The 48th Annual Meeting and Exposition the American Society of Hematology was held in Orlando, Florida from December 8 through December 13, 2006. Over 20,000 hematologists from around the world gathered to learn the latest about the diagnosis and treatment of hematologic disorders. Thrombocytopenia, low platelets, and ITP were center stage. Data about the new treatments that Amgen (AMG 531) and GSK (eltrombopag) have in clinical trials was presented in a number of sessions during the meetings. You can search and read the abstracts at: http://meeting.bloodjournal.org/content/vol108/issue11/. You can read the papers included in the ASH Education Program Book at: http://www.asheducationbook.org/current.shtml
GlaxoSmithKline has announced the initiation of a Phase III clinical trial that will assess the safety, efficacy, and tolerability of eltrombopag in a long-term treatment setting in previously treated patients with chronic idiopathic thrombocytopenia purpura (ITP). Eltrombopag is a novel oral platelet growth factor. The trial, called RAISE, will involve 189 patients who will be treated at 135 centers in 26 countries. The announcement of this trial follows completion of earlier trials of eltrombopag in which the treatment was well tolerated with a dose dependant increase in the platelet count. For more information, go to www.itpstudy.com or www.clinicaltrials.gov
The National Women’s Health Report published a special issue in September on women and autoimmune diseases. It contains articles on common autoimmune diseases, a resources list, and a feature on the need for a low-stress lifestyle when an autoimmune disease is part of life. Practical tips include taking a walk, resting an hour every day, learning techniques to reduce stress hormone levels, and finding a support system.
www.healthywomen.org/Documents/NationalWomensHealthReport.September2006.pdf
Sixteen people in Brownsville, Texas, have contracted Dengue hemorrhagic fever, according to the Centers for Disease Control and Prevention. The disease causes high fever, headache, vomiting, muscle and joint aches, and rashes. It also causes small blood vessel leakage, which can lead to shock, internal bleeding, and death; however, none of the U.S. patients died. Dengue, common in tropical regions, is caused by a virus that is carried by mosquitoes. The mosquitoes breed in open water containers and pools.
Science News, October 28, 2006, page 286.
British authors published a review of research looking at the antioxidant role of grapeseed extract, a dietary supplement rich in flavonoids. Oxidative stress and inflammation have both been implicated in recent years in atherosclerosis and cardiovascular disease. Flavonoids have been found to reduce oxidative stress and inhibit platelet aggregation. Grape seed extracts may be source.
Kar P, Laight D, Shaw KM, Cummings MH. Flavonoid-Rich Grapeseed Extracts: A New Approach in High Cardiovascular Risk Patients? Int J Clin Pract. 2006;60(11):1484-1492. The article was reprinted on Medscape www.medscape.com/viewarticle/546099.
The National Institutes of Health (NIH) has launched a patient friendly website called Genetics Home Reference. It provides helpful information on topics such as newborn screening, plus consumer-friendly descriptions of genetic disorders, including definitions of terms.
Brisk walking may be more important than crossword puzzles for boosting brain power in older adults, according to a study from the University of Illinois, Urbana. Three hours a week of brisk walking (about 3 miles an hour) increases blood flow to the brain and increases production of new brain neurons. Fifty nine adults ages 60 to 79 got either aerobic training, stretching-and-toning training, or nothing. Only the group that did aerobic exercise for one hour three times a week showed an increase in brain volume. Earlier studies had shown that people who do aerobic exercise have a better working memory and are nimbler at switching between mental tasks, but this new study suggests what changes in the brain enable this improved mental capacity. The findings were published in the November 2006 issue of the Journal of Gerontology: Medical Sciences.
Sharon Begley, How to Keep Your Aging Brain Fit. Wall Street Journal, November 16, 2006, page D1.
The Wall Street Journal carried tips from an environmental engineer for reducing mold at home:
In the November 2006 issue of Self Healing, Dr. Andrew Weil’s newsletter, honey is endorsed for its wound healing properties when applied topically to a wound. One review of 22 clinical trials concluded that honey shortens healing time on wounds and provided better pain relief than antifungal creams or antibiotics (International Journal of Lower Extremity Wounds, March 2006). In a separate study, one specific honey product, called Medihoney, healed wounds faster than most antibiotics (Supportive Care in Cancer, January 2006). Medihoney is awaiting FDA approval in the United States. The article notes that there is no evidence that honey helps heal wounds when eaten as a sweetener.
Celery is rich in vitamin K and phytonutrients, such as phthalides, quercetin, apigenin, and luteolin. It’s high in water, but not the high-sodium food that some may call it. Taiwanese researchers found that liver cells treated with celery extract produced more of a liver enzyme that helps remove toxins and drugs from the body.
Environmental Nutrition, December 2006, page 8.
Warfarin is the most commonly used anticoagulant drug, or “blood thinner”. It is prescribed to treat or prevent clots associated with heart attacks, atrial fibrillation, prosthetic valve replacement, deep vein thrombosis, and pulmonary embolism. Cranberry juice has gained popularity as a beverage that can prevent urinary tract infections. A literature review indicates that drinking large amounts of cranberry juice can destabilize warfarin therapy. Although the authors note that small amounts of cranberry juice are not likely to cause problems, they suggest that doctors warn their patients of the potential interactions.
Aston JL, Lodolce AE, Shapiro NL. Interaction between warfarin and cranberry juice. Pharmacotherapy. 2006;26(9):1314-1319. Medscape reprinted the article (www.medscape.com/viewarticle/545631).
Dark chocolate may delay blood clotting, which may be helpful for patients with blood vessels narrowed by cardiovascular disease, according to a recent study by scientists at Johns Hopkins. The study, however, wasn’t designed to evaluate chocolate’s effect. It was designed to look for genetic factors that identify which patients respond best to aspirin therapy to reduce blood clotting. All 1,200 volunteers had slightly elevated risk of heart disease. Two weeks before the study, they were asked to avoid foods rich in flavonols, including chocolate, coffee, red wine, and strawberries. When some participants confessed to eating chocolate anyway, the Hopkins researchers decided to study its effect on platelet activity. They found slower clotting time and actual platelet suppression in the people who admitted to eating chocolate. The study was presented at a meeting of the American Heart Association. Other researchers are calling for larger, randomized trials to see if the effect is real, and warn about overindulging in chocolate, especially higher fat milk chocolate.
Low levels of vitamin D are being linked to muscle pain and weakness, to infection, and to disability in the elderly
Researchers at the University of Minnesota decided to test the vitamin D levels in 150 patients ages 10 to 65 who complained of nonspecific muscle pain and weakness. They were stunned to find that nearly everyone—93 percent—had too low levels. Vitamin D is made by the body when sunlight hits the skin, but many people are minimizing sun exposure to avoid skin cancer. Salmon is a good dietary source of vitamin D, as are fortified milk products.
Self Healing, December 2006, page 2.
Vitamin D boosts production in white blood cells of one of the antimicrobial compounds that defends the body against germs. A review of 100 articles has led a California researcher to propose that vitamin D deficiency may underlie a vulnerability to infections caused by a wide range of bacteria, viruses, and fungi. Vitamin D may do so by boosting an antimicrobial called cathelicidin.
Science News, November 11, 2006, page 312.
Finally, a Dutch study found that people over age 65 with low blood levels of vitamin D were three times more likely to end up in a nursing home than those with high levels. The difference appeared to be due to bone and muscle strength related to falls in older people. The government recommendation for people ages 50 to 70 is 400 IU a day; for those over 70, it is 600 IU a day.
Berkeley Wellness Letter, December 2006, page 1.
Contents:
Thrombocytopenia Drug-Induced Thrombocytopenia: Heparin and Quinine
Drug-induced thrombocytopenia is common but well documented only for a small number of specific compounds. Two drugs known to induce thrombocytopenia are heparin and quinine. A recent article in the New England Journal of Medicine presents a case vignette of heparin induced thrombocytopenia, examines evidence supporting various treatment strategies, and reviews the formal guidelines http://www.chestjournal.org/cgi/content/full/126/3_suppl/311
In studying quinine-induced thrombocytopenia, researchers unexpectedly found quinine-dependant antibodies in addition to the platelet-reactive antibodies they expected. This may help them design a simpler test to confirm the diagnosis of drug-induced thrombocytopenia.
Note: Quinine is used to treat the common symptom of nocturnal leg cramps. It is an ingredient in tonic water and is present in bitter melons.
Arepally, G.M., et al, “Heparin Induced Thrombocytopenia”, The New England Journal of Medicine, 355:809-817, August 24, 2006.
George, J.N., “Quinine: Common Remedy, Serious Reactions, New Insights”, Blood, vol. 108, no. 3, pp. 782-783, August 1, 2006.
Bougie, D.W., et al, “Patients with Quinine-Induced Immune Thrombocytopenia Have Both ‘Drug-Dependent’ and ‘Drug-Specific’ Antibodies”, Blood, vol. 108, no. 3, pp. 922-927, August 1, 2006. http://www.bloodjournal.or
ITP: No Race Disparities in Prevalence Among Males
The authors of a recent letter to the editor of Blood point out that “ethnic, racial, and geographic differences influence virtually all human disease, and certain conditions exhibit well-established differences between Africans and Europeans.” Awareness and careful study of these differences can have important consequences for health care delivery. The authors in their letter report the results of their study of veteran’s health records. This review did not reveal a significant disparity in the prevalence of ITP among Whites and African Americans. An acknowledged limitation of the study is that the database was all male. Also these results are not consistent with the findings of six other studies that addressed the same question and which were summarized in Blood in 2005 (reference below).
Landgren, O., et al, “Immune Thrombocytopenia Purpura Does Not Exhibit a Disparity in Prevalence between African American and White Veterans” (To the Editor), Blood, vol. 108, no. 3, pp. 1111-1112.
Terrell, D.R., et al, “Is Immune Thrombocytopenia Less Common Among Black Americans?”, Blood, vol. 105, no. 3, February 1, 2005 pp. 1368-1369.
IVIG Supply Problems
Some patients are experiencing problems obtaining IVIg. The FDA is investigating the situation and is requesting input from patients and physicians. If your physician feels IVIg is a good treatment for you but it is not available, please call 800-835-4709 or email CBERProductShortages@cber.fda.gov. These are provided to report availability issues only. They are not for reimbursement problems, issues or complaints. For Medicare reimbursement issues call 800-633-4227 (800-MEDICARE)
The HHS is also seeking information on the IVIg access. The are hosting a public meeting on September 28, 2006 from 10 a.m. to 5 p.m at the Sheraton Crystal City Hotel in Arlington, VA
To register go to https://www2.ergweb.com/projects/conferences/hhs/ or call the ERG conference registration line, 781-674-7374 Restoring Bone Density in Patients Taking Glucocorticoids: Fosamax vs. Vitamin D A randomized, double-placebo, double-blind clinical trial lasting 18 months involved 201 patients who were starting glucocorticoids (ex. Prednisone) as treatment for a rheumatic disease. The patients were given either Fosamax and a vitamin-D placebo or vitamin-D and a Fosamax placebo. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months. The researchers report that bone mineral density of the lumbar spine increased by 2.1 percent (1.1% to 3.1%) in the Fosamax group and decreased 1.9 percent (-3.1% to -0.7%) in the vitamin-D group. www.clinicaltrials.gov (ClinicalTrials.gov number, NCT00138983)
De Nijs, et al, “Alendronate [Fosamax] or Alfacalcidol [Vitamin-D] in Glucocorticoid-Induced Osteoporosis”, New England Journal of Medicine, vol. 355, no. 7, August 17, 2006, pp.675-684.
Gender and Genetics: Illness, Treatment and the Gender Divide
Most autoimmune diseases affect women in far greater numbers than they affect men. ITP for instance affects about three times (3:1) as many women as men. The ratio for other autoimmune disease is as high as 10:1. Researchers are looking at genetics to understand this disease disparity. A recent study by a group at the University of California at Los Angeles found that in “liver, fat, and muscle tissue males and females differently expressed 55 to 72 percent” of the 23,000 genes studied. Follow-up studies hint that “sex hormones such as estrogen and testosterone control the expression of many of the genes.” This work with mice (mice and people share about 99% of their genes) “could guide researchers in figuring out why men and women have different risks for different diseases. Further studies might also pinpoint the optimal doses of prescription drugs for men or women or assist researchers in crafting new, gender-specific medicines.”
Brownlee, C., “Gender Divide”, Science News, vol. 170, July 22, 2006, p. 52.
Yang, X., et al, “Tissue Specific Expression and Regulation of Sexually Dimorphic Genes in Mice”, Genome Research, vol. 16, July 6, 2006, pp. 995-1004.
Eat Your Veggies, You Won’t be Sorry
The benefits of vegetables in our diet are becoming much better understood. In response the government has revamped the effort to boost their consumption. New recommendations were published jointly by the Department of Health and Human Services and the Department of Agriculture. They consist of specific amounts of produce, measured in cups rather that the vague “servings” and they vary by age and sex, and level of activity. We have a long way to go. According to the Centers for Disease Control, about 90% of the U.S. population does not meet the government’s recommendations. The USDA recommendations can be found at: https://health.gov/dietaryguidelines/
For fruits and vegetables they read;
Wang, S., McKay, B., “More Reasons to Eat Your Veggies”, Wall Street Journal, July 25, 2006, p. D1.
Alzheimer’s Onset: Impact of Fruit and Vegetable Juices
A new study links the delayed onset of Alzheimer’s to a diet generous with fruit and vegetable juices. See http://www.medscape.com/viewarticle/544012 Diabetes and a Vegan Diet
A recent study compared the vegan diet to the ADA diet for diabetes in 99 patients. Forty-three percent of those on the vegan diet reduced their need to take drugs to manage their diabetes compared to 26 percent of the ADA diet group.
http://www.cbsnews.com/stories/2006/07/26/health/webmd/printable1837927.shtml
Contents:
RITUXAN
Rituxan (rituximab) is approved by the Food and Drug Administration (FDA) for treatment of certain types of lymphoma and for rheumatoid arthritis that has not responded to other therapies. However, the drug is also prescribed in what is called off-label indications for patients with lupus and patients with ITP.
After two patients taking Rituxan for lupus died from a rare brain infection, the Food and Drug Administration and the drug’s makers, Genentech and Biogen Idec, released a “preliminary public safety alert”. It warned doctors to carefully monitor patients taking Rituxan for any reason. The link between Rituxan and the viral brain infection, called progressive multifocal leukoencephalopathy, or PML, is unclear. The drug’s label already includes a warning about PML. And also states that patients who are carriers of the Hepatitis B virus (which means persistently having the virus, not just having a past infection), are at risk of reactivating the hepatitis B with Rituxan treatment. However, when given on its own as a treatment for ITP, Rituxan has not been associated with infections.
The FDA is not suggesting that Rituxan be pulled from the market. The side effect is rare and appears to occur only in people who have received multiple immunosuppressive treatments in addition to Rituxan. Dr. James Bussel, a PDSA medical advisor, states: “We do not believe that this should alter clinical practice unless the patient is receiving multiple immunosuppressive treatments in addition to Rituxan.”
PAINKILLERS
The FDA would like to see stronger labeling rules on over-the-counter painkillers to warn consumers of the risks of stomach bleeding or liver injury. Nonprescription drugs such as ibuprofen (Advil, Motrin), acetaminophen (Tylenol), and aspirin, can cause serious health problems, especially if consumers take too much of a given product, which can occur when people take a combination of over-the-counter cold medicine and another pain reliever. The drugs are safe, but consumers need to be aware of possible side effects and to avoid accidentally overdosing when taking multiple products. The FDA proposal would require all manufacturers to use the same language and make current warnings more prominent.
Wall Street Journal, December 20, 2006, pg D4
UNAPPROVED QUININE PRODUCTS
The FDA has ordered the removal of unapproved drug products containing quinine. The only quinine product currently approved by the FDA is called Qualaquin, by Mutual Pharmaceutical Company. It is indicated for the treatment of a specific type of malaria. But it is often prescribed to treat leg cramps and similar conditions, despite drug labeling that the risks associated with its use in this setting outweigh the potential benefits.
Close monitoring may be required for patients with liver or kidney problems. Serious adverse events include cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs are also possible.
Medscape Medical News, December 13, 2006.
ANIMAL STUDY SUGGESTS ROLE FOR ARSENIC COMPOUND TO TREAT SYSTEMIC B-CELL AUTOIMMUNITY
Arsenic trioxide is a poison that is used to treat acute promyelocytic leukemia. In a mouse model of lupus, the drug halted disease progression through various mechanisms. In a commentary, Pistoia writes that the latest study supports the feasibility of a clinical trial in treatment-resistant patients with lupus or possibly autoimmune lymphoproliferative syndrome.
Pistoia V. Poisoning Autoimmunity. Blood, December 15, 2006, 108(13):3964.
EVIDENCE BUILDING FOR VITAMIN D’S BENEFITS
Scientists now think that vitamin D, which many people do not get enough of, has many more benefits than reducing the risk for rickets. Studies link low blood levels of vitamin D to type 1 diabetes, multiple sclerosis, tuberculosis, colon cancer and flu. High levels prevent against fractures. Our bodies make vitamin D when we get exposure to the sun, but most people spend a lot more time indoors than outdoors, or avoid sun exposure to reduce the risk of skin cancer. Food sources are limited to fortified milk products and new research suggests that the recommended dietary allowance, or RDA, is not sufficient. Meir J. Stampfer, professor of medicine at Harvard Medical School, writes that there is growing agreement among experts that a daily vitamin D supplement makes good sense.
Newsweek, December 11, 2006, pg. 85-86.
MEDICAL OFFICES COULD USE A SAFETY CHECK
Many doctor’s offices fall short when it comes to keeping track of patients, their appointments, and their test results. According to one non-profit group, too many errors occur because of poor communication with referring physicians, inadequate communication with the patient, or inadequate follow-up. Three organizations are offering a new, Web-based “Physician Practice Patient Safety Assessment” to help doctors evaluate how well they run their offices, with a focus on tracking medication use and safety, transferring information to other doctors, and communicating to patients. The tool was developed by the nonprofit Medical Group Management Association, the Institute for Safe Medication Practices, and Health Research and Educational Trust, under a grant from the Commonwealth Fund. Any doctor can download the self-assessment program free at www.physiciansafetytool.org. For a fee, the group will analyze the data and provide a report. Patients can also download materials to get a sense of what their doctors’ offices should be doing.
To help patients do their part, HMO giant Kaiser Permanente is including “after visit summaries” that recount the salient points of a doctor visit, describe prescription medications and doses, and lay out instructions for self-care and follow-up visits.
Landro, L. The Informed Patient. Booking Your Medical Office for a Safety Checkup. Wall Street Journal, November 15, 2006, page D3.
CURRY MAY HELP BRAIN POWER
Diets High in curry may prevent cognitive impairment, according to a study in the Nov. 1 American Journal of Epidemiology. A chemical found in turmeric, an ingredient in curry, had earlier shown anti-inflammatory and anti-cancer properties in animal studies. For this study, medical researchers in Singapore evaluated a database of about 1,000 elderly, mentally sound adults, and found that those who stated they ate curry often or occasionally had slightly higher scores on cognitive-function tests than those who reported rare or no curry consumption.
Science News, November 11, 2006, Pg. 316.
DO GUT BACTERIA PLAY ROLE IN OBESITY?
Obese mice—and people—have more of one type of bacteria and less of another kind, according to two studies published in the journal Nature in January. A family of bacteria called Firmicutes was high among the obese and a type of bacteria called Bacteroidetes were low. The researchers aren’t sure if more Firmicutes makes people fat or if people who are obese grow more of that type of bacteria. Could changing the bacteria in the intestines and stomach make a difference?
In one study, lean mice with no germs in their guts were given larger ratios of Firmicutes. Subsequently, they got twice as fat and took in more calories from the same amount of food than mice with the more normal bacteria ratio. In a second study of obese people, 3 percent of their gut bacteria was Bacteroidetes before dieting. After successful dieting, their levels of Bacteroidetes were much higher.
The studies were done at Washington University in St. Louis.
UNINSURED AND LOW-INCOME PATIENTS CAN GET HELP PAYING FOR MEDICATIONS
Many patient advocacy organizations, pharmaceutical companies, foundations, and other charitable organizations have programs to help patients pay for prescription therapies. To qualify for PAPs and cost-sharing assistance programs, patients must meet income guidelines and other eligibility criteria. The Patient Advocate Foundation ( www.copays.org or 1-866-512-3861) is one of many good resources.
Thomas
http://thomas.loc.gov
“Thomas” is the Federal government’s Website for tracking any piece of pending legislation, including bills related to healthcare or medical research. The site is sponsored by the Library of Congress. National Institute of Child Health & Human Development.
www.nichd.nih.gov
This Website has been redesigned for easier access to a wealth of information for patients and the public. NICHD is the component of the National Institutes of Health that supports research on human development, medical rehabilitation, and the health of children, adults, families, and communities.
Plasma Protein Therapeutics Association
www.pptaglobal.org
Policy issues, standards, newsroom, donor and consumer information and more from the Plasma Protein Therapeutics Association (PPTA), the primary advocate for the world's leading producers of plasma-based and recombinant biological therapeutics. Patient Notification System
www.patientnotificationsystem.org
is a free, confidential, 24-hour communication system of the Plasma Protein Therapeutics Association that provides information on plasma-derived and recombinant analog therapy withdrawals and recalls.
Note: This includes various IVIg products and WinRho® SDF
Contents:
Because rituximab has become a common treatment for patients with idiopathic thrombocytopenic purpura (ITP), researchers at McMasters University in Ontario, Canada, reviewed the medical literature to determine how much evidence exists to support the use of the drug in ITP. They found 19 reports on efficacy (313 patients) and 29 reports on safety (306 patients). More than 60 percent of adults experienced an increase in overall platelet counts and one study found that a shorter period between diagnosis and rituximab administration resulted in better relapse-free survival. However, sixty-six of 306 patients experienced mild or moderate adverse events and 9 patients across the studies died. Importantly, none of the studies were “controlled studies”, comparing patients taking the drug with similar patients not taking the drug. Overall, the authors determined that “the quality of the evidence in support of rituximab for the treatment of adult ITP is poor.” They go on to caution against indiscriminate use of this treatment, stating that randomized, controlled trials of rituximab in patients with ITP are “urgently needed.”
Arnold DM, Dentali F, Crowther MA, Meyer RM, Cook RJ, Sigouin C, Fraser GA, Lim W, Kelton JG. Systematic review: Efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Annals of Internal Medicine. 2007;146:25-33.
IVIG DISTRIBUTION UP IN 2006
Data from the Plasma Protein Therapeutics Association (PPTA) indicate that, during the first 11 months of 2006, IVIG distribution in the U.S. market exceeded the total amount distributed in 2005. More than 29,500 kg of IVIG were distributed between January and November 2006. PPTA has developed a Stakeholder Toolkit with information on plasma protein therapy manufacturing process and available resources (http://pptaglobal.org/en/stakeholder.cfm). Comments and recommendations on the toolkit should be sent to Diana Krueger at dkrueger@pptaglobal.org.
ITP patients may soon be able to boost their platelet production with fewer side effects, thanks to two oral drugs that are nearing the end of clinical trials. Two other drugs in earlier trials are also showing promise. The new drug, a non-peptide oral platelet growth factor is called Promacta (eltrombopag), and in a trial of 231 ITP patients at Weill Cornell Medical Center in New York City, three-fourths of patients getting the drug experienced a rise in platelets sufficient to restore healthy clotting. The maker of eltrombopag, GlaxoSmithKline, also announced results from a phase 2 international trial in 117 adults with chronic ITP, randomized to placebo or 3 different doses of eltrombopag. At all 3 doses, platelet counts rose compared with placebo.
During a presentation at the American Society of Hematology Meeting, Dr. David Kuter presented results from a clinical trial of AMG531. In that trial the compound boosted platelet counts in 31 of 36 ITP patients.
The other drugs that show promise are AKR-501, and SB559448.
Science News, January 13, 2007, pg. 29. Hematology & Oncology News & Issues, January 2007, pg. 21.
People who eat more slowly and deliberately consume fewer calories at a meal than those who speed through the meal, according to research at the University of Rhode Island. Tips in a new book, “Mindless Eating,” by researcher Brian Wansink, of Cornell University, include try to be the last person to start eating, decide how much to eat before sitting down, use smaller dishes so portions look larger, and don’t eat in front of the TV or in the car.
Parker-Pope, T. Latest Weight-Loss Advice: Slow Down and Pay Attention. Wall Street Journal, January 16, 2007, pg. D1.
Bulgur is made from wheat kernels that are first boiled or steamed, then dried and cracked into pieces. It is a good source of complex carbohydrates, contains 6 grams of fiber per cup (twice the amount found in brown rice!), and it offers a healthy dose of minerals and antioxidants. Bulgur can substitute for rice in any dish.
One more tip: exercising for 45 minutes, five days a week, may help prevent you from catching a cold.
Environmental Nutrition, January 2007, pg. 8.
POSITIVE MOOD MAY WARD OFF COLDS
Another way to ward off a cold is to keep a positive mood, according to research from Carnegie Mellon University in Pittsburgh. The researchers suspect that positive emotions stimulate symptom-fighting substances. They exposed more than 300 volunteers to cold viruses via nasal drops. Those who displayed generally positive outlooks, including feelings of liveliness, cheerfulness, and being at ease, were least likely to develop cold symptoms.
Science News, December 16, 2006, pg. 387.
The Dalai Lama has been encouraging brain researchers to study whether thoughts could cause physical changes in the brain. Neuroscientists already knew that the adult brain can change—its structure and activity can morph in response to experience. Experiments had shown that intensely practiced movements can alter the motor cortex of stroke patients and allow them to move once paralyzed arms or legs. But the Dalai Lama was interested in whether thought could rewire the brain. Experiments by scientists at University of Toronto found that, in depressed adults, the antidepressant paroxetine yielded the same outward effect as cognitive-behavior therapy. All of the patients came out of their depression. However, the impacts on the brain were different. Cognitive therapy rewired the brain in different areas than the drug. Additional studies found that meditation can change the function of the brain as well, making it easier for the brain to turn on circuits that underlie compassion and empathy.
How Thinking Can Change the Brain. Wall Street Journal, January 19, 2007, Pg. B1. [Book excerpt from “Train Your Mind, Change Your Brain” by Sharon Begley]
Two Websites vie for consumer audience
Steve Case, founder of American Online, is launching a new Website that will “put health care back into the hands of the consumer.” RevolutionHealth.com will start off free, but eventually charge about $100/year for premium services. It will digitally store medical records and provide telephone services that coach patients about their health, match them with doctors, and help unsnarl insurance claims. The existing leader in the market, WebMD.com, is competing by offering more of its services for consumers free. WebMD.com already maintains health records and enables users to personalize its site.
Tesoriero HW. The Doctor’s Office Gets Crowded on the Web, Wall Street Journal, January 22, 2007, pg. B1.
Adults age 50-plus face a sizable list of health screening tests. Some people don’t get tested when they need to. Others get screened too frequently. The U.S. Preventive Services Task Force suggests that early detection tests should be targeted based on an individual’s age, gender, underlying health conditions and family history. Low-cost and free services can be found through several sources:
Fleck C. How’s Your Health? AARP Bulletin, December 2006, g. 20.
Remodeling? Tips for a Healthier Home
“It’s gotten much easier to avoid troublesome products and to incorporate cleaner materials and techniques into your remodeling job,” according to the Website, www.alternativemedicine.com. Nontoxic materials have come down in price, and many more contractors are accustomed to using them.
For details, go to www.alternativemedicine.com. In the search box, type in “healthy home” to find the full article, “Blueprint for a Healthy Home”, by Sally Lehrman.
Contents:
Because prednisone and prednisolone are widely used first-line therapies for ITP, but long-term responses after therapy stops are very low (10%-25%), researchers in Italy tested high-dose dexamethasone (HD-DXM), another steroid, for untreated patients. In two studies, they found promising results. One study of adults showed an initial response rate of 90% and long-term response rate of 68%. A second, multicenter study in adults and children also found a high long-term response rate. They contend that their results confirm that HD-DXM can be a first-line therapy for adults and children with ITP. For both groups, 6 cycles appeared to be unnecessary. They have proposed a new randomized trial comparing 3 cycles of HD-DXM with conventional prednisone treatment for this population.
Mazzucconi MG, Fazi P, Bernasconi S, Derossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, rodeghiero F, Amendola A, Baronci C, Carbone C, Quatrin S, Fioritoni G, D’Alfonso G, Mandelli F. Therapy with high-dose dexamethsaone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood, 15 Feb, 2007; 109(4):1401-07.
The antibiotic vancomycin can cause antiplatelet antibodies that lead to ITP, according to scientists at the Medical College of Wisconsin and Baylor College of Medicine. Platelet levels returned to normal in every patient after vancomycin was stopped. They suggest that testing for drug-dependent antibodies can be helpful to identify the cause of thrombocytopenia, or low platelet count, in patients receiving vancomycin.
In a Perpective in the same issue of New England Journal of Medicine, Theodore E. Warkentin of McMaster University in Ontario, Canada, describes the impact and mechanism of other drugs implicated in immune-mediated thrombocytopenia, such as quinine and heparin.
Von Drygalski A, Curtis Br, Bougie DW, McFarland JG, Ahl S, Limbu I, Baker KR, Aster H. Vancomycin-induced immune thrombocytopenia. N Engl J Med. 1 March, 2007; 356(9):904-10.
Warkentin TE. Drug-induced immune-mediated thrombocytopenia—from purpura to thrombosis. N Engl J Med. 1 March, 2007; 356(9):891-3.
The American Society of Hematology is offering a new Web-based practice aid to help physicians provide the best care to patients with ITP. PIMs guide practice-based learning and improvement and include links to educational materials and other resources. Physicians who complete a PIM can earn CME credits.
http://www.hematology.org/education/recertification/itp/add_or_viewresults.cfm
Talecris, the maker of Gamunex® an IGIV therapy that requires cold-storage shipping, has made its insulated shipping containers more environmentally friendly by using a fully degradable Control Tem Blue™ container.
The American College of Critical Care Medicine (ACCM) task force issued clinical practice guidelines for support of patients and their families in adult, pediatric, or neonatal intensive care units. The guidelines define standards for incorporating families into decision making and care for ICU patients.
Critical Care Medicine, February 2007;35:605-622.
Medscape produced a CME activity around the new guidelines at: www.medscape.com/viewarticle/551738
Abuse of prescription drugs has surpassed elicit drug use in some places, according to the United Nations. In the U.S., prescription drug abuse is second only to marijuana abuse. The World Health Organization estimates that 10% of drugs on the global market are counterfeit. In developing countries, that number rises to 25% to 50%. The rise in counterfeit drugs is due to unregulated global markets selling through the Internet and mail order.
The Wall street Journal, March 1, 2007, pg. A4.
(Dangerous Doses, a book by Katherine Eban, is an exciting read that describes the problem. See: http://www.dangerousdoses.com/)
An analysis of 111 studies of soft drinks, juice and milk published in Public Library of Science, found that studies funded entirely by the beverage industry were four to eight times more likely to be favorable to those beverages than other research. Of 22 studies funded by the beverage industry, only 14% had unfavorable findings; more than 38% of independently funded research, however, was unfavorable. The researchers would like to see more government funding for nutrition research.
Tufts University Health & Nutrition Letter, March 2007, pg. 3.
The U.S. Food and Drug Administration is attempting to expand its program that enables people with life-threatening or serious illnesses to gain access to drugs that are still in testing and have not yet been approved by the FDA. For decades the FDA has allowed certain patients with AIDS and cancer to access experimental therapies on the grounds of “compassionate use” after all other avenues have been explored. The new rules spell out a broadening of who is eligible for unapproved drugs, how to request them, and how much companies can charge for them. Opponents of the expansion say that expanded access to these drugs will harm clinical trial enrollment, and may provide access to drugs that have not been well enough tested in humans and may cause more harm than good.
The comment period on the proposed rules was set to close in March. http://www.fda.gov/cder/regulatory/applications/IND_PR.ht
Nature Medicine February 2007, 13(2):111.
The mere belief that you are getting a workout may provide similar benefits to actual exercise. Researchers at Harvard University enrolled two groups of hotel housekeepers in the study. One group was told that their regular work was good exercise and met the guidelines for a healthy, active lifestyle. The other group was told nothing. Although the amount of activity done by the women did not change during the 4 weeks of the study, the “informed” group commented that their lives were healthier, and they lost an average of 2 pounds, their blood pressure dropped, and they lost body fat. The women who were told nothing experienced no changes.
The Wall Street Journal, February 2, 2007, pg. B1.
Heart disease is not gender-neutral, according to new research from Cedars-Sinai Medical Center in Los Angeles. Many women have a form of heart disease called coronary microvascular dysfunction that isn’t detected by standard diagnostic procedures, according to the NIH-funded Women’s Ischemia Syndrome Evaluation (WISE) study. This means that, instead of plaque causing obstructions in a large coronary artery, women are more likely to experience narrowing of the tiny vessels of the heart. This may help explain why so few women have the crushing chest pain that men experience. More often, they feel less dramatic symptoms, such as diffuse discomfort, exhaustion, or shortness of breath. The researchers found high levels of certain inflammatory substances in women at higher risk for heart disease. The inflammatory substances course through the blood stream, stripping away cells that line the blood vessels, allowing cholesterol to form plaques and stiffen the vessel walls. Inflammation persists as the vessels try to repair themselves and risk for clots increases. Bottom line: Risk is higher for African American women and premenopausal women with inflammatory disorders, autoimmune diseases, or low estrogen levels. Live heart-healthfully by getting regular exercise, maintaining a healthy weight, not smoking, and controlling levels of cholesterol, glucose, and blood pressure. See a doctor if you experience unexplained fatigue or shortness of breath.
Harvard Women’s Health Watch, February 2007, pg. 1.
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In April, the Food and Drug Administration approved a new use for Rhophylac, an anti-D Rh immunoglobulin. The intravenous compound is now approved as a means of raising platelet counts in Rh0(D) positive adult patients with chronic ITP who have not had their spleen removed. Rhophylac is a product of CSL Behring. For more information visit www.rhophylac.com
A new study sponsored by GlaxoSmithKline will evaluate repeated dosing of eltrombopag in patients who have been previously treated for chronic ITP. Previous treatments could include splenectomy, corticosteroids, immunoglobulins, cyclophosphamide, and rituximab. Eltrombopag is an experimental drug that is being tested as a platelet growth factor because it stimulates the proliferation and differentiation of megakaryocytes, the bone marrow cells that give rise to blood platelets. It is given as a pill once-a-day. In this new study, called REPEAT (Repeat ExPosure to Eltrombopag in Adults with ITP), 50 patients will be recruited at several centers around the world. The drug will be given in three six-week cycles. Eltrombopag is not approved for marketing for any indication at this time.
For further information on the REPEAT trial, visit www.itpstudy.com or www.clinicaltrials.gov
The National Heart Lung and Blood Institute’s new strategic plan, Shaping the Future of Research: A Strategic Plan for The National Heart Lung and Blood Institute, can be downloaded from: www.nhlbi.nih.gov/strategicplan
The United Kingdom’s adult ITP registry has been sitting dormant since 2004 for lack of funding. But now, with support from GlaxoSmithKline and the UK’s ITP Support Association (http://www.itpsupport.org.uk/), data analysis will begin and new patients will be added to the existing database. Between 2001 and 2004, 609 ITP patients were enrolled, “making the study the largest of its kind in the world,” according to the ITP-UK newsletter. The aim of the registry is to learn more about ITP, its prevalence, clinical behavior, and responses to treatment. Progress reports for the study will be published in a bi-monthly newsletter, at www.ukitpregistry.com. The study coordinator is Ameet Sarpatwari (avs31@medschl.cam.ac.uk)
In a report last updated August 2005, the Food and Drug Administration stated that it found no evidence of an overall shortage of Immune Globulin Intravenous (IGIV) a.k.a. IVIG products. But is encourages health care providers and patients who experience difficulty obtaining IVIG products to send an email to CBERPRoductshortages@cber.fda.gov or call 1-800-835-4709.
www.hhs.gov/bloodsafety.igiv.html
In response to concerns about the potential risk of a rare fatal brain infection called variant Creutzfeldt-Jakob Disease for recipients of plasma-derived clotting factors and other plasma products (such as immune globulins), the FDA did a risk assessment and determined that the risks are extremely small, though somewhat uncertain. They devised a Website with several factsheets and Q&As: www.fda.gov/cber/blood/vcjdrisk.htm.
The Illusion of Coverage: How Health Insurance Fails People When They Get Sick, by The Access Project, recounts the personal, emotional, and physical hardships of the millions of hard working, insured Americans who are struggling with medical debt. The report demonstrates the specific ways in which health insurance products fail to protect people financially and fail to guarantee their access to needed care when ill or injured. 70 pp. (2007)
http://www.accessproject.org/adobe/the_illusion_of_coverage.pdf
Three other reports come from Families USA:
A Pound of Flesh: Hospital Billing, Debt Collection, and Patients' Rights provides an overview of some of the progressive reform measures that state policymakers have implemented to help families struggling with medical debt. 8 pp. (March 2007)
www.familiesusa.org/assets/pdfs/medical-debt.PDF
No Bargain: Medicare Drug Plans Deliver High Prices shows the huge differences between prices secured by the Department of Veterans Affairs (VA) — which bargains for cheaper drug prices — and the much higher prices charged by all the private drug plans in Medicare Part D, which cannot bargain for cheaper prices. 23 pp. (January 2007)
http://www.familiesusa.org/assets/pdfs/no-bargain-medicare-drug.pdf
Understanding How Health Insurance Premiums are Regulated provides a comprehensive overview on the different ways states can regulate health insurance premiums. 21 pp. (September 2006)
www.familiesusa.org/assets/pdfs/rate-regulation.pdf
The National Children’s Study will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The goal of the study is to improve the health and well-being of children. With a hefty appropriation of $69 million from Congress, the study is moving forward to expand into additional communities and begin recruitment. A Request for Proposals went out to fund 15-20 new study centers nationwide. The study is a huge undertaking. For example, it faces big obstacles in finding study participants within rural communities. The four South Dakota and Minnesota counties cover more than 2,500 square miles and the researchers are expected to recruit 75% to 80% of the counties’ newborns.
http://www.nationalchildrensstudy.gov/
In a survey of more than 1500 people ages 50 and older, only 3 in 10 told their doctors that they were using a complementary or alternative medicine (CAM). That means 7 of 10 were trying a CAM therapy without discussing it with their regular doctor. Many (42%) said the doctor never asked, 30% did realize they should tell their doctor, and 12% feared the doctor would have a negative reaction. The CAM therapies most often used were massage, chiropractic or some other form of body work, followed by herbal or dietary supplements.
www.aarp.org/research/health/prevention/cam_2007.html
Note: These findings are consistent with our survey (http://www.itppeople.com/surveyres/ ) PDSA recommends telling your doctor about any complementary or alternative therapies you are using.
Because proving that low-calorie diets can increase longevity would take decades, a group of scientists in Baton Rouge, LA, looked for more fast-responding changes in the cells of people put on calorie-restricted, yet nutritionally complete diets. Thirty six overweight people were assigned to one of three groups. The first group ate a diet with 25% fewer calories than their initial energy expenditure. The second group ate 12.5% fewer calories, then exercise to burn another 12.5%. The third group ate a weight-maintenance diet. During the 6-month study, both calorie-restricted groups showed an increase in mitochondria in their muscle cells and a 60% decrease in DNA damage. The mitochondria appeared to be more youthful and efficient. Both of these findings indicate a shift toward longer living. The group now plans to test people of normal body weight for 2 years.
Barry P. Living Long on Less? Science News, March 10, 2007, pg. 147.
Foods rich in folic acid may boost brain power and protect against Alzheimer’s disease, according to studies from the Netherlands and Columbia University Medical Center. The Netherlands study tested 800 microgram supplements of the vitamin in volunteers ages 50 to 70. In three years’ time, those taking the supplement had improved memory and information processing speed. The New York study showed people with the highest intake of folic acid over a 6-year period had the lowest risk for Alzheimer’s. Folic acid is found in green leafy vegetables, citrus fruit, beans, and fortified breads and cereals.
AARP Bulletin, March 2007, pg. 9.
Adults age 50 and older are at increased risk for vitamin B12 deficiency because their ability to absorb B12 from food declines. When B12 levels are low, and folic acid levels are high, older adults run a higher risk of anemia and cognitive impairment. For adults with normal B12 levels, however, folic acid seemed to be beneficial for cognitive function. The authors, from Tufts University, suggest improved efforts to detect and treat low vitamin B12 in seniors, especially in this age in which many foods are fortified with folic acid.
Folic-Acid Effects Depend on B12 Levels, Tufts University Health & Nutrition Letter, 25(2), April 2007, pg. 1-2.
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AMG 531 (Amgen) binds to and activates the receptor for thrombopoietin, a growth factor that induces bone marrow to make more platelets. The drug is being tested for its ability to increase platelet production. A phase 3b, open-label trial in which patients are randomized to either AMG 531 or standard of care for ITP is enrolling patients who are 18 or older with ITP who have not had their spleen removed and have received at least 1 prior therapy for ITP. Treatment period is 52 weeks. The study began enrolling in November 2006, in 21 states, Canada, and Europe. www.clinicaltrials.gov
AKR-501 - This Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study will assess the efficacy, safety and tolerability, of AKR-501 tablets, as compared to placebo, in the treatment of patients with ITP. Approximately 65 eligible patients will be randomized for 28 days. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose. You can find out more information about the study at www.PlateletStudies.com/pdsa.
A recombinant, antibody product that is comprised of 25 different anti-Rhesus D antibodies is moving into a phase 1 trial in healthy volunteers. It is being developed for treatment of ITP and for prevention of hemolytic disease of the newborn. Up to 39 RhD positive and 19 RhD negative healthy volunteers will be enrolled in the double-blind, randomized, placebo-controlled trial to assess safety and tolerability following a single intravenous infusion. The trial is being conducted at a clinic in the U.S.
According to the company news release, “Sym001 is the first ever recombinant polyclonal antibody to enter human clinical trials.” The drug is being developed by Symphogen, a pharmaceutical company in Denmark, and Biovitrum, a biopharma company in Sweden and the U.K.
TPO-mimetics are drugs that bind to the thrombopoietin (TPO) receptor, but bear no structural resemblance to TPO. The hypothesis is that these TPO-mimetics might treat ITP without causing production of anti-TPO antibodies. Examples of TPO-mimetics are AMG 531, Eltrombopag, and AKR-501. Researchers from New York Presbyterian Hospital reported on a phase 1/2 trial of AMG 531 in ITP. After testing various doses in phase 1, phase 2 included 16 patients with long-term ITP in a double-blind, placebo controlled trial. The compound produced a dose-dependent increase in platelet counts in ITP patients. A reviewer writes, “Although the data on TPO-mimetics are currently tantalizing, the long-term effects of these compounds remain to be established.”
Abrams C. Are TPO-Mimetics Better Than the Real Thing? The Hematologist, March/April 2007, Vol 4(2), pg. 7.
Rituximab, a monoclonal antibody against CD20-positive B cells, is increasingly used to treat ITP, but data to support its use are limited. A review of the literature between 1997 and 2004 found just 19 reports that described five or more patients; nine of those were abstracts only. None of the studies were randomized trials. The drug can induce remissions in ITP, but it is difficult to estimate its true efficacy since the literature is biased by small case reports touting high response rates. The reviewer concludes that it would be “worthwhile and beneficial for both patients and physicians to study rituximab in a larger cohort.”
Abrams, C. Rituximab in ITP – When and Why Does it Work? The Hematologist. May/June 2007, Vol 4(3), pg. 8
Researchers at the Blood Center of Wisconsin reported that a 4-year-old girl experienced several episodes of acute thrombocytopenia (low platelet count) after taking acetaminophen (Tylenol). Years earlier they had found a similar reaction to acetaminophen and naproxen (Aleve), and determined that the triggers for platelet destruction were acetaminophen sulfate and naproxen glucuronide. For the more recent patient, the metabolite trigger was different: acetaminophen glucuronide.
Bougie DW, Benito AI, Sanchez-Abarca LI, Torres R, Birenbaum J, Aster RH. Acute thrombocytopenia caused by sensitivity to the glucuronide conjugate of acetaminophen. Blood, 15 April 2007, pg. 3608-9.
The Centers for Medicare and Medicaid has established new, brand-specific codes for 4 intravenous immune globulin (IVIG) products and one Rho(D) immune globulin product. This enables brand-specific reimbursement for Medicare beneficiaries. The IVIG products with their own codes are Octagam, Gammagard, Flebogamma, and Gamunex. The Rho(D) receiving its own code is Rhophylac.
Immunoglobulin is included in the 15th edition of the World Health Organization (WHO) list of Essential Medicines. From the WHO website: “The WHO List of Essential Medicines provides a model for countries to select medicines addressing public health priorities according to quality, safety and efficacy standards.”
The Food and Drug Administration (FDA) warned U.S. consumers that Web sites may be distributing counterfeit prescription drugs, after reports of 24 Web sites distributing fake Xenical, a drug prescribed for weight loss. FDA advice: Be wary if 1) there is no way to contact the Web site pharmacy by phone, 2) if prices are dramatically lower than the competition, or 3) if no prescription from your doctor is required. FDA’s Web site contains tips for consumers as well as the list of 24 questionable Web sites.
The Centers for Disease Control and Prevention’s (CDC) Division of Hereditary Blood Disorders has been officially renamed the Division of Blood Disorders. The Division works with multiple partners to implement specialized prevention programs for persons with blood disorders and their families.
A study in The New England Journal of Medicine tested whether aggressive treatment of gum disease can decrease chronic inflammation and thereby reduce risk for atherosclerosis. The authors demonstrated that a single intensive treatment of severe periodontal disease was associated with a sustained improvement in dental health, endothelial function, and markers of chronic inflammation. Endpoints, however, were surrogate markers for inflammation and blood vessel health. Larger studies are needed.
Silverstein R. Flossing May Prevent Plaque (of a Different Sort)! The Hematologist. May/June 2007, Vol 4(3), pg. 6.
The New York Times and other media outlets reported that arsenic, a recognized cancer-causing agents that may also contribute to heart disease and diabetes, is deliberately given to chicken in the U.S. Arsenic is a government-approved additive in poultry feed because it kills parasites and promotes growth in chickens.
Organic chicken and those labeled “antibiotic-free” do not contain arsenic. Tyson Foods, the nation’s largest chicken producer, has stopped using arsenic in chicken feed; but “there are many more arsenic-fed than arsenic-free chickens for sale in the U.S.”
Burros M. Chicken with Arsenic? Is that O.K.? The New York Times, April 5, 2006.
(Note: Arsenic can reduce platelet counts)
The federal government is warning consumers to stop flushing old drugs down the toilet. Pharmacy groups used to recommend flushing unused drugs to prevent pets and curious children from retrieving them from wastebaskets. But now prescription drugs are found flowing down the nation’s rivers and have been linked with reproductive problems in fish and drug-resistant germs spread by waterfowl. The new campaign, called SMARxT, recommends unused drugs be disposed through municipal hazardous-waste-collection programs. The next best choice is putting them in the trash. But first, individuals are asked to crush pills or dissolve them in water; add them to sawdust, kitty little or some other inedible material; and seal them in a plastic bag.
Science News, April 7, 2007, vol 171, pg. 222.
In our April e-news we reported that the United Kingdom’s adult ITP registry has been sitting dormant since 2004 for lack of funding. This was incorrect. The ITP registry was put on hold because of a change in staffing. Dr. Provan has returned to the project which is now very active and accumulating data. The aim of the registry is to learn more about ITP, its prevalence, clinical behavior, and responses to treatment. Progress reports for the study will be published in a bi-monthly newsletter, at www.ukitpregistry.com. The study coordinator is Ameet Sarpatwari (avs31@medschl.cam.ac.uk)
Contents:
Rigel Pharmaceutical’s experimental drug, R788, is showing some activity in a phase 2 study in ITP patients, so the company has submitted a proposal to the FDA to expand the study to broaden the dosages tested. The oral drug is a syk kinase inhibitor that blocks the activation of immune cells called mast cells, macrophages, and B-cells that promote swelling, inflammatory responses, and tissue damage. It is being tested in patients with ITP, rheumatoid arthritis, and lymphoma. Rigel is based in San Francisco.
AKR-501 - This Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study will assess the efficacy, safety and tolerability, of AKR-501 tablets, as compared to placebo, in the treatment of patients with ITP. Approximately 65 eligible patients will be randomized for 28 days. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose. You can find out more information about the study at www.PlateletStudies.com/pdsa.
Development of new genetic tests for rare diseases has received a boost from a program of the National Institutes of Health (NIH). Called The Collaboration Education and Test Translation Program (CETT), and located in the Office of Rare Diseases at NIH, the program encourages formation of collaborative teams including clinicians, laboratories, researchers, and disease-specific advocacy groups. Collaborative groups can apply to the CETT Program for funds to help develop a new genetic test for a rare disease.
TPO-mimetics are drugs that bind to the thrombopoietin (TPO) receptor, but bear no structural resemblance to TPO. The hypothesis is that these TPO-mimetics might treat ITP without causing production of anti-TPO antibodies. Examples of TPO-mimetics are AMG 531, Eltrombopag, and AKR-501. Researchers from New York Presbyterian Hospital reported on a phase 1/2 trial of AMG 531 in ITP. After testing various doses in phase 1, phase 2 included 16 patients with long-term ITP in a double-blind, placebo controlled trial. The compound produced a dose-dependent increase in platelet counts in ITP patients. A reviewer writes, “Although the data on TPO-mimetics are currently tantalizing, the long-term effects of these compounds remain to be established.”
Abrams C. Are TPO-Mimetics Better Than the Real Thing? The Hematologist, March/April 2007, Vol 4(2), pg. 7.
Mold needs to be taken seriously, especially in people with weakened immune systems, according to a review of several government reports and recent research. The review quotes the Centers for Disease Control and Prevention: "excessive exposure to mold-contaminated materials can cause adverse health effects in susceptible persons regardless of the type of mold or the extent of contamination." Asthma and other respiratory problems appear to be the biggest risks from mold exposure. Modern building practices—for example, tighter building envelopes, more insulation, paper-coated wallboard replacing plaster—have increased risk for mold growth. The report has links to a video on mold clean up, produced for New Orleans residents affected by Hurricane Katrina.
Environmental Health Perspectives Volume 115, Number 6, June 2007
http://www.ehponline.org/members/2007/115-6/focus.html
In laboratory tests, Spanish researchers found olive oil could kill eight strains of the bacterium H. pylori, which causes most stomach ulcers. The results need to be confirmed in humans.
J Agriculture and Food Chemistry, February 21, 2007.
(Note: The eradication of H.pylori is sometimes associated with an increase in platelets for patients with ITP)
Results from the Greek cohort of the long-running EPIC (European Prospective Investigation Into Cancer and Nutrition) study indicate that diets that focus more on protein than carbohydrates may be harmful. From 1993 to 2003, 22,944 healthy adults described their dietary intake through questionnaires. Prolonged consumption of diets low in carbohydrates and high in protein was linked with higher mortality.
Trichopoulou A., et al. Low-carbohydrate—high-protein diet and long-term survival in a general population cohort. European Journal of Clinical Nutrition, 2007; 61:575-581.
(Note: In our 2001 survey responders reported that low-carbohydrate---high-protein diet was not as effective as other diets in helping platelet counts. Visit http://www.itppeople.com/surveyres/ )
Summer brings reminders to keep fruits and vegetables that will be eaten raw separate from raw meat, poultry or seafood—as well as the utensils used for those products. Sliced fruits and vegetables should be refrigerated. Washing fruits and vegetables before preparation is important. This includes scrubbing firm produce, such as melons and cucumbers, with a clean produce brush. Wash cutting boards, dishes, utensils and counter tops with hot soapy water between preparation of different foods.
At the 2007 American Pharmacists Association Annual Meeting participants heard about common medication errors and how to avoid them. The 10 drugs most commonly implicated in adverse events that require treatment in a hospital emergency department are: Insulin, anticoagulants, amoxicillin, aspirin, trimethoprim-sulfamethoxazole, hydrocodone/acetaminophen, ibuprofen, acetaminophen, cephalexin, and penicillin. Unintentional overdoses are the most prevalent cause of problems. Other common misuses are taking incorrect doses, taking doses at the wrong time, forgetting to take doses, or stopping medication too soon. For example, in people with arthritis, misuse of nonsteroidal anti-inflammatory drugs--either prescription or over the counter--leads to 103,000 hospitalizations and 16,000 deaths per year.
www.medscape.com/viewprogram/7099_pnt
Several new groups, some formed by families who lost a loved one due to medical error, are creating online communities to share strategies for preventing medical errors and offering advice to consumers who have experienced harm. One such group, Consumers Advancing Patient Safety, is building a global network for the World Health Organization, and claims that an average of 1 in 10 hospital patients world-wide suffers some form of preventable harm. The Wall Street Journal published this list of organizations:
Landro L. Patients, Families Take Up the Cause of Hospital Safety. Wall Street Journal, May 30, 2007, pg. D1-2.
The authors of “Bottom Line/Health” suggest treating a bruise by crushing a handful of chilled parsley sprigs and applying them straight to the bruise.
(Note: If you try this and it seems to help, please send a message to PDSA)
Contents:
A research report, a commentary and a review paper discussed thrombopoietin (TPO) receptor agonists in the June 1 issue of Blood. Scientists from GlaxoSmithKline reported on a phase 1 clinical trial in healthy volunteers of eltrombopag, an oral TPO receptor agonist. 73 healthy male volunteers were randomized into 6 groups to receive eltrombopag or placebo at various doses for 10 days. The drug increased platelet counts in a dose-dependent manner, and no differences in adverse events occurred between placebo and treatment groups. In a related Commentary, Douglas B. Cines, University of Pennsylvania, expressed excitement about this class of drugs, noting that other studies of eltrombopag and another TPO receptor agonist, AMG531, have yielded good responses with acceptable tolerability in patients with severe ITP.
Developers of thrombopoietic growth factors have learned well from the problems of the first generation of these drugs, and the newer generation is showing promise in clinical trials, according to the review article by David J. Kuter, Massachusetts General Hospital. The first generation of these drugs was pulled from testing when patients began developing autoantibodies. Second-generation drugs, however, are proving to be potent stimulators of platelet production, without urging the immune system to react negatively. He points to AMG 531 and eltrombopag as examples that markedly increase platelet counts in patients with ITP, without significant adverse effects.
Kuter DJ. New thrombopoietic growth factors. Blood, 1 June 2007. Vol 109(11):4607-16.
Jenkins JM, Williams D, Deng J, Uhl J, Kitchen V, Collins D, Erickson-Miller CL. Phase 1 clinical study of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist. Blood, 1 June 2007. Vol 109(11):4739-41. Cines DB. Pumping out Platelets, Blood, 1 June 2007. Vol 109(11):4591-2.
Note: Patients can receive complementary copies of all articles in Blood.
See: http://bloodjournal.hematologylibrary.org/misc/public.dtl#patient
Six sites in Australia will begin clinical testing of a new drug, called PRTX-100, in ITP patients, according to the drug’s maker, Protalex. Chronic ITP patients will be enrolled to evaluate safety and pharmacokinetic data. According to company information, “PRTX-100 is a highly purified form of the Staphylococcal bacterial protein known as Protein A.” The drug binds to and down regulates activation of human B lymphocytes and macrophages to block inflammation in autoimmune diseases.
After FDA staff raised questions about the risks of intravascular hemolysis (IVH—abnormal breakdown of red blood cells in the blood vessels) in patients with ITP taking intravenous anti-D therapy, clinicians at University of Illinois College of Medicine made four recommendations to enable the continued use of “an important and useful option in the treatment of ITP in adults and children”: 1) encourage clinicians to monitor patients closely for systemic complaints and macroscopic hematuria/hemoglobinuria in the 48 hours after infusion; 2) consider alternative therapies in patients with evidence of underlying hemolysis; 3) consider alternatives for patients with comorbid conditions, such as compromised renal function; and 4) obtain a complete blood count, reticulocyte count, DAT and dipstick urinalysis prior to treatment with anti-D and monitor for IVH/renal failure after treatment in patients experiencing untoward side effects.
Blood. June 15, 2007;109(12):5527;5528.
Standard treatment for H. Pylori infection fails for 1 in 4 patients. Italian researchers have found that adding two products to standard therapy can boost eradication and reduce side effects. Standard treatment is a triple therapy consisting of the antibiotics amoxicillin and clarithromycin, plus a proton pump inhibitor. To this regimen, the researchers added lactoferrin and a probiotic supplement. Lactoferrin is a glycoprotein found in the body involved in immune defense. Probiotics contain multiple lactic-acid producing bacteria, and have been shown effective against gastroenteric illnesses, such as inflammatory bowel disease and viral infections. Eight weeks after treatment, patients taking standard therapy plus the two other products had better eradication of H. Pylori infection and fewer episodes of nausea, diarrhea, or other side effects.
Am J Gastroenterol. 2007;102:951-956.
The top two reasons that people say they don’t talk to their doctors about complementary and alternative medicines: the doctors don’t ask, and the patients don’t know they should tell. The NIH National Center for Complementary and Alternative Medicine suggests patients get proactive: 1) When completing patient history forms, include all therapies and treatments you use. Make a list in advance. 2) Tell your health care providers about all therapies or treatments—over-the-counter and prescription medicines, as well as herbal and dietary supplements. 3) Don’t wait for your providers to ask about your CAM use. Be proactive. 4) If you are considering a new CAM therapy, ask your health care providers about its safety, effectiveness, and possible interactions with medications.
InFocus newsletter, Autoimmune Disease Association, June 2007, pg. 6.
People who participate in clinical studies help doctors learn how to better treat, prevent, and diagnose human diseases. There are plenty of good reasons to get involved in clinical research—and plenty of important questions to ask before you do. NIH News in Health covers the subject in its June 2007 issue, including questions to ask.
Newsinhealth.nih.gov/2007/June/docs/01features_01.htm
Concerned about a shortage in young researchers in non-malignant hematology, the NIH’s National Heart, Lung, and Blood Institute has launched a new initiative to train young investigators in this field. Six centers were awarded grants to support early career development in non-malignant hematology, which includes ITP and thrombocytopenia. The centers are Washington University, Harvard University, Duke University/UNC Chapel Hill, Johns Hopkins University, University of Washington, and University of Pennsylvania.
Sadler, JE NHLBI Funds Clinical Research Training in Non-Malignant Hematology. The Hematologist, July/August 2007, pg. 2.
NHLBI’s Diseases and Conditions Index contains updates, animations, and illustrations for consumers. It includes a page on ITP and a new animation on How the Heart Works.
http://www.nhlbi.nih.gov/health/dci/index.html
Lower-heat cooking, such as boiling, steaming or stewing, may be safer than high-temperature grilling, broiling and frying, for preventing inflammation and related conditions such as diabetes and heart disease. According to researchers at Mount Sinai School of Medicine, rapid, high-heat cooking generates toxins known as advanced glycogen endproducts (AGEs), which accumulate in the body over time. In animal studies, the researchers cut AGE intake of mice in half, which increased their lifespan and reduced oxidative stress.
Turn Down Heat to Reduce Aging Toxins. Tufts University Health & Nutrition Letter. July 2007, pg. 8.
A second risk for grilled meats, specifically, is heterocyclic amines (HCAs), cancer-causing substances produced by grilling. To reduce HCAs in food, the Washington Post recommends: 1) microwave meats to partially cook them before grilling; 2) flip meat every minute, to keep internal temperature lower; 3) marinate the meat with fruits such as cherries, which are loaded with antioxidants that seem to suppress HCA formation. Garlic does the same; 4) don’t cook meat to well done; 5) eat cruciferous veggies (broccoli, cabbage, cauliflower, the day before barbecuing to detoxify HCAs.
Squires, S. Lean Plate Club, Washington Post, July 3, 2007, Pg. F1, F6.
The slow movement exercise called Tai Chi may boost immune responses that prevent the painful nerve condition known as shingles, according to researchers at UCLA. The scientists compared two groups of healthy, older adults, ages 59 to 86. Half took Tai Chi classes three times a week, the other half attended classes about healthy diet and stress management. The Tai Chi group had a stronger immune response to the varicella virus, which causes chicken pox and shingles.
Tai Chi Boosts Defenses Against Shingles. Tufts University Health & Nutrition Letter. July 2007, pg. 6.
Current warming conditions are producing faster growing, hardier poison ivy plants. Rising carbon dioxide levels are creating ideal conditions for poison ivy growth, and the oil it produces is especially potent. The oil in the plant that triggers the itchy rash can hang on to clothing and penetrate rubber gloves and boots. Clothing should be removed and washed, and vinyl gloves are recommended for plant removal. If exposure occurs, wash immediately with soap and water. Other options are a wash called Tecnu, Goop, and Dial Ultra dishwashing soap. The Website www.poison-ivy.com, offers cards with life-size images to identify the plant, which comes in a wider variety of shapes than expected.
Parker-Pope, T. Climate Changes are Making Poison Ivy more Potent. The Wall Street Journal, June 26, 2007, pg. D1.
Note: We heard about several patients whose platelets dipped after exposure to poison ivy.
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The Food and Drug Administration has granted marketing approval to CSL Behring for its drug Privigen, an intravenous immunoglobulin for patients with ITP and primary immunodeficiency. The drug does not require refrigeration or reconstitution. In a study of 57 ITP patients, 81% of patients responded with an increased platelet count.
Products used to stop bleeding in emergency rooms and on the battlefield have moved into the consumer market, in the form of powders, bandages, and nose plugs. For example, Z-Medica, Inc. is now selling QuikClot Sport, a porous sack filled with highly absorbent mineral from lava rocks. Place it on the wound and it pulls the water from the blood, leaving behind clot-forming platelets. Other products to help stop bleeding include QR, a powder to sprinkle on wounds by Biolife; BloodStop, a bandage under the CVS private label; a gause product also named BloodStop by LifeSciencePlus; NasalCease, a seaweed extract to help stop nosebleeds by Catalina Healthcare.
New Products to Help Stop Bleeding Quickly. The Wall Street Journal, July 3, 2007, pg. D6.
The Centers for Disease Control and Prevention (CDC) updated its “Yellow book,” which describes travel-related infections and diseases that are common in regions around the world. The latest edition includes recommendations on immunizations, developments in malaria treatment and prevention, advice for avoiding deep vein thrombosis while flying, and a section on avian influenza (bird flu). The book, officially called “CDC Health Information for international Travel 2008,” is available free online.
wwwn.cdc.gov/travel/ybToc.aspx
Standard treatment for H. Pylori infection fails for 1 in 4 patients. Italian researchers have found that adding two products to standard therapy can boost eradication and reduce side effects. Standard treatment is a triple therapy consisting of the antibiotics amoxicillin and clarithromycin, plus a proton pump inhibitor. To this regimen, the researchers added lactoferrin and a probiotic supplement. Lactoferrin is a glycoprotein found in the body involved in immune defense. Probiotics contain multiple lactic-acid producing bacteria, and have been shown effective against gastroenteric illnesses, such as inflammatory bowel disease and viral infections. Eight weeks after treatment, patients taking standard therapy plus the two other products had better eradication of H. Pylori infection and fewer episodes of nausea, diarrhea, or other side effects.
Am J Gastroenterol. 2007;102:951-956.
CDC has updated its guidelines for preventing transmission of infectious agents in hospitals and healthcare settings. The guidelines address a broader range of settings, including home care, long-term care, and free-standing specialty care sites, and addresses a broader scope of issues, including the emergence of new pathogens, such as SARS, and concerns about bioweapons attacks. The full report is available at www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf
Medscape, July 3, 2007; ww.medscape.com/viewarticle/559217
The Environmental Protection Agency has a free database called Envirofacts (www.epa.gov/enviro/) for searching, by ZIP code, information about chemicals, radiation, and hazardous waste that could affect a community. Scorecard (www.scorecard.org), is another free service that compares safety of communities with others in the U.S. The Wall Street Journal warns that many environmental databases are at least one year behind.
Quick Fix, The Wall Street Journal, July 26, 2007, Pg. D1.
Several sources are mining Medicare data and state records and surveying hospitals to devise user-friendly databases to help consumers comparison-shop for health care. Find out whether a hospital follows best practices, which means they adhere to recommended guidelines for certain procedures. Hospital Compare (www.hospitalcompare.hhs.gov) is run by the federal Centers for Medicare and Medicaid Services and other groups. It compares 5,000 hospitals, but the focus is on best practices, rather than how patients fare. The Leapfrog Group, a consortium of big health-care buyers, publishes a free database (www.leapfroggroup.org) that also focuses on best practices. Some are beginning to publish data on how patients do. For example, New York State’s health department compares death rates for heart surgery at all hospitals in the state.
How to Size Up Your Hospital, The Wall Street Journal, July 10, 2007, Pg. D1-2.
NHLBI’s Diseases and Conditions Index contains updates, animations, and illustrations for consumers. It includes a page on ITP and a new animation on How the Heart Works.
http://www.nhlbi.nih.gov/health/dci/index.html
With release of Michael Moore’s latest movie, “SICKO”, Families USA (a national nonprofit organization dedicated to the achievement of high-quality, affordable health care for all Americans) is organizing discussion groups so that people can share personal stories about America’s costly and convoluted health care system and “discuss ways to become part of the solution.” Go to familiesusa.org/resources/action-center/sicko.html. Oprah Winfrey is also collecting personal stories about how people have been affected by the health care system.
Familiesusa.org/resources/action-center/oprah.html
A consortium of 38 medical schools is working to integrate complementary and alternative medicine (CAM) into mainstream medicine while maintaining Western standards of care. Researchers at these centers are trying to determine which CAM practices are safe and effective. The Washington Post asked four specialists at University of Maryland, Johns Hopkins, UCLA, and University of Pennsylvania, who noted that guided imagery, meditation, and other practices to harness the mind to promote health and healing are becoming a popular means of managing stress and pain. Some studies suggest that mind/body exercises with conventional methods can treat cardiovascular disease and bolster the immune system. They are now studying whether a patient’s expectation that a treatment will work affects the outcome—the so-called placebo effect.
Earning a Spot in the Curriculum. Washington Post, July 17, 2007, Health Section F1.6.
Patients with diabetes have a 3 to 4-fold increased risk of brain hemorrhage compared to people without diabetes, according to a study at University of Cincinnati. The effect is strongest among black patients younger than 55 years. Diabetes also increases risk for ischemic stroke, caused by bleeding in the brain. Most patients have little knowledge of the symptoms of stroke or the need to get immediate attention by calling 911. To be effective, some stroke treatments must be given within 3 to 4 hours of the stroke.
Medscape, July 6, 2007
Celiac disease, a problem with absorption of vitamins and minerals from the gut, has many hematologic connections, which may lead the patient to the doctor for evaluation of blood-related problems even before a diagnosis of celiac disease, according to researchers at the Mayo Clinic.
Halfdanarson TR, Litzow MR, Murray JA. Hematologic manifestations of celiac disease. Blood, January 15, 2007, 109(2);412-421.
Researchers at Wayne State University have shown that red blood cells, as they move through the circulatory system, release a chemical that signals blood-clotting platelets to become less sticky, therefore less likely to clog narrow blood vessels. This finding may explain why people with diabetes have circulatory problems. Red blood cells in people with diabetes have a reduced capacity to release the chemical, called ATP. This offers a new target for fighting diabetes symptoms.
Chemical Conversation, Science News, July 21, 2007, pg. 38.
A review of 444 surgical malpractice claims revealed that communication breakdowns, when important information is not transmitted, or transmitted inaccurately, or responsibilities are unclear, play a role. Communication breakdown was most likely to occur during emergency procedures, during a change or staff, or during patient transfer.
Greenberg CC, Regenbogen SE, Studdert DM, et al. Journal of American College of Surgery. 2007;204:533-540.
A randomized trial showed that warming a patient before and after surgery, in addition to warming during surgery, reduces blood loss during surgery and lowers the risk for postoperative complications.
Wong PF, Kumar S, Bohra A, Whetter D, Leaper DJ. British Journal of Surgery, 2007;94:421-426.
Some self-help books can measurably improve mental health. Studies have been conducted to find the books that can have the greatest impact. Research suggests that ‘bibliotherapy” is most successful when combined with conventional therapy. The authors recommend: “Feeling Good,” by David D. Burns; “Mind Over Mood,” by Dennis Greenberger and Christine A. Padesky, and “Control Your Depression,” by Peter Lewinsohn. They do not recommend “Prozac Nation or “You Mean I Don’t Have To Feel This Way?”
Bibliotherapy: Reading Your Way to Mental Health. The Wall Street Journal, July 31, 2007, Pg. D1.
Women who eat at least four servings a week of whole grains were 31% less likely than women who never ate whole-grain foods to die from inflammation-related diseases, such as Crohn’s disease, emphysema, and chronic obstructive pulmonary disease, according to the large Iowa Women’s Health Study, which followed women for 17 years. Previous studies found that whole grains protect against cardiovascular diseases.
Whole Grains Protect More than Heart. Environmental Nutrition Newsletter, August 2007, Pg. 1.
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