as likely to have a low platelet count as previously believed, said a study appearing in the April edition of the Journal of Perinatology.
The researchers collected information on 284 severely underweight infants born at several hospitals during 2003. They found that 73 percent of those infants had thrombocytopenia or a low platelet count. Of these, the smallest infants were the most likely to have thrombocytopenia. Thrombocytopenia occured in 85 percent of the infants weighing less than 800 grams or 1.76 pounds and in 60 percent of the infants weighing between 801 to 900 grams (1.76 to 1.98 pounds). Around half of the infants with birth rates between 901 to 1000 grams (1.98 to 2.2 pounds) had thrombocytopenia.
Nearly half the infants with thrombocytopenia were identified in their first day of life, and within the first week 80 percent of the cases were identified.
The researchers called for further study of thrombocytopenia in infants as well as potential treatments.
"Thrombocytopenia among extremely low birth weight neonates: data from a multi-hospital healthcare system. RD Christensen, E. Henry, SE Wiedmeier, RA Stoddar, MC Sola-Visner, DK Lambert, TI Kiegn and S Ainsworth. Journal of Perinatology. 2006.
Jonathan Davis, Korn frontman, was diagnosed with ITP in London. After experiencing weird bruises all over his body for two weeks he saw a doctor last Friday. After some blood tests he was rushed to the hospital and diagnosed with ITP. Korn is reported to have cancelled tour dates through July 2 and is hoping to reschedule them later this year.
http://www.rollingstone.com/news/story/10542885/in_brief_korns_davis_nearly
Contents:
In a global study, GlaxoSmithKline found that the potential ITP drug, eltrombopag, significantly increased platelet counts in ITP patients. The study was the Phase II trial of three trial phases required for FDA approval. Volunteers with platelet counts below 15,000 were randomly assigned different dosages of eltrombopag or a placebo.
By the end of the six-week trial, 70 percent of the patients taking 50mg of eltrombopag and 81 percent on 75mg had platelet counts over 50,000/mL.
Eltrombopag, an oral drug is a small molecule that, like thrombopoeitin, stimulates platelet production.
Patients did experience some side effects on the drug; the most common complaint was a headache. But, only three of the patients stopped taking eltrombopag because of the side effects.
Source: Medical News Today (www.medicalnewstody.com)
In the past, researchers studying rare diseases struggled to fund their studies, find patients, and co-ordinate their efforts. But this May, the National Institutes of Health (NIH) launched the Rare Disease Clinical Research Network, a $71 million effort to increase rare disease research, according to the NIH.
The NIH expects over 20 studies to open at 50 sites throughout the U.S. and other countries including the United Kingdom, Japan and Brazil.
Although any one rare disease affects less than 200,000 people, 6,000 rare diseases have been identified. Altogether, 25 million people in the U.S. have rare diseases.
The network encourages research in rare diseases by funding trials seeking new drugs, and new applications of current drugs. Researchers will also have easier access to patients through the network.
Doctors and researchers are encouraged to collaborate, sharing experiences, and developing protocols for disease managements.
Source: http://rarediseasesnetwork.epi.usf.edu/index.htm, www.NIH.gov, and Hampton, Tracy. “Rare disease research gets boost.” JAMA. June 28, 2006.
Asbestos, usually associated with lung-cancer, may also cause autoimmune diseases. The new study examined residents from Libby, Mont., a mining town where 1,500 people have become ill from asbestos.
Exposure to asbestos increased a person's risk of three autoimmune diseases, rheumatoid arthritis, lupus, and scleroderma. Mine workers, over 65 with high exposure to the mineral, were twice as likely to have any one of three diseases, and they were three times as likely to have rheumatoid arthritis than other Libby residences, said Science News.
By re-examining a former study of Libby residents, the researchers discovered that 6.7 percent of the Libby residents had one of the autoimmune diseases compared to less than one percent of the general population.
Further study is needed to confirm these results and discover how asbestos exposure increases the risk of autoimmune diseases.
"Mineral Deposit: Asbestos linked to lupus, arthritis." Science News. June 2006.
During pregnancy, a woman's symptoms of arthritis may lessen or disappear until a few months after giving birth, and recently, scientist have revealed a potential connection between the two.
A small study published in the July issue of Arthritis & Rheumatism found that the symptoms of arthritis were inversely associated with the serum fetal DNA in the blood.
The study conducted by Zhen Yan from the Fred Hutchinson Cancer Research Center in Seattle, examined blood samples from 25 patients with rheumatoid arthritis, including six with juvenile idiopathic arthritis.
Most of the women experienced fewer symptoms during pregnancy, when levels of fetal DNA were highest, but they relapsed three to four months after childbirth when no fetal DNA was found in the blood serum.
Although the inverse association gives researchers a clue about the relationship between pregnancy and autoimmune diseases, it leaves many unanswered questions. The researchers do not know if the fetal DNA reduces symptoms or if some other factor affects both the DNA levels and arthritic symptoms. Also, the study was very small, further research is needed to validate the results.
Source: Molnar, Amy. “New study gives insight connection between pregnancies on inflammatory arthritis.” EurekAlert. John Wiley & Sons. June 27, 2006.
New Internet services allow consumers to point and click for less expensive healthcare. Since the advent of online medical advice Web sites, like WebMD, patients have been using the Internet to learn about diseases access their symptoms and view potential treatments.
The trend of online healthcare continues cost-reducing programs, like price comparison lists offered by some insurance companies and online medical testing.
Comparison shopping
Last year, Aetna Inc. revealed a list of prices it had negotiated with local hospitals in Cincinnati, according to Sarah Rubenstein at The Wall Street Journal. Until this service became available, customers could only view hospitals’ listed prices, which do not usually reflect the final price.
Aetna customers in Cincinnati can compare the prices of procedures, like knee replacement, at different local hospitals, and then choose the best hospital for them. Aetna plans on expanding its program and other insurers, including Cigna Corp., Humana Inc. and United Health Group Inc. are creating similar sites.
These Web-based services are not foolproof. The services also require access to the Internet, a privilege many patients do not have. The cost of a visit to the doctor’s office can fluctuate if unexpected tests are needed or if a patients' hospital stay is longer than expected. As of yet, there is no evidence that consumers are using the price lists to make medical decisions.
Order your own on-line lab tests
Other potentially cost-saving online services are being offered by medical labs. Patients can now order medical tests through the Internet, bypassing the preliminary trip to their doctor’s office.
The customers can select a test on the Web site, enter their Zip Code and receive directions to the nearest lab. They pay for the tests through a credit card or health savings account and can save the receipt for possible reimbursement from their insurance agent.
The service's convenience and low-costs are attractive; a blood test is $45 at MyMedLab.com and $295 at a local hospital, according to Nick Timiraos at the Wall Street Journal. But many physicians worry that without a doctor's advice patients may misinterpret the results or rely on false readings.
Rubenstein, Sarah. "Patients get new tools to price health care." The Wall Street Journal. Tuesday June 13, 2006.
Timiraos, Nick. "New online services tout low-cost medical tests." The Wall Street Journal. Tuesday June 20, 2006.
For five days, a small group of elementary school children substituted organic foods for their normal diets, said a study published in the Environmental Health Perspective. During those five days, the amount of dangerous pesticides in the urine decreased, but rose again once the children returned to their normal diets.
The study showed that food is the primary way children are exposed to organophosphorus pesticides, insecticides that may cause neurological effects in animals and humans. The study also showed that children can be protected from these pesticides by switching to organic foods.
"We were able to demonstrate that an organic diet provides a dramatic and immediate protective effect against exposures to organophosphorus pesticides that are commonly used in agricultural production," said the study's authors.
Source: Lu, Chenshen, Kathryn Toepel, Rene Irish, Richard A. Fenske, Dana B. Barr and Roberto Bravo. "Organic diets significantly lower children's dietary exposure to organophosphorus pesticides." Environmental Health Perspective. March 8, 2006.
Kamen, Betty. "Organic diets significantly lower children's dietary exposure to harmful pesticides." Nutrition Hints. www.bettykamen.com
Is there an asthma gene? Or a fat gene? Researchers at the Children’ Hospital of Philadelphia, known as CHOP, want to find out.
They are creating a database to analyze the DNA collected from up to 100,000 of its child patients. In a $40 million project, the hospital will collect blood samples from patients whose parents consent and use a DNA scanner to map the patients’ genes.
Although the information will remain confidential, many people still wonder if the database is ethical and are concerned about how the information may be used. Patients who contribute will not be informed every time the data is used; therefore, they may not speak out if the researches conduct studies they may find objectionable, like looking for genetic differences between ethnic groups.
Other people tout the benefits of such a project. The database will give scientists the opportunity to unearth genetic predispositions which have hereto been obscure.
CHOPS’ program is one of a growing number of programs creating genetic profiles.
Source: Regalado, Antonio. “Plan to build children’s DNA database raises concerns.” The Wall Street Journal. June 7, 2006.
In hospitals, dangerous errors can occur during the “hand-off,” when doctors and nurses change shifts or a patient moves to another unit.
Evidence suggests that miscommunication during these hand-offs is the greatest source of medical error, and the Joint Commission on the Accreditation of Health Care Organizations (JCAHCO) requires hospital to create protocol for these transfers.
One hospital, St. Joseph Medical Center, solved the problem by creating pocket-sized cards which nurses and staff fill out for the next shift of doctors. The program was started in 2004 and by the end of 2005, 98 percent of nurses used it and the number of unexpected medical problems fell from 89.9 to 39.6 per 1,000 patient days.
Source: Landro, Laura. The Wall Street Journal Online. June 28, 2006.
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