- American Society of Hematology holds annual meeting
- GSK announces long-term ITP study to evaluate eltrombopag
- Special journal issue on autoimmune diseases
- Dengue fever strikes the U.S.
- Grapeseed extract is another flavonoid source
- Genetic information for consumers from NIH
- Aerobic exercise keeps the brain fit
- No more mold
- Honey may have wound healing properties
- Pass the celery
- Cranberry juice can cause problems for warfarin users
- Dark chocolate may slow blood clotting
- Vitamin D in the spotlight
- Add to Your Library of ITP Resources (advertisement)
AMERICAN SOCIETY OF HEMATOLOGY HOLDS ANNUAL MEETING
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
GSK ANNOUNCES LONG-TERM ITP STUDY TO EVALUATE ELTROMBOPAG
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
SPECIAL JOURNAL ISSUE ON AUTOIMMUNE DISEASES
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.
DENGUE FEVER STRIKES THE U.S.
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.
GRAPESEED EXTRACT IS ANOTHER FLAVONOID SOURCE
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.
GENETIC INFORMATION FOR CONSUMERS FROM NIH
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.
AEROBIC EXERCISE THE KEEPS BRAIN FIT
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.
NO MORE MOLD
The Wall Street Journal carried tips from an environmental engineer for reducing mold at home:
- Use plastic boxes instead of cardboard for storage.
- Use a humidity gauge ($10 to $50) to measure humidity. A humidity greater than 70% can be trouble.
- To reduce humidity, install a drain system around the perimeter of the house to send water into a pump that removes water from the house. Seal a basement’s dirt floor with a water-proof concrete, which is different from traditional concrete that soaks up moisture.
Tricks of the Trade, Wall Street Journal, November 8, 2006, page D7.
HONEY MAY HAVE WOUND HEALING POWERS
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.
PASS THE CELERY
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.
CRANBERRY JUICE CAN CAUSE PROBLEMS FOR WARFARIN USERS
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 SLOW BLOOD CLOTTING
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.
VITAMIN D IN THE SPOTLIGHT
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.
- Early phase studies of platelet stimulating protein show promise
- More good from cranberries
- Easier blood sticks
- Spice may have health benefits
- Vegetables are good for the mind
- Best antioxidant food choices
- Hospitals going green
- Don’t flush expired meds
- Patient feedback needed on statins
- Blue light helps sleep
- Add to Your Library of ITP Resources (advertisement)
- Natural Herbal Solutions Developed by MDs (advertisement)
EARLY PHASE STUDIES OF PLATELET-STIMULATING PROTEIN SHOW PROMISE
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.
MORE GOOD FROM CRANBERRIES
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.
EASIER BLOOD STICKS
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.
SPICE MAY HAVE HEALTH BENEFITS
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.
VEGETABLES ARE GOOD FOR THE MIND
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
BEST ANTIOXIDANT FOOD CHOICES
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.
HOSPITALS GOING GREEN
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.
DON’T FLUSH EXPIRED MEDS
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.
PATIENT FEEDBACK NEEDED ON STATINS
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.
BLUE LIGHT HELPS SLEEP
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.
- Childhood ITP: Special Issue of “Pediatric Blood & Cancer”
- More Research Needed on Splenectomy in Children
- Anti-D May be Better than IVIG
- Rituximab Worth Trying before Splenectomy
- Hospitals Struggling to Access IVIG at Federal Program’s Discount Prices
- Patient Groups Call for Patient-Centered Approach to Healthcare
- National Geographic Explores Chemical Exposures
- Just How Does IVIG Work in ITP?
- Can a Monoclonal Antibody Replace IVIG?
- Platelets Play Key Role in Liver Regeneration
- Brain Communicates with Spleen to Fight Sepsis
- PDSA Introduces New Logo
- PDSA Conference 2006 DVDs Available (advertisement)
- Natural Herbal Solutions Developed by MDs (advertisement)
CHILDHOOD ITP: SPECIAL ISSUE OF “PEDIATRIC BLOOD & CANCER”
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:
MORE EVIDENCE-BASED RESEARCH NEEDED ON SPLENECTOMY IN CHILDREN
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
ANTI-D SAFE IN CLASSIC CHILDHOOD ITP, BUT SIDE EFFECTS OCCUR
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 SHOULD BE TRIED BEFORE SPLENECTOMY IN CHILDREN
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.
HOSPITALS STRUGGLE TO ACCESS IVIG AT AFFORDABLE PRICES
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 firstname.lastname@example.org (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.”
IAPO STUDY CALLS FOR MORE PATIENT-CENTERED APPROACH TO HEALTHCARE
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
NATIONAL GEOGRAPHIC EXPLORES ENVIRONMENTAL TRIGGERS
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
JUST HOW DOES IVIG WORK IN ITP?
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.
CAN A MONOCLONAL ANTIBODY REPLACE IVIG?
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.
PLATELETS PLAY KEY ROLE IN LIVER REGENERATION
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.
BRAIN COMMUNICATES WITH SPLEEN TO FIGHT SEPSIS
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.
- Drug-Induced Thrombocytopenia: Heparin and Quinine
- ITP: No Race Disparity in Prevalence Among Males
- Treatments and Treatment Related News
- IVIG Access Problems
- Restoring Bone Density in Patients Taking Glucocorticoids: Fosamax vs.Vitamin D
- Gender and Genetics: Illness, Treatment, and the Gender Divide
- Diet News
- Eat Your Veggies, You Won’t be Sorry
- Alzheimer’s Onset: Impact of Fruit and Vegetable Juices
Diabetes and a Vegan Diet
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.
Treatments and Treatment Related News
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: http://www.healthierus.gov/dietaryguidelines
For fruits and vegetables they read;
- Consume a sufficient amount of fruits and vegetables while staying within energy needs. Two cups of fruit and 2½ cups of vegetables per day are recommended for a reference 2,000-calorie intake, with higher or lower amounts depending on the calorie level.
- Choose a variety of fruits and vegetables each day. In particular, select from all five vegetable subgroups (dark green, orange, legumes, starchy vegetables, and other vegetables) several times a week. The 5 top-rated nutritious vegetables are: spinach, romaine lettuce, broccoli, tomatoes, and bell peppers. The 5 top-rated nutritious fruits are: cantaloupe, tangerines, blueberries, apricots, and raspberries
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.
- Platelet Disorders in the News
- Platelet-counter results differ
- Serotonin in platelets promotes healing
- Research facility develops better ways to diagnose immune diseases
- General Health News
- Aspirin-a-day might not keep the doctor away
- Most Americans are oblivious to fat-cancer connection
- Good diet may be better than the best vitamins
- FDA may approve adaptive drug trials
- Paying for it: Americans, British seek better health care for citizens
- United Kingdom tests performance-based payment
- American uninsured frequently forgo health care
- Natural Herbal Solutions Developed by MDs (advertisement)
Platelets Disorders in the News
Platelet counter results differ
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
Serotonin in platelets promotes healing
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
Research facility develops better ways to diagnose immune diseases
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.
General Health News
Aspirin a day might not keep the doctor away
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.
Most Americans are oblivious to fat-cancer connection
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.
Good diet may be better than the best vitamins
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:
- Glucosamin and chondroitin sulfate – used to reduce joint pain in arthritis. In a scientific trial, only patients with moderate to severe pain received a slight benefit from the supplements.
- Calcium and vitamin D – taken to prevent bone thinning and fractures associated with osteoporosis. Most women can get enough calcium and vitamin D from a healthy diet and sun exposure, but some may benefit from supplements.
- B vitamins – B vitamins were believed lower heart disease, but a large study showed no benefits.
- Multivitamins – Daily doses of multivitamins might ward off diseases like cancer and heart disease, but a federal panel declared that there was not enough evidence to recommend taking or not taking the vitamins.
- Echinacea – The herb, Echinacea, is thought to prevent the common cold. But in a clinical study, Echinacea prevented no more colds than a placebo.
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
FDA may approve adaptive drug trials
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
United Kingdom tests performance-based payment for health care providers
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
American uninsured frequently forgo health care
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.
- News from the Disease Front
- Study shows eltrombopag raises platelet counts in ITP patients
- NIH launches network to study rare diseases
- Asbestos implicated in autoimmune diseases
- Study reveals connection between pregnancy and arthritis symptoms
- General Health News
- Online healthcare services may cut costs
- Organic diets lower children's exposure to pesticides
- Children's DNA database sparks debate
- Hospitals seek to prevent errors during "hand-offs"
- Natural Herbal Solutions Developed by MDs (advertisement)
NEWS FROM THE DISEASE FRONT
STUDY SHOWS ELTROMBOPAG RAISES PLATELET COUNTS IN ITP PATIENTS
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)
NIH LAUNCHES NETWORK TO STUDY RARE DISEASES
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 IMPLICATED IN AUTOIMMUNE DISEASES
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.
STUDY REVEALS CONNECTION BETWEEN PREGNANCY AND ARTHRITIS SYMPTOMS
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.
GENERAL HEALTH NEWS
ONLINE HEALTHCARE SERVICES MAY CUT COSTS
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.
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.
ORGANIC DIETS LOWER CHILDREN’S EXPOSURE TO PESTICIDES
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
CHILDREN’S DNA DATABASE SPARKS DEBATE
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.
HOSPITALS SEEK TO PREVENT ERRORS DURING ‘HAND-OFFS’
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.
- General News
- Mirroring each other
- Follow the genetic trail
- D is for defense: Vitamin D may prevent breast cancer
- Sen. Clinton and Sen. Obama recommend changes for medical liability laws
- Improving Drug Safety
- Doctors worry more about drug safety
- Cell-based tests may improve the safety of drug trials
- Made-to-order medicine may be coming soon
- Low Platelets in the News
- Synthetic blood product shows promise for ITP treatment
- More infants may have low blood platelet counts than believed
- Korn Frontman Felled by ITP
General Interest News:
Mirroring each other
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.
Follow the genetic trail
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.
D is for defense: Vitamin D may prevent breast cancer
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.
Sen. Clinton and Sen. Obama recommend changes for medical liability laws
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.
Improving Drug Safety
Doctors worry more about drug safety
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/
Cell-based tests may improve the safety of drug trials
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.
Made-to-order medicine may be coming soon
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
Low Platelets in the News
Synthetic blood product shows promise for ITP treatment
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.
More infants may have low platelet counts than believed
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.
Korn Frontman Felled by ITP
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.
- Malaria Parasite Clearance by the Human Spleen
- Random Donor Platelets Often Effective in NAIT
- Unconscious Mind Helps with Complex Decisions
- IV Equipment Without PVC and DEHP
- Clinicians Role in Developing Off-Label Drug Therapies
- Recombinant Factor VIIa Off-Label Use: Use Caution
- Support for Anti-Oxidant Therapy
- FDA Alliance: An Advocacy Voice
- Drug Studies and the Promotional Material Not Always in Sync
MALARIA PARASITE CLEARANCE BY THE HUMAN SPLEEN
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.
RANDOM DONOR PLATELETS OFTEN EFFECTIVE IN NAIT
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.
UNCONSCIOUS MIND HELPS WITH COMPLEX DECISIONS
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.
IV EQUIPMENT WITHOUT PVC AND DEHP
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.
CLINICIANS ROLE IN DEVELOPING OFF-LABEL DRUG THERAPIES
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.
RECOMBINANT FACTOR VIIa OFF-LABEL USE: USE CAUTION
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.
SUPPORT FOR ANTI-OXIDANT THERAPY
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.)
FDA ALLIANCE: AN ADVOCACY VOICE
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
DRUG STUDIES AND THE PROMOTIONAL MATERIAL NOT ALWAYS IN SYNC
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.
- IVIG Supply
- Clinical Trial Results of Rituxamab in Childhood and Adolescent Chronic ITP
- A Clinical Trial Disaster in the UK Raises Questions
- Vitamin D Helps You Heal
- Black Mold Creates Toxin that Kills Mouse Brain Cells
- NIH Studying Bone Marrow Failure
- FDA Magazine: New Technologies, New Treatments, New Diagnostics
- Drug Action: Men and Women Differ
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.
CLINICAL TRIAL RESULTS OF RITUXIMAB IN CHILDHOOD AND ADOLESCENT CHRONIC ITP
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.
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 email@example.com See. www.bloodjournal.org)
A CLINICAL TRIAL DISASTER IN THE UK RAISES QUESTIONS
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.
VITAMIN D HELPS YOU HEAL
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
BLACK MOLD CREATES TOXIN THAT KILLS MOUSE BRAIN CELLS
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
NIH STUDYING BONE MARROW FAILURE
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.
FDA MAGAZINE: NEW TECHNOLOGIES, NEW TREATMENTS, NEW DIAGNOSTICS
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.
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)
DRUG ACTION: MEN AND WOMEN DIFFER
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)
- Platelet Donation Limits Rejected
- IVIG Availability
- Liquid Formulation of WinRho SDF® Available
- Bird Flu: The Threat and The Panic
- New NHLBI Initiative
- Antibiotic Linked to Blood-Sugar Problems
- Exercise May Help Stave Off Dementia
- Guidelines For Prepared Produce From FDA
PLATELET DONATION LIMITS REJECTED
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/
LIQUID FORMULATION OF WINRHO SDF® AVAILABLE
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)
BIRD FLU: PANDEMIC OR PANIC
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.
NEW NHLBI INIATIVE
“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
ANTIBIOTIC LINKED TO PROBLEMS BLOOD-SUGAR PROBLEMS
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)
EXERCISE MAY HELP STAVE OFF DEMENTIA
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.
GUIDELINES FOR PREPARED PRODUCE FROM FDA
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:
J. Zhang, “FDA Issues Guidelines for Prepared Produce”, Wall Street Journal, March 2, 2006, p. D1
- Being Chilled and Developing Cold Symptoms
- Building Your Inner Life
- Placebos: Have Physical not Just Psychological Effect
- Deer Muscle Found to Harbor Infectious Proteins
- Phase III Clinical Trial for Eltrombopag Treating ITP
- Is Streamlining Preclinical Testing Safe?
- Improving Delivery of Medical Services
BEING CHILLED AND DEVELOPING COLD SYMPTOMS
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.
Primary Source: Family Practice. 2005;23.
BUILDING YOUR INNER LIFE
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.
PLACEBOS: HAVE PHYSICAL NOT JUST PSYCHOLOGICAL EFFECT
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.
DEER MUSCLE FOUND TO HARBOR INFECTIOUS PROTEINS
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.
PHASE III CLINICAL TRIAL FOR ELTROMBOPAG TREATING ITP
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.
IS STREAMLINING PRECLINICAL TESTING SAFE?
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 ANNOUNCES “ITP AND PREGNANCY – FAQ” BOOKLET
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 firstname.lastname@example.org
Berkeley Wellness Letter, December 2006, page 1.
- PDSA Announces “ITP and Pregnancy” Booklet
- ASH Abstracts Available on Line
- WinRho SDF® Linked to Rare Cases of Intravascular Hemolysis
- Do We Need to Improve Delivery of Better Treatments?
- Personalized Medicine Gets Boost
- Diet and Immunity Linked
- Improve Health: Argue Less, Exercise More
- Registration of Clinical Trials Increases 73% over 5 Month Period
PDSA ANNOUNCES “ITP AND PREGNANCY” BOOKLET
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 email@example.com
ASH ABSTRACTS AVAILABLE ON LINE
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.
WIN RHO SDF® LINKED TO RARE CASES OF INTRAVASCULAR HEMOLYSIS
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.
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/.
DO WE NEED TO IMPROVE DELIVERY OF BETTER TREATMENTS?
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.
PERSONALIZED MEDICINE GETS BOOST
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.
DIET AND IMMUNITY LINKED
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.
IMPROVE YOUR HEALTH: ARGUE LESS, EXERCISE MORE
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.
REGISTRATION OF CLINICAL TRIALS INCREASES 73% OVER 5 MONTH PERIOD
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.