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Infection with H. pylori, a bacteria linked with stomach ulcers, appears to be a risk factor for ITP in susceptible individuals. A recent, 5-year study from Italy found that two-thirds of patients with ITP whose only treatment was H. pylori eradication (with antibiotics plus proton-pump inhibitors) experienced a long-term improvement in platelet counts. They further explored the impact of specific genes in the bacteria that make it more or less virulent and found higher levels of a few H. pylori genes in patients with ITP. The authors recommend screening all ITP patients for H. pylori so that treatment of the bacterial infection could precede—and perhaps avoid the need for—more aggressive treatments for ITP.
Emilia G, Luppi M, Zucchini P, Morselli M, Potenza L, Forghieri F, Volzone F, Jovic G, Leonardi G, Donelli A, Torelli G. Helicobacter pylori infection and chronic immune thrombocytopenic purpura: long-term results of bacterium eradication and association with bacterium virulence profiles. Blood, December 1, 2007; 110(12):3833-41.
Cines DB. ITP: Time to “bug off”? Blood, December 1, 2007; 110(12):3818.
Amgen presented results of two randomized, double-blind, placebo-controlled phase 3 studies of AMG531, which the company is now calling romiplostim (tradename Nplate). One study was in adults with chronic ITP who had not undergone spleen removal, the other was in patients whose spleen had been removed. In both studies, significantly more patients on romiplostim experienced a durable platelet response (lasting more than six of the final eight study weeks), although the difference was greater in the patients who had not undergone spleen removal. In both studies, a majority of patients who were taking corticosteroids were able to reduce or discontinue this treatment. Romiplostim works by stimulating the thrombopoietin receptors to stimulate bone marrow cells to increase platelet counts. The researchers presented their results at the American Society of Hematology’s annual meeting in December. The company has filed for marketing approval of Nplate in the U.S, European Union, Australia, and Canada.
http://www.medicalnewstoday.com/articles/91217.php
GlaxoSmithKline submitted a new drug application to the FDA for marketing eltrombopag, its oral platelet growth factor, under the tradename Promacta as a treatment for ITP.
The new director of the FDA’s Office of Orphan Products Development is Timothy Coté, MD, MPH. Coté will be responsible for promoting development of products that demonstrate promise for the diagnosis and treatment of rare diseases and conditions. The Office also provides grant funding for clinical research on rare diseases. Coté was previously at the Centers for Disease Control and Prevention as country director for Rwanda.
A new website, “HematologyTimes.com”, covers clinical practice in hematology. It provides late-breaking news, upcoming events, continuing medical education, discussion forums, and a resources page. A search of “ITP” yielded several reports of presentations from an October conference in San Diego, Cytopenias in 2007: Emphasis ITP.
http://www.hematologytimes.com
FOR CAREGIVERS
The November/December 2007 issue of AARP magazine listed organizations that offer classes, online chats, and other services for caregivers.For example:
Family Caregiver Alliance, National Center on Caregiving: 800-445-8106; http://www.caregiver.orgThe National Alliance for Caregiving: 301-718-8444;
The Relaxation Response:
To learn the nine steps, go to:
http://www.mbmi.org/basics/whatis_rresponse_elicitation.asp
http://www.aarpmagazine.org/caregivingON HEALTH INSURANCE
Families USA provides details on health insurance, including Medicare and Medicaid, for consumers on its website. Most recently, it’s December 2007 report, “Too Great A Burden: America’s Families at Risk,” states that America’s families are shouldering a greater portion of health care costs. The problem is not just for the uninsured, but also those with health insurance.http://www.familiesusa.org/resources/publications/reports/too-great-a-burden.html
Two organizations will merge to form the Alliance for a Stronger FDA. Merging of the Coalition for a Stronger FDA and the FDA Alliance will “create a stronger, more multi-faceted organization dedicated to securing more Congressional funding for the FDA.” The group believes that the FDA needs better funding to fulfill its mission of protecting the public health. Seven former FDA commissioners and three former HHS secretaries are honorary co-chairs.
After extensive input from researchers, patient advocates, and professional societies, the National Heart, Lung, and Blood Institute (NHLBI) has published its strategic plan. It includes basic research to identify biomarkers of disease and new molecular targets for prevention, diagnosis, and treatment. Its clinical and translational research goal aims for personalized preventive and therapeutic regimens based on genetics combined with environmental factors.
http://www.nhlbi.nih.gov/strategicplan/
(Note: Steroids hamper bone-building cells, putting people who take steroids at relatively quick risk of osteoporosis, or bone thinning. Steroids can also raise blood sugar levels and potentially cause diabetes in susceptible individuals.)
BONE HEALTH FOR STEROID USERS
A new study of a drug called teraparatide (Forteo), suggests that it might activate bone-building cells in patients taking steroids. After 18 months, people on teraparatide had stronger gains in hip and vertebral bone density than people taking alendronate (Fosamax), a drug used to preserve bone mass. The study authors conclude that teraparatide appears to be a better option for steroid-induced osteoporosis because it appears to block the ability of steroids to thwart bone formation.Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP. Marcus R. Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis. New England Journal of Medicine. November 15, 2007, 357(20):2028-39.
POOR SLEEP INCREASES DIABETES RISK
A small experiment suggests that disruptions in deep sleep reduces the body’s ability to regulate blood-sugar levels. Previous studies have indicated lack of sleep does the same thing. The University of Chicago authors conclude that this finding adds evidence that poor sleep increases risk for type 2 diabetes.Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proceedings of the National Academy of Sciences. published online January 2, 2008.
BLACK TEA MAY HELP
Meanwhile, black tea may stimulate the body’s insulin response, reducing blood sugar levels, and reducing type 2 diabetes risk. The researchers attribute the response to the phenol compounds found in tea.
Bryans JA, Judd PA, Ellis PR. The Effect of Consuming Instant Black Tea on Postprandial Plasma Glucose and Insulin Concentrations in Healthy Humans. Journal of American College of Nutrition. October 2007. 26(5):471-77[In his comments on the study, at mercola.com, Dr. Mercola notes that some conventional teas carry unsafe amounts of fluoride. Look for brands that tout low fluoride content. He also suggests avoiding added sugar and milk.]
ASPARTAME MAY STIMULATE APPETITE
While many people drink diet beverages to reduce calorie intake, aspartame, a sweetener found in many diet drinks, may stimulate appetite and bring on cravings for carbohydrates, according to several reports over the past 10 years. This is relevant for people who take steroids and are trying to reduce the chance of the weight gain that can occur during steroid therapy.
Exercise and a diet high in fruit, vegetables, nuts, whole grains, fish, and little meat and dairy, may help people live longer, according to two large studies that followed people of average age 62 over a 5-year period. The studies relied on data from the National Institutes of Health-AARP Diet and Health Study, For the diet study, more than 380,000 people average age 62 and free of chronic illness were followed. The closer people conformed to a Mediterranean diet, the less likely they were to have died during that period—about 20% less likely. For exercise, researchers followed more than 250,000 people with no chronic diseases. Those who exercised vigorously for 20 minutes, 3 times a week were 32% less likely to die than sedentary people. Vigorous exercise was defined as any exercise that increased breathing or heart rate or caused a sweat. Even people who exercised only a little showed modest reductions in risk of death.
Archives of Internal Medicine, December 10/24, 2007;167(22):2461-2468 and 2453-2460.
Humans were not designed for a sedentary, socially isolated, indoor, sleep-deprived, poorly nourished life, according to University of Kansas psychologist Stephen Ilardi. He recommends a highly social, active, outdoorsy life. He calls his regimen Therapeutic Lifestyle Change for Depression. His 14-week therapy pairs group therapy with a battery of depression-fighting remedies such as increased sleep, aerobic exercise, omega-3 fatty acids, bright-light exposure, social interaction, and replacing ruminating over negative thoughts with activity. It’s all about moving, interacting, doing. Seventy-seven percent of those on his regiment experienced reduced depression versus 27 percent in the control group that received medication and traditional psychotherapy.
Klein JM. Simply Happy. AARP magazine, November/December 2007, pg. 52-54.
A randomized trial compared a spoonful of buckwheat honey versus the over-the-counter cough medicine dextromethorphan, or no treatment in 130 children with cough. Honey, but not dextromethorphan, was better than no treatment in relieving nighttime coughing, and both children and their parents in the honey group slept better compared with the other groups. The study was funded by the National Honey Board.
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin Jr. CM. Effect of Honey, Dextromethorphan, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents. Archives of Pediatrics and Adolescent Medicine, December 2007.161(12):1121.
Contents:
In the U.S., about 1.5 million platelet transfusions are administered yearly to patients to reduce their risk of severe bleeding. Yet platelet transfusions are expensive and not an ideal solution. About one third are associated with complications. Therapeutic stimulation of marrow platelet production would be a better solution than transfusion of platelets, according to UCSD’S Kenneth Kaushansky, who provides a detailed tour through research on the origin and role of megakaryocytes and platelet development. New understanding of the origins of platelet development continues to offer advances in the ability to manipulate thrombopoiesis for therapeutic benefit.
Kaushansky K. Historical review: megakaryopoiesis and thrombopoiesis. Blood, February 1, 2008, 111(3):981-985.
The current paradigm among researchers is that the balance of activating versus inhibitory Fcγ receptors for IgG contributes to susceptibility to autoimmune disease such as ITP. Researchers in The Netherlands opened a new window into ‘yin and yang’ of Fcγ receptors in ITP. They found that a version of the FCGR2C gene predisposes to ITP. And for the first time, demonstrated a variation in the copy number for the FCGR3A gene. In an accompanying commentary, Steven McKenzie of Thomas Jefferson University calls “exciting” the possibility that these genetic variations contribute to differences in the response to therapy for ITP.
Breunis WB, van Mirre E, Bruin M, Geissler J, de Boer M, Peters M, Roos D, de Haas M, Koene HR, Kuijpers TW. Copy number variation of the activating FCGR2C gene predisposes to idiopathic thrombocytopenic purpura. Blood, February 1, 2008, 111(3):1029-1038.
McKenzie SE. The yin and yang of Fcγ receptors in ITP. Blood, February 1, 2008, 111(3):981-985.
All of the previous articles appeared in the journal Blood. Nonsubscribers can download full articles for $35 each. Articles older than 12 months are available free. http://bloodjournal.hematologylibrary.org/
Patients interested in obtaining a copy of an access-controlled article in Blood that may be helpful to their situation may do so by emailing a request to the Blood Publishing Office . The request should include the following information:
To maintain the high levels of circulating platelets in the adult human—1 trillion platelets—megakaryocytes within the bone marrow must produce about 1 million platelets every second. The protein tyrosine kinase focal adhesion kinase (FAK) was thought to play an important role in megakaryocyte development, but its study in mice has been hampered. Researchers at University of California, San Diego (UCSD), overcame the obstacles, showing that FAK plays a central role in megakaryocyte development and platelet biology, mainly as a negative regulator of megakaryocyte production. In a comment on the paper, Dr. Italiano of Brigham and Women’s Hospital notes that the group’s findings “suggest that manipulation of FAK may provide a way to increase platelet levels in patients with thrombocytopenia or decrease platelet levels in patients with thrombocytosis.”
Hitchcock IS, Fox NE, Prévost N, Sear K, Shattil SJ, Kaushansky K. Roles of focal adhesion kinase (FAK) in megakaryopoiesis and platelet function: studies using a megakaryocyte lineage–specific FAK knockout. Blood January 15, 2008, 111(2):596-604.
Italiano Jr. JE. Megakaryocyte and platelet biology: getting your FAKS straight. Blood. January 15, 2008, 111(2):482-483.
GlaxoSmithKline announced preliminary results of the EXTEND (Eltrombopag eXTENded Dosing) study which showed that in patients with a baseline platelet count lower than 30,000/microliters, over 70 percent achieved a platelet count greater than or equal to 50,000/microliters. Average treatment time was 22 weeks. Starting dose was 50 mg/day, which could be raised to 75 mg in three weeks. Results indicate that PROMACTA (an oral, non-peptide, thrombopoietin receptor agonist that stimulates platelet production in the bone marrow) sustains higher platelet counts during long-term treatment. Findings were presented at the 49th Annual Meeting of the American Society of Hematology held December 8-11 in Atlanta, Georgia. “These long-term results on safety and efficacy are encouraging and suggest that PROMACTA, once approved, may provide physicians with a new treatment option to raise and maintain patients’ platelet levels and alleviate their ITP symptoms,” said James B. Bussel, MD, director of the Platelet Disorders Center of Weill Cornell Medical Center in New York, who led the study.
Bussel JB, Cheng G, Kovaleva L, Saleh MN, et al. Long-Term Safety and Efficacy of Oral Eltrombopag for the Treatment of Subjects with Idiopathic Thrombocytopenic Purpura (ITP): Preliminary Data from the EXTEND study. Presented at the 49th Annual ASH Meeting, Dec 8-11, 2007, Atlanta, GA. Abstract #566, Blood, 2207 Annual Meeting Abstracts, Part 1, Vol. 110, Issue 11, Nov. 16, 2007: p. 174A.
Two studies of traditional Chinese medicine treatments for ITP showed that Shengxueling (SXL), a Chinese medicine, helps ITP. In a 2005 study, with 86 patients randomly assigned to two groups, those in the SXL group had a total effective rate of 85.71 percent, while the placebo group on prednisone, had a total effective rate of 83.33 percent for six months. In the SXL group bleeding lessened or stopped, platelet counts improved, platelet associated immunoglobulin (PAIg) and interleukin4 (IL-4) markedly dropped. In a 2007 study, 69 patients with refractory ITP were randomly assigned to two groups. The 37 patients in the SXL group received an oral dose of 60 mg twice a day for four weeks. A group of 32 patients received a placebo. In the treatment group, 27 patients showed improvement in ITP symptoms, while in 10 it was ineffective. The study concluded that SXL is a safe and effective treatment for ITP, few side effects.
Zhou YM, Huang ZQ, Hu MH, Zhou SH, et al. Clinical study on the effect of Shengxueling on idiopathic thrombocytopenic purpura. 2005. Chinese Journal of Integrative Medicine, March 11 (1): 60-64.
Shao KD, Zhou YH, Shen YP, et al. Treatment of 37 patients with refractory idiopathic thrombocytopenic purpura by shengxueling. 2007. Chinese Journal of Integrative Medicine. March 13 (1):33-36.
www.ncbi.nlm.nih.gov/entrez/query.fcgi
A British study found that cortiosteroids, ex. prednisone, commonly prescribed for various autoimmune disorders including ITP, may pose a 2 ½ times greater risk for cardiovascular disease in patients taking them. A study from The Netherlands found that risk of an irregular heart rhythm, called atrial fibrillation (parts of the heart quiver instead of beat, allowing blood to clot) was six times higher in those who were taking high-dose corticosteroids. Steroids increase blood pressure, lipids, and blood glucose, which are factors that may increase heart disease risk. Steroids also change the potassium balance in heart muscle cells, which may be the root cause of the atrial fibrillation. During the 5-year Netherlands study of nearly 8,000 adults, 435 patients developed atrial fibrillation or died. Researchers showed that those who took high-dose steroids had six times the risk of developing the irregular heart rhythm compared with those who didn’t take steroids.
Heart-Healthy Living, Ed., Jeanne Ambrose, You’re Taking Steroids, Winter 2008, p. 31.
Walker, B. Glucocorticoids and cardiovascular disease. European Journal of Endocrinology, 2007, 157, Issue 5, 545-559.
Patients who are taking coumarins together with selective serotonin reuptake inhibitors (SSRIs) (a class of antidepressant drugs such as Prozac, Paxil and Zoloft) have an increased risk of nongastrointestinal (GI) bleeding according to a study reported in the Archives of Internal Medicine. The coumarins in the study are not used in the U.S., but have similar pharmacodynamics (how drugs interact with cells), so the results may apply to warfarin used in the U.S. Dutch researchers using patient records identified 1,850 patients on coumarin who were admitted to hospitals for bleeding. Patients also taking SSRIs showed higher risk for hospitalization for non-GI bleeding but not for GI bleeds. Patients on non-SSRI antidepressants did not have increased risk. Researchers believe the SSRIs’ ability to inhibit an enzyme that metabolizes coumarins may cause the bleeding effect. They advised intensified monitoring of coumarin patients who are also taking SSRIs.
Schalekamp T, Klungel JH, Souverein PC, de Boer A. Increased Bleeding Risk With Concurrent Use of Selective Serotonin Reuptake Inhibitors and Coumarins. Archives of Internal Medicine, Jan 2008; 168: 180 - 185.
The University of Southern California announced Dec. 13 a historic $60 million gift for the Keck School of Medicine’s Division of Hematology and the USC/Norris Comprehensive Cancer Center. The gift from the Jane Anne Nohl estate is one of the largest donations to a hematology program. “This gift will be used to unlock the mysteries of cancer of the blood and other blood disorders. This knowledge will lead to new and better therapies for treating these debilitating diseases,” said USC’s president, Steven B. Sample.
The gift will be used to support research in blood disorders and for recruiting outstanding researchers from around the country. It was coordinated by Larry Kelly, long-time friend and estate trustee for Jane Nohl, who died in July 2007. She chose USC/Norris and the hematology division because of the outstanding care given to Kelly by Dr. Don Feinstein of the Keck School of Medicine.
http://uscnews.usc.edu/HSCSearch/detail.php?recordnum=14660
Some large health insurance companies, stating they are trying to improve patient safety and reduce health-care costs, are refusing to pay -- and are not letting patients be billed --for medical care linked to errors made by hospital staff. Medicare announced last summer that it would not pay extra costs of treating bed sores, falls, and six preventable injuries and infections that occur while a patient is hospitalized. Next year they will add to the list objects left after surgery, hospital-acquired blood infections, blood clots in legs and lungs, urinary-tract infections from catheters, and pneumonia contracted from a ventilator. Care that insurers are refusing to pay for that they believe hospitals should prevent, include: giving the wrong blood type, operating on the wrong limb, performing the wrong procedure, and using contaminated drugs or devices. Insurers say they are restructuring their contracts with hospitals to make sure hospitals won’t be able to charge patients for care made necessary by a hospital error. However, given the high rate of medical billing errors, patients are advised by consumer advocates to examine their bills carefully and make sure they haven’t been overcharged.
Fuhrmans V. Insurers Stop Paying for Care Linked to Errors.
The Wall Street Journal. Personal Journal. In Depth: Health- Travel, Jan. 15, 2007, D1.
See the National Quality Forum’s list of 28 medical errors for which some insurers may refuse payment, at WSJ’s OnlineToday: http://s.wsj.net/public/resources/documents/WSJ_PRSeriousReportableEvents10-15-06.pdf
http://blogs.wsj.com/health/2007/08/08/medicare-wont-pay-hospitals-to-remedy-flubs/
A one-week yoga program reduced stress and anxiety among survivors of the tsunami that hit several Indian islands in December 2004. Researchers at the Swami Vivekananda Yoga Research Foundation in Bangalore conducted a stress management program for the tsunami survivors one month after the disaster. Self assessment of symptoms and heart and respiratory rate measurements of the 47 adults were carried out before and after the 8-day program. Fear, anxiety, sadness, sleep disturbances, and respiratory rates were significantly reduced following the yoga program. Results appear in the December 2007 issue of eCAM (Evidence-based Complementary and Alternative Medicine). While yoga is considered a relatively safe form of exercise, precautions should be taken if a person is just beginning. The American Academy of Orthopaedic Surgeons recommends: consult your doctor first if you have any medical condition, learn proper techniques from a certified yoga instructor, drink plenty of fluids, warm up before beginning routine, start out slowly, being sure to perform each position correctly, and stop if you feel discomfort or pain.
The first central database of integrative cancer research from around the globe is available online, free for cancer patients, the medical community, and the general public. The Canadian Breast Cancer Foundation awarded InspireHealth (formerly the Centre for Integrated Healing), an integrated cancer care center in Canada, a $142,382 grant to fund the new “Research Information System” for three years. The comprehensive system searches medical databases around the world for the latest cancer care treatments that can be added to conventional treatments on an integrated basis. Areas of interest include: nutrition, supplements, exercise meditation, yoga, emotional and spiritual support, etc. Dr. Hal Gunn, co-founder and CEO of InspireHealth, said, “We need to broaden our emphasis from the current sole focus of treating illness to one which engages people in their own care with a focus on illness prevention through an integrated healthcare approach.”
http://www.canada.com/theprovince/news/story.html
Children exposed to even low levels of lead may experience increase in the release of cortisol—a stress hormone—when they are in a stressful situation, according to a study in Environmental Health Perspectives (EHP). The study involved 169 children, age 9, from the Oswego Children’s Study, who were tested for cortisol levels before and after the stress of having their arm submerged in ice water for one minute. then children were given a simple test following the ice stress, those with high blood lead levels showed a significant release of cortisol. Findings were consistent even in children whose blood lead levels were less than 10 micrograms per deciliter (the action level established by the Centers for Disease Control and Prevention). Researchers said it is important to continue to follow these children to determine the consequences of these early effects of lead exposure on glucocorticoid reactivity.
The full article is online at: http://www.ehponline.org/members/2007/10391/10391.html
Now there are new options for keeping toxic trashed computers, cell phones and other electronic products from ending up in our landfills. Some major manufacturers, like Dell and HP, and stores, like Staples and Best Buy, have started recycling programs. Electronic products are a leading source of lead in municipal water supplies and are also a major source of cadmium and mercury, both highly toxic heavy metals. For more information, visit: www.greenerchoice.org which is a service of Consumer Reports.
“Where to recycle all those Computers and Cell Phones.” Ecoprint: newsletter for the responsible print buyer, Jan-Feb 2008. p. 4.
For ITP patients already coping with blood sugar problems while taking prednisone here is some useful news. Drinking caffeine in tea, coffee, or soft drinks daily raises blood sugar levels and may hinder efforts to control the condition, according to findings from Duke University researchers. They found that when type-2 diabetes patients consumed caffeine with meals, their average daily sugar levels increased 8 percent. Researchers think caffeine may trigger the release of adrenaline – the ‘fight or flight’ hormone – that is known to boost sugar levels. US diabetes levels increased by one-third during the 1990s. More than 190 million people have the disease now.
http://www.foodnavigator-usa.com
Lane JD, Barkauskas CE, Surwit RS, and Feinglos MN. Caffeine impairs glucose metabolism in type 2 diabetes. Diabetes Care. 2004, 27: 2047-2048.
It’s as easy as clipping on an inexpensive pedometer. Researchers at Stanford University Medical School found in their meta-analysis of 26 earlier studies that patients using pedometers experienced increases in physical activity, and decreases in body mass index (BMI) and blood pressure. The studies involved pedometer use by nearly 2,800 adult outpatients, around age 50, with nearly 85% women. They found that participants’ pedometer use increased physical activity by about 2,500 steps per day (a 27% boost in physical activity) compared to control participants who did not wear them. Participants wearing pedometers reduced their systolic blood pressure by 3.8 mm Hg.
Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, et al. Using Pedometers to Increase Physical Activity and Improve Health: A Systematic Review. JAMA. 2007. 298(19):2296-2304.
Richardson CR, ,Newton TL, Abraham JJ, Sen A, et al. A Meta-Analysis of Pedometer-Based Walking Interventions and Weight Loss. Annals of Family Medicine. 2008. 6:69-77.
Contents:
Clinical Trial News
ITP and Platelet Research
Health Resources
Insurance Concerns
Medical Records
General Health Research Findings
Nutrition and Food
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FDA PANEL VOTES ‘YES’ FOR NPLATE
All 10 members of an FDA advisory panel agreed that the benefits of NPlate (romiplostim, AMG531) outweighed the risks at a meeting on March 12. If approved, NPlate, which helps to raise the platelet count of people with ITP by stimulating platelet production in the bone marrow, will be available in conjunction with a risk reduction program that will closely monitor the benefits and risks of this new treatment paradigm.
LIGAND’S DRUG, LGD-4665, PASSES PHASE 1 TESTING
Ligand has announced that LGD-4665, an oral, small molecule drug that mimics the activity of thrombopoietin, a growth factor that promotes growth and production of blood platelets, has passed phase 1 testing. The drug was safe and well tolerated and platelet levels increased. The company plans to initiate clinical studies in patients with ITP in first quarter 2008.
NEW STUDY OF PRTX-100 FOR ITP
Protalex Inc. has begun a phase 1b treatment trial of PRTX-100, a “highly purified native bacterial protein called staphylococcal protein A.” The protein is thought to dampen the body’s autoimmune response to platelets. Two phase 1 studies in healthy volunteers found the drug was well tolerated. The new trial will evaluate safety as well as effects on platelet counts and fatigue in patients with chronic ITP who have not responded to at least one standard treatment. The study, recruiting patients in Australia and New Zealand, is listed on www.clinicaltrials.gov.
SIMPLE TEST CAN FIND CAUSE OF DRUG-INDUCED THROMBOCYTOPENIA
When drug-induced thrombocytopenia occurs, it is important to determine which drug caused the problem to avoid re-exposure. Researchers from Italy found that flow cytometry, a readily available technique, can identify the causative drug. In the two cases described, the antibiotic rifampicin and the anti-clotting drug abciximab caused late-onset thrombocytopenia.
Scognamiglio F, Corso C, Madeo D, et al. Flow cytometry in the diagnosis of drug-induced thrombocytopenia: Two illustrative cases. American Journal of Hematology, published online Nov. 20, 2007.
SHEDDING LIGHT ON PLATELET PRODUCTION
Harvard researchers used multiphoton intravital microscopy to visualize platelet generation within the bone marrow of live mice—and settle debates about how platelets are formed. They found that megakaryocytes within bone marrow extend arm-like pseudopodia into the bone marrow blood vessels. Sheer stress from blood flow fragments these protrusions, generating platelets.
Junt T, Schulze H, Chen Z. et al. Dynamic visualization of thrombopoiesis within bone marrow. Science. 2007;317:1767-70.
Flaumenhaft R. Caught in the Act: Megakaryocytes delivering platelets into the circulation. The Hematologist, March/April 2007, pg. 13-14.
NHLBI OFFERS PODCASTS
The National Heart, Lung, and Blood Institute’s Diseases and Conditions Index offers podcasts and animations to enhance learning. The DCI is a web-based information index about heart, lung and blood diseases and sleep disorders. Podcasts allow you to listen to the information on your MP3 player or computer. As of March, podcasts are available on heart attack, insomnia, and overweight/obesity. www.nhlbi.nih.gov/health/dci/pods/podcasts.html
INSURERS TRYING TO DEFUSE ANGER OVER POLICY CANCELLATIONS
After patients get sick, insurers will investigate a patient’s medical history to look for nondisclosure of pre-existing medical conditions that would have disqualified them from coverage. But public outrage in several stages against insurers that voided policies after beneficiaries started “racking up large claims for cancer or other serious illnesses,” has insurers pushing a proposal that would give consumers the right to appeal policy cancellations, known as rescissions, to an external panel. Some insurers are preparing to roll out their own independent review programs. The article notes that, after coming under attack, Blue Cross reversed a practice of enlisting doctors to report patients’ pre-existing conditions.
Rundle RL. Health insurers address issue of nixed policies.
The Wall Street Journal, February 27, 2008, Pg. D1, D3.
ARE HEALTH INSURERS MAKING CONSUMERS SHOULDER TOO MANY COSTS?
The New York attorney general is going after health insurers that pay out of network providers a going rate, which is lower than their actual fee. Consumers have to pay the difference. There are 16 insurers who are being investigated, but at the core of the investigation is UnitedHealth, which owns the database that the rest of industry uses to set usual and customary charges. Insurers contend the problem is high doctor fees, not low reimbursement rates.
Fuhrmans V, Frances T. Probe targets health insurers on payments.
The Wall Street Journal, February 14, 2008, Pg. D1, D3.
GOOGLE JUMPING IN TO ELECTRONIC HEALTH RECORDS
Google is pilot testing a personal health record with a group of patients at Cleveland Clinic. On Google Health, consumers will be able to enter their basic medical data and ask their doctors to electronically send information to be stored by Google. Microsoft and Revolution Health Group have also launched personal health record sites. These websites raise patient privacy issues. Patients’ online records may not be protected under federal privacy rules of HIPA (Health Insurance Portability and Accountability Act). Plus Google and the other providers face the challenge of receiving medical records from various institutions that store electronic records in different ways.
Lawton C, Worthen B. Good to Offer Health Records on the Web. The Wall Street Journal. February 28, 2008, pp. D1, D4.
EXERCISE SLOWS AGING AT THE DNA
Telomeres guard the ends of chromosomes—like the plastic tips on shoelaces—to fend off aging and cell death. London researchers measured the effect of exercise on telomere length and found that those who reported more than 3 hours per week of moderate-to-vigorous exercise had markedly longer telomeres than the least active individuals.
Live Long and Perspire. Science News, February 2, 2008, Pg. 69.
DO CHANGES IN ADULT STEM CELLS CONTRIBUTE TO AGING?
We all have small reservoirs of so-called adult stem cells in some of our tissues, such as the bone marrow and skin, to generate new cells when existing tissues are worn out or damaged. Even the brain has stem cells that make new nerve cells throughout life. And those adult stem cells produce more copies of themselves, “maintaining a seemingly indefinite pool of cells capable of churning out a stream of replacement cells.” Scientists are beginning to look into whether the declines of old age may be caused by the decline of adult stem cells. The answers, so far, are more complex than expected.
Barry P. Faulty Fountains of Youth. Science News, February 9, 2008, Pg. 88-89.
WHY ARE ALLERGIES ON THE RISE?
Experts estimate that many allergies and immune system diseases have doubled, tripled, or quadrupled in the last few decades. But why? It may be that modern, clean living leaves the immune system untested and more likely to overreact to allergens. As one researcher put it, “Our immune systems are much less busy, and so have much more strong responses to much weaker stimuli, triggering allergies and autoimmune diseases.” Some question the theory, but others are testing giving small amounts of allergenic foods, for example, to try to train the immune systems of people with allergies. Others are using parasitic worms to improve autoimmune diseases such as Crohn’s disease.
Immune Systems Increasingly on Attack. The Washington Post, March 4, 2008, A1, A4.
FATIGUE MAY OCCUR WITH BODY CLOCK FAILURE DURING SICKNESS
A jump in TNF-alpha activity is found in many infectious diseases as well as autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease. This immune system inflammatory protein may be the cause of daytime tiredness during illness. TNF-alpha spurs immune-fighting cells to seek out and destroy the agent causing the illness. But it may also interfere with the body’s clock, which guides the daily cycles of alertness and fatigue. This may be good for stimulating rest during short-term illness, to spur extra rest. But in long-term illness, fatigue may not be useful. The scientists suggest exercise to alleviate fatigue symptoms.
Cavadini G, Petrzilka S, Kohler P, et al. TNF- alpha suppresses the expression of clock genes by interfering with E-box-mediated transcription. Proceedings of the National Academy of Sciences U.S.A. July 31, 2007;104(31):12843-8.
GENETICALLY MODIFIED CROPS ARE PERVASIVE
Seven out of every 10 items in the grocery store has genetically modified ingredients, according to Dr. Joseph Mercola, who suggests ways to reduce your chances of eating GM foods, such as buying organic, avoiding processed foods, and checking the stickers on fruits and vegetables. The Price-Look Up Code (PLC) stickers on fruits and vegetables offer clues to whether the produce is conventionally grown, organically grown, or genetically engineered. Conventionally grown food has a PLU of four digits, such as 1022. Organically grown food has a five-digit PLU that begins with 9, such as 91022. Genetically modified food has a five-digit code that begins with 8, such as 81022. The Mercola website has several articles on genetically modified crops. www.mercola.com
For further info, see The Future of Food, an in-depth look into the controversy of genetically modified foods in a documentary by Deborah Koons Garcia. http://www.thefutureoffood.com/
FOLIC ACID WITH CAVEATS
Some studies have linked high doses of folic acid with increased risk of certain cancers.
Folic acid comes from vitamin supplements and fortified foods, while folate is found naturally in foods. Both are a form of the B vitamin folacin. Getting some folacin —especially folate—may shield normal cells from becoming cancerous, but getting too much folic acid may stimulate cancer growth. Folic acid may deter cognitive decline, but people with low blood levels of vitamin B12 with high folate levels may experience cognitive impairment. Bottom line: Get most of your folate from foods. Good sources are beans, green leafy vegetables, and citrus fruits. Multivitamins are still a good idea, but don’t buy one that exceeds 100% the daily value for folic acid. And avoid heavily fortified cereals and energy bars.
Folic Acid: Too much of a good thing? Food folate to the rescue Environmental Nutrition Newsletter, March 2008, Pg. 1, 6.
The Future of Food, an in-depth look into the controversy of genetically modified foods, is a documentary by Deborah Koons Garcia. http://www.thefutureoffood.com/
Contents:
ITP Treatments
Research On ITP
General Health Research Findings
Health Resources
Nutrition And Food
Environmental Concerns
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PROMACTA IN PRIORITY REVIEW AT FDA
GlaxoSmithKline have received priority review for the drug Promacta (eltrombopag) by the Food and Drug Administration (FDA). The drug is an oral thrombopoietin receptor agonist for short-term treatment of chronic ITP. It increases platelet production.
http://www.ligand.com/
http://www.medicalnewstoday.com/articles/99355.php
CAN ITP BE TRIGGERED BY MMR VACCINE?
The measles-mumps-rubella (MMR) vaccine that is given when a child is two years old is associated with an increased risk of ITP, according to a study by the CDC-supported Vaccine Safety Datalink (VSD) Project, a collaboration of eight large managed-care organizations. In the study of more than 1 million children vaccinated, 259 developed ITP, for a rate of one (1) case of ITP per 40,000 vaccinations.
France EK, Glanz J, Xu S, Hambridge S, et al. Risk of Immune Thrombocytopenic Purpura After Measles-Mumps-Rubella Immunization in Children. Pediatrics, March 2008, 121(3): e687-e692.
http://www.cdc.gov/vaccinesafety/vsd/
U.S. GOVERNMENT CONCLUDES VACCINE CONTRIBUTED TO GIRL’S AUTISM
The U.S. government concluded that mercury-containing vaccines contributed to symptoms of autism in 9-year-old Hannah Poling, who received the shots at 18 months. Centers for Disease Control (CDC) Director Julie Gerberding, however, states there is no link between autism and vaccines. The preservative thimerosol, which contains mercury, was removed from the majority of childhood vaccines in 2001. However, it is still found in some flu vaccines. Today, 1 in 150 children have the complex brain disorder.
www.nytimes.com/2008/03/08/us/08vaccine.html
http://www.cdc.gov/vaccinesafety/concerns/thimerosal.htm
BETTER SCREENING NEEDED FOR ABNORMAL MENSTRUAL BLEEDING IN ADOLESCENT FEMALES
A chart review of 84 adolescent female patients with abnormal menstrual bleeding (very heavy uterine bleeding or bleeding more than seven days) revealed that only a small minority were appropriately screened for blood clotting problems. However, 20% to 40% of adolescents with abnormal uterine bleeding may have an underlying bleeding disorder, including platelet function abnormalities, von Willebrand disease, or clotting factor disorders.
Kulp JL et al. Screening for coagulation disorders in adolescents with abnormal uterine bleeding. Journal of Pediatric Adolescent Gynecology. Feb 2008;21:27.
IS DONATED BLOOD BEING STORED FOR TOO LONG?
The Food and Drug Administration (FDA) allows blood to be stored for transfusions up to six weeks, to endure shortages and maintain supplies of rare blood types. Yet a new study suggests that heart surgery patients fare better if they receive blood that is less than two weeks old. Patients receiving older blood were more likely to die or suffer problems. These results are similar to those in patients undergoing other forms of surgery. About half of heart surgery patients get transfusions.
Koch CG, Li L, Sessler DI, Figueroa P, et al. Duration of Red Cell Storage and Complications After Cardiac Surgery. New England Journal of Medicine, March 20, 2008;358:1229-1239.
THE INTERNET IS TRANSFORMING DOCTOR-PATIENT RELATIONSHIPS
Patients are looking for information online before they seek out medical care, and doctors are having to learn how to work with patients eager to learn about their condition from Internet sources. Representatives from online health Web sites such as WebMD and Revolution Health Group presented this perspective at a meeting of the National Comprehensive Cancer Network, urging the doctors to embrace the trend and not feel threatened by it.
http://www.medscape.com/viewarticle/571138
DEVELOPING NATIONAL STANDARDS FOR PHYSICIAN PERFORMANCE
Health insurers and physician groups have agreed to develop a set of national standards for ranking physicians based on quality of care as well as cost.
Abelson R. National Standards to Rank Physicians Planned. The New York Times, April 1, 2008.
DOCTORS WHO WRITE GUIDELINES OFTEN TIED TO INDUSTRY
Surveys have repeatedly suggested that too many physicians who write practice guidelines for disease treatments have ties to the pharmaceutical industry, which could potentially sway their recommendations. A 2005 survey by the journal Nature found one third of authors who write practice guidelines have ties to the drug industry. In a 2002 study, 87 percent of guideline authors had some form of interaction with the pharmaceutical industry. In February, a Senate committee investigated doctors' potential conflicts of interest. The committee chair, Sen. Herb Kohl (D, Wis.) is sponsoring a bill that would require large pharmaceutical, medical device, and biologic companies to disclose gifts to physicians exceeding $25. Some doctors do not disclose their drug industry ties, even when guidelines require it.
Taylor R, Giles J. Cash interests taint drug advice. Nature, October 20, 2005;37(7062):1070.
Choudry NK, Stelfox HT, Detsky AS. Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry JAMA. 2002;287:612-617.
http://www.ama-assn.org/amednews/2008/03/17/gvsb0317.htm
NEW REPORTS AVAILABLE FROM FAMILIES USA
FamiliesUSA offers several new reports, covers topics such as universal health coverage, new regulations on Medicaid, and racial and ethnic disparities in U.S. healthcare. For details visit their web site. www.familiesusa.org
VITAMIN K MAY FIGHT INFLAMMATION
People with high dietary intake of vitamin K had lower levels of 14 inflammatory markers, some of which are linked to chronic diseases such as arthritis, heart disease, and type-2 diabetes, according to research from Tufts University. Good food sources of vitamin K are leafy greens such as spinach, lettuce, kale, and cabbage, plus cauliflower, broccoli, Brussels sprouts, cereals, milk and soybeans.
Vitamin K May Fight Inflammation Linked to Chronic Diseases. Tufts Health & Nutrition Letter, March 2008, pg. 1.
WATER SUPPLY CONTAINS TINY AMOUNTS OF MANY DRUGS
Trace amounts of numerous pharmaceuticals exist in tap water of 25 of 28 cities recently tested, according to an investigation by the Associated Press. The list of drugs includes antibiotics, painkillers, oral contraceptives, and antidepressants. The drugs reach the water supply when people flush unneeded meds down the toilet, or when the medications they take pass through the body and into the toilet. Water treatment plants do not cleanse these drugs from the water supply. While boiling water does not remove the drug traces, and can even concentrate some; some home filtering systems may remove a few of them, according to an article in the Washington Post. Congress is planning hearings in April.
Squires S. Hearings on Tap Water Planned. The Washington Post, March 13, 2008. Pg. A2.
Doheny K. Low Levels of Drugs Found in Drinking Water. WebMDHealth. March 11, 2008.
CHEMICAL BPA IN HARD PLASTICS CAUSE FOR CONCERN
The chemical bisphenol A, or BPA, which is found in polycarbonate, may be harmful to fetuses, infants and children, yet it is found in plastic water bottles, sippy cups, disposable cutlery, the linings of most canned food, and some food storage containers. The plastics to avoid are those with the recycling symbol “7” at the bottom. Also, do not microwave food in polycarbonate plastic containers, as BPA may be released when the plastic is heated. An upcoming PDSA newsletter will contain a more detailed report on BPAs.
Hard Questions about a Hard Plastic. Nutrition Action Healthletter, April 2008, pg. 8.
For further information about BPA, visit: http://www.cspinet.org/new/pdf/nahbpa.pdf
Contents:
ITP Research and Treatments
General Health and Medicine
Health and Nutrition
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Etanercept May Increase Risk for Serious Infections
Etanercept, an immunosuppressant used to treat autoimmune diseases, including arthritis and sometimes ITP, can lead to severe infections (including tuberculosis, bacterial sepsis, and other infections), according to a warning released by the Food and Drug Administration. A new black box warning has been added to the drug’s package, stating that doctors should screen patients for latent tuberculosis before prescribing the drug. The drug, trade name Enbrel, binds to tumor necrosis factor-alpha, to decrease inflammation. http://www.fda.gov/MedWatch/safety/2008/AmgenDearHCPLetter.pdf
Boxed Warning for Infections and TB Added to Etanercept (Enbrel), MedPage Today, May 1, 2008.
http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/9308
Ligand Initiates Phase IIA Clinical Study of LGD4665 for Raising Platelets
Ligand Pharmaceuticals has begun a phase IIA clinical study of LGD4665, a potent, oral drug that increases platelet count. The drug acts like the natural platelet regulator, thrombopoietin, and induces platelet increases in humans within 3 to 5 days. The study is being conducted in the U.S. and is designed to demonstrate the activity of LGD4665 at safe doses in patients with immune thrombocytopenic purpura (ITP).
Part 1 of the trial is a 6-week randomized, double-blind treatment, while Part 2 is a 3-month open label (active LGD4665) study extension. The double blind part of the study is placebo controlled for 6 weeks where every patient has a 2 out of 3 chance of receiving LGD4665. The study extension examines the optimal doses of LGD4665 for individual patients and its durability in maintaining increased platelet levels. To enter the study, patients must have received one prior therapy for ITP and must have low platelet counts of <30,000/uL (or <50,000uL if patient is on a stable regimen of oral corticosteroid). For more information contact Victor Stevens, 858-550-7739, vstevens@ligand.com or see the www.clinicaltrials.gov website.
EndoS Can Rescue Mice from Severe ITP
A strain of bacteria called Streptococcus pyogenes is being tested in animal models as a treatment for ITP. Studied at the Department of Clinical Sciences at Lund University, Sweden, under the name EndoS, the bacteria break down immunoglobulin G autoantibodies found on the surface of platelets in patients with ITP. In mice with ITP, injection of EndoS rescued five of seven mice.
Tse MT, Targeting Sugar Coating. Nature Reviews Drug Discovery, May 2008.
Collins M, Shannon O, and Bjöorck L, IgG glycan hydrolysis by a bacterial enzyme as a therapy against autoimmune conditions. Proceedings of the National Academy of Sciences, March 18, 2008, Vol. 105, No. 11, 4265-4270 (published online March 10, 2008).
Early intensive blood pressure lowering may be worthwhile after one type of stroke
Reducing blood pressure early and more intensively than current guidelines recommend appears safe and may help control expansion of the blood accumulation in the brain of patients who have just experienced an acute cerebral hemorrhage, according to an Australian study called INTERACT. Two hundred patients received early intensive lowering of blood pressure (to reach a target systolic BP of 140 mm) and 200 received standard guideline-based management (which aims for systolic BP of 180 mm). Although hematomas were less likely to grow in the intensive group, there were no differences in death or need for extended care. The authors recommend a large, randomized controlled trial to determine long-term benefits.
Anderson CS, et al. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomized pilot trial. The Lancet Neurology, early online publication, April 5, 2008.
FDA delays decision on Nplate
Amgen, the makers of the platelet-stimulating drug Nplate, says the FDA has extended its review period by 3 months—from April 23 to July 23. Nplate (romiplostim) is being considered for marketing approval for the treatment of thrombocytopenia in adults with chronic ITP. The delay comes after Amgen submitted details of a risk management program, which the FDA says automatically triggers a 3-month review extension. FDA has expressed concerns about the drug’s impact on other blood disorders.
PharmaTimes, online posting, April 9, 2008.
Sym001, a novel treatment of hemolytic diseases, moves into second clinical trial
Biovitrum and Symphogen A/S have initiated a clinical proof of mechanism study of Sym001, an RhD polyclonal antibody, to clear Rh-positive red blood cells from the circulation in RhD-negative healthy volunteers. Sym001 is a new class of biopharmaceuticals under development to prevent bleeding diseases in newborns and for treatment of ITP. In a phase 1 clinical trial, the drug was safe and well tolerated in healthy volunteers. According to the Denmark-based Symphogen, Sym001 is the first recombinant polyclonal antibody to enter human clinical trials.
Biovitrum and Symphogen initiates a second clinical study with a novel treatment of hemolytic diseases, ABN Newswire, Stockholm, Sweden, April 15, 2008.
http://hugin.info/134557/R/1209264/249831.pdf
Former Amgen Executive, Cynthia Schwalm, Named President of Eisai, Inc.
Eisai Corporation of North America has appointed Cynthia Schwalm as president of Eisai Inc. In her previous role at Amgen, Schwalm was in charge of development of Nplate (romiplostim), a platelet-stimulating drug now in FDA review for the treatment of ITP. She has extensive background in oncology, neurology, critical care, and gastroenterology. Eisai includes several operating companies, including Eisai Research Institute of Boston, Inc, Morphotek, Inc., Eisai Medical Research Inc, and MGI Pharma. MGI Pharma recently acquired AKaRX, which has the drug AKR-501 in clinical trials for the treatment of ITP.
http://www.eisai.com/press_release.asp?ID=147
CDC Says Some People Should Not Get the MMR Vaccine or Should Wait
Recent vaccine guidelines from the U.S. Centers for Disease Control and Prevention (CDC) indicate some people should not get the Measles, Mumps and Rubellla (MMR) vaccine or they should wait. Measles, mumps, and rubella (German Measles) are contagious diseases that spread from person to person through the air. The CDC recommends vaccine caution for patients with any of the following: has a disease that affects the immune system; being treated with drugs that affect the immune system, such as steroids; has cancer; and has ever had a low platelet count (ITP or other blood disorder). The MMR vaccine can cause a temporary low platelet count, which can cause a bleeding disorder (about 1 out of 30,000 doses). Patients should check with their doctor as to whether they should get the MMR vaccine. For information, visit their web site: http://www.cdc.gov/vaccines/Pubs/vis/downloads/vis-mmr.pdf
Vaccine Information Statement (Interim) MMR Vaccine (3/13/08), 42 U.S.C., §300aa -26, CDC.
New NIH Web Site Helps Seniors Learn About Clinical Trials
The National Institute on Aging and the National Library of Medicine together have created a new web site for older adults that provides health information from the National Institutes of Health (NIH). A wide range of topics are easily viewed. The web site at http://nihseniorhealth.gov features a section that focuses on clinical trials (http://nihseniorhealth.gov/participatinginclinicaltrials/toc.html). The web site explains what is a clinical trial, describes informed consent, how to find a clinical trial; and discusses whether you should join a clinical trial.
New Research Shows Yoga Helps Prevent Falls in Elderly Women
Iyengar Yoga improved stability and balance in women over age 65, which could help prevent falls. The CDC reports that in people age 65 and older, falls are the leading cause of nonfatal injuries and hospital admissions. Researchers of the School of Podiatric Medicine and the College of Health Professions at Temple University’s Gait Study Center, examined the gait and postural stability of 24 elderly females enrolled in the Iyengar Yoga program. After the 9-week program, the women walked faster, had increased flexibility in their legs, and greater walking and balance confidence. Some participants who had reported back and knee pain at baseline were pain-free by the end of the study. Participation in the yoga program group setting could also have positive psychological effects.
Yoga poses can prevent falls in women over 65, study suggests, ScienceDaily (April 8, 2008). Retrieved May 16, 2008
http://www.sciencedaily.com/releases/2008/04/080404114445.htm
Supportive Doctor-Patient Relationship Enhances Placebo Effect in Patients
A supportive doctor-patient relationship enhanced the placebo effect in patients with irritable bowel syndrome (IBS). While the placebo effect is widely known, what produces the effect is unclear. Investigators wanted to determine whether the placebo effect consists of three parts – responses to doctor assessment and observation, placebo treatment, and supportive doctor-patient relationship—and whether combining these components enhances patient clinical outcome. In the study, 262 adults with IBS were randomly assigned to clinical assessment only, placebo acupuncture, or placebo acupuncture supplemented with supportive doctor-patient relationships. At 3 weeks, percentage of patients who reported “adequate” pain relief was: 28% in the observation-only group, 44% in the placebo acupuncture group, and 62% in the placebo “augmented” with a supportive doctor-patient relationship. Similar results were reported for overall improvement, symptom severity, and quality of life. The supportive doctor-patient relationship is also likely to enhance treatments that are biologically effective.
BMJ 2008; 336; 999-1003; originally published online 3 Apr 2008
BMJ (formerly the British Medical Journal) is published by BMJ Publishing Group Ltd.
http://www.bmj.com/cgi/content/full/336/7651/999
U.S. Senate and House Pass the Genetic Information Nondiscrimination Act (GINA)
The U.S. Senate, in an overwhelming bipartisan 95-0 vote, passed the Genetic Nondiscrimination Act (GINA) (S. 358) on April 24, 2008. On May 1, 2008, the U.S. House of Representatives voted 414-1 to pass GINA (H.R. 493). The bill prohibits discrimination based on a person’s genetic information and paves the way for responsible use of genetic information. Ten years ago there were about 100 genetic tests, while today there are over 1,000 tests used to diagnose many health conditions. The Coalition for Genetic Fairness (PDSA is a member) worked 13 years for passage of legislation to prevent misuse of genetic information. Fear of discrimination based on genetic information has led many to avoid genetic testing that could help them manage their health and patients opted out of clinical trials over concern their genetic information could be misused. The new bill prohibits discrimination by health insurers or employers based on genetic information. They may not request, require, or purchase genetic test results, or disclose genetic information and employers may not fire, refuse to hire, or otherwise discriminate in compensation, terms, of privileges of employment.
http://www.geneticalliance.org/ws_display.asp?filter=policy.leg.nondiscrim
Coalition for Genetic Fairness http://www.geneticfairness.org/
A Little Exercise Proves Good For Mental Health
As little as 20 minutes of any kind of physical activity, including housework, a week was good for mental health in a study of 20,000 men and women. The study found that the more vigorous the activity, the greater the mental benefit. Activity such as gardening, housework, walking, and sports was associated with a 41 percent lower risk of psychological distress. Physical benefits of exercise are well known, including reduced risk for heart disease, diabetes, high blood pressure. Mental benefits are less clear, although exercise is believed to improve blood flow and reduce inflammation. Also, exercise may improve mood by reducing stress levels.
MedlinePlus, U.S. National Library of Medicine and the National Institutes of Health, April 10, 2008.
www.nlm.nih.gov/medlineplus/news/fullstory_63236.html
1 in 5 Hospitalized Children Harmed by Medical Mix-ups
Medicine mix-ups, accidental overdoses, and bad drug reactions harm 1 in 5 hospitalized children. A recent study used a new detection method that looked at patients’ charts for 15 “triggers” that suggested possible drug-related harm, including use of antidotes for drug overdoses, suspicious side effects, and certain lab tests. Studying medical charts for 960 children in 12 U.S. hospitals found 11 drug-related harmful events occurred for every 100 hospitalized children (around 7.3 percent of hospitalized children) per year. Over half the problems detected related to powerful painkillers, including overdoses and allergic reactions. Mistakes included not monitoring patients, prescribing the wrong medicine, or giving wrong doses. Hospital staff, using the standard method of patient chart reviews and reporting of errors, found less than 4 percent of problems detected with the new method. A parent whose children survived a heparin overdose offered this advice: “Every time a caregiver comes into the room …check and ask … what they’re giving them and why.”
Medicine mix-ups harm hospitalized kids. Associated Press, April 7, 2008.
Takata G, et al., Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm inUS children's hospitals, Pediatrics, Vol. 121, No. 4, April 2008, pages e927-e935.
Vitamin C Inhibits Ulcer-Causing Bacteria H. pylori
Here’s another reason to eat your fruits and vegetables. Japanese researchers found that vitamin C inhibited growth of Helicobacter pylori, a bacterial risk factor for stomach ulcers and gastric cancer. The study found vitamin C could inhibit the growth of 90% of the bacterial strains of H. pylori. Also, in a separate in vivo (using live animals) experiment, H. pylori colonies decreased significantly in animals treated with Vitamin C by mouth for 7 days. Vitamin C (found in fruits and vegetables) is believed to exert its protective effect by scavenging free radicals that may be enhanced by the H. pylori bacteria. In past research, this bacteria was found related to some cases of ITP. For patients with ITP considering trying high doses of vitamin C, remember to first discuss this with your hematologist.
Zhang, H, Wakisaka, N, et. al., Vitamin C inhibits the growth of a bacterial risk factor for gastric carcinoma: Helicobacter pylori. Cancer, 1997, Vol. 80, Iss.10, pages 1897 – 1903. Published Online: 20 Nov 2000
http://www3.interscience.wiley.com/journal/75502577/abstract?
Insufficient Sleep Leads to Many Health Problems
Get your forty winks. The Institute of Medicine reported definite links between sleep deprivation and increased risk for high blood pressure, diabetes, obesity, heart attack and stroke, and depression. A groundbreaking 1999 study found that after six days of only four hours of sleep, health volunteers fell into a pre-diabetic state. Sleep allows the heart time to slow down, and those getting less than six hours of sleep a night had a 66 percent increase in high blood pressure. Scientists are also investigating the relationship between too little sleep and depressed immune function. Another large study, with over 1 million participants, found the highest survival rate in patients who slept seven hours and the lowest survival rate in those who slept less than 4.5 hours a night. While experts say most people need about eight hours of sleep each night, about 40 percent of Americans sleep fewer than seven hours on weekdays. The two main causes found for sleep shortage were long work hours and long commutes.
The Most Common Sleep Disorder: Insufficient Sleep, Dr. Mercola web site,
http://articles.mercola.com/sites/articles/archive/2006/10/28/the-most-common-sleep-disorder-insufficient-sleep.aspx
Insufficient Sleep Associated with Overweight and Obesity, ScienceDaily (Jan 20, 2005).
http://www.sciencedaily.com/releases/2005/01/050111114820.htm
Perceived Insufficient Rest or Sleep – Four States, 2006, CDC Weekly, Feb 29, 2008.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5708a2.htm
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance and Medical Care
Nutrition and Exercise
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Sequential therapy Better Than Standard Triple Therapy for H. pylori
Standard treatment for H. pylori infection fails in one-quarter of patients, possibly due to antibiotic resistance. Sequential therapy—5 days of a proton-pump inhibitor (PPI) and an antibiotic, followed by 5 days of the PPI with two other antibiotics—appears to be superior to standard triple therapy—7 or 10 days of a PPI with two antibiotics—according to a review of 10 randomized trials (involving about 2800 untreated patients). H. pylori was eradicated in 93% of patients with sequential therapy and 77% of those on triple therapy. Patients with ITP and H. pylori infection have been known to experience improvements in their ITP after successful H. pylori treatment.
NS Jafri, CA Hornung, CW Howden. Meta-analysis: Sequential therapy appears superior to standard therapy for Helicobacter pylori in patients naïve to treatment. Annals of Internal Medicine. June 17, 2008; 148(12) published online (www.annals.org).
FDA Reissues Warning for CellCept in Pregnancy
The FDA has reissued a warning that mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic), if used by pregnant women, may cause miscarriages and birth defects, such as oral clefts and other major structural defects. The drugs are used to prevent organ rejection in patients receiving transplants and are sometimes used off-label to treat autoimmune diseases, such as ITP, lupus, and rheumatoid arthritis.
http://www.fda.gov/cder/drug/InfoSheets/HCP/mycophelolateHCP.htm
NIH Launches Undiagnosed Diseases Program
The National Institutes of Health (NIH) has launched a new program to help patients with mysterious conditions that “have long eluded diagnosis.” Physicians across the nation can refer their patients with the most puzzling medical cases, for consultation with NIH physicians. Patients must have a doctor’s referral and provide all medical records and diagnostic test results requested by NIH. As many as 100 patients each year will be accepted and evaluated at the NIH Clinical Center in Bethesda. NIH will enlist the expertise of more than 25 of its senior attending physicians to evaluate patients.
http://rarediseases.info.nih.gov/Undiagnosed or 1-866-444-8806.
Anti-Bleeding Drug, Trasylol, Increases Risk of Death
Patients undergoing heart surgery who received Trasylol (aprotinin) were 53% more likely to die than people who received two other anti-bleeding agents, according to a trial comparing aprotinin with tranexamic acid and aminocaproic acid. The trial was terminated early because of the higher death rate in the aprotinin patients. The drug, which costs substantially more than alternatives, was already on the market, but its marketing has been suspended by its maker, Bayer HealthCare.
Fergusson DA, Hebert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussieres JS, Cote D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Clinch J, Pretorius R. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. New England Journal of Medicine, May 29, 2008 358:2319-2332.
Steering Patients to Clinical Trials
Facing shortfalls of patients for clinical studies, new resources are popping up to extend outreach to boost enrollment in clinical trials. For a long time, researchers have been unable to boost participation in cancer clinical trials among adults, for example, above 3%. EmergingMed.com, for example, charges fees to medical centers, advocacy groups, and research sponsors, but the service is free to individuals, whose personal profiles are matched to enrollment criteria for trials. The government’s ClinicalTrials.gov lists 55,000-plus trials in 155 countries. CenterWatch.com searches 25,000 industry and government-sponsored trials; and there are others. Many groups aim to reduce fear and educate consumers about the benefits of clinical trials, which aim to improve diagnostics and treatments for diseases. A Wall Street Journal article provides a good list of questions to ask before participating: How do the risks, side effects and benefits compare with my current treatment? Who will pay for the experimental treatment? How will patients be informed about new risks identified during the trial? Will results of the trial be provided to me?
Landro L. Matchmakers: Patients meet clinical trials. Wall Street Journal, May 14, 2008, pg. D1-D2.
FDA Adopting New Standards for Clinical Trials Outside the U.S
The FDA is planning to adopt new standards for conducting human clinical trials in countries outside the U.S. The new standards, called Good Clinical Practice (GCP), specify how to run such trials to meet U.S. requirements for marketing approval in the US, but they appear to be less stringent on human rights than the rules that exist today, according to an editorial in Nature. Existing rules require compliance with the Declaration of Helsinki, a declaration of standards (adopted In 1964 and revised several times since) endorsed by medical associations from 85 countries, which calls for patients to be “assured of the best proven diagnostic and therapeutic method.” The editorial suggests that by dropping Helsinki, FDA risks “sending a message that ethical considerations are expendable when research subjects live half a world away.”
Trials on trial. Nature, May 22, 2008, 453(7194):427-28.
Concerns About Pet Vaccines
Pet owners and some veterinarians in Manitoba, Canada, are concerned that common pet vaccinations, such as rabies vaccine, may do more harm than good. According to vets, some pets have had autoimmune reactions to the vaccines. One vet said, "… absolutely over-vaccination certainly exists." Tim Dack, a spokesman for the city's animal services department said given the constant threat of rabies in Manitoba, pets should be vaccinated. However, the city is re-examining its vaccination requirement in light of changing opinions and protocols in the veterinary industry.
CBC News, May 27, 2008 - www.cbc.ca/consumer/story/2008/05/27/pet-vaccines.html
Salmonella Risk for Humans from Dry Dog Food
In 70 cases across 19 states Salmonella poisoning was tied to humans touching dry dog food that was produced in a Pennsylvania plant, according to a report from the Centers from Disease Control and Prevention. Pet owners should always wash their hands with soap and warm water after handling pet food, and children under 5 should not be allowed to touch or eat pet food.
Multistate Outbreak of Human Salmonella Infections Caused by Contaminated Dry Dog Food --- United States, 2006—2007. MMWR Weekly, May 16, 2008, 57(19):521-24.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5719a4.htm
Electronic Medical Records Raise Concerns -
“Google Health” Personal Health Record System Launched
Google has partnered with Cleveland Clinic to open its personal health record system “Google Health” to the public. First tested at Cleveland Clinic, the system allows users to import and link their records from selected health care providers and pharmacies. Patients can store information on allergies and medications they’re taking and search for providers and online health tools. Google has said it will not aggregate users’ health information across services and so user information will not appear on search results. Some privacy advocates worry that services like Google Health, Microsoft’s HealthVault and Revolution Health don’t have to comply with HIPAA or Health Insurance Portability and Accountability act rules on security of medical records.
http://www.nytimes.com/2008/05/20/technology/20google.html?ref=policy
Do Electronic Medical Records Impede Care?
Yes, say Drs. Jerome Groopman and Pamela Hartzband in an article in the New England Journal of Medicine. They say EMRs often contain boilerplate text rather than physicians’ personal notes and reflections on an individual patient, and they can contain large blocks of text, making it difficult for doctors to find the important information quickly.
Hartzband P, Groopman J. Off the record—Avoiding the pitfalls of going electronic. New England Journal of Medicine. April 17, 2008, 358(16):1656-1658.
Are Your Medical Records at Risk?
Recent breaches in security of consumers’ confidential medical data have raised concern about the effectiveness of existing patient privacy safeguards. Hospitals, health insurers, and the federal government have experienced security lapses. Problems seem to be occurring more often due to internal mistakes and carelessness rather than outside hackers. Hospitals are beginning to beef up employee training and require employees to note their relationship with the patient before they can access a chart, for example.
Rubenstein S. Are Your Medical Records at Risk? Wall Street Journal, April 29, 2008, pg D1-D2.
Mouth Bacteria Unleash Inflammation
Certain bacteria that reside in the human mouth produce a compound called PEDHC that causes inflammation that can be hard to shut down, according to research from the University of Connecticut Health Center in Farmington. In research injecting mice with PEDHC, researchers found this substance can tip the body’s balance toward an autoimmune reaction. This finding may lead to improved treatments to prevent autoimmune diseases. Good dental care helps keep one of the bacteria that produce PEDHC from harming gums and teeth.
Raloff J. Triggering autoimmune assaults. Science News, May 10, 2008, pg. 10.
Light Exercise Can Replenish Energy
Even just 10 minutes of exercise a day can boost energy levels, according to research from the University of Georgia. Light workouts even decreased fatigue by 65%. The study adds evidence that exercise can improve physical and mental health.
Light Exercise Beats the Couch for Fighting Fatigue and the “Blahs”. Tufts Health & Nutrition Letter. June 2008, 26(4):1-2.
Positive Mood Can Boost Immunity
Stress can overactivate the immune system, increasing risk for autoimmune diseases such as ITP and arthritis. An Israeli study in Autoimmunity Reviews suggests that pleasant emotions stimulate certain positive elements in the immune system, and negative emotions are linked to poorer immune response to illness. Happier people even come down with fewer colds. Experts suggest eating healthy, not smoking, exercising regularly, reducing stress, and strengthening interpersonal relationships.
http://psychcentral.com/lib/2007/how-does-mood-affect-immunity/
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance and Medical Care
Nutrition, Fitness, and Lifestyle
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Needle-free Lidocaine for Children’s Pain Relief
In a comparison of needle-free powder lidocaine delivered with helium gas into the skin or a sham-placebo delivery system, pain scores were lower in the lidocaine group after the procedures. Pain relief occurred within 1 to 3 minutes. These results may be relevant for children with ITP, who get frequent infusions and shots.
Zempsky WT, et al. Needle-Free Powder Lidocaine Delivery System Provides Rapid Effective Analgesia for Venipuncture or Cannulation Pain in Children: Randomized, Double-Blind Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment Trial. Pediatrics. May 2008, 121(5):979-987.
FDA Postpones Promacta Decision
The FDA has extended the priority review period for Promacta (eltrombopag) because it needs more time to review the application, according to the drug’s developers, GlaxoSmithKline and Ligand. A 16-member outside advisory panel has recommended approval of the drug. The agency has until mid September to complete its review. If approved, Promacta would be the first oral short-term treatment for chronic ITP. Long-term studies are expected to be available by the end of the year.
Ligand Says FDA Extends Blood-Clot Drug Review. Associated Press, June 20, 2008.
Rituximab May Work at Lower Dose
One or two doses of rituximab may be as effective as four, according to a preliminary Australian study in a dozen patients with immune-mediated blood disorders, like ITP. This shorter dose could provide considerable cost savings and fewer trips to the doctor’s office or hospital for infusions.
Fairweather H, Tuckfield A, Grigg A. Abbreviated dose rituximab for immune-mediated hematological disorders. American Journal of Hematology. March 3, 2008, 83(7):554-557.
Antirejection Drug Linked to Brain Viral Infection
The drug CellCept (mycophenolate mofetil) may increase the risk for a potentially fatal viral infection of the brain called progressive multifocal leukoencephalopathy (PML) in transplant recipients, according to the FDA. The drug is used to prevent organ rejection, and is sometimes used for ITP patients. In April, the FDA began investigating another organ rejection drug, Myfortic (mycophenolic acid) in the development of PML. Any patient taking CellCept who experiences confusion or other cognitive symptoms should be evaluated.
Splenectomy May Increase Cardiovascular Trouble
Comparing ITP patients who retained their spleens and those who had their spleens removed, researchers at the University of Miami revealed that patients without a spleen had higher levels of cell-derived microparticles (C-MP), a risk factor for blood clotting, plaque build up in the arteries, and cardiovascular disease. Their study shows that the spleen acts as a filter to remove these harmful microparticles from the body.
Fontana V, Jy W, Ahn ER, Dudkiewicz P, Horstman LL, Duncan R, Ahn YS. Increased procoagulant cell-derived microparticles (C-MP) in splenectomized patients with ITP. Thrombosis Research, March 10, 2008, e-pub.
Receptors on the Liver Reduce Clotting in Sepsis
Sepsis is an infection in the bloodstream that can be life-threatening when it activates inflammation and blood clotting. Research from the University of California, San Diego, revealed how millions of receptors on the liver, called Ashwell receptors, can decrease blood clotting during sepsis by eliminating two clotting factors--platelets and von Willebrand Factor--during the infection. The research suggests that a low platelet count during sepsis may be a good sign.
Grewal PK, Uchiyama S, Ditto D, Varki N, Le DT, Nizet V, Marth JM. The Ashwell receptor mitigates the lethal coagulopathy of sepsis. Nature Medicine. June 2008, 14(6):648-655.
Parasitic Worms May Protect Digestive Tract
Noting that autoimmune digestive disorders, such as inflammatory bowel disease, ulcerative colitis and Crohn’s disease rose significantly about the same time that sanitation methods improved, one researcher suggests that parasitic worms keep their hosts healthy by calming the host’s immune system. Perhaps the human immune system relied on parasitic worms for proper functioning. Reintroducing worms (microscopic eggs from Trichuris suis, the common pig whipworm) in mice resolved these inflammatory diseases. Small studies in humans showed improvements among patients with Crohn’s disease and ulcerative colitis. Scientists are intrigued. Larger trials are under way.
Velasquez-Manoff M. The Worm Turns. New York Times Magazine, June 29, 2008, pg. 17.
Hazards from Mercury in Dental Fillings
On its website, the FDA is alerting consumers about the potential dangers of mercury dental fillings, with plans to issue a more specific rule next year. “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous system of developing children and fetuses,” the website notes. The FDA does not suggest removal of mercury filings. Mercury has been linked to brain and kidney damage at certain levels. One expert suggests that people with weakened immune systems, such as those with ITP taking steroids or those without a spleen, should avoid mercury fillings. Dental fillings without mercury are available. FDA is requesting comments by July 28, 2008.
http://www.fda.gov/cdrh/consumer/amalgams.html
Heavey S. Mercury teeth fillings may harm some: FDA. Reuters.com, June 4, 2008.
More Benefits of Vitamin D – Heart Attack Protection
Men with low Vitamin D levels have higher risk for heart attack than those with normal levels, according to 10-year Harvard University study. Vitamin D may protect against heart attack by lowering blood pressure, reducing inflammation, or reducing plaques in the arteries, according to the researchers. The body makes vitamin D during sunlight exposure. Milk is usually fortified with vitamin D. People can learn their vitamin D levels through a simple blood test.
Giovannucci E, Liu Y, Hollis BW, Rimm EB. 25-Hydroxyvitamin D and Risk of Myocardial Infarction in Men. Archives of Internal Medicine, June 9, 2008, 168(11):1174-1180.
Drug Companies Help Uninsured Buy Meds
Needymeds.com is a free web-based service that links consumers to discount drug programs, called prescription assistance programs or PAPs. Most drug companies help people with no insurance get access to needed medications at low or no cost. Needymeds.com is a free, not-for-profit Web resource. It connects patients to programs for more than 3,500 medications. The site logs 10,000 visitors a day, including people who need the free medications and lots of drug companies lining up to give it away.
Moyer J. Drugmakers Offer Aid to People ‘On the Edge.’ Washington Post, July 1, 2008, pp. F3.
Moving Toward E-Prescribing
The country’s two electronic prescribing networks are merging and will be called SureScripts-RxHub, to simplify the connections among doctors, pharmacies and insurance companies. Electronic prescribing holds promise for avoiding handwriting errors and dangerous drug interactions. But, according to a recent Washington Post article, only 2% of U.S. prescriptions are submitted electronically. The Centers for Medicare and Medicaid released a final rule setting standards and promoting e-prescribing. But they are not mandatory. Congress is attempting to offer financial benefits to doctors who e-prescribe.
Goldfarb ZA. E-Prescription Networks to Merge. Washington Post, July 1, 2008, D1, D3. Keating T. CMS Releases Final Rule on E-Prescribing. Hematology & Oncology News & Issues May 2008, pp. 42.
FDA Rules Brown Rice is a Decent Fiber Source
The FDA is now allowing brown rice packaging to carry whole grain health claims to boast its heart-health benefits. One half cup of cooked brown rice contains two grams of fiber. The FDA-approved claim, which is already allowed on other whole-grain products, states, “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat and cholesterol may reduce the risk of heart disease and some cancers.” To learn more visit: Whole Grains Council
If Disinfectant Harms Mouse Fertility, What About Humans?
Two chemicals widely used in cleaning supplies in homes, offices, and hospitals caused birth defects and fertility problems in mice whose cages were cleaned with these chemicals, according to an article in Nature. Two quarternary ammonium compounds, ADBAC and DDAC, were identified as the chemicals used in Virex disinfectant. The researcher who made the connection calls for more study to see if there should be concern for humans.
Lab disinfectant harms mouse fertility. Nature. June 19, 2008, pp. 964.
Laugh Your Way to Health
Laughter lowers blood sugar, a benefit for diabetics and nondiabetics, alike. In one 2003 study in Japan, people who watched a comedy show were better able process sugar from meals than those who watched a non-funny lecture. Poor blood sugar control is a risk for diabetes as well as heart disease, kidney failure, and blindness.
Hayashi K, et. al., Laughter Lowered the Increase in Postprandial Blood Glucose. Diabetes Care, 2003, 26:1651-1652.
Yoga Puts a Smile on Your Face
A few simple yoga stretches and poses can boost happiness, according to a 5-week study reported on RealAge.com.
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance and Medical Care
Nutrition, Fitness, and Lifestyle
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Romiplostim Shows Sustained Effects, but FDA Approval Postponed
Long-term results of a treatment study of romiplostim (Amgen’s Nplate), showed sustained platelet count increases in adult patients with ITP, along with reduced need for concurrent and rescue ITP medications. After average treatment of 65 weeks, 83% of patients achieved a platelet response above 50,000 platelets per microliter. Results were presented at the June meeting of the European Hematology Association. Romiplostim stimulates the thrombopoietin receptor for platelet production. In related news, the FDA has postponed its decision, which was expected in late July, on approval of the sale of Nplate for patients with ITP whose disease has not responded to other treatments.
Romiplostim Data Show Potential Long-Term Efficacy and Safety in Adults with Chronic Immune Thrombocytopenic Purpura (ITP). Medical News Today, June 17, 2008; www.medicalnewstoday.com
Ed., Zimmerman, D. Amgen Says US FDA Decision on Clot Drug Delayed. Reuters, UK, July 23, 2008.; www.amgen.com
ITP Treatment, Sym001, Moves to Phase 2 Testing
Sym001 has moved into phase 2 testing for treatment of ITP. The drug is a recombinant, polyclonal anti-Rhesus D antibody product, in development by Symphogen and Biovitrum. Up to 55 nonsplenectomized, RhD-positive patients with ITP will be enrolled in the phase 2 study at 23 sites in Europe. The study will determine appropriate dosages to use for Phase III trials by assessing increases in platelet levels and exploring the mechanism of action of Sym001.
Symphogen and Biovitrum Recruit First Patient for Phase II ITP Study, Pharmaceutical Business Review, July 17, 2008. For more details, visit www.symphogen.com
Are Better Anticoagulants in Development?
In an editorial, Nigel Key of University of North Carolina, expresses concerns that new anticoagulant drugs in development may be no better than warfarin, and may hold the same bleeding risks that the older drug does. Effective and safe anticoagulation therapy will be a major health care priority, with the aging U.S. population.
Key NS. Anticoagulant-related Bleeding: Into the Unknown? HemOnc Today, June 25, 2008
Antidepressants Can Boost GI Bleeding; Acid-Reducing Drugs May Help
Two types of anti-depressants, SSRIs and SNRIs (specifically venlafaxine), may increase risk for upper gastrointestinal bleeding. A Spanish study indicates that acid-suppressing drugs appear to reduce that risk for bleeding. This population-based study compared 1,300 adults with upper GI bleeding to 10,000 controls without bleeding. Selective serotonin reuptake inhibitors( SSRI) and selective serotonin and norepinephrine reuptake inhibitors (SNRI) users had double or more risk of bleeding, even more so if the patient was also taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, or corticosteroids. Acid-suppressing drugs reduced the risk.
De Abajo FJ. Garcia-Rodriguez LA. Risk of Upper Gastrointestinal Bleeding Associated with Selective Serotonin Reuptake Inhibitors and Venlafaxine Therapy. Archives of General Psychiatry. 2008;65(7):795-803
Comparing the Presidential Candidates’ Health Proposals
The National Hemophilia Foundation has published a guide on where the presidential candidates stand on key health-care issues, with special attention to issues that might affect individuals with bleeding and clotting disorders. The guide is available through the Foundation at 800-42-HANDI or www.hemophilia.org.
Ragni M. Patients and Politics: Interpreting the Footprints of Donkeys and Elephants for Patients. The Hematologist. July/August 2008, Pg. 14.
Some Governments Getting Serious About Chemical Exposures
Governments are beginning to examine the dangers posed to human health by chemicals in our air, water, food, and products we use. Many cancers and autoimmune diseases might result from chemical pollution. The European Union is requiring industry to prove the safety of chemicals and consumer products before they reach the market, according to a story in the Montreal Gazette. Currently Health Canada is testing 5,000 Canadians for chemical contamination and preliminary results should be available in November. Early results from Europe and the U.S. indicate we are all contaminated with some chemical toxins.
Marsden W. We’re on Chemical Overload. The Montreal Gazette, June 20, 2008, http://www.canada.com/montrealgazette
Antibiotic-Resistant Bacteria Found in Pork
Scientists are beginning to detect bacteria that are resistant to antibiotics in pigs and pork products. University of Iowa public-health doctors found the antibiotic-resistant strain in 147 of 299 pigs tested. These bugs have not yet sickened people in North America, though they’ve been found in 10% of ground pork collected in some Canadian provinces, and caused problems in Scotland and the Netherlands.
Burton TM. Bacteria in Pork Showing Resistance to Antibiotics. The Wall Street Journal, June 16, 2008. Reprinted at:
www.organicconsumers.org/articles/article_13009.cfm
Immune System May Spark Depression
During sickness or infection, the body’s immune system releases proteins called cytokines that trigger inflammation to fight the disease, and in some cases, may cause depression in those who are susceptible. Previous studies have linked cytokines to depression and fatigue. Researchers are attempting to treat depression by blocking the action of cytokines. Depression caused by inflammation is most prevalent in patients with autoimmune diseases, cancer, and infectious diseases.
Maxmen A. Sick and Down. Science News, July 19, 2008, Pg. 26-29.
Tier 4 Drugs and the Cost Conundrum
Many of the newer biological drugs come with high price tags, for example, $50,000 to $100,000 per year--and insurers are putting them into their tier 4 category, requiring patients to pay up to 20% to 33% of the overall cost of these medications, which can easily exceed what their budgets can bear. A health system president and an NIH bioethicist express concern that the tier 4 system as a cost-containment tactic is growing and they make suggestions for getting smarter about which interventions are covered and who gets them based on what really works.
Lee TH, Emanuel EJ. Tier 4 Drugs and the Fraying of the Social Impact. New England Journal of Medicine, July 24, 2008, 359(4):333-335.
Companies Filling Patient Advocate Needs
More companies are offering advocacy services to consumers—either directly or through employers. The services aim to help users “find the right doctor, haggle over insurance coverage and manage other medical system headaches,” according to The Washington Post. Companies like Health Advocate charge $365/year, some charge more and offer telephone or Web-based support. Flagship Global Health, Care Counsel, and Enhanced Care Solutions offer similar services. One non-profit option is the Patient Advocate Foundation, a free service that helps people with chronic, debilitating and life-threatening conditions.
Stobbe M. Patients Turn to Advocates to Navigate Health-Care System. The Washington Post. July 29, 2008. Pg. F6.
Relaxation Techniques Alter Gene Activity
Harvard’s Herbert Benson, a long-time advocate of meditation to reduce stress, has shown that gene expression changes with meditation, yoga and other relaxation techniques that reduce cellular damage from chronic stress. Gene expression changed with stress reduction activity, not only in long-term practitioners, but also in people new to relaxation techniques. They compared gene expression in 19 long-term relaxation practitioners, 19 healthy controls, and 20 newcomers who took up 8 weeks of relaxation-response training.
Dusek JA, Otu HH, Wohlhueter AL, Bhasin M, Zerbini LF, et al. (2008) Genomic Counter-Stress Changes Induced by the Relaxation Response. PLoS ONE 3(7): e2576.
Meditation Can Change the Brain
Herbert Benson and others were interviewed for a recent program on British television (Alternative Therapies, BBC Two, Monday, March 17, at 9pm), exploring the evidence that meditation can make people healthier and happier, altering brain structure. In research by Dr. Sarah Lazar, MRI scans of brains of long-term meditators showed differences in areas of the brain’s cortex, in areas that process emotion. Research also indicated greater activity in brain circuits involved in paying attention. The idea that meditation could improve the wellbeing of patients, even those struggling with mental illness, is exciting for researchers and patients.
http://news.bbc.co.uk/1/hi/health/7319043.stm
Even Cooked Vegetables Carry Risks For Travelers
Most travelers know to avoid the water, unpeeled fruit and raw vegetables, but a new study indicates that even cooked vegetables eaten abroad can carry more risk of contamination. A comparison of cooked vegetables at restaurants in Guadalajara, Mexico, versus Houston, Texas found higher levels of dangerous bacteria in the Mexican restaurants than in the Texas establishments.
Zuger A. Is Any Vegetable a Safe Vegetable? Journal Watch General Medicine, July 24, 2008.
Book Reviews the Dangers of Milk Containing Growth Hormones
A 2006 book calls itself an exposé of the dangers of milk containing rBGH (recombinant Bovine Growth Hormone), used to boost milk production “and Monsanto’s longstanding attempt to suppress this information.” The book presents a comprehensive summary of the scientific literature since 1985. This is another topic related to the future of food and its effects on health.
Got (Genetically Engineered) Milk? By Samuel Epstein. Trafford Publishing, 2006.
EPA Bans Carbofuran Residue on Food
The Environmental Protection Agency (EPA) stated that the chemical residue of the toxic pesticide carbofuran poses an unacceptable risk to small children. The agency’s ban applies to domestic and imported food. Carbofuran, one of the most widely used pesticides in the world, is a neurotoxin that threatens animals as well as humans. In the past it caused the deaths of millions of birds. Some of the crops it is used on include rice, bananas, grapes, coffee, potatoes, soybeans, corn, and sugar cane.
Eilperin J. In Surprise Move, EPA Bans Carbofuran Residue on Food. The Washington Post, July 25, 2008. A2.
http://www.epa.gov/OGWDW/contaminants/dw_contamfs/carbofur.html
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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
To unsubscribe: send an email to: admin@pdsa.org and place ‘remove’ in the subject line. To change your e-mail address, send an e-mail with your old and new address to: admin@pdsa.org
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance and Medical Care
---------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Approves New Treatment for Chronic ITP in Adults
The FDA has approved the use of Nplate (Romiplostim), from Amgen, for splenectomized and nonsplenectomized adults with ITP. The approval was based on safety and efficacy data from two phase 3 studies published in February. Patients taking Nplate had more durable platelet responses and higher platelet counts than control patients. Safety concerns include fibrous deposits in the bone marrow in some patients and a possible drop in platelet counts below their original level after discontinuing therapy. The FDA is requiring that all patients enroll in a special program to track the long-term safety of Nplate therapy. Amgen is launching the Nplate NEXUS program to provide access to chronic ITP patients, including the uninsured, underinsured, or those unable to afford the co-pay. Nplate is the first approved mimic of thrombopoietin, a natural protein in the body that increases platelet production.
www.fda.gov/bbs/topics/NEWS/2008/NEW01876.html
For more information about Nplate see www.nplate.com
Research Sheds New Light on Why People Get ITP
In his review of three papers published in a recent issue of the journal Blood, Dr. John W. Semple, Toronto (a member of the PDSA Medical Advisory Board), explains that defective T regulatory cells (Tregs) “are at the heart of the autoimmune dysregulation in ITP”…and suggests that therapies targeted at Tregs may alleviate the disease. The three studies shed light on how Tregs may initiate and/or mediate the autoimmunity of ITP. One of the studies suggests that rituximab is effective for patients with ITP because it normalizes abnormal autoreactive T-cell responses.
Semple JW. ITP three R’s: regulation, routing, rituximab. Blood, August 15, 2008, 112(4):927-28.
CSL Behring to Acquire Talecris, Provider of IVIg
Pharmaceutical company CSL Behring has signed an agreement to acquire Talecris, a major supplier of plasma-derived protein therapies for medical conditions, including a brand of IVIg often used to treat ITP.. The companies have filed for regulatory approval of the purchase.
ITP Reduces Quality of Life
Patients with ITP scored worse on seven of eight sectors of a health-related quality of life survey, compared with controls, according to researchers at Johns Hopkins School of Medicine. Lower platelet counts were associated with worse scores. Splenectomized patients scored lower than nonsplenectomized patients on five scales: bother, psychological, fear, social activity, and work. Patients from PDSA were recruited to complete the survey until 1,000 surveys were completed. The answers from ITP patients were age and gender matched with a control group.
Full article available at:
www.ingentaconnect.com
Chemical Plays Role in Autoimmune Disorders
Interleukin-17 (IL-17), a chemical messenger in the body, appears to play a role in autoimmune disorders such as rheumatoid arthritis and lupus, according to researchers at University of Alabama. According to the lead author, Hui-Chen Hsu, Ph.D., IL-17 appears to shape the ability of B cells to create more disease-causing antibodies. He said understanding IL-17’s ability to regulate unwanted B cells will help in preventing and treating autoimmune disease.
http://www.aarda.org/research_display.php?ID=54
http://www.arthritis.org/protein-role-autoimmune.php
Vitamin K Affects Bone Health
Higher vitamin K levels improve bone health in healthy children. In children with juvenile idiopathic arthritis (JIA), vitamin K may be one of multiple risk factors for low bone mass, according to the Dutch authors of the study. Children with arthritis with low vitamin K levels had lower bone mass. “The question remains whether JIA patients would benefit from increased dietary vitamin K intake.”
van Summeren MJ, Vermeer C, Engelbert RH, et al. Extremes in vitamin K status are related to bone ultrasound properties in children with juvenile idiopathic arthritis. Clinical Experimental Rheumatology. May-June 2008;26(3):484-91.
Natural Therapy Can Help Mild Depression
People with mild to moderate depression should try natural therapies rather than antidepressant medications, according to James S. Gordon, MD, director of the Center for Mind-Body Medicine in Washington, D.C., and author of a new book on the subject, “Unstuck: Your Guide to the Seven-Stage Journey Out of Depression.” Dr. Gordon argues that depression is not a disease, but rather a state that occurs when “our lives aren’t working.” He recommends regular aerobic exercise, breathing exercises, fish oil supplements, and some form of psychotherapy, as well as finding things you enjoy and can do daily. For patients with severe depression, he recommends seeing a mental health professional.
Defeating Depression Naturally. Self Healing, June 2008, pg. 5.
Reduce Your Exposure to Cell Phone Radiation
While people continue to debate the health hazards of cell phones--do they cause brain cancer or not?—you can take steps to limit your exposure to cell phone radiation, according to a CNN report. Devra Davis, Director of the University of Pittsburgh’s Center for Environmental Oncology recommends the following: use the speakerphone, use a wired headset with a “ferrite bead” that absorbs the radiation so you don’t, and use a Bluetooth earpiece (which emits 100 times less radiation than the actual cell phone). But don’t wear the Bluetooth earpiece all the time; it still emits radiation. Other advice: don’t keep the phone in your pocket or clipped to a belt, it might not be good for your bone marrow; use a hollow tube earpiece; and finally, get a phone with less radiation.
To find the radiation level of several cell phones, visit:
http://reviews.cnet.com/cell-phone-radiation-levels/?tag=mncol;tx
http://www.cnn.com/2008/HEALTH/07/31/ep.cell.phones.cancer/index.html
Multi-Tasking May Overtax Brain
Multi-tasking can lead to reduced efficiency of the brain, reducing productivity, according to several studies recently discussed in Scientific American. The take-home message from mercola.com is: simplify and reduce daily options; don’t belabor largely irrelevant choices. “Save your brain power for the decisions that really matter.”
http://www.sciam.com/article.cfm?id=tough-choices-how-making
Are Air Freshener’s Dangerous?
Most air fresheners emit chemicals classified as toxic or hazardous by U.S. federal law, yet they’re not listed on the product label, according to a University of Washington study, which examined liquid spray air fresheners, plug-in air fresheners, fabric softeners, laundry detergents, dryer sheets, and solid disc deodorizers. Among substances found were acetone (found in nail polish remover) and three chemicals the EPA considers hazardous air pollutants—acetaldehyde, 1,4-dioxane, and methyl chloride. A report of the study on the online Douglass Report suggests readers stop using store-bought air fresheners. Instead, “cut open a lemon or orange, gather some mint leaves, or just open a box of baking soda.”
Average Emergency Room Wait Time Nears 1 Hour
Patients are waiting longer than ever in hospital emergency rooms, according to a new report from the Centers for Disease Control. The wait has risen from 38 minutes a decade ago to close to an hour today. More patients are visiting emergency rooms, yet there are fewer emergency rooms to visit. About 40% of ER patients had private insurance, 25% were covered by state programs for children, 17% were covered by Medicare, and 17% were uninsured. Results were from a national survey of 362 hospital emergency departments.
To see the CDC report visit
http://www.cdc.gov/nchs/data/nhsr/nhsr007.pdf
Payment Before Treatment
More hospitals are asking for payment up front before treatment, states an article in AARP Bulletin. Of the nation’s 3000 nonprofit community hospitals, one in seven require patients to pay or make arrangements for payment prior to being admitted, according to a 2006 IRS survey. Hospitals are required by law to treat medical emergencies before asking for payment. To avoid pre-admission sticker shock, know what your plan covers. And apply for “charity care” if you need it; Federal law requires hospitals receiving federal funds—and most do—to devote a percentage of services to charity cases. The article also suggests ways to negotiate a lower bill.
Kirchheimer S. Cash Before Care. AARP Bulletin, July-August 2008. PG. 21-22.
http://bulletin.aarp.org/yourhealth/caregiving/articles/cash_before_care_0.html
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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
To unsubscribe: send an email to: admin@pdsa.org and place ‘remove’ in the subject line. To change your e-mail address, send an e-mail with your old and new address to: admin@pdsa.org
Contents:
ITP Research and Treatments
General Health, Medicine, Hospitals and Medical Care
Nutrition and Lifestyle
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Public Education Campaign to Include Bleeding Disorders
The American Society of Hematology has developed a Web site, Blood: The Vital Connection, to help consumers understand the important role of blood in overall health. It also contains information on disorders of the blood, including bleeding and clotting disorders, anemia, and cancer, as well as how specific populations of people, such as women, are affected by these conditions.
www.bloodthevitalconnection.org
New Thrombopoietin Treatment Well Tolerated in Healthy Volunteers
Dutch researchers completed a phase 1 clinical trial of a new thrombopoietin mimetic peptide being developed to treat thrombocytopenia. Given in one intravenous dose to healthy human subjects, the drug, RWJ-800088, was well tolerated. Liem-Moolenaar M, Cerneus D, Molloy CJ, End D, et al. Pharmacodynamics and pharmacokinetics of the novel thrombopoietin mimetic RWJ-800088 in humans.
Chemical Pharmacology & Therapeutics 2008, 84(4): 481-487.
FDA Announcements and Warnings
FDA Delays Final Decision on Approval of Promacta for Patients with ITP
Although the FDA set an action date of September 19 for a decision on GlaxoSmithKline's drug PROMACTA (eltrombopag) as a treatment for ITP, the agency has not yet made a decision. In late May, the FDA’s Oncology Drugs Advisory Committee voted 16-0 for approval, but the agency does not always take committee advice. The FDA had no comment. GSK continues to work with FDA toward Promacta approval.http://www.gsk.com/media/pressreleases/2008/2008_pressrelease_10110.htm
FDA Issues Warning on Rituxan
One patient taking Rituxan (rituximab) for arthritis has died from a rare brain infection, called progressive multifocal leukoencephalopathy, or PML. The Food and Drug Administration alerted doctors administering Rituxan to their patients to watch for neurological problems. The drug’s maker, Genentech, has updated the labeling. Earlier in the year, two patients died after taking Rituxan for lupus. Some patients with ITP take Rituxan.http://www.fda.gov/medwAtch/safety/2008/rituxan_DHCP_Final%209411700.pdf
FDA Orders Black Box Warnings on Four Arthritis Drugs
The drugs, Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab) and Cimzia (certolizumab), suppress the immune system to keep it from attacking the body. They are commonly used to treat arthritis, as well as other autoimmune diseases, including ITP. The drugs lower the body’s defenses to certain infections, including a type of fungal infection called histoplasmosis, which mimics the flu and can be deadly. The FDA ordered a “black box” or strongest, warning to be placed in the drug’s prescribing information. Patients should call their doctors if they develop persistent fever, cough, shortness of breath, or fatigue, which are all signs of fungal infection.http://www.usatoday.com/news/health/2008-09-04-fda-arthritis_N.htm?csp=34
NIH Director Zerhouni Stepping Down This Month
NIH Director Elias Zerhouni will leave NIH at the end of October to pursue new opportunities. He has held the position since May 2002. In his statement to the nonprofit community, he wrote, ”You have every right to share credit for the agency’s achievements as you form a unique and essential component of our success.”
http://www.nih.gov/news/health/sep2008/od-24.htm
FDA Publishes List of Drugs with Potential Safety Issues
Four times a year, the FDA will publish a list of drugs it is evaluating for potential safety issues. A 2007 law requires the FDA to make these quarterly reports to the public. A drug’s appearance on the list only means the FDA is evaluating it, not that the FDA has concluded that risks exist. Find the current list, which is for Jan-March 2008, at: http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm#list
Treating Patients' Anxiety Can Improve Chronic Disease
Noting that persistent anxiety can erode mental and physical health, Harvard Women’s Health Watch reviewed the research and treatment options. Anxiety has been linked with irritable bowel syndrome (IBS), chronic respiratory disease, and heart disease. Medications alone are less effective than psychotherapy, but may be helpful when used in combination. Bottom line: consult a doctor if you feel anxiety. Close to 1 in 3 people with anxiety go through life untreated.
Anxiety and Physical Illness. Harvard Women’s Health Watch, July 2008, Pg 6-7.
Protect Yourself from Genetic Discrimination
An interactive, online guide to the Genetic Information Nondiscrimination Act (GINA) is now available through the Coalition for Genetic Fairness. The guide describes what GINA means and summarizes protections it offers. GINA, fully effective November 2009, is the first federal legislation that provides protections against discrimination based on an individual’s genetic information in health insurance coverage and employment.
www.geneticfairness.org/ginaresource.html
Doctors’ Clothing May Harbor Dangerous Germs
With rising concern over drug-resistant bacteria and hospital infections, health care workers are admonished to wash hands well and often. But their ties, white coats, and long sleeves may be a problem as well. Staff in the British National Health Service are no longer allowed to wear ties or long sleeves, which can accumulate germs as doctors move from patient to patient. European countries that have adopted strong infection-control practices – hand washing, sterilization, and strict clothing rules, see much lower rates of drug-resistant staph infections than the U.S., where controls are lax.
Parker-Pope T. The Doctor’s Hands are Germ-Free. The Scrubs Too?
The New York Times, September 23, 2008.
www.nytimes.com/2008/09/23/health/23well.html
Mediterranean-like Diet Lowers Risk of Chronic Disease
People who strictly adhere to a Mediterranean type diet are at lower risk of death as well as heart disease, cancer, and Parkinson’s and Alzheimer’s diseases, according to a meta-analysis of 12 prospective studies by researchers at the University of Florence, Italy. The diet includes high intake of vegetables, fruits, beans, cereals, and fish, with moderate consumption of red wine with meals.
Sofi F, Cesari F, Abbate R, Gensini GF, Casini A. Adherence to Mediterranean Diet and Health Status: Meta-Analysis. BMJ September 11, 2008;337a1344. www.bmj.com/cgi/content/full/337/sep11_2/a1344
Mobile Phone Radiation Linked to Sleep Disruption
When men and women were exposed to three hours of real or sham radiation, at a radiation level equivalent to that emitted by a mobile phone, participants exposed to real radiation took longer to reach deep sleep, and they stayed in deep sleep for a shorter time. Headaches occurred with extended exposure to radiation as well. Researchers from Wayne State University in the U.S. and the Karolinska Institute, in Sweden, conducted the study involving 35 men and 36 women.
www.naturalnews.com/023790.html
Cinnamon Inhibits Mold in Food
Breadmakers may begin using cinnamon in packaging to keep bread from getting moldy. Spanish researchers developed an anti-mold wax paper containing 6 percent cinnamon oil that greatly inhibits mold growth, prolonging freshness by 10 days. The new wrapper was found to be safe and environmentally friendly. Chang K. Cinnamon Is Key Ingredient in Anti-Mold Wrapper.
The New York Times. September 2, 2008., Pg. F3.
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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
To unsubscribe: send an email to: admin@pdsa.org and place ‘remove’ in the subject line. To change your e-mail address, send an e-mail with your old and new address to: admin@pdsa.org
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance, and Medical Care
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FDA Approves New Drug To Treat ITP
PROMACTA® (eltrombopag), the first oral thrombopoietin (TPO) receptor agonist, has been granted accelerated approval by the United States Food and Drug Administration (FDA) to treat adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP). The drug is expected to be made available by next week.
FDA Approves New Drug To Treat ITP
http://www.gsk.com/media/pressreleases/2008/2008_pressrelease_10127.htm
Anticoagulants Can Inhibit Vitamin K and Harm Kids’ Bones
Children taking anticoagulants, such as warfarin, may have lowered levels of vitamin K, which may harm bone health, according to a study from the Netherlands. The researchers recommend close monitoring of bone status in children on anticoagulant therapy.
Avgeri M, Papadopoulou A, Platokouki H, Douros K, Rammos S, Nicolaidou P, Aronis S. Assessment of Bone Mineral Density and Markers of Bone Turnover in Children Under Long-term Oral Anticoagulant Therapy.
Journal of Pediatric Hematology/Oncology, August 2008, 30(8):592-597.
Oncologists Seeing More Patients but Making Less Profit
Many ITP patients see hematologist-oncologists, and these specialists in blood diseases and cancer are spread thin, according to a survey reported in July by Onmark, a national group purchasing organization for community-based medical practices. Oncologists are carrying larger patient loads, as drug prices rise and profits go down.
Community-based oncologists: seeing more patients, making less profit. Hematology & Oncology News & Issues, Oct. 2008, Vol 7 (10), p14.
Common Autoimmune Disease Remains Underdiagnosed and Undertreated
Sjögren’s syndrome is one of the three most common autoimmune disorders, affecting 3 million Americans, 90% of whom are women. Many of its symptoms mimic those of other conditions, so its diagnosis is often missed. In Sjögren’s syndrome, the body attacks its own secretory glands and tissues. Most common symptoms are dry mouth and dry eyes. Diagnosis is delayed on average six years. Delayed treatment can lead to organ damage, plus people with Sjögren’s face a high risk of developing lymphoma and should be alerted to its early signs. Since 2002, there have been internationally accepted criteria for diagnosing the disorder.
http://www.sjogrens.org/syndrome/diagnosis.html
Brody, J. An Autoimmune Disorder, in Camouflage. The New York Times, October 7, 2008, p D7.
Animal Study Shows BSE (Mad Cow Disease) Can be Transmitted by Blood Transfusion
BSE can be transmitted through blood transfusion according to a study in sheep, which suggests that safeguards put in place to protect the human blood supply were justified (The FDA asked blood centers to exclude potential donors who have spent six or more cumulative months in the U.K. between 1980 and 1996 from donating blood.). Transmission even occurred when blood was collected from animals before they developed signs of disease. BSE is a rare neurodegenerative disorder that cannot be detected before the patient experiences problems, such as unsteadiness or involuntary movements.
Houston F, McCutcheon S, Goldmann W, Chong A, Foster J, Siso S, Gonzalez L, Jeffrey M, Hunter N. Prion diseases are efficiently transmitted by blood transfusion in sheep Blood, Jul 22, 2008, Epub.
B12 May Protect Against Brain Shrinkage and Risk of Dementia in Older People
Older adults with lower blood levels of vitamin B12 were more likely to experience brain shrinkage over a 5-year period than those with higher levels, according to a U.K. study. B12 is available from meat, milk, and eggs. Other studies have linked increased levels of B12 to reduced levels of homocysteine, an amino acid reported to increase risk for dementia.
Vogiatzoglou A, Refsum H, Johnston C, Smith SM, Bradley KM, de Jager C, Budge MM, Smith AD. Vitamin B12 status and rate of brain volume loss in community-dwelling elderly. Neurology. 2008 Sep 9;71(11):826-32.
Vitamin D News:
Leading Pediatrician Group Says Children Should Get Double the Recommended Amount of Vitamin D
The American Academy of Pediatrics says children—from newborns to teens—should get 400 units of vitamin D each day, double the amount in current recommendations. Growing evidence suggests that vitamin D not only keeps bones strong, but may reduce risk for cancer, diabetes, and heart disease. Good sources are milk, fortified cereals and oily fish, such as tuna, mackerel, and sardines. Sun exposures—15 minutes a day without sunscreen—also helps the body make vitamin D. But Academy experts suggest that supplementation may be necessary to reach 400 daily units.http://aappolicy.aappublications.org/cgi/content/full/pediatrics;122/5/1142
How to Get Enough Vitamin D: Supplements, Daily Sun Exposure and Special Sun Lamps
It is difficult to get enough vitamin D through foods and sun alone, especially during the winter months when the sun is too weak to trigger the body’s natural ability to make vitamin D. Other good options include: vitamin D supplements (look for vitamin D3), 10-15 minutes of sun exposure during summer months, or a special medium-pressure sunlamp. The FDA has sanctioned some sunlamps made by Sperti, such as the KDB D/UV lamp, as a vitamin D producer for people who need more vitamin D.Ask Tufts Experts, Tufts University Health & Nutrition Letter. November 2008, pg. 7
Vitamin K News:
Vitamin K, So Important to ITP Patients, Is Found in Variety of Foods
Vitamin K helps blood to clot. Foods high in vitamin K include leafy green vegetables (spinach, escarole, kale, seaweed, endive, collard greens, turnip greens, and Swiss chard). Medium sources of vitamin K are: broccoli, Brussels sprouts, Romaine lettuce, parsley, green cabbage, spring onions, coleslaw, pistachios, and mustard greens.Ask Tufts Experts, Tufts University Health & Nutrition Letter. November 2008, pg. 7
Vitamin K2 Reduces Hardening of the Arteries, Protects Heart
Higher intake of vitamin K2—which is different from the vitamin K found in leafy greens—is associated with a 20 percent reduction in hardening of the arteries, according to a study of dietary habits and cardiovascular health in 564 postmenopausal women. Sources of K2, also called menaquinones, are meats and cheeses.Joline W. Beulens, Michiel L. Bots, Femke Atsma, Marie-Louise Bartelink, Matthias Prokop, et al. High dietary menaquinone intake is associated with reduced coronary calcification. Atherosclerosis. published online 26 August 2008.
Holiday Alert: Overdoing the Cinnamon May Mean Too Much Anti-coagulation
Some people take cinnamon for its insulin-like properties to combat insulin resistance and diabetes. But too much cinnamon might not be a good thing. Cinnamon is a source of coumarin, an anti-coagulant that can cause liver inflammation. Different types of cinnamon contain different amounts. The more expensive, Ceylon cinnamon contains less (.0004% coumarin). The more common Cassia cinnamon, contains .5% coumarin. Overdoing cinnamon consumption may be a special risk during the holiday season.
Television Viewing Increases Food Intake Even After the Set is Turned Off
From a study of 16 college students, those who watched television while eating lunch ate more later in the day, after the TV was off. The U.K authors suggest that this effect may be related to an effect of television watching on the person’s ability to remember the amount eaten in the previous meal.
Higgs S, Woodward M. Television watching during lunch increases afternoon snack intake of young women.
Appetite. online 23 July 2008.
Half of US Doctors Report Giving Placebo Treatments Without Telling Patients
Of a random sample of U.S. physicians, about half said they regularly give patients placebo treatments—usually vitamins or OTC analgesics. The survey, by NIH and Mayo Clinic researchers, included 1200 practicing internists and rheumatologists, and more than half responded. About two thirds believed that using a placebo treatment was ethically acceptable. Physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition. Only 5 percent called it a placebo treatment.
Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA, Miller FG. Prescribing “placebo treatments”: results of a national survey of US internists and rheumatologists. BMJ. October 23, 2008;337:a1938.
FDA Sets Stricter Guidelines for Conflict of Interest on Advisory Committees
Individuals who play a crucial role or have a financial interest greater than $50,000 in companies that may be affected by an FDA advisory committee’s actions will not be allowed to participate on that committee, according to new FDA guidance released in August. FDA Advisory committee members must also disclose financial interests held by spouses or minor children.
www.fda.gov/oc/advisory/newacguidance0808.html
Is Risk-Sharing a Solution for Rising New Drug Costs?
In August, the U.K.’s National Institute for Health and Clinical Excellence (NICE) issued a draft guidance that four novel drugs for advanced renal cancer not be used because the manufacturer had not shown cost-effectiveness. Cost constraints are signaling a change in how health-care innovation is assessed, with decision-makers struggling to balance limited health-care budgets with benefits to patients from new (and often more expensive) drugs. A risk sharing between manufacturer and payer may be the way to go, according to an editorial in Nature Reviews Drug Discovery. For example, the U.K.’s National Health Service only pays for the drug Velcade (bortezomib) when a patient shows a response to treatment.
Tackling the Clinical Value Conundrum. Nature Reviews Drug Discovery. November 2008. www.nature.com/nrd/journal/v7/n11/full/nrd2746.html
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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
To unsubscribe: send an email to: admin@pdsa.org and place ‘remove’ in the subject line. To change your e-mail address, send an e-mail with your old and new address to: admin@pdsa.org
Contents:
ITP Research and Treatments
General Health and Medicine
Hospitals, Insurance, and Medical Care
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ITP Increases Risk for Blood Clots
Although patients with ITP experience a low platelet count and bleeding, they are at risk for blood clots, according to a British review of patient records from 1992 to 2005. In a case review of 840 adults with ITP versus 3,360 adults without the disease, those with ITP had slightly higher risk of clotting. Commenting on the study, David Kuter, of Massachusetts General Hospital listed several possible reasons: In ITP patients, platelets are younger and more active. Although platelets are shattered by antibodies in ITP, the fragments can cause clotting. And ITP treatments may cause platelet count to rise too rapidly. The research has not yet been published; it was presented at December’s meeting of the American Society for Hematology (ASH).
Long-Term Safety Data For Nplate Is Promising
Romiplostim (Nplate) appears safe in the long-term (over 48 weeks) for patients with ITP, according to two studies reported at ASH. Bleeding events decreased over time, with no increase in blood clotting, which occurred in 4% of patients. Nplate received FDA approval in August for patients whose ITP had not responded to other therapies. Long-term safety is important since platelet counts fall after the drug is stopped. Both studies were sponsored by Amgen, the drug’s maker.
Rituximab Boosts Effectiveness of Dexamethasone in ITP
Addition of rituximab (Rituxan) to dexamethasone improved initial response, sustained response, and active rescue of patients previously untreated for ITP. 101 patients were randomly assigned to receive dexamethasone alone or dexamethasone plus rituximab. Both initial response at 30 days and sustained response at 6 months were higher in those who received both drugs. The Italian authors suggest that rituximab plus dexamethasone is worth using before splenectomy.
Close To Half Of ITP Patients On Eltrombopag Reduce Other Medications
Of 69 patients in an open-label study of eltrombopag (Promacta), 33 were able to reduce or stop other medications at least temporarily during the 18-month study, according to University of California, San Francisco researchers. Corticosteroids were the medications most frequently stopped.
Eltrombopag Increased Platelet Counts And Reduced Bleeding In ITP
Patients receiving eltrombopag were eight times more likely than those on placebo to achieve target platelet counts in RAISE, a placebo-controlled, double blind, randomized phase 3 study. 197 patients with chronic ITP received either 6 months of daily oral eltrombopag (Promacta) or placebo. More patients in the eltrombopag group were able to stop or reduce other medications and they required less rescue medication than the placebo group. The benefit occurred in patients with and without their spleens. Promacta received accelerated approval from the FDA in November. The study was funded by GlaxoSmithKline, the drug’s maker.
Vitamin K May Fight Diabetes In Men
In a surprise finding from a study of vitamin K supplements to protect bones, Tufts researchers found that the vitamin also reduces insulin resistance—a precursor to diabetes—in older men. The 3-year, randomized, double-blind study in 355 men and women ages 60 to 80 found that a 500-microgram supplement of vitamin K1 can make a difference. The authors note that people can easily get 500 micrograms from their diet. Good sources are green leafy vegetables (kale, spinach, escarole, endive, collard greens, turnip greens, Swiss chard, Romaine lettuce) and broccoli, Brussels sprouts, spring onions, and pistachios. One cup of cooked kale carries 1,062 micrograms of vitamin K1, which is also important for blood clotting.
Vitamin K May Fight Diabetes. Tufts Health & Nutrition Letter. December 2008, pg. 1-2.
Vitamin C Reduces Bone Loss In Men
Bone health is not just about calcium and vitamin D, according to a Tufts University study. A review of bone mineral density (BMD) in 344 men and 540 women, average age 75, and vitamin C intake in the Framingham Osteoporosis Study indicated that men with high intakes of vitamin C—through diet or supplements—had higher BMD in the hip bones. Protection began at 250 milligrams of vitamin C. For people who don’t eat the recommended 5 to 9 servings of fruit and vegetables, supplementation may be necessary to reach this level.
Vitamin C Joins the Fight for Healthier Bones. Tufts Health & Nutrition Letter. December 2008, pg. 8.
Group Urges USDA To Tighten Not Loosen Rules On Genetically Engineered Crops
The U.S. Department of Agriculture (USDA) is rushing through regulations that weaken oversight of all genetically engineered (GE) crops, according to the Center for Food Safety. “The proposed rule has the same gaping holes as the policy it is replacing, and creates a few new ones, as well.” Biotech companies, which grow crops engineered to produce drugs will be able to assess their own crops to determine whether USDA should regulate them. Companies will be allowed to grow untested GE crops with no oversight. The proposed rule bars state and local regulation of GE crops that is more protective than federal regulations.
http://www.centerforfoodsafety.org/USDA_GERegs_PR10_08_08.cfm
Hidden Dangers For Patients Taking Multiple Medications
Many drug combinations have not been tested for safety. “Elderly people are especially vulnerable because they often have several medical problems for which they see different doctors, each prescribing drugs, often without knowing what else the patient is taking,” according to a 2007 article by Jane Brody in the New York Times. Tell your doctors and pharmacist every medication you take so they can determine dangers. Discovery Health has a website for checking drug interactions:
http://health.discovery.com/webapps/drugchecker.do
In Tough Economic Times Patients Scrimp On Medications
People are trying to save money by not filling their prescriptions. Prescription drug sales are down, according to IMS Health, a research firm that tracks prescriptions. Doctors talk of patients scrimping on Lipitor, the cholesterol-lowering medicine, and on their osteoporosis medication. The average co-pay for drugs on insurers’ preferred lists rose to $25 in 2007 from $15 in 2000, according to the Kaiser Family Foundation.
Saul S. In Sour Economy, Some Scale Back on Medications. The New York Times. October 22, 2008.
Splitting Pills Not Always Safe
Pill splitting can save on prescription costs—a 200 mg dose typically costs the same as a 100 mg dose—but not every pill can be split safely. Correct dosage is essential for medications for epilepsy, certain heart problems, and for hormone medications. Other pills that shouldn’t be split: extended release pills, pills containing more than one medication, pills coated to protect the stomach, pills that crumble easily, pills that are difficult to swallow because of bitter taste, and power or gel capsules. Pills that are scored to make cutting easier indicate FDA approval for splitting. But don’t split by hand or knife; buy a pill splitter, which costs about $10.
House Calls. Health After 50, Johns Hopkins, pg. 8.
Fewer Primary Care Doctors Accepting Medicare Patients
More Medicare patients are having trouble finding a new primary care doctor to care for them. The trend appears to be based on physician fears about potential cuts in reimbursement rates from the Federal government and the slow pace of reimbursement and layers of paperwork required. The Medicare Payment Advisory Commission reported in December that nearly 30 percent of 2.6 million Medicare beneficiaries who sought out a new primary care doctor over the past year had trouble finding one. That number is up from 25 percent in 2005. In Virginia, just 2.5 physicians are accepting Medicare per 100 beneficiaries, according to the American College of Emergency Physicians. The national average is 3.2 per 100.
Jenkins CL. The Doctor is Out. The Washington Post, December 9, 2008, Pg. F1, F4.
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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org
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